Abstract

Mild paravalvular regurgitation (PVR) remains a frequent and underappreciated adverse event after transcatheter aortic valve implantation (TAVI) despite remarkable progress in device technology and implantation technique. This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes. In a prospective TAVI registry, PVR prior to discharge was retrospectively assessed in an echocardiographic core laboratory. Patients with ≥moderate PVR were excluded. Mild PVR was categorised into mild and mild-to-moderate PVR using a recently proposed unifying 5-class grading scheme. A total of 1,128 patients undergoing TAVI between 2007 and 2015 were enrolled. Of these, 560 patients had mild PVR, including 433 with mild (5-class) PVR and 127 with mild-to-moderate PVR. Patients with mild PVR were older (83 years vs 82 years, p=0.013) and had a higher surgical risk compared to patients with none/trace PVR (STS-PROM: 6.49±4.68 vs 5.41±3.48, p<0.001). At five years, patients with mild PVR had a higher risk of mortality than those with none/trace PVR (54.6% vs 43.8%; HRadjusted 1.26, 95% CI: 1.06-1.50). When applying the 5-class grading scheme, only mild-to-moderate PVR was associated with an increased risk of mortality at five years (mild PVR: HRadjusted 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HRadjusted 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups. Mild PVR was associated with an increased risk of mortality at five years after TAVI. The detrimental effect was primarily driven by mild-to-moderate PVR using the 5-class grading scheme. https://www. gov. NCT01368250.

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