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Sutureless aortic valve replacement: first-year single-center experience.
Annals of Thoracic Surgery 2012 August
BACKGROUND: Sutureless aortic bioprostheses bear the potential of easy implantation, reduced ischemic time, and surgical trauma in aortic valve replacement. We herein show our clinical and echocardiographic results after a 1-year experience with a new sutureless bioprosthesis.
METHODS: The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center.
RESULTS: The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a "J" sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10.±7.5%, mean aortic cross-clamp time was 43.8±20.8 minutes (36±12.7 minutes for isolated procedures). Mean implantation time was 8±3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5±4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0±0.6. Mean transprosthetic gradients were 13.4±2.8, 12.6±2.3, and 10.8±1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively.
CONCLUSIONS: The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.
METHODS: The Perceval S (Sorin Biomedica Cardio Srl, Saluggia, Italy) is a pericardial aortic prosthesis assembled within a super-elastic alloy frame. It is implanted intra-annularly, without the need of suture. As part of a premarketing multicenter study (Cavalier Trial), since March 2010, 83 patients were screened for implantation in our center.
RESULTS: The patients received a size S (4), M (38), or L (41) prosthesis, either as isolated (57) or combined procedures (26). Fifty-one patients (61.5%) received a "J" sternotomy. Mean logistic European system for cardiac operative risk evaluation was 10.±7.5%, mean aortic cross-clamp time was 43.8±20.8 minutes (36±12.7 minutes for isolated procedures). Mean implantation time was 8±3.8 minutes (range 4 to 28 minutes). In-hospital mortality was 2.4% (1 patient for multiorgan failure and 1 for liver insufficiency); mean hospital stay was 11.5±4.4 days (range 2 to 28 days). We recorded 5 pacemaker implantations (6%). At follow-up, we had 2 deaths (1 patient for congestive heart failure and 1 for gastrointestinal bleeding). At 1 year, mean New York Heart Association functional class was 1.0±0.6. Mean transprosthetic gradients were 13.4±2.8, 12.6±2.3, and 10.8±1.3 mm Hg postoperatively, at 6 months, and at 1 year, respectively.
CONCLUSIONS: The Perceval S shows satisfactory clinical and hemodynamic results. Due to its simple implantation technique, it represents an alternative especially for minimally invasive surgery. Operative trauma can be minimized by short aortic cross-clamp time.
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