Abstract
BACKGROUND: 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. AIMS: This study sought to investigate the impact of mild PVR after TAVI on five-year clinical outcomes. METHODS: 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. RESULTS: 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%; HR(adjusted) 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: HR(adjusted) 1.19, 95% CI: 0.99-1.43, mild-to-moderate PVR: HR(adjusted) 1.56, 95% CI: 1.20-2.02). The effect of mild PVR on five-year mortality was consistent across major subgroups. CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: https://www. CLINICALTRIALS: gov. NCT01368250.