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Intermediate follow up of the TEKNA bileaflet valve
W Seybold-Epting1, R Limet, H Scheld
1West-Pfalz Klinikum, Kaiserslautern, Germany.
Insights
The TEKNA bileaflet valve demonstrated safety and efficacy in a large clinical study. Observed mortality was primarily non-valve-related, with low risks of thromboembolism and bleeding events.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Trials
Background:
- The TEKNA bileaflet valve is a prosthetic device used in cardiac surgery.
- Understanding its clinical performance is crucial for patient outcomes.
Purpose of the Study:
- To collect and analyze intermediate clinical data for the TEKNA bileaflet valve.
- To assess the safety and efficacy of the TEKNA bileaflet valve in a large patient cohort.
Main Methods:
- A nine-center clinical study involving 884 patients implanted between June 1990 and October 1993.
- Mean patient age was 59.1 years, with indications varying by valve position (stenosis for aortic, regurgitation for mitral).
- A mean follow-up of 2.7 years, totaling 2386.1 patient-years, was conducted.
Main Results:
- Total operative mortality was 3.7%, with 0.8% valve-related deaths.
- Long-term postoperative mortality was 2.5%/patient-year, including 1.1%/patient-year valve-related mortality.
- Key long-term valve-related complication rates per patient-year included thromboembolism (0.6%), valve thrombosis (0.3%), bleeding events (1.5%), non-structural deterioration (0.6%), and endocarditis (0.4%). No structural valve deterioration was reported.
Conclusions:
- Observed mortality is predominantly linked to non-valve-related conditions.
- The risk of thromboembolic events (0.9%/pt-yr) and bleeding events (1.5%/pt-yr) is low.
- The TEKNA bileaflet valve is concluded to be safe and efficacious for clinical use.
Background And Aim Of The Study:
The study aim was to collect intermediate clinical data on the TEKNA bileaflet valve.
Methods:
This nine-center clinical study involved 884 patients implanted between June 1990 and October 1993. The population consisted of 522 (59.0%) males and 362 (41.0%) females. Mean age at implant was 59.1 +/- 11.8 years (range: 14.7 to 88.4 years). Indication for valve replacement was dependent on the position: stenosis was the predominant reason in the aortic position; regurgitation was more pronounced for the mitral position. A total of 261 (29.5%) patients underwent concomitant procedures. Mean follow up is 2.7 +/- 1.2 years; total follow up is 2386.1 patient-years (pt-yr).
Results:
Total operative (< or = 30 days postoperative) mortality rate was 3.7%; seven patients (0.8%) died due to valve-related causes. Total postoperative (> 30 days postoperative) mortality rate was 2.5%/pt-yr and included a valve-related mortality rate of 1.1%/pt-yr. The following valve-related complication rates (%/pt-yr) were reported for the long-term postoperative period: thromboembolism 0.6; valve thrombosis 0.3; bleeding events 1.5; non-structural deterioration 0.6; and endocarditis 0.4. No structural valve deterioration was reported. Actuarial freedom at four years was: overall survival rate 86.9 +/- 1.4%; valve-related survival rate 94.7 +/- 1.0%; freedom from thromboembolism 96.8 +/- 0.9%; valve thrombosis 99.3 +/- 0.3%; endocarditis 98.5 +/- 0.5%; bleeding events 94.3 +/- 1.0%; and non-structural deterioration 98.2 +/- 0.6%.
Conclusions:
The data indicate that observed mortality is due mainly to non-valve-related disorders. Risk of thromboembolic and bleeding events was low (0.9%/pt-yr and 1.5%/pt-yr, respectively). We conclude that this valve is safe and efficacious for use.