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CLINICAL RESEARCH: HEART FAILURE

Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device

Francis D. Pagani, MD, PhD^_*,_*, Leslie W. Miller, MD, Stuart D. Russell, MD, Keith D. Aaronson, MD^_*, Ranjit John, MD, Andrew J. Boyle, MD, John V. Conte, MD, Roberta C. Bogaev, MD^||, Thomas E. MacGillivray, MD^¶, Yoshifumi Naka, MD^#, Donna Mancini, MD^#, H. Todd Massey, MD^_**, Leway Chen, MD^_**, Charles T. Klodell, MD, Juan M. Aranda, MD, Nader Moazami, MD, Gregory A. Ewald, MD, David J. Farrar, PhD, O. Howard Frazier, MD^|| for the HeartMate II Investigators

^_* University of Michigan, Ann Arbor, Michigan
Washington Hospital Center, Washington, DC
Johns Hopkins Hospital, Baltimore, Maryland
University of Minnesota, Minneapolis, Minnesota
^|| Texas Heart Institute, Houston, Texas
^¶ Massachusetts General Hospital, Boston, Massachusetts
^# Columbia University, New York, New York
^_** University of Rochester, Rochester, New York
University of Florida, Gainesville, Florida
Barnes-Jewish Hospital, St. Louis, Missouri
Thoratec Corporation, Pleasanton, California

Manuscript received December 1, 2008; revised manuscript received March 3, 2009, accepted March 10, 2009.

^_* Reprint requests and correspondence to: Dr. Francis D. Pagani, Section of Cardiac Surgery, University of Michigan Health System, Cardiovascular Center, Room 5161, 1500 East Medical Center Drive, SPC#5864, Ann Arbor, Michigan 48109 (Email: fpagani{at}umich.edu).

Objectives: This study sought to evaluate the use of a continuous-flow rotary left ventricular assist device (LVAD) as a bridge to heart transplantation.

Background: LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism.

Methods: In a prospective, multicenter study, 281 patients urgently listed (United Network of Organ Sharing status 1A or 1B) for heart transplantation underwent implantation of a continuous-flow LVAD. Survival and transplantation rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months.

Results: Of 281 patients, 222 (79%) underwent transplantation, LVAD removal for cardiac recovery, or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval: 65% to 79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-min walk test (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-min walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients.

Conclusions: A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation, with improved functional status and quality of life. (Thoratec HeartMate II Left Ventricular Assist System [LVAS] for Bridge to Cardiac Transplantation; NCT00121472)

Key Words: heart failure • left ventricular assist device • heart transplantation

Abbreviations and Acronyms   BTT = bridge-to-transplantation   FDA = Food and Drug Administration   LVAD = left ventricular assist device   MCS = mechanical circulatory support   NYHA = New York Heart Association

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