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Published on: May 26, 2023
Long-term evaluation of TTK Chitra™ heart valve prosthesis - a retrospective-prospective cohort study
Praveen Kerala Varma1, Maniyal Vijayakumar2, Gopichettipalayam Subbaratnam Bhuvaneshwar3
1Department of Cardiovascular and Thoracic Surgery, Amrita Institute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham (Amrita University), Kochi, India.
Insights
Long-term follow-up of the TTK Chitra™ heart valve shows good survival rates and low adverse event incidence. This study confirms the continued safety and performance of the TTKCHV at 15 years.
Area of Science:
- Cardiology
- Biomedical Engineering
- Surgical Innovation
Background:
- The TTK Chitra™ heart valve (TTKCHV) has a significant implantation history (>140,000).
- Limited long-term clinical data has been published for the TTKCHV.
- This study addresses the need for comprehensive long-term outcome data.
Purpose of the Study:
- To evaluate the long-term safety and performance of the TTK Chitra™ heart valve.
- To report actuarial survival and freedom from valve-related morbidity and mortality.
- To assess the incidence of adverse events such as structural failure, thrombosis, thromboembolism, and hemorrhage.
Main Methods:
- Prospective follow-up of 476 patients who received TTKCHV implants between January 2006 and December 2018.
- Cohort included patients undergoing aortic valve replacement (AVR), double valve replacement (DVR), and mitral valve replacement (MVR).
- Total follow-up duration of 4079 patient-years with 96% completeness.
Main Results:
- 15-year actuarial survival rates: 82.3% (AVR), 60.7% (MVR), 52.2% (DVR).
- 15-year freedom from valve-related mortality/morbidity: 73.8% (AVR), 64.8% (MVR), 61.9% (DVR).
- Low linearized rates of adverse events, including one structural failure, low valve thrombosis, and manageable rates of thromboembolism and major hemorrhage, lower than previously reported.
Conclusions:
- The TTK Chitra™ heart valve demonstrates continued safety and effective performance over a 15-year period.
- The study provides robust long-term data supporting the TTKCHV's clinical utility.
- Findings suggest favorable outcomes compared to earlier published data.
Purpose:
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.
Methodology:
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.
Results:
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.
Conclusion:
The results highlight the continued safety and performance of the TTK Chitra™ heart valve (TTKCHV) in the long term at 15 years.
Supplementary Information:
The online version contains supplementary material available at 10.1007/s12055-022-01437-9.
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