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1. Long-Term Results After Lung Volume Reduction Surgery: A Single Institution’s Experience

Author

Daniel Mansour, Susan D. Moffatt-Bruce, Philip T. Diaz, Sheri Shimizu-Saito, Chelsea R. Horwood, Mahmoud Abdel-Rasoul, Mahasti Rittinger, Gregory A. Metzger, Rishav Aggarwal, and Jing Han

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Lung volume reduction surgery, Risk Assessment, Severity of Illness Index, Cohort Studies, Hospitals, University, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, Confidence Intervals, Humans, Medicine, Registries, Pneumonectomy, Survival rate, Aged, Ohio, Retrospective Studies, business.industry, Mortality rate, Retrospective cohort study, Middle Aged, Confidence interval, Respiratory Function Tests, Survival Rate, Treatment Outcome, Pulmonary Emphysema, 030228 respiratory system, Cohort, Female, Surgery, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business, Cohort study
Abstract

Background The National Emphysema Treatment Trial (NETT) showed a clear survival and quality of life benefit for patients selected for lung volume reduction surgery (LVRS). However, long-term outcomes after LVRS are still lacking. The aim of this study was to evaluate overall mortality and functional durability in this single-institution cohort of patients undergoing LVRS. Methods A single-institution registry identified all patients who had undergone LVRS from January 2006 through August 2017. Records were retrospectively reviewed, and data were collected to include pulmonary functions test values, he University of California, San Diego shortness of breath questionnaire and complication and mortality rate. Results LVRS was performed in 135 patients with a 2.2% 90-day mortality rate (n = 3). Estimated 1-, 2- and 5-year survival was 0.94 (95% confidence interval [CI], 0.88 to 0.97), 0.91 (95% CI, 0.83 to 0.95), and 0.71 (95% CI, 0.57 to 0.81), respectively. Mean improvement in forced expiratory volume in 1 second% predicted from preoperative baseline at 1 and 2 years was 5.3 (95% CI, 3.1 to 7.4) and 4.3 (95% CI, 1.9 to 6.6), respectively. There was a mean improvement in maximum workload of 5.2 W (95% CI, 0.9 to 9.4) at 1 year. Also, shortness of breath questionnaire scores had a mean decrease of −17.3 points (95% CI, −21.8 to −13) at 6 months and −13.9 points (95% CI, −18.4 to −9.3) at 1 year. Conclusions LVRS is an effective operation with overall improvement in functional status and quality of life in appropriately selected patients.

Published
2019
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2. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned

Author

Roger D. Yusen, Gerard J. Criner, Alice L. Sternberg, David H. Au, Anne L. Fuhlbrigge, Richard K. Albert, Richard Casaburi, James K. Stoller, Kathleen F. Harrington, J. Allen D. Cooper, Philip Diaz, Steven Gay, Richard Kanner, Neil MacIntyre, Fernando J. Martinez, Steven Piantadosi, Frank Sciurba, David Shade, Thomas Stibolt, James Tonascia, Robert Wise, William C. Bailey, Ernestina Sampong, Karin Sloan, Ashley Wagner, Susan Anderson, Marilyn Moy, Osarenoma Okunbor, Scott Marlow, Yvonne Meli, Richard Rice, Loutfi S. Aboussouan, Robert Castele, Joseph Parambil, Sumita Khatri, Aman Pande, Joe Zein, Thomas Olbrych, Stephan Alkins, Christine Jocko, Franck Rahaghi, Jean Barton, Jennifer Underwood, Barry Make, John Davies, Richard Mularski, Allison Naleway, Sarah Vertrees, Janos Porszasz, Peggy Walker, Renee Indelicato, Lennard Specht, Kathleen Ellstrom, Jamie Portillo, David Horak, Brian Tiep, Mary Barnett, Janice Drake, Mahasti Rittinger, Rachael Compton, Scott Miller, Ralph J. Panos, Laura A. Lach, Gerard Criner, Carla Grabianowski, Francis Cordova, Parag Desai, Samuel Krachman, James Mamary, Nathaniel Marchetti, Aditi Satti, Eileen Mumm, Michelle Vega-Olivo, Jenny Hua, Vanna Tauch, Lii-Yoong Criner, Michael Jacobs, Peter Rising, Paul Simonelli, Michele Mitchell, Matthew Lammi, Connie Romaine, Howard Lee, Mary Ianacone, Steven Scharf, Wanda Bell-Farrell, M. Jeffery Mador, Ayesha Rahman, Mumtaz Zaman, Lisa Hill, Alec Platt, J. Allen Cooper, Kathleen Harrington, Mark Dransfield, Patti Smith, Donald Davis, Peruvemba Sriram, Katherine Herring, Fernando Martinez, Meilan Han, Kelly Rysso, Catherine Meldrum, K. P. Ravikrishnan, Daniel Keena, Jennifer DeRidder, Beth Kring, Antonio Anzueto, Alex Aguilera, Timothy Houlihan, Reda Girgis, Jennifer Cannestra, Benjamin Kelly, Mary Beth Scholand, G. Martin Villegas, Judy Carle, Edmunds Udris, Randall Curtis, David Au, Laura C. Feemster, Richard Goodman, Brianna Moss, Lynn Reinke, Moira Aitken, Bruce Culver, Mario Castro, Brigitte Mittler, Jeanne Heaghney, Myron Jacobs, Min Joo, Nina Bracken, Edward Diamond, Mary K. Joseph, Xavier Soler, Arianna Villa, Daniel Layish, Edwin Silverman, Roxanne Kelly, Daniel Cossette, Patricia Belt, Amanda Blackford, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, K Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Mark Van Natta, Laura Wilson, Annette Wagoner, Katherine P. Yates, Rosemarie Hakim, Antonello Punturieri, Julie Bamdad, Thomas Croxton, Joanne Deshler, Pamela McCord-Reynolds, Mario Stylianou, Gail Weinmann, Gordon Bernard, James Anderson, Bernard Lo, Andrew Ries, Stuart Stoloff, Byron Thomashow, Barbara Tilley, and Kevin Weiss

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Randomization, Time Factors, medicine.medical_treatment, Population, law.invention, Hypoxemia, Treatment and control groups, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Patient Admission, Randomized controlled trial, law, Oxygen therapy, Medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, education, Aged, Randomized Controlled Trials as Topic, Clinical Study Design, Aged, 80 and over, education.field_of_study, Geography, business.industry, Oxygen Inhalation Therapy, Middle Aged, Long-Term Care, United States, Clinical trial, Oxygen, 030228 respiratory system, Sample size determination, Emergency medicine, Physical therapy, Quality of Life, Female, medicine.symptom, business
Abstract

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Published
2018

3. CT Metrics of Airway Disease and Emphysema in Severe COPD

Author

James Walter, David Godwin, Joyce Canterbury, Thomas E. Hartman, Yen Pin Chiang, Jeanne Smith, John J. Reilly, Hope Livingston, Abby M. Krichman, Mahasti Rittinger, Karma L. Kreizenbeck, Kymberley Anable, Ameena Al-Amin, Colleen Witt, Karen McVearry, Claude Deschamps, Selim M. Arcasoy, Liz Roessler, James K. Stoller, Yahya M. Berkmen, Paul J. Friedman, Enrique Fernandez, Laura Kotler-Klein, Chris Piker, Robert E. Hyatt, Mark J. Krasna, Priscilla McCreight, Jo Anna Baldwin, Jennifer M Lamb, Francisco Alvarez, Janet R. Maurer, Rodney Simcox, Gerald O'Brien, Iris Moskowitz, Marianne C. Fahs, Judd Gurney, A. Mark Fendrick, Mike Mantinaos, Sanjay Kalra, Robert M. Kaplan, Kevin R. Flaherty, Timothy Gilbert, James K. Garrett, Kathy Mieras, Kapreena Owens, Trina Limberg, Patricia Belt, Rolf D. Hubmayr, Roger Barnette, James Carter, Phillip M. Boiselle, Brian Woodcock, Anne Marie Kuzma, Brian F. Mullan, Dean Follmann, Mary Ellen Kleinhenz, Judith Harle, Ubaldo J. Martin, Bonnie Edwards, Fernando I. Martinez, Sandy Do, Alejandro A. Diaz, F.C. Sciurba, William Russell, David J. Sugarbaker, Theresa Alcorn, Susan Borosh, Patricia McDowell, Carolyn Wheeler, Blake Wood, Edwin K. Silverman, Alan J. Moskowitz, John F. Plankeel, William F. Bria, Susan Clark, Patricia Ward, Scott D. Ramsey, Barry J. Make, David H Kupferberg, Chinh T. Q. Nguyen, Stanley Aukberg, Elisabeth L. George, Steven Piantadosi, Geoffrey McLennan, Carl D. Mottram, Martin Zamora, Marvin Pomerantz, Ella A. Kazerooni, Jennifer Propst, Bessie Kachulis, Carol Fanning, Valentina Yegyan, Kenneth Silver, James P. Kiley, Sabine Duffy, David H. Harpole, Junfeng Guo, Donald C. Oxorn, Andrew L. Ries, Paramjit Gill, Bruce H. Culver, Todd M. Officer, Catherine Wood Larsen, John Hansen-Flaschen, Patrick Ross, Mindi Steiger, Lori Hanson, Rose Butanda, Paul F. Simonelli, Neil W. Brister, Amy Chong, Charles L. White, Eric A. Jensen, Cynthia Raymond, Mark K. Ferguson, Moulay Meziane, Mary Milburn-Barnes, James D. Luketich, Douglas E. Wood, A. John McSweeny, Woo Jin Kim, Kim Stavrolakes, John A. Waldhausen, Gregory L. Aughenbaugh, Chul Kwak, Sara L. Bartling, Joan Osterloh, Larry R. Kaiser, John S. Howe, Michael I. Lewis, Andrew Bowdle, Mark A. Gerhardt, Richard O'Connell, Brian R. Lawlor, Neil R. MacIntyre, David A. Lynch, Milton Joyner, Louie Boitano, James P. Utz, Everett Hood, Paul J. Smith, Joshua O. Benditt, John Apostolakis, Frances L. Brogan, Robert McKenna, Berend Mets, Phyllis Dibbern, Kevin Carney, Joan M. Lacomis, Kevin McCarthy, A. Laurie Shroyer, Mitchell K. O’Shea, Barry Make, Dora Greene, Janice Willey, Catherine Ramirez, Gwendolyn B. Vance, Philip R. Karsell, David DeMets, Angela DiMango, Peter Rising, Erik J. Kraenzler, Michael F. Keresztury, Laurie Ney Silfies, Michael Magliocca, Vivian Knieper, Betsy Ann Bozzarello, Marlene Edgar, Madelina Lorenzon, Deb Andrist, Sophia Chatziioannou, Darryl Atwell, Sally Frese, Ruth Etzioni, Stephen I. Marglin, Maria Shiau, Thomas Schroeder, Vincent J. Carey, Vladmir Formanek, Robert Levine, Cindy Chwalik, David Rittinger, Kenneth Martay, Brett A. Simon, Nancy Kurokawa, Anne L. Fuhlbrigge, Peter J. Julien, Michelle T. Toshima, Sean D. Sullivan, Joanne Deshler, Margaret Wu, Anthony Norris, David A. Lipson, Scott J. Swanson, Diane Lockhart, Omar A. Minai, Joseph l. Reeves-Viets, Raed A. Dweik, Keith S. Naunheim, Angela Delsing, Minnie Ellisor, Jane Whalen-Price, Victor F. Tapson, Leonard Rossoff, Susan M. Peterson, Deborah Nowakowski, David M. Shade, Susanne Snedeker, Susan Craemer, Anne Marie G. Sykes, Jennifer Norten, Manmohan S. Biring, Diane C. Strollo, Beth Elliot, Kedren Williams, Heather Sheaffer, Sheila Shearer, Robert P. Hoffman, Robert Quaife, J. Mendez, Donald A. Mahler, Janice Cook-Granroth, Scott Marlow, Zab Mosenifar, Malcolm M. DeCamp, Paul J. Christensen, Rosetta Jackson, Wissam Chatila, Robert Schilz, Glenda DeMercado, Peter B. O'Donovan, Kimberly Dubose, Robert J. Keenan, Satoshi Furukawa, Theodore Kopp, Gerald T. Ayres, Betty Collison, Stephen J. Swensen, Jennifer Stone-Wynne, Nicole Jenson, Stanley S. Siegelman, Tina Bees, Owen B. Wilson, R. Duane Davis, Pierre A. DeVilliers, Marcia Katz, Carolyn M. Clancy, Eddie L. Hoover, Bryan Benedict, Karen Kirsch, Philip M. Hartigan, Simon C. Body, Mark Stafford-Smith, David A. Zisman, Jeanne M. Hoffman, Fernando J. Martinez, Clarence Weir, Jeffrey D. Edelman, William Stanford, Zab Mohsenifar, Michael P. Donahoe, Michele Donithan, Catherine A. Meldrum, William A. Slivka, Lori Zaremba, Michael W. Smith, Martin D. Abel, Robert B Gerber, Sarah Hooper, Steven M. Scharf, Karen A. Hanson, Katherine P. Grichnik, J. Sanford Schwartz, Margaret L. Snyder, Charles J. Hearn, Joe Chin, Tammy Ojo, Gregory D.N. Pearson, Vera Edmonds, George R. Washko, Christine Young, Jennifer Minkoff-Rau, Ron Daniele, Chun Yip, Gregory L. Foster, Harold I. Palevsky, Joan E. Sexton, Dev Pathak, Pamela Fox, Paul E. Kazanjian, Karen King, Jacqueline Pfeffer, Imran Nizami, Judith Wagner, Catherine Wrona, John H. M. Austin, Karla Conejo-Gonzales, Sharon Bendel, Amir Sharafkhaneh, Carol Geaga, Denise Vilotijevic, Thomas H. Sisson, Steven H. Sheingold, Ryan Colvin, Elaine Baker, Karen Collins, Charles F. Emery, Mark Ginsburg, Abass Alavi, David D. Frankville, Joseph M. Reinhardt, Jan Drake, John M. Travaline, Rafael Espada, Kathy Lautensack, Leslie E. Quint, Jeffrey T. Chapman, Rosemary Lann, Steven M. Berkowitz, Alice L. Sternberg, Thurman Gillespy, Nadia Howlader, Frank J. Papatheofanis, Robert Frantz, Manuel L. Brown, Sarah Shirey, Yvonne Meli, Andra E. Ibrahim, Patricia A. Jellen, Rebecca Crouch, Warren B. Gefter, Michael J. Reardon, Jonathan B. Orens, Neal S. Kleiman, Marilyn L. Moy, Daniel L. Miller, Julie Fuller, Reuben M. Cherniack, Claudette Sikora, Lynn Bosco, Harry Handelsman, R. Edward Coleman, Judith M. Aronchick, James Tonascia, Delmar J. Gillespie, Patricia Berkoski, David P. Kapelanski, Cesar A. Keller, Amanda L. Blackford, Charles C. Miller, Kelly M. Campbell, Jill Meinert, Carl R. Fuhrman, Gordon R. Bernard, Connie Hudson, Roger Russell, Lewis Poole, Dale Williams, Magdy Younes, Shing Lee, Steven L. Sax, Martin Carlos, Diane C. Saunders, John Dodge, Matthew N. Bartels, Amy Jahn, Karen Taylor, Gregg L Ruppel, Wallace T. Miller, Mary Gilmartin, Tanisha Carino, Alfred P. Fishman, Gerene Bauldoff, Frank C. Sciurba, Gerard J. Criner, John Haddad, Mark D. Iannettoni, Terri Durr, Gordon F. Harms, Susan Golden, Norman E. Torres, Lisa Geyman, Alan Hibbit, Paul Rysso, Gilbert E. D'Alonzo, Henry E. Fessler, Mark L. Van Natta, Peter Wahl, James H. Harrell, Willard Chamberlain, Roger D. Yusen, Boleyn Hammel, Dawn E. Sassi-Dambron, Mark S. Allen, Jennifer Cutler, Shangqian Qi, Susan Rinaldo-Gallo, John D. Newell, June Hart, Raúl San José Estépar, Kerri McKeon, Staci Opelman, Eric S. Edell, Kathy Winner, Joe R. Rodarte, Mark A. King, Eric A. Hoffman, Laura A. Wilson, Phil Cagle, Jennifer Meyers, Kristin Berry, Mark P. Steele, Katherine Hale, Peter Barnard, Charles Soltoff, Melissa Weeks, Arfa Khan, Cary Stolar, Jeanine P. Wiener-Kronish, Jeannie Ricketts, Nancy Battaglia, Francine L. Jacobson, Satish G. Jhingran, Robert B. Teague, Mary Louise Dempsey, Leighton Chan, Philip T. Diaz, David Hicks, David E. Midthun, Charlene Levine, Andetta R. Hunsaker, Tomeka Simon, Jered Sieren, Susan Lubell, Scott A. Schartel, H P McAdams, Francis Cordova, Kris Bradt, Jeffery J. Johnson, Kenneth White, Mercedes True, Erin A. Sullivan, Byron Thomashow, Gail Weinmann, Robert A. Wise, Donna Tsang, Robert M. Kotloff, Atul C. Mehta, Gregory Tino, and Angela Wurster

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pathology, Critical Care and Intensive Care Medicine, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, Cohort Studies, Pulmonary Disease, Chronic Obstructive, Predictive Value of Tests, Forced Expiratory Volume, Internal medicine, medicine, Humans, Lung volumes, Respiratory system, Aged, Probability, Original Research, Analysis of Variance, Univariate analysis, COPD, business.industry, Total Lung Capacity, Respiratory disease, Middle Aged, respiratory system, Airway obstruction, medicine.disease, Respiratory Function Tests, respiratory tract diseases, Airway Obstruction, Dyspnea, medicine.anatomical_structure, Pulmonary Emphysema, Multivariate Analysis, Cardiology, Female, Pulmonary Ventilation, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business, Airway, Respiratory tract
Abstract

Background CT scan measures of emphysema and airway disease have been correlated with lung function in cohorts of subjects with a range of COPD severity. The contribution of CT scan-assessed airway disease to objective measures of lung function and respiratory symptoms such as dyspnea in severe emphysema is less clear. Methods Using data from 338 subjects in the National Emphysema Treatment Trial (NETT) Genetics Ancillary Study, densitometric measures of emphysema using a threshold of −950 Hounsfield units (%LAA-950) and airway wall phenotypes of the wall thickness (WT) and the square root of wall area (SRWA) of a 10-mm luminal perimeter airway were calculated for each subject. Linear regression analysis was performed for outcome variables FEV 1 and percent predicted value of FEV 1 with CT scan measures of emphysema and airway disease. Results In univariate analysis, there were significant negative correlations between %LAA-950 and both the WT ( r = −0.28, p = 0.0001) and SRWA ( r = −0.19, p = 0.0008). Airway wall thickness was weakly but significantly correlated with postbronchodilator FEV 1 % predicted (R = −0.12, p = 0.02). Multivariate analysis showed significant associations between either WT or SRWA (β = −5.2, p = 0.009; β = −2.6, p = 0.008, respectively) and %LAA-950 (β = −10.6, p = 0.03) with the postbronchodilator FEV 1 % predicted. Male subjects exhibited significantly thicker airway wall phenotypes (p = 0.007 for WT and p = 0.0006 for SRWA). Conclusions Airway disease and emphysema detected by CT scanning are inversely related in patients with severe COPD. Airway wall phenotypes were influenced by gender and associated with lung function in subjects with severe emphysema.

Published
2009
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