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Big data, Cardiovascular Medicine, Patient Care, Public Health, Research, Stanford News

Widely prescribed heartburn drugs may heighten heart-attack risk

Widely prescribed heartburn drugs may heighten heart-attack risk

PrilosecHeartburn – that burning sensation in the chest that occurs when stomach acid rises up into your esophagus – has absolutely nothing whatsoever to do with the heart. People with heartburn (that’s a lot of us) are at no increased risk of developing heart disease. At least, not unless they’re taking the most commonly used class of drugs for treating heartburn.

That drug class would be proton-pump inhibitors, or PPIs, and it includes omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium) and a few more. All three are available over the counter. Although the labels direct users not to take these drugs for longer than a couple of weeks without consulting their physicians, people often pop them on a daily basis for months or years on end.

But a new PLOS ONE study, led by Stanford biomedical-informatics expert Nigam Shah, PhD, MBBS, and cardiovascular surgeon Nick Leeper, MD, shows a clear association between prior use of PPIs for heartburn and elevated risk of serious cardiovascular events including heart attacks. In a news release covering that “big data” study, which combed through nearly 3 million electronic health records to ferret out the PPI/cardiovascular-risk connection, I wrote:

… PPIs are among the world’s most widely prescribed drugs, with $14 billion in annual sales… In any given year, more than 20 million Americans – about one in every 14 – use PPIs… More than 100 million prescriptions are filled every year in the United States for PPIs, a class of drugs long considered benign except for people concurrently taking the blood thinner clopidogrel (Plavix). However, the new study upends this view: It indicates that PPI use was associated with a roughly 20 percent increase in the rate of subsequent heart-attack risk among all adult PPI users, even when excluding those also taking clopidogrel.

That increased risk was seen among younger adults (under age 45), too.

The study, in other words, found that everybody’s cardiovascular risk goes up if they use PPIs. Now, a 20 percent increase in risk may not amount to much if your baseline risk is very low to begin with (say, that of a 20-year-old woman in top physical condition with no genetic predisposition to high blood pressure or elevated cholesterol). But for many of us, especially if we’re middle-aged, a little pudgy, or struggling with hypertension or hypercholesterolemia, that 20 percent looms larger.

Importantly, people who take the second-most-widely prescribed class of drugs prescribed for heartburn, so-called H2 blockers, appear to suffer no ill effects from them in the cardiovascular-risk department, according to the study’s findings. H2 blockers, which have been around longer than PPIs, are reasonably effective.

So, why do PPIs, but not H2 blockers, cause trouble? As I noted in my release:

The study’s findings lend support to an explanation for an untoward effect of PPIs on heart-disease risk proposed by Stanford scientists a few years ago. Research done then showed that PPIs impede the production of an important substance, nitric oxide, in the endothelial cells that line all of the nearly 100,000 miles of blood vessels in an averag adult’s body.

Nitric oxide relaxes blood vessels. So it figures that chronic use of a drug that shuts down that chemical’s generation could cause chronic blood-vessel constriction and follow-on cardiovascular problems.

Read those labels, people.

Previously: How efforts to mine electronic health records are beginnning to influence critical care, New research scrutinizes off-label drug use and Damage to dead-cell disposal system may increase heart disease
Photo by John

 

Bioengineering, Cardiovascular Medicine, Stanford News, Surgery, Technology

A jugaad for keeping pacemakers in place

A jugaad for keeping pacemakers in place

This post is part of the Biodesign’s Jugaad series following a group of Stanford Biodesign fellows from India. (Jugaad is a Hindi word that means an inexpensive, innovative solution.) The fellows will spend months immersed in the interdisciplinary environment of Stanford Bio-X, learning the Biodesign process of researching clinical needs and prototyping a medical device. The Biodesign program is now in its 14th year, and past fellows have successfully launched 36 companies focused on developing devices for unmet medical needs.

IMG_6308After months of observing clinics and winnowing down the most pressing (and commercially viable) medical needs, the Stanford-India Biodesign team has developed what looks like nothing so much as a very elaborate clothespin. It is intended to help doctors ensure that coiled pacemaker leads that screw into heart tissue stay put. Currently, about five percent of those leads fall out, requiring costly additional surgery. Worldwide, the number of people whose leads fall out is estimated at 80,000 to 100,000.

Debayan Saha says their prototype is a perfect example of Indian Jugaad. It’s made of what looks like the contents of a scrap pile, and he says could both work and be cheap to produce in it’s current low-tech form. But just because it’s inexpensive doesn’t mean it’s not cleverly designed. That’s what the Indian team brings to Biodesign, he said – smart technology at low cost.

“Getting the prototype exactly right made use of all the resources we have here at Stanford,” Saha said. “But the final product is something we could produce at very low cost.” Creating technology in a developing country requires creative solutions to keep that technology affordable.

IMG_6326The group has a provisional patent on their device and they will present their it to the entire biodesign team June 8. Until that presentation they are keeping it’s exact function under wraps. They did recently test the prototype in a lamb heart, with good results. They were consistently able to screw the pacemaker lead more securely into the heart tissue.

Harsh Sheth, MD, said the team (which also includes Shashi Ranjan, PhD) will be heading back to India at the end of June and will repeat the same process there – visiting clinics, assessing needs, and prototyping a solution. He said they might later return to their Stanford prototype or keep working on whatever they design in India.

Previously: From popsicle sticks to improved medical careThe next challenge for biodesign: constraining health-care costs and Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India
Photos, of Debayan Saha screwing a pacemaker lead into a lamb heart using their prototype, and of the coiled screw going into the heart, courtesy of Amy Adams

Cardiovascular Medicine, Events, Patient Care, Stanford News

Honoring doctors, nurses of the early days of Stanford’s coronary care unit

Honoring doctors, nurses of the early days of Stanford’s coronary care unit

image.img.320.highWhen I was in the hospital recently to give birth to my daughter, I saw my doctors briefly during their rounds, but it was the nurses and nurse midwives who primarily cared for me. So when I read in a recent Inside Stanford Medicine feature story that 50 years ago, nurses weren’t even allowed to perform tasks like start IVs, I was shocked.

In the 1960s, Stanford was home to one of the earliest coronary care units, led by Alfred Spivack, MD. Spivack taught the nurses working on the unit to take on tasks that were, at the time, mainly done by physicians. Joan Fair, PhD, RN, who was one of the unit’s original nurses and is now a cardiovascular researcher, recalls:

“Some doctors were totally against nurses doing these kinds of things… It also took time for some doctors to accept our opinions about how their patients were doing, or if we saw a problem and called them and asked them to take a different line of treatment.”

Joan Mersch, MSN, the unit’s former nurse coordinator, described in the piece how beneficial this extra training was to patients. “When you know how to read electrocardiograms, recognize lethal cardiac rhythms, perform resuscitation and defibrillation — it saves patient lives,” she said. “You understand what needs to be done, and you can take action.”

A big proponent of using technology to improve care, Spivack depended on the nurses to learn how to use the devices and incorporate them in the daily care of patients. And he also encouraged the nurses to pursue their research interests; many, like Fair, went on to obtain graduate degrees.

Last month, almost two dozen former nurses from the unit came together for a dinner celebrating a major gift from Spivack, which will pay for the nurses’ station in the new heart acute care unit when the new adult hospital opens in 2018.

Photo by Steve Fisch

Bioengineering, Cardiovascular Medicine, Stanford News

From popsicle sticks to improved medical care

From popsicle sticks to improved medical care

This post is part of the Biodesign’s Jugaad series following a group of Stanford Biodesign fellows from India. (Jugaad is a Hindi word that means an inexpensive, innovative solution.) The fellows will spend months immersed in the interdisciplinary environment of Stanford Bio-X, learning the Biodesign process of researching clinical needs and prototyping a medical device. The Biodesign program is now in its 14th year, and past fellows have successfully launched 36 companies focused on developing devices for unmet medical needs

IMG_6141 300Shashi Ranjan, PhD, and Harsh Sheth, MD, fiddled with popsicle sticks and tiny wires in the final throes of prototyping possible biodesign solutions for two medical needs: fixing pacemaker leads or improving catheter urine drainage.

The popsicle stick device hardly looked like something that would inspire confidence in a person undergoing surgery, but if it worked and could be miniaturized and made out of more durable materials it could provide a solution for the pacemaker leads that are prone to coming unfixed after they are inserted.

The team had narrowed their search down from the 315 medical needs they had originally identified using a weighted matrix of requirements. Sheth told me that what stood out about addressing the final two needs was the large number of people who could benefit, lack of other solutions and lack of competing products.

All of those add up to a product that could inspire venture funding and eventual development, which is the goal of the biodesign process.

Sheth said the prototypes they were building now would help determine which of the two needs the group eventually chose to address, and how. They had four ideas to try out for the pacemaker leads and five ideas for improving urine drainage. “We’ll know which of these ideas have value after this step,” Sheth told me.

The group (which includes Debayan Saha, who was elsewhere during this prototyping session) returns to India after the Stanford phase of the fellowship ends in June. At that point they’ll repeat the process of identifying medical needs and prototyping solutions in India. Sheth and Ranjan said they hope to have patents in place for their Stanford prototype, with the idea of potentially returning to it after the fellowship.

Previously: The next challenge for biodesign: constraining health-care costsFollowing the heart and the mind in biodesign and Stanford-India Biodesign co-founder: Our hope is to “inspire others and create a ripple effect” in India

Cardiovascular Medicine, Pediatrics, Stanford News, Transplants

Ventricular assist device helps teen graduate from high school

Ventricular assist device helps teen graduate from high school

TJ Balliao verticalWhen 17-year-old TJ Balliao was diagnosed with heart failure earlier this year, his doctors at Lucile Packard Children’s Hospital Stanford told him that he needed to receive a ventricular assist device right away. TJ was experiencing bouts of unstable heart rhythm so serious that medication alone wasn’t enough to keep him alive. The VAD, a pump implanted in his heart to help it move blood through his body, could help him survive long enough to receive a heart transplant.

But something unexpected happened after the surgery to implant TJ’s ventricular assist device. He made a strong recovery – so strong that his cardiologist, David Rosenthal, MD, offered him the opportunity to go home with his VAD, graduate from high school with his class this June, and delay a heart transplant indefinitely.

In a recent story I wrote about TJ’s case, Rosenthal explained how this could benefit TJ not just now, but also in the long run:

“It’s possible that using a VAD to intentionally delay a heart transplant could add to the patient’s total lifespan,” said Rosenthal, who directs the hospital’s pediatric heart failure and transplantation program and is professor of pediatrics at the Stanford University School of Medicine. “Survival after transplant is not as long as the natural lifespan, especially for children.”

The benefits of a VAD are many. It helps patients maintain strength while waiting for a new heart; otherwise, heart failure weakens the body, making recovery from eventual transplant more difficult. When a child is stabilized by use of a VAD, the medical team can be more selective about choosing a donor heart that is an excellent match for the recipient, too. “Plus,” said Rosenthal, “there is some likelihood that a small proportion of patients’ hearts will be able to recover and those children will avoid transplant completely.”

TJ and his medical team aren’t sure if or when he will ultimately move toward getting a heart transplant. But he’s been accepted to San Jose State University to study civil engineering, so he may be in class in the fall with his VAD battery pack at his side.

Previously: Packard Children’s heart transplant family featured tonight on Dateline, Liberated from LVAD support: One patient’s story and Pediatric social worker discusses the emotional side of heart transplants
Photo courtesy of Lucile Packard Children’s Hospital Stanford

Cardiovascular Medicine, Medical Education, Research, Stanford News

Stanford med student/HHMI fellow testing new way to deliver treatment to heart

Stanford med student/HHMI fellow testing new way to deliver treatment to heart

Jensen and Woo 560

The human heart has fascinated second-year medical student Christopher Jensen ever since he first flipped through anatomy books as a child. Now, the Howard Hughes Medical Institute (HHMI) has given Jensen a special opportunity to pursue his passion.

Jensen is one of 68 medical students from across the U.S. chosen to take part in the HHMI Medical Research Fellows Program. This program gives medical students a chance to try their hand at research by offering them funding, mentorship and a full year to explore the medical research project of their choice.

Recently, I spoke with Jensen about his interest in the heart and his HHMI project. “I was homeschooled,” Jensen told me. “My parents bought me books on biology and I thought that anatomy – the heart in particular – was fascinating.”

Later, when Jensen studied biology at school, his interest grew: “The more I learned about the heart, the more I wanted to understand it better. I was in awe and wonder of how this one organ could supply blood for the whole body.”

Jensen’s curiosity about the heart led him to Stanford where he met his HHMI mentor, Y. Joseph Woo, MD, chair of Stanford’s Department of Cardiothoracic Surgery. “When I saw Woo’s work I was enthralled,” Jensen said.

Jensen’s one-year research project with Woo will focus on a growth factor, called Neuregulin-1ß, that plays an essential role in the development of heart, skin and brain cells. “We’ve already demonstrated neuregulin’s ability to rescue and regenerate heart muscle immediately after a heart attack,” Jensen told me.

In these studies, Neuregulin-1ß is given during surgery as an injection to the heart. This delivery method prevents neuregulin from acting on the entire body (which could have negative side effects) but it limits this treatment to surgical procedures. Jensen’s goal is to develop a non-surgical way to target heart cells with the neuregulin treatment so it can quickly be given to a patient after they have a heart attack.

Over the next year, Jensen and Woo will test a special hydrogel that could provide a way to transport neuregulin through the veins to targeted tissues in the heart. The hydrogel, Jensen explained, forms a gummy, slow-dissolving solid when it reaches the heart. This therapy could help cardiac surgeons target heart cells with Neuregulin-1ß for long periods of time whenever the treatment is needed. “This would be a phenomenal advancement and could pave the way for minimally invasive therapies in the hospital,” Jensen said.

“I’m excited about this research,” Jensen told me. “It could lead to other work in the field or a career in cardiac surgery and research.” It also possible that, one day, it could lead to a therapy to treat patients suffering from heart failure.

Previously: A new era for stem cells in cardiac medicine? A simple, effective way to generate patient-specific heart muscle cells
Photo courtesy of Christopher Jensen

Cardiovascular Medicine, Chronic Disease, Patient Care, Stanford News

Monitoring heart failure from home

Monitoring heart failure from home

blood pressure readingSometimes, the best way to prevent a visit to the hospital is to become your own care provider. That’s the theory behind a new Stanford-led project that monitors heart-failure patients at home.

From an Inside Stanford Medicine story on the pilot program:

“There is abundant evidence in the literature that suggests home monitoring can improve patient outcomes,” said Rita Ghatak, PhD, director of Stanford’s Aging Adult Services, one of the sponsors of the program. “It can improve survival, days out of the hospital, quality of life and it provides an extra measure of psychosocial support.”

Project leaders teach heart-failure patients, such as 74-old-year Earl Shook, who is featured in the story, how to measure their blood pressure and oxygen saturation at home. Patients also receive visits from specially trained nurses. A nurse caught when Shook’s blood pressure was climbing too high and helped get him in to the cardiologist the next day.

Shook said it was hard to leave the hospital, but he was reassured by the home-monitoring program. “It let me know there was somebody still caring for me.”

Previously: Exercise may boost heart failure patients’ mental and physical health, Failing at prescribing the best heart-failure treatments and Home health-care treatments for lymphedema patients cut costs and improve care 
Photo by sriram bala

Ask Stanford Med, Bioengineering, Cardiovascular Medicine, Stanford News, Technology

The next challenge for biodesign: constraining health-care costs

The next challenge for biodesign: constraining health-care costs

This post is part of the Biodesign’s Jugaad series following a group of Stanford Biodesign fellows from India. (Jugaad is a Hindi word that means an inexpensive, innovative solution.) The fellows will spend months immersed in the interdisciplinary environment of Stanford Bio-X, learning the Biodesign process of researching clinical needs and prototyping a medical device. The Biodesign program is now in its 14th year, and past fellows have successfully launched 36 companies focused on developing devices for unmet medical needs.

5445002411_0f22229afd_z 300Founder and director of the Stanford Biodesign Program Paul Yock, MD, describes himself as a “gismologist.” His inventions include a balloon angioplasty system that is in widespread use and many other devices primarily related to ultrasound imaging of the vascular system. I recently spoke with him about the program he helped found, the iterative biodesign process, and the ongoing relationship with the Stanford-India Biodesign Program.

What’s next for the Stanford Biodesign Program?

We’ve been really pleased with the results of the Biodesign Program so far in terms of being able to take newcomers into the process, then repeatedly and reliably seeing good ideas coming out and seeing patients getting treated from those good ideas.

The challenge is that the world has changed profoundly since we founded this program. There’s no question that new technologies – despite being good for patients – contribute to escalation of health-care costs. We are in a phase of reinventing our process to take into account the fact that the sickest patient in the system is the system itself. We have to invent technologies that help constrain costs. We will need to modify the process of needs-finding not only to look for important clinical needs but important value needs as well. Inventors in general don’t like thinking about economics and so we have to not only figure out how to update the process but also figure out how to make it attractive for our fellows to learn and practice.

Could the India fellows help you incorporate affordability into the process?

One of the big reasons we decided to do the India program in the first place was to shock our system into thinking about really affordable technology innovation. It is remarkable how good our fellows from India are at thinking this way and how immersed they have been from an early age with value-based design and invention.

Affordability is very much a part of the Indian culture and technology innovation is clearly something that we are very good at here. I think we have only started to capitalize on the fusion of their culture and ours. I think there is a hybridization here that really is going to be cool. Our grand strategy is to have a number of different platforms – it could be companies, incubators, or other experiences – where our fellows can get a deep exposure in India. We aren’t fans of parachuting people in for two weeks to invent something good to give to India. What we really want to do is have trainees get a deep experience in what it’s like to invent and develop technologies in that setting to influence the way we invent here.

How did you arrive at the drawn out, iterative process the fellows use to identify medical needs they want to address?

There’s a long tradition of what is called user centered design that says if you want to design a product you need to talk to the user and understand what their needs are. That’s essentially where our process starts. What’s fundamentally different with health care is that there isn’t just one user. There’s this really complex network of stakeholders who influence whether a technology will actually make it into patient care. You can’t just design for the patient because there are also the doctors, nurses, hospitals, insurance companies, regulatory agencies and financers to name a few. To make it all still more complex, this whole system is in tremendous flux because of health-care reform.

So what we’ve done is blow out the needs characterization stage to take all these stakeholders into account in a rigorous way, up front, before any inventing happens.  There’s also a bit of psychology at play here. In health care it is really easy to fall in love with the first need that comes your way. Looked at in isolation, pretty much any clinical need looks compelling. You need to put in a disciplined process, a semi-quantitative way of weighing one need against the other in order to make a good decision about which need to pursue. It is easier to get rid of the one you thought you loved if it really doesn’t meet the criteria you set out.

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Behavioral Science, Cardiovascular Medicine, Patient Care, Research, Stanford News

A little help from pharmacists helps a-fib patients adhere to prescriptions

A little help from pharmacists helps a-fib patients adhere to prescriptions

TurakhiaIt’s not always easy to take drugs as prescribed — life often gets in the way of taking a pill at the same time each day. And it’s relatively easy to ignore the tiny printing on a medication container, to rationalize why that doesn’t apply to you, or how a few exceptions certainly wouldn’t hurt.

Except sometimes precise prescription adherence is important. And that’s the case for a new class of blood thinners such as dabigatran that are used to treat atrial fibrillation.

With these twice-daily oral drugs, “even missing a few doses can lead to acute events such as stroke,” said Mintu Turakhia, MD. Along with other researchers, Turakhia was puzzled when he learned that patients weren’t adhering very well to these drugs. It seemed surprising because the drugs didn’t require frequent blood tests like warfarin, the traditional blood thinner used to treat atrial fibrillation.

Digging into the data, Turakhia and his team found that adherence varied by treatment site, not by individual patient. How odd, they thought. To figure out what was going on, “we rolled up our sleeves and looked at what each site was doing,” Turakhia said.

My colleague explained the result of the researchers’ work, which appears today in the Journal of the American Medical Association, in a release:

At the sites with the highest patient adherence, there was usually a pharmacist actively educating patients on medication adherence, reviewing any possible drug interactions, and following up to make sure patients were taking the medication when they were supposed to and that prescriptions were being refilled on time…

“We’re suggesting that greater structured management of these patients, beyond the doctor just prescribing medications for them, is a good idea,” Turakhia said. “Extra support, like that provided in the VA anticoagulation clinics with supportive pharmacist care, greatly improves medication adherence.”

Previously: One label fits all? A universal schedule for prescription drugs, Raising awareness about the importance of taking medications properly and Study highlights increased risk of death among patients with atrial fibrillation who take digoxin
Photo of Turakhia by Norbert von der Groeben

Cardiovascular Medicine, Chronic Disease, Patient Care, Women's Health

Welcome to your new country: A heart patient on her “travels” with heart disease

Welcome to your new country: A heart patient on her "travels" with heart disease

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We’ve partnered with Inspire, a company that builds and manages online support communities for patients and caregivers, to launch a patient-focused series here on Scope. Once a month, patients affected by serious and often rare diseases share their unique stories; this month’s column comes from heart patient Carolyn Thomas

My doctor once compared my uneasy adjustment to life as a heart patient with being like a stressful move to a foreign country.

I used to be pretty comfortable living in my old country, pre-heart attack. I had a wonderful family and close friends, a public relations career I loved, a nice home – and a busy, happy, healthy, regular life.

Then on May 6, 2008, I was hospitalized with what doctors call a “widowmaker” heart attack.

And that was the day I moved far, far away to a different country.

Many who are freshly diagnosed with a chronic and progressive illness feel like this. The late Jessie Gruman, PhD, who spent decades as a patient, described in a Be a Prepared Patient Forum column that sense of being drop-kicked into a foreign country: “I don’t know the language, the culture is unfamiliar, I have no idea what is expected of me, I have no map, and I desperately want to find my way home.”

Deported to the foreign country called Heart Disease, I too found that nothing around me felt familiar or normal anymore once I was home from hospital.

I felt exhausted and anxious at the same time, convinced by ongoing chest pain, shortness of breath and crushing fatigue that a second heart attack was imminent. I felt a cold, low-grade terror on a daily basis.

Instead of feeling happy and grateful because I had survived what many do not, I frightened myself by weeping openly over nothing in particular. I slept in my clothes. I didn’t care how I looked or how I smelled. I had no interest in reading, walking, talking, showering or even getting out of bed. Everything seemed like just way too much trouble.

Where once I had been competent, I now felt unsure.

Where once I had made decisions with sure-footed speed, I now seemed incapable of deciding anything.

And my worried family and friends couldn’t even begin to comprehend what was going on for me – because I could scarcely understand it myself. Sensing their distress, I tried to paste on my bravest smiley face around them so we could all pretend that everything was normal again. But making even minimal conversation felt so exhausting that it eventually seemed so much easier to just avoid others entirely.

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