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

Comparison of in-hospital outcomes and complications of leadless pacemaker and traditional transvenous pacemaker implantation

“…A meta-analysis of four studies with 744 patients comparing LPM with a single-lead transvenous pacemaker showed no difference in a hematoma (RR 0.67, 95% CI 0.21–2.18, three studies), device dislocation (RR 0.33, 95% CI 0.06–1.74, three studies), and any other complications (RR 0.44, 95% CI 0.17–1.09, four studies). 18 Furthermore, in a more recent study by Boveda et al ., 19 it was found that despite a higher rate of pericardial complications in patients with LPM and device-related complications in patients with TV-VVI pacemakers, the 30-day and 2-year adjusted all-cause mortality was similar in both cohorts. In our cohort of 35 430 patients studying only in-patient complications, we were able to show a higher likelihood of vascular complications, a need for blood transfusions, device-related complications, and cardiac and VTE complications in the LPM group.…”

“…Finally, with respect to intracardiac device revisions, our results are in line with the current literature that has shown TV-VVI pacemakers to be at a higher risk of this complication, especially in high-risk groups with diabetes mellitus, COPD, tricuspid valve disease, and ESRD. 17 , 19 …”

“…However, consistent with our results that showed an increased risk of developing pericardial complications in patients with LPM, some studies have also found a higher incidence of pericarditis and pericardial effusion. 8 , 17 , 19 , 26 It can be postulated that due to the low overall prevalence of pericardial complications, underpowered studies were not able to reach significance, as even in patients defined as high-risk groups [which include chronic kidney disease Stages 4–5 (CKD4/5), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant], cardiac effusion and perforation were more commonly found in patients with LPM than those with transvenous VVI. 19 Using the NIS database with 7780 patients with LPM, the prevalence of pericardial complications (pericarditis, pericardial effusion, requirement of pericardiocentesis, and others) has been highlighted.…”

Advances in cardiac pacing with leadless pacemakers and conduction system pacing

“…Safety outcomes from initial studies were comparable and, at times, worse (higher rate of cardiac tamponade) when compared with conventional PPM implantation; this was largely driven by the novelty of the technology and user inexperience [36]. However, over the last 2-3 years, longer-term follow-up of nearly 18 000 patients in the Micra CED registry, almost one-third of whom received a LLPM, showed that LLPM had a 38% lower rate of reinterventions and 31% lower rate of chronic complications (VTE, pericarditis, hemothorax, device breakdown or infection) [37 ], likely from growing user experience and further operative maturation. Studies have also investigated outcomes in other population cohorts and reinforced the safety of these LLPMs in patients with LVADs [39] and those upgrading from transvenous pacemaker [40], although these are at single centers with higher than average operator comfort.…”

Left atrial strain is a good predictor of atrio‐ventricular synchrony in leadless pacemaker pacing

“…Leadless pacing may mitigate risks and preserve venous access. In a real‐world study, leadless pacemaker patients have shown lower mid‐and long‐term complications and re‐interventions rates compared with transvenous ventricular pacemaker patients also in high‐risk subgroups 3,4 . Recently leadless cardiac pacemakers (LCPMs) have evolved from a single chamber VVI‐R pacemaker to a second‐generation device that, in patient with sinus rhythm, can provide atrio‐ventricular synchrony (AVS) through a 3‐axis accelerometer, detecting atrial contractions.…”