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 accessAbstract
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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Citations
Cites
Advanced heart failure treated with continuous-flow left ventricular assist device
Slaughter, M. S., Rogers, J. G., Milano, C. A., Russell, S. D., Conte, J. V., Feldman, D., Sun, B., Tatooles, A. J., Delgado, R. M., Long, J. W., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0909938 · Cited by 3,063
Self-citationUse of a Continuous-Flow Device in Patients Awaiting Heart Transplantation
Miller, L. W., Pagani, F. D., Russell, S. D., John, R., Boyle, A. J., Aaronson, K. D., Conte, J. V., Naka, Y., Mancini, D., Delgado, R. M., et al. (2007) · New England Journal of Medicine · doi:10.1056/nejmoa067758 · Cited by 1,733
Self-citationGo, A. S., Mozaffarian, D., Roger, V. L., Benjamin, E. J., Berry, J. D., Blaha, M. J., Dai, S., Ford, E. S., Fox, C. S., Franco, S., et al. (2014) · Circulation · doi:10.1161/01.cir.0000442015.53336.12 · Cited by 1,408
Extended Mechanical Circulatory Support With a Continuous-Flow Rotary Left Ventricular Assist Device
Pagani, F. D., Miller, L. W., Russell, S. D., Aaronson, K. D., John, R., Boyle, A. J., Conte, J. V., Bogaev, R. C., MacGillivray, T. E., Naka, Y., et al. (2009) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2009.03.055 · Cited by 869
Self-citationUnexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis
Starling, R. C., Moazami, N., Silvestry, S. C., Ewald, G., Rogers, J. G., Milano, C. A., Rame, J. E., Acker, M. A., Blackstone, E. H., Ehrlinger, J., et al. (2014) · New England Journal of Medicine · doi:10.1056/nejmoa1313385 · Cited by 786
Self-citationNajjar, S. S., Slaughter, M. S., Pagani, F. D., Starling, R. C., McGee, E. C., Eckman, P., Tatooles, A. J., Moazami, N., Kormos, R. L., Hathaway, D. R., et al. (2014) · The Journal of Heart and Lung Transplantation · doi:10.1016/j.healun.2013.12.001 · Cited by 460
Self-citationStarling, R. C., Naka, Y., Boyle, A. J., Gonzalez-Stawinski, G., John, R., Jorde, U., Russell, S. D., Conte, J. V., Aaronson, K. D., McGee, E. C., et al. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2010.10.062 · Cited by 452
Self-citationKirklin, J. K., Naftel, D. C., Kormos, R. L., Pagani, F. D., Myers, S. L., Stevenson, L. W., Acker, M. A., Goldstein, D., Silvestry, S., Milano, C. A., et al. (2013) · The Journal of Heart and Lung Transplantation · doi:10.1016/j.healun.2013.11.001 · Cited by 416
Self-citationSlaughter, M. S., Pagani, F. D., McGee, E. C., Birks, E. J., Cotts, W. G., Gregoric, I., Howard Frazier, O., Icenogle, T., Najjar, S. S., Boyce, S. W., et al. (2013) · The Journal of Heart and Lung Transplantation · doi:10.1016/j.healun.2013.04.004 · Cited by 349
Self-citationPark, S. J., Milano, C. A., Tatooles, A. J., Rogers, J. G., Adamson, R. M., Steidley, D. E., Ewald, G. A., Sundareswaran, K. S., Farrar, D. J., Slaughter, M. S., et al. (2012) · Circulation: Heart Failure · doi:10.1161/circheartfailure.111.963991 · Cited by 341
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Cited by
McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab670 · Cited by 19,442
2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure
McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., et al. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab368 · Cited by 13,344
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Circulation · doi:10.1161/cir.0000000000001063 · Cited by 4,922
Self-citation2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure
Heidenreich, P. A., Bozkurt, B., Aguilar, D., Allen, L. A., Byun, J. J., Colvin, M. M., Deswal, A., Drazner, M. H., Dunlay, S. M., Evers, L. R., et al. (2022) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2021.12.012 · Cited by 2,862
Self-citationA Fully Magnetically Levitated Left Ventricular Assist Device — Final Report
Mehra, M. R., Uriel, N., Naka, Y., Cleveland, J. C., Yuzefpolskaya, M., Salerno, C. T., Walsh, M. N., Milano, C. A., Patel, C. B., Hutchins, S. W., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1900486 · Cited by 1,312
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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
- Publisher
- Massachusetts Medical Society
- 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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