On any given day, at least 50 per cent of patients who have been advised stents to remove heart blockages do not require it, says heart surgeon Ramakanta Panda, head of the Asian Heart Institute.
“Though stents play a critical role in the lives of those with heart blockages, it is grossly over used in the country,” he says, indicating the reason for mistrust among patients when it comes to stents.
In fact, a recent study by interventional cardiologists in the country also revealed interesting data on stents usage, triggering an intense debate on stents, pricing, its use and abuse.
And coming at a time when medical technology has been brought under the Drugs and Cosmetics Act, this discussion on stents could well be a touchstone for dealing with the larger medical-tech sector on issues like quality, safety and pricing.
Stents are wire mesh tubes, of varying types, made locally and imported. “There are clear-cut indications where a stent can be used,” says Panda, referring to American and European guidelines. “India needs its own guidelines, that may not be very different, but can help bring down the misuse,” he says.
For instance, every heart block does not need a stent and can be managed with medical treatment. And again, every block does not need a drug-coated stent or the latest technology of absorbable stents (costing between ₹1.5 to ₹2 lakh), he says.
Comparative dataThe size of artery, type of block etc become deciding factors, says Panda, advising patients to take a “proper” second opinion to ensure the judicious use of a stent. If indeed required, the stent is a good option, he clarifies. “It is also critical to have long-term trial data on these products,” says Panda. “Products selling in India have local regulatory approvals, but they need long-term comparative data with existing products to build confidence among doctors and patients,” he adds.
Echoing a similar view, Praveen Chandra, chairperson of the National Interventional Council (that did the recent study on stents) adds that local production also needs to be encouraged to infuse competition and bring down prices. “Not all patients can afford these products,” he says, with prices varying from local products at ₹25,000 to ₹50,000-odd to imported variants at ₹60,000 to about ₹1 lakh-plus. The advantage of making a product locally is that it should be less expensive. “Unfortunately, there isn’t much of a price difference,” observes Panda.
Addressing affordability, he says, stents for the poor should be subsidised, while for the rest it can be supported through health insurance, co-payment facilities and differential pricing depending on economic strata. Putting the stent controversy in context, All India Institute of Medical Sciences’ Professor of Cardiology, Nitish Naik says, “Stents are like a double edged sword, clearly they are useful.”
Rising costsBut the controversy started when blocks reappeared despite the stent. Besides, unlike normally where prices fall on a new technology over time, with stents, newer products came at higher prices as it had more features, he explains.
Doctors, device-makers and patients need to take responsibility for abusing stents, he says, as patients too preferred a stent which they saw as simpler than a surgery.
But the approach needs to be different, be it a 100 percent blocked artery or an artery blocked for over 10 years. Opening it up could lead to risky complications, he says, and medical management could do just as well.
In some patients, the body naturally develops a bypass channel, he says, stressing the need for “appropriate use criteria.” And while patients need to be educated, physicians too need to give up their “cavalier approach of opening up every vessel,” he says.
The situation gets further complicated by incentive-driven reimbursements based on revenues generated by the hospital etc, says Naik. But enforcing guidelines on rational use, and encouraging competition to bring down prices could put some trust back in stents, ensuring they are used for no other reason than a medical one.