Key result
Transcatheter pacing systems are linked to ~61% fewer overall complications versus conventional transvenous pacemakers.
Why the study?
There were no prospective clinical trials comparing conventional transvenous single-chamber pacemakers (VVI-PM) with transcatheter pacing systems (TPS).
Do transcatheter pacing systems reduce complications compared to conventional transvenous pacemakers in patients requiring single-chamber pacing?
Observational (n=443)
No
Do transcatheter pacing systems reduce complications compared to conventional transvenous pacemakers in patients requiring single-chamber pacing?
Hazard Ratio: 0.39 (95% CI 0.15–0.98)
p-value: p=0.013
In a real-world cohort, transcatheter pacing systems were associated with fewer overall complications compared to conventional transvenous single-chamber pacemakers, supporting their safety profile in clinical practice.
TPS associated with fewer overall complications than VVI-PM; leaves open whether leadless systems reduce major events or mortality.
PURPOSE: Despite the developments in conventional transvenous pacemakers (VVI-PM), the procedure is still associated with significant complications. Although there are no prospective clinical trials that compared VVI-PM with transcatheter pacemaker systems (TPS). METHODS: This is a prospective, observational, single-center study that included all patients with an indication for a single-chamber pacemaker implant within a 4-year period. All clinical, ECG and echocardiographic characteristics at implant, electrical parameters, associated complications and mortality were analyzed. A Cox survival model and a Bayesian cohort analysis were performed for differences in complication rates between groups. RESULTS: There were 443 patients included (198 TPS and 245 VVI-PM). The mean age was 81.5 years (TPS group, 79.2 ± 6.6 years; VVI-PM group, 83.5 ± 8.9 years). There was a male predominance in TPS group (123, 62.1% vs. 67, 27.3%; p < 0.001). The presence of systolic dysfunction and renal insufficiency were more frequent in VVI-PM group than in TPS patients. Mean follow-up was 22.3 ± 15.9 months. In a multivariable paired data the TPS group presented fewer complications than VVI-PM group (HR = 0.39 [0.15-0.98], p-value 0.013), but major complications were not different (6, 3% vs 14, 5.6% respectively, p = 0.1761). There was no difference in the mortality rate between the groups. The TPS group had less risk than VVI-PM group to have a complication, with a 96% of probability. CONCLUSIONS: TPS patients had a lower overall complication rate than VVI-PM patients including matched-pair samples using a Bayesian analysis. These results confirm the safety profile of TPS in clinical practice.
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Martínez‐Sande et al. (2021) conducted an observational in Indication for a single-chamber pacemaker implant (n=443). Transcatheter pacing systems (TPS) vs. Conventional transvenous pacemakers (VVI-PM) was evaluated on Overall complications (HR 0.39, 95% CI 0.15-0.98, p=0.013). Transcatheter pacing systems were associated with a significantly lower overall complication rate compared to conventional transvenous pacemakers (HR 0.39; 95% CI 0.15-0.98; p=0.013).