Aims: The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA).
Methods and results: From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6%, 30.3%, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2%, 12.1%, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0% vs. 29.2%, p=0.007); Moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6% vs. 2.8%; p<0.001) and this result was sustained at 3-year follow-up (62.2% vs. 27.7%; p<0.001). Mean pressure gradients decreased from 52.2±18.1 mmHg (pre-TAVI) to 10.3±3.1 mmHg (1 year post-TAVI) (p <0.001); Aortic Valve Area increased from 0.6±0.2 cm2 (pre-TAVI) to 1.8±0.4 cm2 (1 year post-TAVI); these results remained stable over the 3 years of follow up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed.
Conclusions: This multicenter study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow up.