Outcomes. Glickman Urological & Kidney Institute

Transcription

1 Outcomes 28 Glickman Urological & Kidney Institute

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3 Surgical Overview To promote quality improvement, Cleveland Clinic has created a series of Outcomes books similar to this one for many of its institutes. Designed for a physician audience, the Outcomes books contain a summary of our surgical and medical trends and approaches, data on patient volume and outcomes, and a review of new technologies and innovations. Although we are unable to report all outcomes for all treatments provided at Cleveland Clinic omission of outcomes for a particular treatment does not mean we necessarily do not offer that treatment our goal is to increase outcomes reporting each year. When outcomes for a specific treatment are unavailable, we often report process measures associated with improved outcomes. When process measures are unavailable, we may report volume measures; a volume/outcome relationship has been demonstrated for many treatments, particularly those involving surgical techniques. In addition to our internal efforts to measure clinical quality, Cleveland Clinic supports transparent public reporting of healthcare quality data and participates in the following public reporting initiatives: Joint Commission Performance Measurement Initiative ( Centers for Medicare and Medicaid (CMS) Hospital Compare ( Leapfrog Group ( Ohio Department of Health Service Reporting ( Our commitment to providing accurate, timely information about patient care will also help patients and referring physicians make informed healthcare decisions. We hope you find these data valuable. To view all our Outcomes books, visit Cleveland Clinic s Quality and Patient Safety website at clevelandclinic.org/ quality/outcomes. Glickman Urological & Kidney Institute 1

4 Dear Colleague, On behalf of Cleveland Clinic, I am pleased to present our 28 Outcomes books. The primary purpose of our annual Outcomes book initiative is to promote quality improvement at Cleveland Clinic, thereby optimizing the care we provide to our patients. Measuring and reporting outcomes reflects our organizational commitment to accountability, transparency and results. Each year, external stakeholders are requiring hospitals to report more and more quality and patient safety data. We view our Outcomes books as voluntary supplements to the required public reporting and an opportunity to share selected innovations with colleagues across the country. Designed for the physician reader, each book in the annual series focuses on care provided by one of our patient-centered clinical institutes. We hope you find the content informative. Sincerely, Delos M. Cosgrove, MD CEO and President 2 Outcomes 28

5 what s inside Chairman s Letter 4 Institute Overview 5 Quality and Outcomes Measures In-Hospital Mortality 1 Length of Stay 11 Urologic Oncology 12 Transplantation 61 Innovations 11 Selected Publications 116 Staff Listing 124 Contact Information 126 Institute Locations 127 Cleveland Clinic Overview 13 Resources for Physicians 131 Prosthetics and Reconstruction 66 Female Urology 69 Endourology and Stone Disease 77 Benign Prostate Hypertrophy 81 Pediatric Urology 82 Male Infertility 84 Minority Men s Health Center 86 Hemodialysis 88 ICU Nephrology 93 Chronic Kidney Disease (CKD) 96 Hypertension 1 Surgical Quality Improvement 12 Patient Experience 16 Glickman Urological & Kidney Institute 3

6 Chairman s Letter It is my pleasure to present this collection of outcomes from the Glickman Urological & Kidney Institute. This compilation of quality and outcomes measurements is important to share with our referring physicians as well as others who are interested in the medical and surgical activities of our Institute. Our programs have been ranked among the top in the nation for almost a decade due to our talented staff, constant focus on improvement and innovation, and outstanding leadership. The loss of our former Institute Chairman, Dr. Andrew Novick, late last year has affected us all deeply, yet inspired us to continue to build upon his legacy of excellence. This past year offered exciting opportunities including the opening of our new facility, the Glickman Tower, which enables us to improve the patient experience through increased capacity and enhanced technology. Our 21-bed state-of-the art dialysis unit with a scenic view is one example. The 6 th Annual Cleveland Clinic Innovation Summit was focused on minimally invasive urologic and gynecologic technology and attracted international healthcare, business and media leaders. Among the top 1 medical innovations named for 29 were single-port and natural orifice surgeries, both being pioneered here by our urologic surgeons. I look forward to leading the Institute into a future of continued excellence and significant contributions to the fields of urology and nephrology. We hope you find this Outcomes summary useful and we look forward to working with you to provide the best in patient care. Sincerely, Eric Klein, MD Chairman Glickman Urological & Kidney Institute 4

7 Institute Overview The Glickman Urological & Kidney Institute s activities encompass a unique combination of high-volume and challenging clinical material, extensive clinical scientific activities, and credible laboratory research within an environment that nurtures the future leaders of our specialties. The Institute s 81 physicians and scientists offer in-depth expertise in every subspecialty area. In 28, the faculty was responsible for serving a significant number of patients, while publishing 378 journal publications, 89 book chapters, seven books and recording over $25 million in research funding. Glickman Urological & Kidney Institute offers a full range of urological and kidney care for adults and children. Many of the institute s physicians have subspecialty training in the following areas: bladder, prostate and testicular cancer; urinary incontinence; chronic urinary tract infections and obstructions; dialysis; hypertension; kidney disease, kidney transplantation; male infertility; pediatric urology and nephrology; prostate disease; and sexual dysfunction/impotence. These subspecializations enable our physicians to gain valuable experience using the latest techniques, which in turn fosters development of innovative procedures such as single-port laparoscopic surgery, robotic prostatectomy, autotransplantation for intractable kidney stone disease, remote blood pressure monitoring, focal therapy and outpatient ureteral reimplantation. In addition, this environment provides us with an opportunity to compile meaningful outcomes data and ultimately translates into better servicing of our patients. Every year since 199, U.S.News & World Report has ranked our urology program as one of the top five in the United States. In each of those years, the report also has named Cleveland Clinic one of America s Best Hospitals. In 28, our urology program was ranked second in the nation by U.S.News & World Report for the ninth year in a row, and our kidney program was ranked fourth in the nation. Glickman Tower- home of the Glickman Urological & Kidney Institute New Patient Visits Total Patient Visits 6,347 5,739 5,228 5,319 6,145 5,582 13,153 12,4 1,58 13,336 11, ,6 Surgeries 14,5 15,5 18, 2, 21,312 2,975 Dialysis Treatments 14,187 13,19 12,772 12,524 13,6 12,188 Admissions 3,178 3,45 3,326 3,48 3,731 3,887 Patient Days 15,536 16,289 15,534 16,247 17,781 19,7 LOS Glickman Urological & Kidney Institute 5

8 Institute Chairman Overview Letter > 1: Number of single-port surgeries performed by our urologic surgeons to date. 75: Percentage of men in whom sexual function is preserved after undergoing focal therapy for prostate cancer. 118,: Number of patient visits to the Glickman Urological & Kidney Institute in 28. Medical Innovations Summit Cleveland Clinic hosted its 6th annual Medical Innovation Summit this year, highlighting minimally invasive urologic and gynecologic technology. The summit, held in November, is an international gathering of healthcare, business and media leaders for the purpose of examining trends in medical innovation. The 28 Medical Innovation Summit featured live broadcasts of laparoscopic partial nephrectomy and a single-port operation performed by Cleveland Clinic urologic surgeons. Discussion topics included focal and image-guided therapy for localized prostate cancer. Other topics for panel discussions and presentations included natural orifice translumenal endoscopic surgery (NOTES), advances in laparoscopic and robotic surgery, IT and digitization in healthcare, emerging markets and reproductive health. Cleveland Clinic clinicians and researchers announced their third annual selection of the Top 1 medical innovations they expect to have a significant impact in 29. Included on the list were laparo-endoscopic single-site surgery (LESS) and NOTES, both being pioneered by urologic surgeons here. 65 Percent of hypertensive patients who undergo treatment here and reach their recommended goal for blood pressure. Centers of Excellence Within the Glickman Urological & Kidney Institute are groupings of physicians with a collective expertise in specific disciplines in urological and kidney disease care. These groupings form centers of excellence that focus on specific diseases and conditions, with physicians collaborating to provide dynamic solutions for their patients. Center for Chronic Kidney Disease Nephrologists in Cleveland Clinic s Glickman Urological & Kidney Institute are experts in treating chronic kidney disease (CKD). Our innovative model of health management focuses on educating and involving patients in their care. We work to slow the progression of CKD, identify risk for cardiovascular disease and evaluate CKD patients to decrease the risk of complications from surgery. 6 Outcomes 28

9 Institute Overview Center for Dialysis Cleveland Clinic has provided dialysis care to patients for nearly 6 years and was one of the first centers in the world to offer dialysis. Numerous scientific breakthroughs in the technology of dialysis and treatment of patients have occurred at Cleveland Clinic. We continue to offer the latest in technical advances combined with a caring, patientcentered approach. Center for Endourology & Stone Disease State-of-the-art center dedicated to advancing genitourinary surgical procedures for the treatment of stone disease. By offering an entire spectrum of care for stone disease, Cleveland Clinic urologists are committed to managing this life-long condition through a unique collaboration that ultimately improves a patient s quality of life. Center for Blood Pressure Disorders The Center for Blood Pressure Disorders at Cleveland Clinic is internationally acclaimed, having been at the forefront of basic and clinical research and advances in hypertension management for more than 7 years. Our research scientists have identified some of the chemicals that lead to hypertension and successfully performed the initial clinical trials with antihypertensive medications, leading to their inclusion and integration in standard hypertension management. The Center for Blood Pressure Disorders successfully runs one of the largest clinical programs for hypertension in the United States and treats difficult to control hypertension in patients referred from all over the United States, Europe and Asia. Our comprehensive hypertension management program is staffed by nephrologists, internists, dedicated physician assistants and experienced clinical nurse practitioners. Center for Female Pelvic Medicine & Reconstructive Surgery One of the largest centers for female pelvic medicine in the country. Provides individualized treatment with the latest procedures for disorders such as urinary incontinence, pelvic organ prolapse and genitourinary reconstruction, and treatment for women with recurrent infections, interstitial cystitis and overactive bladder. Center for Genitourinary Reconstruction Provides exceptional expertise in prosthetic surgery and genitourethral reconstruction. Advanced specialty training and high patient volume has led to extensive experience and excellent outcomes with these often complex procedures, establishing the center as a regional and national referral center. Center for Male Infertility Provides comprehensive care that offers individualized evaluation and treatments for male infertility, including sperm aspiration, microsurgical reconstruction to bypass obstructions in the sperm ducts and surgical repair of varicocele. Center for Pediatric Urology Provides comprehensive care that includes outpatient clinic care and ambulatory procedures, as well as major inhospital operative procedures, including open and minimally invasive reconstruction of the genitourinary tract, endoscopic management of urinary tract stones and congenital anomalies, and surgical treatment of pediatric tumors of the kidneys, bladder and genitalia. Glickman Urological & Kidney Institute 7

10 Institute Overview 4,: Number of partial nephrectomies performed by surgeons in the Glickman Urological & Kidney Institute to date. Center for Renal Transplantation Provides kidney and pancreas transplantation through the highest quality medical care that offers years of experience, research and improved medications that prevent rejection. Kidney transplants completed at Cleveland Clinic are overwhelmingly successful and postoperative complications are few. 1,: Number of laparoscopic partial nephrectomies performed by surgeons in the Glickman Urological & Kidney Institute to date. Center for Robotic & Image Guided Surgery Has one of the world s largest experience in urologic laparoscopic and robotic surgery. By pioneering and perfecting minimally invasive surgical procedures, researching new ideas and providing education, Cleveland Clinic urologists are committed to providing state-of-the-art patient care through a unique partnership with subspecialties within the Glickman Urological & Kidney Institute. 12,2 Number of dialysis treatments performed by physicians in the Glickman Urological & Kidney Institute. Center for Urologic Oncology Cleveland Clinic urologists perform more than 22, procedures a year for urologic cancers. The Center for Urologic Oncology collaborates with physicians from the Taussig Cancer Institute to provide leadingedge treatment for kidney, prostate, bladder and testicular cancers. Our experience, coupled with dedicated research staff makes us one of the largest urologic oncology centers in the nation. 8 Outcomes 28

11 In Memoriam Andrew C. Novick, MD Andrew C. Novick, MD, was an outstanding physician, pioneer and giant in the field of urology. Under his leadership for 23 years, the Glickman Urological & Kidney Institute became the largest and most subspecialized urology and kidney disease program in the world. During his 3-year career at Cleveland Clinic, Dr. Novick pioneered nephron-sparing surgery for the treatment of kidney cancer, and also extracorporeal ( bench ) kidney surgery. He discovered a correlation between chronic kidney disease and atherosclerotic renal artery disease. He also devoted significant effort to the understanding and management of end-stage renal disease through renal transplantation, and to preserving renal function through reconstructive surgery. Dr. Novick held almost every major leadership position in urological and surgical societies, including President of the American Board of Urology. He also received the St. Paul s Medal from the British Association of Urological Surgeons, the Barringer Medal from the American Association of Genitourinary Surgeons, and the American Urological Association s Ramon Guiteras Award. Glickman Urological & Kidney Institute 9

12 Surgical In-Hospital Overview Mortality In-hospital mortality for patients admitted to urology or nephrology services can be compared to peer teaching hospitals using APR-DRG methodology. Demographics and secondary diagnoses are used to calculate expected rates based on risk of mortality. The standardized mortality ratio is calculated as observed/expected, and a value less than one suggests that mortality is lower than expected given our case mix. Expected and Observed In-Hospital Mortality Nephrology Percent 1 8 Expected Observed SMR = SMR = SMR =.44 SMR = Standardized Mortality Ratio Expected and Observed In-Hospital Mortality Urology Percent 5 4 Expected Observed SMR = SMR = SMR =.45 SMR = Standardized Mortality Ratio 1 Outcomes 28

13 Length of Stay Efficiency of care for our patients on urology or nephrology services is assessed in part through hospital average length of stay (LOS). Target LOS is calculated based on APR-DRG categories. Hospital Length of Stay (LOS) Nephrology Days 1 8 Expected Observed Hospital Length of Stay (LOS) Urology Days Expected Observed Glickman Urological & Kidney Institute 11

14 Urologic Oncology Tumors of the Kidney Treatment of renal cell carcinoma is the indication for the majority of renal surgery. In 28, more than 75 patients had surgery for treatment of renal tumors. Surgical treatment by radical or partial nephrectomy remains the only curative treatment for localized renal cell carcinoma. Patients with advanced or metastatic disease are treated with a combination of surgery and systemic medical therapy through a multidisciplinary approach in conjunction with dedicated urologic medical oncologists. Overall mortality rate remains less than one percent. Radical Nephrectomy Laparoscopic radical nephrectomy has rapidly become the standard of care for radical nephrectomy. Patients selected for open radical nephrectomy include those with very large tumors, marked adenopathy, tumor thrombus in the vena cava, or tumor involving adjacent organs. Radical Nephrectomy Volume Laparascopic Radical Nephrectomy Open Radical Nephrectomy Outcomes 28

15 Perioperative Outcomes in Patients with Renal Tumors and IVC Thrombus Treated Surgically With (135) and Without (9) Preoperative Embolization (N = 225) No Embolization With Pre-Op Embolization p value Median Operative Time, mins (IQR) 313 (24-42) 39 (27-48) <.1 No. Vascular Bypass Total (%) 25 (28) 7 (52) <.1 No. Cardiopulmonary Bypass (%) 21 (23) 64 (47) No. Venovenous Bypass (%) 4 (4) 6 (4) Median Estimated Blood Loss, L (IQR) 1.5 (.8-3.7) 2. ( ).2 Median Perioperative Blood Transfusion, Units (range) 4 (-39) 8 (-91).1 No. Patients with Intraoperative Complications (%) 1 (11) 19 (14).5 No. Patients with Postoperative Complications (%) 26 (29) 58 (43).32 No. Patients with Major Postoperative Complications (%) 6 (7%) 26 (19%).8 Median Length of Hospitalization, days (IQR) 7 (6-9) 7 (6-1).6 Median Length of ICU stay, days (IQR).5 (-2) 2 (-4) <.1 Subramanian et al, in press No. Perioperative Death (%) 3 (3) 17 (13).17 No. Intraoperative Death (%) 2 (2) No. Postoperative Death (%) 3 (3) 15 (11) Subramanian et al, in press Glickman Urological & Kidney Institute 13

16 Urologic Oncology Minimally Invasive Nephron-Sparing Surgery Perioperative Outcomes Partial Nephrectomy Cryoablation Radiofrequency Ablation OR Time (min) EBL (cc) Hospital Stay (days) <1 Intraop Complications 6.6% 3% - Postop Complications 14.8% 2% 3% Open Conversion 1.2% Transfusion Rate 3% 2% 14 Outcomes 28

17 Laparoscopic Radical Nephrectomy Procedures Open (N = 53) Laparoscopic (N = 63) 1 Blood Loss (cc) Length of Stay (Days) Laparoscopic Radical Nephrectomy, Seven-year Survival Survival at Seven Years 1 8 Open Laparascopic T1 Disease Specific Survival T2 Disease Specific Survival T1 Overall Survival T2 Overall Survival N = Glickman Urological & Kidney Institute 15

18 Urologic Oncology Cancer-specific Survival Open Radical Nephrectomy vs. Laparoscopic Radical Nephrectomy Percent Log Rank P =.75 Open Surgery (N = 52) Laparascopic (N = 63) Months Since Surgery Outcomes 28

19 Laparoscopic Radical Nephrectomy Survival Percent year 1-year 2 Overall Survival Cancer-specific Survival Recurrence-free Survival Seven-year Oncologic Outcomes of Laparoscopic Radical Nephrectomy for Cancer Stratified by Clinical Stage. Renal functional outcomes are presented at a median follow-up of 65 months (19 92 months) for LRN and 76 months (8-15) for ORN. LRN ORN p-value N Tumor size (cm) Seven-year overall survival 72% 84% ns Seven-year cancer-specific survival 91% 93% ns Seven-year recurrence-free survival 91% 93% ns LRN=laparoscopic radical nephrectomy, ORN=open radical nephrectomy Reference: Colombo JR Jr, Haber GP, Jelovsek JE, Lane B, Novick AC, Gill IS. Seven Years After Laparoscopic Radical Nephrectomy: Oncologic and Renal Functional Outcomes. Urology. 28 Glickman Urological & Kidney Institute 17

20 Urologic Oncology Partial Nephrectomy The Glickman Urological & Kidney Institute pioneered and developed both open and laparoscopic techniques for partial nephrectomy for renal tumors. Partial nephrectomy offers patients the advantage of preserving more renal tissue and kidney function. With more than 4, partial nephrectomy procedures performed, our experience is the largest of any center in the world for these delicate surgeries. Volume Open Partial Nephrectomy Laparoscopic Partial Nephrectomy Total Number of Operations for Suspected Cancer by Year Number of Operations 8 OPN ORN 6 Ablation LPN 4 LRN Outcomes 28

21 Perioperative Data (N = 57) Hospital Stay (Days) 3.4 Blood Transfusion 7.1% Conversion to Open.8% Source: Burak T, et al. Risk Factor Analysis of Postoperative Complications in Laparoscopic Partial Nephrectomy. J Urol 28. Rates of Overall Postoperative, Urological and Nonurological Complications after Laparoscopic Partial Nephrectomy (N = 57) Number of Tumors Sep 1999 LPN Complex Percent Complications Overall Urological Non-urological 2 1 Sep Source: Burak T, et al. Risk Factor Analysis of Postoperative Complications in Laparoscopic Partial Nephrectomy. J Urol 28. Glickman Urological & Kidney Institute 19

22 Urologic Oncology Trends comparing proportion of extirpative surgery for suspected renal cell cancer according to treatment modality during 1 years. Laparoscopic Radical Nephrectomy (LRN) vs Open Radical Nephrectomy (ORN) Percent LRN ORN Minimally Invasive Surgery (MIS), including Ablation and Laparoscopy, vs Open Surgery Percent MIS Open Laparoscopic Partial Nephrectomy (LPN) vs Open Partial Nephrectomy (OPN) Percent LPN OPN Outcomes 28

23 Open Partial Nephrectomy Cancer-Specific Survival After Nephron Sparing Surgery According to Tumor Size in (N =485) Percent Group 1 Group 2 Group 3 Group 4 < 2.5 cm N = 142 < cm N = 168 < cm N = 125 > 7 cm N = Months Since Surgery Nephron sparing surgery for localized renal cell carcinoma: impact of tumor size on patient survival, tumor recurrence and TNM staging. Hafez KS, Fergany AF, Novick AC. J Urol Dec; 162(6): Long-term Survival Open Partial Nephrectomy (N = 17) Percent Cancer-specific Overall Months Since Surgery The Glickman Urological & Kidney Institute reported the longest actual follow-up for patients with open partial nephrectomy. Source: Fergany. J Urol. 2; 163(2):442. Glickman Urological & Kidney Institute 21

24 Urologic Oncology Tumor Recurrence after Open Partial Nephrectomy (N = 4) Percent Local Distant Both Total 4 patients with solitary kidney Mean follow-up: 48 months 78% of patients undergoing partial nephrectomy remain disease-free without recurrence; only 3.5% of patients have recurrent tumor in the kidney remnant. Source: Fergany, et al. Open Partial Nephrectomy. Solitary Kidney. Postoperative Surgical Complications after Open Partial Nephrectomy (No Complication Required Reoperation) (N = 4) Percent Leakage of Urine Hemorrhage Thromboembolic Complications Ileus Ureteric Injury Total Extensive surgical experience results in a low incidence of surgical complications for open partial nephrectomy. Source: Fergany, et al. Open Partial Nephrectomy. Solitary Kidney. 22 Outcomes 28

25 Five - and Ten - Year Disease Specific Survival Rates after Open Partial Surgery According to Tumor Stage (N = 4) Percent years 1 years N = T1a 134 T1a 85 T2 28 T3a 56 T3b 54 Disease-specific survival of tumors localized to the kidney (T1-T2) is typically above 9 percent after open partial nephrectomy. Source: Fergany, et al. Open Partial Nephrectomy. Solitary Kidney. Glickman Urological & Kidney Institute 23

26 Urologic Oncology Nomogram for Predicting Malignancy in Solid Renal Tumors 7 cm or less (N = 862) Points Age N Local Symptoms at Diagnosis History of Smoking Y Y N CT size (cm) Gender F M Total Points Probability of Aggressive Given Cancer Instructions for Physician: Locate patient age on Age axis. Draw line straight upward to Points axis to determine how many points toward aggressive cancer the patient receives for his or her age. Repeat this process for other axes, each time drawing straight upward to Points axis. Sum points achieved for each predictor and locate this sum on Total Points axis. Draw straight line down to find patient probability as P (A C). To determine patient probability of finding potentially aggressive cancer, multiply P (A C) by P(C), where P(C) is found previously. Reference this probability P(A). To determine that patient probability of finding indolent cancer after partial nephrectomy calculate P(C) - P(A). Instruction to Patient: Mr. or Ms. X, if we had 1 men or women exactly like you, we would expect to find benign kidney cancer in 1-P(C), indolent kidney cancer in P(C) - P(A) and potentially aggressive kidney cancer in P(A) after partial nephrectomy. 24 Outcomes 28

27 Postoperative Change in Kidney Function after Open Partial Nephrectomy for Solitary Kidney (N = 4) 21% No Change 41% Minor Increase* 38% Significant Increase *Less than 5% of preoperative creatinine Source: Fergany, et al. Open Partial Nephrectomy. Solitary Kidney. Long-term Preservation of Renal Function after Open Partial Nephrectomy (N = 4) Percent Short-Term (12 Months after Surgery) Long-Term* Mean time to renal failure: four years *Long-term kidney function can be expected to be maintained in more than 95% of patients with solitary kidney after open partial nephrectomy. Source: Fergany, et al. Open Partial Nephrectomy. Solitary Kidney. Glickman Urological & Kidney Institute 25

28 Urologic Oncology Laparoscopic Partial Nephrectomy The laparoscopic surgeons at the Glickman Urological & Kidney Institute developed and refined the technique of laparoscopic partial nephrectomy, utilizing the experience gained from the open procedure. Initially confined to small peripheral tumors, we have expanded the procedure to include more complicated situations of hilar, intrarenal, multiple, and large tumors. Our experience in this field continues to be the most extensive in the world, with more than 1, cases performed to date. At five years, local recurrence rate is 2.5 percent, overall and cancer specific survival is 86 percent and 1 percent, respectively. Lane BR, Gill IS. 5-Year outcomes of laparoscopic partial nephrectomy. J Urol. 27 Jan; 177(1):7-4. Perioperative Data Perioperative Data Mean Hospital Stay (Days) 3.4 Blood Transfusion 7.1% Conversion to Open.8% Source: Turna B, et al. Risk Factor Analysis of Postoperative Complications in Laparoscopic Partial Nephrectomy. J Urol 28. N= 57, Laparoscopic Partial Nephrectomy (Results in Solitary Kidney) Tumor Size (mean): Blood Loss (median): Warm Ischemia Time (median): Operative Time (median): Hospital Stay (median): 3.5 cm 2 cc 29 min 3.3 hrs 2.8 days 26 Outcomes 28

29 Clinical, Surgical and Pathological Data Regarding Patients Undergoing Open Partial Nephrectomy (OPN) or Laparoscopic Partial Nephrectomy (LPN) in a Solitary Kidney (N = 169 OPN, 3 LPN) OPN LPN p Value Median clinical tumor cm (IQR) 3.8 ( ) 2.8 ( ).1 No. clinical stage T1b (4 7 cm) (%) 74 (44) 6 (2) No. central tumor (abuts collecting system) (%) 14 (62) 14 (47).18 Median total operative mins 264 (23 35) 25 ( ).3 Median warm ischemia mins 21 (17 27) 29 (19 35).3 Median ml EBL 3 (2 45) 2 (1 3).84 Median days hospital stay 5 (5 7) 3 (2 5).4 Median pathological tumor cm 3.2 ( ) 2.7 (2. 3.5).9 Source: Lane BR, Novick AC, Babineau D, Fergany AF, Kaouk JH, Gill IS. Comparison of laparoscopic and open partial nephrectomy for tumor in a solitary kidney. J Urol. 28 Mar Overall Postoperative, Urological and Nonurological Complications Volume Total Number of LPN Urological Complications Non-Urological Complications Source: Turna B, et al. Risk Factor Analysis of Postoperative Complications in Laparoscopic Partial Nephrectomy. J Urol 28. Glickman Urological & Kidney Institute 27

30 Urologic Oncology Indication for Laparoscopic Partial Nephrectomy (N = 57) N = 57 18% Relative 6% Elective 22% Absolute Single Port (LESS) Laparoscopic Donor Nephrectomy (N = 18) June 27 November 28 Days 1 8 Mean LDN Mean LESS LDN Oral Pills Return to Work 1% Recovery LDN = laparoscopic donor nephrectomy LESS = laparo-endoscopic single-site surgery 28 Outcomes 28

31 Global Satisfaction (N = 18) Scale: Mean LESS LDN 8.6 Mean LDN Scar Satisfaction (N = 18) Scale: Mean LESS LDN 7.4 Mean LDN Glickman Urological & Kidney Institute 29

32 Urologic Oncology Renal Tumor Ablation At the forefront of developing ablative techniques for treatment of renal tumors, our laparoscopic surgeons perform renal cryoablation laparoscopically or under CT guidance. We recently reported the longest and most careful follow-up of our experience with this procedure. Radiofrequency ablation of renal tumors is performed percutaneously under sedation and CT guidance. Both renal cryoablation (CRYO) and radiofrequency ablation (RFA) established a secure place in the treatment of kidney tumors in select patients with multiple medical or surgical risk factors. Five-Year Outcome of Laparoscopic Renal Cryoablation (N = 32) Percent Five-Year Cancer Specific Survival Five-Year Overall Survival Local Tumor Recurrence within Five Years Development of Metastasis within Five Years Hegarty NJ, Gill IS, Kaouk JH, Spaliviero M, Desai MM, Novick AC, Remer EM. Renal cryoablation: 5 year outcomes. J Urol 26 (abstract-191) 3 Outcomes 28

33 Glickman Urological & Kidney Institute 31

34 Urologic Oncology Laparoscopic and Percutaneous Renal Cryoablation Operative Data Laparoscopic N=244 Percutaneous N=63 p-value General Anesthesia 1.% 19.% <.1 OR Time (min) 175.5± ± Transfusion 5 (2.%) 1 (1.6%).84 Intraoperative Complications 2 (.8%) 1 (1.6%).6 Hospital Stay (hrs) 59.1± ±23.3 <.1 Postoperative Complications 14 (5.8%) 5 (7.6%).28 Laparoscopic and Percutaneous Renal Cryoablation Functional Outcomes Creatinine (mg/dl) Preoperative Postoperative Laparoscopic 1.4±.7 1.5±.9 Percutaneous 1.3±.4 1.4±.6 p-value Survival Data Overall survival 2 years 5 years 1 years Laparoscopic 95.8% 9.1% 76.3% Percutaneous 95.7% - - Cancer specific survival Laparoscopic 98.% 96.5% 95.3% Percutaneous 97.2% - - Recurrence free survival Laparoscopic 94.4% 91.6% 91.6% Percutaneous 96.5% Outcomes 28

35 Nephroureterectomy Laparoscopic surgery has taken a dominant role in nephroureterectomy for renal and ureteric transitional cell carcinoma. Minimally invasive techniques developed at the Glickman Urological & Kidney Institute are used to manage the distal ureter in addition to standard open techniques for distal ureterectomy and bladder cuff excision. Nephroureterectomy Procedures Volume Laparascopic Nephroureterectomy Open Nephroureterectomy Glickman Urological & Kidney Institute 33

36 Urologic Oncology Oncological Outcomes of Laparoscopic Radical Nephroureterectomy according to Pathological Stage, Grade and Location of Upper Tract TCC (N = 1) Survival Overall Two year Survival Recurrence Free Overall Five year Survival Cancerspecific Cancerspecific Recurrence Free By Stage pta-tis-t1 91% 98% 73% 71% 85% 55% pt2 76% 9% 38% 57% 81% 31% pt3 58% 68% 66% 35% 61% 55% pt4 25% 1% 25% % % % By Grade High 76% 88% 6% 5% 71% 5% Low 88% 95% 78% 71% 85% 53% By Location Pelvicalyceal 81% 89% 61% 57% 72% 53% Pelvicalyceal-ureter 75% 1% 74% 54% 88% 32% Ureter 86% 9% 72% 69% 84% 53% Overall 81% 91% 66% 59% 77% 5% Source: Laparoscopic Nephrectomy Department Database Recurrence after Laparoscopic Nephroureterectomy for Upper Tract Urothelial Tumor (N = 1) Survival Non-Urothelial Recurrence Urothelial Recurrence Overall Recurrence Months Since Surgery 34 Outcomes 28

37 Kaplan-Meier Curves for Overall and Cancer-Specific Survival Since Surgery (N = 1) Survival Cancer-Specific Survival Overall Survival Months Since Surgery Kaplan-Meier Curves for Overall, Urothelial and Non-Urothelial Recurrence Free Rate Since Surgery (N = 1) Survival Cancer-Specific Non-Urothelial Overall Urothelial Overall Months Since Surgery Log-rank test; p =.6 Glickman Urological & Kidney Institute 35

38 Urologic Oncology Kaplan-Meier Curves for Cancer-Specific Survival Tumor Stage ( pt2 Versus >pt2) Survival pt2 (N = 72) > pt2 (N = 28) Months Since Surgery Kaplan-Meier Curves for Recurrence-Free Survival for Concomitant Bladder Tumor at the Diagnosis Survival 1..8 Without Bladder (N = 8) With Bladder (N = 2) Months Since Surgery 36 Outcomes 28

39 Prostate Cancer Prostate cancer is the most common male malignancy. Patients with prostate cancer represent a significant percentage of the Glickman Urological & Kidney Institute practice volume. Every effective treatment modality for prostate cancer is performed at the Institute, including open and laparoscopic prostatectomy, radiation and cryotherapy. Systemic treatment with hormones or chemotherapy is also performed in a combined multidisciplinary approach that includes our urologists as well as our medical oncologists. Prostate Cancer Patients Volume 1,2 1, Radical Prostatectomy Brachytherapy External Beam Therapy Glickman Urological & Kidney Institute 37

40 Urologic Oncology Nomogram for Predicting 1-year Biochemical Free Survival Based on Preoperative Clinical Information Points Prostate Specific Antigen T2a T2c Clinical Stage T1c T2b T3 Surgeon Experience Biopsy Gleason Sum Total Points Yr Biochemical Recurrence Free Probability Instructions for Physician: Locate the patient s PSA on the Prostate Specific Antigen axis. Draw a line straight upwards to the Points axis to determine how many points towards recurrence the patient receives for his PSA. Repeat this process for the other variables, each time drawing straight upward to the Points axis. Sum the points achieved for each predictor and locate this sum on the Total Points axis. Draw a line straight down to find the patient s probability of remaining recurrence free for 1 years, assuming he does not die of another cause first. Instruction to Patient: Mr. X, if we had 1 men exactly like you, we would expect <predicted percentage from nomogram> to remain free of their disease at 1 years following radical prostatectomy, and recurrence after 1 years is very rare. 38 Outcomes 28

41 Calibration Curves for Preoperative Nomograms Observed 1-year Biochemical Recurrence Free Probability With Surgeon Experience Without Surgeon Experience Predicted 1-year Biochemical Recurrence Free Probability Calibration Curves for Postoperative Nomograms Observed 1-year Biochemical Recurrence Free Probability Predicted 1-year Biochemical Recurrence Free Probability Glickman Urological & Kidney Institute 39

42 Urologic Oncology Nomogram for Predicting 1-year Biochemical Free Survival Based on Postoperative Information Points Prostate Specific Antigen Extracapsular Extension Seminal Vesical Involvement Pelvic Lymph Node Status Surgeon Experience Postoperative Gleason Sum Positive Surgical Margin Total Points Yes No Yes No Pos. Neg [ 4, 7) Yes [ 8,1] No Yr Biochemical Recurrence Free Probability Instructions for Physician: Locate the patient s PSA on the Prostate Specific Antigen axis. Draw a line straight upwards to the Points axis to determine how many points towards recurrence the patient receives for his PSA. Repeat this process for the other variables, each time drawing straight upward to the Points axis. Sum the points achieved for each predictor and locate this sum on the Total Points axis. Draw a line straight down to find the patient s probability of remaining recurrence free for 1 years, assuming he does not die of another cause first. Instruction to Patient: Mr. X, if we had 1 men exactly like you, we would expect <predicted percentage from nomogram> to remain free of their disease at 1 years following radical prostatectomy, and recurrence after 1 years is very rare. 4 Outcomes 28

43 Transrectal Ultrasound Guided Prostate Biopsy Overall Biopsy Results (N = 1495) September 27 September 28 N = % Negative 1% 5% Positive Gleason Score at Biopsy Percent GS 6 GS 7 GS 8 or more Glickman Urological & Kidney Institute 41

44 Urologic Oncology Percent of Patients with High Grade PIN (prostatic intraepithelial neoplasia) and No Cancer Complications Percent Percent Initial 1st Repeated 2nd or More Overall Infection Hematuria Rectal Bleeding Urine Retention Others* * Others: include vasovagal syncope, transient lower urinary symptoms Prostate Cancer Specific Mortality (Radiotherapy (RT), Prostate Implantation (PI), Radical Prostatectomy (RP) Cumulative Incidence of Prostate Cancer Mortality by Treatment Percent RT N = 759 PI N = 1279 RP N = Years Since Treatment 42 Outcomes 28

45 Glickman Urological & Kidney Institute urologists and statisticians have generated a number of important nomograms for patients with prostate cancer. These nomograms help guide physicians and patients in selecting the best individual treatment options. A Nomogram for Predicting Significant Upgrading in Patients with Low and Intermediate Grade Prostate Cancer Between 2 27, 117 patients underwent radical prostatectomy following biopsy showing GS 6 and / or 7 (3+4), which is demonstrated below. Points Age Race Abdominal DRE T. Volume ClinT Number of Previous Biopsies PSA Number of Cores Number of Positive Cores Maximum Percent Cancer Secondary Gleason Grade Perinueral Inflammation HGPIN Atypia Total Points Predicted Probability of Upgrading GS B W O Yes No T No Yes No Yes Yes No 4 Yes No Instructions for Physician: Locate the patient s Age on the Age axis. Draw a line straight upwards to the Points axis to determine how many points towards recurrence the patient receives for his Age. Repeat this process for the other variables, each time drawing straight upward to the Points axis. Sum the points achieved for each predictor and locate this sum on the Total Points axis. Draw a line straight down to find the patient s probability of upgrading on final pathology. Instruction to Patient: Mr. X, if we had 1 men exactly like you, we would expect <predicted percentage from nomogram> to have their final Gleason sum upgraded following prostatectomy. T1c T2 Glickman Urological & Kidney Institute 43

46 Urologic Oncology A Nomogram for Predicting a Positive Repeat Prostate Biopsy in Patients with a Previous Negative Biopsy From 1999 to June 27, 48 patients underwent one or more repeat biopsies after an initial negative biopsy, which the below nomogram demonstrates. Points Age DRE Number of Negative Cores Removed History of HGPIN History of ASAP PSA Neg No 55 <1/2 lobe >1/2 lobe Yes Yes No Points Months from Previous Negative Biopsy Months from Initial Negative Biopsy Total Points Prob. Positive Biopsy Instructions for Physician: Locate the patient s Age on the Age axis. Draw a line straight upwards to the Points axis to determine how many points toward recurrence the patient receives for his Age. Repeat this process for the other variables, each time drawing straight upward to the Points axis. Sum the points achieved for each predictor and locate this sum on the Total Points axis. Draw a line straight down to find the patient s probability of a positive repeat biopsy. Instruction to Patient: Mr. X, if we had 1 men exactly like you, we would expect <predicted percentage from nomogram> to have a positive repeat biopsy. 44 Outcomes 28

47 Radical Retropubic Prostatectomy Radical retropubic prostatectomy evolved into a precise anatomic surgical procedure with early identification and separation of the neurovascular bundles that supply the erectile tissue of the penis and contribute to postoperative continence. Continence and potency rates for patients undergoing radical retropubic prostatectomy are on par with other centers of excellence in the United States and internationally. Mortality rate for patients undergoing surgery for prostate cancer remains less than.2 percent. Biochemical Freedom from Recurrence by Pathologic Stage for Radical Retropubic Prostatectomy Percent pt2 pt2+ pt3, M- pt3, M+ SV+, M- LN+ SV+, M+ Months Since Surgery Time to Achieve Urinary Continence* after Radical Retropubic Prostatectomy Source: Department Database *Continence = no pad use Immediate 46% Overall 92% Median 4 weeks Glickman Urological & Kidney Institute 45

48 Urologic Oncology Laparoscopic Prostatectomy In 28, about 6 patients underwent laparoscopic prostatectomy. This large experience has translated into excellent outcomes similar to standard open surgery. In order to minimize nerve damage, a novel, thermal energyfree technique of nerve-sparing laparoscopic radical prostatectomy is performed with real-time transrectal ultrasound monitoring. Our technique involves transient bulldog clamping of lateral pedicle, cold-cut release of neurovascular bundle, and delicate homeostatic suturing. Perioperative Outcomes of Laparoscopic Radical Prostatectomy (N = 11) Pre-Op PSA (ng/ml) 5.9 ng/ml Clinical Stage T1c 84% T2a 13% T2b 3% OR Time 3.5 Hours Estimated Blood Loss 317 ml Hospital Stay 1.6 Days Pathologic Stage pt2 73% pt3 27% Positive Surgical Margins for Cancer after Nerve-sparing Laparoscopic Radical Prostatectomy (N = 5) Percent pt2 pt3 Overall 46 Outcomes 28

49 Laparoscopic Prostatectomy Erectile Function Recovery Rates after Nerve-sparing Laparoscopic Radical Prostatectomy Thermal Energy-Free Laparoscopic Nerve-Sparing Radical Prostatectomy: 3- and 6- month Potency Outcomes SHIM Score Energy-free technique (N = 54) Conventional technique using thermal energy (N = 22) 3 month 6 month Thermal Energy-Free Laparoscopic Nerve-Sparing Radical Prostatectomy: One-Year Intercourse Rate SHIM Score 1 8 Energy-free technique (N = 54) 6 4 Conventional technique using thermal energy (N = 22) 2 Pre-op SHIM 22 All Patients SHIM score: Sexual Health Inventory for Men, generally accepted as the standard for objective evaluation of male erectile function. Score is 5-25, 21 or less accepted as erectile dysfunction warranting evaluation or management. Ukimura O, Gill IS. Real-time transrectal ultrasound guidance during nerve sparing laparoscopic radical prostatectomy: pictorial essay. J Urol. 26 Apr;175(4): Gill IS, Ukimura O. 1-year potency outcomes of thermal energy-free laparoscopic radical prostatectomy. Urology (in press). Glickman Urological & Kidney Institute 47

50 Urologic Oncology Real-time transrectal ultrasound monitoring of neurovascular bundles during laparoscopic radical prostatectomy Cold scissor dissection of the neurovascular bundles during laparoscopic prostatectomy under ultrasound guidance to minimize nerve damage 48 Outcomes 28

51 Posterior Musculofacial Plate Reconstruction A modification of the standard urethrovesical anastomosis during laparoscopic prostatectomy, this reconstruction results in significantly earlier and better continence rates. Membranous urethral length was increased by a mean of 2 mm as measured by transrectal ultrasound. Patient self-report of number of pads used in 24 hours at three days and six weeks after catheter removal. Number of Pads at Three Days Group N Mean Std. Dev. Control group Reconstruction group Student s t-test P=.1 Number of Pads at Six Weeks Group N Mean Std. Dev. Control group Reconstruction group Student s t-test P=.5 Glickman Urological & Kidney Institute 49

52 Urologic Oncology Robotic-Assisted Prostatectomy The Glickman Urological & Kidney Institute performed 58 robotic-assisted prostatectomy procedures offering patients another minimally invasive approach to prostatectomy. Average operating time is 3.3 hours, blood loss is 275 cc and hospital stay is 36 hours. Patients can expect normal urinary control in 88 percent of cases, normal potency in 87 percent of patients less than 6 years of age. Brachytherapy Interstitial radioactive iodine seed implantation into the prostate using computerized templates under ultrasonic guidance is performed in increasing numbers in conjunction with our radiation oncologists. Currently, more patients receive this form of radiation treatment than traditional external beam radiation, with long-term cure rates higher than 9 percent in patients with favorable disease features. Prostate Brachytherapy Volume Outcomes 28

53 Prostate Cryotherapy Cryotherapy has recently been used for treatment of prostate cancer as primary treatment and after failure of radiation treatment. Treatment results are encouraging, with minimal complications and excellent biochemical response rate. Bladder Cancer The number of patients treated for bladder cancer steadily increased over the last few years. Patients with superficial, muscle-invasive, as well as advanced and metastatic diseases are managed according to modern guidelines with excellent outcomes. The urologic oncologists at the Glickman Urological & Kidney Institute performed more than 6 cystoscopic resection procedures and approximately 15 radical cystectomy operations in 28. Laparoscopic radical cystectomy is offered to select patients, offering the advantage of less postoperative pain and shorter recovery. Data source for the following information is departmental bladder cancer database. Transurethral Resection of Bladder Volume 1, Modern continent urinary diversion techniques are performed for patients who prefer to avoid external collecting appliances. Systemic chemotherapy is used in conjunction with surgery in an adjuvant or neoadjuvant manner in select patients with high risk or advanced disease. Overall surgical mortality for patients undergoing cystectomy is around one percent, with no mortality in patients younger than 6 years old. Glickman Urological & Kidney Institute 51

54 Urologic Oncology Perioperative Mortality Following Radical Cystoprostatectomy Percent Average Blood Loss cc/ml 1,5 1, Outcomes 28

55 Average Length of Stay Following Radical Cystoprostatectomy Days Radical Cystectomy Volume Continent Diversion Ileal Conduit Open Radical Cystectomy Volume Glickman Urological & Kidney Institute 53

56 Urologic Oncology Laparoscopic Cystectomy Volume Laparoscopic Cystectomy Procedures 1, EBL Length of Stay 1 Linear (EBL) Outcomes 28

57 Laparoscopic and Robotic Radical Cystectomy Minimally invasive surgical techniques attempt to duplicate the excellent oncological outcomes of open radical cystectomy with a superior patient recovery profile: decreased blood loss, shorter hospital stay and quicker convalescence. Our institutional experience with laparoscopic and robotic radical cystectomy exceeds 9 cases, 18 of which have been done robotically. We recently compared the perioperative outcomes of laparoscopic-assisted radical cystectomy (N = 5) with a contemporary cohort of open radical cystectomy (N = 5). Table illustrates the comparative data of the two cohorts from Laparoscopic radical cystectomy N = 5 Open radical cystectomy N = 5 P.1 Number 5 5 Operative time (hrs) 6.3± ±.28.1 Blood loss (cc) 363±259 81±684.4 Transfusion (%) 12% 4%.1 Ileus (%) 16% 3%.9 Oral intake (days) 3.4± ±2.1.4 Minor postop complications (%) 18% 22%.62 Major postop complications (%) 8% 6%.69 Ambulation (days) 3.± ± Hospital stay (days) 8.± ± Lymph nodes on final pathology (n) 14.8± ± Positive surgical margins (%) 2% 6%.29 Haber GP, Campbell SC, Colombo JR Jr, Gianduzzo T, Aron M, Fergany A, Kaouk J, Gill IS. Comparison between Open and Laparoscopic Assisted Radical Cystectomy for Bladder Cancer. (Urology November 27) Glickman Urological & Kidney Institute 55

58 Urologic Oncology Testis Cancer Testis cancer patients are all managed with a careful multidisciplinary approach, including specialized urologic medical oncologists. This approach maximizes the cure rates without subjecting patients to unnecessary treatment-related toxicity. This approach is especially important for the young patient population with this type of aggressive malignancy. Retroperitoneal lymph node dissection incorporates nerve-sparing techniques to preserve the sympathetic outflow tracts in the retroperitoneum and maintain antegrade ejaculation postoperatively. Retroperitoneal Dissection for Testis Cancer Volume Results of Patients Undergoing Primary vs. Postchemotherapy Retroperitoneal Lymph Node Dissection for Testis Cancer *GCT = Germ cell tumor Primary Post chemo p-value No. pts (%) 112 (54) 96 (46) Mean patient age (range) 29 (16-53) 31 (18-6).69 No. nodal pathology (%) No. tumor or necrosis 63 (56) 34 (35) Mixed GCT* 41 (37) 1 (1) Teratoma only 7 (6) 47 (49) Rhabdomyosarcoma 1 (1) () Seminoma () 2 (2) Adenocarcinoma () 3 (3) Median operative time (min) <.1 Median estimated blood loss (ml) 45 1 <.1 No. transfusion rate (%) 7 (6) 4 (42) <.1 Median length of stay (days) Median follow up (months) Antegrade ejaculation postoperative (%) 8 41 <.1 56 Outcomes 28

59 Adrenal Tumors The field of adrenal surgery is one of the major domains of laparoscopy. Laparoscopic urologists have accumulated vast experience in this area, including all types of benign, malignant and hormonally active adrenal tumors. A small select group of patients still undergo open surgical adrenalectomy, usually in the presence of larger adrenocortical carcinoma. Adrenalectomy Volume 1 8 Open Adrenalectomy Laparoscopic Adrenalectomy Indications for Laparoscopic Adrenalectomy 6% Cushing s Syndrome 21% Pheochromocytoma 1% 21% Aldosteronism 52% Adrenal Mass Glickman Urological & Kidney Institute 57

60 Urologic Oncology Laparoscopic Adrenalectomy for Adrenocortical Carcinoma N=17 Tumors <5 cm N=14 Tumors 5 cm Mean Operative Time (min) Median Hospital Stay (days) 1 2 No. Local Recurrence (%) 12% 31% Median Specimen Wt (gm) Alive at Last Follow-up/Total No. (%) 56% 53% Cancer Specific Survival for Patients with Adrenal Carcinoma Following Laparoscopic Adrenalectomy (N = 31) Percent Months Since Surgery Outcomes 28

61 Overview of Laparoscopic Oncologic Surgery Our collective experience with all laparoscopic procedures performed for all oncologic indications was recently reviewed. From April January 26, 1,867 laparoscopic surgeries were performed for urologic cancer. The graph demonstrates the number of procedures performed per year. Procedures included laparoscopic partial nephrectomy (LPN), laparoscopic radical prostatectomy (LRP), laparoscopic radical cystectomy (LRC), laparoscopic radical nephrectomy (LRN) and laparoscopic nephroureterectomy (LNU). More than 6 percent of procedures performed after 21 are classified as very difficult or extremely difficult according to the standardized European Scoring System (ESS). Despite the significantly increased technical complexity of the procedures, the complication rate decreased (17 percent vs percent) in the same time period. Procedures LPN LRP LRC LRN LNU Months Since Surgery Laparoscopic Oncological Surgery Complications Percent p = Colombo JR Jr, Haber GP, Jelovsek JE, Nguyen MM, Fergany A, Desai MM, Kaouk JH, Gill IS. Complications of laparoscopic surgery for urological cancer: single institutional analysis. J Urol (September 27). Glickman Urological & Kidney Institute 59

62 Urologic Oncology Robotic Urology Over 1, robotic procedures have been performed. Robotic procedures performed at Cleveland Clinic include robotic nerve-sparing radical prostatectomy, robotic radical cystoprostatectomy and cystectomy, robotic pyeloplasty, robotic adrenalectomy, robotic partial nephrectomy and robotic sural nerve grafting. Robotic Procedures Volume Procedure Distribution 7% Robotic Sacrocolpopexy 7% Robotic Pyeloplasty 7% Robotic Cystectomy 1% 79% Robotic Prostatectomy 6 Outcomes 28

63 Transplantation Kidney Transplant Transplant surgeons at the Glickman Urological & Kidney Institute perform kidney and pancreas transplantation surgery, sometimes in combination as a kidney/pancreas transplant. Kidney transplantation offers longer survival, superior lifestyle and fewer complications than dialysis for patients in end-stage renal failure. Our kidney transplant program continues to generate a substantial volume, with a total of 166 kidney transplants performed in 28. As in the recent past, over 4 percent of kidneys now come from a living donor. There is an important role for the living unrelated donor, which now represents 4 percent of all living donor kidneys. Patient survival after kidney transplant is excellent at 96.3 percent. One year graft survival is favorable at 9.4 percent. The major dilemma in transplantation across the country continues to be the insufficient supply of organs for those in need. Our median wait time for a cadaveric kidney is 6 days. UNOS has identified our donor service area as ranked No. 4 in the nation for living donor kidney transplant and No. 5 for transplanting high risk kidneys. Kidney Transplants Transplants 2 15 Living Donor Deceased Donor Year The overwhelming majority of living donors at the Glickman Urological & Kidney Institute undergo laparoscopic donor nephrectomy. Performed by laparoscopic surgeons, the laparoscopic procedure offers markedly decreased pain, improved cosmesis and shorter hospital stay. The long-term kidney function results are comparable to the open procedure. Glickman Urological & Kidney Institute 61

64 Transplantation Donor Kidney Transplants 1 8 Open Donor Kidney Laparoscopic Donor Kidney Days on Waiting List and Post-Transplant Length of Stay (LOS) 28 Operation Mean Median N Days Waiting (Deceased Donor) Post Transplant LOS Primary Diagnosis for Patients Transplanted 28 1% 4% Unknown 6% Others* 1% Vascular Disease 1% Cystic Fibrosis 1% Cirrhosis 1% Congenital Hereditary Disease 2% Obstructive Disease 5% Multi-System Disease 6% Retransplant/Graft Failure 1% Hypertension 11% Nephritis/Interstitial Disease 12% Glomerular Disease 15% Cystic Disease 26% Diabetes *Other categories include Alport syndrome, malignant disease, metabolic disease, nephrolithiasis, obstructive disease and others. 62 Outcomes 28

65 Kidney Transplant Survival (Includes: Kidney/Heart, Kidney/Liver, Kidney/Pancreas) (N = 692) Percent Months Since Transplant Includes primary kidney, kidney/pancreas, kidney/liver, and kidney/heart transplants Kidney Transplant Graft Survival (Includes: Kidney/Heart, Kidney/Liver, Kidney/Pancreas) (N=692) Percent Months Since Transplant Includes primary kidney, kidney/pancreas, kidney/liver, and kidney/ heart transplants Total Number Total pre-transplant evaluations in Number of deceased donor kidney recipients in Days on Wait List (mean +/- SD) 911 +/- 77 Days on Wait List (median) 87 Post-Tx Length of Stay (mean +/- SD) 7 +/- 7 Post-Tx Length of Stay (median) 6 Mortality (hospital deaths within 3 days post-tx) Glickman Urological & Kidney Institute 63

66 Transplant Pancreas Transplant Volume

67 Postoperative Nausea and Vomiting Representatives of the Department of General Anesthesiology visit kidney transplant surgery in-patients on their second postoperative day in the hospital to evaluate the early postoperative period. One outcomes measure is postoperative nausea or vomiting (PONV), which is collected from medical record review. The Department features the management of postoperative nausea and vomiting in its clinical quality improvement program. The proportions of kidney transplant surgery patients experiencing no PONV, are shown below. Within 24 Hours After Kidney Transplant Surgery (N = 129) 28 Percent % Vomiting % Nausea only % Neither nausea nor vomiting N = 1Q 43 2Q 26 3Q 27 4Q 33 Patient Satisfaction A question in the interview obtained during postoperative rounds on postoperative day two asks for the patient s response to the statement, I was satisfied with my anesthesia care. The percentages by calendar quarter of kidney transplant surgery patients responding Agree very much, the highest rating, are shown below. Satisfaction with Anesthesia Care for Kidney Transplant Surgery (N = 84) 28 Percent Very Satisfied N = 1Q 3 2Q 17 3Q 15 4Q 22 Glickman Urological & Kidney Institute 65

68 Prosthetics and Reconstruction Reconstructive surgery of the penis is performed for acquired erectile deformity (Peyronie s disease) or congenital curvature. Multiple options for correction of the deformity are available to these patients, including penile plication or plaque excision with tunical grafting. Inflatable penile prostheses are offered to patients with a combination of erectile dysfunction in addition to the deformity. Male Reconstruction Procedures Volume Tunical Plication Plaque Surgery with Grafting Urethroplasty Male urethral reconstruction is often required for patients with urethral stricture disease. These delicate and usually difficult reconstructive operations combine urologic as well as plastic surgical principles and are only performed in a handful of centers. About 79 such operations were performed last year at Cleveland Clinic, incorporating all modern techniques of grafts, flaps and simpler anastomotic procedures. A significant number of patients with complex urethral fistulae (including recto-urethral fistulae) are also repaired surgically each year, a combined experience that rivals any other urologic center in the United States. 66 Outcomes 28

69 Genitourinary Prosthetics Volume Male Slings* Revisions/ Explants Artificial Sphincter Penile Prosthesis * 28 was the first year the Center for Genitourinary Reconstruction performed male slings. Reconstructive surgeons at the Glickman Urological & Kidney Institute have pioneered and developed the field of urologic prosthesis for erectile dysfunction as well as urinary incontinence. Inflatable penile prostheses are used for treatment of erectile dysfunction and produce excellent long-term outcomes. Different types of prostheses are offered according to the clinical situation and indications. The main indication for placing an artificial urinary sphincter is incontinence following radical prostatectomy. Patients with this prosthetic implant can expect almost complete continence with excellent long-term mechanical reliability. Glickman Urological & Kidney Institute 67

70 Prosthetics and Reconstruction Operation Inflatable Penile Prosthesis Artificial Urinary Sphincter Surgery Male Sling Number Length of Stay 23 hrs 23 hrs 23 hrs Infection 1.6% Erosion Other Reops 1.6% Long-Term Mechanical Reliability of AMS 7 Series Inflatable Penis Prostheses Prosthesis - Products 5 Years 1 Years AMS 7 CX/CXM 92% 81% AMS ULTREX 94% 53% Sources: Long-term mechanical reliability of AMS 7 CX/CXM inflatable penile prosthesis. Dhar N, Angermeier K W, Montague DK, Milbank AJ, Montague DK, Angermeier KW, et al. J Urol. 25 Mechanical failure of the American Medical Systems Ultrex inflatable penile prosthesis: Before and after 1993 structural modification. J Urol. 22; 167(6): Outcomes 28

71 Female Urology A large number of female patients are referred for management of urinary incontinence. Most patients have stress, urge incontinence or a combination of the two. Modern video-urodynamic testing is performed for these patients, and various urethral sling procedures are performed according to the clinical indication. Tension-free vaginal-tape (TVT) is currently performed in the outpatient setting. In a study population of 85 patients, mean discharge time was 2.4 hours after surgery, with only one patient returning to the emergency room for urethral catheterization. Pelvic Floor Prolapse Surgery for pelvic floor prolapse is performed by urologic surgeons with specialized training in the field of female and vaginal surgery. The mean length of stay for vaginal repair of pelvic organ prolapse in 27 was 28 hours, with 85 percent of 11 patients discharged on the first postoperative day. Surgery for Vaginal Prolapse Volume Vaginal Prolapse Repair Sacrospinous Ligament Fixation Laparoscopic Colpopexy Outcomes of Surgery for Pelvic Organ Prolapse Repair Traditional Open Abdominal Approach Traditional Laparoscopic Approach New Cleveland Clinic Laparoscopic Assisted Approach Length of Stay (days) Total Operating Times (including Times for Additional Procedures) 218 minutes 269 minutes 234 minutes Average Estimated Blood Loss 234 cc 172 cc 62 cc Need for Repeat Prolapse Surgery 3.3% 1.7% 6.25% Glickman Urological & Kidney Institute 69

72 Female Urology Complications of Surgical Approach for Pelvic Organ Prolapse Repair Percent 15 1 New Cleveland Clinic Laparoscopic Approach (N = 32) Traditional Laparoscopic Approach (N = 61) Traditional Open Abdominal Approach (N = 56) 5 Bladder Injury and Repair Small Bowel Injury and Repair Deep Vein Thrombosis Ventral Hernia Mesh Erosion 7 Outcomes 28

73 Robotic-assisted abdominal sacrocolpopexy is used for repair of advanced pelvic organ prolapse, in the presence or absence of the uterus. Average blood loss for such procedures is 8 cc, and average hospital stay is 2.4 days. Anti-incontinence surgery is performed as indicated in conjunction with these procedures. Reducing Length of Stay in Transvaginal Pelvic Organ Prolapse Repair February 25 July cases -6 anterior repairs -1 posterior repairs -7 colpocleises -11 sacrospinous fixations -6 transvaginal repairs with mesh Median patient age = 58 years (range 35-93) Mean LOS Median LOS Discharged on POD#1 86% Type of Anesthesia 28:27 hours 25:45 hours Post-op Labs 1.6% Transfusions Presentation to ER in 3 days 3% Readmission within 7 days 2%* Readmission within 3 days 1%** Discharge with uretheral catheter 25% * One for abdominal pain, one for urinary retention ** Treatment of a lower extremity DVT 85% general, 15% spinal Glickman Urological & Kidney Institute 71

74 Female Urology Vaginal Slings Mid-urethral slings have rapidly established themselves as the method of choice for most patients undergoing surgery for stress urinary incontinence. The Glickman Urological & Kidney Institute introduced the technique of Percutaneous Vaginal Tape (PVT). The polypropylene mesh is placed in the mid-urethral location in an antegrade fashion to minimize the likelihood of major bowel, bladder and bleeding complications. The newly introduced PVT procedure is as effective and safe as the gold standard Tension Free Vaginal Tape (TVT) kit procedure for the treatment of stress urinary incontinence in females, but the contemporary PVT procedure is inexpensive and minimally invasive, does not require special instrumentation, and is simple to perform worldwide. Vaginal Sling Procedures Volume Length of Stay when Using a Fast-Track Regimen for Mid-urethral Sling Surgery (N = 86) February 25 July 27 Mean LOS Median LOS Type of Anesthesia Post-op Labs Transfusions Presentation to ER in 3 days 1% Readmission within 7 days % Readmission within 3 days 1%* Discharge with urethral catheter 8% 2:42 hours 2:15 hours 79% local/iv, 21% general/spinal 72 Outcomes 28

75 Laparoscopic Augmentation The laparoscopic technique of colocystoplasty with a continent catheterizable stoma was developed at the Glickman Urological & Kidney Institute. This technique provides a minimally invasive alternative to major open abdominal surgery with prolonged recovery and significantly shorter hospital stay and recovery. Learning Curve Laparoscopic Series and Operative Time Minutes Cases *Cases arranged chronologically Bladder and bowel scale function before (pre) and after (post) open and laparoscopic approaches. Significant improvements are noted by the patient in bladder function without causing any bowel dysfunction. Number 5 P =.7 P <.1 4 P =.7 Pre Post P =.97 P =.63 P =.47 N = Open 9 Bladder Function Lap 9 Open 9 Bowel Function Lap 9 Glickman Urological & Kidney Institute 73

76 Female Urology Perioperative Parameters of Bladder Augmentation Open Abdominal Approach Laparoscopic Approach Gender (Female/Male) 8/1 8/1 Cystometric Capacity 149 ml 167 ml Mean Operative Time in Minutes (Range) Mean Time to Achieve Oral Intake (Days) Mean Hospital Stay (Days) Mean Change in Bladder Scale (SD) View of the colonic patch sutured to bladder for augmentation with subsequent formation of a catheterizeable ileal stoma to the umbilicus 74 Outcomes 28

77 Vesico-Vaginal Fistula Vesico-vaginal fistulas (VVF), or communications between the bladder and vagina, represent some of the most problematic reconstructions for most pelvic surgeons. Urologists at Glickman Urological & Kidney Institute perform a large volume of transvaginal VVF repairs as a tertiary referral center. Since many recurrent fistulas are referred, we are among the most experienced in the country in recurrent VVF repairs managed vaginally. The vaginal approach offers minimal pain and shorter recovery compared to the open trans-abdominal approach that is traditionally used. With the vaginal approach, 9 percent of our patients spend less than 24 hours in the hospital postoperatively. Implant Interstim Volume Interstim Volume Distribution 4% Neurogenic Retention 13% Ideopathic Retention 15% Interstitial Cystitis 1% 16% Neurogenic Overactive Bladder 52% Ideopathic Overactive Bladder Glickman Urological & Kidney Institute 75

78 Female Urology Intravesical Injection of Botox Botulinum toxin type A is used by Glickman Urological & Kidney Institute physicians for treatment of refractory conditions of detrusor overactivity, interstitial cystitis, urinary sphincter spasm, retention and levator muscle spasm. Botulinum Toxin Type A Injection for the Treatment of Detrusor Sphincteric Dyssynergia (DSD) Baseline Value Value Three-month follow-up Mean % changes p-value Value Six-month follow-up Mean % changes Residual Volume % %.2 CIC % %.4 Frequency % %.8 Bladder Perception % % IIQ % %.24 UDI % %.14 CIC: Chronic Intermittent Catheterization IIQ-7: Incontinence Impact Questionnaire Short Version UID-6: Urogenital Distress Inventory p-value 76 Outcomes 28

79 Endourology and Stone Disease Stone Disease Patients with urinary calculi represent a large volume of clinical practice. All modern techniques for managing these patients are conducted, including detailed metabolic evaluation and medical treatment to minimize chances of stone recurrence. For patients requiring intervention, options include shock wave lithotripsy, ureteroscopy or percutaneous nephroscopic extraction. Modern instrumentation such as thin flexible ureteroscopes and laser lithotripsy are used to minimize patient morbidity and shorten hospital stay. Stone Procedures Volume 1,5 1, 5 Percutaneous Renal Surgery Ureteroscopy Stone Procedures Results of Percutaneous Nephrolitholomy in Patients on Anticoagulation (N = 27) Intraoperative data Transfusion (%) EBL (ml) Complications (%) Bleeding 2 (7%) Thromboembolic 1 (4%) Glickman Urological & Kidney Institute 77

80 Endourology and Stone Disease Comparison of Ureterorenoscopy with HO-YAG Laser Lithotripsy in Patients with (37) and without (37) Anticoagulation Overall AC Control p Value Operative time (mins): Mean ± SD 69.9 ± ± Range Median 6 5 No. balloon dilation (%) 1 (3) 3 (8).339 No. uretheral access sheath (%) 8 (22) 1 (3).128 No. intraop complications (%) 1 (3).314 Postop hemoglobin (gm/dl): Mean ± SD 13.2 ± ± Range Median No. postop complications (%) 4 (11) 2 (5).3943 % Stone-free Wilson Rank Sum Test for continuous data and chi-square test for categorical data. Hemoglobin (g/dl) Control Group Aspirin Coumadin Ciopidogrel Preoperative Discharge 78 Outcomes 28

81 Ureteropelvic Junction Obstruction This common condition causing hydronephrosis is managed with minimally invasive techniques. Laparoscopic urologists perform increasing numbers of laparoscopic pyeloplasty, with the assistance of the davinci robotic system. The percutaneous nephroscopic technique of endopyeloplasty was introduced at the Glickman Urological & Kidney Institute. This entails incision of the obstructed ureteropelvic junction as well as suturing the incised repair through a nephroscopic approach. Pyeloplasty Volume Oncological Results Following Percutaneous Resection of Upper Tract Transitional Cell Carcinoma in Patients with a Solitary Kidney No. of Patients 34 No. of Procedures 37 Recurrences 4 Disease-free Survival 79% Cancer-specific Survival 93% Mean follow-up: 47 months All recurrences were treated successfully endoscopically. With intermediate-term follow-up, this extremely high-risk group demonstrates a cancer-specific survival of 93%. Glickman Urological & Kidney Institute 79

82 Endourology and Stone Disease Patients with large renal calculi are treated with multiple-tract percutaneous treatment of staghorn renal calculi: nephrosto-lithotomy, a delicate and difficult procedure frequently performed by endourologists. High stone-free rates can be achieved with low complication rates even when multiple access tracts are required for stone clearance. While transfusion rates are higher in multiple tract patients, this tends to relate more to the lower preoperative hemoglobin levels seen in this group. Single Tract Multiple Tracts Stone Size (mm 2 ) 423 2,157 Stone-free Rate 1% 95% Major Complications Minor Complications 1% 1% Blood Transfusion 4 Percutaneous surgery in patients with a solitary kidney has no significant adverse effects on renal function. This study reflects the safety of percutaneous renal surgery in this delicate and high-risk patient population. No patient in this group had significant deterioration in kidney function following percutaneous procedures for a variety of indications. Study Period No. of Patients 89 No. of Procedures 97 Renal Status Indication Anatomically Solitary Functionally Solitary Renal Calculus Upper Tract TCC Stone + UPJ Obstruction Outcomes 28

83 Benign Prostate Hypertrophy This common cause of lower urinary tract symptoms is a common cause of urologic clinic visits worldwide. Urologists at the Glickman Urological & Kidney Institute developed the technique of Photoselective Vaporization of the Prostate (PVP) in which laser energy is used to remove the prostatic adenoma. Using this technique, more than 55 procedures have been performed, nearly 25 in 28 without the need for blood transfusion or hyponatremia. Patients on anticoagulation can undergo this procedure safely. For the gold-standard transurethral resection of the prostate, saline resection apparatus (GYRUS), which allows resection of prostate adenoma using saline instead of the usual irrigants such as glycine, is now used. This has virtually eliminated transurethral resection (TUR) syndrome from our practice, resulting in a safer resection without resection time limits, even for larger adenoma. Treatments for Benign Prostatic Hypertrophy Treatments Photoselective Vaporization of Prostate Transurethral Resection of Prostate Glickman Urological & Kidney Institute 81

84 Pediatric Urology Our pediatric urologists perform all aspects of modern pediatric urological care. This includes outpatient clinic care and ambulatory procedures, as well as major in-hospital operative procedures. A variety of pediatric procedures are performed, including genital reconstruction for hypospadias and similar congenital anomalies, surgery for undescended testis, surgery for reflux and ureterojunction pelvic obstruction, and pediatric urologic oncology. Pediatric Surgery Volumes Volume 1,5 1, Pediatric Ureteropelvic Junction Obstruction In cases of prenatally detected hydronephrosis, the use of a standard ultrasound grading system and selective utilization of follow-up renal function testing, in addition to parental compliance, has allowed our pediatric surgeons to avoid surgery in a majority of these cases. Pyeloplasty is selectively performed according to strict criteria determined during follow-up of these kidneys. Our protocol spans more than 1 years (since 1995), and includes 198 kidneys. The Fate of 198 Hydronephrotic Kidneys with Ureteropelvic Junction Obstruction N % Pyeloplasty at admission 2 1 Conservative follow-up Pyeloplasty required Spontaneous resolution Still under follow-up Improved Stable Newly entered Lost to follow-up 9 5 Total Outcomes 28

85 Subtrigonal Injection of Deflux for Vesicoureteral Reflux in Children This outpatient endoscopic procedure provides an alternative to surgical management, as well as long years of antibiotic prophylaxis for children with reflux. Our pediatric urologists have performed this procedure in children aged 15 months to 14 years, with only one patient eventually requiring surgery. Success by Grade of Reflux Grade 1 4/4 1% Grade 2 25/3 83% Grade 3 9/11 82% Grade 4 4/4 1% Success = no reflux on follow-up studies Pediatric Patients by Location Volume 5, 4, 3, 2, 1, Beachwood FHC Strongsville FHC West FHC Elyria Fairview Hillcrest Main Campus *FHC=Family Health Center Surgical Intervention for Pediatric Urinary Stones Multiple techniques are used including new finer endoscopes that allow access to the ureter and renal pelvis, as well as the use of ungated shock wave lithotripsy (SWL) treatments that have shown 1 percent safety and 92 percent efficacy in stone destruction without associated arrhythmia. Jeffrey S. Palmer: Retrograde Proximal Semirigid Ureteroscopy: Safe and Effective in Prepubertal Children. Presented at the World Congress of Endourology, Cancun, November 27. Jeffrey S. Palmer: Ungated ESWL in Pediatric Population: Safe and Effective. Presented at the World Congress of Endourology, Cancun, November 27. Glickman Urological & Kidney Institute 83

86 Male Infertility Diagnostic and therapeutic procedures for male infertility are a highly specialized area of urological care. These procedures include varicocele ligation, sperm aspiration from the testis or the epididymis for assisted reproductive techniques, highly delicate microvascular repair of epididymis, or vas deferens obstruction. Male Infertility Activity Procedures Varicocle Litigation Vasovasotomy Epididymovasostomy MicroTESE Microscopic vasovasostomy and vaso-epididymostomy procedures allow normal conception for men after vasectomy or other congenital or inflammatory causes of obstruction. More than 4 of these delicate procedures have been performed at the Glickman Urological & Kidney Institute, with excellent patency results and pregnancy rates. 84 Outcomes 28

87 Center Evaluations 27 Patients New Consult Clinic Procedure Operating Room Procedure Patency and Pregnancy vs. Reason for Obstruction Vasoepididymostomy (N = 354) Percent 1 8 % Patent % Pregnant Caput Cap + Non-Cap Level of Obstruction All Glickman Urological & Kidney Institute 85

88 Minority Men s Health Center Cleveland Clinic s Minority Men s Health Center (MMHC) is a specialized center dedicated to meeting the health needs of minority men in the city of Cleveland and its environs, providing comprehensive health access, treatment and education to historically underserved populations of minority men. The MMHC realizes its mission by attracting minority patients for diagnosis and culturally sensitive care, conducting research to clarify the causes of health disparities, and performing clinical research to test promising methods for the diagnosis and treatment of health disorders. The MMHC has been successful in reaching a group of men at high-risk for prostate cancer (i.e., black males). Review of the Prostate Cancer Detection Rates (PCaDR) at Cleveland Clinic MMHC Glickman Urological & Kidney Institute from the years: 24 to 27 (47 percent) is higher than the national average detection rates reported in several series (24-33 percent). (References listed below: 1 to 3.) Prostate Cancer Detection Rates May 24 December 27 Number/Percent MMHC Prostate Biopsy (Number) MMHC Prostate Cancers (Number) MMHC Prostate Cancer Detection Rate (%) PCPT Prostate Cancer Detection Rate (%) CECD Study (%) 26 Race Study Detection Rate (%) 1. National Cancer Institute, The Prostate Cancer Prevention Trial, or PCPT, is a study designed to see whether the drug finasteride (trade name Proscar) can prevent prostate cancer in men ages 55 and older. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Finasteride (Proscar) for the Chemoprevention of Prostate Cancer. Trial Lead Organizations, Southwest Oncology Group, Ian Thompson, MD, Protocol chair 2. Pelzer A, Bektic J, Berger AP, Pallwein L, Halpern EJ, Horninger W, Bartsch G, Frauscher. Prostate cancer detection in men with prostate specific antigen 4 to 1 ng/ml using a combined approach of contrast enhanced color Doppler targeted and systematic biopsy. F. 1: J Urol. 25 Jun; 173(6): alexandre.pelzer@uibk.ac.at 3. Yanke BV, Carver BS, Bianco FJ Jr, Simoneaux WJ, Venable DD, Powell IJ, Eastham JA., African-American race is a predictor of prostate cancer detection: incorporation into a pre- biopsy nomogram. BJU Int. 26 Oct; 98(4):783-7., State University of New York Downstate Medical Center, New York, NY, US 86 Outcomes 28

89 Minority Men s Health Fair The Minority Men s Health Center hosts an annual health fair aimed at raising awareness for healthcare disparities in minority men. The event has taken place for the past seven years during April, Minority Health Awareness Month. The 28 health fair attracted over 2, men. Over 9 entities provided health information and free screenings. Participants Volumes 2,5 2, 1,5 1, Screenings Volumes 1, Prostate Screenings - DRE Prostate Screenings - PSA Blood Pressure (Healthy Heart) Blood Sugar (Healthy Heart) Cholesterol (Healthy Heart) HIV Screenings (Agape) Urinalysis (Nephrology/Hypertension) Glaucoma Screenings Oral Cancer Bone Density Glickman Urological & Kidney Institute 87

90 Hemodialysis The Department of Nephrology and Hypertension at Cleveland Clinic has partnered with Ohio Renal Care Group/ Fresenius Medical System (ORCG/FMS), which is a shared initiative among MetroHealth Medical Center, ORCG/FMS and Cleveland Clinic. This partnership enables Cleveland Clinic nephrologists and nurse practitioners to benefit from the independent quality assessment program provided by ORCG/ FMS. This quality assessment program is comprehensive, timely and data-driven. The quality outcomes presented are aggregate Cleveland Clinic/ORCG data, compared with quality outcomes for the ESRD networks in our region, and the United States. Data sources include network reports, the Clinical Performance Measures Project, Dialysis Facility Reports, and information collected by Fresenius and analyzed by Cleveland Clinic s team. The primary outcomes of mortality, hospitalization and percentage of eligible patients listed for transplantation are provided for the five units at which a Cleveland Clinic nephrologist is medical director. All other data are for all patients cared for in their hemodialysis units by Cleveland Clinic teams of nephrologists and nurse practitioners. We are proud that the quality outcomes measured confirm that the Cleveland Clinic teams of nephrologists and nurse practitioners continue to provide excellent care for our hemodialysis patients. The Standardized Mortality Ratio for hemodialysis units with Cleveland Clinic nephrologists as medical director was Better than Expected for The Standardized Admission Ratio was Below Expected for the dialysis units where a Cleveland Clinic nephrologist is the medical director. The Standardized Total Days Hospitalization is better than expected for the dialysis units where a Cleveland Clinic nephrologist is the medical director. The percentage of our prevalent patients who have fistulas is above both network and national averages. The percentage of our patients with a spkt/v > 1.2 was 92 percent, which is above or equal to network and national averages. The percentage of our patients with Hgb > 11g/dL was lower than regional network and national averages for the time period sampled. Cleveland Clinic patient average hemoglobin was sampled after the target Hgb was changed to the more focused goal of 11-12g/dL, and thus may reflect a higher percentage of patients within the tighter and more recent Hgb goal range of 11-12g/dL. The Cleveland Clinic team, including nutritionists in each unit, continues to achieve excellent overall results for nutrition in our hemodialysis patients, as reflected by the percentage of patients with an albumin level > 4g/dL. The percent of patients that are eligible for the transplant waitlist within Cleveland Clinic is higher than the national average. 88 Outcomes 28

91 The following graphs illustrate Cleveland Clinic s performance compared to The Forum of ESRD Networks. The Forum of ESRD Networks is a not-for-profit organization that advocates on behalf of its membership and coordinates projects and activities of mutual interests to ESRD Networks. All 18 ESRD Networks are members of the Forum which facilitates the flow of information and advances a national quality agenda with CMS (the Centers for Medicare & Medicaid Services) and other renal organizations. At Cleveland Clinic, we benchmark ourselves against the networks in contiguous states. These networks include: Network 2 New York Network 4 Pennsylvania Network 9/1 Ohio, Kentucky, Indiana and Illinois Standardized Mortality Ratio Ratio p=.5 p=.5 p< Year 27 Ohio ESRD Network United States Data source is the 28 Dialysis Facility Reports, University of Michigan Epidemiology and Cost Center. State, network and U.S. averages are given as regional averages per year, Data aggregated by year for five Cleveland Clinic hemodialysis units by Cleveland Clinic staff. The standardized mortality ratio is the ratio of observed deaths to expected deaths; no sample sizes or units are needed or given. Glickman Urological & Kidney Institute 89

92 Hemodialysis Standardized Total Admission Ratio Ratio p<.1 p=.34 p= Year 27 Ohio ESRD Network United States Data source is the 28 Dialysis Facility Reports, University of Michigan Epidemiology and Cost Center. State, network and U.S. averages are given as regional averages per year, Data aggregated by year for five Cleveland Clinic hemodialysis units by Cleveland Clinic staff. Standardized Total Days Hospitalization Days 1.2 All Units Benchmank Year Ohio Network 9/ Dialysis Facility Reports, University of Michigan Epidemiology and Cost Center, aggregated by the Cleveland Clinic. Data for State, Network, and U.S. averages are given as regional averages per year, Values for patient years at risk for State, Network, and U.S. are shown for the average facility, annualized. Patient years at risk are as follows: 24 = = = Outcomes 28

93 The data provided below for Cleveland Clinic health system sites is a point prevalent sample from December 27. The data provided for the Networks and U.S. are from the 26 Annual Report for ESRD CPM Project, a period prevalent sample from October 25 - December 25. Vascular Access for Hemodialysis % Fistulas Percent CC Sites N = 325 Network 2 Network 4 Network 9 Network 1 United States Adequacy of Hemodialysis Dose % Patients spkt/v 1.2 Percent CC Sites N = 325 Network 2 Network 4 Network 9 Network 1 United States Glickman Urological & Kidney Institute 91

94 Hemodialysis Anemia Management in Hemodialysis Patients: % Patients Hgb > 11 g/dl Percent CC Sites N = 325 Network 2 Network 4 Network 9 Network 1 United States Nutritional Status of Hemodialysis Patients % Patients Albumin 4. g/dl Percent CC Sites N = 325 Network 2 Network 4 Network 9 Network 1 United States Percent Eligible Patients on the Waitlist for Transplantation Percent All CC Units United States Outcomes 28

95 ICU Nephrology The incidence of acute kidney injury (AKI) has been increasing in the last few years, including the rate of acute renal failure (ARF) in its severe form (i.e., requiring renal replacement therapy [RRT]). The rising trend of AKI is a direct consequence of the aging population with a higher prevalence of pre-existing kidney dysfunction, diabetes, hypertension and obesity. AKI is one of the most serious complications among the critically ill, which portends a multifold increase in the risk of death. This is particularly true in surgical procedures that carry a relatively higher incidence of kidney injury. Although overall postoperative mortality after cardiac surgery was relatively low, mortality in patients with severe AKI requiring dialysis exceeded 5 percent. However, at Cleveland Clinic, despite the steady increase of AKI after cardiac surgery over time, the mortality rates decreased during the same time periods. This was demonstrated in a cohort of 33,217 patients who underwent cardiac surgery at Cleveland Clinic between April 1993 and July 27. Improved survival among patients with AKI requiring dialysis is attributed to improving overall patient care (surgical techniques, nursing and critical care), complemented by advances in practices of dialysis care, including initiation of dialysis therapy, dose of dialysis, or use of different modalities of RRT. References: 1. Thakar CV, Worley S, Arrigain S, Yared JP, Paganini EP. Improved survival in acute kidney injury after cardiac surgery. Am J Kidney Dis 27; 5: Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol 25; 16: Glickman Urological & Kidney Institute 93

96 ICU Nephrology Incidence of Renal Consultations in ICUs at Cleveland Clinic Volume 1,2 Consults ESRD Consults ARF 1, Treatment Days per Dialysis Modality Days 4, 3, ICU IHD ICU CRRT 2, 1, Outcomes 28

97 % ARF Requiring Dialysis per Score Category Percent Incidence of post-cardiac surgery acute kidney injury requiring dialytic support per Cleveland Clinic preoperative score. Trends in Acute Kidney Injury (AKI) and Associated Mortality After Cardiac Surgery. Volume 1,4 1,2 1, AKI and Survived AKI and Expired AKI-D 5% drop in GFR Combined AKI Abbreviations: Acute Kidney Injury requiring dialysis, AKI-D; Glomerular Filtration Rate, GFR Glickman Urological & Kidney Institute 95

98 Chronic Kidney Disease (CKD) The goals of the CKD Clinic are threefold: to delay the progression of chronic kidney disease (CKD) to ease the burden of end-stage renal disease (ESRD) to reduce morbidity and mortality of the CKD patients with intensive cardiovascular risk management to optimize the transition to renal replacement therapy (RRT), such as dialysis and kidney transplantation. The CKD Clinic was established to accept patients referred from Cleveland Clinic and outside physicians for evaluation and management of their CKD. Enrollment of patients in the CKD Clinic and use of the electronic medical record (EMR) permits establishment of a CKD database of the demographics, clinical parameters and outcome measure of these patients. In addition, the CKD database provides fertile ground for identifying and enrolling patients in clinical research projects. The CKD Clinic provides comprehensive medical care utilizing a team approach which includes a nephrologist, certified nurse practitioners, nursing staff, CKD educators and a renal dietitian. Currently, more than 35 patients are enrolled in the CKD Clinic. The EMR of the CKD database permitted us to analyze the success rates of reaching prescribed guideline targets for CKD patients. These targets would include such important areas as anemia management, management of hyperlipidemia and CKD education. A recent analysis of these CKD target measurements revealed some gratifying results. These data clearly provide proof of concept of the CKD team care model. Initial analysis of the CKD Clinic data regarding management of hyperlipidemia is encouraging. The Kidney Disease Outcomes Quality Initiative guidelines suggest a lower target of LDL less than 1 for patients with CKD. The CKD patients had LDL cholesterol less than 1 mg/dl. Moreover, 66 percent of the patients had an LDL cholesterol less than 8 mg/dl. Recent analysis of the Treat to New Targets (TNT) suggests that an LDL level of 8 in CKD patients results in less cardiovascular events and mortality. Further studies in the CKD population will probe this hypothesis. 96 Outcomes 28

99 CKD Clinic Process Measures (N = 371) Percent LDL Done Vitamin D Done PTH Done CKD Clinic Outcomes (N = 371) Percent LDL < 1 Vitamin D < 31 PTH > 12 Analysis of our CKD Clinic data revealed other impressive observations: 66 percent of CKD patients with LDL cholesterol less than 1 mg/dl 92 percent of CKD patients had PTH level measured as part of a bone mineral metabolism therapy algorithm 91 percent of the CKD patients had Vitamin 25D levels measured and 59 percent of the patients had levels consistent with Vitamin D deficiency requiring therapy with ergocalciferol 42 percent of patients had PTH elevation greater than 12, which is consistent with secondary hyperparathyroidism. These data from the CKD Clinic analysis document the powerful positive impact that our team care approach of the CKD Clinic has had on the effective management of the medical issues relating to CKD. We are working with other nationally-recognized CKD clinic centers to help the National Kidney Foundation establish benchmarks of care for the CKD patient. Glickman Urological & Kidney Institute 97

100 Chronic Kidney Disease (CKD) Anemia Management in Chronic Kidney Disease (CKD) The Anemia Management Clinic for CKD patients has become a powerful tool in providing optimal patient management. The Figure on the next page depicts the project s success, showing the percentage of patients reaching target hemoglobin greater than 11. gm/dl. The Anemia Management Clinic continues to thrive as an essential asset for our patients with CKD. We continue to provide comprehensive support for CKD and transplant patients through a program of anemia management with continuing care and cooperation with our Nephrology staff. Through close monitoring by our nursing staff and aggressive replacement of iron stores to minimize the dose of erythropoiesis-stimulating agents (ESA s), the Anemia Management Clinic continues to find the right balance between maintaining adequate hemoglobin levels and addressing recent concerns regarding the safety of ESA therapy. Since 27, the management of anemia using ESA s has been an area of concern and controversy. There has been significant debate regarding the treatment of anemia in CKD since the publication of the CHOIR (Correction of Hemoglobin and Outcomes in Renal Insufficiency) and CREATE (Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta) trials in the New England Journal of Medicine in November 26. Prior to these publications, therapy with erythropoiesis stimulating agents (e.g., Procrit and Aranesp ) had been used to target the hemoglobin of > 11. gm/dl without an upper fixed level, but generally not >13. gm/dl. Thus, our target of quality had been the percent of patients who achieved a hemoglobin >11. gm/dl. However, the CHOIR study suggested an increased combined risk of cardiovascular events and mortality when targeting hemoglobin to >13. gm/dl, and the CREATE trial showed a similar trend. Given these controversies about anemia management in CKD, the FDA Black Box Warning on ESA labeling changed the recommended target hemoglobin range from 1 to 12 gm/dl. The Kidney Disease Outcomes Quality Initiative guidelines were subsequently modified to target hemoglobin from 11 to 12 gm/dl. In response to these concerns, initial changes to our protocol during the fourth quarter of 27 led to a rather dramatic drop in the percent of patients who were at our target hemoglobin of >11. gm/dl. However, re-analysis of the data from the CHOIR study shows that regardless of which arm patients were randomized to, those who achieved a higher hemoglobin level tended to have better outcomes, most notably when the hemoglobin passed a point just under 11. gm/dl. Our interpretation of these conflicting data was that people who are less responsive to ESA therapy (requiring higher doses but still have lower hemoglobin levels) tend to have worse outcomes. It is unclear whether this is due to a side effect of the medications being used at higher doses or to co-morbidities that lead to both resistance to ESA therapy and worse outcomes. But it also gave us confidence that our target hemoglobin of >11. gm/dl is justified. As a result, we made several adjustments to our protocols mid-28. These included identifying people who were not responding optimally to our predetermined maximal monthly doses and switching them all from four-week to two-week interval injections. Many people responded immediately to this change and soon had higher hemoglobins at lower average monthly doses. Those who did not respond were designated hypo-responders and their dose was tapered back to the minimum dose required to maintain their hemoglobin at its current level. With these changes, we have seen our average darbopoetin dose drop by 2mcg/month to 137.1mcg/month and our percent of patients at our target hemoglobin over 11 increase from 54 percent 98 Outcomes 28

101 back up to our clinic standard of 7 percent. For this reason, our monthly average at goal Hb>11. gm/dl is 64.9 percent. If the last six months alone are averaged, this number is at 69.3 percent, which meets our clinic standard. Interestingly, the number of patients with unacceptably high hemoglobins (>13. gm/dl) remained stable at 5 to 1 percent (these patients receive no ESA until the hemoglobin level drops back down). Given the revised FDA and K/DOQI guidelines, we also began to track the percent of patients reaching hemoglobin targets of gm/dl and gm/dl, which are also reflected in our figure. Of note, these figures reflect our care for all patients with CKD and anemia, including those with transplants and autoimmune diseases who are typically excluded from published studies on clinical efficacy of ESA therapy. We are confident that the extensive monitoring within our Anemia Management Clinic provides our patients with the most effective, yet safest means for providing optimal anemia management. Anemia Management Percent of Patients at Target Hemoglobin and Monthly Census Percent Number 1 35 Percent Reaching Target 3 8 Number of Patients Percent of Patients Reaching Defined Industry Target Hemoglobin (N = 26) 28 Percent Hb gm/dl (K/DOQI Target) Hb 1-12 gm/dl (FDA Target) Hb 11 gm/dl (Department Target) Glickman Urological & Kidney Institute 99

102 Hypertension The Department of Nephrology and Hypertension is known for outstanding patient care in the following areas of hypertension: Essential Hypertension vascular, hypotension, benign, labile Resistant Hypertension renal artery stenosis, fibromuscular hyperplasia, aldosteronism, pheochromocytoma, Cushing s disease, renovascular hypertension (HYTN), coarctation of aorta, HYTN with hypokalemia, Accelerated HYTN, HYTN in pregnancy, Pre-eclampsia, Renal artery thrombosis Among the several hundred patients who are followed longitudinally for hypertension many have been referred specifically because of the inability to achieve target blood pressure. Blood pressure control is particularly challenging in this population. Blood Pressure Among Patients with Hypertension Percent 1 8 Range Achieved <13/8 Range Achieved <14/ N = Outcomes 28

103 Blood Pressure Control in Primary Care The data below reflects care in our Nephrology and Hypertension specialty clinic. Cleveland Clinic also provides primary health care to a large population of hypertension patients. The percentage of these patients who had blood pressure less than 14/9 mm/hg at their most recent office visit (NCQA, NQF measure) was evaluated. Lipid (LDL Cholesterol) Control in Diabetes Percent NCQA Average 27 NCQA Average N = 26 9, ,78 Lipids Checked 28 9, , ,78 LDL <1 (excellent) 28 9,94 Blood Pressure Control in Diabetes Percent NCQA Average 27 NCQA Average N = 26 11, , ,94 Glickman Urological & Kidney Institute 11

104 Surgical Quality Improvement Hospital Compare: Surgical Care Improvement Project (SCIP) Hospital Compare is a consumer-oriented website hosted by the Centers for Medicare & Medicaid Services (CMS) in collaboration with the Hospital Quality Alliance (HQA). Hospitals that have agreed to public reporting submit process-of-care data showing how consistently they provide recommended care to adult patients, irrespective of payer. (These results also are posted on The Joint Commission s website.) Thirty-day risk-adjusted all-cause mortality rates are outcomes based on Medicare claims and enrollment information. Cleveland Clinic s 28 surgical care performance appears below. SCIP - Prophylactic Antibiotic Received within 1 Hour Prior to Surgical Incision (N = 92) Discharges January December 28 National Average* 86 Cleveland Clinic Percent of Patients * Source: discharges July 27- June Outcomes 28

105 SCIP - Prophylactic Antibiotic Discontinued within 24 Hours After Surgery End Time (N = 813) Discharges January December 28 National Average* 84 Cleveland Clinic Percent of Patients * Source: discharges July 27- June 28 SCIP - Prophylactic Antibiotic Selection for Surgical Patients (N = 937) Discharges January December 28 National Average* 92 Cleveland Clinic Percent of Patients * Source: discharges July 27- June 28 Glickman Urological & Kidney Institute 13

106 Surgical Quality Improvement SCIP - Surgery Patients with Recommended Venous Thromboembolism Prophylaxis Ordered (N = 677) Discharges January December 28 National Average* 84 Cleveland Clinic Percent of Patients * Source: discharges July 27- June 28 SCIP - Surgery Patients Who Received Appropriate Venous Thromboembolism Prophylaxis within 24 Hours Prior to Surgery to 24 Hours After Surgery (N = 677) Discharges January December 28 National Average* 81 Cleveland Clinic Percent of Patients * Source: discharges July 27- June Outcomes 28

107 SCIP - Surgery Patients with Appropriate Hair Removal (N = 1,386) Discharges January December 28 National Average* 95 Cleveland Clinic Percent of Patients * Source: discharges January - June 28 National Surgical Quality Improvement Project - Urology Surgery Morbidity (N = 85) April 3, 28 - June 3, 28 Percent Expected Observed The American College of Surgeons National Surgical Quality Improvement Project (NSQIP) is a national program that objectively measures and reports risk-adjusted surgical outcomes based on defined sampling and abstraction methodology. Cleveland Clinic recently expanded NSQIP participation to include certain subspecialties. At this time, two months of 28 urology surgery morbidity data are available and shown above. There was no statistically significant difference between the observed and expected rates. Glickman Urological & Kidney Institute 15

108 Patient Experience Cleveland Clinic has placed a renewed emphasis on improving the patient experience by establishing the role of Chief Experience Officer. Recognizing that patients seek more than solely a successful clinical outcome, the mission of the Office of Patient Experience is to create an environment that enhances the well-being of our patients, families and employees in a way that elevates Cleveland Clinic s reputation as one of the world s best hospitals. In 28, the Office of Patient Experience dedicated teams within the institutes to research and implement innovative patient- and family-based programs that support this mission. Outpatient Glickman Urological & Kidney Institute Overall Rating of Outpatient Care and Services Percent (N = 3,15) 28 (N = 3,15) 4 2 Excellent Very Good Good Fair Poor Source: Quality Data Management, a national hospital survey vendor 16 Outcomes 28

109 Rating of Outpatient Provider Percent (N = 3,15) 28 (N = 3,15) 4 2 Excellent Very Good Good Fair Poor Source: Quality Data Management, a national hospital survey vendor Recommend Outpatient Provider Percent (N = 3,15) 28 (N = 3,15) 4 2 Extremely Likely Very Likely Somewhat Likely Source: Quality Data Management, a national hospital survey vendor Somewhat Unlikely Very Unlikely Glickman Urological & Kidney Institute 17

110 Patient Experience Inpatient Glickman Urological & Kidney Institute With the support of the Centers for Medicare and Medicaid Services (CMS) and its partner organizations, the first national standard patient experience hospital survey (HCAHPS) was implemented in late 26. Results collected for reporting are available at HCAHPS Overall Assessment Percent total survey respondents = total survey respondents = 97 62% 62% Rate Hospital % respondents choosing 9 or 1 71% 73% Would Recommend % respondents choosing 'definitely yes' Source: Quality Data Management and Press Ganey, national hospital survey vendors 18 Outcomes 28

111 HCAHPS Domains of Care Percent 1 8 Respondents choosing 'always' or 'yes' 27 total survey respondents = total survey respondents = Discharge Information Doctor Communication Nurse Communication Pain Management Room Clean Communication New Medications Responsiveness to Needs Quiet at Night Source: Quality Data Management and Press Ganey, national hospital survey vendors For comparison purposes, 27 and Q1 28 HCAHPS scores have been adjusted to account for a survey mode administration change as recommended by CMS. Glickman Urological & Kidney Institute 19

112 Innovations Outpatient Ureteral Reimplantation Pediatric urologic surgeons at the Glickman Urological & Kidney Institute have modified the extravesical ureteral reimplantation technique and developed a critical pathway in order to consistently have sameday discharge of unilateral, bilateral and complicated reimplantations without urinary retention or increased morbidity. The modified surgical technique limits ureteral dissection and mobilization, in addition to detrusor dissection as distally as possible. Parents receive extensive preoperative and postoperative education, and the child is required to fulfill strict criteria in order to be discharged. This technique has resulted in high parental and patient satisfaction. Management of Intractable Kidney Stone Disease with Autotransplantation and Pyelovesicostomy For stone-forming patients with no other conservative options, we performed autotransplantation of their kidney(s) with direct pyelovesicostomy. This operation enables passage of larger stones without pain, as well as aiding in preventing stone formation in many cases due to the mechanical washing machine effect of the urine swirling into the kidney(s) during voiding. There were no serious complications in this group of patients and all experienced significant reduction or elimination of their narcotic dependency. Innovative Combination of New Technologies in Reconstructive Laparoscopic Surgery A novel platform to perform reconstructive procedures has been developed by laparoscopic surgeons at Cleveland Clinic s Glickman Urological & Kidney Institute. An innovative combination of a new robotic-endoscope holder (EndoControl, Grenoble, France), 3-D vision (Viking System, San Diego, USA) and articulated instruments (Tuebingen Scientific, Stuttgart, Germany) were used. All three technologies were compatible and stable. The articulated instruments have deflectable and rotatable tips that provide six degrees of freedom. This combination represents an alternative to the main disadvantages of straight instruments and 2-D vision afforded by current laparoscopic systems. A combination of multiple compact robots with instrument tracking and tactile feedback is under investigation. This research won the first place award at the Engineering and Urology Society s 28 meeting. 11 Outcomes 28

113 Stereotactic Percutaneous Cryoablation for Renal Tumor Stereotactic surgical navigation (routinely used in neurosurgery) has been used for the first time for a urological application with the aim of increasing the precision of needle placement during percutaneous cryoablation of renal tumors. In collaboration with Koelis-France, our surgeons have developed a stereotactic navigation system specifically for percutaneous probe ablation of kidney tumors. Accuracy using this navigation system was 4 mm and radiation exposure was reduced. This technology has the potential not only to increase accuracy, but also decrease radiation exposure needed for this procedure LaparoEndoscopic Single-Site (LESS) Surgery LaparoEndoscopic Single-Site (LESS) Surgery constitutes the latest and most advanced approach to laparoscopic abdominal and pelvic surgery. Laparoscopic surgeons at the Glickman Urological & Kidney Institute have developed and employed a novel port with multiple working channels that allows laparoscopic surgery to be completed through a single, 2 cm incision. In many instances, this single incision is buried in the umbilicus and offers a nearly scarless postoperative appearance. Thus far, we have successfully completed more than 1 of the LESS surgical procedures, which include radical prostatectomy, radical nephrectomy, partial nephrectomy, simple nephrectomy, varicocelectomy, nephroureterectomy, radical cystectomy, sacral colpopexy, renal cryoablation, dismembered pyeloplasty, ureteral reimplantation and living donor nephrectomy. Outcomes from the LESS surgical approach have been favorable with superior pain profiles and cosmesis when compared to standard laparoscopic techniques. Glickman Urological & Kidney Institute 111

114 Innovations Single-Port Single-Surgeon Surgery Single-port single-surgeon transumbilical partial nephrectomy, pyeloplasty and radical nephrectomy were performed in our laboratory using a novel light endoscopic robot (EndoControl, Grenoble, France). The low profile robot allows more space around the umbilicus where all instruments are inserted and affords flexibility and ease of movement, especially for single-port laparoscopic surgeries. This research has the potential to make single-port laparoscopy more effective toward surgery without visible scars. STEP (Single-Port Transvesical Simple Prostatectomy) This is a new procedure for enucleating the prostate in men with large-volume benign prostatic hyperplasia. A singleport device (r-port) is introduced percutaneously into the bladder under cystoscopic guidance. After establishing pneumovesicum, the adenoma is enucleated in its entirety and extracted through the vesical port site. Hemostasis is performed under direct vision. Gene Expression Profiling to Differentiate Aggressive from Indolent Renal Tumors Gene expression profiling (GEP) using a kidney cancerrelevant complementary DNA (cdna) array is being tested to differentiate between aggressive and indolent conventional renal cell carcinoma (crcc). Results from GEP may be most useful in unilateral crcc when results are discordant with predictions of tumor behavior based on standard clinicopathologic features. In addition, GEP can provide prognostic information that may help characterize tumors of unknown clinical stage, such as bilateral metachronous crcc. Corporeal Excavation for Difficult Penile Prosthesis Implantation Our surgeons are continuing to refine the technique known as corporeal excavation, which we initially reported in 26 (Urology. 26;67: 172-5). This reconstructive procedure is often the last hope for men who have erectile dysfunction as the result of ischemic priapism, or who need penile prosthesis reimplantation after removal of an infected penile prosthesis. Our initial report of nine men who have had this procedure has now been extended to more than 2. A New Penoscrotal Incision for Inflatable Penile Prosthesis Implantation The most common incision for inflatable penile prosthesis implantation is the transverse upper scrotal incision which provides a flap of tissue to bury tubing and to limit pump migration into the upper scrotum. A new penoscrotal incision developed by surgeons at the Glickman Urological & Kidney Institute starts with a longitudinal incision along the median penile and scrotal raphes. The deeper layers of dartos fascia are divided transversely at the penoscrotal junction providing the same flap of tissue to bury the tubing and limit upper pump migration. The skin closure, however, is now along natural tissue lines thus providing a superior cosmetic result. 112 Outcomes 28

115 UPOINT Phenotypic Classification of Chronic Pelvic Pain The chronic pelvic pain syndromes interstitial cystitis and category III prostatitis ( nonbacterial prostatitis, chronic pelvic pain syndrome) are poorly understood conditions. Our surgeons have developed a clinical phenotype system to classify patients with chronic pelvic pain called by the mnemonic UPOINT. Each letter represents a clinical domain that is scored yes or no and which has specific therapies associated with it: U - Urinary symptoms, P- Pyschosocial (depression, helplessness, catastrophizing), O - Organ specific (evidence for prostate or bladder involvement), I- Infection, N- Neurologic/Systemic (chronic fatigue syndrome, fibromyalgia) and T- Tenderness of pelvic floor muscles. We have validated the UPOINT system for both chronic prostatitis and interstitial cystitis and ongoing studies are examining how well therapy works when selected based on the phenotype. Focal Therapy for Prostate Cancer Transverse ultrasound image showing ice ball (hypoechoic area with white rim denoting its outer edge) encompassing most of the prostate. The arrows demonstrate a semilunarshaped portion of the prostate at its lateral aspect that remains unfrozen in order to preserve the entire left neurovascular bundle. Prostate cancer is usually located throughout the prostate, but early diagnosis allows identification of some tumors while still confined to one lobe. Glickman Urological & Kidney Institute urologists treat highly selected patients using focal therapy confined to the part of the prostate where cancer has been identified by a combination of MRI and saturation biopsy. With this diagnostic approach, 9 percent of patients have complete tumor eradication, and if any cancer is identified on subsequent follow-up, repeat treatment is available. Sexual function is preserved in 75 percent of men using this technique with very low risk (<5%) for other side effects. Single-Port Multi-Laparoscopic Access System for Foreign Body Removal in the Bladder Traditionally, removal of foreign bodies in the bladder involves opening the bladder through an abdominal approach, removing the foreign bodies under direct vision and placement of a suprapubic tube. Surgeons at the Glickman Urological & Kidney Institute utilize the Triport (Advanced Surgical Concepts, Bray, Ireland) approach, which allows simultaneous passage of three instruments through a single laparoscopic port. The port is placed directly into the bladder after it is maximally filled with saline. Using flexible instruments designed for use with the single-port system, the foreign body material may be grasped and dissected through the detrusor. Patients treated with this novel approach can be managed in the outpatient setting. No suprapubic catheter is necessary, and urethral catheter drainage for one week is sufficient. Laparoscopic Single-Port Abdominal Sacrocolpopexy Single-port laparoscopic surgery has been used for oncologic renal, prostate and reconstructive surgery. Over the last year, pelvic organ prolapse surgery has been added to this growing list of applications and adopted first by surgeons at the Glickman Urological & Kidney Institute. Our short-term, newly published experience demonstrates the safety and feasibility of this minimallyinvasive prolapse repair that offers the potential for less port placement complications in the short and long-term for female patients undergoing major pelvic reconstruction procedures. Glickman Urological & Kidney Institute 113

116 Innovations The Cleveland Clinic Continent Neo-Urachus Many patients with neurogenic bladder dysfunction or other causes of lower urinary tract dysfunction may require the need for intermittent bladder catheterization through a continent access other than the native urethra. To this end, surgeons at the Glickman Urological & Kidney Institute have developed an innovative outpatient surgical technique called the continent neo-urachus. The neo-urachus is simply formed by making a tube of skin from an in-situ abdominal skin flap, small bowel segment or Boari bladder flap over an 18F catheter that extends from the umbilicus to the dome of the bladder. Prior to attachment of the tube to the bladder, the tube is placed through an opening between the braiding or crossing of the overlying rectus muscle fibers for formation of an external compressive continence mechanism (illustration below). This concept for a continence mechanism may be extended to the revisions of non-orthotopic neo-bladders or diversion channels that have developed incontinence. 114 Outcomes 28

117 Second Stage Urethroplasty Augmented by Additional Grafting: An Alternative to Revision of the First Stage By using the innovative approach of second stage urethroplasty augmented by additional grafting, our patients are able to avoid an additional surgical procedure to complete their complex urethral reconstruction. Following first stage urethroplasty, some patients require additional surgical revisions prior to second stage closure. As an alternative, our surgeons proceed directly to second stage urethroplasty in a select group of patients using additional grafts to augment the repair. In this manner, augmentation of the urethral plate with either an oral mucosa or preputial skin graft during second stage urethroplasty is a viable option and may provide excellent cosmetic and functional results. Other Miscellaneous Innovations: Trial demonstrating feasibility of dorsal genital nerve stimulation (and design of actual device for this stimulation) for idiopathic overactive bladder in women Demonstration of a postoperative care pathway for midurethral slings allowing for discharge home within three hours after surgery without routine admission, labwork and postoperative antibiotics Suburethral tape and paraurethral slings for the treatment of stress urinary incontinence Double head urethral catheter for the treatment of male urinary retention Prostatic Spanner stent; one size fits all for the treatment of male urinary retention. This replaces the current Spanner stent that comes in five different sizes. Cone-shaped bladder biopsy forceps for bladder cancer Demonstration of XMRV chromosomal insertion sites Novel bladder instillation therapy for patients suffering with interstitial cystitis, radiation cystitis and hemorrhagic cystitis Glickman Urological & Kidney Institute 115

118 Selected Publications Glickman Urological & Kidney Institute staff authored 474 publications in 28. For a complete list go to quality/outcomes Nephrology & Hypertension Augustine JJ, Poggio ED, Heeger PS, Hricik DE. Preferential benefit of antibody induction therapy in kidney recipients with high pretransplant frequencies of donor-reactive interferongamma enzyme-linked immunosorbent spots. Transplantation. 28 Aug 27;86(4): Bierer SB, Dannefer EF, Taylor C, Hall P, Hull AL. Methods to assess students acquisition, application and integration of basic science knowledge in an innovative competency-based curriculum. Med Teach. 28;3(7): Brotman DJ, Davidson MB, Boumitri M, Vidt DG. Impaired diurnal blood pressure variation and all-cause mortality. Am J Hypertens. 28 Jan;21(1): Chand DH, Teo BW, Fatica RA, Brier M. Influence of vascular access type on outcome measures in patients on maintenance hemodialysis. Nephron Clin Pract. 28; 18(2):c91-c98. Demirjian S, Teo BW. The authors reply [Alkalemia during continuous renal replacement therapy]. Crit Care Med. 28 Nov;36(11): Demirjian S, Teo BW, Paganini EP. Alkalemia during continuous renal replacement therapy and mortality in critically ill patients. Crit Care Med. 28 May;36(5): Demirjian SG, Nurko S. Anemia of chronic kidney disease: when normalcy becomes undesirable. Cleve Clin J Med. 28 May;75(5): Guipponi M, Toh MY, Tan J, Park D, Hanson K, Ballana E, Kwong D, Cannon PZF, Wu Q, Gout A, Delorenzi M, Speed TP, Smith RJH, Dahl HH, Petersen M, Teasdale RD, Estivill X, Park WJ, Scott HS. An integrated genetic and functional analysis of the role of type II transmembrane serine proteases (TMPRSSs) in hearing loss. Hum Mutat. 28 Jan;29(1): Herts BR, Schneider E, Poggio ED, Obuchowski NA, Baker ME. Identifying outpatients with renal insufficiency before contrast-enhanced CT by using estimated glomerular filtration rates versus serum creatinine levels. Radiology. 28 Jul;248(1): Issa N, Poggio ED, Fatica RA, Patel R, Ruggieri PM, Heyka RJ. Nephrogenic systemic fibrosis and its association with gadolinium exposure during MRI. Cleve Clin J Med. 28 Feb;75(2): Issa N, Meyer KH, Arrigain S, Choure G, Fatica RA, Nurko S, Stephany BR, Poggio ED. Evaluation of creatinine-based estimates of glomerular filtration rate in a large cohort of living kidney donors. Transplantation. 28 Jul 27;86(2): Outcomes 28

119 Liew YP, Bartholomew JR, Demirjian S, Michaels J, Schreiber MJ, Jr. Combined effect of chronic kidney disease and peripheral arterial disease on all-cause mortality in a high-risk population. Clin J Am Soc Nephrol. 28 Jul;3(4): Mayuga KA, Butters KB, Fouad-Tarazi F. Early versus late postural tachycardia: a re-evaluation of a syndrome. Clin Auton Res. 28 Jun;18(3): Pinsky MR, Brophy P, Padilla J, Paganini E, Pannu N. Fluid and volume monitoring. Int J Artif Organs. 28 Feb;31(2): Schold JD, Srinivas TR, Kayler LK, Meier-Kriesche HU. The overlapping risk profile between dialysis patients listed and not listed for renal transplantation. Am J Transplant. 28 Jan;8(1): Schold JD, Srinivas TR, Howard RJ, Jamieson IR, Meier-Kriesche HU. The association of candidate mortality rates with kidney transplant outcomes and center performance evaluations. Transplantation. 28 Jan 15;85(1):1-6. Srinivas TR, Meier-Kriesche HU. Minimizing immunosuppression, an alternative approach to reducing side effects: objectives and interim result. Clin J Am Soc Nephrol. 28 Mar;3 Suppl 2:S11-S116. Tolwani A, Paganini E, Joannidis M, Zamperetti N, Verbine A, Vidyasagar V, Clark W, Ronco C. Treatment of patients with cardiac surgery associated-acute kidney injury. Int J Artif Organs. 28 Feb;31(2): Yarlagadda SG, Coca SG, Garg AX, Doshi M, Poggio E, Marcus RJ, Parikh CR. Marked variation in the definition and diagnosis of delayed graft function: a systematic review. Nephrol Dial Transplant. 28 Sep;23(9): Regional Urology Abouassaly R, Tan N, Moussa A, Jones JS. Risk of prostate cancer after diagnosis of atypical glands suspicious for carcinoma on saturation and traditional biopsies. J Urol. 28 Sep;18(3): Derweesh IH, Ismail HR, Goldfarb DA, Araki M, Zhou L, Modlin C, Krishnamurthi V, Flechner SM, Novick AC. Intraoperative placing of drains decreases the incidence of lymphocele and deep vein thrombosis after renal transplantation. BJU Int. 28 Jun;11(11): Desai MM, Aron M, Canes D, Fareed K, Carmona O, Haber GP, Crouzet S, Astigueta JC, Lopez R, de Andrade R, Stein RJ, Ulchaker J, Sotelo R, Gill IS. Single-port transvesical simple prostatectomy: initial clinical report. Urology. 28 Nov;72(5): Dong F, Jones JS, Stephenson AJ, Magi-Galluzzi C, Reuther AM, Klein EA. Prostate cancer volume at biopsy predicts clinically significant upgrading. J Urol. 28 Mar;179(3): Goldman HB, Amundsen CL, Mangel J, Grill J, Bennett M, Gustafson KJ, Grill WM. Dorsal genital nerve stimulation for the treatment of overactive bladder symptoms. Neurourol Urodyn. 28;27(6): Kaouk JH, Hafron J, Goel R, Haber GP, Jones JS. Robotic salvage retropubic prostatectomy after radiation/ brachytherapy: initial results. BJU Int. 28 Jul;12(1): Kaouk JH, Palmer JS. Single-port laparoscopic surgery: initial experience in children for varicocelectomy. BJU Int. 28 Jul;12(1): Nguyen CT, Babineau DC, Jones JS. Impact of urologic resident training on patient pain and morbidity associated with office-based cystoscopy. Urology. 28 May;71(5): Glickman Urological & Kidney Institute 117

120 Selected Publications Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 28 Mar;179(3): Ridgeway B, Walters MD, Paraiso MFR, Barber MD, McAchran SE, Goldman HB, Jelovsek JE. Early experience with mesh excision for adverse outcomes after transvaginal mesh placement using prolapse kits. Am J Obstet Gynecol. 28 Dec;199(6): Smith AK, Hansel DE, Jones JS. Role of cystitis cystica et glandularis and intestinal metaplasia in development of bladder carcinoma. Urology. 28 May;71(5): Tan N, Lane BR, Li J, Moussa AS, Soriano M, Jones JS. Prostate cancers diagnosed at repeat biopsy are smaller and less likely to be high grade. J Urol. 28 Oct;18(4): Tanchanco R, Krishnamurthi V, Winans C, Wee A, Duclos A, Nurko S, Fatica R, Lard M, Poggio ED. Beneficial outcomes of a steroid-free regimen with thymoglobulin induction in pancreas-kidney transplantation. Transplant Proc. 28 Jun;4(5): Vaze A, Goldman H, Jones JS, Rackley R, Vasavada S, Gustafson KJ. Determining the course of the dorsal nerve of the clitoris. Urology. 28 Nov;72(5): Urology Abouassaly R, Tan N, Moussa A, Jones JS. Risk of prostate cancer after diagnosis of atypical glands suspicious for carcinoma on saturation and traditional biopsies. J Urol. 28 Sep;18(3): Abouassaly R, Lane BR, Novick AC. Active surveillance of renal masses in elderly patients. J Urol. 28 Aug;18(2):55-58; discussion Agarwal A, Deepinder F, Sharma RK, Ranga G, Li J. Effect of cell phone usage on semen analysis in men attending infertility clinic: an observational study. Fertil Steril. 28 Jan;89(1): Agarwal A, Gupta S, Sekhon L, Shah R. Redox considerations in female reproductive function and assisted reproduction: from molecular mechanisms to health implications. Antioxid Redox Signal. 28 Aug;1(8): Aron M, Koenig P, Kaouk JH, Nguyen MM, Desai MM, Gill IS. Robotic and laparoscopic partial nephrectomy: a matched-pair comparison from a high-volume centre. BJU Int. 28 Jul;12(1): Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 28 Mar;111(3): Berger A, Haber GP, Kamoi K, Aron M, Desai MM, Kaouk JH, Gill IS. Laparoscopic radical nephroureterectomy for upper tract transitional cell carcinoma: oncological outcomes at 7 years. J Urol. 28 Sep;18(3): Outcomes 28

121 Chuang FP, Novick AC, Sun GH, Kleeman M, Flechner S, Krishnamurthi V, Modlin C, Shoskes D, Goldfarb DA. Graft outcomes of living donor renal transplantations in elderly recipients. Transplant Proc. 28 Sep;4(7): Colombo JR, Jr., Desai M, Canes D, Frota R, Haber GP, Moinzadeh A, Tuerk I, Desai MR, Gill IS. Laparoscopic partial cystectomy for urachal and bladder cancer. Clinics. 28 Dec;63(6): Colombo JR, Jr., Haber GP, Gill IS. Laparoscopic partial nephrectomy in patients with compromised renal function. Urology. 28 Jun;71(6): Colombo JR, Jr., Haber GP, Jelovsek JE, Lane B, Novick AC, Gill IS. Seven years after laparoscopic radical nephrectomy: oncologic and renal functional outcomes. Urology. 28 Jun;71(6): Das T, Sa G, Paszkiewicz-Kozik E, Hilston C, Molto L, Rayman P, Kudo D, Biswas K, Bukowski RM, Finke JH, Tannenbaum CS. Renal cell carcinoma tumors induce T cell apoptosis through receptor-dependent and receptor-independent pathways. J Immunol. 28 Apr 1;18(7): Deroche T, Walker E, Magi-Galluzzi C, Zhou M. Pathologic characteristics of solitary small renal masses: can they be predicted by preoperative clinical parameters? Am J Clin Pathol. 28 Oct;13(4): Desai MM, Aron M, Canes D, Fareed K, Carmona O, Haber GP, Crouzet S, Astigueta JC, Lopez R, de Andrade R, Stein RJ, Ulchaker J, Sotelo R, Gill IS. Single-port transvesical simple prostatectomy: initial clinical report. Urology. 28 Nov;72(5): Dhar NB, Jones JS, Reuther AM, Dreicer R, Campbell SC, Sanii K, Klein EA. Presentation, location and overall survival of pelvic recurrence after radical cystectomy for transitional cell carcinoma of the bladder. BJU Int. 28 Apr;11(8): Fergany AF, Gill IS. Laparoscopic radical cystectomy. Urol Clin North Am. 28 Aug;35(3): Finke JH, Rini B, Ireland J, Rayman P, Richmond A, Golshayan A, Wood L, Elson P, Garcia J, Dreicer R, Bukowski R. Sunitinib reverses type-1 immune suppression and decreases T-regulatory cells in renal cell carcinoma patients. Clin Cancer Res. 28 Oct 15;14(2): Garcia JA, Klein EA, Magi-Galluzzi C, Elson P, Triozzi P, Dreicer R. Clinical and biological effects of neoadjuvant sargramostim and thalidomide in patients with locally advanced prostate carcinoma. Clin Cancer Res. 28 May 15;14(1): Gill IS, Canes D, Aron M, Haber GP, Goldfarb DA, Flechner S, Desai MR, Kaouk JH, Desai MM. Single port transumbilical (E-NOTES) donor nephrectomy. J Urol. 28 Aug;18(2): Goel RK, Kaouk JH. Probe ablative treatment for small renal masses: cryoablation vs. radio frequency ablation. Curr Opin Urol. 28 Sep;18(5): Haber GP, Aron M, Ukimura O, Gill IS. Energy-free nerve-sparing laparoscopic radical prostatectomy: the bulldog technique. BJU Int. 28 Dec;12(11): Hansel DE, Swain E, Dreicer R, Tubbs RR. HER2 overexpression and amplification in urothelial carcinoma of the bladder is associated with MYC coamplification in a subset of cases. Am J Clin Pathol. 28 Aug;13(2): Herts BR, Schneider E, Poggio ED, Obuchowski NA, Baker ME. Identifying outpatients with renal insufficiency before contrast-enhanced CT by using estimated glomerular filtration rates versus serum creatinine levels. Radiology. 28 Jul;248(1): Glickman Urological & Kidney Institute 119

122 Selected Publications Jelovsek JE, Barber MD, Karram MM, Walters MD, Paraiso MFR. Randomised trial of laparoscopic Burch colposuspension versus tension-free vaginal tape: long-term follow up. BJOG. 28 Feb;115(2): ; discussion 225. Kaouk JH, Goel RK, Haber GP, Crouzet S, Desai MM, Gill IS. Single-port laparoscopic radical prostatectomy. Urology. 28 Dec;72(6): Kaouk JH, Haber GP, Goel RK, Desai MM, Aron M, Rackley RR, Moore C, Gill IS. Single-port laparoscopic surgery in urology: initial experience. Urology. 28 Jan;71(1):3-6. Kaouk JH, Hafron J, Goel R, Haber GP, Jones JS. Robotic salvage retropubic prostatectomy after radiation/ brachytherapy: initial results. BJU Int. 28 Jul;12(1): Karnak I, Woo LL, Shah SN, Sirajuddin A, Kay R, Ross JH. Prenatally detected ureteropelvic junction obstruction: clinical features and associated urologic abnormalities. Pediatr Surg Int. 28 Apr;24(4): Kefer JC, Desai MM, Fergany A, Novick AC, Gill IS. Outcomes of partial nephrectomy in patients on chronic oral anticoagulant therapy. J Urol. 28 Dec;18(6): Klein EA, Stephenson AJ, Raghavan D, Dreicer R. Systems pathology and predicting outcome after radical prostatectomy. J Clin Oncol. 28 Aug 2;26(24): Lane BR, Aydin H, Danforth TL, Zhou M, Remer EM, Novick AC, Campbell SC. Clinical correlates of renal angiomyolipoma subtypes in 29 patients: classic, fat poor, tuberous sclerosis associated and epithelioid. J Urol. 28 Sep;18(3): Lane BR, Babineau DC, Poggio ED, Weight CJ, Larson BT, Gill IS, Novick AC. Factors predicting renal functional outcome after partial nephrectomy. J Urol. 28 Dec;18(6): Lane BR, Campbell SC, Remer EM, Fergany AF, Williams SB, Novick AC, Weight CJ, Magi-Galluzzi C, Zhou M. Adult cystic nephroma and mixed epithelial and stromal tumor of the kidney: clinical, radiographic, and pathologic characteristics. Urology. 28 Jun;71(6): Lane BR, Samplaski MK, Herts BR, Zhou M, Novick AC, Campbell SC. Renal mass biopsy--a renaissance? J Urol. 28 Jan;179(1):2-27. Larson BT, Magi-Galluzzi C, Casey G, Plummer SJ, Silverman R, Klein EA. Pathological aggressiveness of prostatic carcinomas related to RNASEL R462Q allelic variants. J Urol. 28 Apr;179(4): Lee UJ, Goldman H, Moore C, Daneshgari F, Rackley RR, Vasavada SP. Rate of de novo stress urinary incontinence after urethal diverticulum repair. Urology. 28 May;71(5): Lin YC, Haber GP, Turna B, Frota R, Koenig P, Desai M, Kaouk J, Gill IS. Laparoscopic renal oncological surgery in the presence of abdominal aortic and vena caval pathology: 8-year experience. J Urol. 28 Feb;179(2): Nguyen CT, Lane BR, Kaouk JH, Hegarty N, Gill IS, Novick AC, Campbell SC. Surgical salvage of renal cell carcinoma recurrence after thermal ablative therapy. J Urol. 28 Jul;18(1): Nguyen MM, Gill IS. Halving ischemia time during laparoscopic partial nephrectomy. J Urol. 28 Feb;179(2): ; discussion Outcomes 28

123 Nguyen MM, Kamoi K, Stein RJ, Aron M, Hafron JM, Turna B, Myers RP, Gill IS. Early continence outcomes of posterior musculofascial plate reconstruction during robotic and laparoscopic prostatectomy. BJU Int. 28 May;11(9): Nozaki T, Rosenblum JM, Ishii D, Tanabe K, Fairchild RL. CD4 T cell-mediated rejection of cardiac allografts in B cell-deficient mice. J Immunol. 28 Oct 15;181(8): Palmer JS. Extravesical ureteral reimplantation: an outpatient procedure. J Urol. 28 Oct;18 (4 Suppl): Rini BI, Choueiri TK, Elson P, Khasawneh MK, Cotta C, Unnithan J, Wood L, Mekhail T, Garcia J, Dreicer R, Bukowski RM. Sunitinib-induced macrocytosis in patients with metastatic renal cell carcinoma. Cancer. 28 Sep 15;113(6): Roma A, Varsegi M, Magi-Galluzzi C, Ulbright T, Zhou M. The distinction of bronchogenic cyst from metastatic testicular teratoma: a light microscopic and immunohistochemical study. Am J Clin Pathol. 28 Aug;13(2): Rovner ES, Rackley R, Nitti VW, Wang JT, Guan Z. Tolterodine extended release is efficacious in continent and incontinent subjects with overactive bladder. Urology. 28 Sep;72(3): Schenk AD, Nozaki T, Rabant M, Valujskikh A, Fairchild RL. Donor-reactive CD8 memory T cells infiltrate cardiac allografts within 24-h post-transplant in naive recipients. Am J Transplant. 28 Aug;8(8): Sharma D, Arya M, Muneer A, Grange P, Gill IS. Intraluminal robotics: a new dawn in minimally invasive surgery? BJU Int. 28 Aug;12(3): Sharma N, O Hara J, Novick AC, Lieber M, Remer EM, Herts BR. Correlation between loss of renal function and loss of renal volume after partial nephrectomy for tumor in a solitary kidney. J Urol. 28 Apr;179(4): Simmons MN, Schreiber MJ, Gill IS. Surgical renal ischemia: a contemporary overview. J Urol. 28 Jul;18(1):19-3. Smith AK, Hansel DE, Jones JS. Role of cystitis cystica et glandularis and intestinal metaplasia in development of bladder carcinoma. Urology. 28 May;71(5): Stephenson AJ, Gill IS. Laparoscopic radical cystectomy for muscle-invasive bladder cancer: pathological and oncological outcomes. BJU Int. 28 Nov;12(9 Pt B): Tamaskar I, Bukowski R, Elson P, Ioachimescu AG, Wood L, Dreicer R, Mekhail T, Garcia J, Rini BI. Thyroid function test abnormalities in patients with metastatic renal cell carcinoma treated with sorafenib. Ann Oncol. 28 Feb;19(2): Tamaskar I, Garcia JA, Elson P, Wood L, Mekhail T, Dreicer R, Rini BI, Bukowski RM. Antitumor effects of sunitinib or sorafenib in patients with metastatic renal cell carcinoma who received prior antiangiogenic therapy. J Urol. 28 Jan;179(1):81-86; discussion 86. Tanchanco R, Krishnamurthi V, Winans C, Wee A, Duclos A, Nurko S, Fatica R, Lard M, Poggio ED. Beneficial outcomes of a steroid-free regimen with thymoglobulin induction in pancreas-kidney transplantation. Transplant Proc. 28 Jun;4(5): Glickman Urological & Kidney Institute 121

124 Selected Publications Thomas AA, Rackley RR, Lee U, Goldman HB, Vasavada SP, Hansel DE. Urethral diverticula in 9 female patients: a study with emphasis on neoplastic alterations. J Urol. 28 Dec;18(6): Turna B, Aron M, Frota R, Desai MM, Kaouk J, Gill IS. Feasibility of laparoscopic partial nephrectomy after previous ipsilateral renal procedures. Urology. 28 Sep;72(3): Turna B, Aron M, Gill IS. Expanding indications for laparoscopic partial nephrectomy. Urology. 28 Sep;72(3): Turna B, Frota R, Kamoi K, Lin YC, Aron M, Desai MM, Kaouk JH, Gill IS. Risk factor analysis of postoperative complications in laparoscopic partial nephrectomy. J Urol. 28 Apr;179(4): ; discussion Ukimura O, Ahlering TE, Gill IS. Transrectal ultrasoundguided, energy-free, nerve-sparing laparoscopic radical prostatectomy. J Endourol. 28 Sep;22(9): Weight CJ, Fergany AF, Gunn PW, Lane BR, Novick AC. The impact of minimally invasive techniques on open partial nephrectomy: a 1-year single institutional experience. J Urol. 28 Jul;18(1): Weight CJ, Kaouk JH, Hegarty NJ, Remer EM, O Malley CM, Lane BR, Gill IS, Novick AC. Correlation of radiographic imaging and histopathology following cryoablation and radio frequency ablation for renal tumors. J Urol. 28 Apr;179(4): ;discussion Weight CJ, Reuther AM, Gunn PW, Zippe CR, Dhar NB, Klein EA. Limited pelvic lymph node dissection does not improve biochemical relapse-free survival at 1 years after radical prostatectomy in patients with low-risk prostate cancer. Urology. 28 Jan;71(1): Wesa AK, Herrem CJ, Mandic M, Taylor JL, Vasquez C, Kawabe M, Tatsumi T, Leibowitz MS, Finke JH, Bukowski RM, Bruckheimer E, Kinch MS, Storkus WJ. Enhancement in specific CD8+ T cell recognition of EphA2+ tumors in vitro and in vivo after treatment with ligand agonists. J Immunol. 28 Dec 1;181(11): White PF, O Hara JF, Roberson CR, Wender RH, Candiotti KA. The impact of current antiemetic practices on patient outcomes: a prospective study on high-risk patients. Anesth Analg. 28 Aug;17(2): Wood HM, Kay R, Angermeier KW, Ross JH. Timing of the presentation of urethrocutaneous fistulas after hypospadias repair in pediatric patients. J Urol. 28 Oct;18 (4 Suppl): Wood HM, Kuang M, Woo L, Hijaz A, Butler RS, Penn M, Rackley R, Damaser MS. Cytokine expression after vaginal distention of different durations in virgin Sprague-Dawley rats. J Urol. 28 Aug;18(2): Zaramo CEB, Morton T, Yoo JW, Bowen GR, Modlin CS. Culturally competent methods to promote organ donation rates among african-americans using venues of the bureau of motor vehicles. Transplant Proc. 28 May;4(4): Outcomes 28

125 Anesthesiology Biki B, Mascha E, Moriarty DC, Fitzpatrick JM, Sessler DI, Buggy DJ. Anesthetic technique for radical prostatectomy surgery affects cancer recurrence: a retrospective analysis. Anesthesiology. 28 Aug;19(2): Farag E, Baccala AA, Jr., Doutt RF, Ulchaker J, O Hara J. Laser bladder perforation from photoselective vaporization of prostate resulting in rhabdomyolysis induced acute renal failure. Minerva Anestesiol. 28 Jun;74(6): Glickman Urological & Kidney Institute 123

126 Staff Listing Institute Chairman Eric A. Klein, MD Institute Patient Experience Officer Anthony Thomas, MD Institute Quality Review Officer Howard Goldman, MD Anesthesiology Armin Schubert, MD, MBA Chairman, General Anesthesiology Jerome O Hara, Jr., MD Section Head, Urology & Regional Urology Anesthesia Matvey Bobylev, MD Jacek Cywinski, MD J. Michael DeUngria, MD (deceased) Brian Fitzsimons, MD Saras Karri, MD Edward Noguera, MD Mauricio Perilla, MD R. Michael Ritchey, MD Stacy Ritzman, MD J. Victor Ryckman, MD Vivek Sabharwal, MD Solur Udayashankar, MD Nephrology and Hypertension Martin Schreiber, MD Department Chairman Institute Vice Chairman William Braun, MD Emmanuel Bravo, MD Saud Butt, MD Sevag Demirjian, MD Richard Fatica, MD Rachel Fissell, MD William Fissell, MD Surafel Gebreselassie, MD Phillip Hall, MD Christopher Hebert, MD Robert Heyka, MD Sorana Hila, MD Priya Kalahasti, MD Martin Lascano, MD Joseph Nally, MD Quality Review Officer, Nephrology and Hypertension Sankar Navaneethan, MD Saul Nurko, MD Emilio Poggio, MD Marc Pohl, MD Mohammed Rafey, MD James Simon, MD Titte Srinivas, MD Brian Stephany, MD Qingyu Wu, MD, PhD 124 Outcomes 28

127 Regional Urology J. Stephen Jones, MD Department Chairman Institute Vice Chairman Ryan Berglund, MD Jonathan Boyd, MD Shih Chieh Chueh, MD, PhD George Coseriu, MD Louis D Amico, MD Khaled Fareed, MD William Forsythe, MD Howard Goldman, MD Quality Review Officer, Urology and Regional Urology Michael Gong, MD Elroy Kursh, MD William Larchian, MD David Levy, MD Sanford Luria, MD Stephen Mahoney, MD Charles Modlin, MD Mark Noble, MD Jeffrey Palmer, MD Arthur Porter, MD Edmund Sabanegh, MD Kamrooz Sanii, MD Bashir Sankari, MD Gaurang Shah, MD Robert Shapiro, MD Luay Susan, MD Alvin Wee, MD Lawrence Wyner, MD Craig Zippe, MD Urology Drogo Montague, MD Interim Department Chairman Insitute Vice Chairman Ashok Agarwal, MD Kenneth Angermeier, MD Steven Campbell, MD Mihir Desai, MD Amr Fergany, MD Stuart Flechner, MD Inderbir Gill, MD David Goldfarb, MD Sajal Gupta, MD Jihad Kaouk, MD Venkatesh Krishnamurthi, MD Milton Lakin, MD Courtenay Moore, MD Andrew Novick, MD (deceased) Former Institute Chairman Thomas Powell, MD John Rabets, MD Raymond Rackley, MD Jonathan Ross, MD Daniel Shoskes, MD Robert Stein, MD Andrew Stephenson, MD James Ulchaker, MD Sandip Vasavada, MD Some physicians may practice in multiple locations. For a complete list including staff photos, please visit clevelandclinic.org/staff Glickman Urological & Kidney Institute 125

128 Contact Information General Patient Referral 24/7 hospital transfers or physician consults Additional Contact Information General Information Urology Appointments/Referrals or , ext. 456 Hospital Patient Information Nephrology Appointments/Referrals or , ext Patient Appointments or Minority Men s Health Center Appointments/Referrals or , ext. 456 On the Web at clevelandclinic.org/glickman Medical Concierge for Out-of-State Patients Complimentary assistance for out-of-state patients and families , ext. 5558, or medicalconcierge@ccf.org Global Patient Services/International Center Complimentary assistance for international patients and families or visit clevelandclinic.org/gps Cleveland Clinic in Florida For address corrections or changes, please call Outcomes 28

129 Institute Locations Main Campus 95 Euclid Ave. Cleveland, OH Elyria Memorial Hospital 125 E. Broad St., Suite 28 Elyria, OH Avon Lake Family Health Center 45 Avon Belden Road Avon Lake, OH Beachwood Family Health and Surgery Center 269 Cedar Road, Suite 36 Beachwood, OH Charleston, West Virginia Charleston Area Medical Center 121 Washington Street East, Suite 1 Charleston, WV Cleveland Clinic in Florida 295 Cleveland Clinic Boulevard Weston, Florida Euclid Hospital Medical Office Building 99 Northline Circle, Suite 21 Euclid, OH Fairview Hospital 1811 Lorain Ave. Cleveland, OH Hillcrest Urology Hillcrest Hospital Atrium 677 Mayfield Road, Suite 226 Mayfield Heights, OH Huron Hospital Terrace Road East Cleveland, OH Glickman Urological & Kidney Institute 127

130 Institute Locations Independence Family Health Center 51 Rockside Road Crown Centre II Independence, OH Lakewood Hospital INA Building 1471 Detroit Ave., Suite 64 Lakewood, OH Lorain Family Health and Surgery Center 57 Cooper Foster Park Road Lorain, OH Marymount Hospital 123 McCracken Road Garfield Heights, OH Urology at Mayfield Hillcrest Hospital Atrium 677 Mayfield Road, Suite 237 Mayfield Heights, OH Outcomes 28

131 Parma Community General Hospital 77 Powers Blvd. Parma, OH St. Vincent Indianapolis Hospital 21 W. 86th St. Indianapolis, IN Solon Family Health Center 298 Bainbridge Road Solon, OH Strongsville Family Health and Surgery Center SouthPark Center Strongsville, OH Westlake Family Health Center 333 Clemens Road Westlake, OH Glickman Urological & Kidney Institute 129

132 Cleveland Clinic Overview In 27, Cleveland Clinic restructured its practice, bundling all clinical specialties into integrated practice units called institutes. An institute combines all the specialties surrounding a specific organ or disease system under a single roof. Each institute has a single leadership and focuses the energies of multiple professionals onto the patient. From access and communication to billing and point-of-care service, institutes will improve the patient experience at Cleveland Clinic. Cleveland Clinic s main campus, with 5 buildings on 166 acres in Cleveland, Ohio, includes a 1,-bed hospital, outpatient clinic, specialty institutes and supporting labs and facilities. Cleveland Clinic also operates 15 family health centers; eight community hospitals; one affiliate hospital; a rehabilitation hospital for children; a 15-bed hospital and clinic in Weston, Fla.; and health and wellness centers in Palm Beach, Fla., and Toronto, Canada. Cleveland Clinic Abu Dhabi (United Arab Emirates), a multispecialty care hospital and clinic, is scheduled to open in late 212. Now in its fifth year of existence, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University offers all students full tuition scholarships. The program will graduate its first 29 students as physician-scientists in 29. Cleveland Clinic is consistently ranked among the top hospitals in America by U.S.News & World Report, and our heart and heart surgery program has been ranked No. 1 since For more information about Cleveland Clinic, please visit clevelandclinic.org At the Cleveland Clinic Lerner Research Institute, hundreds of principal investigators, project scientists, research associates and postdoctoral fellows are involved in laboratory-based, translational and clinical research. Total annual research expenditures exceed $244 million from federal agencies, non-federal societies and associations, endowment funds and other sources. In an effort to bring research from bench to bedside, Cleveland Clinic physicians are involved in more than 2,4 clinical studies at any given time. 13 Outcomes 28

133 Resources for Physicians Cleveland Clinic Secure Online Services Cleveland Clinic uses state-of-the-art digital information systems to offer secure online services such as online medical second opinions, medical record access, patient treatment progress for referring physicians (see below), and imaging interpretations by our subspecialty trained radiologists. For more information, please visit eclevelandclinic.org. MyChart This secure online tool connects patients to their own health information from the privacy of their home any time, day or night. Some features include renewing prescriptions, reviewing test results and viewing medications, all online. For the convenience of physicians and patients across the country, MyChart now offers a secure connection to Google Health. Google Health users can securely share personal health information with Cleveland Clinic, and record and share the details of their Cleveland Clinic treatment with the physicians and healthcare providers of their choice. To establish a MyChart account, visit clevelandclinic.org/mychart. DrConnect Whether you are referring from near or far, DrConnect streamlines communication from Cleveland Clinic physicians to your office. This complimentary online tool offers secure access to your patient s treatment progress at Cleveland Clinic. With one-click convenience, you can track your patient s care using the secure DrConnect website. To establish a DrConnect account, visit clevelandclinic.org/ drconnect or drconnect@ccf.org. MyConsult Online Medical Second Opinion This secure online service provides specialist consultations from our Cleveland Clinic experts and remote medical second opinions for more than 1, life-threatening and lifealtering diagnoses. MyConsult is particularly valuable for people who wish to avoid the time and expense of travel. For more information, visit clevelandclinic.org/myconsult, eclevelandclinic@ccf.org or call , ext Critical Care Transport: Anywhere in the world Cleveland Clinic s critical care transport team serves critically ill and highly complex patients across the globe. The transport fleet comprises mobile ICU vehicles, helicopters and fixed-wing aircraft. The transport teams are staffed by physicians, critical care nurse practitioners, critical care nurses, paramedics and ancillary staff, and are customized to meet the needs of the patient. Critical care transport is available for children and adults. To arrange a transfer for STEMI (ST elevated myocardial infarction), acute stroke, ICH (intracerebral hemorrhage), SAH (subarachnoid hemorrhage) or aortic syndromes, call CODE (2633). For all other transfers, call or CME Opportunities: Live and Online Cleveland Clinic s Center for Continuing Education s website, clevelandclinicmeded.com, offers hundreds of convenient, complimentary learning opportunities, from webcasts and podcasts to a host of medical publications including the Disease Management Project Online Medical Textbook, with more than 15 chapters. The site also offers a schedule of live CME courses, including international summits that focus on key areas of translational research. Many live CME courses are hosted in Cleveland, an economical option for business travel. Physicians can manage their CME credits by using the mycme Web Portal. Available 24/7, the site offers CME opportunities to medical professionals across the globe. Glickman Urological & Kidney Institute 131

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