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

Francis D. Pagani, Leslie W. Miller, Stuart D. Russell, Keith D. Aaronson, Ranjit John, Andrew J. Boyle, John Conte, Roberta C. Bogaev, Thomas E. MacGillivray, Yoshifumi Naka, Donna Mancini, H. Todd Massey, Leway Chen, Charles T. Klodell, Juan M. Aranda, Nader Moazami, Gregory A. Ewald, David J. Farrar, O. Howard Frazier

Research output: Contribution to journalArticle

644 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Pages (from-to)312-321
Number of pages10
JournalJournal of the American College of Cardiology
Volume54
Issue number4
DOIs
StatePublished - Jul 21 2009

Fingerprint

Heart-Assist Devices
Heart Transplantation
Heart Failure
Transplantation
Quality of Life
Device Removal
Cardiomyopathies
Multicenter Studies
Thrombosis
Survival Rate
Hemodynamics
Stroke
Prospective Studies
Confidence Intervals
Hemorrhage
Survival
Therapeutics
Infection

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Pagani, F. D., Miller, L. W., Russell, S. D., Aaronson, K. D., John, R., Boyle, A. J., ... Frazier, O. H. (2009). Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. Journal of the American College of Cardiology, 54(4), 312-321. https://doi.org/10.1016/j.jacc.2009.03.055
Pagani, Francis D. ; Miller, Leslie W. ; Russell, Stuart D. ; Aaronson, Keith D. ; John, Ranjit ; Boyle, Andrew J. ; Conte, John ; Bogaev, Roberta C. ; MacGillivray, Thomas E. ; Naka, Yoshifumi ; Mancini, Donna ; Massey, H. Todd ; Chen, Leway ; Klodell, Charles T. ; Aranda, Juan M. ; Moazami, Nader ; Ewald, Gregory A. ; Farrar, David J. ; Frazier, O. Howard. / Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. In: Journal of the American College of Cardiology. 2009 ; Vol. 54, No. 4. pp. 312-321.
@article{b481b8ad1c704729b315612c6525da2c,
title = "Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device",
abstract = "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).",
author = "Pagani, {Francis D.} and Miller, {Leslie W.} and Russell, {Stuart D.} and Aaronson, {Keith D.} and Ranjit John and Boyle, {Andrew J.} and John Conte and Bogaev, {Roberta C.} and MacGillivray, {Thomas E.} and Yoshifumi Naka and Donna Mancini and Massey, {H. Todd} and Leway Chen and Klodell, {Charles T.} and Aranda, {Juan M.} and Nader Moazami and Ewald, {Gregory A.} and Farrar, {David J.} and Frazier, {O. Howard}",
year = "2009",
month = "7",
day = "21",
doi = "10.1016/j.jacc.2009.03.055",
language = "English (US)",
volume = "54",
pages = "312--321",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "4",

}

Pagani, FD, Miller, LW, Russell, SD, Aaronson, KD, John, R, Boyle, AJ, Conte, J, Bogaev, RC, MacGillivray, TE, Naka, Y, Mancini, D, Massey, HT, Chen, L, Klodell, CT, Aranda, JM, Moazami, N, Ewald, GA, Farrar, DJ & Frazier, OH 2009, 'Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device', Journal of the American College of Cardiology, vol. 54, no. 4, pp. 312-321. https://doi.org/10.1016/j.jacc.2009.03.055

Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device. / Pagani, Francis D.; Miller, Leslie W.; Russell, Stuart D.; Aaronson, Keith D.; John, Ranjit; Boyle, Andrew J.; Conte, John; Bogaev, Roberta C.; MacGillivray, Thomas E.; Naka, Yoshifumi; Mancini, Donna; Massey, H. Todd; Chen, Leway; Klodell, Charles T.; Aranda, Juan M.; Moazami, Nader; Ewald, Gregory A.; Farrar, David J.; Frazier, O. Howard.

In: Journal of the American College of Cardiology, Vol. 54, No. 4, 21.07.2009, p. 312-321.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device

AU - Pagani, Francis D.

AU - Miller, Leslie W.

AU - Russell, Stuart D.

AU - Aaronson, Keith D.

AU - John, Ranjit

AU - Boyle, Andrew J.

AU - Conte, John

AU - Bogaev, Roberta C.

AU - MacGillivray, Thomas E.

AU - Naka, Yoshifumi

AU - Mancini, Donna

AU - Massey, H. Todd

AU - Chen, Leway

AU - Klodell, Charles T.

AU - Aranda, Juan M.

AU - Moazami, Nader

AU - Ewald, Gregory A.

AU - Farrar, David J.

AU - Frazier, O. Howard

PY - 2009/7/21

Y1 - 2009/7/21

N2 - 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).

AB - 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).

UR - http://www.scopus.com/inward/record.url?scp=67650093608&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67650093608&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2009.03.055

DO - 10.1016/j.jacc.2009.03.055

M3 - Article

C2 - 19608028

AN - SCOPUS:67650093608

VL - 54

SP - 312

EP - 321

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

SN - 0735-1097

IS - 4

ER -