INTERMEDIATE FOLLOW-UP OF THE TEKNA(TM) BILEAFLET VALVE

Background and aim of the study: The study aim was to collect intermed iate clinical data on the TEKNA(TM) bileaflet valve. Methods: This nin e-center clinical study involved 884 patients implanted between June 1 990 and October 1993. The population consisted of 522 (59.0%) males an d 362 (41.0%) females. Mean age at implant was 59.1 +/- 11.8 years (ra nge: 14.7 to 88.4 years). Indication for valve replacement was depende nt 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-year s (pt-yr). Results: Total operative (less than or equal to 30 days pos toperative) mortality rate was 3.7%; seven patients (0.8%) died due to valve-related causes. Total postoperative (>30 days postoperative) mo rtality rate was 2.5%/pt-yr and included a valve-related mortality rat e of 1.1%/pt-yr. The following valve-related complication rates (%/pt- yr) were reported for the long-term postoperative period: thromboembol ism 0.6; valve thrombosis 0.3; bleeding events 1.5; non-structural det erioration 0.6; and endocarditis 0.4. No structural valve deterioratio n 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%; e ndocarditis 98.5 +/- 0.5%; bleeding events 94.3 +/- 1.0%; and non-stru ctural deterioration 98.2 +/- 0.6%. Conclusion: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.