2-Year Follow-Up of Patients Undergoing Transcatheter Aortic Valve Implantation Using a Self-Expanding Valve Prosthesis
What is the safety, device performance, and clinical outcome up to 2 years for patients undergoing transcatheter aortic valve implantation (TAVI)?
The investigators conducted a prospective, multicenter, single-arm study with symptomatic patients undergoing TAVI for treatment of severe aortic valve stenosis using the 18-F Medtronic CoreValve prosthesis. The major adverse cardiovascular and cerebrovascular events (MACCE) were defined as the composite of all-cause death, myocardial infarction, emergent cardiac surgery or percutaneous reintervention, and stroke. Survival and other time-to-event analyses at 2 years were performed by Kaplan-Meier analysis.
In all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but two cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. Thirty-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs. 45.8%, p = 0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient 8.5 ± 2.5 mm Hg at 30 days and 9.0 ± 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration.
The authors concluded that the TAVI procedure provides sustained clinical and hemodynamic benefits for as long as 2 years for patients with symptomatic severe aortic stenosis at increased risk for surgery.
This study provides reassurance on the durability of both the safety and the efficacy of TAVI using the self-expanding Medtronic CoreValve prosthesis for the treatment of patients with severe aortic valve stenosis. Two years after implantation, there was no evidence of structural valve deterioration or significant changes of the hemodynamic status of the prostheses. Taken together with the results of the PARTNER trial, the data suggest that TAVI may be a reasonable option in patients with symptomatic severe aortic stenosis at increased risk for surgery. Additional long-term randomized studies are needed to confirm durability of these devices according to surgical standards as well as assess the utility of TAVI in lower-risk patients.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention
Keywords: Heart Valve Prosthesis, Myocardial Infarction, Follow-Up Studies, Cardiac Surgical Procedures
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