Prevalence of moderate or severe tricuspid regurgitation following leadless pacemaker implantation: a systematic review and single-arm meta-analysis
R Motta, D Hora, K Chagas, L Barbosa, L Silva, W Furtado, A Rosa Filho, G CarvalhoAbstract
Background
Leadless Pacemaker (LP) implantation emerged as a growing alternative to transvenous pacemakers, eliminating lead and pocket-related complications. However, the presence of the device within the right ventricular cavity raised concerns about its impact on tricuspid valve (TV) function. Cohort studies reported variable rates of moderate or severe Tricuspid Regurgitation (TR) after implantation, necessitating a pooled estimate of this prevalence to better inform clinical practice.
Purpose
This systematic review and single-arm meta-analysis aimed to estimate the pooled prevalence of Moderate or Severe Tricuspid Regurgitation in patients undergoing Leadless Pacemaker implantation at follow-up.
Methods
A systematic search of PubMed, EMBASE, and Cochrane Library databases was conducted for cohort studies and registries that assessed the impact of Leadless Pacemaker implantation on tricuspid valve function. Studies reporting the number of patients with Moderate or Severe TR at the final follow-up and the total sample size were included. The results were expressed as pooled proportions with 95% Confidence Intervals (95% CI) using a random-effects model. All statistical analyses were performed using R.
Results
Our meta-analysis included eight observational studies involving 1,090 patients. The pooled prevalence of Moderate or Severe Tricuspid Regurgitation at follow-up was estimated at 30.11 [95% CI (23.95 - 37.08)] across five studies involving 186 patients, with low heterogeneity (I² = 1.9%). The pooled incidence of Major Complications was estimated at 3.29 [95% CI (0.27 - 29.78)] across three studies involving 945 patients, showing high heterogeneity (I² = 96.6%). For the functional outcome, the pooled mean Tricuspid Annular Plane Systolic Excursion (TAPSE) was 23.07 [95% CI (10.41 - 35.74)] across three studies involving 81 patients, with high heterogeneity (I² = 98.8%).
Conclusion
These results suggest that Leadless Pacemaker implantation is associated with a significant prevalence of Moderate or Severe Tricuspid Regurgitation at follow-up, affecting approximately one-third of patients. Conversely, the pooled incidence of Major Complications is estimated to be low. The high heterogeneity observed in the TAPSE and Major Complications analyses highlights the need for standardized protocols and suggests that patient selection and follow-up duration are critical factors influencing these outcomes.