Long-term evaluation of TTK Chitra™ heart valve prosthesis - a retrospective-prospective cohort study.

The TTK Chitra™ heart valve has more than 1,40,000 implantations so far, but no long-term data has been published. This study aims to provide long-term results of the valve. A cohort of 476 patients with implantations from January 2006 to December 2018 were followed up prospectively consisting of 104 aortic valve replacement (AVR), 87 double valve replacement (DVR), and 285 mitral valve replacement (MVR) patients. Total follow-up was 4079 patient-years (py) (AVR = 983, MVR = 2392, DVR = 704), being 96% complete. The results showed that actuarial survival at 15 years was 82.3% for AVR, 60.7% for MVR, and 52.2% for DVR. Freedom from all valve-related mortality and morbidity at 15 years was 73.8%, 64.8%, and 61.9% for AVR, MVR, and DVR, respectively. There was one instance of structural failure of valve disc leading to severe valvar regurgitation. Valve thrombosis incidence was 1 in AVR (0.1%/py), 6 in MVR (0.25%/py), and 1 in DVR (0.14%/py). Thrombo-embolic episodes occurred in 50 patients (AVR = 7 patients at 0.7%/py; MVR = 36 patients at 1.5%/py; DVR = 7 patients at 0.99%/py) and major hemorrhage (bleeding) in 24 patients (AVR = 0.61%/py; MVR = 0.5%/py; and DVR = 0.85%/py). The linearized rates of adverse events in this study were found to be lower than earlier published results. The results highlight the continued safety and performance of the TTK Chitra™ heart valve (TTKCHV) in the long term at 15 years. The online version contains supplementary material available at 10.1007/s12055-022-01437-9.

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© The Author(s) 2022.

Déclaration de conflit d'intérêts

Conflict of interestDr. G. S. Bhuvaneshwar reports receiving consultation fees from TTK Healthcare Limited on guidance provided for the company’s post-market clinical studies. The remaining authors have no conflicts of interest to declare.