TricValve bicaval implantation in pacemaker patients with severe tricuspid regurgitation showed no higher risk of heart failure compared to non-pacemaker patients (HR 0.98; 95% CI 0.48-1.98; p=0.945).
Observational (n=204)
Yes
Does TricValve bicaval implantation have similar safety and efficacy in patients with severe tricuspid regurgitation who are pacemaker carriers compared to non-pacemaker patients?
TricValve bicaval implantation is safe and effective in patients with severe tricuspid regurgitation and pacemakers, with outcomes comparable to non-pacemaker patients.
Effect estimate: HR 0.98 (95% CI 0.48-1.98)
p-value: p=0.945
Abstract Introduction The evidence regarding the outcomes of TricValve device in patients with pacemakers and severe tricuspid regurgitation is limited. Purpose The aim of the present study is to evaluate the safety and efficacy of the TricValve bicaval implantation in patients with pacemakers. Methods Tricbicaval is an investigator-initiated multicenter study that retrospectively enrolled all consecutive patients with severe tricuspid regurgitation (TR) treated with the TricValve system. Results a total of 204 patients were included, of whom 70 (34.3%) were pacemaker carriers. The mean age of pacemaker patients was 77.6 years. Compared to non-pacemaker patients, pacemaker carriers had a higher prevalence of renal impairment (80.0% with an estimated glomerular filtration rate 60 ml/min vs. 66.4% in the non-carrier group; p=0.042) and coronary artery disease (31.4% vs. 14.2%; p=0.004). In 35.5% of cases, the etiology of TR was attributed to the pacemaker lead. The procedural success rate was similar between groups (97.1% in pacemaker patients vs. 95.5% in non-pacemaker patients). Pacemaker lead-related complications following the implantation were rare. Only one case (1.4%) of ventricular lead damage was reported, which required the implantation of a second lead without further complications. At one-year follow-up, similar to non-pacemaker patients, pacemaker carriers showed significant improvements in NYHA functional class (76.8% in baseline class III-IV vs. 20% at 12 months; p=0.001) and a marked reduction in signs of right heart failure (68.6% with baseline peripheral edema vs. 26.9% at 12 months). Pacemaker patients did not have a higher risk of heart failure (HR 0.98; 95% CI 0.48–1.98; p=0.945; figure 1) or all-cause mortality (HR 1.62; 95% CI 0.87–3.02; p=0.129) compared to non-pacemaker patients. Conclusions TricValve bicaval implantation in pacemaker patients is safe, with a low risk of lead damage and procedural success rates comparable to those of non-pacemaker patients.
Rodriguez et al. (2025) conducted an observational in Severe tricuspid regurgitation (n=204). TricValve bicaval implantation vs. Non-pacemaker patients was evaluated on Heart failure (HR 0.98, 95% CI 0.48-1.98, p=0.945). TricValve bicaval implantation in pacemaker patients with severe tricuspid regurgitation showed no higher risk of heart failure compared to non-pacemaker patients (HR 0.98; 95% CI 0.48-1.98; p=0.945).