An Evidence-Based Estimate on the Size of the Potential Patient Pool for Lung Volume Reduction Surgery

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1 An Evidence-Based Estimate on the Size of the Potential Patient Pool for Lung Volume Reduction Surgery Praveen Akuthota, MD, Diana Litmanovich, MD, Moshe Zutler, MD, Phillip M. Boiselle, MD, Alexander A. Bankier, MD, PhD, David H. Roberts, MD, Bartolome R. Celli, MD, Malcolm M. DeCamp, MD, and Robert L. Berger, MD Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Section of Thoracic Radiology, Department of Radiology, and Division of Cardiothoracic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, and Pulmonary and Critical Care Medicine Division, Department of Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts; Division of Thoracic Surgery, Northwestern Memorial Hospital, Northwestern University Feinberg School of Medicine, Chicago, Illinois Background. Observational and randomized studies have demonstrated that lung volume reduction surgery (LVRS) improves symptoms, lung function, and survival in selected patients with emphysema. In spite of an approximately 3.8 million patient prevalence of the disease in the US, only 119 LVRS procedures were performed nationwide under Medicare during In order to obtain evidencebased estimate on the size of the patient pool potentially suitable for LVRS, we analyzed the database from our clinical practice that is representative of a substantial segment of the general emphysema population. Methods. Our pulmonary function test laboratory database between 1996 and 2006 was searched for patients with stage III and IV global initiative for chronic obstructive lung disease (GOLD) who also had lung volumes and carbon monoxide diffusing capacity data. Patients without available chest computed tomographic scans (CT) or with primary diagnoses other than emphysema were excluded. The resultant emphysema cohort was screened using clinical inclusion and exclusion criteria adopted from the National Emphysema Treatment Trial. A suitable clinical profile combined with CT scan evidence of 40% or greater involvement of the lungs and predominantly upper lobe distribution of emphysema were regarded as favorable markers for LVRS. Results. Pulmonary function test criteria were met by 959 patients and CT scans were available in 588 patients, but 175 patients were excluded because of primary diagnoses other than emphysema. In the remaining 413 patients, 61 or 15% exhibited favorable clinical profiles and anatomy for LVRS. Conclusions. In a subset of patients that resembles a substantial segment of the general population with advanced emphysema, up to 15% appeared potential candidates for LVRS. Formation of a task force by relevant medical specialty and patient advocate organizations to address the apparent underutilization of LVRS is recommended. (Ann Thorac Surg 2012;94:205 11) 2012 by The Society of Thoracic Surgeons Emphysema of the lung is common, progressive, disabling, and frequently lethal. Medical therapy offers modest symptomatic improvement but often fails to provide satisfactory relief from symptoms and does not halt progression of the disease. A variety of surgical procedures to treat emphysema have been employed over the past century but only lung transplantation and lung volume reduction surgery (LVRS) have proven effective [1]. Almost 40 years after its introduction by Brantigan and colleagues [2], Cooper and colleagues revisited LVRS in the 1990s [3, 4] and showed that in addition to symptomatic relief the operation improved measured lung function and exercise tolerance in a carefully selected and well-defined subset of patients. The favorable results were confirmed by observational studies and by randomized clinical trials (RCT), including the 1,218 patient nationwide randomized National Emphysema Treatment Trial (NETT) co-sponsored by the National Institutes of Health and Medicare [5 9]. The randomized clinical trials compared LVRS with optimal medical therapy and showed that the operation improves not only quality of life and respiratory physiology but also survival, especially in patients with predominantly upper lobe (PUL) distribution of the emphysema [5 9]. In spite of its proven therapeutic effectiveness and prevalence of approximately 3.8 million emphysema patients in the US, only 119 LVRS operations were performed nationwide during 2008 under the aegis of Medicare [10, 11]. Estimates on the potential patient pool for Accepted for publication March 20, Address correspondence to Dr Berger, Beth Israel Deaconess Medical Center, 185 Pilgrim Rd, Deaconess, Ste 201, Boston, MA 02215; robert_berger@hms.harvard.edu. Dr Bankier discloses that he has financial relationships with Spiration and Elsevier by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc

2 206 AKUTHOTA ET AL Ann Thorac Surg SIZE OF POTENTIAL PATIENT POOL FOR LVRS 2012;94: Abbreviations and Acronyms BIDMC Beth Israel Deaconess Medical Center BLVR bronchoscopic lung volume reduction CT computerized tomography GOLD Global Initiative for Chronic Obstructive Lung Disease LVRS lung volume reduction surgery NETT National Emphysema Treatment Trial OMR Online Medical Record PACS Picture Archiving and Communications System PFT pulmonary function tests PUL predominantly upper lobe RCT randomized clinical trial LVRS have varied widely from several thousand to a high of 1.35 million [3, 12]. No report was found in the medical literature with information to shed light on the discrepancy between estimates on the potential need for LVRS and its actual utilization. For an insight into this health care dilemma, we embarked on a study to seek evidence-based information about the size of the potential patient pool that could benefit from LVRS by analyzing the practice database at the Beth Israel Deaconess Medical Center (BIDMC), an academic institution that serves both an urban community and referred patients from throughout New England. The broad source of referrals implies that this database is representative of a substantial segment of individuals affected by emphysema in the United States. Materials and Methods The protocol for this study was approved by the BIDMC Institutional Review Board. The data analyzed were obtained from the PFT laboratory, Online Medical Record, and the Picture Archiving and Communications System (Centricity 2.1, General Electric, Milwaukee, WI) databases. Patient Selection The PFT laboratory database at BIDMC was queried for the period of January 1, 1996 to December 31, 2006 to identify patients with stage III and IV chronic obstructive lung disease (GOLD) (forced expiratory volume in the first second of expiration [FEV 1 ] 50%, FEV 1 /forced vital capacity 0.7) who also had data available regarding lung volumes and carbon monoxide diffusion capacity [13]. The next step in the screening process excluded patients without available CT scans of the chest while those with available computed tomographic (CT) scans were examined through the Online Medical Record for relevant clinical features. Individuals with diagnoses other than emphysema (such as chronic obstructive pulmonary disease [COPD] without emphysema, asthma, bronchiectasis, cryptogenic organizing pneumonia, and sarcoidosis) were excluded from the study. In order to identify potential LVRS candidates on clinical grounds, the remaining cohort with a primary diagnosis of emphysema and available CT scans was screened using inclusion and exclusion criteria adopted from NETT [7, 8] (Table 1). Patients who qualified for LVRS by clinical criteria but showed radiographic evidence of large consolidation, atelectasis, diffuse fibrosis, large or infected bullae, hilar or parenchymal mass, extensive pleural plaques, pleural effusion, or hydropneumothorax were excluded while patients whose CT scans showed a combination of greater than 40% involvement with emphysema and predominantly upper lobe (PUL) distribution of disease were classified as potential candidates for LVRS. The flowchart for patient screening is shown in Fig 1. Computed Tomographic Images The CT images were obtained with helical CT scanners. The technical parameters varied depending upon type of scanner used and nature of clinical condition for which the examination was ordered. Only CT scans that included both lungs from apices to bases at full suspended inspiration were accepted. The images were visually assessed by 1 radiologist with extensive experience in the evaluation of emphysema. Extent of emphysema was scored as percentage of total lung involved using the following gradation: Grade 0 none; grade 1 1% to 19%; grade 2 20% to 39%; grade 3 40% to 59%; grade 4 60% to 79%; grade 5 80% to 100%. The distribution Table 1. Inclusion and Exclusion Criteria for 959 Chronic Obstructive Pulmonary Disease Patients Inclusion Criteria GOLD stage III and IV PFT Available Dlco and LV data Available CT scan of chest Primary diagnosis of emphysema modified NETT clinical inclusion criteria Exclusion Criteria Prior LVRS, thoracotomy or sternotomy Extensive interstitial or pleural disease Clinically significant bronchiectasis Recurrent pulmonary infections Pulmonary hypertension Systemic prednisone 20 mg daily Supplementary O 2 6 LPM at rest Po 2 45 mm Hg or PCO 2 60 mm Hg on room air MI or CHF within 6 months of PFTs, LVEF 0.40 or life threatening arrhythmia Uncontrolled hypertension (SBP 200 and/or DBP 110) BMI 31.1 for males, 32.3 for females BMI body mass index; CHF congestive heart failure; CT computed tomography; DBP diastolic blood pressure; Dlco carbon monoxide diffusing capacity; GOLD Global Initiative for Chronic Obstructive Lung Disease; LPM liter per minute; LV lung volume; LVEF left ventricular ejection fraction; LVRS lung volume reduction surgery; MI myocardial infarction; NETT National Emphysema Treatment Trial; PFT pulmonary function tests; Pco 2 partial pressure of carbon dioxide; Po 2 partial pressure of oxygen; SBP systolic blood pressure.

3 Ann Thorac Surg AKUTHOTA ET AL 2012;94: SIZE OF POTENTIAL PATIENT POOL FOR LVRS 207 PFT Database Screen: 959 pa ents CT Scan Available: 588 pa ents No CT Scan: 371 pa ents Emphysema: 413 pa ents Alternate Diagnosis: 175 pa ents Met Clinical Criteria for LVRS: 206 pa ents Ineligible by Radiographic Criteria: 12 pa ents Excluded by Clinical Criteria: 195 pa ents Upper-Lobe Predominant Disease: 61 pa ents Fig 1. Study flowchart. (CT computerized tomography; LVRS lung volume reduction surgery; PFT pulmonary function tests.) of emphysema was categorized as the following: (1) predominantly upper lobe; (2) predominantly lower lobe; or (3) diffuse. A subset with available thin-section CT scans of the chest (section thickness of 1 mm, intersection interval of 10 mm) from clinically suitable patients for LVRS was evaluated with an alternate, semiquantitative method for assessing extent of emphysema adopted from Goddard and colleagues [14], Bergin and colleagues [15], and Bankier and colleagues [16]. The images were examined by 2 radiologists independently. Interobserver agreement was analyzed by a kappa ( ) statistic and the 95% confidence intervals for the coefficients. A value of 0.20 or less was scored as poor agreement, between 0.21 and 0.40 as fair, between 0.41 and 0.60 as moderate, between 0.61 and 0.80 as good, and between 0.81 and 1.00 as excellent agreement. Results From the 11-year period under review, 959 patients met GOLD stage III and IV spirometric criteria and had available lung volume as well as diffusion capacity data. From this initial cohort 371 patients were excluded from the study because of lack of stored CT scans, leaving 588 patients with digitally archived chest CT scans. Of these, 175 carried primary diagnoses other than emphysema and were not further studied. The remaining 413 patients with a primary diagnosis of emphysema were screened by clinical inclusion and exclusion criteria adopted from NETT resulting in rejection of 195 patients because of malignancy with predicted lifespan less than 2 years (54 patients), lobectomy (45 patients), sternotomy (39 patients), pulmonary hypertension (28 patients), morbid obesity (7 patients), systemic corticosteroids greater than 20 mg daily (4 patients), and other causes (23 patients). A few patients met multiple exclusion criteria. From the remaining 218 patients, 12 (5.5%) were excluded on radiographic grounds (pleural plaques, parenchymal consolidation, extensive pulmonary fibrosis, acute pulmonary process, neoplasia, or technical factors) leaving 206 patients with a combination of primary diagnosis of emphysema, stored CT scans, and clinical profiles deemed favorable for LVRS (Table 1). In this last cohort 50 patients had archived thin-section CT scans of the chest but 1 was excluded on radiographic grounds, leaving a 49-patient subset for a separate analysis. Age, gender, and percent of predicted normal values for FEV 1, total lung capacity, RV, and carbon monoxide diffusing capacity (Dlco) in the 206 potential candidates for LVRS were consistent with the inclusion criteria of NETT and of a representative observational series [7, 17) (Table 2). The clinical profiles of the 206 patients who

4 208 AKUTHOTA ET AL Ann Thorac Surg SIZE OF POTENTIAL PATIENT POOL FOR LVRS 2012;94: Table 2. Clinical Profile of Potential Candidates for LVRS and Eligibility Criteria by Representative Observational and Randomized Studies Variable For LVRS (206 Patients) CT Subset (50 Patients) NETT [Ref 7] Ginsburg et al [Ref 17] Age at PFT years Sex M/F (%) 49.5/50.5 FEV 1 (L) ) FEV 1 - % of predicted FVC (L) FVC-%ofpredicted FEV 1 /FVC TLC (L) TLC % of predicted RV (L) RV- % of predicted Dlco Dlco % of predicted standard deviation; CT computerized tomography; Dlco carbon monoxide diffusing capacity (corrected for hemoglobin); FEV 1 forced expiratory volume in the first second; FVC forced vital capacity; LVRS lung volume reduction surgery; NETT National Emphysema Treatment Trial; PFT pulmonary function tests; RV residual volume; TLC total lung capacity. qualified as potential LVRS candidates and its 50 patient subset with available thin-section CT scans were similar (Table 2). On CT scan, 50% of the 206 patients who qualified for LVRS on clinical basis and 70% of the 49-patient subset with thin-section CT scans exhibited greater than 40% involvement with emphysema; percentage of PUL distribution of disease, however was identical (30%) in both groups. In the 413 patient cohort with a primary diagnosis of emphysema and resembling a substantial segment of the general emphysema population, 61 patients or 15% showed greater than 40% involvement with emphysema and PUL distribution of disease. The latter combination is viewed as favorable outcome markers for LVRS. In groups having less than 40% of the lungs involved by emphysema, 67% of the 103 patients who qualified for LVRS on clinical basis and 93% of the 15-patient subset with thin-section CT scan showed PUL distribution of the disease (Table 3). Analyzed by 2 independent radiologists, the 49-patient subset with thin-section CT images showed a weighted kappa coefficient for agreement between the 2 readers of (standard error 0.006, 95% confidence interval to 0.893), indicating excellent agreement. Comment Lung volume reduction surgery underwent one of the most rigorous evaluations of an operative procedure in the history of surgery. The process produced robust evidence that the operation improves symptoms, respiratory physiology, and survival in a clearly identifiable Table 3. Extent and Distribution of Emphysema in 206 Patients Clinically Suitable for LVRS Grade-Extent Total No (%) PUL No. (%) PLL No. (%) Diffuse No. (%) Grade 0 (none) 13 (6.3) Grade 1 (0 to 19%) 47 (22.8) 42 (20.3) 0 (0) 5 (2.4) Grade 2 (20-39%) 43 (20.8) 27 (13.1) 3 (1.4) 13 (6.3) Grade 3 (40-59%) 62 (30.1) 42 (20.4) a 6 (2.9) 14 (6.8) Grade 4 (60-79%) 37 (17.9) 19 (9.2) a 7 (3.4) 11 (5.3) Grade 5 (80-100%) 4 (1.9) 0 (0) a 1 (0.4) 3 (1.4) Total 206 (100%) 130 (63.11%) 17 (8.2) 46 (22.3) a Potential candidates for LVRS on clinical grounds and computed tomographic findings. LVRS lung volume reduction surgery; PLL predominantly lower lobe; PUL predominantly upper lobe.

5 Ann Thorac Surg AKUTHOTA ET AL 2012;94: SIZE OF POTENTIAL PATIENT POOL FOR LVRS 209 subgroup of patients with advanced emphysema. Data from NETT also suggest that the incidence of COPD exacerbations was reduced after LVRS [18]. Moreover, it has been reported that patients in need of surgery for lung cancer, coronary artery or valvular heart disease, and aortic aneurysms, but deemed prohibitive operative risks because of severely compromised pulmonary function from coexisting emphysema, tolerated the indicated surgical procedure after LVRS improved lung function [19, 20]. In spite of this documented therapeutic efficacy, combined with an emphysema population in the millions, LVRS is rarely used. The present retrospective study, designed to shed light on a paradox in health care utilization, reveals that as many as 15% of 413 patients with a primary diagnosis of advanced emphysema and available CT scans of the chest exhibit a pattern that has been associated with favorable outcomes from LVRS. This observation is consistent with experience by Weinstein and colleagues [21] who reported that from the 261 emphysema patients referred for LVRS, 10.3% proceeded to have the operation. A review of the NETT trial published in 2011 by Criner and colleagues [22], also called attention to the underutilization of LVRS. The authors suggest that the reasons for the underutilization include restricted patient access due to the small number of centers designated by Medicare for performing the operation, the perception that the procedure is overly complex, lack of awareness of the therapeutic benefits of the operation by physicians, discouraging the results in the high risk for LVRS subset, and a perception that the operation is associated with high risk as well as high cost [22, 23]. The perception regarding the high risk can be examined by objective data from available clinical experience. Operative mortality from LVRS in representative observational and randomized series has ranged between 0% and 5%. Sanchez and NETT reported 90-day operative mortalities of 4% in 250 consecutive PUL patients and 2.9% in 261 non high-risk patients randomized to surgery, respectively [8, 24]. In a series of 49 consecutive LVRS procedures, published in 2011, there were no 90- day postoperative deaths [17]. The approximately 40% percent morbidity associated with LVRS appears ominous on first glance but the large majority of complications consist of persistent non-lethal air leaks and other manageable adverse events, unlikely to affect long-term outcome [25, 26]. The cost associated with LVRS may not be as high as perceived. The NETT reported higher mean total medical cost per patient in the LVRS cohort than in the medical arm ($71,515 vs $23,371; p 0.001) during the first postoperative year mainly due to the expense incurred by surgery. However, duringa7to36-month period after surgery, mean total medical costs per patient was lower in the LVRS than in the medical arm ($36,199 vs $49,628, p 0.001), driven largely by the higher rate of hospitalizations in medically treated patients [22]. Thus, the overall risk-to-benefit ratio and cost for LVRS appears acceptable for a severely disabling and frequently lethal illness [24]. The reasons for the low utilization must lie elsewhere. A review of the history of this operation may shed light on the puzzle. The reintroduction of LVRS in the mid-1990s was followed by a wave of enthusiasm about the procedure. At the 1996 Annual Convention of the American Thoracic Society, in addition to symposia and lectures 44 abstracts were presented on LVRS, most with favorable results [5]. Analysis of International Classification of Diseases-9 Codes Claims applicable to LVRS revealed a sharp increase in utilization of the procedure. Between July and September 1995 approximately 48 claims per month were submitted to Medicare, but between October and December of the same year the monthly submissions rose to 164 cases [27]. The rapid increase in utilization fueled concern that with unchecked growth as many as 1.35 million LVRS operations at a cost of $47 billion to Medicare might be performed [12]. Questions were also raised about efficacy and safety of the procedure [27]. In December 1995, HCFA (Health Care Financing Administration) suspended reimbursement for LVRS. A sharp drop in utilization followed. During March 1996 only 11 Medicare claims were processed for LVRS representing a 93% drop in the number submitted for the same period just 4 months earlier [27]. The non-reimbursement policy was challenged by physicians and patients. An editorial in a peerreviewed journal and a position paper by the American Thoracic Society in 1996 urged HCFA to restore coverage for LVRS [28, 29]. Reimbursement, however, was not reinstated and utilization of LVRS declined steadily. The downward trend was bolstered by a NETT publication in 2001 on the poor results from LVRS in 70 high risk for LVRS patients, a cohort constituting only 16.5% of the total group randomized to surgery [23]. Major media outlets compounded the pessimism about LVRS with headlines, such as Lung Surgery Found Ineffective for Emphysema [30], Emphysema Surgery Called Perilous [31], and Surgery Is A Killer In Emphysema Cases [32]. The first comprehensive report from the NETT trial, published in 2003, confirmed symptomatic, physiologic, and survival benefits from LVRS in the previously welldefined patient subsets [8]. However, a companion editorial issued an equivocal endorsement [33]. Medicare restored LVRS coverage limited to a small number of designated centers for patient subsets with favorable results in the NETT trial. Interest in the procedure, however, was not rekindled. Follow-up NETT data on LVRS, published in 2006 [9], revealed that in addition to functional and physiologic improvements, 5-year survival benefits were also obtained by a subset of the non-high risk for LVRS population. A companion editorial acknowledged the efficacy of LVRS in a select group of patients but maintained that to go from 1218 patients in the NETT to the hundreds of thousands of patients who could become candidates for LVRS will require extensive thoughtful consideration on the part of physicians and surgeons as well as patients and their family in the

6 210 AKUTHOTA ET AL Ann Thorac Surg SIZE OF POTENTIAL PATIENT POOL FOR LVRS 2012;94: decision-making process [34]. No clarification was given about the nature of the extensive thoughtful consideration. The most recent (2011) guidelines on treatment of COPD issued by prominent American and European thoracic societies do not even mention LVRS as a therapeutic option [35]. After demonstration by the LVRS experience that the procedure is physiologically sound and clinically effective, several nonoperative bronchoscopic lung volume reduction (BLVR) methods have been tested but their effectiveness remains to be determined [36]. A safe and effective BLVR with reduced human risk and financial cost would probably be used on a larger scale than the operative approach. The retrospective nature of the present study represents distinct shortcomings, but a concerted effort was made to minimize bias while designing a feasible protocol with applicability to real world practice. In addition, the CT scans were interpreted by visual examination without computerized quantification of emphysema. The approach may not be optimal but it is the standard method employed for assessing emphysema on CT scans for clinical purposes and was used by NETT [7 9]. The findings with the semiquantitative analysis in the 49- patient thin-section CT scan subset and in the larger 206-patient cohort were similar, supporting the clinical validity of the visual assessment method. The high level agreement by 2 radiologists in the thin CT scan subset tends to validate the results of our analysis of the larger 206-patient cohort. In conclusion, this study suggests that up to 15% of patients with moderate to severe emphysema as defined by symptoms, spirometry, lung volumes, diffusion capacity, and CT scan of the chest could benefit from LVRS. Other factors, including serious comorbidity, patient s reluctance, and surgeon s judgment could decrease the percentage but the number of operations performed has been much smaller than even a modified representation of our estimate would imply. The discrepancy raises serious questions about the wisdom of prevailing utilization. We believe that formation of a task force by medical specialty and patient advocate organizations offers the most promising road to resolution of this health care dilemma. The task force could objectively define the optimal ways to assure that an effective therapy is available to patients who may benefit from its application. The authors would like to thank Richard Johnston, manager of the PFT Laboratories at BIDMC for his contributions to the study and Richard Whyte M.D. for his review of the manuscript. This study was supported by the Thoracic Foundation (Overholt), Boston, MA. References 1. Cooper JD. The history of surgical procedures for emphysema. Ann Thorac Surg 1997;63: Brantigan OC, Mueller E, Kress MB. A surgical approach to pulmonary emphysema. Am Rev Respir Dis 1959;80: Cooper JD, Patterson GA, Sundaresan RS, et al. Results of 150 consecutive bilateral lung volume reduction procedures in patients with severe emphysema. J Thorac Cardiovasc Surg 1996;112: Cooper JD, Trulock EP, Triantafillou AN, et al. Bilateral pneumectomy (volume reduction) for chronic obstructive pulmonary disease. J Thorac Cardiovasc Surg 1995;109: Berger RL, Celli BR, Meneghetti AL, et al. Limitations of randomized clinical trials for evaluating emerging operations: The case of lung volume reduction surgery. Ann Thorac Surg 2001;72: Berger RL, Wood KA, Cabral HJ, et al. Lung volume reduction surgery: a meta-analysis of randomized clinical trials. Treat Respir Med 2005;4: National Emphysema Treatment Trial Research Group. Rationale and design of The National Emphysema Treatment Trial: a prospective randomized trial of lung volume reduction surgery. Chest 1999;116: Fishman A, Martinez F, Naunheim K, et al. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med 2003;348: Naunheim KS, Wood DE, Mohsenifar Z, et al. Long-term follow-up of patients receiving lung-volume-reduction surgery versus medical therapy for severe emphysema by the National Emphysema Treatment Trial Research Group. Ann Thorac Surg 2006;82: Summary Health Statistics for U.S, Adults: National Health Interview Survey U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. 11. Medicare Part B Physician/Supplier BESS Data for Calendar Year Available at Make BJ, Fein AM. Is volume reduction surgery appropriate in the treatment of emphysema? No. Am J Respir Crit Care Med 1996;153: Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med 2001;163: Goddard PR, Nicholson EM, Laszlo G, Watt I. Computed tomography in pulmonary emphysema. Clin Radiol 1982;33: Bergin C, Müller N, Nichols DM, et al. The diagnosis of emphysema. A computed tomographic-pathologic correlation. Am Rev Respir Dis 1986;133: Bankier AA, De Maertelaer V, Keyzer C, Gevenois PA. Pulmonary emphysema: subjective visual grading versus objective quantification with macroscopic morphometry and thin-section CT densitometry. Radiology 1999;211: Ginsburg ME, Thomashow BM, Yip CK, et al. Lung volume reduction surgery using the NETT selection criteria. Ann Thorac Surg 2011;91: Washko GR, Fan VS, Ramsey SD, et al. The effect of lung volume reduction surgery on chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med 2008;177: Choong CK, Mahesh B, Patterson G, Cooper JD. Concomitant lung cancer resection and Lung Volume Reduction Surgery. Thorac Surg Clin 2009;19: Choong CK, Schmid RA, Miller DM, et al. Combined cardiac and lung volume reduction surgery. Thorac Surg Clin 2009; 5: Weinstein MS, Kuzma RN, Vance GB, et al. Who is eligible for lung volume reduction surgery? [Abstract] Am J Respir Crit Care Med 2006;173:A Criner JG, Cordova F, Sternberg AL, Martinez FJ. The National Emphysema Treatment Trial (NETT) Part II: Lessons learned about lung volume reduction surgery. Am J Respir Crit Care Med 2011;184:

7 Ann Thorac Surg AKUTHOTA ET AL 2012;94: SIZE OF POTENTIAL PATIENT POOL FOR LVRS National Emphysema Treatment Trial Research Group. Patients at high risk of death after lung-volume-reduction surgery. N Engl J Med 2001;345: Sanchez PG, Kucharczuk JC, Su S, Kaiser LR, Cooper JD. National Emphysema Treatment Trial redux: accentuating the positive. J Thorac Cardiovasc Surg 2010;140: DeCamp MM Jr, McKenna RJ Jr, Deschamps CC, Krasna MJ. Lung volume reduction surgery. Technique, operative mortality and morbidity. Proc Am Thorac Soc 2008;5: DeCamp MM, Blackstone EH, Naunheim KS, et al. Patient and surgical factors influencing air leak after lung volume reduction surgery: lessons learned from the National Emphysema Treatment Trial. Ann Thorac Surg 2006;82: Huizenga HF, Ramsey FD, Albert RK. Estimated growth of lung volume reduction surgery among Medicare enrollees. Chest 1998;114: Dantzker DR, Scharf SM. Surgery to reduce lung volume. N Engl J Med 1996;334: INVITED COMMENTARY Akuthota and colleagues [1] highlight an unnecessary injustice for the hundreds of thousands of patients with end-stage emphysema worldwide for whom lung volume reduction surgery (LVRS) could prove lifechanging. There has been little or no controversy in the literature regarding the benefit of LVRS in appropriately selected patients. Single-institution reports, multiinstitutional reviews, metaanalyses, and randomized trials all uniformly provide objective, definitive evidence of short-term benefit. The long-term benefits were clearly delineated in a report published 6 years ago, and still referral for LVRS remains infrequent. Multiple nonsurgical procedures (bronchial fenestration, endobronchial valve implantation, thermal ablation, and sclerosis of lung parenchyma) have been devised in the hope of reproducing the improvements in survival, function, and quality of life achieved by surgical intervention. Although all have been proved to be safe, none has demonstrated the efficacy of LVRS. The failure of the medical community to embrace LVRS is likely multifactorial. Certification mandated by the Center for Medicare and Medicaid Services is onerous and expensive, and thus the centers providing LVRS are few and far between. The pulmonary community is unaware or disbelieving regarding the true benefit of the procedure. The patients are ignorant of the potential for increased function and survival. All these reasons are understandable, but none should be considered acceptable or excusable. The potential exists to significantly lengthen and otherwise improve 29. Hudson LD. President ATS to Sheingold S HCFA Administrator; April 2, Kolata G. Lung surgery was found ineffective in emphysema. New York Times. October 10, Dunn J. Emphysema surgery called perilous. San Francisco Chronicle. August 15, Surgery is a killer in emphysema cases. Associated Press. Worcester Gazette Drazen JM, Epstein AM. Guidance concerning surgery for emphysema. N Engl J Med 2003;348: Lenfant C. Will lung volume reduction surgery be widely applied? Ann Thorac Surg 2006;82: Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med 2011;155: Berger RL, DeCamp MM, Criner GJ, Celli BR. Lung volume reduction therapies for advanced emphysema 2009; An update. Chest 2010;138: thousands of lives. The failure of both the European and American pulmonary societies to include LVRS in their 2011 treatment guidelines for chronic obstructive pulmonary disease is as confounding as it is frustrating. The Society of Thoracic Surgeons, the American Thoracic Society, and the European Respiratory Society should consider that their duty includes not just the discovery of life-altering technology but its active dissemination, ensuring that all patients who might benefit for medical advances have access to them. This calls for a collaborative effort by these societies to promote LVRS to the appropriate patients by use of clinical guidelines and educational efforts for physicians and patients alike. Unrealized potential helps no one. Keith Naunheim, MD Department of Surgery Saint Louis University Health Sciences Center 3635 Vista Ave PO Box St. Louis, MO naunheim@slu.edu Reference 1. Akuthota P, Litmanovich D, Zutler M, et al. An evidencebased estimate on the size of potential patient pool for lung volume reduction surgery. Ann Thorac Surg 2012;94: by The Society of Thoracic Surgeons /$36.00 Published by Elsevier Inc

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