Wearable Cardioverter-Defibrillator after Myocardial Infarction
Jeffrey E Olgin, Mark J Pletcher, Eric Vittinghoff, Jerzy Wranicz, Rajesh Malik, Daniel P Morin, Steven Zweibel, Alfred E Buxton, Claude S Elayi, Eugene H Chung, Eric Rashba, Martin Borggrefe, Trisha F Hue, Carol Maguire, Feng Lin, Joel A Simon, Stephen Hulley, Byron K Lee, VEST Investigators, James Merrill, Peem Lorvidhaya, Pughazhendi Vijayaraman, Jay Gross, J Paul Mounsey, Nicholas Skipitaris, Robert Phang, Lawrence Rosenthal, David Sandler, Soufian AlMahameed, Lawrence Nair, Aylmer Tang, Robert Lee Jobe, David Slotwiner, Neal Kavesh, Mauricio Arruda, Venkateshwar Gottipaty, Kara Quan, Emad Aziz, Jay Franklin, Theofanie Mela, Michael Stillabower, Tariq Salam, M Imran Dotani, Donald Hegland, William Miles, Edo Kaluski, Peter Lee, Richard Wu, Michael Gen, Manoj Duggal, Duy Nguyen, Gregory Marcus, Sandeep Joshi, Sarah Taylor, Ali Al-Mudamgha, Emile Daoud, Paul Maccaro, Rajiv Chandra, Tony Simmons, Steven Compton, Romakota Reddy, Nicholas Stamato, Chandrashekar Kumber, John Hayes, Ulrika Birgersdotter-Green, Robert Kinn, Gopi Dandamudi, Mina Chung, Rudolph Licandro, Miguel Valderrabano, Jonathan Weinstock, Waseemuddin Kazi, Jonathan Hobson, Walter Clair, Andrew Kaplan, Harlan Grogin, Bruce Koplan, David Schwartzman, Angel Leon, Frank Schwender, Malcolm Foster III, Anne Dougherty, Charles Athill, Gerald Sotsky, Mirro, Michael, Venkat Pasnoori, George Monir, Wilson Wong, Wassim Choucair, Piotr Wanczura, Aleksander Zurakowski, Grzegorz Skonieczny, Milosz Marona, Leszek Kinasz, Nader Elmasri, Marcin Grabowski, Maciej Sterlinski, Marcin Debinski, Maciej Pruski, Grzegorz Raczak, Andrzej Lubinski, Andrzej Przybylski, Zbigniew Orski, Janusz Prokopczuk, Monika Lica-Gorzynska, Beata Wozakowska-Kapłon, Danuta Czarnecka, Hubert Krupa, Robert Romanekl, Bartosz Skwarna, Artur Mendyk, Karol Stania, Rainer Hambrecht, Markus Zabel, Thomas Kleeman, Dierk Thomas, Thomas Munzel, Bela Merkely, Zoltan Csanádi, Jeffrey E Olgin, Mark J Pletcher, Eric Vittinghoff, Jerzy Wranicz, Rajesh Malik, Daniel P Morin, Steven Zweibel, Alfred E Buxton, Claude S Elayi, Eugene H Chung, Eric Rashba, Martin Borggrefe, Trisha F Hue, Carol Maguire, Feng Lin, Joel A Simon, Stephen Hulley, Byron K Lee, VEST Investigators, James Merrill, Peem Lorvidhaya, Pughazhendi Vijayaraman, Jay Gross, J Paul Mounsey, Nicholas Skipitaris, Robert Phang, Lawrence Rosenthal, David Sandler, Soufian AlMahameed, Lawrence Nair, Aylmer Tang, Robert Lee Jobe, David Slotwiner, Neal Kavesh, Mauricio Arruda, Venkateshwar Gottipaty, Kara Quan, Emad Aziz, Jay Franklin, Theofanie Mela, Michael Stillabower, Tariq Salam, M Imran Dotani, Donald Hegland, William Miles, Edo Kaluski, Peter Lee, Richard Wu, Michael Gen, Manoj Duggal, Duy Nguyen, Gregory Marcus, Sandeep Joshi, Sarah Taylor, Ali Al-Mudamgha, Emile Daoud, Paul Maccaro, Rajiv Chandra, Tony Simmons, Steven Compton, Romakota Reddy, Nicholas Stamato, Chandrashekar Kumber, John Hayes, Ulrika Birgersdotter-Green, Robert Kinn, Gopi Dandamudi, Mina Chung, Rudolph Licandro, Miguel Valderrabano, Jonathan Weinstock, Waseemuddin Kazi, Jonathan Hobson, Walter Clair, Andrew Kaplan, Harlan Grogin, Bruce Koplan, David Schwartzman, Angel Leon, Frank Schwender, Malcolm Foster III, Anne Dougherty, Charles Athill, Gerald Sotsky, Mirro, Michael, Venkat Pasnoori, George Monir, Wilson Wong, Wassim Choucair, Piotr Wanczura, Aleksander Zurakowski, Grzegorz Skonieczny, Milosz Marona, Leszek Kinasz, Nader Elmasri, Marcin Grabowski, Maciej Sterlinski, Marcin Debinski, Maciej Pruski, Grzegorz Raczak, Andrzej Lubinski, Andrzej Przybylski, Zbigniew Orski, Janusz Prokopczuk, Monika Lica-Gorzynska, Beata Wozakowska-Kapłon, Danuta Czarnecka, Hubert Krupa, Robert Romanekl, Bartosz Skwarna, Artur Mendyk, Karol Stania, Rainer Hambrecht, Markus Zabel, Thomas Kleeman, Dierk Thomas, Thomas Munzel, Bela Merkely, Zoltan Csanádi
Abstract
Background: Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear.
Methods: We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death.
Results: Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock.
Conclusions: Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).
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Source: PubMed