Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients

Study Questions:

What are the clinical outcomes associated with transcatheter aortic-valve implantation (TAVI) in real-world clinical experience?

Methods:

The authors reported the results of all patients in France undergoing TAVI between January 2010 and October 2011 who were prospectively enrolled in the French national TAVI registry (FRANCE 2).

Results:

TAVI was performed at 34 centers in 3,195 patients who were at high surgical risk for surgical aortic valve replacement. The average age of the cohort was 82 years and roughly half (49%) of the patients were female. The Edwards SAPIEN valve was used in 66.9% and the Medtronic CoreValve device was used in 33.1% of the patients. Most procedures were performed in a catheterization laboratory (74.7%), with 15.3% performed in a hybrid room and 10% in an operating room (10.0%). The procedure was performed using the transfemoral approach in 74.6%; subclavian approach in 5.8%, and a transapical approach in 17.8%. The procedural success rate was 96.9%. One-month mortality was 9.7%, and the death rate at 1 year was 24.0%. Mortality was significantly lower with the transfemoral approach than with the transapical approach (8.5% vs. 13.9% at 30 days and 17.2% vs. 22.4% at 6 months). The incidence of stroke was 3.4% at 30 days, 3.8% at 6 months, and 4.1% at 1 year, and the rates of major stroke were 1.9%, 2.1%, and 2.2%, respectively. A new, permanent pacemaker was required more frequently in patients receiving CoreValve devices than in those receiving the SAPIEN devices (24.2% vs. 11.5%). Major vascular complications occurred in 156 patients (4.7%). The independent predictors of mortality were a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical approach, and significant periprosthetic regurgitation.

Conclusions:

The authors concluded that this prospective registry study reflects real-life TAVI experience in high-risk elderly patients with aortic stenosis.

Perspective:

The results of this study demonstrate the outcomes associated with TAVI in real-world unselected patients. The outcomes in this registry mirror those seen in the clinical trials and establish TAVI as a viable therapy for elderly patients who are at high risk for surgery.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Incidence, Heart Valve Prosthesis, France, Cardiology, Catheterization, Heart Valve Prosthesis Implantation, Angioplasty, New York


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