PVP. Photoselective Vaporization of the. Prostate. Breakthrough Treatment for BPH. Includes interviews with:

Transcription

1 Supplement To The Leading Newsmagazine for Urologists May 2002 Vol. 30 Supplement 1 Photoselective Vaporization of the PVP Prostate Breakthrough Treatment for BPH Includes interviews with: Reza S. Malek, MD Professor of Urology Mayo Clinic Rochester, Minnesota Mahmood A. Hai, MD Staff Urologist Oakwood Annapolis Hospital Wayne, Michigan Unyime O. Nseyo, MD Professor and Chairman Division of Urology Virginia Commonwealth University Richmond, Virginia Jeffrey Lapeyrolerie, MD Staff Urologist St. Vincent Charity Hospital Cleveland, Ohio

2 Ray Lender GENERAL MANAGER Matthew Holland GROUP DIRECTOR Kimberly Barnett ASSOCIATE PUBLISHER UROLOGY TIMES This Urology Times supplement was produced by Advanstar Medical Education Services under an unrestricted educational grant from Laserscope ( The views and opinions in this supplement are those of the interviewed physicians and do not necessarily reflect the views of the editors, Advanstar Medical Education Services, or Laserscope. Copyright 2002 Advanstar Communications Inc. All rights reserved. Robert L. Krakoff CHAIRMAN AND CHIEF EXECUTIVE OFFICER James M. Alic VICE CHAIRMAN Joseph Loggia PRESIDENT AND CHIEF OPERATING OFFICER David W. Montgomery VICE PRESIDENT-FINANCE, CHIEF FINANCIAL OFFICER AND SECRETARY Alexander S. DeBarr Daniel M. Phillips EXECUTIVE VICE PRESIDENTS Eric I. Lisman EXECUTIVE VICE PRESIDENT- CORPORATE DEVELOPMENT Adele D. Hartwick VICE PRESIDENT, TREASURER AND CONTROLLER Rick Treese VICE PRESIDENT AND CHIEF TECHNOLOGY OFFICER EDITORIAL OFFICES: 7500 Old Oak Blvd. Cleveland, OH (440) PUBLISHING OFFICES: One Park Ave. New York, NY (917)

3 PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) BREAKTHROUGH TREATMENT FOR BPH Includes interviews with: Reza S. Malek, MD Professor of Urology, Department of Urology Mayo Clinic Rochester, Minnesota Mahmood A. Hai, MD Staff Urologist Oakwood Annapolis Hospital, Wayne, Michigan Private Practice Affiliates in Urology, Westland, Michigan Unyime O. Nseyo, MD Professor and Chairman, Division of Urology Virginia Commonwealth University Richmond, Virginia Jeffrey Lapeyrolerie, MD Staff Urologist St. Vincent Charity Hospital Cleveland, Ohio 3

4 PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) BREAKTHROUGH TREATMENT FOR BPH INTRODUCTION Given its proven long-term track record, transurethral resection of the prostate (TURP) is considered the gold standard for treating benign prostatic hyperplasia (BPH). Unfortunately, this procedure is associated with long hospitalization stays of 1 to 2 days, slow recovery times of 4 to 6 weeks, and risk of postoperative pain, discomfort, bleeding, urinary incontinence, retrograde ejaculation, and impotence. 1 To overcome the disadvantages associated with TURP, alternative procedures for BPH, such as transurethral needle ablation, microwave therapy and various laser procedures have been introduced. Although less invasive than TURP, they do not offer quite the same efficacy as TURP in terms of improved symptom scores and uroflow rates. 2,3 Long-term outcomes are currently unknown given their new status in the marketplace. In recent years, Dr. Reza Malek and colleagues at the Mayo Clinic have pioneered the use of a high-power Potassium-Titanyl-Phosphate (KTP) laser for photoselective vaporization of the prostate (PVP) to treat BPH. Their work was motivated by the limitations of the VLAP procedure that mainly used Nd:YAG lasers. The large optical penetration depth of the Nd:YAG laser radiation of 10 mm led to deep tissue coagulation, which was responsible for a broad spectrum of side effects. The researchers at the Mayo Clinic progressed to the use of high power KTP lasers with a wavelength of 532 nm, PVP. PVP is different from VLAP in that the KTP laser wavelength is highly absorbed by oxyhemoglobin and penetrates the prostatic tissue only 1 to 2 mm deep. These important characteristics allow the laser energy to be confined in a small volume of tissue eliminating the risks caused by excessive coagulation. The high power KTP laser instantly removes tissue by vaporization of cellular water. Only a thin 1- to 2-mm rim of coagulated tissue remains. The KTP laser is now available with 80 watts of average power and 240 watts of peak power, which allows for larger amounts of adenomatous tissue to be quickly vaporized and removed with minimal blood loss and coagulation. The KTP laser is available as the Niagara PV System from Laserscope, San Jose, California. Practical experience with PVP an interview with 4 leading urologists The Niagara technology has been utilized investigationally for nearly 5 years and the first commercially available product, the Niagara PV System, began shipping in late January Clinical data supporting its use in treating BPH has been favorable, showing significant advantages over TURP. To help urologists obtain a better insight into the use of PVP and the Niagara PV System for the management of BPH, Drs. Reza Malek, Mahmood Hai, Unyime Nseyo, and Jeffrey Lapeyrolerie shared their thoughts about this procedure. Dr. Lapeyrolerie, who only recently began performing PVP, discussed his training and perceptions of the procedure s learning curve. 4

5 PVP for the management of BPH Please explain the importance of BPH in a urology practice. Dr. Hai: BPH is one of the most common conditions afflicting males who present to the urologist. There are approximately 2 million people who are symptomatic from BPH and receiving treatment. According to Medicare figures, about 130,000 to 150,000 of these people undergo TURP; the rest either receive other forms of surgical treatment, such as transurethral needle ablation or microwave therapy, or take medical, herbal, or nonformulary products to relieve their symptoms. It is very important for a urologist to have an appropriate and effective treatment for BPH. Dr. Nseyo: BPH, which oftentimes leads to bladder outlet obstruction, is a very important and expensive public health problem. It is a disease of the aging and the majority of the baby boomer generation are now reaching their 50s and 60s, so you are talking about a large number of patients. Please describe the procedure of PVP. Dr. Malek: PVP is the application of high-power KTP laser energy to vaporize benign obstructive prostatic tissue that develops with BPH. The PVP procedure was invented at the Mayo Clinic in 1997, but the KTP laser has been around since the 1980s. When first introduced, the KTP laser was available in 20 watts of power, which subsequently was increased to 40 watts. At this time, Nd:YAG laser coagulation was being used for BPH; however, dysuria plagued about 30% of the patients and urinary retention lasted up to 11 days. We found that the KTP laser vaporized tissue very effectively and so we developed a hybrid technique using both the KTP and the Nd:YAG lasers. With this combination, we were able to create a channel in the previously YAG laser-treated tissue so that patients could urinate faster and would require only 3 days of catheterization rather than 5 to 11 days. In addition, dysuria was reduced to 12.5%, which is similar to the incidence after TURP. With experience, we realized that the KTP laser alone, rather than the hybrid, produced more favorable results. At our behest, Laserscope developed a 60-watt machine, which proved safe and successful when introduced clinically in Using the 60-watt laser, the procedure could be used on an average prostate of 30 to 40 cc and up to 60 cc in volume. Patients were able to void after their catheter was removed in less than 24 hours; therefore, urinary retention was no longer a problem. Patients had excellent flow rates and made rapid recoveries with practically a meager number of complications compared with other procedures, especially TURP. We now have a machine with 80 watts of KTP power the Niagara PV System. The increased power has allowed us to perform the surgery 30% to 50% faster compared with the 60-watt laser. The 80-watt laser also appears to be more hemostatic I ve done a number of cases with this laser and haven t seen a single drop of blood loss! Dr. Hai: PVP is a form of laser procedure that is most effective in vaporizing prostatic tissue. The KTP laser is photoselective and has an attractiveness towards 5

6 hemoglobin, sealing off the blood vessels so there is no bleeding at all. The laser also has a very strong effect in vaporizing the prostatic tissue; in essence, the tissue turns into vapor without leaving any residue or charring effect. The depth of penetration with this laser is very controlled it only affects tissue 1 to 2 mm in depth. There is no extensive damage beyond what is vaporized. These are the reasons why PVP is a very successful procedure. I have been using lasers for more than 10 years and have been involved in perfecting the PVP technique. Recently, I began working with the 80-watt KTP laser and have done about 70 cases so far. The increased wattage has reduced bleeding and increased the efficacy of vaporization, allowing us to perform the procedure faster with less anesthesia time. I perform the procedure with a continuous flow cystoscope and use a video system with magnification, which allows everyone in the operating room to view the procedure. The video system also protects your eyes and is easier on your back. The KTP laser comes out at the tip of a disposable fiberoptic delivery system at a 70 angle towards the operator. There is no danger of it hitting beyond your visual field and causing any damage. The PVP procedure takes anywhere from 20 to 50 minutes to perform, depending on the size of the prostate gland. A 30- to 50-g prostate can be completed in 20 minutes, but a 100- to 120-g prostate may take up to 50 minutes. A prostate larger than 120 g would probably be treated with open prostatectomy. We rarely see prostates larger than this size because people will seek treatment before it gets that large. Dr. Nseyo: PVP is really a revolutionary procedure where a high-powered KTP laser is transmitted through a fiber to evaporate the prostate. It melts away tissue, with clouds of vapor right in front of you. We recently treated a 100-g prostate in 52 minutes, and the patient had an indwelling catheter only overnight. We could not have achieved that with TURP. If we had used TURP, the patient would have had significant blood loss, or would have remained in the hospital with a catheter for a long time. An open prostatectomy would have resulted in significant blood loss, requiring blood transfusion and a 2- to 3-day hospital stay. I ve been a urologist for about 18 years, and I m very impressed with PVP. How does PVP compare with other procedures for treating BPH? Dr. Malek: If you look at surgery as a form of controlled injury, then PVP is the most benign form of surgical injury that I ve ever inflicted on the prostate to relieve obstruction. In a study I published with Randall Kuntzman and David Barrett in the Journal of Urology in 2000, complications with PVP were relatively scarce in the 55 patients that we followed over 24 months. 4 There were no intraoperative or immediate postoperative problems, except for nonurological febrile reactions in 2 patients. Hematuria was negligible or nonexistent, despite the use of antiplatelet medications. Sterile dysuria occurred in only 7% of patients compared with 10.2% reported for TURP. 5 Retrograde ejaculation was present in 9% of patients after 2 years compared with 96% of patients treated with holmium:yag laser prostatectomy. The incidence of retrograde ejaculation was less than expected given our deliberate attempt to resect the bladder neck widely, as in TURP. 6

7 Compared with our procedure using the KTP laser, holmium:yag laser prostatectomy takes longer to perform versus TURP, is accompanied by hematuria requiring bladder irrigation in 1.6% of patients, re-catheterization in 8%, and urinary symptoms requiring analgesia in 46%. 6 After PVP, patients become very comfortable very quickly. With other procedures, including minimally invasive procedures such as transurethral needle ablation, microwave therapy, and interstitial laser, it takes weeks for people to be comfortable. Dr. Hai: PVP is a marked improvement over all the other procedures. Minimally invasive procedures such as transurethral needle ablation and microwave therapy decrease symptoms by damaging the nerves. For this reason, improvement is temporary and in due course 3, 6, 12 months later the patient presents with the same symptoms. In addition, these procedures do not remove much tissue to open up the prostatic channel. Flow rates may improve temporarily, but in time, they return to the baseline rates. Many patients undergoing these procedures go into urinary retention and require catheters for weeks or even months. Even though these procedures are minimally invasive in the sense that they are performed in the office, some patients need more than 1 session or repeat treatments to obtain relief, and many return to medication or seek other forms of treatment. For years, TURP has been the gold standard for surgical treatment of BPH. Although we considered this procedure very benign, 25% to 30% of patients have some form of complication from it excessive bleeding, TUR syndrome, urinary retention, urinary incontinence, and impotence. Since TURP is performed under general or spinal anesthesia, most patients are hospitalized and catheterized for 1 to 5 days. A few patients may also need constant irrigation after the procedure because of bleeding. In addition, there are certain risks and complications specific to the elderly population. Dr. Nseyo: PVP compares fairly well with the gold standard TURP. The data show an advantage of PVP over TURP. Treating a 100-g prostate in under an hour can t be done with TURP. PVP reduces hospitalization stay, anesthesia time, and the amount of irrigation required compared with TURP. These translate into lower costs. There is also a positive impact on quality of life. The patient is out of the hospital the next day and is able to resume nonvigorous activities within a week. Compared with other minimally invasive procedures, PVP requires 1 session of therapy. You couldn t treat a 100-g prostate with transurethral needle ablation or microwave in a single session. Interstitial laser prostatectomy coagulates the prostate, allowing it to scar over time and open up the urinary tract. This means that the patient has acute inflammation, must wear a catheter, or be subjected to significant irritable voiding symptoms. These issues are not seen with PVP. The problem I see with current minimally invasive therapies is the delayed effect of the treatment and the need for catheterization for prolonged periods of time. None of the new minimally invasive procedures have been able to withstand the test of time. Within 2 to 5 years, the effects seem to wane, requiring retreatment. PVP may become an outpatient procedure, which is a big selling point. It should be pointed out, however, that the drive for outpatient procedures may be more in 7

8 the interest of the practitioner, not the patient. The patient wears the catheter and not the physician. Putting the patient first makes me think twice before offering the treatment modality that I do. Are there any disadvantages to PVP? Dr. Malek: In my experience, there are no disadvantages to this procedure. The only ones I can see are if PVP is performed by an inexperienced physician in a large prostate and by someone who is not familiar with lasers and the damage that they can inflict. Urologists need to have a clear understanding as to what lasers are all about and what they do. If the laser is not delivered (ie, aimed and fired) properly, one could damage the trigone, the orifices of the ureters that are located on the trigone, and even the urinary sphincter. The KTP laser is capable of damage just like any other surgical device. Dr. Hai: I have not found any significant disadvantages. Contraindications to this procedure include patients with acute prostatitis, diagnosis of acute urinary tract infection at the time of treatment, or a confirmed or suspected malignancy of the prostate. Dr. Nseyo: I think the disadvantage is not seeing a clean prostate when the procedure is completed because of the vaporization. I ve seen photos from the Mayo Clinic by Dr. Malek, and in about a month, the entire prostate is very well healed. It looks smooth and clean. The cloudy appearance of the prostate immediately after PVP shouldn t be a concern because it doesn t affect the patient s outcome. Patient selection and effectiveness of treatment How do you determine if a patient is an appropriate candidate for PVP? Dr. Malek: Any patient with an obstructive prostate is a candidate. Any patient who fails medical therapy or fails other forms of therapy, such as transurethral needle ablation or microwave therapy, would be a candidate for PVP as well. There is a prostate size limit of 120 cc for PVP, which is pretty much the limit for TURP. When the prostate reaches 90 to 100 cc, urologists will usually perform open enucleation rather than TURP. These prostates, however, could be treated with PVP. Dr. Hai: There is no age limit as to who can be treated with PVP. Patients presenting with symptomatic BPH requiring surgical intervention, chronic or acute retention, bladder neck contractures, and/or urethral strictures are candidates for PVP. Individuals who have chosen to discontinue medical therapy or have failed medical therapy, transurethral needle ablation, or microwave therapy are also candidates. Patients should have a prostate size between 10 and 120 g and should have an ASA classification of physical status of class 1 to 4. PVP can be used as first-line therapy for BPH. More and more patients are inclined to choose PVP as first-line therapy based on its advantages. If a patient has very minimal symptoms or is elderly with multiple medical problems, I would steer him towards medical therapy first. For the majority of patients, PVP can be first-line therapy. 8

9 Dr. Nseyo: We are following the protocol established by Dr. Hai. The same patient I would treat with TURP, I would treat with PVP. Actually, now I can treat the patient on anticoagulants without discontinuing his medication. I would consider any patient who has failed medical therapy, has contraindications to medical therapy, or has an absolute indication for surgical therapy, an appropriate candidate for PVP. The only person I would eliminate is the one who is in retention because there is no way of knowing immediately how successful the procedure was. Can a patient on anticoagulants receive treatment with PVP? Dr. Malek: Yes, it can be done without discontinuing the medication prior to surgery. If a person is taking warfarin, aspirin, or nonsteroidal anti-inflammatory drugs, TURP could not be done. With PVP, aspirin is not a problem, but warfarin could cause oozing, which may require a longer catheterization or irrigation. Dr. Hai: Yes; however, we prefer to stop the anticoagulation medication a week before the procedure. If a patient absolutely has to be on the medication, we leave the catheter in for a longer period of time perhaps 1 or 2 days until the urine is totally clear and there is no unwanted bleeding. For those patients who stop their blood thinners, we restart them 2 days after surgery. Dr. Nseyo: Yes. A big advantage of PVP is that you don t have to take a patient off anticoagulants prior to surgery like you do for TURP. What is your success rate with PVP? Dr. Malek: I have data on 71 men for 36 months. At baseline, their AUA Symptom Score was 22 preoperatively, which decreased throughout the 36- month follow-up. At 3 months, their score decreased to 5.3; at 6 months, it was 4.2; at 12 months, 3.9; and at 24 and 36 months, 3.6. That s an 80% sustained improvement in the AUA Symptom Score over 3 years. The baseline maximum flow rate (Qmax) was 7.8 ml/s. At 3, 6, 12, 24, and 36 months, it increased to 27, 26.9, 27.3, 26.2, and 23.3 ml/s, respectively. Here, the sustained improvement is 200%! We have yet to see a single failure, and we re entering our fifth year shortly. There hasn t been a single patient who required reoperation or a single case of urethral stricture. We had 1 patient with a bladder neck contracture that was very mild and very soft; all it required was 1 dilation. To date, 95% of the patients are very satisfied with the procedure. The mean quality-of-life score at 3 years for our patients was 0.29, with 0 being delighted and 6 being terrible. Dr. Hai: Using the 80-watt KTP laser, we have found 85.3% improvement in AUA Symptom Score at the end of 6 months and about 88% improvement at the end of 12 months. Improvements in uroflow rates were 185.1% at 6 months and close to 200% at 12 months. Postvoid residual volume dropped to 3% at the end of 6 months and remained about the same for the 12-month time point. We are also finding a reduction in serum PSA of 43.6% at 6 months, indicating the removal of a fair amount of prostatic tissue. Dr. Nseyo: Overall, we ve been impressed. I ve done 6 or 7 cases since October. Every patient has been happy. In a sense, patients are surprised that 9

10 they can get up and go home so soon after the procedure. When they talk to their friends who have had surgery for BPH, they hear stories of days of hospitalization and weeks of catheterization. We now have a waiting list for people wanting to get into our program. Has patient satisfaction increased since you began offering PVP to your patients? Dr. Malek: Yes. Compared with my previous laser experience using the Nd:YAG laser and the hybrid Nd:YAG/lower-power KTP laser, satisfaction has increased dramatically. Dr. Hai: Yes, patients have been extremely satisfied, to the point that they have been referring everybody that they think needs this procedure: Don t do any other procedure; this is so much simpler. Word of mouth has been very strong motivation, even for patients who are on medical therapy. Dr. Nseyo: Yes. The patients we ve treated with PVP have been very happy and very much satisfied. I just treated a patient with a 100-g prostate who couldn t be happier. He said he should have done this procedure 5 years ago, but was afraid of TURP based on what he had heard about it. The PVP procedure How well do patients tolerate PVP with local or minimal anesthesia? Dr. Malek: I don t have experience with that, but I ve seen it done. There doesn t seem to be any difference between local anesthesia and general anesthesia. Anyone who is going to have this procedure can have a local pudendal block supplemented by IV sedation, as developed by Dr. Hai. As far as I m concerned, it s perfectly doable and very feasible. Dr. Hai: I started doing the procedure using spinal anesthesia because that is the standard with TURP. I have done my last 35 or 40 outpatient cases under local anesthesia with a pudendal block and IV sedation. Most patients are amazed that there was no pain or discomfort. Dr. Nseyo: We are not using local anesthesia. We usually give the patient a choice of anesthesia, either general or spinal. Most of my treatments are under 30 minutes for 50-g prostates, so the anesthesia time is short anyway. What pre- and postoperative procedures do you normally follow for PVP? Dr. Malek: The presurgical procedures are standard for any BPH procedure flow rate, residual volume, cystoscopy, serum creatinine, CBC, and a preanesthetic evaluation. Patients also need a prostate exam, ultrasound of the prostate to measure volume and confirm absence of nodules or areas requiring biopsies, and a measure of PSA levels. We have to make sure that we are not dealing with any form of occult malignancy that s escaping our detection. We give antibiotics intraoperatively and for a week or 10 days postoperatively, just to be on the safe side. I usually perform the procedure in the mornings and insert a 10

11 catheter, which is removed the next morning. With the last 7 or 8 patients I ve treated with the 80-watt laser, I could easily have taken the catheter out on the day of surgery since the urine was so clear and the patients were so comfortable. However, I don t want anyone to fail and be recatheterized, so I haven t done that yet. I tell my patients not to do anything strenuous lifting, pulling, pushing, intercourse, etc postoperatively for about 4 to 6 weeks after surgery. They can, however, do routine, normal everyday activities, such as going to the office, 1 or 2 days after surgery. Dr. Hai: A preoperative evaluation should be performed prior to PVP to rule out any significant coexisting disease that might simulate lower urinary tract symptoms. Patients should undergo a complete urodynamic and symptomatic evaluation in order to properly diagnose BPH. Prior to PVP, physicians may choose to prescribe preoperative antibiotics and should instruct patients to discontinue anticoagulant therapy 1 week before. At the end of the procedure, patients should be assessed for indwelling catheterization. If a catheter is required, a 16 to 22 Fr Foley catheter with a 5 to 30 cc balloon is used. After adequate recovery, patients may go home the same day of treatment. I will prescribe an oral lower GI antibiotic for 3 to 5 days, a nonsteroidal anti-inflammatory agent for 2 to 3 days (unless contraindicated) and analgesics (if required). I instruct patients to increase their fluid (water) intake and to avoid coffee, tea, carbonated drinks, alcoholic beverages, citrus juices, spicy foods, and smoking for 2 to 3 days, and strenuous exercise and heavy lifting (including bike riding) for 2 weeks. Patients are allowed to return to their normal activities, including employment and sexual intercourse, within 2 weeks after treatment. Unlike TURP, where patients must stay home for 4 to 8 weeks after surgery, patients having PVP can return to desk jobs within 2 to 3 days and to heavy, strenuous work in 1 to 2 weeks. I usually see patients for a postoperative follow-up visit 2 weeks after the procedure. Dr. Nseyo: Preoperatively, we do a complete history and physical examination and assess the patient s voiding symptoms, determine the prostate size by ultrasound, and get a urinalysis to make sure there isn t an infection present. We also rule out cancer through PSA levels and digital rectal examination. Prior to the procedure, we will routinely do a cystoscopy to assay the urethra, prostatic urethra, and bladder, and to determine where the orifices are and where each ureter is coming into the bladder. From here, we map out the procedure, usually starting at the median lobe, then progressing to the lateral aspect, and finishing at the anterior lobe. Although there isn t much bleeding, we insert a Foley catheter and keep the patient overnight just for his comfort. The catheter is removed during the 24-hour follow-up exam the next day, and the patient goes home. I usually prescribe antibiotics to protect against infection. So far, we haven t had to give any pain medication, except for bladder spasm during the time the catheter is in place. We check the patients weekly by telephone and see them again 7 days after the surgery. A month later, we assay their urination and occasionally, at 3 months, examine the size of the prostate to give us some level of confidence as to how well we are doing. As far as returning to work, I tell patients that they can go back after a week, but they can t drive for the immediate 72 hours, which is the norm for any type of surgery. 11

12 What is the incidence and duration of catheterization with PVP? Dr. Malek: I catheterize my patients for less than 24 hours. I want experience with more patients before eliminating the overnight catheterization. Dr. Hai: About 60% of patients are discharged with catheters. These patients include those who have been in chronic urinary retention, have decompensated bladders, or are at risk of bleeding. It is better for these patients to have catheters, and I have no qualms about leaving a catheter in if it s for the betterment of the patient and he will have fewer symptoms. The catheters are removed 8 to 24 hours postoperatively, so the patients don t mind having them. Those individuals who do not have a catheter must void before being discharged. We want to be certain that they are urinating normally. Dr. Nseyo: It is my practice to catheterize all my PVP patients since most of them are older and come from long distances. I practice at a quaternary referral center in the VA system, so many patients come from out of town. I don t want to risk sending them home immediately and having complications; therefore, I keep them overnight with a catheter. This practice is not predicated by the treatment, but is my clinical judgment based on their distance from home. What do you think explains the short duration of catheterization? Dr. Malek: First of all, you immediately create a TURP-like cavity. Second, our animal studies revealed that the response to KTP-laser injury was far less than to any other form of injury induced on the prostate. When we used the YAG laser alone in the dog prostate, there was a tremendous amount of collagen formation in the prostatic fossa, whether we used low-power coagulation or high-power vaporization with YAG. When using the KTP laser at 60 watts to vaporize, there is practically no collagen. This is a huge difference. Instead of having a relatively rigid tube that s produced by TURP or YAG laser, the tube produced by KTP laser, which is probably just as large as that of TURP, is very pliable; it s very flexible, and it distends. This is why people can urinate as well as they do after PVP, with a 200% improvement in their flow rate. Dr. Hai: There are 2 main reasons. The first is that we have excellent bleeding control because of the affinity of the KTP laser to hemoglobin, which seals off the blood vessels and results in no bleeding. The second is that there is no late sloughing of the tissue since the KTP laser does not damage deeper tissue. The depth of penetration and the removal of tissue is exactly where you vaporized the tissue. With other forms of laser, such as the YAG laser, there is a lot of tissue damage deeper to where you did the lasing. The tissue would therefore slough off and cause obstruction. Dr. Nseyo: The laser does not coagulate tissue; it vaporizes it so that there isn t any tissue left behind to break off and cause bleeding later on. The high-power KTP laser also seals the blood vessels at the same time it vaporizes. Are there any complications associated with PVP? Dr. Malek: The ones we ve had in 71 patients include nonurologic fever in 3% of patients (due to pneumonia and allergic reaction to sulfa), mild dysuria in 6%, delayed hematuria in 3%, epididymitis in 2%, and bladder neck contracture in 2%. 12

13 None of the patients experiencing dysuria ever complained. When they came for reevaluation at 3 months and I specifically asked them if they had any form of discomfort postoperatively, they said, Yes, some burning for the first few days. Only one patient had burning for 2 weeks. None of them required medications or bothered to call me. This number is vastly lower than that reported for holmium:yag laser. The cases of delayed hematuria were a result of strenuous activity. One patient sat on a lawn mower and mowed the lawn within 2 or 3 weeks of the procedure, and the other ran for an hour on a treadmill. Dr. Hai: The complications have been absolutely minimal. Mild dysuria may occur the patient feels a slight burning/discomfort sensation. This is especially true in patients who have had a catheter. Discomfort is relieved by any anti-inflammatory agent. We have not seen any major bleeding. One patient had a bleeding problem because the procedure had to be done while he was on warfarin. We left the catheter in place for 2 days. We have not had any strictures, bladder neck contractures, delayed bleeding, or urinary retention. Dr. Nseyo: I haven t really seen any complication yet, but I don t think I ve done enough procedures to see any major problems. What is the learning curve for PVP? Dr. Malek: There are 2 prerequisites for learning PVP. The first is knowing how to do a TURP, and the second is being familiar with laser application. Probably 5 to 10 uncomplicated cases with smaller prostates of 20 to 40 cc are needed to get a good feel for how things look and how things develop before delving into larger prostates that would anatomically be more difficult to manage. PVP is not something a urologist can learn by looking at a tape; it requires some form of preceptorship. Dr. Hai: The learning curve is very short because urologists are very conversant with using continuous flow cystoscopy, endoscopic procedures, and most have performed TURPs. It s basically the PVP technique that they need to learn. I would say that a physician who is actively practicing urology and does 2 or 3 procedures under a preceptorship, watches the procedure being performed, or attends a training session, should be able to do it on his own. It is important that the instructor is very familiar with the technique. In my clinic, we have physicians from all over the country coming to learn the procedure. After seeing me do it, they feel comfortable doing it on their own. I do suggest that they start with a smaller gland initially, about 30 to 35 g, and as they gain experience, they can move on to larger glands. Dr. Nseyo: I think the learning curve is very short. It is nothing compared with the holmium:yag laser prostatectomy, which is very steep. I did my preceptorship with Dr. Hai. After coming back and talking to him on the phone, I was able to get started. I ve trained my residents and they were all able to do the procedure. Urologists will come to realize that PVP is easier to learn than TURP. Practical advantages of PVP in urology What are the benefits of PVP to the urologist? Dr. Malek: Since this is an outpatient procedure that does not require hospitalization, it is substantially less expensive than TURP even though there is a fiber cost. 13

14 Dr. Hai: We are all looking for an easy, simple procedure for our symptomatic BPH patients. I think PVP is the answer. It s a procedure that is safe, essentially bloodless, and there are no chips to morcellate because there is complete vaporization of the tissue. For urologists, PVP is a friendly, easy-to-learn procedure that can be used on fairly large-sized glands. Urologists do not need to acquire any major surgical instruments to do it, and hospitals can either purchase or lease the equipment. Since PVP is performed on an outpatient basis, it reduces health care costs. If and when we start doing the procedure in the office, the reimbursement will be much better for urologists. Dr. Nseyo: PVP is a fast, rapid procedure with a quick turnaround time and low morbidity. A urologist can do several of these procedures in a day. PVP on a 50-g prostate can be performed in 30 minutes; on a 100-g prostate, it can be done in an hour. You can do 5 cases all within the morning hours, and still go to the office. You couldn t do this with TURP. There is also instant outcome assessment patients can urinate the next day or sooner. The learning curve is quick and patient satisfaction is high. There are few complications one would expect, so there aren t large numbers of phone calls to answer. Can a urologist use PVP as a practice-building tool? Dr. Malek: I imagine so because PVP is such an attractive alternative to what is available for people who need a TURP. Since news on this procedure has become available on the Internet, I have had many people calling me asking for more information. Dr. Hai: Yes. As more patients are learning about PVP, they are asking urologists about the procedure. If the urologist doesn t perform the procedure, the patient will find someone who does because he doesn t want to go through TURP, be in the hospital, and risk the complications. We ve had some patients, who were scheduled for a TURP change their minds about it once they heard about PVP. Urologists doing PVP will definitely have a larger clientele. Laserscope has been very helpful to these urologists by including their names, addresses, and telephone numbers on the company web site. This support is very helpful for a physician trying to build up his practice. Dr. Nseyo: Yes, you can do that; PVP can be used to draw patients because it s something that s never been available. The urologist can now offer patients a procedure that is essentially a prostatectomy with instant results and minimal morbidity. Transurethral needle ablation and microwave therapy are associated with delayed efficacy in the relief of symptoms. TURP offers the instant efficacy but is associated with significant morbidity because of the longer surgery time. What is your experience with reimbursement for PVP? Dr. Malek: Medicare covers it completely, exactly as they do with TURP. PVP is listed as transurethral resection of the prostate with KTP laser. We have patients from all over the country, not just this area, and there haven t been any questions. Dr. Hai: PVP is an approved procedure for all insurances including Medicare and Blue Cross. The procedure is compensated similarly to TURP. Urologists can and 14

15 will be reimbursed for other ancillary procedures that are done in evaluating the patient, such as cystoscopy, uroflow, and ultrasound. Dr. Nseyo: Most of the patients I ve treated are within the VA system. I have not heard of any reimbursement problems. How does hospital management look at PVP once you begin doing the procedure? What has the public reaction been? Dr. Malek: I imagine hospital management reaction would be positive because it s financially attractive for them. As far as public reaction, patients have been delighted with the results. Dr. Hai: PVP has been a great benefit for the hospital because with DRGs, there is 1 lump sum payment for these patients. For TURP, patients stay in the hospital for 2 to 3 days, so it s costing the hospital much more to provide the same care. With PVP, we are sending patients home the same day, and there is minimal anesthesia, recovery room time, and complications. If you compare the costs incurred for a patient treated with TURP who stayed in the hospital for 3 days, went home, had secondary bleeding a week later, was readmitted, perhaps had to be taken to the operating room, and finally went home with the costs for a patient treated with PVP as an outpatient and never returned to the hospital, you will see a big difference. The hospital has been very, very happy with PVP. Public reaction has been amazing as well. We had a press conference a few weeks ago, and the reporters were absolutely amazed at the results. One of our patients who was interviewed expressed how minimally symptomatic he was after the procedure. Dr. Nseyo: Hospital management has been impressed because we are not using a lot of their consumables and the procedure has a quick turnaround time. TURP has a risk of TUR syndrome, which may require a stay in the ICU. With PVP, anesthesia time and recovery time are both reduced, which translates into cost savings. You can t ask for anything better. When urologists learn to do the procedure well by regional block and local anesthesia, the significant costs of anesthesia will be eliminated. I ve been impressed with the public reaction. I have patients coming in from different states who are all professionals, so they ve been shopping around and realize the value of the procedure. How will urologists view TURP given the success of PVP and the trend toward minimally invasive procedures? Dr. Malek: I think they will view PVP very favorably. There is 1 obstacle, however, and that is that many urologists have had negative experiences with the Nd:YAG laser and many do not appreciate the fact that all lasers are not created equal. Each laser is different based on its wavelength and its method of application. For example, low-power Nd:YAG coagulates the tissue, but high-power Nd:YAG coagulates the tissue and vaporizes it as well. Since coagulation is still present with the high-power Nd:YAG laser, there is still a 30% rate of dysuria with this laser. The KTP laser only vaporizes tissue, and coagulation is minimal at 2 mm, irrespective of power. The holmium:yag laser has about a millimeter or so of coagulation, 15

16 but the tissue must be cut and removed in big chunks. It s a completely different technique. Since laser wavelengths and effects on tissue differ, the healing process and response to tissue injury will also differ from one laser to the next. Once urologists appreciate these differences, they see results corroborated by a few people, and gain experience, then I think the stigma will be removed from laser prostate surgery. Dr. Hai: People are getting tired of the problems associated with TURP, but until now there was no better way of treating BPH. Once urologists see me do the procedure in training, they say, This is amazing. And they want to know when they can start doing PVP on their own. A problem with other minimally invasive procedures is that patients come to the office repeatedly, require catheterization, and are not any better 6 months after the procedure. With PVP, there is better patient satisfaction and improved relationship with primary care physicians, who will be happy that a single procedure resolved the entire problem for their patients. Dr. Nseyo: I think urologists will view TURP as a last resort for a subset of patients. PVP may be equally efficacious for patients who have failed therapy with transurethral needle ablation, interstitial laser prostatectomy, or microwave therapy. Please discuss the future of PVP. Dr. Hai: Based on Dr. Malek s results and my results with the 80-watt KTP laser, it is very obvious that the outcomes of PVP are superior to those of TURP, without any of the complications, lengthy hospital stays, and increased costs. I am absolutely certain that PVP will become the gold standard for treating BPH. Once PVP can be performed in the office, it will become even more desirable because the patient will be in and out quicker, the urologist will be reimbursed better, and the insurance companies will be pleased with the shorter recovery times. Dr. Nseyo: As far as PVP becoming the gold standard for BPH, only time will tell. It is exciting for those using it because it does wonders for the patient. After urologists have mastered the technique under a controlled environment and feel comfortable about it, PVP will probably become an office procedure. The drive towards the office is from urologists and not patients, particularly in light of today s reimbursement policies. Never fail to think about the patient. We have to make sure that patients are comfortable with whatever local anesthesia we use, because if they experience any discomfort, they will spread the word. There is nothing wrong with the way the procedure is currently performed in the ambulatory surgery center of the hospital. I don t doubt that PVP will become an office procedure. Until then, however, we need to determine the best type of local anesthesia and master the technique. Getting started on PVP From the perspective of Dr. Jeffrey Lapeyrolerie What was your attraction to using PVP? My attraction is based on previous experience with laser surgery and reports that a new device utilizing KTP was available. Also, the results from Dr. Malek s and Dr. Hai s clinical trials appeared favorable minimal anesthesia, minimal bleeding, and 40% of patients did not require catheterization after the procedure. I was 16

17 intrigued, and so at the first opportunity available to me, I visited Dr. Hai to find out more about it. How easy was it for you to master this new technology? Mastery of the technology was not very difficult. I have experience with lasers in urology and with video-assisted endoscopy, which makes PVP easier to learn. Unfortunately, the lasers available earlier in my career did not give the long-term results we anticipated. What was your learning curve? I was fortunate in having a good instructor. Dr. Hai has tremendous experience with lasers in urology. After visiting with him, participating in his didactic session, and watching him perform 3 procedures, I felt very comfortable in doing my first case. A month after doing my first procedure, I have treated 20 patients. The hospital circulated a press release after my first 2 cases, which resulted in significant interest from the community. Since I was the first physician in Ohio to perform the procedure, I think patients seeking an alternative to TURP naturally sought me out. How many procedures do you think a urologist would need to perform before hitting his stride? It depends on the individual. After the first 10 cases, I felt very comfortable with the procedure. For urologists who are experienced with TURP, the transfer to laser technology probably will not be difficult for a couple of reasons. The first is that the 2 procedures share the same landmarks for resection, and the second is that urologists are accustomed to using endoscopic techniques. I think the most difficult aspect of the learning curve is to get a feel for the vaporization capability of the laser and the proximity to the tissue. These are the finer points of the procedure. Understanding the anatomy and visualizing the landmarks will be transferable from a physician s transurethral experience; therefore, I think most urologists will probably feel very comfortable with the procedure after performing 5 or 10 cases. Individuals who are not experienced with lasers may have a little more trepidation about using the device. The older KTP lasers were significantly less powerful than the one currently available. The latter device is still safe, but we need to respect its ability to vaporize tissue. Urologists considering using this device need to receive some training, which should include a practical session in a nonhuman model to get a feel for the laser before performing the procedure on a patient. Urologists experienced with using KTP, YAG, or SLT contact lasers in the prostate will be readily able to transfer this experience to PVP using the Niagara PV technology. How would you compare your experience with the Niagara PV System and other lasers that you ve used in the past? The end result with the Niagara PV System is much more gratifying for both the patient and the urologist compared with other lasers that I ve used in the past. This device is very effective in vaporizing tissue and leaving a more open prostatic fossa at the conclusion of treatment. The 2 greatest advantages of using this device are the low incidence of irritative symptoms and the low incidence of bleeding after the procedure. Most patients urinate better shortly after surgery with a minimum of irritative symptoms. 17

18 What is the level of patient satisfaction with PVP? In my short-term experience, all patients have been extremely satisfied. Some patients are predicted to do better, and those are individuals who were voiding with difficulty before the procedure. I have treated 3 patients in urinary retention. One urinated with zero postvoid residual volume immediately after the procedure; he was on intermittent self-catheterization previously and was considered high-risk for TURP. He continued self-catheterization for a while but since his residual was minimal, he discontinued catheterization and has been very satisfied. The other 2 patients in retention are continuing to have difficulty, probably the result of longstanding severe bladder outlet obstruction, which has apparently led to more severe detrusor decompensation. Those 2 patients are not considered treatment failures because detrusor function may recover in time. How satisfied are you with the results of PVP? With my limited experience, I m very satisfied with the efficacy and the other advantages of the Niagara PV System. The device appears to have very good promise. The group of patients treated by Drs. Malek and Hai appear to demonstrate long-term efficacy, and I m encouraged by this outcome. I see PVP as an important addition to the urologist s armamentarium for treating bladder outlet obstruction from an enlarged prostate. Niagara PV System and Niagara PVP Procedure are trademarks of Laserscope. References: 1. Kaplan SA, Goluboff ET, Olsson CA, Deverka PA, Chmiel JJ. Effect of demographic factors, urinary peak flow rates, and Boyarsky symptom scores on patient treatment choice in benign prostatic hyperplasia. Urology. 1995;45: Chandrasekar P, Virdi JS. Transurethral needle ablation of the prostate (TUNA ): a prospective study, six year follow-up. Presented at the American Urological Association Annual Meeting; Kaplan SA, Larson TR, Utz WJ, et al. Combined long term outcomes stratified by patient age at treatment center. Results of the TARGIS System multi-center study for BPH. Presented at the American Urological Association Annual Meeting; Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000;163: Cowles RS 3rd, Kabalin JN, Childs S, et al. A prospective randomized comparison of transurethral resection to visual laser ablation of the prostate for the treatment of benign prostatic hyperplasia. Urology. 1995;46: Gilling PJ, Mackey M, Cresswell M. Kennett K, Kabalin JN, Fraundorfer MR. Holmium laser versus transurethral resection of the prostate: a randomized prospective trial with 1-year followup. J Urol. 1999;162:

19 Shown above: Continuing education, training, and additional information on the Niagara PV System and Niagara PVP Procedure are available through a specialized web site, national workshops, and preceptorship programs. Outside Back Cover Supporting References: 1. Kaplan SA, Larson TR, Utz WJ, et al. Combined long term outcomes stratified by patient age at treatment center. Results of the TARGIS System multi-center study for BPH. Presented at the American Urological Association Annual Meeting; Muschter R, Schorsch I, Matalon G, et al. Water induced thermotherapy (WIT): a prospective multi-center study with 3 year follow-up results. Presented at the American Urological Association Annual Meeting; Chandrasekar P, Virdi JS. Transurethral needle ablation of the prostate (TUNA ): a prospective study, six year follow-up. Presented at the American Urological Association Annual Meeting; Virdi JS, Chandrasekar P, Kapasi F. Interstitial laser ablation (Indigo ) of the prostate: a randomized prospective study, three year follow-up. Presented at the American Urological Association Annual Meeting; Shingleton WB, Farabaugh P, Jackson MS. Prospective randomized study of laser prostatectomy and TURP in men with BPH 3 year follow-up. Presented at the American Urological Association Annual Meeting; Malek RS, Kuntzman RS, Barrett DM. KTP laser prostatectomy: long-term experience. Presented at the American Urological Association Annual Meeting;