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OBJECTIVE: Important comorbid conditions in intermediate-risk patients referred for aortic valve replacement (AVR) require less invasive strategies. We describe our initial experience with Perceval S (Sorin Group, Saluggia, Italy) (“P”) and 3f Enable (ATS Medical, Minneapolis, MN) (“E”) sutureless aortic bioprostheses.
METHODS: Patients undergoing sutureless AVR in 2 cardiac surgery departments between March 2009 and August 2011 were enrolled. We compared intraoperative data, postoperative clinical outcomes, and echocardiographic results from patients receiving a “P” (n=94) or “E” (N=32) prosthesis, respectively.
RESULTS: Baseline patient characteristics were similar in both groups, “P” and “E”. Mean logistic EuroSCORE was 11.2% ± 8.5%. From 126 patients, 78 underwent minimally invasive AVR with either an upper partial ministernotomy (n=66) or right anterior minithoracotomy (n=12) approach. Concomitant procedures were performed in 27 (28.7% of “P”) and 9 (28.1% of “E”) patients (p=0.56). In-hospital mortality was 2.4% (“P”: n=2, “E”: n=1). Mean prosthesis diameter was 23.5 ± 1.4 mm (“P”) compared to 22.1 ± 2 mm (“E”) (p= <0.001). Aortic cross-clamp (ACC) time was 70.5 ± 20.5 minutes in “P” and 76.4 ± 16.7 minutes in “E” (p=0.58). At a mean follow-up of 8.3 ± 4.5 months, survival was 96.8% (one death after 11 months in “P”), and freedom from reoperation was 99.2% (one reoperation in “E”). In 5 patients (“P”: n=1, “E”: n=4), a moderate paravalvular leak was present (p=0.013). Mean transvalvular gradient was 13.9 ± 4.1 mmHg with Perceval S and 11.2 ± 5.2 mmHg with 3f-Enable (p=0.012).
CONCLUSIONS: AVR with sutureless aortic bioprosthesis in intermediate-risk patients is safe and feasible, also with a minimally invasive approach. It is associated with good outcomes and a low mortality rate. The implants perform hemodynamically excellent. The 3f-Enable shows lower mean transvalvular gradients but a higher rate of paravalvular leaks. This new technology needs long-term follow-up.