The bronchoscopy procedure time for the treatment group was 57 (±25) minutes compared with 29 (±11) minutes for the sham control group (P<0.0001). The median hospital stay was 1 day for both groups and the mean was 2.2 (±6) for the treatment group and 1.0 (±0) for the control group. The number of valves was 931 in 142 treatment subjects or an average of 6.6 valves per subject.
The primary composite measure showed that 6 of 121 (5.0%) of the subjects in the treatment group and 1 of 134 (0.7%) in the control group were responders by SGRQ and CT with a 2-sided 95% BCI of (0.048%, 9.212%) for the difference between percentages of responders. The posterior probability superiority in the treatment group was 97.0%, which exceeded the prespecified success threshold of 95%. These results are shown in Table 2, along with individual results of the components of SGRQ and CT lobar volume changes. The SGRQ did not show improvement in the treatment group at 6 months and the proportion of responders was not different between treatment and control groups. The lobar volume changes were significantly different with the treated UL demonstrating an average decrease of −224 mL at 6 months compared with −17 mL for the control group (BCI, −272, −143). The proportion of subjects with a decrease in UL volume was 82%. The average increase in volume of the NUL was 214 mL in the treatment group compared with −27 mL in the control group (BCI, 155, 326). The proportion of responders by both UL and NUL was significantly greater, 19.2%, in the treatment group compared with 2.3% in the control group (BCI, 9.4%, 24.6%).
Table 3 shows a comparison of mean change between baseline and 6 months for the treatment and control groups. Overall, the treatment group declined in FEV1, FVC, RV, PCO2, and 6-minute walk test. The significant changes in some parameters in the treatment group are associated with procedure adverse events (e-Appendix) and safety results.
There were no occurrences of migration, erosion, expectoration, or serious device-related pneumonia in the study subjects. There were no unanticipated, serious, device-related adverse events. The primary safety measure was the difference between the treatment and control groups in the defined SAE per subject. There were significantly more subjects with an SAE in the treatment group (n=20 or 14.1%) compared with the control group (n=5 or 3.7%) (BCI, 4.0, 17.1). Analysis of the SAEs shows that no one type of event was primarily responsible for the difference. The separate categories are shown in Table 4 and the most frequent event is COPD exacerbations (7 in the treatment group and 2 in the control group). There were 6 deaths in the treatment group and 1 in the control group. No death was considered device related. Three deaths were cardiovascular in origin (day 26 in the control group, and day 95, 165 in the treatment group). One death (day 82) was related to a COPD exacerbation that progressed to respiratory failure, 1 death (day 59) started with gastrointestinal bleeding on day 5, and another was from liver cirrhosis and multiorgan failure (day 190). One death (day 14) was probably procedure related as discussed below.
Device-related or Procedure-related SAEs
The number of SAEs was 28 for 20 treatment and 5 control subjects and 19 were neither procedure nor device related. Six were procedure related, and 3 were considered device related. The 3 device-related events were pneumothoraces related to complete occlusion treatment (e-Appendix). The 6 procedure-related SAEs that occurred in 5 treatment subjects included 2 COPD exacerbations on day 2, 2 respiratory failures on days 6, 7 with 1 progressing to death, and 1 bronchospasm on day 5. The subject that died on day 14 developed apnea during the procedure, was hospitalized for 4 days, and readmitted on day 7 with systemic inflammatory response syndrome and respiratory failure. Figure 3 shows the timing of all 36 SAEs and highlights that the largest number of events occurred within 1 week of the procedure. Of all adverse events, including moderate and mild events, 57% of the treatment group and 48% of the control adverse events occurred within the first 4 weeks after the procedure (data not shown).
There were more COPD exacerbations after bronchoscopy, in the period of 0 to 4 weeks, in the treatment group (44 episodes) compared with the control group (10 episodes). During weeks 5 to 24, the COPD exacerbations were not different between treatment and control groups with 51 in the treatment and 41 in the control group (P=0.45).
There were only 3 (2.1%) instances of pneumonia in a valve treated location and none were serious. There were 26 episodes in a nonvalve treated location and 6 or 23% occurred in the first 4 weeks. There were 3 episodes of serious pneumonia and 2 of these were in control group patients.
The goal of this trial was to demonstrate acceptable clinical efficacy and a low incidence of adverse events, specifically pneumothorax. The incidence of pneumothorax with bilateral-partial treatment was very low with only 1 episode (0.7%) which resolved after 2 days. The effectiveness, although statistically significant for the treatment responders compared with control, was not clinically meaningful with a 5% responder rate. The partial bronchial valve occlusion of both ULs had, as expected, a significant effect on the lobar volumes at end-inspiration with >200 mL volume shift to the untreated lobes. This pattern confirms prior work9,16,17 showing redistribution of air to the nontreated lobes. We previously found that a 350 mL shift was associated with significant improvement in the SGRQ and others have confirmed a target-lobe volume reduction of >350 mL as clinically significant.13,18 This trial achieved, on average, a volume shift of only 200 mL and this is likely responsible for the lack of improvement in quality of life for the treatment group.
The inclusion of a patient-reported outcome, the SGRQ, as a coprimary measure, necessitated a double-blind study design. Others have questioned this study design16,19 as a chest x-ray shows the device and the risk of serious complications for the control group. Blinding was successfully maintained in 97% of the subjects and there were no serious complications from the procedure for the control patients. The sham procedure and blinding did allow measurement of the combined placebo and study effects for the control group. These effects were notable because as shown in Table 2, at 6 months the SGRQ was improved in the control group by 1.4 points, and was improved >3 points at 1 and 3 months after treatment [e-Appendix, see Supplemental Digital Content, http://links.lww.com/LBR/A114].
Complications associated with the IBV Valve device itself were minimal with only 2% incidence of pneumonia in the valve location and no significant increase in COPD exacerbations compared with control during weeks 5 to 25. There was 1 instance of hemoptysis (0.7%) requiring bronchoscopic evaluation in the treatment group. These results compared favorably to the results from the Endobronchial Valve for Emphysema Palliation Trial (VENT trial) and the Zephyr valve16 where there were 13 episodes (6.1%) of hemoptysis including 1 fatality and significantly more episodes of COPD exacerbations in the treatment group compared with the control group.
Complications associated with the procedure in this trial were greater in the treatment group. However, comparing 30-day mortality with the NETT, this IBV trial had a 30-day mortality of 0.7% in the treatment group compared with 2.2% in the NETT surgery group and 0.2% in the NETT control group.5 Importantly, the 30-day mortality in IBV-treated subjects in this trial was not significantly different from the control group in NETT (P=0.37). Using the NETT definitions for major pulmonary and cardiovascular morbidity,8 this trial treatment group had 30-day instances of 4.2% and 1.5% compared with 28.1% and 20.0%, respectively, in the NETT. Nonetheless, the procedure-related complications in this trial were increased in the treatment group compared with control, probably because of the longer procedure duration.
In the Multicenter European study with IBV Valves,17 which had a similar design as the present study, the type of adverse events reported are similar to the ones reported in the current study. The European study had a blinding duration of only 3 months and the total number of enrolled subjects was 73 patients (37 treatments and 36 controls). In the European study there were 7 patients with SAEs in the treatment group (18.9%) and 4 in the control group (11.11%) compared with the 14.1% and 3.7% reported in the study being reported.
While this trial was ongoing, the VENT trial was published in 2 parts.16,18 Those investigators performed single-lobe complete occlusion with the Zephyr valve but did not achieve clinically meaningful results. Despite technical problems resulting in only 56% and 48% complete lobar occlusion at 6 months, the investigators identified a subgroup with higher heterogeneity and complete interlobar fissures that had a greater response. A recent randomized study using the IBV Valve confirmed single-lobe complete treatment was superior to bilateral-partial occlusion treatment.20 Using imaging biomarkers for patient selection with excellent technical results, they showed that single-lobe complete occlusion significantly improved pulmonary function, exercise, and quality of life.
Bilateral-partial bronchial valve occlusion of both ULs of in patients with severe emphysema shifted lung volume from the treated lobes to the untreated lobes to a significant degree. However, the lobar volume shift of 200 mL was not accompanied by an improvement in the health-related quality of life measure as seen previously. This trial was a technical and statistical success, but it did not achieve clinically meaningful results. Device safety was confirmed and pneumothorax was reduced by partial lobar treatment. This and concurrent studies add to the accumulating knowledge that bronchial valve treatment, especially when using imaging biomarkers for low collateral ventilation paired with complete occlusion of a single lobe, remains a promising treatment for selected patients with severe emphysema.
The authors would like to thank Andrew Mugglin PhD for statistical support and guidance.
IBV Valve Trial Research Team (alphabetical by institution):
Akron General Medical Center, Akron. OH. Sanjiv Tewari, MD (Principal Investigator); Debra Hudock, RN, MSN, CNS (Principal Clinic Coordinator); Diane Fultz, RRT; Christine Fygetakes, RRT; Lee Ann Williams, CNP; Akhil Bindra, MD; Harish Kakarala, MD; Kar-Ming Lo, MD; Michael Passero, MD.
Alexian Brothers Hospital Network, Elk Grove Village, IL. Edward J. Diamond, MD (Principal Investigator); Kevin Kovitz, MD (Coprincipal Investigator); Mary Vance (Principal Clinic Coordinator); Judy Goodman, CCRC; Leah Gooch; Mary Joseph, PhD; Rebecca Meredith, BA; John E. Pantano, MD; Marilyn Borkgren, RN; Sadia Benzaquen, MD; Sara Greenhill, MD.
Cleveland Clinic Foundation, Cleveland, OH. Michael Machuzak, MD (Principal Investigator); Thomas Gildea, MD (Coprincipal Investigator); Yvonne Meli, RN, BC, CCRP (Principal Clinic Coordinator); Diane Faile, BS, RRT; Richard Rice; Atul Mehta, MBBS; Brian Mann, MD; David Mason, MD; Joseph G. Parambil, MD; Omar A. Minai, MD.
Columbia University Medical Center, New York, NY. Roger Maxfield, MD (Principal Investigator); Patricia Jellen, MSN RN (Principal Clinic Coordinator); Fran Brogan, MSN; Angela Di Mango, MD; Byron Thomahow, MD; Chip Yip, MD; David Lederer, MD; Mathew Bachetta, MD; William Bulman, MD; Joshua Sonett, MD; Mark Ginsburg, MD.
Emory University Hospital, Atlanta, GA. Seth D. Force, MD (Principal Investigator); (Jennifer) Noel, Walker, RN (Principal Clinic Coordinator); Alexis, Neill, RN; Ellen Lyons, RRT; Jayne Thompson, RN; Maryse Van Dyke; Shannon Smith, RN; David Shaz, MD; Alvaro Velasquez, MD.
HealthPartners Research Foundation/Regions Hospital, St. Paul, MN. Charlene E. McEvoy, MD (Principal Investigator); Avi Nahum, MD (Coprincipal Investigator); Alain Broccard, MD; (Coprincipal Investigator); Natalie K. Woodruff (Principal Clinic Coordinator); Alex Adams, RRT; Pamela J. Neuenfeldt; Eric Korbach, MD; Kealy Ham, MD; Krista Graven, MD.
Kaiser Permanente Medical Center Los Angeles, Los Angeles, CA. Luis M. Moreta-Sainz, MD (Principal Investigator); Nancy Elbaum, RN (Principal Clinic Coordinator); Cecilia Pineda, RN; Mercedes Cardona; Arash Kharestan, MD; Mihran Garabedian, MD.
Kaiser Permanente Northwest, Portland, OR. Richard A. Mularski, MD,MSHS, MCR (Principal Investigator); Thomas P. Yan, MD, (Coprincipal Investigator); Kathleen Arnold, RN, BSN (Principal Clinic Coordinator); Carol Young; Elease Rumbaugh, RN, NP; Heather Houston, RN; Helen Walsh, RN, MPH; Roger Macdonald, RN, MEd, ND; Alistair Scriven, MD; David Schmidt, MD, PhD; Jonathan Rettmann, MD; Joshua Filner, MD, MPH; Noel Wardell, MD; Susan Mikkelsen, MD; Thomas Stibolt, MD.
Lehigh Valley Medical, Allentown, PA. Robert (Robb) Kruklitis, MD, PhD (Principal Investigator); Gerard Petersen, MD (Coprincipal Investigator); Jennifer Rovella, MD (Coprincipal Investigator); Madeline Sharkey, RN (Principal Clinic Coordinator); Marika Vermeersch, RN; Terry Kloiber; Dorothea Direso, MD; Jeff Marsh, MD; Jonathon Hertz, MD; Joseph Paprota, MD.
Medical College of Wisconsin, Milwaukee, WI. Mario Gasparri, MD (Principal Investigator); Christopher Plambeck, MD (Coprincipal I); Barb Alivo, RN (Principal Clinic Coordinator); Trisha Wilcox, NP; Joanne Scherwinski; Daryl Pearlstein, MD; Randolph Lipchik, MD; William Tisol, MD.
Mission Internal Medicine Group, Mission Viejo, CA. George Schiffman, MD, FCCP (Principal Investigator); Rudy Marquez, MD, FCCP (Coprincipal Investigator); Gladys Andreas (Principal Clinic Coordinator); Bruce Tammelin, MD; Edmond Vartany, MD; Richard Bell; Margaret Amaya.
Mount Sinai School of Medicine, New York, NY. Timothy Harkins, MD (Principal Investigator); E. Neil Schachter, MD, (Coprincipal Investigator); Olivera Calukovic (Principal Clinic Coordinator); E. Neil Schachter, MD; Scott J. Swanson, MD; Ireen Khan; Ketan Patil; Nancy Davis, RN; Oleg Epelbaum, MD; Paul Barrette; Savil Erickson-Torres, MD; Susan Comninel, RN; Virginia Litle, MD.
National Jewish Hospital, Denver, CO. Russell Bowler, MD (Principal Investigator); Ali Musani, MD (Coprincipal Investigator); Holly Currier (Principal Clinic Coordinator); Kim McPeak; Adam Friedlander, MD; Kurt Jensen, MD; Scott Van daWalker, NP; Katherine Ross Garces, RN.
Oklahoma State University, Tulsa, OK. Daniel Nader, DO (Principal Investigator); Johnny Stephens, PharmD (Coprincipal Investigator); Faye Biggs (Principal Clinic Coordinator); Diana Tameny (Principal Clinic Coordinator); Jeffrey Stroup, PharmD., BCPS; Mary Donovan, RN; Damon Baker, DO; Montgomery Roberts, DO; Mousumi Som, MD; Nicole A. Farrar, DO; Randall Reust, DO; Scott Hendrickson, DO.
Overlook Hospital, Summit, NJ. Robert A. Restifo, DO (Principal Investigator); Robert Sussman, MD;Vincent Donnabella, MD (Coprincipal Investigator); Federico Cerrone, MD; Mark Zimmerman, MD; Virginia Hala, RN, CCRC (Principal Clinic Coordinator); Marissa Rienton Lim, CCRC; Kathy Izzo, CCRC.
Pulmonary & Critical Care Associates of Baltimore, Baltimore, MD. William Krimsky, MD (Principal Investigator); Ajay Behari, MD (Coprincipal Investigator); Sy Sarkar, MD (Coprincipal Investigator); Stuart King (Principal Clinic Coordinator); Eileen Opdyke, RN; Joel Atwood; Sherry Crawshaw, PA; Stuart Willes, MD.
Pulmonary Associates of Mobile, P.C., Mobile, AL. Allan Seibert, MD (Principal Investigator); Michele Hemphill, RN (Principal Clinic Coordinator); Letoya Craig; Nicole Saizan, RN; Tony Cowan, RT; Caesar Agagan, MD; Peter Lutz, MD.
Rhode Island Hospital, Providence, RI. Douglas Martin, MD (Principal Investigator); Sidney Braman, MD (Principal Investigator); Muhanned Abu-Hijleh (Principal Investigator); Amy Palmisciano RN, BSN (Principal Clinic Coordinator); Avery Couture; Christine Newman, RN; Erin E. Johnson; Gina Ruggiera; Melissa Skoutas; Kevin Dushay, MD; Yaser Abu-El-Sameed, MD.
Sarasota Memorial Hospital, Sarasota, FL. Kirk Voelker, MD (Principal Investigator); Kathy Pope-Nix, RN (Principal Clinic Coordinator); Nancy Clapp, RN, BA, CCRC; Gregory Ferreira, MD; Kisha Morgan, MD; Todd Horiuchi, MD; Mary Bradley, RN; Gail Wagoner, RN.
Scott & White Memorial Hospital, Temple, TX. Juan Sanchez, MD (Principal Investigator); Dominic deKeratry, MD (Principal Investigator); Craig Cernosek, DC, CRC III (Principal Clinic Coordinator); Chris Herrick; Heather Smith; Melisa Carney; Rhoda Wardlow; Ryan Whittle; Ester-Fields, DO; Marilynn-Prince-Fiocco, MD; Shirley-Fong-Jones, MD.
Southern Illinois University School of Medicine, Springfield, IL. Stephen R. Hazelrigg, MD (Principal Investigator); Cathy Leslie, RN (Principal Clinic Coordinator); Cathy Leslie, RN; Cheryl Ogden, RN; Diane Drew; Theresa Boley, RN.
St. Joseph Medical Center, FHS, Tacoma, WA Richard A. Kahlstrom, MD (Principal Investigator); Navdeep Rai, MD (Coprincipal Investigator); Chris Biljan, RN (Principal Clinic Coordinator); Laura Crews, RN, BSN, CCRC; Trina Wesner; Ann Lee, MD; Clifton Ty Baylor, MD; David Shaw, MD; Manuel Iregui, MD; Stacie Krabill, ARNP; Stephen Ryan, MD; Lydia Clipper, RNC, CCRP; Wendy White; Alejandro Arroliga, MD.
University of Alabama at Birmingham, Birmingham, AL. Robert Cerfolio, MD (Principal Investigator); Keith M. Wille, MD; Sandra Calloway (Principal Clinic Coordinator); Hilary Moran, RN; Jeana Alexander, RN, BSN; Valerie Maldonado.
University of California Davis Medical Center, Sacramento, CA. Andrew Chan, MD (Principal Investigator); Roblee Allen, MD (Coprincipal Investigator); Maya Juarez (Principal Clinic Coordinator); Tina Tham; Timothy Albertson, MD; Brian Morrissey, MD; Mark Avdalovic, MD; Richart Harper, MD; Samuel Louie, MD; Nicholas Stollenwerk, MD; Macey Sockolov; Ricio Mendoza; Jimmy Yu, Krysta Chaldekas; Sandy Algaze; Tina Tran.
University of California Medical Center at Los Angeles, Los Angeles, CA. Christopher Cooper, MD (Principal Investigator); Irawan Susanto, MD; Patricia Eshaghian, MD; Robert Cameron, MD; Eric Kleerup, MD; Donald Tashkin, MD; Milan Patel (Principal Clinic Coordinator); John Dermand (Principal Clinic Coordinator); Marlon Abrazado (Technical Support).
University of California San Diego Health System, San Diego, CA. Gordon Yung, MD (Principal Investigator); Smita A. Desai, DO (Coprincipal Investigator); Christopher Whitehead (Principal Clinic Coordinator); Bobbie Munden, RN (Principal Clinic Coordinator); Laura Gabel (Koenig) CCRC; Colleen Channick, MD; Samir Makani, MD; Victor Test, MD.
University of Chicago Medicine, Chicago, IL. D. Kyle Hogarth, MD (Principal Investigator); Imre Noth, MD (Coprincipal Investigator); Spring Holland, CCRC (Principal Clinic Coordinator); Cathy Brown, RN; Latriese Sardin; Irena Garic; Edward Naurekas, MD; Mary Strek, MD; Pamela McShane, MD; Steven White, MD.
University of Florida, Gainesville, FL. Michael A. Jantz, MD, FCCP (Principal Investigator); Sebastian Fernandez-Bussy, MD (Coprincipal Investigator); Robin Carrie, ARNP (Principle Clinic Coordinator); Edward Hensel, RN; Jessica Sanders, CVT, CPFT; Hassan Alnuaimat, MD; Carolyn Graisbery, RN.
University of Iowa Hospitals and Clinics, Iowa City, IA. Geoffrey McLennan, MB, BS, FRACP, PhD (Principal Investigator); Kimberly Baker, MD (Principal Investigator); Tom Recker, MD (Coprincipal Investigator); Kim Sprenger, RN (Principal Clinic Coordinator); Andrea Chapman; Angela Delsing; Janet Keating; Kaylene Crawford; Phyllis Pirotte, RN; Sara Kraus; Dawn Flaherty, MD; Dwight Look, MD; Karl Thomas, MD; Sherif El-Mahdy, MD.
University of Louisville, Louisville, KY. Jinesh Mehta, MD (Principal Investigator); Maria del Mar Cirino-Marcano, MD (Principal Investigator); Rodney Folz, MD (Principal Investigator); Fidaa Shaib, MD (Coprincipal Investigator); Brian Beattie (Principal Clinic Coordinator); Anna Rich; Brian Mattingly; Heidi Wilson; Mohamed Saad, MD.
University of Pennsylvania Health System, Philadelphia, PA. Andrew R. Haas, MD, PhD (Principal Investigator); Colin T. Gillespie, MD; Daniel H. Sterman, MD; Barbara Finkel, MSN, RN, CCRC (Principal Clinic Coordinator); Susan Metzger, MSN, RN (Current Clinic Coordinator); Kayla MyThao Le; Victoria Fleck; Hans Lee, MD; Michael W. Sims, MD; Steven L. Leh, MD.
University of Texas Health Science Center at San Antonio, San Antonio, TX. Luis F. Angel, MD (Principal Investigator); Regina T. Whitener (Principal Clinic Coordinator); Deborah J. Levine, MD; Stephanie Levine, MD; Adam Cline.
University of Utah Health Sciences Division, Salt Lake City, UT. Mark Elstad, MD (Principal Investigator); Barbara Cahill, MD (Coprincipal Investigator); Chakravarthy Reddy, MD (Coprincipal Investigator); Wayne Samuelson, MD (Coprincipal Investigator); Sanjeev Murthi Raman, MD (Coprincipal Investigator); Tauni Maughan, BSN (Principal Clinic Coordinator); Judy Jensen, MS, CCRC (Principal Clinic Coordinator); Kelly Peterson-Short, RN (Coprincipal Coordinator); Leonie Morrison-de Boer, MD (Coprincipal Coordinator).
University of Virginia Medical Center, Charlottesville, VA. Jonathon D. Truwit, MD, MBA (Principal Investigator); Y. Michael Shim, MD (Coprincipal Investigator); Margaret E. Donowitz, MSN, RN, APN2 (Principal Clinic Coordinator); A. Renee Campbell, RRT, RPFT; Ajeet G. Vinayak, MD; Kyle B. Enfield, MD.
University of Washington Medical Center, Seattle, WA. Douglas E. Wood, MD (Principal Investigator); Michael Mulligan, MD (Coprincipal Investigator); Linda Harrison, CCRC (Principal Clinic Coordinator); Catherine Pagoaga; Connie J. Wallum; Mehakpreet, Romana, MD; Skye Steptoe.
VA Palo Alto Health Care System, Palo Alto, CA. Ware Kuschner, MD (Principal Investigator); Ganesh Krishna, MD (Principal Investigator); Harmon Paintal, MD (Coprincipal Investigator); Madhuri Agrawal (Principal Clinic Coordinator); Edmond Varney, MD; Rudy Marquez, MD.
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emphysema; bronchial valves; endobronchial therapy
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