Early benefits associated with the Micra leadless pacemaker (Medtronic) appear to be sustained through 2 years among more than 10,000 Medicare patients, according to new data from the Micra Coverage with Evidence Development (CED) study.
Micra leadless pacing cut the relative risk of reintervention by 38% and chronic complications by 31% compared with conventional transvenous pacemakers.
Despite the Micra group being sicker, there was no significant difference in adjusted all-cause mortality at 2 years, Jonathan Piccini, MD, reported in a late-breaking session at the virtual European Society of Cardiology (ESC) Congress 2021.
The single-chamber transcatheter Micra pacemaker was approved in the United States in April 2016, with the Centers for Medicare & Medicaid allowing reimbursement for implantation the following year through the CED study.
Short-term results reported last year showed no difference in the adjusted rate of acute complications or survival at 30 days between the Micra and traditional pacemaker groups but 23% fewer complications with Micra pacing at 6 months, said Piccini, Duke University Medical Center, Durham, North Carolina. Longer-term outcomes in real-world populations, however, have not been previously examined.
The present analysis included 6219 patients (44.1% female) who received the Micra pacemaker and 10,212 patients who (43.2% female) who received a transvenous device.
The Micra group was younger (mean, 79.5 vs 82.0 years) and less likely to have atrial fibrillation (81.5% vs 89.0%) but had more comorbid illness including end-stage renal disease (12% vs 2.3%), diabetes (45.1% vs 41.3%), and coronary artery disease (56.1% vs 53.3%). Mean Charlson Comorbidity Index scores were 5.1 vs 4.6, respectively.
After using propensity score overlap weights to account for baseline differences, the rate of chronic complication at 2 years was 4.6% with the Micra leadless pacemaker and 6.5% with transvenous pacemakers (hazard ratio [HR], 0.69; 95% CI, 0.60 – 0.81).