Paravalvular leak (PVL) was first noted as a frequent adverse event after transcatheter aortic valve implantation (TAVI) and has often been connected to poorer patient prognosis, such as higher death rates. This investigation aimed to examine the extended clinical consequences of PVL in individuals receiving the most recent models of transcatheter aortic valves, drawing on the national, prospective, multicenter OBSERVANT II registry. The OBSERVANT II registry prospectively collected data on every successive patient with severe aortic stenosis treated by TAVI at 28 Italian institutions between December 2016 and September 2018. In total, 2125 patients formed the basis of this evaluation. They were categorized by the presence of moderate-to-severe PVL (significant PVL, n = 155) versus absent or trace-to-mild PVL (no significant PVL, n = 1970). The main outcome measure was 5-year major adverse cardiac and cerebrovascular events (MACCE), which combined all-cause mortality, stroke, myocardial infarction, and coronary revascularization procedures. Additional endpoints consisted of 5-year overall mortality and readmission due to heart failure (HF). Within the studied population, moderate-to-severe PVL occurred in 7% of cases. Key factors associated with PVL development included advancing age, greater aortic annulus perimeter, and the use of self-expandable valves. After five years, the likelihood of experiencing MACCE, overall death, or heart failure readmission showed no meaningful variation across the two groups [HR = 1.07 (95% CI: 0.85–1.34) P = 0.571; HR = 1.10 (95% CI: 0.87–1.39) P = 0.435; HR = 1.20 (95% CI: 0.88–1.62) P = 0.245, respectively]. According to this OBSERVANT II registry evaluation, the presence of moderate or severe PVL did not correlate with elevated rates of MACCE or heart failure re-hospitalization over the 5-year observation period.
