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Leadless pacemakers linked with fewer overall complications vs. transvenous pacemakers

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SAN FRANCISCO — Patients requiring single-chamber pacing experience fewer overall complications with a leadless pacemaker than with a transvenous pacemaker, according to data presented at the Heart Rhythm Society Annual Scientific Sessions.

Vivek Y. Reddy, MD , and colleagues compared acute and midterm adverse event rates of leadless pacemakers (Nanostim, St. Jude Medical) vs. transvenous pacemakers. Using data from the LEADLESS II clinical trial and Truven Health MarketScan databases, 718 patients with a leadless pacemaker and 10,521 patients with a transvenous pacemaker were included in the study. Mean follow-up was 10 months.

Vivek Y. Reddy

“Leadless pacemaker complications occurred mostly in the first month in contrast to traditional pacemakers, which had a higher overall complication rate,” Reddy, director of cardiac arrhythmia services for Mount Sinai Hospital, said during a press conference.

According to Reddy, there was a 68% reduction in complications in the leadless pacemaker cohort. The overall complication rate for the leadless pacemaker was 6.4% and the rate of cardiac tamponade was 1.5%.

“You could say, is 1.5% complication rate too high? It is a reasonable question to ask. Yes, it is too high, but on the flip side a higher complication rate is expected with starting a new procedure,” Reddy said.

The transvenous pacemaker cohort experienced higher infection and lead-related adverse events, but dislodgement and pericardial effusion rates were similar between the two cohorts.

“Our findings reinforce the use of leadless pacemaker as an alternative to the standard pacemaker in patients requiring single-chamber pacemakers,” Reddy said. – by Tracey Romero

Reference:

Reddy V, et al. LBCT 02. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 4-7, 2016; San Francisco.

Disclosure: St. Jude Medical funded the study. Reddy reports consulting for St. Jude Medical, receiving speaking fees from Boston Scientific and receiving research funding from St. Jude Medical.