Transcatheter therapies in patients with mitral regurgitation or poor left ventricular function
Transcatheter aortic valve replacement for severe aortic stenosis in elderly patients with severely depressed left ventricular function
Aims: A low ejection fraction is a predictor of morbidity and mortality after surgical aortic valve replacement but little is known about its effect on clinical outcomes after TAVI. We sought to assess early risks and benefits of TAVI with SAPIENT XT (Edwards Lifesciences LLC, Irvine, CA, USA) in elderly patients with aortic stenosis and severely depressed EF.
Methods and results: SOURCE XT is a multicentre, prospective, post-approval study which enrolled >2,600 consecutive patients at 94 sites in 17 countries. A total of 157 patients, 81.3±5.4-years-old, were with severely depressed EF≤30% (EF≤30), and 2,142 patients, 81.7±5.8-yrs-old, with EF>30% (EF>30) served as controls. Compared to patients with EF>30, patients with EF≤30 were more likely to be male (68.8% vs. 42.9%, p<0.0001) with NYHA III/IV (90.4 vs. 77.0%, p<0.0001) and greater STS score (9.5±6.1 vs. 8.4±7.0, p=0.042). Patients with EF≤30 had significantly higher incidence of CHF, previous MI or insulin-dependent diabetes. Effective orifice area was similar for the two groups (0.7±0.2 vs. 0.7±0.2 cm², p=0.41); however, mean gradient was significantly lower (34.1±12.4 mmHg vs. 47.5±16.3 mmHg, p<0.0001) and pulmonary pressure was significantly higher (51.2±13.1 mmHg vs. 44.7±14.9 mmHg, p<0.0001) in EF≤30 vs. EF>30. At 30-day follow-up, overall mortality (10.2% vs. 6.1%, p=0.044), cardiac death (5.3% vs. 2.1%, p=0.017) and stroke (4.6% vs. 2.0%, p=0.036) were significantly higher in EF≤30 as compared to EF>30. There were no significant differences between EF≤30 and EF>30 in terms of MI (1.3% vs. 0.6%, p=0.27), major vascular complications (1.9% vs. 1.7%, p=0.79), major bleeding events (9.0% vs. 7.3%, p=0.42) or new onset atrial fibrillation (6.7% vs. 5.1%, p=0.42). NYHA Class improved significantly at 30 days with majority of patients being in NYHA I/II (92.7% for EF≤30 and 89.6% for EF>30, p=0.36).
Conclusions: Severely depressed EF in patients with aortic stenosis undergoing TAVI was associated with significant comorbidity at baseline and increased mortality and stroke at 30 days; however, periprocedural complications were similar to patients with EF>30% and functional improvement was significant. A careful consideration of all risk factors is necessary to optimise outcomes after TAVI in low-EF patients.
