Why the study?
Does leadless intracardiac pacemaker implantation increase major adverse clinical events compared to transvenous ventricular pacing leads?
Does leadless intracardiac pacemaker implantation increase major adverse clinical events compared to transvenous ventricular pacing leads?
While severe perforation complications with leadless pacemakers are rare (<1%), traditional transvenous ventricular pacing leads are associated with significantly fewer major adverse clinical events.
May favor transvenous leads to reduce MACE; hypothesis-generating and should not yet change leadless pacemaker practice.
Micra leadless pacemaker implantation may be complicated by myocardial and vascular perforations and tears that result in cardiac tamponade and death. We estimate the incidence is low (<1%). Rescue surgery to repair perforations may be lifesaving. MACE are significantly less for implantation of CapSureFix transvenous ventricular pacing leads.
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Hauser et al. (2021) studied this question.
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