Contemporaneous Comparison of Outcomes Among Patients Implanted With a Leadless vs Transvenous Single-Chamber Ventricular Pacemaker

Abstract

IMPORTANCEThe safety and efficacy of leadless VVI pacemakers have been demonstrated in multiple clinical trials, but the comparative performance of the device in a large, real-world population has not been examined. OBJECTIVE To compare patient characteristics and complications among patients implanted with leadless VVI and transvenous VVI pacemakers. DESIGN, SETTING, PARTICIPANTS The Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra CED) is a continuously enrolling observational cohort study evaluating complications, utilization, and outcomes of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted between March 9, 2017, and December 1, 2018, were identified and included. All Medicare patients implanted with leadless VVI and transvenous VVI pacemakers during the study period were enrolled. Patients with less than 12 months of continuous enrollment in Medicare prior to leadless VVI or transvenous VVI implant and with evidence of a prior cardiovascular implantable electronic device were excluded, leaving 5746 patients with leadless VVI pacemakers and 9662 patients with transvenous VVI pacemakers. Data were analyzed from May 2018 to April 2021. EXPOSURES Medicare patients implanted with leadless VVI pacemakers or transvenous VVI pacemakers. MAIN OUTCOMES AND MEASURESThe main outcomes were acute (30-day) complications and 6-month complications. RESULTSOf 15 408 patients, 6701 (43.5%) were female, and the mean (SD) age was 81.0 (8.7) years. Compared with patients with transvenous VVI pacemakers, patients with leadless VVI pacemakers were more likely to have end-stage kidney disease (690 [12.0%] vs 226 [2.3%]; P < .001) and a higher mean (SD) Charlson Comorbidity Index score (5.1 [3.4] vs 4.6 [3.0]; P < .001). The unadjusted acute complication rate was higher in patients with leadless VVI pacemakers relative to transvenous VVI pacemakers (484 of 5746 [8.4%] vs 707 of 9662 [7.3%]; P = .02). However, there was no significant difference in overall acute complication rates following adjustment for patient characteristics (7.7% vs 7.4%; risk difference, 0.3; 95% CI, −0.6 to 1.3; P = .49). Pericardial effusion and/or perforation within 30 days was significantly higher among patients with leadless VVI pacemakers compared with patients with transvenous VVI pacemakers in both unadjusted and adjusted models (unadjusted, 47 of 5746 [0.8%] vs 38 of 9662 [0.4%]; P < .001; adjusted, 0.8% vs 0.4%; risk difference, 0.4; 95% CI, 0.1 to 0.7; P = .004). Patients implanted with leadless VVI pacemakers had a lower rate of 6-month complications compared with patients implanted with transvenous VVI pacemakers (unadjusted hazard ratio, 0.84; 95% CI, 0.68-1.03; P = .10; adjusted hazard ratio, 0.77; 95% CI, 0.62-0.96; P = .02). CONCLUSIONS AND RELEVANCEIn this study, despite significant differences in patient characteristics, patients in whom a leadless pacemaker was implanted were observed to have higher rates of pericardial effusion and/or perforation but lower rates...

Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up

“…The results of this current study build off of recently published results of shorter-term (30-day and 6-month) outcomes of the Micra CED study, 5 which found patients implanted with a leadless VVI pacemaker had higher rates of pericardial effusion and/or perforation, but lower rates of other device-related complications and need for system revisions, with no difference in the adjusted overall rate of acute (30-day) complications. These results are similar to a 2017 review by Tjong and Reddy, 12 which found slightly higher rates of short-term complications in leadless patients.…”

“…Post-market device data linked to CMS claims data have now served to provide important insight into multiple new device technologies, including transcatheter mitral repair 19 and now leadless VVI pacing. 5 Studies relying solely on CMS FFS claims data cannot supplant a holistic approach to post-market evaluation; however, CMS data can provide essential insights into utilization, safety, and outcomes in general US practice that cannot be provided in a traditional disease-specific registry platform. Notably, the Micra CED study illustrates the feasibility of utilizing real-world data to generate evidence measuring the effectiveness of new technology and can serve as a potential model for coverage of new medical technologies in other healthcare systems.…”

“…The design of the Micra CED study has been described previously. 5 , 6 The CED study is a continuously enrolling cohort study designed to evaluate complications, utilization, and outcomes of the leadless-VVI pacing system in the US Medicare population. The study uses administrative claims data to enrol patients, ascertain patient characteristics, identify comorbidities, and measure outcomes.…”

“…Acute and 6-month outcomes of the Micra CED study have been previously reported. 5 Leadless VVI pacemaker implants were associated with higher rates of pericardial effusion, but lower rates of other device-related complications and need for system revision at 6 months. The objective of this analysis is to evaluate and compare device reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI pacemakers.…”

On the Management of Ventricular Arrhythmias Following Leadless Pacemaker Implantation

“…While the rate of cardiac perforation associated with leadless pacing systems has been found to be less than 1% (0.77% in the Micra™ PAR population and 0.8% in the Micra™ CED population, respectively), this rate appears to be higher than that associated with transvenous pacemaker implantation (0.4% in the control group of the Micra™ CED study). 4 In a report of the MAUDE database, three episodes of VF/VF were reported, all in the setting of perforation and effusion. 5 …”