Three-Year TAVI Outcomes Published for Medtronic's 18-F CoreValve System

January 12, 2012—Three-year outcomes of transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve ReValving system (Medtronic, Inc., Minneapolis, MN) were published by Gian Paolo Ussia, MD, et al for the CoreValve Italian registry investigators online ahead of print in the European Heart Journal.

The purpose of the study was to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third-generation 18-F CoreValve device in order to address the lack of evidence on the long-term durability of currently available TAVI devices.

The investigators concluded that this multicenter study demonstrates that TAVI with the 18-F CoreValve ReValving system is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis at up to 3-year follow-up and that noncardiac causes accounted for the majority of deaths at follow-up.

In this study, the investigators analyzed 181 patients from the Italian CoreValve registry who underwent TAVI from June 2007 to August 2008 and who were eligible for 3-year follow-up. All outcomes were defined according to the Valve Academic Research Consortium.

As detailed in the European Heart Journal, 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 rate at 3-year follow-up (49 vs 29.2%; P = .007); moreover, patients experiencing postprocedural major or life-threatening bleeding had a higher rate of mortality that was already seen at 30 days (21.6 vs 2.8%; P < .001), and this result was sustained at 3-year follow-up (62.2 vs 27.7%; P < .001).

The investigators also found that mean pressure gradients decreased from 52.2 ± 18.1 mm Hg (pre-TAVI) to 10.3 ± 3.1 mm Hg (1 year post-TAVI) (P < .001), and 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 during 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, reported the investigators in the European Heart Journal.