Early clinical experience with a new tubular equine pericardial stentless aortic valve.
Abstract: 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. Conclusions: 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.
Publication Date: 2005-04-01 PubMed ID: 15799933DOI: 10.1532/HSF98.20041087Google Scholar: Lookup
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- Clinical Trial
- Journal Article
- Multicenter Study
Summary
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This research study examines the early clinical experiences with a new type of stentless aortic valve, known as the 3F Therapeutics bioprosthesis, in patients undergoing aortic valve replacement surgeries.
Study Design
- The research was carried out in a single center, but the results contribute to an ongoing, larger, non-randomized worldwide multicenter study examining the efficacy and procedure of implanting the 3F Therapeutics bioprosthesis.
- Between June 2001 and March 2004, the study followed 24 patients (with 14 men and 10 women) who underwent aortic valve replacement with the 3F valve.
- The ages of the patients ranged from 31 to 88 years with an average age of 72 years.
- Various other procedures were carried out in conjunction with the aortic valve replacement, including revascularization in 12 patients, biatrial ablation therapy, myectomy and combined carotid endarterectomy.
Data Collection and Analysis
- Echocardiographic systolic gradient and valve performance were observed both during and after the operation using Doppler echocardiography to assess the efficacy of the implantation procedure.
- There were two perioperative deaths noted in the study, one due to aortic rupture unrelated to the valve, and another due to a cerebral embolism.
Results and Conclusions
- The research found that the 3F aortic valve showed encouraging preliminary hemodynamic results, with systolic gradients maintained fairly consistent at 30 days, 6 months, and 12 months post-operation.
- The implantation technique for the 3F Valve was found to be simpler than with other stentless valves, due to the new design of the valve.
- During the follow-up period, trivial central aortic valve regurgitation was found in 6 patients – this suggests that leakage may occur in some patients.
- Anticoagulation treatment was found to be necessary for the first three months after the operation, but the long-term requirement of this treatment is still under observation.
- Though the results showed promise, the researchers concluded that a long-term observation is necessary to properly assess the lifespan and durability of the 3F valve.
Cite This Article
APA
Eckstein FS, Tevaearai H, Keller D, Schmidli J, Immer FF, Seiler C, Saner H, Carrel TP.
(2005).
Early clinical experience with a new tubular equine pericardial stentless aortic valve.
Heart Surg Forum, 7(5), E498-E502.
https://doi.org/10.1532/HSF98.20041087 Publication
Researcher Affiliations
- Departments of Cardiovascular Surgery and Cardiology, University Hospital Berne, Berne, Switzerland. friedrich.eckstein@insel.ch
MeSH Terms
- Aortic Valve / surgery
- Aortic Valve Stenosis / surgery
- Bioprosthesis
- Heart Valve Prosthesis
- Humans
- Internationality
- Pilot Projects
- Stents
- Treatment Outcome
Citations
This article has been cited 1 times.- Weber M, Heta E, Moreira R, Gesche VN, Schermer T, Frese J, Jockenhoevel S, Mela P. Tissue-engineered fibrin-based heart valve with a tubular leaflet design. Tissue Eng Part C Methods 2014 Apr;20(4):265-75.
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