Key result
The 3F stentless aortic bioprosthesis demonstrated favorable early hemodynamics with a mean systolic gradient of 13.3 mm Hg at 12 months, though trivial regurgitation occurred in 6 patients and one device-related fatal stroke was observed.
Why the study?
Does the 3F Therapeutics stentless aortic bioprosthesis provide safe and effective hemodynamic performance in patients undergoing aortic valve replacement?
Observational (n=24)
No
Does the 3F Therapeutics stentless aortic bioprosthesis provide safe and effective hemodynamic performance in patients undergoing aortic valve replacement?
The 3F Therapeutics stentless aortic bioprosthesis demonstrates favorable early hemodynamic performance and simplified implantation in patients undergoing aortic valve replacement.
Early hemodynamics with the 3F bioprosthesis appear acceptable; leaves open long-term safety and durability in randomized cohorts.
BACKGROUND: This study details a single-center experience with the 3F Therapeutics stentless aortic bioprosthesis(investigational device) and is part of a prospective,nonrandomized worldwide multicenter study. We assessed the implantation procedure and the valve's efficacy in terms of early mortality and morbidity and early echocardiographic valve performance. METHODS: Between June 2001 and March 2004, 24 patients (14 men/10 women) underwent aortic valve replacement(AVR) with a 3F valve. Mean age was 72 +/- 13 years(range, 31-88 years). Combined revascularization was performed in 12 patients; 1 patient received biatrial ablation therapy, 1 patient a myectomy, and 3 patients combined carotid endarterectomy. Echocardiographic systolic gradient and valve performance were investigated intra- and postoperatively by Doppler echocardiography. RESULTS: There were 2 perioperative deaths, 1 non-valve related, due to aortic rupture in an 83-year-old woman, and 1 fatal cerebral embolism in a 77-year-old woman 5 days postoperatively. Cardiopulmonary bypass time was 102 +/- 32 minutes,aortic cross-clamp time was 79 +/- 24 minutes. Sizes for implanted 3F valves were 5 x 23 mm, 6 x 25 mm, 7 x 27 mm,and 6 x 29 mm. Follow-up systolic gradient results were 11.5 +/- 4.7 mm Hg at 30 days (n = 21), 11.4 +/- 4.5 mm Hg at 6 months (n = 18), and 13.3 +/- 4.4 mm Hg at 12 months (n =13). During the follow-up period trivial central aortic valve regurgitation was found in 6 patients. CONCLUSION: The 3F aortic valve shows favorable preliminary hemodynamic results. Owing to the new valve design,implantation technique is simplified compared with other stentless valves. Anticoagulation treatment is mandatory for the first 3 months postoperatively. Long-term observation is necessary to assess life span and durability.
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Eckstein et al. (2004) conducted an observational in Aortic valve disease requiring replacement (n=24). 3F Therapeutics stentless aortic bioprosthesis was evaluated on Echocardiographic systolic gradient at 12 months. The 3F stentless aortic bioprosthesis demonstrated favorable early hemodynamics with a mean systolic gradient of 13.3 mm Hg at 12 months, though trivial regurgitation occurred in 6 patients and one device-related fatal stroke was observed.
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