Advanced heart failure treated with continuous-flow left ventricular assist device
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 3rd, James W Long, Thomas C Wozniak, Waqas Ghumman, David J Farrar, O Howard Frazier, HeartMate II Investigators, M Sobieski, C Gallagher, P Pappas, M Silver, A Lodge, L Blue, A Shah, D Yuh, S Ullrich, D Dordunoo, D Rivard, B Kar, B Radovancevic, I Gregoric, A Civitello, E Massin, C Gemmato, M Jafar, R Bogaev, F Smart, J Sirak, S Sudhaker, T Yanssens, B Reid, S Horton, D Renland, J Revenaugh, M Eidson, M Turrentine, S Becka, D Dean, S Murali, G Magovern, S Bailey, G Sokos, L Kernickey, N Moazami, G Ewald, K Shelton, D Anderson, I Wang, E Garrett, T Edwards, R Carter, C Porter, P Shekar, G Couper, M Givertz, S Kelly, E Raines, K Miller, L McClement-Green, E Haeusslein, G J Avery, P Brandenhoff, J Carnam, T Oka, R Courville, N Smedira, R Starling, J Navia, G Gonzalez, T Mihaljevic, L Teague, Y Naka, K Idrissi, A Stewart, D Vega, A Smith, R Laskar, J Thompson, J Entwistle, H Eisen, S Hankins, T Metzger, R Brewer, B Czerska, C Williams, B Braxton, W Pae, J Boehmer, T Stephensen, M Lazar, A Myers, M Acker, M Jessup, R Morris, S Desai, M O'Hara, J Long, D Horstmanshof, J Chaffin, C Elkins, P Kanaly, E Leiker, L Gray, R Dowling, S Pagni, G Bhat, P Adkisson, S Prabu, R Sharma, S Aggarwal, T MacGillivray, A Agnihotri, J Madsen, G Vlahakes, B Rosengard, M Semigran, S Ennis, J Camuso, R Daly, S Park, L Durham, B Edwards, C Anderson, I Penev, F Arabia, P DeValeria, E Guyah, L Lanza, R Scott, E Steidley, K McAleer, T Dewey, M Magee, M Mack, A Anderson, T Worley, D Goldstein, S Maybaum, D D'Alessandro, N McAllister, K Brooks, D Denofrio, D Pham, H Rastegar, A Ehsan, H Cote, M Camacho, M Zucker, L McBride, S Shah, C Carr, R Cecere, N Giannetti, C Barber, T Icenogle, J Everett, D Sandler, M Pulhman, J Rich, J Herre, L Pine, K Fleischer, M McGrath, C Klodell, J Aranda, N Staples, W Dembitsky, B Jaski, R Adamson, S Baradarian, S Chillcott, A Tector, B Pisani, J Crouch, F Downey, D Kress, M McDonald, D O'Hair, M Savitt, M Miller, C Sheffield, C Caldeira, L DiChiara, V Rao, J MacIver, J Kirklin, R Bourge, D McGiffin, S Pamboukian, B Rayburn, J Tallaj, D Baldwin, J Cleveland, J Lindenfeld, A Brieke, B Reece, S Shakar, E Wolfel, A Cannon, B Griffith, E Feller, J Brown, L Romar, F Pagani, K Aaronson, J Haft, T Koelling, B Dyke, E Devaney, S Wright, L McGowan, A Boyle, R John, L Joyce, M Colvin-Adams, E Missov, C Toninato, R Kormos, D McNamara, K Lockard, T Massey, L Chen, W Hallinan, V Chiodo, P Hobart, E Verrier, D Fishbein, C Salerno, G Aldea, S Andrus, N Mokadam, N Edwards, M Johnson, W Kao, T Kohmoto, J Yakey, A Li, S Boyce, L Miller, L Sweet, K Petro, M Shah, L Miller, F Pagani, O Frazier, S Russell, Y Naka, M Slaughter, D Farrar, C Yancy, S Hunt, W Holman, W Richenbacher, D Heitjan, S Moore, V Jeevanandam, C Thomas, S Gordon, L Damme, J Heatley, S Reichenbach, 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 3rd, James W Long, Thomas C Wozniak, Waqas Ghumman, David J Farrar, O Howard Frazier, HeartMate II Investigators, M Sobieski, C Gallagher, P Pappas, M Silver, A Lodge, L Blue, A Shah, D Yuh, S Ullrich, D Dordunoo, D Rivard, B Kar, B Radovancevic, I Gregoric, A Civitello, E Massin, C Gemmato, M Jafar, R Bogaev, F Smart, J Sirak, S Sudhaker, T Yanssens, B Reid, S Horton, D Renland, J Revenaugh, M Eidson, M Turrentine, S Becka, D Dean, S Murali, G Magovern, S Bailey, G Sokos, L Kernickey, N Moazami, G Ewald, K Shelton, D Anderson, I Wang, E Garrett, T Edwards, R Carter, C Porter, P Shekar, G Couper, M Givertz, S Kelly, E Raines, K Miller, L McClement-Green, E Haeusslein, G J Avery, P Brandenhoff, J Carnam, T Oka, R Courville, N Smedira, R Starling, J Navia, G Gonzalez, T Mihaljevic, L Teague, Y Naka, K Idrissi, A Stewart, D Vega, A Smith, R Laskar, J Thompson, J Entwistle, H Eisen, S Hankins, T Metzger, R Brewer, B Czerska, C Williams, B Braxton, W Pae, J Boehmer, T Stephensen, M Lazar, A Myers, M Acker, M Jessup, R Morris, S Desai, M O'Hara, J Long, D Horstmanshof, J Chaffin, C Elkins, P Kanaly, E Leiker, L Gray, R Dowling, S Pagni, G Bhat, P Adkisson, S Prabu, R Sharma, S Aggarwal, T MacGillivray, A Agnihotri, J Madsen, G Vlahakes, B Rosengard, M Semigran, S Ennis, J Camuso, R Daly, S Park, L Durham, B Edwards, C Anderson, I Penev, F Arabia, P DeValeria, E Guyah, L Lanza, R Scott, E Steidley, K McAleer, T Dewey, M Magee, M Mack, A Anderson, T Worley, D Goldstein, S Maybaum, D D'Alessandro, N McAllister, K Brooks, D Denofrio, D Pham, H Rastegar, A Ehsan, H Cote, M Camacho, M Zucker, L McBride, S Shah, C Carr, R Cecere, N Giannetti, C Barber, T Icenogle, J Everett, D Sandler, M Pulhman, J Rich, J Herre, L Pine, K Fleischer, M McGrath, C Klodell, J Aranda, N Staples, W Dembitsky, B Jaski, R Adamson, S Baradarian, S Chillcott, A Tector, B Pisani, J Crouch, F Downey, D Kress, M McDonald, D O'Hair, M Savitt, M Miller, C Sheffield, C Caldeira, L DiChiara, V Rao, J MacIver, J Kirklin, R Bourge, D McGiffin, S Pamboukian, B Rayburn, J Tallaj, D Baldwin, J Cleveland, J Lindenfeld, A Brieke, B Reece, S Shakar, E Wolfel, A Cannon, B Griffith, E Feller, J Brown, L Romar, F Pagani, K Aaronson, J Haft, T Koelling, B Dyke, E Devaney, S Wright, L McGowan, A Boyle, R John, L Joyce, M Colvin-Adams, E Missov, C Toninato, R Kormos, D McNamara, K Lockard, T Massey, L Chen, W Hallinan, V Chiodo, P Hobart, E Verrier, D Fishbein, C Salerno, G Aldea, S Andrus, N Mokadam, N Edwards, M Johnson, W Kao, T Kohmoto, J Yakey, A Li, S Boyce, L Miller, L Sweet, K Petro, M Shah, L Miller, F Pagani, O Frazier, S Russell, Y Naka, M Slaughter, D Farrar, C Yancy, S Hunt, W Holman, W Richenbacher, D Heitjan, S Moore, V Jeevanandam, C Thomas, S Gordon, L Damme, J Heatley, S Reichenbach
Abstract
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
Source: PubMed