Summary of the clinical performance and safety

The results and analyses of the data obtained through clinical evaluation and post-market clinical follow-up , clearly leads to the conclusions that the clinical efficacy of the valve in terms of survival and improvement in quality of life is comparable to those obtained with any other well-known valve in clinical use today. The device continues to be safe and perform as per current clinical expectations and norms.

Clinical data from Clinical Investigation:

Clinical Investigation of TTK Chitra Heart Valve (TTKCHV) was carried out in India during 1990-95 as per ANSI/AAMI CVP3-1981 American National standard for Cardiac Valve Prosthesis, which was the relevant and available standard at the time of development.

Results are available in the below-listed publications:

• a) Bhuvaneshwar. GS, Muraleedharan CV, Arthur Viyayan Lal G, Sankarkumar R & Valiathan MS, " Development of the Chitra Tilting Disc Heart Valve Prosthesis”, J Heart Valve Disease, 5:4, 1996.
• b) Sankarkumar R, Bhuvaneshwar GS et al. “Chitra Heart Valve: Results of a multi-centric clinical study”, J Heart Valve Disease, 10:5, 2001.

The results of clinical investigation studies clearly indicated that the performance of TTKCHV is comparable to any other tilting disc valve in current clinical use. The systemic embolism rates are comparable to published values for tilting disc and bileaflet valves, the incidence of bleeding was lower. The absence of any report of paravalvular leak or discomfort due to valve sounds were notable features of the TTK Chitra Valve. The closing sounds are soft and dull due to the use of UHMWPE disc.

Clinical data from Post Market Clinical follow up

The success of a prosthetic valve is measured in terms of its hemodynamic performance, long-term durability without increased risk of thromboembolism or the necessity for long- term anticoagulation and its associated risk of bleeding. A few post market studies were conducted to assess the safety and performance of TTKCHV.

G. Kuppuswamy Naidu Memorial Hospital, Coimbatore, Tamil Nadu, India carried out a clinical performance review of the TTK Chitra heart valve in 2011. The evaluation was based on a literature search and review that covered the performance of the TTK Chitra mechanical heart valve based on published clinical data from studies conducted by various investigators during the period 1990 to 2010. The study showed that the linearized occurrence rates for paravalvular leak, haemorrhage, and endocarditis are relatively low and in some cases, nil. Many studies also showed acceptable thromboembolic levels. Published clinical studies on the TTK Chitra heart valve from various institutions and hospitals prove that it is an excellent valve substitute.

A Post Market Clinical follow-up Study (PMCFUP) of TTK Chitra Heart Valves Model TC1/TC1-H (PMCFUP.2-TCHV-TC1) – a “Prospective, Single-centre, Single arm, Clinical follow-up Study” was conducted at the Department of Cardiothoracic and Vascular Surgery, PSG Institute of Medical Sciences and Research, Coimbatore, India during Aug 2015 to Feb 2017.

The objective of the study was to assess the safety and effectiveness of the TTK Chitra heart valve in terms of:

• Adverse event (AE) rates
• Clinical status as indicated by the improvement in NYHA (New York Heart Association) functional classification
• Hemodynamic performance as measured by Echocardiography.

The study covered all 250 patients who underwent heart valve replacement with the TTK Chitra heart valve between 1st Jan 2009 to 15th May 2012. The results concluded that TTKCHV is mechanically sound, structurally reliable and hemodynamically comparable to other mechanical prostheses in current clinical use.

“Long-term evaluation of TTK Chitra heart valve prosthesis- a retrospective cohort study” is another Post market clinical Follow-Up study conducted at Amrita Institute of Medical Sciences, Kochi, India from January 2020- March 2022 to evaluate the long-term clinical and hemodynamic performance of the valve using a set guideline issued by Society of Thoracic Surgeons for reporting valve related clinical outcome and valve-related complications. The study group included 476 patients implanted with TTK Chitra heart valve at aortic and mitral positions during the period of January 2006 to December 2018 at the site. This study was completed on 31st March 2022. The study concluded that TTKCHV continues to be a safe and effective mechanical heart valve for replacement of diseased heart valves as evidenced in this long-term clinical study. The use of the valve in the paediatric patient group offers good long-term survival.

Results are available in the below-listed publications:

• Evaluation of TTK Chitra heart valve prosthesis in paediatric patients -Published: 22 November 2022; DOI: https://doi.org/10.1007/s12055-022-01440-0 [Brief Research Report]
• Long-term Evaluation of TTK Chitra™ Heart Valve Prosthesis — a retrospective-prospective cohort study -Published: 03 December 2022; DOI: https://doi.org/10.1007/s12055-022-01437-9 [Original Article]

A “Retrospective-Prospective, Single-Centre, Single arm, Clinical follow-up study” was conducted at the Department of Cardiothoracic Surgery, G. Kuppuswamy Naidu Memorial (GKNM) Hospital, Coimbatore, India. The study was initiated in October 2020 and closed in May 2022. The objective of the study is to assess the continued safety and performance of TTK Chitra Heart Valves by establishing the following:

• the clinical risks (valve-related adverse events) continue to be within the limits specified as OPC in ISO 5840:2015 and are similar/comparable to other mechanical valves in the market.
• The clinical performance of the valve continues to be the same when measured by Echocardiography, improvement in NYHA class and overall quality of life.

The study covered all 213 patients who underwent heart valve replacement with TTK Chitra heart valve at the investigative site between 1st Jan 2011 and 31st Dec 2012. The study concluded that the device continues to comply with the Essential Requirements of 93/42/EEC and the General Safety and Performance requirements of 2017/745. The fact that the incidence of clinical complications with the TTK Chitra valve is well within the OPC limits of the standard ISO 5840: 2021 (Part 2), clearly demonstrates that the valve is SAFE and the BENEFIT / RISK PROFILE is acceptable at the current state of the art in the world and comparable to other well-known and established mechanical valves in the market today.

Open-access publications on TTK Chitra Valve during the year 2015 - 2022

• Dr. Anupama Rao, Dr. Padma S, Dr. Anurag Vidhale, Dr. PK Dash. Hemodynamic results of TTK-Chitra valve in aortic position in patients undergoing aortic valve replacement for aortic stenosis. Int J Surg Sci 2020;4(4):237-240. DOI: https://doi.org/10.33545/surgery.2020.v4.i4d.566 eventually end up in the ocean.
• Singh, A., Singh, S. P., Tripathi, V. D., Yadav, M., Haseen, M. A., & Krishna, V. Comparison of Post Operative Clinical Outcomes Between “ Made in India” TTK Chitra Mechanical Heart Valve versus St Jude Mechanical Heart in Valve Replacement Surgery. International Journal of Current Research and Review 2020; 12(19), 76–81. https://doi.org/10.31782/IJCRR.2020.12197
• Venkatavijay K, Vivekananda Y, Hemasundar K, L Rajitha N N. Outcomes of complete mitral valve excision and replacement with tilting disc (TTK Chitra) valve for rheumatic mitral valve stenosis. J NTR Univ Health Sci 2020; 9:12-9. https://www.jdrntruhs.org/text.asp?2020/9/1/12/284319
• Megavath Motilal, VijayaRamarajuNadakuditi, Alla Gopala KrishnaGokhale,Dr.SudhakarKoneru, Manoj Kumar Moharana, K.V.Ramana, “Clinical Experience on TTK Chitra Tilting Disc Valve in Government General Hospital, Guntur.” IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) 2019; 18(3):35-38. https://www.iosrjournals.org/iosr-jdms/papers/Vol18-issue3/Series-10/H1803103538.pdf
• Durga Prasad Rath, Arun Kumar. “Clinical Profile and the Factors Associated With Outcomes among Patients Implanted With Indigenous Prosthetic Heart Valve”. IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) 2019; 18(6): 01-03 https://www.iosrjournals.org/iosr-jdms/papers/Vol18-issue6/Series-18/A1806180103.pdf
• D. Sreenivasa, Dr. Mohammed Sakib, D. Mallesh. “Echocardiographic Profile of Normaly Functioning TTK Chitra Tilting Disc Prosthetic Valves.” IOSR-JDMS. 2016; 15 (6), PP 66-68 https://iosrjournals.org/iosr-jdms/papers/Vol15-Issue%206/Version-10/O1506106668.pdf.