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Cited by 758

The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.

Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure

Open access
Rogers, Joseph G., Pagani, Francis D., Tatooles, Antone J., Bhat, Geetha, Slaughter, Mark S., Birks, Emma J., Boyce, Steven W., Najjar, Samer S., Jeevanandam, Valluvan, Anderson, Allen S., Gregoric, Igor D., Mallidi, Hari, Leadley, Katrin, Aaronson, Keith D., Frazier, O.H., Milano, Carmelo A.·2017·New England Journal of Medicine

Abstract

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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Metadata

Authors
Rogers, J. G., Pagani, F. D., Tatooles, A. J., Bhat, G., Slaughter, M. S., Birks, E. J., Boyce, S. W., Najjar, S. S., Jeevanandam, V., Anderson, A. S., Gregoric, I. D., Mallidi, H., Leadley, K., Aaronson, K. D., Frazier, O. H., & Milano, C. A.
Venue
New England Journal of Medicine
Published
2017-02-02
Volume
376
Issue
5
Pages
451-460
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2585810302
Cited by
758
References
14
FWCI
43.88
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. https://app.cochat.ai/papers/10.1056/nejmoa1602954
The paper
Rogers, J. G., Pagani, F. D., Tatooles, A. J., Bhat, G., Slaughter, M. S., Birks, E. J., Boyce, S. W., Najjar, S. S., Jeevanandam, V., Anderson, A. S., Gregoric, I. D., Mallidi, H., Leadley, K., Aaronson, K. D., Frazier, O. H., & Milano, C. A. (2017). Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1602954

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.