Transcatheter therapies in patients with mitral regurgitation or poor left ventricular function
Thirty-day outcomes after TAVI in patients with severe aortic stenosis and moderate or severe mitral regurgitation
Aims: Moderate and severe mitral regurgitation (MR) is associated with higher mortality in patients with CHF, but little is known about its impact on outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Isolated surgical aortic valve replacement usually has a positive impact on functional MR but the effect of TAVI is not well understood. We sought to assess the effect of MR on early clinical outcomes after transcatheter SAPIEN XT valve (Edwards Lifesciences LLC, Irvine, CA, USA) implantation, and the impact of TAVR on MR.
Methods and results: SOURCE XT is a multicentre, prospective, post-approval study which enrolled >2,600 consecutive patients at 94 sites in 17 countries. Total of 968 patients (36.8%) did not have any MR at baseline, 1,144 patients (43.5%) were with mild MR, 461 patients (17.5%) were with moderate MR, and 56 patients (2.1%) were with severe MR. Patients with moderate or severe MR were included in the MR Group (MR-Gr, n=517) and those with none or mild MR were included in the control group (C-Gr, n=2,112). Compared to the C-Gr, patients in the MR-Gr were more likely to be older (82.3±5.4 vs. 81.6±5.9, p=0.0148), female (63.1% vs. 56.5%, p=0.0073) with NYHA III/IV (81.4 vs. 75.9%, p=0.0073) and greater STS score (10±8.3 vs. 8.1±6.6, p<0.0001). MR-Gr patients had significantly higher incidence of CHF, atrial fibrillation or renal insufficiency. Mean gradient was similar for the two groups (47.5±17.0 vs. 47.3±20.1 mmHg, p=0.81); however, EF was significantly lower (50.1±12.0% vs. 53.0±11.2%, p<0.0001) and pulmonary pressure was significantly higher (50.5±16.0 mmHg vs. 43.3±14.1 mmHg, p<0.0001) in MR-Gr vs. C-Gr. There were no significant differences between MR-Gr and C-Gr in terms of overall mortality (7.2% vs. 5.9%, p=0.28), cardiac death (2.5% vs. 2.2%, p=0.64), stroke (1.2% vs. 2.6%, p=0.0627), major vascular complications (1.4% vs. 1.9%, p=0.41) or major bleeding events (7.4% vs. 7.8%, p=0.81). One month after TAVI, MR had improved by at least 1 degree in 30.4% of patients with any MR at baseline and in 44% of patients with moderate or severe MR.
Conclusions: Despite significant comorbidity, TAVI in patients with severe aortic stenosis and concomitant moderate or severe MR was not associated with an increased mortality. Furthermore, MR was improved in 44% of patients but longer follow-up is needed to understand the potential benefit of TAVI in this subset of patients.
