Unknown

Dataset Information

0

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


ABSTRACT:

Aims

Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients.

Methods and results

The Micra Coverage with Evidence Development study is a continuously enrolling, observational, cohort study of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted with a leadless VVI pacemaker between March 9, 2017, and December 31, 2018, were identified using Medicare claims data linked to manufacturer device registration data (n = 6219). All transvenous VVI patients from facilities with leadless VVI implants during the study period were obtained directly from Medicare claims (n = 10 212). Cox models were used to compare 2-year outcomes between groups. Compared to transvenous VVI, patients with leadless VVI 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, 95% confidence interval (CI) 0.45-0.85, P = 0.003] and chronic complications (adjusted HR 0.69, 95% CI 0.60-0.81, P < 0.0001) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups (adjusted HR 0.97, 95% CI 0.91-1.04, P = 0.37).

Conclusion

In a real-world study of US Medicare patients, the Micra leadless VVI pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous VVI pacing. There was no difference in adjusted all-cause mortality at 2 years.

SUBMITTER: El-Chami MF 

PROVIDER: S-EPMC8934700 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

altmetric image

Publications

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

El-Chami Mikhael F MF   Bockstedt Lindsay L   Longacre Colleen C   Higuera Lucas L   Stromberg Kurt K   Crossley George G   Kowal Robert C RC   Piccini Jonathan P JP  

European heart journal 20220301 12


<h4>Aims</h4>Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients.<h4>Methods and results</h4>The Micra Coverage with Evidence Development study is a continuou  ...[more]

Similar Datasets

| S-EPMC10998730 | biostudies-literature
| S-EPMC10062361 | biostudies-literature
| S-EPMC8319824 | biostudies-literature
| S-EPMC11542626 | biostudies-literature
| S-EPMC11558452 | biostudies-literature
| S-EPMC4589655 | biostudies-literature
| S-EPMC7721444 | biostudies-literature