The criteria specified by the Drug Controller General of India (DCGI) for hospitals willing to use transcatheter aortic valve implantation (TAVI) devices in elderly patients with severe aortic stenosis, who are declared unfit for open heart surgery, will defeat the ultimate purpose of ensuring better healthcare delivery for elderly populace in the country, said Dr. Kaushal Pandey, noted cardiac surgeon at Hinduja Hospital, Mumbai.

Taking into account the TAVI success rate, DCGI had last month granted permission to US-based medical device makers Medtronic and Edwards Lifesciences Corporation to supply TAVI devices to hospitals in the country with the rider that the hospitals should be equipped with Hybrid OR and should employ a cardiologist and a cardiac surgeon for the TAVI procedure, as a “Heart Care Team”.

“An operation theatre with cath lab (Hybrid OR) costs a hospital around Rs.8-10 crore which is more than double the cost of non cath lab operating theatre. Only six hospitals in the country have Hybrid OR including Mumbai-based Holy Family Hospital & Medical Research Centre. As per the DCGI order, if hospitals will go for cath lab operating room, they are forced to recover the cost from patients who are already reeling under expensive medical costs. TAVI valve costs a patient around Rs.20 lakhs as compared to an aortic valve replacement surgery which costs a patient Rs.50,000 to Rs.2 lakhs. Total cost of TAVI procedure to the patient will be Rs.26-30 lakhs, while for AVR will be Rs.4-6 lakhs. The DCGI criteria have spiraled TAVI cost,” he said.

In order to make TAVI affordable for elderly patients, the DCGI needs to do away with the stringent conditions imposed on hospitals, the cardiac surgeon said.

Cautioning against the misuse of TAVI procedure in the country, Dr Pandey stressed the need to set up a Heart Care Team at par with such team in USA where a Heart Care Team consisting of cardiologists and cardiac surgeons recommend the patients for TAVI. Surgical AVR is the gold standard. Indiscriminate use of TAVI cannot be justified. The AVR tissue valve is superior to TAVI valve, both in results and long term durability.

In the absence of such a system in India, medicos can force the gullible patients to go for TAVI for illegal gains, he added.

In a country like India where corruption is very high, it is very difficult to form Heart Care Team consisting of cardiologists and cardiac surgeons in the country to ensure needy patients benefit from TAVI, he lamented.