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Leadless vs. Transvenous Single-Chamber Ventricular Pacing
Quick Takes
- In this study, Micra leadless pacemaker is associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of complications compared with transvenous VVI pacemaker.
- There is no difference in adjusted all-cause mortality at 2 years between patients with leadless and single-lead pacemakers.
Study Questions:
What are outcomes of the leadless Micra VVI pacemaker compared with the traditional transvenous VVI pacemaker in a real-world population?
Methods:
Medicare claims data were used to identify patients implanted with leadless and transvenous VVI pacemakers. Cox models were used to compare 2-year outcomes between groups.
Results:
There were 6,219 patients with a leadless pacemaker and 10,212 patients with a transvenous pacemaker. Compared to transvenous devices, patients with leadless devices had more end-stage renal disease (12.0% vs. 2.3%) and a higher Charlson comorbidity index (5.1 vs. 4.6). Leadless VVI patients had significantly fewer reinterventions (adjusted hazard ratio [HR], 0.62) and chronic complications (adjusted HR, 0.69) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups.
Conclusions:
The authors concluded that in a real-world population of patients, Micra leadless VVI pacemaker was associated with a 38% lower rate of reinterventions and a 31% lower rate of chronic complications than transvenous VVI pacemaker. No difference in all-cause mortality was seen at 2 years.
Perspective:
Prior studies showed that the Micra leadless pacemaker is associated with a lower rate of complications than a transvenous pacemaker, mostly due to fewer dislodgements and procedure-related infections within the first 6 months, although there may be a small increase in acute procedure-related complications. The current study shows Micra pacemaker outcomes are favorable compared with single-chamber transvenous pacemakers at 2 years. Some advantages of leadless pacemakers are fewer vascular complications, fewer infections, and less tricuspid valve interference. While this data is observational, and subject to selection bias and other confounders, it is reassuring to see favorable outcomes at the longer follow-up. The current study uses the Micra CED (Micra Coverage With Evidence Development) study, which is continuously enrolling patients, as mandated by Centers for Medicare & Medicaid Services coverage. This will assure future updates of long-term leadless pacemaker outcomes.
Clinical Topics: Arrhythmias and Clinical EP, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Cardiac Pacing, Artificial, Cardiology Interventions, Comorbidity, Geriatrics, Heart Failure, Infections, Kidney Failure, Chronic, Medicare, Outcome Assessment, Health Care, Pacemaker, Artificial, Vascular Diseases
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