Key result
Mild-or-greater PVL without PPI was associated with higher 3-year all-cause mortality than new-onset PPI without PVL (21.9% vs. 12.9%, P=0.02) and independently predicted HF hospitalization (HR 1.38).
Why the study?
Procedural strategies during TAVI often create a trade-off between reducing paravalvular leak (PVL) and avoiding conduction disturbances requiring permanent pacemaker implantation (PPI), yet the relative prognostic impact of PVL versus PPI after TAVI remained unclear.
Does mild-or-greater paravalvular leak versus new-onset permanent pacemaker implantation have a worse impact on three-year all-cause mortality and heart failure hospitalization in patients with LVEF ≥40% undergoing TAVI?
Cohort (n=2,673)
Yes
Does mild-or-greater paravalvular leak versus new-onset permanent pacemaker implantation have a worse impact on three-year all-cause mortality and heart failure hospitalization in patients with LVEF ≥40% undergoing TAVI?
In TAVI patients with LVEF ≥40%, mild-or-greater paravalvular leak carries a worse prognostic impact—particularly as an independent predictor of heart failure hospitalization—than new-onset permanent pacemaker implantation, suggesting PVL reduction should be prioritized when a procedural trade-off is unavoidable.
Background Paravalvular leak (PVL) and permanent pacemaker implantation (PPI) remain clinically important complications after transcatheter aortic valve implantation (TAVI). Procedural strategies aimed at reducing PVL, including valve oversizing and post-dilatation, may increase the risk of conduction disturbances and PPI. Conversely, strategies intended to minimize conduction disturbances and avoid PPI, such as selecting a smaller valve size and avoiding post-dilatation, may increase the risk of residual PVL. However, the relative prognostic impact of PVL versus PPI after TAVI remains unclear. Purpose The purpose of the present study was to compare the prognostic impact of mild-or-greater PVL and new-onset PPI after TAVI in a multicenter registry. Methods We analyzed data from a prospective, multicenter registry in Japan that enrolled 3,129 consecutive patients undergoing TAVI at seven centers between April 2010 and June 2022. After excluding patients with prior PPI, missing post-procedural PVL data, preprocedural left ventricular ejection fraction (LVEF) <40%, a history of surgical or transcatheter aortic valve replacement, or unsuccessful transcatheter valve implantation, 2,673 patients were included in the present analysis. PVL(+) was defined as mild or greater PVL on post-procedural transthoracic echocardiography, and PPI(+) as new-onset PPI during the index hospitalization. Patients were categorized into four groups: PVL(–)/PPI(–) (n=1,864), PVL(+)/PPI(–) (n=614), PVL(–)/PPI(+) (n=135), and PVL(+)/PPI(+) (n=60). The primary endpoint was three-year all-cause mortality and the secondary endpoint was three-year heart failure hospitalization (HFH). Results For all-cause mortality, Kaplan–Meier analysis across the four groups showed the highest mortality in the PVL(+)/PPI(+) group, and PVL(+)/PPI(–) patients had significantly higher three-year all-cause mortality than PVL(–)/PPI(+) patients (21.9% vs. 12.9%, P=0.02) (Figure 1A). However, in multivariable analysis, neither PVL(+) nor PPI(+) was an independent prognostic factor for all-cause mortality. In a subgroup analysis restricted to PVL(+)/PPI(–) and PVL(–)/PPI(+) patients, PVL(+) showed a consistent trend toward worse all-cause mortality than PPI(+) across most subgroups (Figure 2). For HFH, Kaplan–Meier analysis demonstrated that HFH rates were comparable between PVL(+)/PPI(–) and PVL(–)/PPI(+) patients (10.1% vs. 10.6%, P=0.95) (Figure 1B). However, in multivariable analysis, PVL(+) was an independent predictor of HFH (HR 1.38, P=0.03), whereas PPI(+) was not (HR 1.52, P=0.07). Conclusion In patients undergoing TAVI with LVEF ≥40%, mild-or-greater PVL was associated with a stronger adverse prognostic factor than new-onset PPI. When a trade-off between PVL reduction and conduction safety is unavoidable, prioritizing PVL reduction may be reasonable, while individualized decision-making remains essential.
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Kirii et al. (2026) conducted a cohort in Aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) (n=2,673). Mild-or-greater paravalvular leak without permanent pacemaker implantation (PVL+/PPI–) vs. New-onset permanent pacemaker implantation without paravalvular leak (PVL–/PPI+) was evaluated on Three-year all-cause mortality (p=0.02). Mild-or-greater PVL without PPI was associated with higher 3-year all-cause mortality than new-onset PPI without PVL (21.9% vs. 12.9%, P=0.02) and independently predicted HF hospitalization (HR 1.38).
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