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Ann Thorac Surg 2006;82:197-207
© 2006 The Society of Thoracic Surgeons
a Section of Thoracic Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts
b Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio
c Department of Quantitative Health Sciences, The Cleveland Clinic Foundation, Cleveland, Ohio
d Department of Pulmonary, Allergy, and Critical Care Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio
e Division of Cardiothoracic Surgery, St. Louis University Health Sciences Center, St. Louis, Missouri
f Thoracic Surgery Division, University of Maryland Medical Center, Baltimore, Maryland
g Division of Cardiothoracic Surgery, University of Washington, Seattle, Washington
h Center for Chest Diseases, Cedars-Sinai Medical Center, Los Angeles, California
Accepted for publication February 22, 2006.
* Address correspondence to Dr DeCamp, Beth Israel Deaconess Medical Center, 110 Francis Street Suite A, Boston, MA 02215 (Email: mdecamp{at}bidmc.harvard.edu).
Presented at the Fifty-first Annual Meeting of the Southern Thoracic Surgical Association, Cancun, Mexico, Nov 2–4, 2004.
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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METHODS: Detailed air leak data were available for 552 of 580 patients receiving bilateral stapled LVRS in the National Emphysema Treatment Trial. Risk factors for prevalence and duration of air leak were identified by logistic and hazard function analyses. Medical consequences were estimated in propensity-matched pairs with and without air leak.
RESULTS: Within 30 days of LVRS, 90% of patients developed air leak (median duration = 7 days). Its occurrence was more common and duration prolonged in patients with lower diffusing capacity (p = 0.06), upper lobe disease (p = 0.04), and important pleural adhesions (p = 0.007). Duration was also protracted in Caucasians (p < 0.0001), patients using inhaled steroids (p = 0.004), and those with lower 1-second forced expiratory volume (p = 0.0003). Surgical approach, buttressing, stapler brand, and intraoperative adjunctive procedures were not associated with fewer or less prolonged air leaks (p 
0.2). Postoperative complications occurred more often in matched patients experiencing air leak (57% vs 30%, p = 0.0004), and postoperative stay was longer (11.8 ± 6.5 days vs 7.6 ± 4.4 days, p = 0.0005).
CONCLUSIONS: Air leak accompanies LVRS in 90% of patients, is often prolonged, and is associated with a more complicated and protracted hospital course. Its occurrence and duration are associated with characteristics of patients and their disease, not with a specific surgical technique.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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Purposes of this study were to identify risk factors for air leak occurrence and duration after LVRS, including evaluation of buttressing, and to estimate the medical consequences of air leak, with the goal of determining optimal perioperative technique(s) to preempt or treat post-LVRS air leak.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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The NETT investigators recorded materials used for staple line buttressing, including bovine pericardium and polytetrafluoroethylene (PTFE) and fibrin glue (combined with bovine pericardium in all but one case, in which it was combined with PTFE). Uncommonly, no buttressing material was used (Table 1). Staplers used were predominantly open and endoscopic instruments manufactured by US Surgical Corporation (Norwalk, CT) or Ethicon (Cincinnati, OH). A few 3M (St Paul, MN) devices were used.
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Data Analysis
Post-LVRS air leak prevalence
Risk factors for post-LVRS air leak prevalence were identified using multivariable logistic regression analysis. Analysis included factors related to the following.
Categoric variables used are detailed in Table 2 and continuous variables in Table 3. Generally, except for incision, surgical variables were recorded separately for right and left lungs, and overall (either lung) values were derived from these.
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Post-LVRS air leak duration
Among patients experiencing air leak, its duration was recorded only to day 30; air leaks persisting beyond this were treated as incomplete (censored) data. Air leak duration of patients dying within 30 days, whose air leak had not resolved, was censored on the day of death. Because of these two censoring mechanisms and the non-Gaussian distribution of values of duration, time-to-event techniques were employed to analyze air leak duration. These included the nonparametric Kaplan-Meier method [6] and a parametric decomposition method that identified two components of resolution of air leak, arbitrarily labeled early and late [7]. Within each component, factors associated with duration of air leak were identified simultaneously by bootstrap bagging.
Medical consequences of post-LVRS air leak
To estimate the medical consequences of air leak, the logistic regression model for air leak was amplified with demographic, physiologic, and medical treatment data to derive a probability of air leak (propensity score) for each patient [7, 8]. Patients in whom air leak occurred were matched by propensity score with those in whom it did not occur (54 of 56 patients without air leak were able to be matched). Frequency of occurrence of postoperative complications [9] was compared, as was postoperative length of stay.
Presentation
Proportions and Kaplan-Meier estimates are accompanied by asymmetric 68% confidence limits (CL), comparable to ±1 standard error.
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Results |
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TopAbstractIntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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Of interest, within NETT, air leak occurrence and duration were neither operator nor operation dependent. Specifically, development of postoperative air leak and its duration were not affected by surgical variables, including operative approach (median sternotomy versus VATS), buttressing material, fibrin glue, pleural tenting, or use of adjunctive chemical agents to produce pleurodesis.
More than 95% of surgical patients in NETT underwent some form of staple line buttressing. In neither the small randomized ancillary study of NETT (6 centers, 38 patients) comparing outcomes after bovine pericardium or PTFE buttressing (personal communication), nor this larger nonrandomized comparison (17 centers, 522 patients), was there any demonstrable benefit of one material over the other. Whether buttressing with any material limits air leak or improves outcome remains controversial. Hazelrigg and colleagues [16] demonstrated a 2- to 3-day reduction in length of stay (LOS) when buttressing (n = 58) was compared with non-buttressed (n = 65), unilateral, stapled LVRS. In a randomized, three-center trial (n = 65 total, 33 non-buttressed), Stammberger and colleagues [17] reported a statistically significant reduction in air leak duration after bilateral, buttressed, VATS LVRS, but no reduction in LOS. Within NETT, only 3.6% of patients had no buttressing during LVRS, suggesting surgeon selection bias; this makes comparison of clinical outcomes with the buttressed group ill-advised.
Air leak occurrence was common in NETT and depended on both the pattern and severity of lung destruction. Interestingly, its occurrence became nearly universal with worsening disease affecting the lung parenchyma (lower DLCO) or pleura (adhesions) (Table 4). In contrast, emphysema predominantly affecting the lower lobes was associated with fewer air leaks of shorter duration (Tables 4, 5; Fig 2E). These curious findings must be interpreted cautiously, because only 13% of the surgical cohort (Table 1) had this pattern of disease. Moreover, LVRS for these patients provided no survival benefit and variable functional outcome when compared with those randomized to best medical therapy [3].
Because air leak is almost inevitable after LVRS, it is more useful to analyze factors that affect its duration to identify areas where practice alterations may modulate morbidity (Table 5). Again, disease severity (FEV1, DLCO, adhesions) (Figs 2C, 2D, 2E) as well as pattern of emphysema (Fig 2E) were independent predictors of air leak duration. Previous NETT publications confirmed that extremely low FEV1 and DLCO were factors associated with excessive mortality after LVRS [18]. These new morbidity data as well as the propensity-matched pairs analysis (Fig 3) establish an important link between prolonged air leak, other postoperative complications (pneumonia and readmission to the intensive care unit), prolonged hospital LOS, and perhaps postoperative mortality. Because postoperative death and prolonged air leak are competing time-related outcomes after LVRS, we could not statistically associate the two; however, they share similar predictors and are logically connected. These analyses highlight the importance of careful radiographic review to detect subtle hints of adhesion, such as pleural thickening, that might mitigate against surgical intervention in the LVRS candidate at the lower end of the physiologic emphysema spectrum.
Preoperative use of inhaled (Fig 2B) but not oral steroids was an independent predictor of air leak duration. As the emphysema disease process proceeds, there is loss of the elastic interstitium of the lung, manifested by obstructive spirometry and airflow resistance [19,20], destruction of alveolar walls as demonstrated radiographically [21] and microscopically [22], and reduction in cross-sectional area of the pulmonary circulation detected by low DLCO [23]. Although corticosteroids may reduce inflammation in the bronchitic component of chronic obstructive pulmonary disease (COPD), they also inhibit wound healing and may prolong healing of visceral pleural injury after LVRS. In the absence of pharmacokinetic data, we speculate that the pathophysiology of COPD may favor drug delivery, concentration, and retention (gas trapping) of steroid by inhalation, in contrast to the bloodborne enteral route. A higher tissue concentration of corticosteroid within the operated lung parenchyma would then prolong air leak.
Caucasians are reportedly two to three times more likely than minorities to develop emphysema [24, 25]; however, this epidemiologic observation cannot explain the statistically significant (p < 0.0001) shorter duration of air leak among minorities in NETT (Table 5; Fig 2A). Although there may be genetic or physiologic differences that favor enhanced lung healing, selection bias likely plays a larger role, as only 4.7% of NETT participants were minorities (Table 2).
Air leak accompanies LVRS in 90% of patients, is prolonged in half, and is associated with a more complicated and protracted hospital course. Its prevalence and duration are associated with patient characteristics, use of inhaled steroids, worse pulmonary function, distribution of disease (less common and shorter in lower lobe disease; common and longer when extensive pleural adhesions are present), but not by surgical techniques such as choice of staple line buttressing materials or use of pleural tents or pleurodesis. Discontinuing inhaled corticosteroids perioperatively appears prudent, as does closer scrutiny of marginal physiologic candidates for the stigmata of pleural adhesions.
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Appendix 1 |
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TopAbstractIntroductionPatients and MethodsResultsCommentAppendix 1DiscussionFootnotesReferences |
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Source of Funding
The National Emphysema Treatment Trial (NETT) is supported by contracts with the National Heart, Lung, and Blood Institute (N01HR76101, N01HR76102, N01HR76103, N01HR76104, N01HR76105, N01HR76106, N01HR76107, N01HR76108, N01HR76109, N01HR76110, N01HR76111, N01HR76112, N01HR76113, N01HR76114, N01HR76115, N01HR76116, N01HR76118, and N01HR76119), the Centers for Medicare and Medicaid Services (CMS; formerly the Health Care Financing Administration); and the Agency for Healthcare Research and Quality (AHRQ).
Members of the NETT Research Group
Office of the Chair of the Steering Committee, University of Pennsylvania, Philadelphia, PA: Alfred P. Fishman, MD (Chair); Betsy Ann Bozzarello; Ameena Al-Amin.
Clinical Centers
In compliance with the Helsinki declaration, the institutional review boards of each participating institution approved the NETT protocol.
Baylor College of Medicine, Houston, TX: Marcia Katz, MD (Principal Investigator); Carolyn Wheeler, RN, BSN (Principal Clinic Coordinator); Elaine Baker, RRT, RPFT; Peter Barnard, PhD, RPFT; Phil Cagle, MD; James Carter, MD; Sophia Chatziioannou, MD; Karla Conejo-Gonzales; Kimberly Dubose, RRT; John Haddad, MD; David Hicks, RRT, RPFT; Neal Kleiman, MD; Mary Milburn-Barnes, CRTT; Chinh Nguyen, RPFT; Michael Reardon, MD; Joseph Reeves-Viets, MD; Steven Sax, MD; Amir Sharafkhaneh, MD; Owen Wilson, PhD; Christine Young PT; Rafael Espada, MD (Principal Investigator 1996-2002); Rose Butanda (1999-2001); Minnie Ellisor (2002); Pamela Fox, MD (1999-2001); Katherine Hale, MD (1998-2000); Everett Hood, RPFT (1998 ß 2000); Amy Jahn (1998-2000); Satish Jhingran, MD (1998-2001); Karen King, RPFT (1998-1999); Charles Miller III, PhD (1996-1999); Imran Nizami, MD (Co-Principal Investigator, 2000-2001); Todd Officer (1998-2000); Jeannie Ricketts (1998 -2000); Joe Rodarte, MD (Co-Principal Investigator 1996-2000); Robert Teague, MD (Co-Principal Investigator 1999-2000); Kedren Williams (1998-1999).
Brigham and Women's Hospital, Boston, MA: John Reilly, MD (Principal Investigator); David Sugarbaker, MD (Co-Principal Investigator); Carol Fanning, RRT (Principal Clinic Coordinator); Simon Body, MD; Sabine Duffy, MD; Vladmir Formanek, MD; Anne Fuhlbrigge, MD; Philip Hartigan, MD; Sarah Hooper, EP; Andetta Hunsaker, MD; Francine Jacobson, MD; Marilyn Moy, MD; Susan Peterson, RRT; Roger Russell, MD; Diane Saunders; Scott Swanson, MD (Co-Principal Investigator, 1996-2001).
Cedars-Sinai Medical Center, Los Angeles, CA: Rob McKenna, MD (Principal Investigator); Zab Mohsenifar, MD (Co-Principal Investigator); Carol Geaga, RN (Principal Clinic Coordinator); Manmohan Biring, MD; Susan Clark, RN, MN; Jennifer Cutler, MD; Robert Frantz, MD; Peter Julien, MD; Michael Lewis, MD; Jennifer Minkoff-Rau, MSW; Valentina Yegyan, BS, CPFT; Milton Joyner, BA (1996-2002).
Cleveland Clinic Foundation, Cleveland, OH: Malcolm DeCamp, MD (Principal Investigator); James Stoller, MD (Co-Principal Investigator); Yvonne Meli, RN,C (Principal Clinic Coordinator); John Apostolakis, MD; Darryl Atwell, MD; Jeffrey Chapman, MD; Pierre DeVilliers, MD; Raed Dweik, MD; Erik Kraenzler, MD; Rosemary Lann, LISW; Nancy Kurokawa, RRT, CPFT; Scott Marlow, RRT; Kevin McCarthy, RCPT; Pricilla McCreight, RRT, CPFT; Atul Mehta, MD; Moulay Meziane, MD; Omar Minai, MD; Mindi Steiger, RRT; Kenneth White, RPFT; Janet Maurer, MD (Principal Investigator, 1996-2001); Terri Durr, RN (2000-2001); Charles Hearn, DO (1998-2001); Susan Lubell, PA-C (1999-2000); Peter O'Donovan, MD (1998-2003); Robert Schilz, DO (1998-2002).
Columbia University, New York, NY in consortium with Long Island Jewish Medical Center, New Hyde Park, NY: Mark Ginsburg, MD (Principal Investigator); Byron Thomashow, MD (Co-Principal Investigator); Patricia Jellen, MSN, RN (Principal Clinic Coordinator); John Austin, MD; Matthew Bartels, MD; Yahya Berkmen, MD; Patricia Berkoski, MS, RRT (Site coordinator, LIJ); Frances Brogan, MSN, RN; Amy Chong, BS, CRT; Glenda DeMercado, BSN; Angela DiMango, MD; Sandy Do, MS, PT; Bessie Kachulis, MD; Arfa Khan, MD; Berend Mets, MD; Mitchell O=Shea, BS, RT, CPFT; Gregory Pearson, MD; Leonard Rossoff, MD; Steven Scharf, MD, PhD (Co-Principal Investigator, 1998-2002); Maria Shiau, MD; Paul Simonelli, MD; Kim Stavrolakes, MS, PT; Donna Tsang, BS; Denise Vilotijevic, MS, PT; Chun Yip, MD; Mike Mantinaos, MD (1998-2001); Kerri McKeon, BS, RRT, RN (1998-1999); Jacqueline Pfeffer, MPH, PT (1997-2002).
Duke University Medical Center, Durham, NC: Neil MacIntyre, MD (Principal Investigator); R. Duane Davis, MD (Co-Principal Investigator); John Howe, RN (Principal Clinic Coordinator); R. Edward Coleman, MD; Rebecca Crouch, RPT; Dora Greene; Katherine Grichnik, MD; David Harpole, Jr., MD; Abby Krichman, RRT; Brian Lawlor, RRT; Holman McAdams, MD; John Plankeel, MD; Susan Rinaldo-Gallo, MED; Sheila Shearer, RRT; Jeanne Smith, ACSW; Mark Stafford-Smith, MD; Victor Tapson, MD; Mark Steele, MD (1998-1999); Jennifer Norten, MD (1998-1999).
Mayo Foundation, Rochester, MN: James Utz, MD (Principal Investigator); Claude Deschamps, MD (Co-Principal Investigator); Kathy Mieras, CCRP (Principal Clinic Coordinator); Martin Abel, MD; Mark Allen, MD; Deb Andrist, RN; Gregory Aughenbaugh, MD; Sharon Bendel, RN; Eric Edell, MD; Marlene Edgar; Bonnie Edwards; Beth Elliot, MD; James Garrett, RRT; Delmar Gillespie, MD; Judd Gurney, MD; Boleyn Hammel; Karen Hanson, RRT; Lori Hanson, RRT; Gordon Harms, MD; June Hart; Thomas Hartman, MD; Robert Hyatt, MD; Eric Jensen, MD; Nicole Jenson, RRT; Sanjay Kalra, MD; Philip Karsell, MD; Jennifer Lamb; David Midthun, MD; Carl Mottram, RRT; Stephen Swensen, MD; Anne-Marie Sykes, MD; Karen Taylor; Norman Torres, MD; Rolf Hubmayr, MD (1998-2000); Daniel Miller, MD (1999-2002); Sara Bartling, RN (1998-2000); Kris Bradt (1998-2002).
National Jewish Medical and Research Center, Denver, CO: Barry Make, MD (Principal Investigator); Marvin Pomerantz, MD (Co-Principal Investigator); Mary Gilmartin, RN, RRT (Principal Clinic Coordinator); Joyce Canterbury; Martin Carlos; Phyllis Dibbern, PT; Enrique Fernandez, MD; Lisa Geyman, MSPT; Connie Hudson; David Lynch, MD; John Newell, MD; Robert Quaife, MD; Jennifer Propst, RN; Cynthia Raymond, MS; Jane Whalen-Price, PT; Kathy Winner, OTR; Martin Zamora, MD; Reuben Cherniack, MD (Principal Investigator, 1997-2000).
Ohio State University, Columbus, OH: Philip Diaz, MD (Principal Investigator); Patrick Ross, MD (Co-Principal Investigator); Tina Bees (Principal Clinic Coordinator); Jan Drake; Charles Emery, PhD; Mark Gerhardt, MD, PhD; Mark King, MD; David Rittinger; Mahasti Rittinger.
Saint Louis University, Saint Louis, MO: Keith Naunheim, MD (Principal Investigator); Robert Gerber, MD (Co-Principal Investigator); Joan Osterloh, RN, MSN (Principal Clinic Coordinator); Susan Borosh; Willard Chamberlain, DO; Sally Frese; Alan Hibbit; Mary Ellen Kleinhenz, MD; Gregg Ruppel; Cary Stolar, MD; Janice Willey; Francisco Alvarez, MD (Co-Principal Investigator, 1999-2002); Cesar Keller, MD (Co-Principal Investigator, 1996-2000).
Temple University, Philadelphia, PA: Gerard Criner, MD (Principal Investigator); Satoshi Furukawa, MD (Co-Principal Investigator); Anne Marie Kuzma, RN, MSN (Principal Clinic Coordinator); Roger Barnette, MD; Neil Brister, MD; Kevin Carney, RN, CCTC; Wissam Chatila, MD; Francis Cordova, MD; Gilbert D'Alonzo, DO; Michael Keresztury, MD; Karen Kirsch; Chul Kwak, MD; Kathy Lautensack, RN, BSN; Madelina Lorenzon, CPFT; Ubaldo Martin, MD; Peter Rising, MS; Scott Schartel, MD; John Travaline, MD; Gwendolyn Vance, RN, CCTC; Phillip Boiselle, MD (1997-2000); Gerald O=Brien, MD (1997-2000).
University of California, San Diego, San Diego, CA: Andrew Ries, MD, MPH (Principal Investigator); Robert Kaplan, PhD (Co-Principal Investigator); Catherine Ramirez, BS, RCP (Principal Clinic Coordinator); David Frankville, MD; Paul Friedman, MD; James Harrell, MD; Jeffery Johnson; David Kapelanski, MD; David Kupferberg, MD, MPH; Catherine Larsen, MPH; Trina Limberg, RRT; Michael Magliocca, RN, CNP; Frank J. Papatheofanis, MD, PhD; Dawn Sassi-Dambron, RN; Melissa Weeks.
University of Maryland at Baltimore, Baltimore, MD in consortium with Johns Hopkins Hospital, Baltimore, MD: Mark Krasna, MD (Principal Investigator); Henry Fessler, MD (Co-Principal Investigator); Iris Moskowitz (Principal Clinic Coordinator); Timothy Gilbert, MD; Jonathan Orens, MD; Steven Scharf, MD, PhD; David Shade; Stanley Siegelman, MD; Kenneth Silver, MD; Clarence Weir; Charles White, MD.
University of Michigan, Ann Arbor, MI: Fernando Martinez, MD (Principal Investigator); Mark Iannettoni, MD (Co-Principal Investigator); Catherine Meldrum, BSN, RN, CCRN (Principal Clinic Coordinator); William Bria, MD; Kelly Campbell; Paul Christensen, MD; Kevin Flaherty, MD; Steven Gay, MD; Paramjit Gill, RN; Paul Kazanjian, MD; Ella Kazerooni, MD; Vivian Knieper; Tammy Ojo, MD; Lewis Poole; Leslie Quint, MD; Paul Rysso; Thomas Sisson, MD; Mercedes True; Brian Woodcock, MD; Lori Zaremba, RN.
University of Pennsylvania, Philadelphia, PA: Larry Kaiser, MD (Principal Investigator); John Hansen-Flaschen, MD (Co-Principal Investigator); Mary Louise Dempsey, BSN, RN (Principal Clinic Coordinator); Abass Alavi, MD; Theresa Alcorn, Selim Arcasoy, MD; Judith Aronchick, MD; Stanley Aukberg, MD; Bryan Benedict, RRT; Susan Craemer, BS, RRT, CPFT; Ron Daniele, MD; Jeffrey Edelman, MD; Warren Gefter, MD; Laura Kotler-Klein, MSS; Robert Kotloff, MD; David Lipson, MD; Wallace Miller, Jr., MD; Richard O=Connell, RPFT; Staci Opelman, MSW; Harold Palevsky, MD; William Russell, RPFT; Heather Sheaffer, MSW; Rodney Simcox, BSRT, RRT; Susanne Snedeker, RRT, CPFT; Jennifer Stone-Wynne, MSW; Gregory Tino, MD; Peter Wahl; James Walter, RPFT; Patricia Ward; David Zisman, MD; James Mendez, MSN, CRNP (1997-2001); Angela Wurster, MSN, CRNP (1997-1999).
University of Pittsburgh, Pittsburgh, PA: Frank Sciurba, MD (Principal Investigator); James Luketich, MD (Co-Principal Investigator); Colleen Witt, MS (Principal Clinic Coordinator); Gerald Ayres; Michael Donahoe, MD; Carl Fuhrman, MD; Robert Hoffman, MD; Joan Lacomis, MD; Joan Sexton; William Slivka; Diane Strollo, MD; Erin Sullivan, MD; Tomeka Simon; Catherine Wrona, RN, BSN; Gerene Bauldoff, RN, MSN (1997-2000); Manuel Brown, MD (1997-2002); Elisabeth George, RN, MSN (Principal Clinic Coordinator 1997-2001); Robert Keenan, MD (Co-Principal Investigator 1997-2000); Theodore Kopp, MS (1997-1999); Laurie Silfies (1997-2001).
University of Washington, Seattle, WA: Joshua Benditt, MD (Principal Investigator), Douglas Wood, MD (Co-Principal Investigator); Margaret Snyder, MN (Principal Clinic Coordinator); Kymberley Anable; Nancy Battaglia; Louie Boitano; Andrew Bowdle, MD; Leighton Chan, MD; Cindy Chwalik; Bruce Culver, MD; Thurman Gillespy, MD; David Godwin, MD; Jeanne Hoffman; Andra Ibrahim, MD; Diane Lockhart; Stephen Marglin, MD; Kenneth Martay, MD; Patricia McDowell; Donald Oxorn, MD; Liz Roessler; Michelle Toshima; Susan Golden (1998-2000).
Other Participants
Agency for Healthcare Research and Quality, Rockville, MD: Lynn Bosco, MD, MPH; Yen-Pin Chiang, PhD; Carolyn Clancy, MD; Harry Handelsman, DO.
Centers for Medicare and Medicaid Services, Baltimore, MD: Steven M Berkowitz, PhD; Tanisha Carino, PhD; Joe Chin, MD; JoAnna Baldwin; Karen McVearry; Anthony Norris; Sarah Shirey; Claudette Sikora; Steven Sheingold, PhD (1997-2004).
Coordinating Center, The Johns Hopkins University, Baltimore, MD: Steven Piantadosi, MD, PhD (Principal Investigator); James Tonascia, PhD (Co-Principal Investigator); Patricia Belt; Amanda Blackford, ScM; Karen Collins; Betty Collison; Ryan Colvin, MPH; John Dodge; Michele Donithan, MHS; Vera Edmonds; Gregory L. Foster, MA; Julie Fuller; Judith Harle; Rosetta Jackson; Shing Lee, ScM; Charlene Levine; Hope Livingston; Jill Meinert; Jennifer Meyers; Deborah Nowakowski; Kapreena Owens; Shangqian Qi, MD; Michael Smith; Brett Simon, MD; Paul Smith; Alice Sternberg, ScM; Mark Van Natta, MHS; Laura Wilson, ScM; Robert Wise, MD.
Cost Effectiveness Subcommittee: Robert M. Kaplan, PhD (Chair); J. Sanford Schwartz, MD (Co-Chair); Yen-Pin Chiang, PhD; Marianne C. Fahs, PhD; A. Mark Fendrick, MD; Alan J. Moskowitz, MD; Dev Pathak, PhD; Scott Ramsey, MD, PhD; Steven Sheingold, PhD; A. Laurie Shroyer, PhD; Judith Wagner, PhD; Roger Yusen, MD.
Cost Effectiveness Data Center, Fred Hutchinson Cancer Research Center, Seattle, WA: Scott Ramsey, MD, PhD (Principal Investigator); Ruth Etzioni, PhD; Sean Sullivan, PhD; Douglas Wood, MD; Thomas Schroeder, MA; Karma Kreizenbeck; Kristin Berry, MS; Nadia Howlader, MS.
CT Scan Image Storage and Analysis Center, University of Iowa, Iowa City, IA: Eric Hoffman, PhD (Principal Investigator); Janice Cook-Granroth, BS; Angela Delsing, RT; Junfeng Guo, PhD; Geoffrey McLennan, MD; Brian Mullan, MD; Chris Piker, BS; Joseph Reinhardt, PhD; Blake Robinswood; Jered Sieren, RTR; William Stanford, MD.
Data and Safety Monitoring Board: John A. Waldhausen, MD (Chair); Gordon Bernard, MD; David DeMets, PhD; Mark Ferguson, MD; Eddie Hoover, MD; Robert Levine, MD; Donald Mahler, MD; A. John McSweeny, PhD; Jeanine Wiener-Kronish, MD; O. Dale Williams, PhD; Magdy Younes, MD.
Marketing Center, Temple University, Philadelphia, PA: Gerard Criner, MD (Principal Investigator); Charles Soltoff, MBA.
Project Office, National Heart, Lung, and Blood Institute, Bethesda, MD: Gail Weinmann, MD (Project Officer); Joanne Deshler (Contracting Officer); Dean Follmann, PhD; James Kiley, PhD; Margaret Wu, PhD (1996-2001).
Other Acknowledgments
Arthur Gelb, MD, Lakewood Regional Medical Center, Lakewood, CA.
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Discussion |
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One thing I do want to comment about is I think as we think about these patients, and I think a finding from this was in regards to the inhaled steroids, which a lot of times we have focused so much on decreasing the oral amount of steroids that we forgot about these patients were doubling or even tripling their amount of inhaled steroids. So I think that is going to be a very important thing as we go into this second wave of treatment.
The one thing I wonder, if you could comment on, is in the paper you have suggested now if patients have a moderate amount of adhesions found on radiologic findings beforehand that they may not be a candidate for surgery, and I want to know how you would address that issue and also how you would take care of it at the time of surgery? A lot of times we would do an extrapleural dissection to take care of that.
And the last question is, 13% of your patients had an air leak longer than 30 days, and I wonder if you could comment. I know Eugene Blackstone has done the statistical analysis on this, did you all carve that group out and see if that was a special group and what you do to prevent that? Thank you.
DR D E CAMP: I appreciate your comments, Dr. Miller. I will take the last one first. The way that the data was collected, for patients whose air leak extended beyond 30 days, we don't have the date when that air leak stopped. So we censored those patients from our analysis in terms of defining risk factors for air leak duration. Most of those patients were discharged with Heimlich valves where the day-to-day issue of management wasn't a big deal. We would see them back in a week and if their air leak had stopped, would take out the tube.
To back up and answer your question about adhesions, the scoring of adhesions was none; minimal, defined as 5 to 10%; moderate, up to 20%; and extensive was greater than 20%. It was the surgeon's estimate. I think those are handled differently whether you are doing thoracoscopy versus whether you are doing sternotomy. My personal practice was with thoracoscopy. I tended to leave those areas alone, if I could, and if I could still do the requisite amount of resection, 30% of the volume of the lung. If forced to deal with adhesions, I think approaching them extrapleurally is exactly the right thing to do. You are leaving essentially the parietal pleura as an autologous buttress, and I think if you do this through a sternotomy you pretty much have to start that way if you are faced with dense adhesions.
I would use this data in my practice to extend the exercise of good surgical judgment. I would use the adhesion data not alone, but if I had a patient who had marginal pulmonary function, which already places them at a higher risk, and I saw radiographic evidence of adhesions (significant pleural thickening), I might be inclined to turn that patient down. In the New England Journal report of high risk patients (20% FEV1 and 20% DLCO), you have got to remember, those are somewhat arbitrary numbers, such that the person at 22% doesn't mean they are going to survive and at 18% they are going to die.
The inhaled steroids was very interesting. Only after we saw this result did we start thinking about what steroids do. We had very few wound complications. We actually had a lot of lung parenchymal healing problems based on the air leak data. So I guess I have changed my whole philosophy about that. I don't think there is much downside to getting rid of the inhaled steroids beforehand, and I just speculate that the reason for that is the retention of drug in the lung tissue.
DR ROBERT J. CERFOLIO (Birmingham, AL): That was a very, very nice presentation, and again, an important topic on the major morbidity of our patients. Three quick questions. The first concerns your chest tube management—maybe you could just tell us how that was done. I know there were a lot of surgeons, but your general management.
The second question is that 66% of the patients were eliminated because they had an air leak for greater than 30 days. We presented here a few years ago about removing chest tubes in patients with persistent air leaks at two weeks. Do you not buy that data, or do you think it doesn't apply to the LVRS patients because of their emphysema, and do you have any experience of removing these tubes after the patients have been home after two or three weeks, whether they are leaking or not. We have done this in now over 100 patients with good results—the tube can come out despite the presence of an air leak if they have been home on a Heimlich valve with no problems after two weeks.
And then finally, the reoperations. I can't tell you the last time I reoperated on a patient for an air leak, and yet you had a whole bunch. Can you tell us how you handled that, the indications for the surgery, and what you did at the time of surgery. Thanks.
DR D E CAMP: Chest tube management was left to the discretion of the surgeon. Most of the surgeons ascribed to the "no suction or less suction" is best philosophy. I personally didn't use suction unless the patient was developing lots of subcutaneous emphysema. I didn't really worry about the chest x-ray. Again, this is 17 centers and probably 25 surgeons, so that wasn't standardized. I do ascribe to what you say, and at two or three weeks after surgery I will clamp the tube, and if nothing happens, I will pull it out regardless of whether it is leaking or not, hoping and expecting that the lung is stuck. Again, we had 25 different surgeons, many with different practices. We don't have the data on their individual tube management beyond thirty days.
Finally, the reoperations. I didn't have any. They were statistically equally distributed between VATS and median sternotomy, and I can't tell you what the risk factors were, though if you didn't have an air leak, you certainly didn't need a reoperation.
DR JOHN H. CALHOON (San Antonio, TX): A very nice presentation. You told us what did not work for air leaks. What does work for air leaks, in your opinion, in this?
DR D E CAMP: I personally think this is the one surgical population where routine buttressing makes sense; the tissue is like wet toilet paper. We don't have a large enough cohort of unbuttressed to buttressed patients to compare. There are a few a single-institution series from the early to mid '90s when lung volume reduction surgery was being born, that showed reduction in length of stay or reduction in chest tube drainage with buttressing compared to an unbuttressed technique. I think it makes sense to buttress the staple line though I know that other people say that the majority of prolonged air leaks when they are reexplored are not at the staple line, rather they are found at other areas of the lung and perhaps are more related to wall tension or unrecognized adhesions.
DR D. GLENN PENNINGTON (Johnson City, TN): You are obviously not going to stop buttressing. Are you going to stop using sealants.
DR D E CAMP: I don't use sealants routinely. I think a lot of these air leaks can be managed in an ambulatory fashion, though this is the first evidence that we have seen that air leaks aren't benign and they do beget other complications.
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For a complete National Emphysema Treatment Trial (NETT) Credit Roster, see Appendix 1.
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, n = 469) versus other ethnicities (
, n = 24). (B) Use of inhaled steroids (
20, n = 119; 
= 30 to 40, n = 126; 
> 40, n = 51). Number of patients remaining with air leaks at various time points is not shown because of busyness of the figure. (D) One-second forced expiratory volume (FEV1, percent of predicted; 