WASHINGTON — Health transparency rules have helped researchers gain more insight into hospital pricing practices, Ge Bai, PhD, CPA, said here Wednesday at an event sponsored by Georgetown University’s Center on Health Insurance Reforms.
The price transparency regulations that were part of the Affordable Care Act (ACA) “gave us unprecedented insight into what’s really going on in the commercial market,” said Bai, who is professor of health policy and management at Johns Hopkins Bloomberg School of Public Health in Baltimore.
For example, in a research letter published in 2023 in JAMA, Bai and colleagues analyzed price data that hospitals were required to post under the ACA transparency rule and found that “in the same county, the hospital-based colonoscopy [price] is almost 50% higher than the same service in a physician practice,” she said. Prior to the transparency rules, “we could not have such granular data.”
The researchers also found substantial variation in payments to individual hospitals, even when the payments were coming from the same health insurer. “Let’s say it’s Johns Hopkins [hospital] and Blue Cross Blue Shield,” she said. “Blue Cross Blue Shield has multiple plans, right? We found that within the same hospital and the same insurance company payer, the variation can be two times — if one plan pays $100 [for a particular service], the other plan pays $200. That tells us many insurance companies are not doing their job.”
States have become more active in requiring healthcare entities to be more transparent about their pricing, said Hemi Tewarson, JD, MPH, executive director of the National Academy for State Health Policy. “Since 2017, 24 states have enacted 38 laws requiring prescription drug supply chains to report information on drug prices,” she said, adding that requirements vary from having manufacturers report price increases and launch prices or new drugs above certain thresholds, to wholesalers being required to report on cost and volume, to health plans reporting on the most frequently prescribed and the most costly drugs they cover.
In addition, “there’s also 19 states that have enacted laws requiring PBMs [pharmacy benefit managers] to report information on drug coverage and other benefit management information. And there are a number of states that have passed a lot of PBM reform bills,” something Tewarson said she expects will continue into 2025.
Anthony Wright, executive director of Families USA, a healthcare consumer group, said the lack of transparency “drives consumers nuts. This is one of the few areas of public life where you can’t go and get the price for the service that you need.” And while the number of uninsured Americans is decreasing, “there are an increasing number of people who are underinsured, who have these high-deductible health plans or are otherwise exposed because they have co-insurance or other [payments] … These prices actually do matter to their very life — to their budget, to whether they can make the rent, and whether they can pay for groceries.”
Although transparency is improving, it’s still not enough, Wright said. “We need to have a better handle on this.” He noted that the “machine-readable” pricing data that hospitals are required to produce “is not what normal people need. In order for something to be ‘shoppable,’ it needs to be specific, and it needs to be searchable. It needs to be easy.”
And patients need to have some skin in the game if prices are to come down, said Bai. “We do not care if we spend other people’s money … If I don’t have skin in the game, if I cannot personally, directly benefit, I’m not going to care.”
Panelists at the event agreed that quality data was another element of healthcare services that needs more transparency; however, Bai urged caution about mandating more quality measures. “If we want to do a mandate, we should be careful because it could be counterproductive,” she said.
Joyce Frieden oversees MedPage Today’s Washington coverage, including stories about Congress, the White House, the Supreme Court, healthcare trade associations, and federal agencies. She has 35 years of experience covering health policy. Follow
After their younger son was bitten by a rattlesnake and ended up in the pediatric intensive care unit, a San Diego couple received a huge bill. Listen to hear why antivenom is so expensive.
This spring, a San Diego toddler spent two days in a pediatric intensive care unit after a rattlesnake bit his hand in his family’s backyard.
The bills that followed were staggering, with the lifesaving antivenom the 2-year-old needed accounting for more than two-thirds of the total cost — $213,000.
Why is antivenom so expensive? One explanation is the markup hospitals add to balance overhead costs and make money. Another explanation is a lack of meaningful competition. There are only two rattlesnake antivenoms approved by the Food and Drug Administration.
Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center, said it can be difficult to sort out drug pricing because a hospital bill is often an instrument insurers and hospitals use to negotiate prices. Patients such as the Pfeffers often get stuck in the middle.
“When you see the word ‘charges,’ that’s a made-up number. That isn’t connected at all, usually, to what the actual drug cost,” Dusetzina said.
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Many things can contribute to headaches, including family history and age. But people often notice a link between headaches and hormonal changes.
The hormones estrogen (ES-truh-jen) and progesterone (pro-JES-tuh-rohn) play key roles in the menstrual cycle and pregnancy. Hormones also may affect headache-related chemicals in the brain.
Having steady estrogen levels can improve headaches. But drops or changes in estrogen levels can make headaches worse.
However, you’re not completely at the mercy of your hormones. Your healthcare professional can help you treat or prevent hormone-related headaches.
During your period
The drop in estrogen just before your period may cause headaches. Many people with migraines report that they have migraines before or during their periods, also known as menstruation.
You can turn to proven treatments for migraines related to hormone changes. These treatments include:
Ice. Hold a cold cloth or an ice pack to the painful area on your head or neck. Wrap the ice pack in a towel to protect your skin.
Relaxation exercises. Learning these exercises can help lower stress. Stress can be a trigger for headaches.
Biofeedback. Biofeedback helps you monitor how your body responds to stress. It has been shown to help some people with migraines.
Acupuncture. Acupuncture may improve your headaches and help you relax.
Pain relievers you can get without a prescription. Your healthcare professional may recommend that you take a nonsteroidal anti-inflammatory drug, also known as an NSAID. This class of medicines includes naproxen sodium (Aleve) and ibuprofen (Advil, Motrin IB, others). These medicines may relieve your pain soon after your headache begins.
Triptans. These medicines block pain signals in the brain. Triptans often relieve headache pain within two hours. They also help with vomiting.
Antinausea medicines. Your healthcare professional may recommend medicines to treat nausea and vomiting that can happen with migraines. The medicines may include prochlorperazine (Compro) and promethazine (Promethegan).
Gepants. Calcitonin gene-related peptide antagonists, known as gepants, are newer medicines for treating migraine.
Other prescription pain medicines. Sometimes your healthcare professional may suggest other prescription pain medicines such as dihydroergotamine (Trudhesa, Migranal). These can’t be used with triptans.
Preventive treatment
If you have several very bad headaches a month, your healthcare professional may recommend taking NSAIDs or triptans before a headache begins. This may mean taking a headache medicine a few days before your period if you have regular menstrual periods. Then continue taking it during your period.
If you have migraines throughout the month, your healthcare professional may recommend that you take medicines every day. This also may be recommended if your periods aren’t regular. Daily medicines might include beta blockers, antiseizure medicines, calcium channel blockers, antidepressants or magnesium.
Your healthcare professional also might recommend monthly injections of a calcitonin gene-related peptide monoclonal antibody. The injections may help prevent headaches, especially if other medicines haven’t worked.
To decide which medicines may be right for you, your healthcare professional also reviews any other medical conditions you have.
Lifestyle changes also may help you have fewer headaches. These changes can shorten the headaches or help make them less painful. Lifestyle changes include reducing stress, not skipping meals and exercising regularly.
Hormonal birth control use
Hormonal contraception can change headache patterns. It can improve headaches in some people but might make them worse in others. Hormonal contraceptives include birth control pills, patches or vaginal rings.
Birth control may help relieve headaches by minimizing the drop in estrogen that happens during a period. You may have fewer migraines. Or your migraines may be less painful.
Using hormonal birth control to prevent migraines may be right for you if you don’t smoke and if you don’t have migraine with aura. But if you smoke or experience aura, talk with your healthcare professional before starting birth control that contains estrogen.
Migraine with aura means having nervous system symptoms before or during a migraine. You might see flashes of light or notice blind spots in your vision. Or you may have other vision changes. You might feel tingling in your hands or face. Rarely, migraine with aura can cause trouble speaking, problems using language or weakness on one side of the body.
Talk with your healthcare professional if you have migraine with aura. If you have new bouts of vision changes, sensory changes, weakness or trouble speaking without a migraine, seek medical care right away. This is true especially if you haven’t experienced these symptoms before.
If you have a history of migraine with aura, it’s important that you don’t take estrogen if you smoke. Smoking while taking birth control that contains estrogen puts you at higher risk of having a stroke.
While birth control can help relieve headaches for some, it may trigger headaches for others. But headaches might only occur during the first month of taking birth control. Talk with your healthcare professional if birth control triggers your headaches.
If birth control seems to cause your headaches, your healthcare professional might recommend:
Using a monthly birth control pill pack with fewer placebos. Placebos are pills that don’t contain hormones.
Stopping the placebo days completely for several months. This can be done by taking extended-cycle estrogen-progestin birth control pills. These pills typically are taken for 84 days, followed by seven placebo pills. You also might consider taking continuous-cycle estrogen-progestin birth control pills. This type of medicine is taken for a full year without any placebo pills.
Using birth control pills that have a lower dose of estrogen. This helps reduce the drop in estrogen during the placebo days.
Taking NSAIDs and triptans during the placebo days.
Taking a low dose of estrogen pills or wearing an estrogen patch during the placebo days.
Adjusting your use of a birth control patch. If you use a birth control patch during three weeks of the month, use a skin patch that contains estrogen on the fourth week.
Taking the minipill. If you’re not able to take estrogen-progestin birth control pills, the minipill norethindrone (Camila, Heather, others) contains progestin but not estrogen.
During pregnancy
Migraines often improve or even stop during pregnancy. This may be because estrogen levels rise quickly in early pregnancy and stay high throughout pregnancy. However, tension headaches usually won’t improve, as they aren’t affected by hormone changes.
If you have regular headaches, it’s important to talk with your healthcare professional about medicines that are safe during pregnancy. Have this conversation before getting pregnant. Many headache medicines can have harmful effects on a developing baby or their effects are not known.
If your headaches go away during pregnancy, they might return after delivery. This is because of the sudden drop in estrogen levels that happens after giving birth. It also may be due to stress, a change in eating habits and lack of sleep.
If headaches return while you’re breastfeeding, talk with your healthcare professional about which medicines are safe to take.
During perimenopause and menopause
Hormone-related migraines may become more frequent and painful during the years leading up to your last period, known as perimenopause. This is because hormone levels rise and fall as you approach your last period. You’ve reached menopause once you don’t get any more periods.
For some people, migraines improve once periods stop. But tension headaches often get worse. If your headaches continue, you likely can stay on your medicines or use other therapies.
Hormone replacement therapy, also known as HRT, is sometimes used to treat perimenopause and menopause. HRT may worsen headaches in some people, and it may improve headaches in others. Or it may cause no changes. If you’re taking HRT, your healthcare professional might recommend an estrogen skin patch. The patch provides a low, steady supply of estrogen.
If HRT makes your headaches worse, your healthcare professional might lower the estrogen dose. Or you might try a different form of estrogen or stop the hormone replacement therapy.
Talk with your healthcare professional if you’re considering taking HRT and you smoke.
You are unique
Some people are more sensitive to the effects of hormones. If headaches are affecting your daily activities, work or personal life, ask your healthcare professional for help.
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Nov. 20, 2024
Jankovic J, et al., eds. Headache and other craniofacial pain. In: Bradley and Daroff’s Neurology in Clinical Practice. 8th ed. Elsevier; 2022. https://www.clinicalkey.com. Accessed Jan. 11, 2023.
Migraine. Office on Women’s Health. https://www.womenshealth.gov/a-z-topics/migraine. Accessed Jan. 11, 2023.
Magro I, et al. Headache in pregnancy. Otolaryngologic Clinics of North America. 2022; doi:10.1016/j.otc.2022.02.013.
Kirkpatrick L, et al. Preventive approaches in women’s neurology: Prepartum, pregnancy and postpartum. Seminars in Neurology. 2022; doi:10.1055/a-1958-0633.
Understanding migraine with aura. American Migraine Foundation. https://americanmigrainefoundation.org/resource-library/understanding-migraine-aura/. Accessed Oct. 28, 2024.
Nappi RE, et al. Role of estrogens in menstrual migraine. Cells. 2022; doi:10.3390/cells11081355.
Jiang Y, et al. Recent advances in targeting calcitonin gene-related peptide for the treatment of menstrual migraine: A narrative review. Medicine. 2022; doi:10.1097/MD.0000000000029361.
Kissoon NR (expert opinion). Mayo Clinic. Jan. 20, 2023.
Van Lohuizen R, et al. Considerations for hormonal therapy in migraine patients: A critical review of current practice. Expert Review of Neurotherapeutics. 2023; doi:10.1080/14737175.2023.2296610.
Menstrual migraine treatment and prevention. American Migraine Foundation. https://americanmigrainefoundation.org/resource-library/menstrual-migraine-treatment-and-prevention/. Accessed Oct. 29, 2024.
The London Clinic and Northwestern Medicine are teaming up for a strategic international collaboration that seeks to expand both organizations’ commitments to advancing healthcare delivery and improving patient outcomes.
WHY IT MATTERS
The London Clinic is one of the U.K.’s largest independent charitable organizations. Al Russell, CEO of the London Clinic, called the partnership with the Chicago-based health system a “defining moment” in the independent hospital’s history.
“Not only have we found a partner that shares the same not-for-profit values, but one with the scale that will give our charity access to the resources we need.”
While the clinic said it will draw on Northwestern’s healthcare innovation, technology experience and research to improve patient outcomes and increase its community impact, the nonprofit academic health system said it is also seeking to build partnerships with other international healthcare organizations.
In addition to a shared commitment to expanding community outreach and access to care, the collaborators will combine clinical expertise to deliver better care through innovative and advanced treatment and share best practices to optimize operational efficiencies.
THE LARGER TREND
Northwestern Medicine has leveraged cutting-edge technologies in its focus to improve clinical decision-making and increase access to care.
Through partnerships with Dell’s AI Innovation Lab and Dell Technologies, the health system has helped to develop artificial intelligence to advance the practice of medicine in working to develop generative multimodal large language models that can be integrated into hospital workflows, such as evaluating chest X-rays.
“When we think about what AI can do, we don’t just see the technology itself; we see the many patients and lives it will positively impact,” Dr. Mozziyar Etemadi, Northwestern’s medical director of advanced technologies, said in a statement in August.
ON THE RECORD
“Driven by our Patients First mission, we believe this strategic collaboration has the potential to redefine patient care and accelerate our ability to learn and share from a like-minded organization with an exceptional reputation for clinical care,” said Dr. Howard Chrisman, Northwestern’s president and CEO, in a statement.
“Leveraging the expertise of both organizations will enhance our collective ability to implement innovative healthcare solutions and drive breakthrough research for the betterment of all patients.”
I have skin in this game – my dad is the president of St Austell Wheelers cycle club in Cornwall. Over the years, I have bought him everything from a Bart Simpson bicycle bell (which he selflessly attached to his Ribble road bike) to a myriad of jerseys, to Rouleur mugs with his favourite riders’ faces on them. I have got it right and disastrously misjudged it (that bell – sorry, dad).
This year, he says, “There are two things on my wishlist: a new pair of legs, or an electric bike!” He’s in good company; commentating legend Phil Liggett is also a fan of e-bikes. “Young and old alike are discovering the freedom of the roads, lanes and tracks by pedalling with a little assistance,” he says.
Clearly, there are mountains of options out there, so we’ve spoken to a whole host of two-wheeled enthusiasts to find the gifts that cyclists really want for Christmas.
Laura Laker, cycling journalist, co-host of the Streets Ahead podcast and author of Potholes and Pavements, says protective neckwear is a great gift “because the weather can be unpredictable, and snoods don’t flap around like a scarf”.
“It’s common for cyclists not to stretch enough, and even commutes can tighten muscles over time,” says Laker. “There’s good evidence that foam rollers reduce muscle soreness after an intense effort (like chasing a rain cloud home), while massage sticks and massage balls are good stocking fillers.”
“On returning from a ride covered in muck, luxurious-feeling bath products can work wonders, physically and mentally,” says Laker. “Bath salts soothe aching muscles, while oils help get some of the stickier splashes off – and they’re kinder than Swarfega. Neal’s Yard offers some great options.”
“For the cyclist who has everything,” Laker suggests supporting a cycling charity. “Cycling UK’s staff and volunteers are superheroes, fighting for cycling day in, day out. You get free third-party insurance with membership, plus a regular members’ magazine and bike shop discounts.”
Are you even a cyclist if you aren’t wearing Oakley glasses? Sam Challis, tech editor at Cyclist magazine, suggests the Sphaera because they have “an oversized lens for an expansive field of view and frames that have been shaped to play nicely with modern helmets”.
A more affordable option, Challis says, is the 100% Slendale glasses. These are a “toned-down update on one of [former Slovak cyclist] Peter Sagan’s favourite models – slimmer, and therefore lighter, with cut-outs in the lens for ventilation”.
A seat pack is an overlooked accessory, according to Challis, but this one will “protect multitools from rust, and there’s space for everything you’d need”. Neat.
Do you have a child who’s into BMX? Ken Floyde, chair and founder of the Brixton BMX Club, suggests a BMX race bike, a full-face BMX helmet, knee and elbow pads, or body armour, as “once they have these, they can go ride at a BMX track”. Floyde’s track in Brockwell Park will be open on Christmas Day for eager riders.
The alternative is a BMX Street Bike with stunt pegs, which they can ride at a skatepark, says Floyde, who “would dearly love the [1984] book BMX from Start to Finish by Ken Evans and Andy Ruffell”.
Martine Tommis, a cyclist with the women’s club Team Glow in Manchester, suggests the bookCoffee First, Then the World by cyclist Jenny Graham about her round-the-world cycle.
Chris Boardman, former Olympian turned cycling advocate and National Active Travel commissioner, says: “My ideas of fitness and health now are exploring by bike in the Cairngorms.” He suggests Ordnance Survey mapping software as a gift because it gives him “the confidence to explore widely”.
For all-weather cycling, whether commuting or for pleasure, waterproof over-trousers are a must. While most have a waterproof jacket, these “complete the coverage and stop the weather being a barrier”, says Boardman.
Marlon Plein, of BabyLDN, builds custom bikes from recycled, unloved, discarded bicycles and runs a community bike repair and spares shop in south-east London. He would love a cargo bike. “An Omnium would be a godsend, so I can carry large items and large quantities from A to B with ease. They’re light, sturdy and super-practical.”
Professional photographer Juan Trujillo Andrades has travelled all over Europe photographing cycling and is a keen rider himself. He loves gravel riding and suggests an “insulated or down jacket that’s warm, comfy and looks the part when going through muddy lanes or hopping around town”.
Do you struggle to get out in bad weather? “Sometimes a bit of inspiration is what you need,” says Trujillo Andrades, who suggests “a collection of prints from the Handmade Cyclist dedicated to the five ‘monuments’”.
Handlebar bag
Wizard Works Lil Presto barrel bag, from £52 wizard.works
For those who take a more relaxed approach, a handlebar bag is perfect “to carry not just essentials like tools and your phone, but also a sandwich or some homemade biscuits. They are easily removed if you want to lock your bike somewhere and take your valuables with you,” says Trujillo Andrades.
Fran Brown, a nine-time world champion in paracycling, recommends a bike-specific pressure washer as “the easiest and quickest way to clean your bike and kit after messy winter rides without ruining any of the components”.
“An insulated flask-style drink bottle can turn a miserable winter ride into a far nicer experience,” says Brown. She also says that an Audible subscription is perfect for entertainment as you pedal on a turbo on days when outdoor rides are out of the question.
Energy bars that taste good
Veloforte starter pack, £20.89 veloforte.com Veloforte protein bars variety pack, from £16.82 amazon.co.uk
Emily Chappell, winner of the 2016 ultra-endurance Transcontinental Race and author of Where There’s A Will, recommends stuffing a stocking withVeloforte energy bars as “unlike most sports nutrition, they’re actually enjoyable to eat”.
“This is simply the best portable pump I’ve come across,” says Chappell. “A foldable foot peg turns it into a track pump, and it’s more comfortable to use than any other I’ve tried, meaning you don’t find yourself giving up before the tyre’s properly inflated.”
For bikepacking, “the beam can be red or white, meaning that [this headlamp] can make a good addition to – or emergency substitute for – regular bike lights. They’re tiny and lightweight, and the drawstring means they attach easily to almost anything; body, bike or bag,” says Chappell.
St Austell Wheelers member Dave Bulled started cycling two years ago. “To begin with, I only went on short 10km rides, but I enjoyed it so much that I joined a club and started to record my rides on my smartwatch, which was super useful for keeping track and improving my fitness,” he says.
Clare Taylor, a fellow St Austell Wheelers club member and GP, wants accessories to keep warm on winter rides, so suggests waterproof gloves, overshoes, warm waterproof Sealskinz socks and merino wool base layers.
In her stocking, Taylor would love “a big pot of the ultimate chamois cream, an essential for a comfortable ride as it minimises chafing between your skin and the pad in your cycling shorts. This brand is known to be a cyclist’s favourite.”
Taylor is also after a decent “coffee lock”, cycling lingo for a lock to secure your bike while you enjoy a reviving shot of caffeine mid-ride. “After all, cycling is all about the cake and coffee stops,”she says.
Turbo trainer for cold weather
Zwift Ride indoor bike with Wahoo Kickr Core, £1,199.99 uk.zwift.com
Wahoo Kickr Core Zwift One indoor turbo trainer, £449.99 uk.wahoofitness.com
For Mani Arthur, founder of the Black Cyclists Network, a “Zwift indoor bike is the best way to get you through the winter”. The Wahoo Kickr Core Zwift One indoor turbo trainer is a cheaper option.
For those whose extremities run cold, whether on the road or up a mountain, heated gloves may be the ultimate luxury. This pair has leather palms, breathable insulation, a waterproof layer and a rechargeable battery with up to six hours of toasty time.
Every cyclist needs a helmet, but for Arthur, it has to be this one, which is “currently worn by [Slovenian cyclist] Tadej Pogačar”, who won the Giro d’Italia, Tour de France and the men’s elite race at the Road world championships in 2024. I think we can call that tried and tested.
This nifty piece of kit “will get you out of most emergencies”, says Arthur. It includes various allen and torx keys, Phillips and flat-head screwdrivers, a chain split link breaker, spoke keys and a small knife with a part-serrated blade.
If he is confirmed as H.H.S. secretary, the longtime vaccine critic would be in a position to change the government’s immunization recommendations and delay the development of new vaccines.
CHICAGO — Secondhand permanent pacemaker use in poorer countries, following thorough cleaning and repackaging, has not resulted in patient harm so far, according to the My Heart Your Heart trialists.
In patients who could not afford new devices on their own, use of so-called “reconditioned” pacemakers met criteria for non-inferiority on the basis of infections at 90 days compared with new devices (1.5% vs 2.9%), reported Thomas Crawford, MD, of University of Michigan Health in Ann Arbor, at the American Heart Association (AHA) annual meeting.
The randomized trial’s preliminary results from 90 days also showed similarly low complications at 90 days between new and used pacemaker recipients, respectively (P>0.1 for all comparisons):
Infection resolved with antibiotics and pacemaker removal: 2.2% vs 1.5%
Cellulitis resolved with antibiotics: 0.7% vs 0%
Lead dislodgement: 5% vs 7.3%
Pacemaker removal: 2.2% vs 1.5%
Death: 0% vs 2.2%
“There were no observed malfunctions or failures of the pulse generator in either new or reconditioned pacemakers. Longer-term follow-up will be necessary to confirm the safety and efficacy of reconditioned pacemakers,” Crawford told the audience. The study’s full 12-month report is still pending, with audit of the clinical data entry ongoing at some sites.
Crawford explained the rationale for testing the postmortem reuse of pacemakers: without a truly low-cost pacemaker on the market, many patients in low- and middle-income countries would have no access to this therapy. Compared with a $2,000 device sold new in these countries, the off-label reuse of pacemakers could make devices available for $50 to $100 each to patients who need them (with additional leads costing $50 to $200 separately), he estimated during an AHA press conference.
When it comes to promoting equitable access and social justice in medicine, “this is a great example of walking the walk and not just talking the talk,” commented Miguel Leal, MD, of Emory University in Atlanta, discussing My Heart Your Heart during the press conference.
“It’s great that we have these no-inferiority endpoints met, because now we have momentum to stimulate this type of science to be reproduced in many centers, hopefully with bigger numbers of patients and also longer-term follow-up,” Leal added.
My Heart Your Heart is a randomized single-blind trial conducted in Venezuela, Nigeria, Paraguay, Kenya, Mozambique, and Mexico. Participating sites have to demonstrate qualified physicians and facilities. Among the ethical, legal, and regulatory obstacles investigators faced were obtaining an FDA export permit and foreign government approvals. Devices picked for reprocessing in the trial all have to have at least 4 years of remaining battery life.
“Collaboration between centers of excellence in the U.S., charitable organizations, and foreign entities may allow safe and effective large scale pacemaker reconditioning,” Crawford suggested.
“We were able to establish relationships with physicians there who had the implementation skills and who also were able to access the government to allow this process to happen … Understandably, institutions are risk averse, and so it’s not something that’s legal anywhere in the world, even though it happens in those countries,” he added.
Leal said the ability to expand the My Heart Your Heart program relies on local infrastructure.
“We have to identify certain metropolitan areas in these countries and make them centers for dissemination of technique and knowledge,” he said. “We produce in the United States approximately 120 electrophysiologists per year. More than 150 countries in the world have zero electrophysiologists. So there’s also that big gap that needs to be addressed as well, but it starts with this type of initiative.”
My Heart Your Heart was conducted by volunteers and companies providing free services. At seven sites in six countries, there were 298 people randomized to a new pacemaker or a reconditioned device from 2022 to 2024. Both groups were around age 70 and roughly evenly split between men and women.
Patients had to have a class I indication for de novo bradycardia pacing and no financial means of buying a new pacemaker. Those deemed ineligible for the study — having severe comorbidities, age younger than 18 years, or pregnancy, among other criteria — could be offered devices as part of a registry.
The trial was designed with the primary endpoint being freedom from procedure-related infection at 12 months. A key secondary endpoint is freedom from pacemaker software or hardware malfunction or unexplained death at 12 months.
By 90 days, when there was infection in a patient, it had occurred about 20 days from implant of a new device versus 41.5 days from implant of a reconditioned device.
Study authors acknowledged that a larger sample size may be needed to show differences in device failure or other rare events.
Crawford cautioned that besides device cost, plenty other barriers stand in the way of pacemaker adoption in low- and middle-income countries, including limited diagnostic tools, a lack of properly equipped facilities and trained staff, and patient education.
“In many of these countries, the physician has to kind of break the concept out of the blue and say, ‘Hey, there’s such a device that can actually make you feel better, can make you live longer. You’ve never heard of it, but we got one from a deceased person in the United States here,'” he said. “There’s a lot of work that needs to be done in actually disseminating the knowledge about what this technology can do for a patient.”
Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
Disclosures
The My Heart Your Heart trial was funded by charitable giving.
Crawford disclosed no relationships with industry.
Leal disclosed a relationship with Medtronic.
Primary Source
American Heart Association
Source Reference: Crawford T, et al “Preliminary results of randomized trial of new versus reconditioned pacemakers for patients unable to obtain a new device in low and middle-income countries: the My Heart Your Heart Randomized Controlled Trial (MHYH-RCT)” AHA 2024.