Inflammation a Core Feature of Depression

 New research suggests that depression and inflammation are biologically linked ― a finding that may have important implications for patients whose condition fails to respond to treatment with antidepressants.

In the largest-ever examination of genetic, environmental, lifestyle, and medical drivers of inflammation in major depressive disorder (MDD), levels of the key inflammation marker C-reactive protein (CRP) were higher in patients with depression than in those with no mental disorder.

This was true after adjusting for sociodemographic factors such as age, sex, body mass index (BMI), alcohol consumption, early-life trauma, socioeconomic status, and physical health ― evidence a core biological mechanism is at work.

The study's joint senior author, Carmine Pariante, MD, Kings College London, London, United Kingdom, said there may be elements of cause and effect in the presence of inflammation in depressed patients.

"We know that patients with depression can have profound changes in all aspects of the body, mostly associated with the stress responses. So the activation of the immune system is present in depression, possibly because it's together with other stress responses," he told a news briefing

The study was published online May 14 in the American Journal of Psychiatry.

Breaking a Vicious Cycle

In animal models, stress stimulates the entire immune system, bone marrow included, which leads to the hyperactive production of immune cells.

Humans with depression also produce more white blood cells, particularly monocytes. The release of these important immune cells into the bloodstream prompts further response elsewhere in the body.

Inflammation is an immune response to infection or other stresses on the body. High inflammation levels are associated with autoimmune disorders and can be risk factors for cardiovascular illness or other ailments.

"Then the immune factors they have circulated, they are able to go back and influence the brain. They either change the blood-brain barrier, or move across the blood-brain barrier, or transmit the signal ― the information ― across the blood-brain barrier and perpetuate the depressive systems by changing the function of brain areas responsible for interpretation of emotions," said Pariante, professor of biological psychiatry at the Institute of Psychiatry, Psychology and Neuroscience, Kings College London.

All this results in a negative feedback loop in which inflammation makes the body believe it is under threat, produces a more robust immune response, and perpetuates or exacerbates depressive symptoms.

"That's why it's so important to understand what is happening but also to break this vicious cycle, because then we could really change the outcome and potentially improve the treatment of these patients," he said.

The findings indicate there may be a benefit in including anti-inflammatories in the treatment regimens of patients with MDD whose condition does not respond to antidepressants. Changes to lifestyle and diet, such as adding high-dose fish oil supplements, and increased exercise could help as well, Pariante said.

In part, this is because inflammation dampens the effectiveness of antidepressants by reducing the brain's production of mood-determining chemicals such as serotonin.

"We need to remember that around one third of depressed patients don't respond to any of the available medication, so we are a long way from having a silver bullet that can help all depressed patients," he said.

He noted that even if only some patients with MDD could be helped by the addition of an anti-inflammatory, that would be a "really important step forward."

A New Finding

For the study, the investigators analyzed blood samples, genetic data, and physical and health questionnaires collected by the UK Biobank, a database of information from more than half a million UK participants who were recruited from 2006 to 2010.

The study compared 26,894 patients who had received a lifetime diagnosis of MDD with 59,001 control persons who had no known mental disorder.

Although the researchers found a link between the genetic predisposition for depression ― as indicated by a polygenic risk score ― and higher levels of inflammation, this association disappeared when higher BMI and smoking were removed from the analysis.

This contrasted with autoimmune disorders such as rheumatoid arthritis, in which the association between genetic risk and inflammation remained after correcting for behavioral factors.

Pariante said this was a new finding.

"Here we've shown that the genetic contribution to inflammation in depression comes mostly from eating and smoking habits," said joint senior author Prof Cathryn Lewis, head of the Social, Genetic and Developmental Psychiatry Center at the Institute of Psychiatry, Psychology and Neuroscience, King's College London.

"That finding is important to help us understand depression better," she said.

Previous studies have shown that patients with depression have high levels of inflammation, but no study has been as large as the current one or has dealt with such a wide range of causative factors.

Pariante said the results may also have implications for long-COVID patients, many of whom suffer exhaustion or depression.

"The research on long COVID-19 is still at the beginning. There's much more discussion than actual data," he said in response to a question from Medscape Medical News. Some studies have indicated that patients who experience higher levels of inflammation during SARS-CoV-2 infection were more likely to suffer mental disorders 3 to 6 months after having COVID-19.

"So it is definitely this biological pathway through which high levels of inflammation change brain functioning, induce symptoms...that are relevant to fatigue, for example, or to lack of motivation or lack of willingness to engage in social activity. This could be relevant to some people with long-COVID," Pariante said.

As previously reported by Medscape Medical News, a study published online April 6 in The Lancet showed that one third of 236,379 COVID-19 survivors in a US database were diagnosed with at least 1 of 14 psychiatric or neurologic disorders within a 6-month span. The rates of illnesses ranging from depression to stroke were much higher among those who required hospital admission.

The authors cited several limitations of the study, including the fact that lifetime depression was diagnosed in participants 6 to 10 years after the collection of blood samples and that CRP analysis was based on a single blood sample.

Am J Psychiatry. Published online May 14, 2021. Abstract

https://www.medscape.com/viewarticle/951135

After the Pandemic: Chronic Pain Care May Be Virtually Transformed

 For MedPage Today's "After the Pandemic" series, we asked our editorial board members to discuss what significant and lasting effects the COVID-19 pandemic will have on medicine and the delivery of healthcare.

Here, we interview Beth Darnall, PhD, associate professor in the department of anesthesiology, perioperative, and pain medicine at Stanford University School of Medicine and director of the Stanford Pain Relief Innovations Lab in Palo Alto, California.

Can you share an anecdote about a patient and how the pandemic affected his or her situation?

Darnall: This story is about a person who is not my patient but whose care I am deeply aware of. Her medical emergency was a confluence of the pandemic and the ice storms that occurred in Texas several months ago.

She has an intrathecal pump for pain management that was due for refill, but travel was impossible. As the medical system often provides patients no back-ups for such emergencies, her situation was such that the pump would run dry, be destroyed, and thus require surgical explant and reimplantation with a new device -- a highly burdensome and costly exercise.

The other emergent issue was opioid withdrawal with no recourse or oral medications available to address this -- an extremely stressful situation occurring while home temperatures were in the 40s and the house ceiling had collapsed.

The clinic had minimal hours due to COVID and then the storm, but she was able to arrange for an 11th-hour emergency visit that required a total of 4 hours of driving (to and from the clinic) during icy conditions when travel was discouraged, forcing her to incur additional risks.

Such weather-related emergencies are rare, though her story illustrates the compounding burdens patients face with obtaining pain management when these situations occur, particularly when options are restricted due to the pandemic.

Chronic pain care changed for patients during the pandemic; many used telehealth for the first time, for example. Will some of these changes continue once the public health emergency ends?

Darnall: For psychologists, restrictions around telehealth and interstate care have been relaxed. We need continuation of this flexible model to ensure patients have access to the care they need.

What are some success stories, either in chronic pain treatment or in research, that emerged during the pandemic? What promise do they hold for post-pandemic times?

Darnall: Clinically, many psychologists are reporting much higher patient engagement rates for behavioral treatments (e.g., pain management classes, cognitive behavioral therapy) since these moved online.

Our group ran a fully online study, a randomized controlled trial of a single-session pain relief skills class, during the pandemic. We enrolled 100 people with chronic pain in the first 11 days that study enrollment was open. People want convenient home-based pain care; we had the highest engagement for this study than any other study we have conducted.

We had similar engagement for another randomized placebo-controlled study of home-based virtual reality treatment for chronic pain. We enrolled about 180 community-based participants in about 1 month and had excellent engagement with both study interventions (therapeutic and sham virtual reality).

Of course, the best part is treatment efficacy: people are showing improvements across a range of outcomes with durability of those effects. Collectively, we are seeing good support for home-based pain care as being scalable and meeting patients' needs and wants.

What did the pandemic teach chronic pain patients and clinicians?

Darnall: My takeaways:

1. We need systems in place to ensure patients have access to their prescribed medication in emergent situations. Otherwise, patients risk iatrogenic harms because the medical system is not prepared to help them navigate environmental issues.

2. Telehealth appears to be acceptable and convenient for many.

3. Patients are eager for home-based pain management options.

Disclosures

Darnall leads NIH and PCORI-funded clinical trials that investigate behavioral medicine for acute and chronic pain and is chief science advisor at AppliedVR.

https://www.medpagetoday.com/special-reports/after-the-pandemic/92573

Let's Stop Subsidizing Obesity

 Obesity is one of the leading health challenges in the U.S., so why is the federal government subsidizing it among low-income Americans?

This question comes to mind in response to President Biden's efforts to increase benefits for participants in the Supplemental Nutrition Assistance Program (SNAP), the nation's largest food relief program for low-income individuals. However, any changes in SNAP -- formerly known as food stamps -- should be tied to reforms that promote healthier eating. Public health experts, big-city mayors, and even SNAP beneficiaries support such a move.

The Role of SNAP in Rising Obesity Rates

The country's rising obesity rate provides the backdrop to the need for SNAP reform. More than 42% of American adults, and nearly 20% of children are obese, leaving the U.S. with the highest obesity rate in the world among nations with at least 5 million people.

While people typically face an increased risk of obesity-related conditions over time (such as hypertension, diabetes, and cardiovascular disease, as well as several types of cancer, including of the breast, brain, liver, and pancreas), we've seen during the COVID-19 pandemic that the health implications of obesity can be immediate. Obesity is associated with a greater risk of COVID-19-related hospital admissions, intensive care, and mortality.

More than 40 million Americans benefited from SNAP in fiscal year 2021, and almost half (43%) of beneficiaries are children. Given the program's size, it could be a powerful vehicle for healthier eating and a lower obesity rate.

Instead, it is contributing to the obesity epidemic. Beyond a prohibition on the purchase of hot food, alcohol, tobacco products, vitamins, or medicines, virtually any other food or beverage item -- including soda, candies, and processed meats -- can be purchased with SNAP benefits.

The result is high levels of SNAP spending on many of the foods and beverages at the root of the nation's obesity epidemic. About 20 cents of every SNAP dollar goes toward sweetened beverages, desserts, salty snacks, candy, and sugar, according to a report commissioned by the U.S. Department of Agriculture (USDA). Soft drinks, potato chips, and processed meats are among the top ten items purchased with SNAP benefits. Regular consumption of these calorically dense and nutritionally poor foods is associated with an increased risk of obesity, cardiometabolic conditions, and cancer. Processed meat has been classified by the World Health Organization as a Group 1 human carcinogen, putting it in the same category as asbestos and tobacco.

Permitting unlimited purchases of nutrient-poor food is emblematic of how SNAP fails its beneficiaries and contributes to elevated obesity rates in lower-income individuals -- rates that are nearly eight percentage points higher than among those with higher incomes, according to the CDC. SNAP participation is also associated with increased body weight, and the program's beneficiaries have lower dietary quality and worse health indicators than those who are eligible for the program but don't participate.

In a study conducted at the Harvard School of Public Health, researchers compared the diets of SNAP participants to low-income adults not receiving SNAP benefits. The researchers found SNAP participants consumed 39% fewer servings of whole grains and 46% more servings of red meat. Among women, SNAP participants consumed 61% more sugar-sweetened beverages than non-participants.

Policy Change As a Remedy

One option to help address this issue is to limit the use of SNAP benefits to products that meet rigorous nutritional standards. In 2013, 18 mayors endorsed this idea. The mayors -- including Michael Bloomberg, Cory Booker, and Rahm Emanuel -- represented most of the country's largest cities. In a letter, they called for testing and evaluating approaches that would limit SNAP's subsidization of products such as sugar-sweetened beverages.

Similarly, the lead researcher on the Harvard study said, "Further consideration needs to be given to policies to create incentives for SNAP participants to access and purchase healthier foods, and to limit the purchase of unhealthy food with SNAP benefits."

Restrictions on benefits-eligible foods would not be unique to SNAP. Other federal programs, such as the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), prohibit beneficiaries from purchasing candy, soda, or snack foods. After this change was made to WIC in 2009, researchers at Yale University found that WIC-authorized stores in Connecticut began carrying more healthy food options -- a development that may be replicated with SNAP purchasing reforms. Such restrictions are likely one reason why participation in WIC is not correlated with increased body mass index.

While some advocacy groups oppose purchasing restrictions on the grounds that they would stigmatize SNAP beneficiaries, beneficiaries see the issue differently. A statewide survey of SNAP participants in California found 74% support for a ban on using the program's benefits for soda purchases. Another survey of more than 400 SNAP beneficiaries found 54% of respondents supporting such a ban. And close to half of those who opposed the ban said they would support it if it involved providing additional benefits to purchase healthy foods.

Those extra benefits were at the heart of a pilot project the USDA launched in Hampden County, Massachusetts in 2011. About 7,500 of households receiving SNAP benefits received an extra 30 cents for every dollar of assistance spent on fruits and vegetables at participating retailers. The effect? Consumption of fruits and vegetables was 26% higher among those in the pilot project relative to those who were not.

Poor dietary patterns, and the resulting obesity, have been steadily eroding the health of the U.S. population for decades. COVID-19 has illuminated the urgent need to address obesity-related health risks, especially in economically disadvantaged communities. Reducing those risks through fundamental changes to how SNAP benefits are utilized is long overdue.

Vanita Rahman, MD, is the Clinic Director at the Barnard Medical Center, a clinical instructor in medicine at the George Washington University School of Medicine, and author of Stronger with Plants. Matthew Rees is editor of the Food and Health Facts newsletter and a senior fellow at Dartmouth's Tuck School of Business.

https://www.medpagetoday.com/primarycare/obesity/92509

Some aren’t ready to give up masks despite new CDC guidance

 Like more than 120 million other Americans, Jan Massie is fully vaccinated against COVID-19 and can pretty much give up wearing a mask under the latest guidance from the Centers for Disease Control and Prevention. But she’s still covering her face, even as the temperature rises in her native Alabama, because of benefits she says are too great to give up.

The retired educator didn’t catch the illness caused by the new coronavirus, and she also didn’t get the flu or her twice-yearly colds while masked during the pandemic. Unlike some, she’s not gotten any hostile blowback in public for wearing a mask. So why quit now?

“I’ve worn a mask where it really wasn’t required,” Massie, who lives in suburban Birmingham, said Saturday. “Many people, more than I expected, still are, too.”

With COVID-19 cases on the decline after more than 580,000 deaths and with more than a third of the U.S. population fully vaccinated, millions are deciding whether to continue wearing face masks, which were both a shield against infection and a point of heated political debate over the last year. People have myriad reasons for deciding to stop, or continuing to wear, a mask.

Many are ready to put aside the sadness, isolation and wariness of the pandemic. Ditching face masks — even ones bedazzled with sequins or sports team logos — is a visible, liberating way to move ahead. Yet others are still worried about new virus variants and the off-chance they might contract the virus and pass it along to others, though the risks of both are greatly reduced for those who are fully vaccinated.

Denise Duckworth was among the unmasked as she strolled through a revived French Quarter in New Orleans, where jazz musicians and tourists have returned to the streets.

“I’ve always been against masks, and I think all their rules have been hypocritical, and they’ve been confusing,” said Duckworth, visiting from Kansas City, Missouri.

Like most others, Duckworth wasn’t wearing a face mask on an upbeat Friday that made the Quarter feel more normal than it had in months. Alex Bodell of Ithaca, New York, stood out in the crowd because of the black mask covering his nose and face, but he was more at ease that way.

“I certainly feel a lot more comfortable, and I think I’m enjoying myself a lot more here being fully vaccinated and feeling that, you know, kind of regardless of my mask that I’m covered,” he said.

The CDC last week said fully vaccinated people — those who are two weeks past their final dose of a COVID-19 vaccine — can quit wearing masks outdoors in crowds and in most indoor settings and give up social distancing. Partially vaccinated or unvaccinated people should continue wearing masks, the agency said.

The guidance still calls for masks in crowded indoor settings including buses, airplanes, hospitals, prisons and homeless shelters. But it clears a path toward reopening workplaces, schools and other venues that went dark during the pandemic.

Maskless during an outdoor event in Fargo, North Dakota, college student Andrew Kodet said he’s been immunized and will follow the CDC guidelines.

“If you’ve been vaccinated and you’ve put the effort into it to avoid spreading the disease, it’s about time to begin this rebuilding process,” said Kodet, 20. “There is nothing political about it with me.”

Near Boston in Cambridge, Massachusetts, epidemiologist Vanessa Li isn’t past the two-week point of her second vaccine dose and is continuing to wear her mask even outside, particularly when lots of other people are around.

“I guess I am hesitant to take it off because it’s been such a habit and internationally there’s been different strains and different risk levels,” said Li, 25, of Somerville. “Global travel is picking up and it’s still prevalent, so I’m not really sure how at risk everyone is at the moment.”

Wearing a mask as he made an espresso at his coffee shop in San Francisco, Justin Lawrence said he’s got to comply with local rules that mandate facial coverings for indoor activities.

“It puts small businesses in the place of having to police people all over again, and you can’t tell by looking at somebody that they’ve been vaccinated,” said Lawrence, who co-owns Fayes Coffee in the Mission District.

The decision to continuing wearing a mask came down to uncertainty for Evan Mandel. Both vaccinated and masked as he waited outside to enter the Art Institute of Chicago, Mandel said there are enough questions that he avoids joggers who are breathing heavily and could send particles carrying the virus that much further.

“I still hold my breath or get off to the side,” he said.

And then there are rules. Andy Lamparter wore a mask at Saturday’s Preakness Stakes in Baltimore, where Pimlico Race Course required them amid a sharply reduced crowd of 10,000 people, but he wasn’t too happy about it. “It’s annoying because I do have my shots,” he said.

Raquel Mitchell recovered from a bout of COVID-19 in December and is adamant against getting a vaccine, which she doesn’t trust because of the quick development. She’s still wearing a mask and taking other precautions, like dining outdoors at restaurants near her home in New York’s East Harlem area and either asking for plastic utensils or bringing her own.

When will she feel it’s safe enough to ease up?

“I don’t know. Never,” said Mitchell. “It’s going to be really difficult for me.”

https://apnews.com/article/us-news-coronavirus-pandemic-lifestyle-health-e19a27a9ad10da204b0f0d64fd4bfcf1

Taiwan upbeat on economic prospects despite COVID-19 spike

 Taiwan’s economic prospects are bright and growth this year will come in as expected so long as the COVID-19 situation can be quickly brought under control, the government said on Sunday, pointing to limited impact from a recent spike in cases.

Export-dependent Taiwan raised its coronavirus alert level in the capital, Taipei, and the surrounding city on Saturday, imposing two weeks of restrictions that will shut many venues and limit gatherings after a rise in community transmissions.

In a statement after Premier Su Tseng-chang held a meeting with top economic officials, such as central bank governor Yang Chin-long and Economy Minister Wang Mei-hua, Taiwan’s Cabinet said they all agreed the outlook was good.

The profits of listed companies have increased significantly over last year, and export orders are also performing well, it added.

The current pandemic situation is having a short-term impact on consumers, but as long as infections can be controlled soon, added to a proposed T$210 billion ($7.51 billion) in government spending support, expectations for 2021 economic growth can be maintained, it said.

The Cabinet proposed the new spending on Thursday, though it still needs parliamentary approval.

The sudden rise in domestic cases last week spooked Taiwan’s stock market.

Su urged all departments to keep a close watch on market developments and “take necessary steps for the normal operation of financial institutions and order and stability of the stock and foreign exchange markets”, the Cabinet added.

Regulator the Financial Supervisory Commission said it would step in to ensure stability if there were “irrational falls” on the stock market, but gave no details.

Taiwan’s economy grew at its fastest pace in more than a decade in the first three months of 2021 as the “work from home” boom sparked strong global demand for the island’s hi-tech exports.

In March, the central bank raised its 2021 estimate for gross domestic product (GDP) growth to 4.53% from 3.68% forecast in December and has said further upward revisions are likely.

Taiwan’s manufacturers, such as the world’s largest contract chip maker, Taiwan Semiconductor Manufacturing Co Ltd , are a key part of the global supply chain for technology giants such as Apple Inc.

https://www.reuters.com/article/healthcoronavirus-taiwan-economy/update-1-taiwan-upbeat-on-economic-prospects-despite-covid-19-spike-idUSL2N2N3029

ACC 2021: BMS unveils more data for mavacamten, nabbed in $13B MyoKardia buyout

 Bristol Myers Squibb ponied up $13 billion for MyoKardia last fall, just months after it showed its targeted drug could prevent thickened heart muscle from blocking blood flow in patients with an inherited heart disorder. Now, the Big Pharma is unveiling more data from that phase 3 study, highlighting the drug’s effect on patients’ symptoms and quality of life. 

Dubbed Explorer-HCM, the study pitted the drug, mavacamten, against placebo in 251 patients with obstructive hypertrophic cardiomyopathy. Also called HCM, the inherited disorder causes the muscle walls of the heart to thicken, potentially to the point where they can obstruct blood flow. 

After 30 weeks, the drug, mavacamten, beat placebo at improving patients’ scores from baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ), a measure of how patients perceive their health status, including their heart failure symptoms and how they affect their quality of life, and physical and social function. 

The analysis also found that more than twice as many patients on mavacamten than placebo logged an improvement of more than 20 points on the questionnaire (36% versus 15%), a change that Jay Edelberg, M.D., Ph.D., head of heart failure and cardiomyopathy development at Bristol Myers, called “transformative.” 

The new analysis was presented virtually on Saturday at the annual meeting of the American College of Cardiology. 

The KCCQ is an important tool for cardiologists caring for patients with HCM, who may experience their own unique symptoms, said Edelberg, who was previously the chief medical officer at MyoKardia. 

Thickening of the heart muscle and obstructions can lead to chest pain, palpitations, fatigue, lightheadedness or fainting, though some people may not show symptoms at all. Left untreated, patients can develop heart failure and require interventions such as ablation or open surgery. 

“The KCCQ is important, of course, for showing how they are doing in their day-to-day management,” Edelberg said. But that’s not all: “It’s not just an element of feeling better, but actually, it is a prognostic indicator. An improvement of five points is considered clinically meaningful.” 

Unlike other HCM treatments, which focus on managing symptoms, mavacamten is designed to tackle the condition at its source. It inhibits myosin to reduce the excess number of cellular motors that engage with each heartbeat, thereby cutting the strength of each contraction of the ventricle. This way, the person’s pulse rate can stay the same while the heart has an easier time pumping and refilling with blood. 

“What we’ve seen with mavacamten is that so many of our patients have really improved their symptoms,” Edelberg said. “They’ve improved their ability to exercise, and we’ve seen almost 30% of our patients become asymptomatic after just 30 weeks.” 

Last August, MyoKardia presented data from the study showing the drug beat placebo at improving patients’ heart function and oxygen consumption after 30 weeks. Two-thirds of the mavacamten patients hit that mark compared with 17.2% of patients who received placebo. Those data teed up an FDA submission for mavacamten, which the agency accepted in March. It expects to decide the drug’s fate by Jan. 28, 2022. 

As Bristol Myers starts working with regulators to win approvals for mavacamten in obstructive HCM, it will continue developing the drug for other types of heart disease, including non-obstructive HCM and heart failure with preserved ejection fraction (HFpEF), a type of heart failure which the organ pumps normally, but its tissue is too stiff to fill properly. The company is also testing whether the drug can spare patients from surgical procedures.

https://www.fiercebiotech.com/biotech/acc-2021-bms-unveils-more-data-for-mavacamten-nabbed-13b-myokardia-buyout

ACC 2021: 10-minute add-on heart surgery cuts stroke risk by one-third

 As long as surgeons have a patient under anesthesia for one heart procedure, they may as well make it two—and according to a new study, the benefits in preventing future strokes could last a lifetime.

Researchers examined whether making a quick detour during surgery to close off the left atrial appendage—a small pouch in the wall of the heart muscle, where it’s believed blood can pool and form dangerous clots—could help reduce the overall risk of stroke in patients with atrial fibrillation that isn’t caused by a heart valve.

They found that taking less than 10 minutes to seal that appendage with sutures, staples or other surgical devices could reduce the number of ischemic strokes by at least a third—or by up to 42% over the long term, after the initial 30 days following the procedure.

This benefit would come on top of commonly used prescription blood thinners, with no evidence of additional side effects seen in the randomized study, which was halted early due to the procedure’s observed progress. 

“We were ecstatic to see these results,” said the study’s lead author, Richard Whitlock, a cardiac surgeon at McMaster University in Canada, who described them as confirmation of a new paradigm in stroke prevention. The late-breaking data were presented during the annual scientific sessions of the American College of Cardiology and published in the New England Journal of Medicine.

“This trial opens a new option for treatment of these patients by layering a mechanical approach—occlusion—on top of a medical approach,” Whitlock said. “Instead of a tension between anticoagulation and occlusion, we need to start thinking about using these as additive approaches when patients are at high risk for stroke.”

The study only examined approaches taken during open surgery for another heart condition, rather than transcatheter devices used to obstruct the appendage’s opening—such as Boston Scientific’s Watchman or Abbott’s Amplatzer Amulet—which can be delivered separately in a minimally invasive procedure.

It enrolled more than 4,800 participants in 27 countries, with about two-thirds undergoing procedures to treat their heart valves and about 20% receiving coronary artery bypass grafts. All had documented atrial fibrillation and high risks of stroke, and all received a standard course of blood thinners after surgery.

After a median follow-up of nearly four years, 4.8% of patients who received occlusion had suffered a stroke, compared with 7% of patients who had not received the additional procedure. The overall rates of death, including 30-day mortality, and hospitalizations for heart failure remained similar between the two groups.

“This is a procedure that’s done once, and it keeps giving a benefit over time,” Whitlock said. “This is going to prevent thousands of strokes.” 

Abbott is currently putting its Amplatzer device up against a newer generation of blood thinners in a head-to-head study, to see if it can serve as an alternative to a lifelong medication regimen.

The randomized trial is expected to collect at least two years of data on non-vitamin K antagonist oral anticoagulants, or NOACs, such as the blockbuster drugs Eliquis, Xarelto and Pradaxa, among patients with atrial fibrillation. The Amplatzer, meanwhile, is threaded into the heart through a cut in the thigh, before expanding to seal the gaps formed by the appendage.

Previously, a 2015 study of Boston Scientific’s Watchman found that the device became more effective and less costly than warfarin after 10 years, and outpaced the category of newer blood thinners after five years.

In a separate late-breaking Watchman study also presented this year at ACC, real-world data showed Boston Scientific’s implant led to stroke rates 77% lower than typically expected among older people with atrial fibrillation and high risk scores. 

However, the registry also demonstrated all-cause mortality and bleeding were consistent with the co-morbidities in the elderly, underlining “the need to individualize one’s approach to stroke prevention so that patients reap the clinical benefit of stroke reduction,” said lead author Matthew Price, director of the cardiac cath lab at Scripps Clinic.

https://www.fiercebiotech.com/medtech/acc-2021-researchers-find-10-minute-add-heart-surgery-cuts-stroke-risk-by-one-third