The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy

Journal of Heart and Lung Transplantation

Volumn 35, Issue 11, 2016, Pages 1277-1283

  Pagani, Francis D ^a   Aaronson, Keith D ^a   Kormos, Robert ^b   Mann, Douglas L ^c   Spino, Cathie ^a   Jeffries, Neal ^d   Taddei Peters, Wendy C ^d   Mancini, Donna M ^e   McNamara, Dennis M ^b   Grady, Kathleen L ^f   Gorcsan, John ^b   Petrucci, Ralph ^g   Anderson, Allen S ^f   Glick, Henry A ^h   Acker, Michael A ^h   Eduardo Rame, J ^h   Goldstein, Daniel J ⁱ   Pamboukian, Salpy V ^j   Miller, Marissa A ^d   Timothy Baldwin, J ^d  

^a UNIVERSITY OF MICHIGAN   (United States)

^b UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

^c WASHINGTON UNIVERSITY   (United States)

^d NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^e Och Spine at New York Presbyterian Hospitals   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

^g DREXEL UNIVERSITY   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^j UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

more..

Author keywords

assisted circulation; clinical trials; heart failure; mechanical circulatory support; ventricular assist device

Indexed keywords

INOTROPIC AGENT;

DISEASE MANAGEMENT; EDITORIAL; FUNCTIONAL STATUS; HEART FAILURE; HUMAN; LEFT VENTRICULAR ASSIST DEVICE; PILOT STUDY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SURVIVAL; CLINICAL TRIAL (TOPIC); HEART ASSIST DEVICE; NATIONAL HEALTH ORGANIZATION; PROCEDURES; TREATMENT WITHDRAWAL; UNITED STATES;

CLINICAL TRIALS AS TOPIC; HEART FAILURE; HEART-ASSIST DEVICES; HUMANS; NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (U.S.); PILOT PROJECTS; QUALITY OF LIFE; UNITED STATES; WITHHOLDING TREATMENT;

EID: 84994474433     PISSN: 10532498     EISSN: 15573117     Source Type: Journal    
DOI: 10.1016/j.healun.2016.09.002     Document Type: Editorial

References (21)

1. 1 Baldwin, J.T., Mann, D.L., NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial. J Card Fail 16 (2010), 855–858.
2. 2 Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute. Randomized Evaluation of VAD InterVEntion before Inotropic Therapy Solicitation Number: NHLBI-HV-10-14. Available at: https://www.fbo.gov/?s=opportunity&mode=form&id=b48428fc701236673ae5d0ceab01c0f4&tab=core&_cview=1. Accessed April 25, 2016 [In press].
3. 3 Aaronson, K.D., Pagani, F.D., Kormos, R., et al. Design for the Randomized Evaluation of VAD Intervention Before Inotropic Therapy (REVIVE-IT) Study. J Heart Lung Transplant, 2016 [In press].
4. 4 Rose, E.A., Gelijns, A.C., Moskowitz, A.J., et al. Long-term mechanical left ventricular assistance for end-stage heart failure. N Engl J Med 345 (2001), 1435–1443.
5. 5 Wieselthaler, G.M., Driscoll, G., Jansz, P., Khaghani, A., Strueber, M., HVAD Clinical Investigators. Initial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial. J Heart Lung Transplant 29 (2010), 1218–1225.
6. 6 Aaronson, K.D., Slaughter, M.S., Miller, L.W., et al. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 125 (2012), 3191–3200.
7. 7 Slaughter, M.S., Pagani, F.D., McGee, E.C., et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant 32 (2013), 675–683.
8. 8 Miller, L.W., Pagani, F.D., Russell, S.D., et al. Use of a continuous-flow device in patients awaiting heart transplantation. N Engl J Med 357 (2007), 885–896.
9. 9 Pagani, F.D., Miller, L.W., Russell, S.D., et al. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device. J Am Coll Cardiol 54 (2009), 312–321.
10. 10 Slaughter, M., Rogers, J.G., Milano, C.A., et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med 361 (2009), 2241–2251.
11. 11 Starling, R.C., Naka, Y., Boyle, A.J., et al. Results of the post-US Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). J Am Coll Cardiol 57 (2011), 1890–1898.
12. 12 Park, S.J., Milano, C.A., Tatooles, A.J., et al. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail 5 (2012), 241–248.
13. 13 Jorde, U.P., Kushwaha, S.S., Tatooles, A.J., et al. Results of the destination therapy post-Food and Drug Administration approval study with a continuous flow left ventricular assist device. J Am Coll Cardiol 63 (2014), 1751–1757.
14. 14 Transcripts of the Food and Drug Administration Advisory Panel Meeting, Circulatory Systems Device Panel, April 25, 2012, reviewing data from ADVANCE trial (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) supporting HeartWare, Inc.’s Premarket Application (PMA) for the HVAD for bridge to transplant (BTT) indication. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM304770.pdf. Accessed April 25, 2016.
15. 15 Pagani, F.D., Milano, C.A., Tatooles, A.J., et al. HeartWare HVAD for the treatment of patients with advanced heart failure ineligible for cardiac transplantation: results of the ENDURANCE destination therapy trial. J Heart Lung Transplant, 34(4 Suppl), 2015, S9.
16. 16 Kirklin, J.K., Naftel, D.C., Kormos, R.L., et al. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant 33 (2014), 12–22.
17. 17 Starling, R.C., Moazami, N., Silvestry, S.C., et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med 370 (2013), 33–40.
18. 18 Food and Drug Administration. Serious adverse events with implantable left ventricular assist devices (LVADs): FDA safety communication. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm457327.htm. Accessed April 25, 2016.
19. 19 Estep, J.D., Starling, R.C., Horstmanshof, D.A., et al. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients. J Am Coll Cardiol 66 (2015), 1747–1761.
20. 20 Netuka, I., Sood, P., Pya, Y., et al. Fully magnetically levitated left ventricular assist system for treating advanced heart failure. A multicenter study. J Am Coll Cardiol 66 (2015), 2579–2589.
21. 21 Heatley, G., Sood, P., Goldstein, D., et al. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant 35 (2016), 528–536.