Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups

Abstract

Aims: This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications.

Methods and results: This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [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)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (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)] had lower rates of the combined outcome.

Conclusion: In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups.

Trial registration: ClinicalTrials.gov ID NCT03039712.

Keywords: Complications; High-risk patients; Leadless pacemakers; System reintervention; Transvenous pacemakers.

Graphical Abstract

Figure 1

Two-year chronic complications results. Notes: Hazard ratios of 2-year chronic complication rates between leadless-VVI patients and transvenous-VVI patients for each high-risk subgroup, estimated with Fine–Gray competing risk models. Spikes represent Bonferroni-adjusted confidence intervals (number of tests = 27). aDCSI, adapted Diabetes Complication Severity Index; COPD, chronic obstructive pulmonary disease; CKD, chronic kidney disease; ESRD, end-stage renal disease. ESRD and CKD Stages 4 or 5 are not mutually exclusive.

Figure 2

Two-year device-related reinterventions. Notes: Hazards ratios of 2-year device-related reintervention rates between leadless-VVI patients and transvenous-VVI patients for each high-risk subgroup, estimated with Fine–Gray competing risk models. Spikes represent Bonferroni-adjusted Confidence Intervals (number of tests = 9). aDCSI, adapted Diabetes Complication Severity Index; COPD, chronic obstructive pulmonary disease; CKD, chronic kidney disease; ESRD, end-stage renal disease; ESRD and CKD Stages 4 or 5 are not mutually exclusive.

Figure 3

Two-year combined device-related chronic complication and select reinterventions. Notes: hazards ratios of 2-year combined device-related chronic complications (device breakdown, dislodgment, other mechanical complications, infection, device-related pain, device-related stenosis, and pocket complications) and select reinterventions (system revision, lead revision or replacement, system replacement, system removal) rates between leadless-VVI patients and transvenous-VVI patients for each high-risk subgroup, estimated with Fine–Gray competing risk models. Spikes represent Bonferroni-adjusted confidence intervals (number of tests = 27). aDCSI, adapted Diabetes Complication Severity Index; COPD, chronic obstructive pulmonary disease; CKD, chronic kidney disease; ESRD, end-stage renal disease. ESRD and CKD Stages 4 or 5 are not mutually exclusive.

Figure 4

Sensitivity analysis results. Notes: Hazard ratios adjusted using overlapping weights. Confidence intervals adjusted for multiple comparisons (number of tests = 12). P-values of interactions are 0.0962 (chronic complications), 0.5408 (reinterventions), and 0.2319 (composite endpoint). High-risk comorbidities are chronic kidney disease Stages 4 and 5, chronic obstructive pulmonary disease, diabetes with low adapted Diabetes Complication Severity Index, diabetes with high adapted Diabetes Complication Severity Index, end-stage renal disease, malignancy with treatment, malignancy without treatment, and tricuspid valve disease. ESRD and CKD Stages 4 or 5 are not mutually exclusive. Conf. Int., confidence internal; HR, hazard ratio; L-VVI, leadless-VVI; TV-VVI, transvenous-VVI.