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.
Abstract

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