Leadless pacemaker perforations: Clinical consequences and related device and user problems

Abstract

Background Cardiac perforation during leadless pacemaker implantation is more likely to require intervention than perforation by a transvenous lead. This study reports the consequences of Micra pacemaker perforations and related device and operator use problems based on information the manufacturer has submitted to the Food and Drug Administration (FDA). Methods FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for Micra perforations. Data extracted included deaths, major adverse clinical events (MACEs), and device and/or operator use problems. Results Between 2016 and July 2021, 563 perforations were reported within 30 days of implant and resulted in 150 deaths (27%), 499 cardiac tamponades (89%), 64 pericardial effusions (11%), and 146 patients (26%) required emergency surgery. Half of perforations were associated with 139 (25%) device problems, 78 (14%) operator use problems, and 62 (11%) combined device and operator use problems. Inadequate electrical measurements or difficult positioning were the most frequent device problems (n = 129); non‐septal implants and perforation of other structures were the most frequent operator use problems (n = 69); a combined operator use and device problem resulted in 62 delivery system perforations. No device or operator use problem was identified for 282 perforations (50%), but they were associated with 78 deaths, 245 tamponades, and 57 emergency surgeries. Conclusion The Micra perforations reported in MAUDE are often associated with death and major complications requiring emergency intervention. Device and use problems account for at least half of perforations. Studies are needed to identify who is at risk for a perforation and how MACE can be avoided or mitigated.

Anatomical location of leadless pacemaker and the risk of pacing‐induced cardiomyopathy

“…Being an observational study, it may be conceptualized that HS implantation of LP was sought by the operating physician to avoid complications compared to the AS position. A prior study by Hauser et al 16 . showed that HS LP implantation was associated with a lower risk of perforation.…”

“…Being an observational study, it may be conceptualized that HS implantation of LP was sought by the operating physician to avoid complications compared to the AS position. A prior study by Hauser et al 16 showed that HS LP implantation was associated with a lower risk of perforation. However, this hypothesis seems less plausible based on our study results, because: (1) in our study, the number of deployment attempts that was needed to get the LP in an optimal location (a potential surrogate for procedural and anatomical complexity) and complication rates were similar in the AS group compared to the HS group (Tables 1), and (2) if avoiding complications was really the intent, then it is possible that the HS LP group was likely a sicker/fail group of patients compared to the AS group.…”

Strategies for Safe Implantation and Effective Performance of Single-Chamber and Dual-Chamber Leadless Pacemakers

“…Data from a real-world setting showed that 36% (82/228) of pericardial effusion patients had the need for pericardiocentesis, and 11.5% (26/228) required a thoracotomy. A higher proportion (26% (146/563)) of Micra-related perforations requiring emergency surgery was also reported in the MAUDE [ 37 ].…”

Cardioneuroablation for pediatric patients with functional sinus node dysfunction and paroxysmal atrioventricular block

“…24 While transcatheter leadless pacemakers are another consideration for pacing, there have been reports of tricuspid valve injury during implantation necessitating surgical intervention. 27 Additionally, recent literature reported complications in 10 of 62 pediatric patients who underwent transvenous leadless pacemaker implantation, including cardiac perforation and femoral venous thrombus. 28 Therefore, CNA may be an alternative treatment for pediatric patients with severe functional pauses, particularly those with a lower weight, with the potential for less morbidity than pacemaker implantation.…”