Transcatheter tricuspid valve interventions in patients with cardiac implantable electronic devices: a systematic review and meta-analysis

Background Severe tricuspid regurgitation (TR) is associated with significant morbidity and mortality. Transcatheter tricuspid valve interventions (TTVI) are commonly employed in severe tricuspid valvulopathy in patients with high surgical risk. Up to a third of patients undergoing TTVI will also have a cardiac implantable electronic device (CIED), which may increase the risk of both developing TR and the complications of TTVI. However, there have been no meta-analyses conducted assessing the influence of CIEDs on TTVI outcomes. Purpose To compare the clinical safety and efficacy of TTVI in patients with CIED versus without CIEDs. Methods PubMed, Cochrane CENTRAL, and Embase were systematically searched for randomised and non-randomised studies on the topic. Studies reporting data on TTVI outcomes stratified by CIED status were included. A systematic review and meta-analysis was conducted, using the Mantel-Haenszel method and a random-effects model, reporting risk ratios (RR) and 95% confidence intervals (CI) for all dichotomous outcomes. The primary outcome was in-hospital procedural mortality. Results 10 studies (n=6,664) were included in the systematic review, with data from 7 studies (n=5,427) included in the meta-analysis, with a focus on in-hospital and 30 day follow-up data. 3 studies were not included in the meta-analysis due to a lack of compatible data. Procedural mortality was not significantly different (RR 1.17; 95% CI 0.48-2.86). Residual TR moderate or worse (RR 1.12; 95% CI 0.97-1.30), successful device implantation (RR 1.00; 95% CI 0.95-1.06), major bleeding (RR 0.81; 95% CI 0.51-1.29), re-intervention (RR 1.20; 95% CI 0.67-2.13), stroke (RR 0.76; 95% CI 0.16-3.61), heart failure hospitalization (RR 1.03; 95% CI 0.71-1.48), patients ≤NYHA Class 2 (RR 1.00; 95% CI 0.91-1.09), and 1-year all-cause mortality (RR 1.23; 95% CI 0.86-1.74) were not significantly different. Residual TR severe or worse was more frequent in the CIED group (RR 1.38; 95% CI 1.03-1.84). Conclusion CIED status is not associated with a significantly higher early or late mortality, reduced procedural success, or major adverse events after TTVI. The increased risk of severe or worse residual TR suggests possible decreased efficacy of TR attenuation in patients with CIED.Successful Dev. Implant. and Severe+ TR at FUFor image description, please refer to the figure legend and surrounding text.Proc. Mortality and Maj.