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