While coronary stents can be lifesaving for an acute heart attack, decades of research shows that they are not beneficial for patients with stable heart disease. Yet hospitals perform hundreds of thousands of these procedures unnecessarily, exposing patients to needless risk and wasting billions.

Why do doctors continue to do procedures without evidence they benefit patients? At a panel discussion hosted by the Lown Institute, overuse experts David Brown, Thomas Power, Betty Rambur, and Vikas Saini discussed the implications of stent overuse, what causes overuse, and what we need to change. Watch the full video recording of the event below:

How prevalent is stent overuse?

The Lown Institute report found that more than one in five stents that hospitals performed from 2019-2021 for Medicare patients met criteria for overuse. Stents were defined as meeting overuse criteria for patients with a diagnosis of ischemic heart disease at least six months prior to the procedure, excluding patients with a diagnosis of unstable angina or heart attack within the past two weeks, and excluding patients who visited the emergency department over the past two weeks.

The rate of overuse varied widely among hospitals; at some hospitals, more than 40 percent of all stents were overuse, while at others, fewer than 10 percent were overuse.

The panelists found these numbers illuminating, but not shocking. In fact, Dr. Brown found the hospitals on the low end the most surprising, expecting even the low outliers to have much higher overuse rates.

“[These results are] the logical consequence of unbridled overuse of services.”

Betty Rambur, Professor of Nursing at the University of Rhode Island

What’s driving stent overuse?

Our panelists pointed out many reasons why a clinician might perform an unnecessary stent. The narrative of an artery being a “clogged pipe” that just needs to be opened is very convincing both for doctors and patients. In reality, a clogged artery is indicative of systemic heart disease that requires medication and lifestyle changes; simply opening one artery won’t prevent future cardiovascular events, said Brown.

“When a patient is shown a coronary angiogram showing right narrowing of an artery… there is an intuitive desire to make it go away.”

Dr. David L. Brown, Clinical Professor of Medicine, Keck Medicine of USC

Another reason is that guidelines are far behind the evidence, making change a slow process. Medicare’s coverage guidelines allow doctors to be paid for stents that we now know do not benefit patients — as long as Medicare will still pay for them, our health system will deliver them. Specialty guidelines also have not kept up with evidence. For example, the American Heart Association’s latest chest pain guidelines are “full of recommendations for procedural overuse…modeled on the clogged pipe paradigm of coronary disease” said Brown. “They’ve been missing in action, to say the least.”

And of course, financial incentives play a role. Our fee-for-service payment system incentivizes hospitals to do more elective procedures, and gives less to hospitals spending more time with patients or pursuing preventive measures. The $2.4 billion in waste from overused stents could be put to a much better use.

“There are harms to other patients by using healthcare dollars on low-value services, thereby depriving other patients of services that are higher value.”

Dr. Thomas Power, Senior Medical Director of Cardiology and Sleep Programs at Carelon Medical Benefits Management

Despite being the wealthiest country in the world, we have a “resource-constrained system” because not everyone can access the care they need. Imagine what the billions we spend on low-value care each year could do to change that.

The post The prevalence and harm of unnecessary stents appeared first on Lown Institute.

To learn more about what experts in the field are saying about this issue, check out this recent STAT News article quoting Lown Institute president Dr. Vikas Saini.

Private equity takeovers

The past few years have seen rising private equity investment in healthcare, with 9% of all private and 30% of all proprietary for-profit hospitals owned by private equity firms. What does this mean for health system performance?. 

“The interest of private equity in cardiology is not humanitarian. They see dollar signs and they’re going for them.”

Dr. Vikas Saini, president of the Lown Institute, in StatNews

A systematic review of 55 publications exploring the effects of private equity ownership on healthcare system performance gives us the bottom line up front: private equity ownership in healthcare means higher costs for both patients and payers and a range of mixed to harmful effects on quality of care. To better understand this phenomenon, let’s take a closer look at private equity’s newest fixation: cardiology.

Why cardiology?

Fields like dermatology, ophthalmology, gastroenterology, and others have attracted private equity firms’ attention because of the ability to conduct elective procedures in the outpatient setting. Medicare’s 2020 rule allowing for reimbursement for cardiac procedures in ambulatory surgery centers – along with the prevalence and severity of cardiac disease in the US –  has made cardiology an attractive target for private equity firms. According to StatNews, at least 10 private equity firms are “racing” to buy up cardiology practices. They are tracking hot spots for cardiology acquisitions that have popped up in Florida, New Jersey, New Mexico, and other states.

The shift to outpatient and cardiac care overuse

The shift of cardiac procedures to outpatient settings combined with private equity investment may increase the risk of overuse, or unnecessary procedures. 

CMS boosted reimbursement rates for stents performed in outpatient settings in 2008, based on a desire to increase procedural efficiency and cut costs. But they may have fueled the cardiac overuse crisis by creating a financial incentive for physicians to perform more and more procedures, regardless of whether they would benefit their patients. For example, ProPublica and the New York Times reported on doctors who conducted dozens of unnecessary vascular procedures, leading some patients to have their legs amputated. 

Unnecessary coronary stenting may be next. Coronary stenting – also referred to as percutaneous coronary intervention (PCI) – involves the insertion of a small, mesh tube inside the coronary arteries to widen blood vessels that are narrowed or blocked by plaque. 

While coronary stents can save lives when someone is having a heart attack, several studies have indicated that their utility is limited beyond that. Coronary stents do not benefit patients with stable heart disease, nor are they an effective tool for preventing cardiac events or reducing symptoms such as angina when compared to a placebo. Despite this evidence, top-performing hospitals continue to embrace and profit from this procedure, charging insurers up to $25,521 per PCI.

However, coronary stents are only a small piece of the financial prize that is cardiac overuse. A 2019 study revealed that non-invasive cardiologists produced $2.31 million and invasive cardiologists $3.48 million annually for the hospitals in which they were affiliated.

The financial promise of private equity ownership of cardiac care raises alarm bells for cardiologists such as Lown Institute President Dr. Saini. Private equity firms insist they will act in accordance with provider guidelines and stay out of providers’ operations, but who’s watching them? With the intersection of private equity and overuse looming large, we need the answer to this question.

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In 2020, hospitals placed more than 45,000 coronary stents in Medicare patients that met criteria for overuse, a recent report from the Lown Institute Hospitals Index finds. Coronary stents were the most overused service by volume of the eight measured, and were provided unnecessarily even at some of the most prestigious hospitals in the country.

Coronary stenting or balloon angoplasty (known as percutaneous coronary intervention or “PCI”) for stable heart disease has long been considered an indicator of overuse, because many years of evidence shows that PCI doesn’t provide benefits to patients beyond medication therapy. However, some hospitals disagree, saying their stents are appropriate.

What’s the evidence behind PCI, and why do hospitals keep doing these procedures? We revisit this issue with a look back at research and interviews over last few years to give you the answers.

Dr. Lown’s example

The practice of placing a stent or balloon into patients’ arteries to open up blockages started in Switzerland in 1977 when Dr. Andreas Grüntzig first performed this intervention. This procedure quickly became the standard of care for treating heart attack patients and saved countless lives.

Soon, PCI became more popular for treating patients not having heart attacks, but for patients with stable heart disease as well. The assumption was that unblocking arteries would prevent a future heart attack or stroke, just as unblocking a clogged pipe prevents it from bursting. However, there was little evidence to support this theory.

As PCI became widespread, cardiologists like Dr. Bernard Lown recognized that they were widely overused and put patients at unnecessary risk of harm. As Dr. Lown wrote, his team took a conservative approach, avoiding PCI and the coronary artery imaging that typically leads to these interventions. Instead they treated risk factors, prescribed medications when necessary, recommended lifestyle changes, and discussed stress. Over 35 years, their clinic saw about a thousand patients scheduled for surgeries looking for a second opinion; fewer than 30% of patients were referred for PCI. Their published work showed a low rate of cardiac events and mortality for patients managed conservatively.

Do stents for stable heart disease work?

Dr. Lown’s experiment showed that many patients with stable heart disease could be managed without surgery and avoid poor outcomes. This finding would later be validated in multiple randomized trials. See the following timeline of trials of PCI compared to medical therapy:

Why do we still put in stents?

Despite trial after trial showing a lack of benefit, why are these invasive cardiac procedures still common for patients with stable heart disease? These trial findings go against the intuitive idea that arteries with plaque are like a “clogged pipe” and that opening blocked arteries prevents heart attacks and death. In fact, it’s not a single blocked artery, but the presence of plaque throughout the coronary system (known as atherosclerotic plaque burden) that is most dangerous. Opening up an artery only treats the symptom of the disease; plaque buildup in the arteries is best ameliorated with lifestyle changes and medical therapy.

As Louisville cardiologist Dr. John Mandrola wrote about the ISCHEMIA trial in Medscape, it is hard to disabuse the clogged pipe analogy because it fits so well with how we believe our bodies should work. “While part of our brains can understand the data, another part of our brain cannot unsee the gnarliness of a severely stenosed coronary artery,” he wrote.

It’s also difficult for cardiologists to change their practices when they want to do something to improve their patients’ condition. “It’s hard to think that the procedure we were trained to do for so many years doesn’t actually help patients,” said Dr. David L. Brown, professor of medicine at Washington University of St. Louis, in response to the ORBITA trial. “But if cardiologists look at the evidence objectively and with an open mind, that should be all it takes for them to make changes in how they talk to patients about the issue,” he said.

We also can’t ignore the financial incentives behind cardiac interventions. Clinicians are paid much more for doing surgical interventions than they are for consulting patients on lifestyle changes. When you add the financial reward on top of the belief that they are helping patients “that’s the methamphetamine of being a physician, it’s very mentally addictive,” said Dr. Vinay Prasad, Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. Even when faced with new evidence about an intervention, it’s difficult to sway doctors’ views. “Smart people are very good at coming up with reasons why the new study doesn’t apply to them,” said Prasad.

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But what about payments to doctors from companies that make medical devices? These conflicts of interest are less publicized, but are just impactful–if not more–than payments made by drug companies.

In a recent study in Health Affairs, Alon Bergman, postdoctoral fellow at the Leonard Davis Institute of Health Economics and the Wharton School at the University of Pennsylvania, and colleagues conducted a comprehensive examination of medical device industry payments across payment types and specialties. They found that the medical device industry is spending far more than pharma on payments to physicians, and these payments are targeted more specifically to physicians who use their products.

Between 2014-2017, device companies paid $904 million each year to physicians, compared to $821 million that pharma spent. That doesn’t seem like much more, but the device industry has a lot less revenue than pharma, so these payments represent a greater investment relative to the size of the industry. Device companies spent 1.7% of industry revenue on payments to physicians while pharma companies spent 0.24%.

Medical device companies spent more money overall but gave to fewer physicians than pharmaceutical companies did. Each year, about 30% of physicians received a payment from a device company, while about half of physicians received a payment from pharma. Device companies targeted neurosurgeons and orthopedic surgeons specifically; about 75% of physicians in these specialties received a payment. Physicians in surgical specialties typically received more than $400 annually from device companies, while physicians in other specialties received less than $50.

Within the surgical specialties, medical device companies appear to target physicians that do the greatest number of surgeries. The more a surgeon’s Medicare billing amount, the more they received from medical device companies. Surgeons in the 10% for Medicare billing received more than $10,000 from device companies, on average. Pharma also rewards high-billing physicians with greater payments, but even those in the top decile received $4,000 on average–less than half of what medical device companies pay their top physicians.

“The relatively steep relationship between device payments and billing suggests that device firms have greater potential scope than drug firms to influence spending on relevant patient populations,” the authors write. Previous research on the relationship between medical device company payments and physician decisions indicates that physicians are much more likely to use a device made by the manufacturer that gives them the largest payment.

“It becomes a lot harder to [decide which product is best] when that salesperson is also taking you out to $500 dinners and pays you tens of thousands of dollars in consulting fees over the last few years,” said Aaron Mitchell, oncologist and health services researcher at Memorial Sloan Kettering Cancer Research Center, in STAT.

Medical device industry payments differ from pharmaceutical industry payments in another key way: Medical device companies are paying physicians more for product development (categories of payments such as royalties, licensing, and investment) and education, while pharma companies are paying more for speaking fees and food and beverage costs. The authors propose that medical device vendors “may solicit input from practitioners on development, and physicians may approach vendors with ideas for devices,” especially because many medical devices do not have to go through clinical trials to be approved by the US Food and Drug Administration. The fact that new medical devices can go on the market with barely any testing leaves the field wide open for manufacturers and doctors to collaborate on new devices, although patient safety could suffer because of lack of regulation.

This groundbreaking study shows that payments to physicians from medical device company deserve just as much scrutiny as payments from drug companies, if not more. The specific nature of medical device usage means that targeting high-performing surgeons with big payouts could have a large impact on which devices get used the most. And these payments represent a high barrier to entry for new medical device companies that can’t afford to match them. These are areas in great need of more regulation, to prevent potential harm to patients from conflicts of interest.

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In this study, researchers looked at a sample of 145,900 patients who received either an implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator device. These are devices for patients with heart failure, which are designed to prevent life-threatening arrhythmias (abnormal heart rhythms) by giving a small “shock” to the heart when necessary.

Of the 4,435 physicians who implanted these devices from 2016-2018, 94% of them received some payment from device manufacturers. The majority of doctors (75%) received payments from 3 or 4 manufacturers; only 8% received payments from just one manufacturer. The vast majority of payments (88%) amounted to $10,000 or less, but some payments were as high as $320,000.

Physicians were much more likely to use the device made by the manufacturer that gave them the largest payment than any of the other manufacturers. Overall, 47% of patients received a device from the manufacturer that gave their physician the most money. For physicians that received more than $25,000 annually, 51.1% to 59.5% of patients received a cardiac device from the manufacturers that provided the largest payment.

Physicians were also more likely to use the device from the manufacturer that paid the second-most, compared to manufacturers that paid less. One of the device makers (known in the study only as “Manufacturer B”) appeared to be the most generous spender. Among the doctors that got the most from Manufacturer B, 74% of the total payment was from this device maker. And among the doctors that got the most from the three other device makers, Manufacturer B’s payments made up the next-largest proportion of their total payments. This may have had an effect on which devices doctors used; in total, 40% of all the devices implanted were from Manufacturer B.

Another interesting finding from the study was a comparison between physicians who had not received any payments and physicians who did. Doctors who did not receive payments were less likely to be giving patients a device for primary prevention (to stop a first cardiac event) as opposed to secondary prevention (prevent another cardiac event). Among doctors who did not receive payments, 75.9% of patients were given a device for primary prevention, compared to 78.3% of the patients in the total sample. These doctors were also more likely to give patients a single-chamber ICD as opposed to a dual chamber ICD or CRT-D. While these differences were slight, they may indicate that doctors receiving payments have a bias toward implanting more expensive devices for patients who may not need them.

In the study, there was no difference in rate of complications or death depending on whether or how much a physician was paid. So why do these payments matter? In an accompanying editorial, Harvard Law professor Carmel Shachar and JAMA Deputy Editor Dr. Gregory Curfman point out that payments to doctors from drug companies raise the price of devices. “The payments to physicians…were funded by ICD sales, and these devices would be less expensive without these payments,” they write.

Shachar and Curfman also note that “these payments may undermine the reputation and trust of the medical profession, potentially damaging the complex relationship between patients and physicians.” If patients knew how much their doctor’s (conscious or unconscious) decision was potentially affected on the amount they were paid by medical device companies, this could certainly reduce trust in the medical profession– trust that we need now more than ever.

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How can we reduce unnecessary stenting? A series of articles in JAMA Internal Medicine provides some suggestions.

1. Update guidelines to incorporate more recent studies

An analysis in JAMA Internal Medicine from Dr. Ali O. Malik at St. Luke’s Mid America Heart Institute and colleagues looked at what would happen if leading cardiovascular societies incorporated findings from the recent ISCHEMIA study. The ISCHEMIA trial found that stents did not prevent strokes or heart attacks for for patients with stable heart disease, providing more evidence that stenting is not indicated for asymptomatic patients unless management of heart disease with medication fails.

Malik et al. examined a cohort of more than 350,000 patients with stable heart disease who had a stent placed from April 2018 to June 2019. They wanted to know, based on the findings of the ISCHEMIA trial, who in this cohort received a stent unnecessarily, and do these numbers differ from the appropriate use criteria (AUC) that cardiovascular societies generally use?

They found that 13% of the patients in the sample did not have symptoms but that the AUC originally categorized their procedures as “appropriate,” “maybe appropriate” or “unable to be classified.” However, incorporating the ISCHEMIA results would have led to these procedures being categorized as “rarely appropriate.” That 45,442 people who could have avoiding an unnecessary stent if the guidelines reflected the most recent evidence. The authors estimate that the number of stent procedures that are “rarely appropriate” could be as much as seven times higher than the amount the AUC currently classifies as “rarely appropriate.”

2. Hold providers accountable for egregious overuse

The second research letter in JAMA Internal Medicine investigates whether investigations of providers by the US Department of Justice for submitting false claims helps reduce unnecessary stent procedures. Dr. David H. Howard, Professor of Health Policy and Management at Emory University, and Dr. Nihar R. Desai, Associate Professor of Medicine at the Yale School of Medicine, looked at eight hospitals that were investigated for performing unnecessary stent procedures between 2007 and 2015. They matched these hospitals to hospitals in the same state that had similar volumes of stent procedures in 2006. Then they compared the number of low-value stent procedures performed at hospitals that were investigated with matched hospitals from 2006 to 2017.

Howard and Desai found that both groups of hospitals decreased their number of unnecessary stents substantially, but the hospitals that were investigated reduced their number of unnecessary stents more. In the 8 investigated hospitals, the average number low-value stents declined from 1440 procedures in 2006 to 271 procedures in 2017, a reduction of 81 percent. For hospitals that were not investigated, the average number of low-value stents declined by 68 percent, from 1168 to 369 procedures per year.

The hospitals that were investigated were perhaps more egregious in their submission of false claims, but they were not the only hospitals that performed a large number of unnecessary stent procedures. According to Howard and Desai’s analysis, the hospitals that were investigated performed about 14% of the unnecessary stents in the states they studied (Florida, New Jersey, Kentucky, and Maryland) in 2006. There were more than 200 other hospitals that performed at least 25 low-value stent procedures in these states during the study period.

These two studies provide avenues for reducing unnecessary stents, an endeavor that could save as much as $6 billion a year, estimate UCSF physician Dr. James Salazar and UCSF Professor and JAMA Internal Medicine Editor Rita Rubin in an accompanying Editor’s Note. However, Salazar and Rubin emphasize that much more needs to be done to reduce low-value stents in our health care system, such as our “enthusiasm for technology regardless of net benefits” and eliminating the incentive of fee-for-service payments for procedures that aren’t appropriate for the patient.

The post Two ways to stop unnecessary stenting appeared first on Lown Institute.

It’s also a good idea for another reason: many of these elective procedures were never needed in the first place, and they expose patients to unnecessary harm. In a recent article in The Conversation, University of Sydney Professor Adam Elshaug and director of the Grattan Institute health program Steven Duckett pointed out that COVID-19 could be an opportunity to significantly reduce low-value care.

Low-value care, also known as overuse, refers to medical services for which the harms outweigh the benefits for patients. Not all elective surgeries are low-value, nor are all low-value services elective. However, many elective procedures–such as spinal fusion, vertebroplasty for osteoperosis, knee arthroscopy for osetoarthritis, stents for stable heart disease, just to name a few–have proven to be no more effective than a placebo. Even more procedures reside in a gray area in which little is known about the true benefit to patients, because not enough research has been done.

Low-value procedures are not only ineffective, they expose patients to the risk of hospital-acquired complications. In a 2019 study in JAMA Internal Medicine, out of 9000 patients who received a low-value procedure in the hospital, 1.5% had a hospital-acquired complication. Seven percent of patients who underwent spinal fusion, carotid endarterectomy, or renal artery stents had a complication.

Why have hospitals continued to perform low-value elective procedures? “For most hospitals, elective surgery is where the money is,” said Shannon Brownlee, Senior Vice President of the Lown Institute. Most hospitals are paid fee-for-service, and elective surgeries are typically high-margin procedures that drive much of hospital revenue.

“For most hospitals, elective surgery is where the money is.”

Shannon Brownlee

In our health care system that rewards doing more (and more complex procedures), hospitals have to perform elective surgeries to survive financially. Now that hospitals cannot perform elective procedures, many are hemorrhaging money. Some are even furloughing health care workers because they cannot afford to pay them. We have created a system in which hospital financial stability is in some ways dependent on low-value care.

COVID-19 should be a wake-up call to policymakers and hospital administrators that our current hospital payment system is broken. But the pandemic gives us an unprecedented opportunity for change. As Elshaug and Duckett explain, the pandemic has swiftly reoriented hospital supplies and staff away from elective procedures and toward helping people who need it now–something policymakers have struggled to do for years. Although hospitals are itching to get back to doing elective surgeries–hospital groups have already released guidelines for returning to the status quo– we should not just go “back to normal” once the virus is more contained.

Here are some things we should be doing instead:

• Stop paying for low-value care. There are a great many tests and procedures that Medicare and Medicaid pay for, despite not showing evidence of benefit for certain patients. Government programs should stop reimbursing for these procedures when they are unnecessary, to reduce the incentives for clinicians to perform them.
• Switch to value-based payments rather than fee-for-service. Our fee-for-service reimbursement system for hospitals feeds into our desire to do more, regardless of whether or not it makes patients healthier. But fee-for-service is not the only way to pay hospitals. In Maryland, hospitals are reimbursed per patient through their global budget system, which gives them an incentive to keep patients healthy and out of the hospital. This type of reimbursement system would encourage hospitals to do some of the innovative practices they have started during the pandemic, such as increasing telehealth visits and moving towards community-based and home-based care.
• Evaluate hospitals based on overuse. Hospitals are evaluated on many quality metrics, but they are rarely evaluated for how often they provide low-value care, especially in the more well-known hospital rankings.

“Look at outcomes during this period of shutdown, and I bet you’ll see something shocking.”

Dr. Zubin Damania

Last, but not least: Take the opportunity to research health outcomes associated with fewer elective surgeries being provided nationally. “Look at outcomes during this period of shutdown, and I bet you’ll see something shocking,” said Dr. Zubin Damania, internist and founder of Turntable Health. Damania predicts a similar result as the 2018 study that examined health outcomes for people suffering heart attacks when interventional cardiologists were at conferences. They found that these patients were more likely to survive in the month after their heart attack than patients seen when all the cardiologists were present. Tracking patient outcomes during this pandemic will provide important information about the health effects of elective surgeries.

Hospitals are hoping to start up elective surgeries as soon as they can, but it is not clear whether this would benefit patients. We should take this opportunity to change how we pay for care, evaluate hospitals’ provision of low-value care, and measure the effects of reduced elective surgeries on patient health.

The post A silver lining to COVID-19: Fewer low-value elective procedures appeared first on Lown Institute.

In response to this campaign, the US Food and Drug Administration (FDA) unveiled a list of reforms they say will be “transformative” for medical device approval. But as Shannon Brownlee and Jeanne Lenzer argue in a recent Washington Post op-ed, these reforms will have very little impact on patient safety, because they don’t change the fundamental flaw in the medical device approval process — the fact that most medical devices can still be approved without undergoing any clinical trials in humans. 

“The FDA’s promised transformation is mere window dressing” – Shannon Brownlee & Jeanne Lenzer

About 80 percent of medical devices are approved through a process called the 510(k) pathway, which allows devices to be approved without a clinical trial, as long as the new device is similar enough to an already existing “predicate” device. The FDA’s plan to fix the gaps in regulation is to recommend that companies cite predicate devices no older than 10 years, a non-mandatory policy that device companies can easily circumvent. 

Underpinning the problems with medical device regulation is the fact that the FDA is a “captive agency” of industry, write Brownlee and Lenzer. The FDA relies on industry fees for 35% of their budget, and many of the scientists that work at the FDA either come from industry or later go on to work in industry (a phenomenon known as the “revolving door.”) As a result, the FDA sees drug and device companies as its primary customers, not patients. 

The FDA sees drug and device companies as its primary customers, not patients. 

What kind of regulations would result in real change for patients? Brownlee and Lenzer suggest several policies, including: requiring all implanted devices to undergo clinical trials before approval; create registries that track device outcomes; give the FDA sufficient public funding; and demand that FDA leadership be free from financial conflicts of interest. 

Brownlee and Lenzer’s op-ed has already garnered more than 350 comments in just a few days. Read the full piece and join the conversation at The Washington Post. 

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In his piece, Dr. Saini argues that by labeling stents as “ineffective,” we’re missing a key point of the ORBITA trial – the impressive power of medical therapy. The ORBITA story is the newest part of a decades-long battle to try and keep doctors from harming their patients by doing too much. Saini asks, how can we begin to advocate for a patient-centered approach based on evidence, when all other forces are pushing cardiologists toward surgical interventions?   

Read Saini’s piece published in Health Affairs here, and see a longer version of the remarks below, which includes additional historical and political context. You can read Brownlee’s piece in Health Affairs at this link.

The remarkable results of the ORBITA trial raise two important questions about how we practice medicine: what is our scientific paradigm to evaluate what works and who decides what matters to patients? In cardiology, a decades-long process of re-evaluation has been in progress ever since the defibrillator first enabled the massive expansion of cardiac surgery.

In 1977 when Bernard Lown, whose team had developed the first usable defibrillator in 1962 and who had pioneered the coronary care unit at Harvard, felt forced to start managing patients without a coronary angiogram to avoid the reflexive urge of the house staff and other attendings (they kept scaring his patients into surgery), he began to wake up in the middle of the night worried that someone would drop dead and he’d be run out of Harvard and out of the practice of medicine.

Lucky for him that didn’t happen. Instead he and his group, which I joined in 1984 as a fellow and then as an attending, went on to develop a methodical, meticulous approach to stable coronary artery disease that emphasized medical treatment, diet, exercise, risk factor management, and most importantly, attention to the role of psychological stresses in the patients life.

Their first paper on a series of 212 patients was initially rejected by the New England Journal of Medicine, then published after Lown complained publicly to the editor, Bud Relman, at a cocktail party. The study showed remarkably low mortality using their noninvasive approach.

There was incredulity from the cardiology mainstream. There were criticisms: that it was not randomized, that not all had the coronary angiograms to prove that they had the disease, and that the patient population was highly selected – all valid points , but also, in 1981, completely beside the point. A biological possibility, like Roger Bannister running the 4 minute mile in 1954, had been demonstrated.

Over the next 20 years, as word leaked out around Boston and literally all over the world, we developed probably the deepest and longest experience anywhere of what is now called optimal medical therapy. We saw hundreds of 2^nd opinion patients who had been told they needed surgery or stenting. Many even had an OR date scheduled. We managed 85% of them medically. They did well. We now have [currently unpublished] 12 year outcomes confirming those results. Furthermore, our analysis also suggests that the Appropriate Use Criteria developed in recent years by the cardiology professional societies to address this long-standing controversy are probably still insufficiently sharp an instrument to discern which patients are most likely to benefit from mechanical revascularization.

What has now become, cumulatively over many decades, a nearly trillion dollar question is this: how is it that such a heretical approach is conceived and executed, then ignored?

In the world of health care reform, it is now common to talk about “positive deviants”, i.e. out-of-the-mainstream examples of good clinical practice that ought to scale. Positive deviants should play a critical role in generating hypotheses by offering counter-narratives about what works. They also point to the risks of fetishizing randomized clinical trials in a situation where only the largest financial interests and the groupthink of the peer-review process can organize and conduct such trials.

That’s partly why old worldviews are so sticky. It took 25 years after Lown’s publication for the cardiology community to see the results of the COURAGE trial, which finally tested the value of stenting. It took another 10 years for the results of ORBITA to remind us that distorted worldviews can persist interminably.

Those results also remind us that another world is possible.

All of us therefore need to understand how such deviants arise in the first place, and then how to encourage them, embrace them and scale them up. At its core, the answer is that positive deviants arise out of the invention of an alternative approach powered by a alternative worldview.

Last week when I told Dr. Lown, who just turned 97, about this meeting, he had this to say:

“The situation is not futile, but advancing age brings great sobriety: it’s hard to influence a social enterprise like health when powerful economic interests are pushing in the opposite direction. If you can grapple with that, you can affect real social change.”

And make no mistake about it, this is not about one study or one paper. This is about changing social relationships. All you have to do is spend a few minutes on Twitter if you want to see the harsh thalamic reality of medical politics behind the masks of high mindedness.

If the results of the COURAGE trial, the first decent-sized RCT of stents vs medical management, were unsurprising to us at Lown, ORBITA on the other hand was at first glance astonishing. “Stents don’t work?” was the title we gave to the panel on ORBITA at our annual conference this year.

But upon reflection, we overreacted, and it seems to me that many people have been missing the forest for the trees. What’s been lost in the debate, ironically, is the remarkable power of medical therapy, underestimated for decades, driven by a mechanistic paradigm.

What’s been lost in the debate, ironically, is the remarkable power of medical therapy, underestimated for decades, driven by a mechanistic paradigm.

The initial astonishment at ORBITA’s results had been colored by the implicit, perhaps even unconscious comparisons to trials of medications where the control group consisted of people who are completely untreated. However, in ORBITA stenting was not compared to such a group; instead the control patient was treated with maximal medical therapy.

This confusion is understandable because the defined endpoint for ORBITA was explicitly derived from trials of medical therapy against no treatment. What the ORBITA team said was that since medical therapy in prior trials significantly improved exercise tolerance by nearly a minute in untreated patients, trying to detect a mere half a minute improvement with stenting seems really fair and reasonable. The logic (driven by the high confidence that stents are such powerful therapy) was that 30 seconds would be more than enough in patients, even those well-treated with medications.

Let’s be clear: ORBITA does not show that stenting is no better than sham for improving exercise tolerance – what it does show is that stenting is no better than sham for improving exercise tolerance in patients who have been optimized on medical therapy.

A more precise interpretation of the results therefore might be that compared to a completely untreated patient, optimal medical therapy has already captured most of the “therapeutic opportunity” for symptom relief. Beyond that, stenting is left without much more to add in most patients.

I think it’s important that we get this right and not overextrapolate. ORBITA has not disproven the idea that narrowing of the epicardial arteries of the heart can cause angina. Stenting did result in significantly more freedom from angina in the study. 

What it has shown is that persistent narrowing of a coronary artery is not by itself a sufficient cause for function-limiting angina. But most cardiologists knew that already, or should have. We can have angina without blockage. We can have blockage without angina. Sometimes angina can remit almost completely on a good medical program.

I suspect that with a large enough sample, one might well be able to show that stenting has an incremental benefit on exercise tolerance. But so what? For whom would that be of value? The answer is: only for a subset of patients of unknown size, probably much smaller than most have assumed.

ORBITA reminds us to ask about the context and purpose of therapy – are we seeking the abolition of symptoms or enough control to achieve a functional life? That depends on whether we are treating a 60 year old hard-charging business executive or an 85 year old grandma who goes for a short, slow walk every day.

We know that most people do not get an adequate trial of medical therapy. The reasons are many. Most cardiologists are not trained to do it with anything like the rigor we practiced under Dr. Lown’s tutelage. Moreover, when one’s worldview is skewed by the dominant paradigm, in which the “real” cause is the blockage and medications are merely “bandaids,” there is an understandable itchiness to get on with the “cure.” That is conveyed to the patient, the nursing staff, primary care physicians and everyone else in a myriad of ways.

Heart disease is a well-known killer, but Dr. Lown was fond of saying, after his mentor Dr Samuel Levine: “Angina pectoris is a benign condition.”

That simple, provocative, counterintuitive statement conjures an entirely different worldview from that of, say, Eugene Braunwald, also at the Brigham, and a dominant figure in American cardiology, who would tell his trainees that you couldn’t manage CAD competently without defining the anatomy with an angiogram.

And it is that difference in worldview that allowed the positively deviant practice of the Lown Cardiovascular Group. Like the Catholic doctrine of a preferential option for the poor, we need to cultivate an unconflicted bias in favor of the patient. The whole patient.

One very simple example: exercise tolerance testing. At the Lown lab our central goal was to assess the patient’s overall fitness and functional status using the treadmill, with the presence of angina or rhythm disturbances being critical, but secondary.

We did not stop the test for changes in the EKG, even if profound, nor for the mere presence of angina. Angina only stopped the test when, either due to the intensity of discomfort, or to changes in blood pressure, the patient had to stop. Of course to do this safely required intense scrutiny during the test, high vigilance, and (at least so it seemed to a young cardiology fellow) nerves of steel.

This focus on the patient allowed us to better discriminate who would benefit from an invasive intervention. Call it holistic stress testing. Is that unscientific? No. It addressed the prime directive – when practicing medicine, don’t treat the number. Assess the whole person and that person’s life.

Our task now as a society is to forge such a new worldview, a new paradigm throughout health care, one in which we’re going to need a different kind of doctor and a different kind of science.

As Dr. David Brown has cited Thomas Kuhn, let me cite his predecessor, the German philosopher Georg Hegel. To get to a new paradigm, we need to aufhebung – to abolish, preserve and transcend, all at the same time —  the old way of thinking. Central to that aufhebung is the need to transcend the pathological reductionism of our time. In other words, we need to bring the era of Flexner and Osler to a close and replace it with 21^st century science.

Did you know that you can build a whole scientific career on one molecule? And since there are almost an infinite number of molecules in the human body, there are infinite career opportunities, as well as infinite opportunities for monetization. The slogan in Kendall Square, Cambridge could easily be: A company for every molecule and a molecule for every company!

This problem runs so deep that even if the United States were to get to single-payer coverage, this work would remain, because without it, all those dancing molecules and their noisy PR promoters will bankrupt the nation.

But beyond a scientific revolution we’re also going to need a new social paradigm.

That paradigm is almost certainly going to require a redistribution of power to patients and communities, so they can get the scientific information they need and decide for themselves what matters most. What ORBITA reminds us is that patient preferences matter a lot in defining the right care. If the scientific enterprise cannot account for that need, it will soon become morally bankrupt.

There are many specific policy ideas that can help us get there – too many to enumerate here — but it’s going to be a long road.

There is incredibly good news however.

And this graph on the right is the proof. It’s a commonplace to point out that the US is a massive outlier among the OECD countries when it comes to healthcare spending. But what is less well-known is that our rogue status only emerged in the late 1970’s. In other words, the fault is not in our stars, nor in the air nor the water, nor in our DNA. Instead the graph shows that our current predicament is the tail end of a massive policy experiment.

And the results are in. We can debate the mechanisms, but reliance on the “magic of the market place,” as reflected in a series of policies adopted in the late 1970’s and early 80’s, has failed miserably in health care. This graph of paying more and more for less and less shows the sad result of the rent-seeking and wealth extraction that has come to dominate the American healthcare system today. It’s time for new thinking.

The post The real reason why ORBITA is groundbreaking appeared first on Lown Institute.

Now, several ORBITA skeptics have published letters in The Lancet with their feedback – and the authors have responded. Study authors Dr. Darrel P. Francis and Dr. Rasha Al-Lamee wrote a rebuttal to these letters that can only be described as a “mic drop.” 

Here are some of the common criticisms of the study that they knocked down:

“The study is too small!”

A common criticism of ORBITA is that it was “underpowered” – there weren’t enough patients in the sample to detect a difference from the intervention. However, the study had enough people to detect a 30-second difference in exercise time, which is a conservative effect estimate given that previous trials detected a 90-second effect. Also, the sample size of ORBITA (200) is similar to that of previous stent trials which were positive (the ACME trial had 212 people).   

“The study is too short!”

Some commentators thought that six weeks was not a long enough time to measure patient symptoms, and that measuring exercise time over a longer period would yield a better result. The authors wrote that they don’t know why someone would assume better long-term results, because “anatomical and haemodynamic relief is immediate, and the 6-week stress echo shows almost total eradication of ischaemia.”

“Those patients weren’t sick enough to benefit from a stent!”

Several writers contended that some patients in the study did not have severe enough angina to benefit from a stent, so they shouldn’t have expected a large change in exercise time. However, all the patients in ORBITA had already had the clinical decision before they were randomized – so their doctor believed that they needed a stent. Additionally, the authors note that “the proportion of patients had not had recent angina at randomisation (11%)  is similar to other unblinded trials showing impressive angina relief: 9% in ACME, 11% in FAME 2, and 13% in COURAGE.”

 “You did the stats wrong!”

Some commenters suggested using different statistical tests instead of the ones the authors used. The authors remind readers that other trials used the same statistical tests as ORBITA, and no one suggested they change the test for previous trials which were positive. More importantly, it would be unethical to change statistical methods once they have the data, just to get the result they wanted – that’s why prespecified analysis exists. 

Francis and Al-Lamee write that they were disappointed that stents didn’t do better than placebo, but they refuse to “apply a positive spin” on the study because, “as authors we have a duty to preserve scientific integrity.”

Read all of the letters and the authors’ rebuttal on The Lancet website.

The post The ORBITA debate continues: Authors refute letters in The Lancet appeared first on Lown Institute.