Carregant...
Fitxers
Tipus de document
ArticleVersió
Versió acceptadaData de publicació
Llicència de publicació
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/222719
A Modular Communicative Leadless Pacing-Defibrillator System
Títol de la revista
Director/Tutor
ISSN de la revista
Títol del volum
Recurs relacionat
Resum
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
Matèries (anglès)
Citació
Citació
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. A Modular Communicative Leadless Pacing-Defibrillator System. _New England Journal of Medicine_. 2024. Vol. 391, núm. 15, pàgs. 1402-1412. [consulta: 14 de gener de 2026]. ISSN: 0028-4793. [Disponible a: https://hdl.handle.net/2445/222719]