Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure
Mandeep R Mehra, Daniel J Goldstein, Nir Uriel, Joseph C Cleveland Jr, Melana Yuzefpolskaya, Christopher Salerno, Mary N Walsh, Carmelo A Milano, Chetan B Patel, Gregory A Ewald, Akinobu Itoh, David Dean, Arun Krishnamoorthy, William G Cotts, Antone J Tatooles, Ulrich P Jorde, Brian A Bruckner, Jerry D Estep, Valluvan Jeevanandam, Gabriel Sayer, Douglas Horstmanshof, James W Long, Sanjeev Gulati, Eric R Skipper, John B O'Connell, Gerald Heatley, Poornima Sood, Yoshifumi Naka, MOMENTUM 3 Investigators, Steve Gordon, Jeffrey Teuteberg, Carole Thomas, William Holman, Daniel Heitjan, Sharon Hunt, Stuart Russell, Benjamin Sun, Sirtaz Adatya, Francis Pagani, Ranjit John, Robert Adamson, Hari Mallidi, Steven Singh, Masahiro Ono, Christiano Caldeira, Scott Silvestry, Francis Downey, Michael McGrath, Christopher Barreiro, Aditya Bansal, Michael Givertz, Claudius Mahr, Nahush Mokadam, John Um, Anelechi Anyanwu, Ahmet Kilic, Bassam Shukrallah, John Ransom, Stephen Bailey, Brett Sheridan, Jason Katz, Jeffrey Morgan, Hassan Nemeh, Walter Pae, Margarita Camacho, Pavan Atluri, Leway Chen, David Majure, Farooq Sheikh, Marc Katz, Steven Fiser, Mary Keebler, John Kern, Leora Yarboro, Abeel Mangi, Allen Anderson, Charles Klodell, Thomas Beaver, Marin Strueber, Asghar Khagani, Marzia Leacche, Shashank Desai, Ramesh Singh, Shahab Akhter, Takushi Kohmoto, Don Chomsky, Igor Gregoric, Vigneshwar Kasirajan, Daniel Tang, John Stulak, Meredith Brisco, Adrian Van Bakel, Nader Moazami, Edward Soltesz, Andreas Brieke, Jay Bhama, Mandeep R Mehra, Daniel J Goldstein, Nir Uriel, Joseph C Cleveland Jr, Melana Yuzefpolskaya, Christopher Salerno, Mary N Walsh, Carmelo A Milano, Chetan B Patel, Gregory A Ewald, Akinobu Itoh, David Dean, Arun Krishnamoorthy, William G Cotts, Antone J Tatooles, Ulrich P Jorde, Brian A Bruckner, Jerry D Estep, Valluvan Jeevanandam, Gabriel Sayer, Douglas Horstmanshof, James W Long, Sanjeev Gulati, Eric R Skipper, John B O'Connell, Gerald Heatley, Poornima Sood, Yoshifumi Naka, MOMENTUM 3 Investigators, Steve Gordon, Jeffrey Teuteberg, Carole Thomas, William Holman, Daniel Heitjan, Sharon Hunt, Stuart Russell, Benjamin Sun, Sirtaz Adatya, Francis Pagani, Ranjit John, Robert Adamson, Hari Mallidi, Steven Singh, Masahiro Ono, Christiano Caldeira, Scott Silvestry, Francis Downey, Michael McGrath, Christopher Barreiro, Aditya Bansal, Michael Givertz, Claudius Mahr, Nahush Mokadam, John Um, Anelechi Anyanwu, Ahmet Kilic, Bassam Shukrallah, John Ransom, Stephen Bailey, Brett Sheridan, Jason Katz, Jeffrey Morgan, Hassan Nemeh, Walter Pae, Margarita Camacho, Pavan Atluri, Leway Chen, David Majure, Farooq Sheikh, Marc Katz, Steven Fiser, Mary Keebler, John Kern, Leora Yarboro, Abeel Mangi, Allen Anderson, Charles Klodell, Thomas Beaver, Marin Strueber, Asghar Khagani, Marzia Leacche, Shashank Desai, Ramesh Singh, Shahab Akhter, Takushi Kohmoto, Don Chomsky, Igor Gregoric, Vigneshwar Kasirajan, Daniel Tang, John Stulak, Meredith Brisco, Adrian Van Bakel, Nader Moazami, Edward Soltesz, Andreas Brieke, Jay Bhama
Abstract
Background: In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.
Methods: In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points.
Results: Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02).
Conclusions: In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).
Source: PubMed