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One in 3 stent implants in India is possibly unnecessary

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Several senior cardiologists in India have raised concern over rise in the cases of unnecessary implant of stents in India. They say if an audit of stent implant cases was done, over a third of the elective procedures could turn out to be needless.

A few years ago in the US, which has better monitoring and oversight of medical procedures than India, studies had found that only half the non-emergency cardiac stenting procedures were appropriate. Several cardiologists and hospitals were forced to cough up millions of dollars in penalties for unnecessary stenting. Stent companies too paid heavy penalties to settle charges of giving kickbacks to doctors.

There is no regulation of hospitals in India, especially in the private sector where a majority of urban Indians seek healthcare. “At least 25-30% of the stenting done in this country is inappropriate. There are cases of stents being used in absolutely normal patients. External audit of every cath lab and all cardiac procedures is urgently needed. Every state government ought to have doctors with calibre and integrity comprising an audit committee. And doctors caught doing inappropriate stenting ought to be jailed for fraud to set an example,” said Dr T S Kler, head of the department of cardiology in Fortis Escorts Heart Institute.

In 2007 a study in the US that tracked patients over five years showed that in people with stable coronary artery disease, stents were no better than drug therapy. Until this finding, doctors had claimed that stenting in such cases showed excellent results.

In India, there are hospitals that boast of conducting up to 25,000 angioplasties a year and several cardiologists are too close to stent makers and suppliers for comfort. In the absence of any monitoring or oversight, patients in India have no protection from unnecessary use of stent.

“I agree that a significant percentage of angioplasties are inappropriate. I think the Cardiology Society of India should bring out guidelines and create a mechanism to audit themselves rather than giving a chance for an external body to be created. Such an audit is needed as society has lost trust in doctors because of such inappropriate use,” says Dr Devi Shetty, chairman of Narayana Health.

In 2009, an expert panel of cardiologists in the US published criteria for appropriate use of stents. A study preceding the publication looked at 2.7 million stenting procedures in 766 hospitals. It showed that inappropriate stenting in non-acute cases, fell from 25% in 2009 to 13% by 2014. Equally significantly, the total number of stenting in non-acute cases fell by about a third. As a result, the total number of cases of inappropriate stenting fell from 21,000 to just 8,000.

While there is broad consensus among cardiologists that stents can save the life of a patient with symptoms of heart attack, the decision to use stents on an elective basis is far more complicated. With the National Pharmaceutical Pricing Authority revealing that hospitals make the highest profit on stents, it seems obvious why hospitals are not pushing for audits to curb inappropriate use.

Source: http://timesofindia.indiatimes.com/india/one-in-3-stent-implants-in-india-is-possibly-unnecessary/articleshow/57071863.cms

Image source: https://www.drbillsukala.com.au/exercise/exercise-after-angioplasty-stent/

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Focus shifts to expensive pacemakers, lenses, catheters

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After the capping of cardiac stent prices, the Rajya Sabha petitions committee has turned its attention to overpricing of other medical devices. On Tuesday, the committee heard the National Pharmaceutical Pricing Authority (NPPA) and the department of pharmaceuticals (DoP) on the issue. 

The health ministry has classified 22 medical devices, including cardiac stents, as drugs under the Drugs and Cosmetics Act 1940. These include intraocular lens, knee and hip implants, syringes and catheters.

The committee is hearing a petition filed by one Sulagna Chattopadhyay on overpricing of medical devices. The petition had sought measures to regulate the price of medical devices and to investigate the role of regulatory bodies like the drug controller in preventing overpricing.

The All India Drug Action Network, a civil society group working on pricing of drugs and devices, argued before the committee that it was equally important for pacemakers, implantable cardioverter defibrillator, artificial heart valves, intraocular lenses, and hip and knee replacements to be made accessible via price control. The committee has been holding hearings since the beginning of 2016. It has visited several places including Bengaluru, Coorg, Mumbai and Bhopal to hold hearings.

“We asked for more cath labs in the public health system and for fixing procedure rates so cardiac procedures become more affordable. We also want price control of other devices such as pacemakers, cochlear implants and artificial joints,” said Dr Ravi D’Souza of Sochara, a group working on public health. D’Souza had deposed before the committee in Bhopal. 

“After stents, the panel’s focus has shifted to other medical devices. However, there are still loopholes it can help fix: the cost of catheters, balloons, guidewires, which are high. Barely a dent has been made in overall angioplasty costs. Medical device firms and their associations are on a misinformation campaign to safeguard their interests by preventing price regulation of other devices. The committee should move swiftly and recommend price checks on other devices to benefit the poor,” said Malini Aisola of AIDAN. Chattopadhyay said she too has asked for the price of balloons, catheters and guide wires also to be capped to make angioplasty truly affordable. 

(This article was originally published in The Times of India) 

Source : http://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/focus-shifts-to-expensive-pacemakers-lenses-catheters/articleshow/58624368.cms

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Good News: National Pharmaceutical Pricing Authority reduces price of stents

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The National Pharmaceutical Pricing Authority (NPPA) Monday further slashed prices of the expensive cardiac stents while marginally increasing the cost of the basic stents.

After several rounds of consultation with various stakeholders, the NPPA cut the price of drug-eluting stent (DES) by Rs 1,710 (from Rs 29,600 to Rs 27,890) while increasing the price of bare metal stent (BMS) by Rs 400 (from Rs 7,260 to Rs 7,660).

The trade margin has been capped at 8%, the NPPA said in an order, which makes the current rates valid till March 31.

“All manufacturers of coronary stents, selling branded or non-branded… at prices higher than the ceiling price… shall revise the price of all such stents downward not exceeding the ceiling price,” the order said.

The order mandates hospitals to provide a clear break-up of the prices levied for other items used in medical procedures.

While there was fear of NPPA giving into industry pressure and increasing the price, experts feel the price could have been decreased further. “It is not really slashing of the price. There was scope for further reduction,” says GS Grewal, core committee member, Alliance of Doctors on Ethical Healthcare.

Source: https://www.hindustantimes.com/health/national-pharmaceutical-pricing-authority-reduces-price-of-stents/story-3yxo4QkQTEuFijtkCh8smK.html

Photo: Dmitry Stolyarov, a heart surgeon, holds a stent.(REUTERS File Photo)

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Stents no better than drugs for many heart patients: U.S. study!!

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CHICAGO: Many patients with severe but stable heart disease who routinely undergo invasive procedures to clear and prop open clogged arteries would do as well by just taking medications and making lifestyle changes, reported U.S. researchers.

If adopted into practice, the findings could save hundreds of millions of dollars a year in healthcare costs, researchers said.

The $100 million government-backed study, presented at the American Heart Association (AHA) meeting in Philadelphia, is the largest yet to look at whether procedures to restore normal blood flow in patients with stable heart disease offers an added benefit over more conservative treatment with aspirin, cholesterol-lowering drugs and other measures.

At least two prior studies determined that artery-clearing and stenting or bypass surgery in addition to medical treatment does not significantly lower the risk of heart attacks or death compared with non-invasive medical approaches alone.

Many cardiologists are reluctant to change practice in part because patients who get stents to keep the artery open report feeling better right away, experts said.

NYU Langone cardiologist Dr. Judith Hochman, who chaired the study, estimated that some 500,000 new patients a year are diagnosed with stable coronary artery disease, in which heart arteries narrowed by fatty deposits cause periodic angina, or chest pain, typically after exercising or emotional distress.

Current guidelines recommend patients with severe narrowing of their arteries have heart bypass surgery or a stent implanted to restore blood flow. Stents are tiny tubes that keep the artery open after blockage-clearing angioplasty.

“There’s always been a fear that if you don’t do something quickly, they will have a heart attack or drop dead,” Hochman said.

The 7-year, 5,179-patient ISCHEMIA study did not show a significant benefit from that course of action.

“For those with mild or no chest pain, there’s really not a role for immediately stenting,” Hochman said.

Just eliminating unnecessary stenting procedures could save the U.S. healthcare system $570 million annually, said Stanford University School of Medicine cardiologist and study co-chair Dr. David Maron. He estimates the cost per stenting procedure at about $25,000 and bypass surgery at $45,000.

“I would hope this would change practice,” said Dr. William Boden of the VA New England Healthcare System, another study author. “We are wasting a lot of money.”

The main goal of the trial was an overall reduction in deaths, heart attacks, hospitalization for unstable chest pain or heart failure and resuscitation after cardiac arrest.

On these measures, the addition of stenting or bypass surgery to reroute blood flow around the arterial blockage was no better at reducing the adverse events than medical therapy alone. The invasive treatments did result in better symptom relief and quality of life in those who had frequent chest pain.

The trial, sponsored by the National Heart, Lung and Blood Institute, involved patients with moderate to severe but stable ischemia – a condition in which clogged arteries are not able to supply the heart with enough oxygen-rich blood.

Everyone received medicines and lifestyle advice, while half also had one of the invasive procedures.

Cleveland Clinic cardiologist Dr. Steven Nissen was convinced. “We can reserve these interventions for people who truly fail medical therapy,” he said.

Experts said the study was well done, and its findings will be hard to ignore. But it may take several years for the changes to filter into practice, especially in community settings, said Dr. Ashish Pershad, an interventional cardiologist at Banner – University Medicine Heart Institute in Phoenix.

The findings do not apply to all heart patients, including those with blockages in the left main coronary artery, Hochman said. And, she added, “if you’re having a heart attack, stents save lives.”

Source: https://health.economictimes.indiatimes.com/news/industry/stents-no-better-than-drugs-for-many-heart-patients-u-s-study/72093423

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