The 3f Enable sutureless bioprosthesis: Early results, safeguards, and pitfalls.

OBJECTIVE

The aim of the study was to evaluate the clinical and hemodynamic performance of the 3f Enable (Medtronic Inc, Minneapolis, Minn) sutureless bioprosthesis in the early postoperative period. Its implantation technique was also evaluated highlighting the modifications in regard to the original technique and mistakes made throughout the learning curve.

METHODS

This is a prospective, nonrandomized study. From February 2011 to March 2014, a total of 60 patients underwent aortic valve replacement with the 3f Enable valve at the Hospiten Rambla. All intraoperative and postoperative data were prospectively collected.

RESULTS

The mean age was 81.3 ± 3.78 years. Mean logistic European System for Cardiac Operative Risk Evaluation I was 13.78%. An associated concomitant procedure was performed in 23 patients (38.3%). The extracorporeal circulation and crossclamping times were 49.8 ± 15.7 minutes and 35.4 ± 8.9 minutes, respectively. The average stay in the intensive care unit was 34.7 hours. Mean systolic pressure gradients ranged from 8.01 mm Hg (size 19 valve) to 7.2 mm Hg (size 25 valve). Mean effective orifice area ranged from 1.9 cm(2) (size 19 valve) to 2.5 cm(2) (size 25 valve). Severe mismatch (<0.65 cm(2)/m(2)) did not occur in any patient. Only 1.66% of patients had more than mild aortic insufficiency at discharge. The early (30-day) mortality was 6.6% (n = 4).

CONCLUSIONS

The 3f Enable bioprosthesis is an important alternative to conventional prostheses, with reduction of surgery times and good hemodynamic results on discharge. It is especially useful for high-risk patients and octogenarians. Studies on a greater number of patients and long-term follow-ups are necessary.