Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/222719
Title: A Modular Communicative Leadless Pacing-Defibrillator System
Author: Knops, Reinoud E.
Lloyd, Michael S.
Roberts, Paul R.
Wright, David J.
Boersma, Lucas V. A.
Doshi, Rahul
Friedman, Paul A.
Neuzil, Petr
Blomstroem Lundqvist, Madelene Carina
Bongiorni, Maria Grazia
Burke, Martin C.
Gras, Daniel
Kutalek, Steven P.
Amin, Anish K.
Fu, Eugene Y.
Epstein, Laurence M.
Tolosana, José M. (José María)
Callahan, Thomas D.
Aasbo, Johan D.
Augostini, Ralph
Manyam, Harish
Nair, Devi G.
Mondesert, Blandine
Su, Wilber W.
Pepper, Chris
Miller, Marc A.
Grammes, Jon
Saleh, Karim
Marquie, Christelle
Merchant, Faisal M.
Cha, Yong-Mei
Cunnington, Colin
Frankel, David S.
West, Julie
Matznick, Elizabeth
Swackhamer, Bryan
Brisben, Amy J.
Weinstock, Jonathan
Stein, Kenneth M.
Reddy, Vivek Y.
Mont Girbau, Lluís
the MODULAR ATP Investigators
Keywords: Desfibril·ladors cardioversors implantables
Arrítmia
Implantable cardioverter-defibrillators
Arrhythmia
Issue Date: 17-Oct-2024
Publisher: Massachusetts Medical Society
Abstract: The subcutaneous implantable cardioverter–defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing–defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. Methods We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker–defibrillator system. The safety end point was freedom from leadless pacemaker–related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). Results We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker–related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. Conclusions The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months
Note: Versió postprint del document publicat a: https://doi.org/10.1056/NEJMoa2401807
It is part of: New England Journal of Medicine, 2024, vol. 391, num.15, p. 1402-1412
URI: https://hdl.handle.net/2445/222719
Related resource: https://doi.org/10.1056/NEJMoa2401807
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

Files in This Item:
File Description SizeFormat 
894947.pdf671.41 kBAdobe PDFView/Open


This item is licensed under a Creative Commons License Creative Commons