Chronic outcomes of leadless vs transvenous single chamber ventricular pacemakers in high-risk subgroups

Abstract

Abstract Background The Micra leadless pacemaker (LP-VVI) has been shown to have lower chronic complications and device-related reinterventions compared to transvenous ventricular pacemakers (TV-VVI) in a large, real-world population. This study compares the complication and reintervention rate in subgroups with comorbidities associated with higher risk of pacemaker complications and hypothesized to benefit from leadless pacing. Methods The longitudinal Micra Coverage with Evidence Development (CED) Study compared the outcomes of Medicare patients receiving LP-VVI to those receiving a TV-VVI in the US. Patients in the Micra CED study were included in this study if they had a diagnosis of chronic kidney disease Stages 4–5 (CKD45), end-stage renal disease (ESRD), malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) on any administrative claim in the 12 months prior to pacemaker implant. A pre-specified set of complications and system reinterventions were identified using the relevant diagnosis and procedure codes. Adjusted and unadjusted Fine-Gray competing risks models were used to compare reinterventions and complications between LP-VVI and TV-VVI patients within each subgroup. All results were adjusted for multiple comparisons using a Bonferroni correction. An ad-hoc comparison of a composite endpoint of select reinterventions (system replacement, removal, revision, and lead reinterventions) and device complications was also conducted. Results The sample size of patients in each subgroup ranged from 2,032 patients with ESRD to 11,936 patients with diabetes. The percent of LP-VVI patients in each subgroup ranged from 44.0 in the TVD subgroup to 74.9 in the ESRD subgroup. Compared to patients implanted with a TV-VVI, patients with a LP-VVI with malignancy, diabetes, TVD, and COPD had significantly fewer complications (Table 1; Malignancy, HR 0.68, [0.48–0.95]; Diabetes, HR 0.69, [0.53–0.89]; TVD, HR 0.60 [0.44–0.82]; COPD, HR 0.73, [0.55–0.98]). LP-VVI patients with diabetes, TVD, and COPD also had lower rates of reintervention (Table; Diabetes, HR 0.58, [0.37–0.89]; TVD, HR 0.46 [0.28–0.76]; COPD, HR 0.51, [0.29–0.90]). LP-VVI patients with malignancy, diabetes, TVD, and COPD had lower rates of the combined endpoint of device complications and select reinterventions (Table; Malignancy, HR 0.52, [0.32–0.83]; Diabetes, HR 0.52, [0.35–0.77]; TVD, HR 0.44 [0.28–0.70]; COPD, HR 0.55, [0.34–0.89]). Conclusions In a real-world study of US Medicare patients, the leadless pacemaker was associated with lower rates of chronic complications and reinterventions at 2 years compared with TV-VVI pacing in several high-risk subgroups. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic