One-year interim follow-up results of the TRAVERCE trial: the initial feasibility study for trans-apical aortic-valve implantation.

OBJECTIVES

To evaluate the interim results of the initial multicenter feasibility trial for trans-apical aortic-valve implantation (TA-AVI) in high-risk elderly patients with severe aortic stenosis.

METHODS

A total of 168 patients were prospectively included in three European centers between February 2006 and April 2008. The Cribier-Edwards or Edwards SAPIEN™ Trans-catheter Heart Valve (23 mm and 26 mm) was implanted using an oversizing concept. Interventions were performed in a hybrid operative room (OR) (one center), with a mobile C-arm in the OR (one) and in the catheterization laboratory (one). Inclusion criteria included age ≥70 years and an increased risk profile (additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) ≥9).

RESULTS

Patient age was 82.1±5.6 years, 76% were female and the EuroSCORE was 11.3±1.8 (additive) and 27±12.7% (logistic). Cardiopulmonary bypass was used by intention in 14.2% during the initial phase, secondarily in 10.1% and 75% of the patients were treated off-pump. Valve implantation led to a good immediate result in 161 (95.8%) patients and problems were encountered in seven patients (malposition (two patients), migration (three patients) and severe incompetence (two patients)). Nine patients were converted to conventional surgery, early stroke occurred in two (1.2%) patients and 10 (6%) patients received a new pacemaker. At 30 days, 25 patients died, 48% of them due to cardiac-related causes. Overall survival at 30 days, 6 months and 1 year was 85%, 70% and 63%, respectively.

CONCLUSIONS

The initial multicenter feasibility trial for TA-AVI (TRAVERCE) shows acceptable results of this promising technique, especially in view of the high-risk profile of the patients.