Assessment of Antitachycardia Pacing in Primary Prevention Patients
Authors: Claudio Schuger, Boyoung Joung, Kenji Ando, Lluís Mont, Pier D. Lambiase, Gilles E. O’Hara, John M. Jennings, Derek Yung, Giuseppe Boriani, Jonathan P. Piccini, Nicholas Wold, Kenneth M. Stein, James P. Daubert, Piamsook Angkeow, Anand S. Kenia, Waddah Maskoun, Gurjit Singh, Kevin F. Kwaku, Blandine Mondesert, Steven J. Bailin, Troy E. Rhodes, Prashant D. Bhave, Ghulam M. Chaudhry, Andrew T. Lawrence, Jose Manuel Porres, José Maria Tolosana-Viu, Paul A. Scott, Erich L. Kiehl, Sri Sundaram, Kevin C. Floyd, Taral K. Patel, Ronald K. Binder, Pietro Francia, Rafael Peinado, David J. Wright, Ihab Girgis, Clemens Steinwender, Ashish Patwala, Johan D. Aasbo, Sandeep Duggal, Craig McCotter, Glenn R. Meininger, Jihn Han, Justin Z. Lee, Daniel J. Cantillon, Darren S. Sidney, Khashayar Hematpour, Saumya Sharma, Phi Wiegn, Vijay Chilakamarri, Sreekanth Karanam, Hyung Wook Park, Nam-Sik Yoon, Myung Hwan Bae, Jason I. Koontz, Gad A. Silberman, Carlos Sebastian Ribas, Evan E. Lockwood, Dwayne N. Campbell, Mohammad Jazayeri, Paul Gerczuk, Chafik Assal, Arne Sippens Groenewegen, Charles J. Love, John Rhyner, Benjamin D'Souza, Steven J. Compton, Leenhapong Navaravong, Mihail Chelu, T. Jared Bunch, Jose Teixeira, Rangarao Tummala, Bruce Graham, Shane F. Tsai, Paari S. Dominic, David B. Meyer, Jonathan Man, Eue-Keun Choi, Sandhya Dhruvakumar, James Reiss, Jonathan Lowy, Chethan Gangireddy, Richard Balasubramaniam, Robert Malanuk, Anthony Ochoa, Brian Jaffe, Matthew Sevensma, Harpreet Grewal, Charles Athill, Andy Tran, John LeMaitre, Satoshi Shizuta, Kengo Kusano, Arnoldas Giedrimas, George E. Mark, Haseeb Jafri, Kai Sung, Sergio F. Cossu, Jongil Choi, Young Hoon Kim, Yonathan Melman, Michael Rozengarten, Eran S. Zacks, Pasquale Nocerino, John Garner, Steven Rowe, Jim W. Cheung, Jeffrey Rothfeld, Steven Hearne, Stephen Keim, Ricardo Cardona-Guarache, Maheer Gandhavadi, Vivek Bhatia, Jerome Kuhnlein, Abhimanyu Beri, Stephen Watts, Charles A. Joyner, Amr El-Shafei, Dionyssios Robotis, Kyoung-Min Park, Abdul Alawwa, Raffaele Sangiuolo, Ronald Lo, Yan Dong, Porur Somasundaram, Daisuke Izumi, Ritsushi Kato, Koichi Fuse, Paolo Capogrosso, Marcello De Divitiis, Rohit Kedia, Xiushi Liu, Jongmin Hwang, Seongwook Han, Sang-Weon Park, Il-Young Oh, Young Jin Cho, Yong Seog Oh, Yusuke Kondo, Sheetal Chandhok, Kamel N. Addo, Andrew L. Smock, Jay Koons, Satish R. Tiyyagura, Robert Winslow, Martin C. Burke, Maninder Bedi, Isaac Wiener, Vatsal Inamdar, Xiaoke Liu, Dae Kyeong Kim, Travis S. Wall, Laurence D. Sterns, Neal Kavesh, Kevin Browne, Randel L. Smith, Praveer Jain, Kenichi Tsujita, Hiroshige Yamabe, Shinichi Niwano, Rajesh Malik, Brett Berman, Benoit Coutu, Frank J. Rubalcava, Kishore Subnani, John Vijay Jayachandran, Ki Won Hwang, Devi G. Nair, James A. Coman, Sephal K. Doshi, Steven M. Markowitz, Christopher Pulling, Sean Pokorney, Albert Sun, Larry Jackson, Daniel J. Friedman
Journal: JAMA (2024)

Importance The emergence of novel programming guidelines that reduce premature and inappropriate therapies along with the availability of new implantable cardioverter-defibrillator (ICD) technologies lacking traditional endocardial antitachycardia pacing (ATP) capabilities requires the reevaluation of ATP as a first strategy in terminating fast ventricular tachycardias (VTs) in primary prevention ICD recipients. Objective To assess the role of ATP in terminating fast VTs in primary prevention ICD recipients with contemporary programming. Design, Setting, and Participants This global, prospective, double-blind, randomized clinical trial had an equivalence design with a relative margin of 35%. Superiority tests were performed at interim analyses and the final analysis if equivalence was not proven. Patients were enrolled between September 2016 and April 2021 at 134 sites in 8 countries, with the last date of follow-up on July 6, 2023. Patients were required to have an indication for a primary prevention ICD, including left ventricular ejection fraction less than or equal to 35%. Interventions Patients were randomized in a 1:1 ratio to receive ATP plus shock vs shock only. Main Outcomes and Measures The primary end point was time to first all-cause shock. Secondary end points included time to first appropriate shock, time to first inappropriate shock, all-cause mortality, and the composite of time to first all-cause shock plus all-cause mortality. Results A total of 2595 patients were randomized (mean age, 63.9 years; 22.4% were females). At a mean follow-up of 38 months, first all-cause shock occurred in 129 participants in the ATP plus shock group and 178 participants in the shock only group. The hazard ratio (HR) for the primary end point was 0.72 (95.9% CI, 0.57-0.92), with P = .005 for superiority of the ATP plus shock group over the shock only group. During follow-up in an intention-to-treat analysis, the total shock burden per 100 patient-years was not statistically different, at 12.3 and 14.9, respectively ( P = .70). Conclusions and Relevance The use of a single burst of ATP prior to shock in primary prevention ICD recipients with modern ICD detection programming prolonged the time to first all-cause ICD shock. Trial Registration ClinicalTrials.gov Identifier: NCT02923726