E A Rose, A C Gelijns, A J Moskowitz, D F Heitjan, L W Stevenson, W Dembitsky, J W Long, D D Ascheim, A R Tierney, R G Levitan, J T Watson, P Meier, N S Ronan, P A Shapiro, R M Lazar, L W Miller, L Gupta, O H Frazier, P Desvigne-Nickens, M C Oz, V L Poirier, Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group
Long-term use of a left ventricular assist device for end-stage heart failure.
N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.
Abstract/Text
BACKGROUND: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated.
METHODS: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure.
RESULTS: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group.
CONCLUSIONS: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.
Mark S Slaughter, Joseph G Rogers, Carmelo A Milano, Stuart D Russell, John V Conte, David Feldman, Benjamin Sun, Antone J Tatooles, Reynolds M Delgado, James W Long, Thomas C Wozniak, Waqas Ghumman, David J Farrar, O Howard Frazier, HeartMate II Investigators
Advanced heart failure treated with continuous-flow left ventricular assist device.
N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
Abstract/Text
BACKGROUND: Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.
METHODS: In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity.
RESULTS: Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups.
CONCLUSIONS: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)
2009 Massachusetts Medical Society
Koichiro Kinugawa
How to treat stage D heart failure? - When to implant left ventricular assist devices in the era of continuous flow pumps?-.
Circ J. 2011;75(9):2038-45. Epub 2011 Aug 2.
Abstract/Text
The new classification of heart failure in the American College of Cardiology/American Heart Association guidelines includes stage D, which is refractory severe heart failure that does not respond to medical or resynchronization therapy. Among the many treatment strategies for stage D heart failure, only heart transplantation and ventricular assist devices have been established as improving prognosis. With the evolution in the mechanics of ventricular assist devices in recent years, the postoperative prognosis has improved, and less sick patients can now be candidates for these devices. In Japan, 2 continuous flow devices have been approved since April 2011, and now is the best time to consider the indications for their use.
James K Kirklin, David C Naftel, Robert L Kormos, Lynne W Stevenson, Francis D Pagani, Marissa A Miller, Karen L Ulisney, J Timothy Baldwin, James B Young
Third INTERMACS Annual Report: the evolution of destination therapy in the United States.
J Heart Lung Transplant. 2011 Feb;30(2):115-23. doi: 10.1016/j.healun.2010.12.001.
Abstract/Text
The third annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) provides documentation of the current landscape of durable mechanical circulatory support in the United States. With nearly 3,000 patients entered into the database, the transition to continuous-flow pump technology is evident and dramatic. This report focuses on the rapidly expanding experience with mechanical circulatory support as destination therapy. The current 1-year survival of 75% with continuous-flow destination therapy provides a benchmark for the evolving application of this therapy.
Copyright © 2011 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
James K Kirklin, David C Naftel, Robert L Kormos, Lynne W Stevenson, Francis D Pagani, Marissa A Miller, J Timothy Baldwin, James B Young
The Fourth INTERMACS Annual Report: 4,000 implants and counting.
J Heart Lung Transplant. 2012 Feb;31(2):117-26. doi: 10.1016/j.healun.2011.12.001.
Abstract/Text
The Fourth Annual Report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 5 years of patient and data collection. With more than 4,000 patients entered into the database, the evolution of pump technology, strategy at implant, and pre-implant patient profiles are chronicled. A risk factor analysis of the entire adult primary implant population is provided, and the recent composition of patient profiles is examined. Current actuarial survival with continuous-flow pumps exceeds 80% at 1 year and 70% at 2 years.
Copyright © 2012. Published by Elsevier Inc.
Kenneth Dickstein, Alain Cohen-Solal, Gerasimos Filippatos, John J V McMurray, Piotr Ponikowski, Philip Alexander Poole-Wilson, Anna Strömberg, Dirk J van Veldhuisen, Dan Atar, Arno W Hoes, Andre Keren, Alexandre Mebazaa, Markku Nieminen, Silvia Giuliana Priori, Karl Swedberg, ESC Committee for Practice Guidelines (CPG)
ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM).
Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17.
Abstract/Text
Kenneth Dickstein, Panos E Vardas, Angelo Auricchio, Jean-Claude Daubert, Cecilia Linde, John McMurray, Piotr Ponikowski, Silvia Giuliana Priori, Richard Sutton, Dirk J van Veldhuisen, ESC Committee for Practice Guidelines (CPG)
2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association.
Eur Heart J. 2010 Nov;31(21):2677-87. doi: 10.1093/eurheartj/ehq337. Epub 2010 Aug 27.
Abstract/Text
Sharon Ann Hunt, William T Abraham, Marshall H Chin, Arthur M Feldman, Gary S Francis, Theodore G Ganiats, Mariell Jessup, Marvin A Konstam, Donna M Mancini, Keith Michl, John A Oates, Peter S Rahko, Marc A Silver, Lynne Warner Stevenson, Clyde W Yancy
2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation.
Circulation. 2009 Apr 14;119(14):e391-479. doi: 10.1161/CIRCULATIONAHA.109.192065. Epub 2009 Mar 26.
Abstract/Text
Robert S McKelvie, Gordon W Moe, Anson Cheung, Jeannine Costigan, Anique Ducharme, Estrellita Estrella-Holder, Justin A Ezekowitz, John Floras, Nadia Giannetti, Adam Grzeslo, Karen Harkness, George A Heckman, Jonathan G Howlett, Simon Kouz, Kori Leblanc, Elizabeth Mann, Eileen O'Meara, Miroslav Rajda, Vivek Rao, Jessica Simon, Elizabeth Swiggum, Shelley Zieroth, J Malcolm O Arnold, Tom Ashton, Michel D'Astous, Paul Dorian, Haissam Haddad, Debra L Isaac, Marie-Hélène Leblanc, Peter Liu, Bruce Sussex, Heather J Ross
The 2011 Canadian Cardiovascular Society heart failure management guidelines update: focus on sleep apnea, renal dysfunction, mechanical circulatory support, and palliative care.
Can J Cardiol. 2011 May-Jun;27(3):319-38. doi: 10.1016/j.cjca.2011.03.011.
Abstract/Text
The 2011 Canadian Cardiovascular Society Heart Failure (HF) Guidelines Focused Update reviews the recently published clinical trials that will potentially impact on management. Also reviewed is the less studied but clinically important area of sleep apnea. Finally, patients with advanced HF represent a group of patients who pose major difficulties to clinicians. Advanced HF therefore is examined from the perspectives of HF complicated by renal failure, the role of palliative care, and the role of mechanical circulatory support (MCS). All of these topics are reviewed from a perspective of practical applications. Important new studies have demonstrated in less symptomatic HF patients that cardiac resynchronization therapy will be of benefit. As well, aldosterone receptor antagonists can be used with benefit in less symptomatic HF patients. The important role of palliative care and the need to address end-of-life issues in advanced HF are emphasized. Physicians need to be aware of the possibility of sleep apnea complicating the course of HF and the role of a sleep study for the proper assessment and management of the conditon. Patients with either acute severe or chronic advanced HF with otherwise good life expectancy should be referred to a cardiac centre capable of providing MCS. Furthermore, patients awaiting heart transplantation who deteriorate or are otherwise not likely to survive until a donor organ is found should be referred for MCS.
Copyright © 2011 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
Jennifer L Peura, Monica Colvin-Adams, Gary S Francis, Kathleen L Grady, Timothy M Hoffman, Mariell Jessup, Ranjit John, Michael S Kiernan, Judith E Mitchell, John B O'Connell, Francis D Pagani, Michael Petty, Pasala Ravichandran, Joseph G Rogers, Marc J Semigran, J Matthew Toole, American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia
Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association.
Circulation. 2012 Nov 27;126(22):2648-67. doi: 10.1161/CIR.0b013e3182769a54. Epub 2012 Oct 29.
Abstract/Text
