BACKGROUND AND PURPOSE: Patients with aortic valve (AV) pathology and severe comorbidities should benefit from reduced myocardial ischemic and extracorporeal circulation (ECC) time. Sutureless implantation of AV prosthesis may reduce myocardial ischemic and ECC time significantly. The authors report on their preliminary results with the first implants of the 3F-Enable sutureless AV prosthesis. MATERIAL AND METHODS: The 3F-Enable prosthesis was implanted in five patients. Prostheses sizes were 27 mm (n = 3), 23 mm (n = 1), and 21 mm (n = 1), respectively. Intraoperatively, at patient's discharge as well as 3 and 6 months postoperatively, the AV prosthesis was evaluated by echocardiography. RESULTS: ECC time was 87 +/- 36 min (range 49-141 min), myocardial ischemic time 55 +/- 27 min (range 32-97 min), and AV implant time 184 +/- 195 s (range 10-420 s). The latest postoperative echo (5.2 +/- 1 months postoperatively) revealed a fully competent AV in three patients, in two patient paravalvular leakage was detected at the severity of an aortic regurgitation (AR) II degrees , and AR II degrees -III degrees , respectively. The mean pressure gradients were 5.8 +/- 1.3 mmHg (range 4.2-7.1 mmHg), valve orifice area was 3.2 +/- 0.4 cm2 (range 2.6-3.6 cm2). CONCLUSION: The first clinical results of the 3F-Enable sutureless AV prosthesis are feasible; however, a paravalvular leakage was detected in two patients (40%). Thus, device and procedural enhancements are required to assure positioning and anchoring of the prosthesis.
BACKGROUND AND PURPOSE:Patients with aortic valve (AV) pathology and severe comorbidities should benefit from reduced myocardial ischemic and extracorporeal circulation (ECC) time. Sutureless implantation of AV prosthesis may reduce myocardial ischemic and ECC time significantly. The authors report on their preliminary results with the first implants of the 3F-Enable sutureless AV prosthesis. MATERIAL AND METHODS: The 3F-Enable prosthesis was implanted in five patients. Prostheses sizes were 27 mm (n = 3), 23 mm (n = 1), and 21 mm (n = 1), respectively. Intraoperatively, at patient's discharge as well as 3 and 6 months postoperatively, the AV prosthesis was evaluated by echocardiography. RESULTS: ECC time was 87 +/- 36 min (range 49-141 min), myocardial ischemic time 55 +/- 27 min (range 32-97 min), and AV implant time 184 +/- 195 s (range 10-420 s). The latest postoperative echo (5.2 +/- 1 months postoperatively) revealed a fully competent AV in three patients, in two patient paravalvular leakage was detected at the severity of an aortic regurgitation (AR) II degrees , and AR II degrees -III degrees , respectively. The mean pressure gradients were 5.8 +/- 1.3 mmHg (range 4.2-7.1 mmHg), valve orifice area was 3.2 +/- 0.4 cm2 (range 2.6-3.6 cm2). CONCLUSION: The first clinical results of the 3F-Enable sutureless AV prosthesis are feasible; however, a paravalvular leakage was detected in two patients (40%). Thus, device and procedural enhancements are required to assure positioning and anchoring of the prosthesis.