THV therapy in India- Why the low uptake?

September 14, 2018 0 By CH Unnikrishnan

Dr Rajaram Anantharaman

Transcatheter heart valves are emerging as one of the rapidly growing device markets globally.

Transcatheter Aortic Valve Replacement

Since the first Transcatheter Aortic Valve Replacement (TAVR) in 2002 by Prof Alain Cribier in Hospital Charles Nicolle at the University of Rouen, the procedure is now approved in more than 50 countries and more than 100,000 have been performed worldwide. The majority have involved Edwards Sapien and Medtronic Corevalve. In India, only 400+ procedures have been done since the first trans-apical TAVR was carried out by a team led by Dr Prashant Vaijyanath andDr K M Cherian at Frontier Lifeline Hospital, Chennai in 2010. This is well below its potential. Globally, the prevalence of AS is 2% in those over 65 years and 12% in those over 75 years. Extrapolating this to the population of India (about 1.3 billion), approximately 70 million will be over 65, out of which around 300,000 will be eligible, and require, TAVR for inoperable and severe AS.

Transcatheter Pulmonary Valve Replacement (TPVR)

With the growing population of adult congenital heart disease patients, there is the need for a less-invasive option for replacing a narrowed RV to PA conduit or significant restenosis or regurgitation of a pulmonary artery conduit. Since the first report of percutaneous pulmonary valve replacement by Philip Bonheoffer in 2000, more than 10,000 procedures have been done worldwide, with the majority using the Melody valve. But less than 10 implants have been done in India. With more and more congenital heart disease patients who live to their adulthood needing RV to PA conduit replacement for restenosis as well as children who have already undergone multiple heart surgeries developing leaking or narrowed pulmonary valve, there is a large group of patients who will benefit from the less-invasive life-saving procedure. Despite this, large players like Medtronic are not offering their TPVR programmes in India, nor are commercially available dedicated transcatheter pulmonary valves available in India.

Valve in Valve (THV) Replacement

Valve-in-valve transcatheter valve replacement for a failed surgical bioprosthetic valve (ViV) has emerged as a low risk alternative for this category of high risk re-do surgery patients. More than 10,000 procedures have been performed worldwide. Here too, India is lagging behind with less than 20 ViV done in total. One of the first ViVs in India was implanted by a team led by Dr Rajaram Anantharaman at Frontier Lifeline Hospital. This is not due to a dearth of patients. There is a large group of young patients with rheumatic valve disease (which is still prevalent in India) who received surgical bioprosthetic valve that are now failing, and require their second or third surgery before they are 40 to 50 years old. They are among those who can benefit the most from low-risk ViV implants.

Low-cost heart valves for Indian patients

Dr K M Cherian Heart Foundation has been developing low-cost affordable device solutions in the first SEZ in India at Frontier Medivelle, Chennai. Some of the them include decellularized bovine and porcine pericardial patches and bovine jugular vein conduits, which have already helped a large group of patients in need. A low-cost bioprosthetic valve is also being developed in association with Georgia Tech, USA, which is currently in phase III study. Most recently, the foundation is developing a low-cost transcatheter valve for both aortic and pulmonary positions in collaboration with CSIR-NAL, who are pioneers in developing nitinol-based self-expanding devices. Let us hope that Prime Minister Narendra Modi’s initiative of ‘Make in India’, along with the government’s new policies on devices, will help in developing indigenous devices at affordable cost to overcome the current low implant rates via such life-saving therapies for such no-option patients.

The author is Senior Consultant Interventional Cardiologist and Lead for TAVR, Heart Transplant and Cardiomyopathy C.R.Y Clinic,Frontier Lifeline Hospital, Dr K M Cherian Heart Foundation, Chennai