A Leadless Intracardiac Transcatheter Pacing System

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Abstract

A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead.

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Most cited references 14

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A Proportional Hazards Model for the Subdistribution of a Competing Risk

Jason P. Fine, Robert J Gray (1999)

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Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study.

Erik Udo, Nicolaas Zuithoff, Norbert van Hemel … (2012)

Today quantitative information about the type of complications and their incidence during long-term pacemaker (PM) follow-up is scarce. To assess the incidence and determinants of short- and long-term complications after first pacemaker implantation for bradycardia. A prospective multicenter cohort study (the FOLLOWPACE study) was conducted among 1517 patients receiving a PM between January 2003 and November 2007. The independent association of patient and implantation-procedure characteristics with the incidence of PM complications was analyzed using multivariable Cox regression analysis. A total of 1517 patients in 23 Dutch PM centers were followed for a mean of 5.8 years (SD 1.1), resulting in 8797 patient-years. Within 2 months, 188 (12.4%) patients developed PM complications. Male gender, age at implantation, body mass index, a history of cerebrovascular accident, congestive heart failure, use of anticoagulant drugs, and passive atrial lead fixation were independent predictors for complications within 2 months, yielding a C-index of 0.62 (95% confidence interval 0.57-0.66). Annual hospital implanting volume did not additionally contribute to the prediction of short-term complications. Thereafter, 140 (9.2%) patients experienced complications, mostly lead-related complications (n = 84). Independent predictors for long-term complications were age, body mass index, hypertension, and a dual-chamber device, yielding a C-index of 0.62 (95% confidence interval 0.57-0.67). The occurrence of a short-term PM complication was not predictive of future PM complications. Complication incidence in modern pacing therapy is still substantial. Most complications occur early after PM implantation. Although various patient- and procedure-related characteristics are independent predictors for early and late complications, their ability to identify the patient at high risk is rather poor. This relatively high incidence of PM complications and their poor prediction underscores the usefulness of current guidelines for regular follow-up of patients with PM. Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

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Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker.

Vivek Reddy, Derek Exner, Daniel Cantillon … (2015)

Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter.