Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation

O. H. Frazier, Eric A. Rose, Mehmet C. Dz, Walter Dembitsky, Patrick McCarthy, Branislav Radovancevic, Victor L. Poirier, Kurt A. Dasse, Gregory Couper, Nancy Cummings, Rita Vargo, Ann Foray-Kaplon, Cathie Vacha, Sheryl Kamis, Michael Yeager, Katharine Catanese, Nelson Burton, Aaron Hill, Karen Muncy, Michael AckerMary Lou O'Hara, James Long, Jennifer Pitt, John Marks, Ann Bagley, Bryan Foy, Kimberly Martin, Marianne Laff, Alan Peterson, Margaret Scatena, Linda Beatty, George Maier, Kathy Baker, Maureen Flattery, Michael Mack, Tollea McMellon, Laszlo Fuzesi, Louise Klapp, Elizabeth Cortez, Clifford Van Meter, Sonja Hollenbach, Patricia Uber, Lindsay Kersker, William Piccione, Annette Mattea, Kathleen Grady, Timothy Icenogle, David Sato, Steve Himley, Debbie Butters, Mark Puhlman, Suzanne Chillcott, Douglas Murphy, Paige Davis, Susan Leighty, Alfred Tector, Diane Dressler, Paulette Schauer, Lynne Mathiak, Valluvan Jeevanandam, Satoshi Furukawa, Barbara Todd, Joelle Hargraves, Timothy Myers, Dan Tamez, Kathy Miller, Steven Boyce, Leslie Sweet, Sheila Walsh, William Holman, Linda Brantley, Candace Wainscott, Wayne Richenbacher, Sara Vance, Carolyn Laxson, Francis Pagani, Hilary Monaghan, Robert Mentzer, Charles Canver, Linda Jacobs, Janice Yakey

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Abstract

Background: Despite advances in heart transplantation and mechanical circulatory support, mortality among transplant candidates remains high. Better ways are needed to ensure the survival of transplant candidates both inside and outside the hospital. Methods: In a prospective, multicenter clinical trial conducted at 24 centers in the United States, 280 transplant candidates (232 men, 48 women; median age, 55 years; range, 11-72 years) unresponsive to inotropic drugs, intra-aortic balloon counterpulsation, or both, were treated with the HeartMate Vented Electric Left Ventricular Assist System (VE LVAS). A cohort of 48 patients (40 men, 8 women; median age, 50 years; range, 21-67 years) not supported with an LVAS served as a historical control group. Outcomes were measured in terms of laboratory data (hemodynamic, hematologic, and biochemical), adverse events, New York Heart Association functional class, and survival. Results: The VE LVAS-treated and non-VE LVAS-treated (control) groups were similar in terms of age, sex, and distribution of patients by diagnosis (ischemic cardiomyopathy, idiopathic cardiomyopathy, and subacute myocardial infarction). VE LVAS support lasted an average of 112 days (range, < 1-691 days), with 54 patients supported for > 180 days. Mean VE LVAS flow (expressed as pump index) throughout support was 2.8 L · min-1 · m-2. Median total bilirubin values decreased from 1.2 mg/dL at baseline to 0.7 mg/dL (P = .0001); median creatinine values decreased from 1.5 mg/dL at baseline to 1.1 mg/dL (P = .0001). VE LVAS-related adverse events included bleeding in 31 patients (11%), infection in 113 (40%), neurologic dysfunction in 14 (5%), and thromboembolic events in 17 (6%). A total of 160 (58%) patients were enrolled in a hospital release program. Twenty-nine percent of the VE LVAS-treated patients (82/280) died before receiving a transplant, compared with 67% of controls (32/48) (P < .001). Conversely, 71% of the VE LVAS-treated patients (198/280) survived: 67% (188/280) ultimately received a heart transplant, and 4% (10/280) had the device removed electively. One-year post-transplant survival of VE LVAS-treated patients was significantly better than that of controls (84% [158/188] vs 63% [10/16]; log rank analysis P = .0197). Conclusion: The HeartMate VE LVAS provides adequate hemodynamic support, has an acceptably low incidence of adverse effects, and improves survival in heart transplant candidates both inside and outside the hospital. The studies of the HeartMate LVAS (both pneumatic and electric) for Food and Drug Administration approval are the only studies with a valid control group to show a survival benefit for cardiac transplantation.

Original languageEnglish
Pages (from-to)1186-1195
Number of pages10
JournalJournal of Thoracic and Cardiovascular Surgery
Volume122
Issue number6
DOIs
StatePublished - 1 Dec 2001
Externally publishedYes

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