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Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.

Publication ,  Journal Article
Rogers, JG; Pagani, FD; Tatooles, AJ; Bhat, G; Slaughter, MS; Birks, EJ; Boyce, SW; Najjar, SS; Jeevanandam, V; Anderson, AS; Gregoric, ID ...
Published in: N Engl J Med
February 2, 2017

BACKGROUND: Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation. METHODS: We conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary end point was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points. RESULTS: The intention-to treat-population included 297 participants assigned to the study device and 148 participants assigned to the control device. The primary end point was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary end point showed noninferiority of the study device relative to the control device (estimated success rates, 55.4% and 59.1%, respectively, calculated by the Weibull model; absolute difference, 3.7 percentage points; 95% upper confidence limit, 12.56 percentage points; P=0.01 for noninferiority). More patients in the control group than in the study group had device malfunction or device failure requiring replacement (16.2% vs. 8.8%), and more patients in the study group had strokes (29.7% vs. 12.1%). Quality of life and functional capacity improved to a similar degree in the two groups. CONCLUSIONS: In this trial involving patients with advanced heart failure who were ineligible for heart transplantation, a small, intrapericardial, centrifugal-flow LVAD was found to be noninferior to an axial-flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure. (Funded by HeartWare; ENDURANCE ClinicalTrials.gov number, NCT01166347 .).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

February 2, 2017

Volume

376

Issue

5

Start / End Page

451 / 460

Location

United States

Related Subject Headings

  • Stroke
  • Quality of Life
  • Prosthesis Failure
  • Prosthesis Design
  • Middle Aged
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Humans
  • Heart-Assist Devices
  • Heart Failure
 

Citation

APA
Chicago
ICMJE
MLA
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Rogers, J. G., Pagani, F. D., Tatooles, A. J., Bhat, G., Slaughter, M. S., Birks, E. J., … Milano, C. A. (2017). Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med, 376(5), 451–460. https://doi.org/10.1056/NEJMoa1602954
Rogers, Joseph G., Francis D. Pagani, Antone J. Tatooles, Geetha Bhat, Mark S. Slaughter, Emma J. Birks, Steven W. Boyce, et al. “Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.N Engl J Med 376, no. 5 (February 2, 2017): 451–60. https://doi.org/10.1056/NEJMoa1602954.
Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, et al. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451–60.
Rogers, Joseph G., et al. “Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure.N Engl J Med, vol. 376, no. 5, Feb. 2017, pp. 451–60. Pubmed, doi:10.1056/NEJMoa1602954.
Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451–460.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

February 2, 2017

Volume

376

Issue

5

Start / End Page

451 / 460

Location

United States

Related Subject Headings

  • Stroke
  • Quality of Life
  • Prosthesis Failure
  • Prosthesis Design
  • Middle Aged
  • Kaplan-Meier Estimate
  • Intention to Treat Analysis
  • Humans
  • Heart-Assist Devices
  • Heart Failure