Long-Term Impact of Mild Paravalvular Regurgitation After Transcatheter Aortic Valve Replacement: The OCEAN-TAVI...

The clinical significance of mild paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR) remains uncertain.

The aim of this study was to evaluate the impact of mild PVR on long-term clinical outcomes and bioprosthetic valve failure (BVF) following TAVR.

A total of 5,068 patients from the OCEAN-TAVI (Optimized Catheter Valvular Intervention-Transcatheter Aortic Valve Implantation; UMIN000020423) registry who underwent TAVR and had no or trace or mild PVR at discharge were analyzed. Patients were stratified according to PVR severity and followed for up to 9 years. The primary outcomes were all-cause mortality and BVF, defined according to Valve Academic Research Consortium 3 criteria.

Median follow-up duration was 4.7 years (Q1-Q3: 2.9-6.0 years). Mild PVR was observed in 1,601 patients (31.6%). At 9-year follow-up, Kaplan-Meier analysis demonstrated a significantly higher cumulative incidence of all-cause mortality (75.9% [95% CI: 71.3%-80.2%] vs 72.2% [95% CI: 68.1%-76.3%]; log-rank P = 0.014) and BVF (20.7% [95% CI: 12.8%-32.5%] vs 17.3% [95% CI: 11.0%-26.6%]; P = 0.029) in patients with mild PVR than in those with no or trace PVR. Fine-Gray analysis confirmed mild PVR as an independent predictor of BVF (subdistribution HR [sHR]: 1.48; 95% CI: 1.07-2.04; P = 0.018), and Cox regression showed a significant association with all-cause mortality (HR: 1.11; 95% CI: 1.02-1.21; P = 0.014). The risk for BVF was especially elevated in patients receiving balloon-expandable valves (sHR: 1.46; 95% CI: 1.02-2.08; P = 0.038), those undergoing nontransfemoral TAVR (sHR: 5.58; 95% CI: 1.57-19.9; P = 0.0086), and those with impaired renal function (estimated glomerular filtration rate < 30 mL/min/1.73 m²; sHR: 3.86; 95% CI: 1.30-11.5; P = 0.015). Baseline mild PVR was independently associated with an increased risk for progression to moderate or greater PVR (HR: 3.74; 95% CI: 2.84-4.92; P < 0.001).

Mild PVR after TAVR is associated with a significantly increased risk for BVF and all-cause mortality, highlighting the importance of optimizing valve deployment and monitoring patients with even mild PVR.