Authors

• Dijana Bešić — University Hospital Dubrava, Zagreb, Croatia — ORCID: 0000-0001-9701-0253
• Mario Špoljarić — General Hospital “Dr. Josip Benčević” Slavonski Brod, Slavonski Brod, Croatia — ORCID: 0000-0001-5770-3012
• Marin Viđak — University Hospital Dubrava, Zagreb, Croatia — ORCID: 0000-0003-0341-9598
• Irzal Hadžibegović — University Hospital Dubrava, Zagreb, Croatia — ORCID: 0000-0002-3768-9134
• Marija Križanović — University of Zagreb, Zagreb, Croatia — ORCID: 0009-0006-6666-7694
• Šime Manola — University Hospital Dubrava, Zagreb, Croatia — ORCID: 0000-0001-6444-2674
• Ivana Jurin — University Hospital Dubrava, Zagreb, Croatia — ORCID: 0000-0002-2637-9691

Keywords

paravalvular leak, real-world data, transcatheter aortic valve implantation, outcomes

DOI

Full Text

**Introduction**: Paravalvular leak (PVL) has historically been recognized as the most frequent complication following transcatheter aortic valve implantation (TAVI), with significant impact on patient outcomes. However, recent studies suggest that moderate/severe PVL may not be independently associated with increased risk of major adverse cardiac and cerebrovascular events (MACCE), challenging earlier evidence that even mild PVL contributes to worse prognosis. (1, 2) Aim: To evaluate the impact of immediate post-procedural PVL on long-term clinical outcomes in a real-world cohort of patients undergoing TAVI. **Patients and Methods**: This retrospective, registry-based study included patients who underwent TAVI between September 2011 and July 2025 at a single tertiary center. Patients were stratified based on PVL severity: moderate/severe PVL versus no/trace-to-mild PVL. Clinical endpoints included all-cause mortality and the composite MACCE (stroke, myocardial infarction, new-onset atrial fibrillation or complete AV block, venous thromboembolism, major bleeding, and aortic root rupture). Logistic regression was used to evaluate associations, with a significance threshold of p < 0.05. **Results**: A total of 692 patients were included, with a median age of 80 years [IQR 76–83] and median follow-up duration of 381 days [IQR 178–812]. Moderate/severe PVL was present in 65 patients (9.4%). Its presence was marginally associated with increased all-cause mortality (p = 0.046), but not with the incidence of MACCE. **Conclusions**: In this real-world cohort, moderate/severe PVL following TAVI was associated with a slight increase in all-cause mortality, but not with composite adverse cardiovascular events. Despite these findings, minimizing PVL should remain a key technical objective during the TAVI procedure to optimize long-term outcomes.

Literature

1. Généreux P, Head SJ, Hahn R, Daneault B, Kodali S, Williams MR, et al. Paravalvular leak after transcatheter aortic valve replacement: the new Achilles’ heel? A comprehensive review of the literature. J Am Coll Cardiol. 2013 March 19;61(11):1125–36. https://doi.org/10.1016/j.jacc.2012.08.1039
2. Aurigemma C, Trani C, D’Errigo P, Barbanti M, Biancari F, Tarantini G, et al. OBSERVANT II Research Group. Long-Term Clinical Impact of Paravalvular Leak Following Transcatheter Aortic Valve Implantation. J Clin Med. 2025 January 18;14(2):605. https://doi.org/10.3390/jcm14020605