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Cardiovascular Medicine

Bioengineering, Cardiovascular Medicine, Stanford News, Technology

Following the heart and the mind in biodesign

Following the heart and the mind in biodesign

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.

15125593898_7ee05d0a60_zWhen I showed up to meet with the Biodesign fellows, Debayan Saha greeted me by saying, “We are arguing – please join us.”

The source of the argument turned out to be a thorny one. The team had previously attended cardiovascular disease clinics and from those visits identified more than 300 possible needs that, if addressed, might improve patient care.

Now, their job was to narrow down those 300+ needs to the one they would eventually develop a prototype device to address.

Part of the process Stanford Biodesign fellows learn is a rigorous method for identifying medical needs that also make business sense to address. The first step: eliminate the duds.

In this round, the each team member had individually rated the needs according to their individual levels of interest on a scale of 1 to 4. That interest could reflect the fact that they think the technology is interesting, or the fact that the need is one they would be excited about addressing.

Now they were trying to rate the needs on the same 1 to 4 scale according to the number of people who would benefit if it were addressed. The combination of these two ratings—one subjective and the other objective—would produce a shorter list of needs that were both of interest to the fellows and would benefit enough people that any future company could be successful

That objective rating was the source of the polite disagreement I had walked into. As one example, if a particular need applied to people who had a stroke, should they assume that all people who have had a stroke would benefit from a solution (giving the need a higher rating of 4), or would only a small subset benefit (giving the need a lower rating of 1 or 2)?

By and large Harsh Sheth, MD, leaned toward 4s while Shashi Ranjan, PhD, leaned toward 2s. Saha mostly just leaned back. Much discussion ensued.

In the end the team managed to assign a single score indicating the number of people represented by each need. When combined with their subjective scores, the group was able to eliminate the lowest scoring needs and reduce the list to a mere 133.

One interesting thing I learned is that this careful rubric is harder to apply in India, where good numbers about how many people have particular conditions are harder to come by. Ranjan told me that even in India they would likely use U.S. numbers for some conditions and just scale up to the Indian population. I mentally added this lack of good data to the list of reasons Stanford-India Biodesign Program executive director (U.S.) Rajiv Doshi, MD, told me that biodesign is more challenging in India.

Previously: Writing a “very specific sentence” is critical for good biodesign and Good medical technology starts with patients’ needs
Photo by Yasmeen

Cardiovascular Medicine, In the News, Pediatrics, Surgery

Marathon surgery at Stanford gives 6-year-old boy a chance to thrive

Marathon surgery at Stanford gives 6-year-old boy a chance to thrive

image.img.320.highA rare chromosomal disorder called Williams syndrome left 6-year-old Jordan Ervin with a host of medical problems, including severe heart defects. But it also gave him a gregarious personality and an infectious smile, one that made the multiple medical appointments and hospitalizations much easier to handle, according to his mother, Seville Spearman.

“Jordan is such a champ,’’  Spearman said in a recent Inside Stanford Medicine article. “He’s always been just a really happy kid.”

And in December, he became a much healthier one thanks to the skillful work of Stanford cardiothoracic surgeon Frank Hanley, MD. More from the piece:

It was a complicated case. The stenotic arteries caused severe pulmonary hypertension. In less-severe cases, in which there is only one area of stenosis near or at the pulmonary valve, doctors can perform a fairly simple surgical catheter procedure that uses a tiny balloon to expand the artery. But Jordan had multiple narrowings: 12 in his left lung and 14 in the right lung. The balloon technique is much less effective in this scenario, and no other surgical techniques have been developed to treat these stenoses. So Jordan would need a different approach.

That approach was developed by Hanley, who receives referrals from all over the world. He’s the pioneer of a one-stage, fix-all-the-defects surgery called unifocalization.

“We’re definitely on the leading edge of this kind of surgery,’’ said Hanley, who holds the Lawrence Crowley, MD, Endowed Professorship in Child Health. “Jordan is going to have perfectly normal life expectancy.”

Ervin is back in school in Illinois, where his parents are delighted with the outcome. His mother said in the story, “Everything is back to normal, but I will never take anything for granted again.”

Previously: How better understanding Williams syndrome could advance autism research, Pediatric surgeon fixes “heart that can’t be fixed” and Patient is “living to live instead of living to survive,” thanks to heart repair surgery
Photo by Norbert von der Groeben

Cardiovascular Medicine, Chronic Disease, Genetics, Public Health, Research

International team led by Stanford researchers identifies gene linked to insulin resistance

International team led by Stanford researchers identifies gene linked to insulin resistance

261445720_2f253a1336_zBack in the 1970s and 1980s, Stanford’s Gerald Reaven, MD, had the darndest time convincing others that type 2 diabetes wasn’t caused by a lack of insulin. No one would believe him that, as we now know, type 2 diabetics are insulin resistant — their cells no longer respond to insulin’s cue to take in glucose.

Fast-forward a few years. Insulin resistance has been implicated in a slew of symptoms such as high blood pressure and heart troubles known as metabolic syndrome — it isn’t just a problem for diabetes. Scientists knew that about half of insulin resistance was governed by weight, exercise and diet. But the heredity half was a mystery — until now.

Thanks to an international collaboration and many months of work, a team of researchers led by Joshua Knowles, MD, PhD, and Thomas Quertermous, MD, have found the first gene known to contribute to insulin resistance. It’s called NAT2, and when mutated, it leads to a greater chance for carriers to become insulin resistant.

From the release:

“It’s still early days,” Knowles said. “We’re just scratching the surface with the handful of variants that are related to insulin resistance that have been found.”

Researchers found NAT2 by compiling data from about 5,600 individuals for whom they had both genetic information and a direct test of insulin sensitivity. Measuring insulin sensitivity takes several hours and is usually done in research settings. No genes met the high standards demanded by genome-wide association studies. Yet NAT2 appeared promising, so researchers followed up with experiments using mice.

When they knocked out the analogous gene in mice, the mice’s cells took up less glucose in response to insulin. These mice also had higher fasting-glucose, insulin and triglyceride levels.

“Our goal was to try to get a better understanding of the foundation of insulin resistance,” Knowlessaid. “Ultimately, we hope this effort will lead to new drugs, new therapies and new diagnostic tests.”

Previously: New insulin-decreasing hormone discovered, named for goddess of starvation, Stanford researchers identify a new pathway governing growth of insulin-producing cells and Faulty fat cells may help explain how type 2 diabetes begins
Image by Andy Leppard

Bioengineering, Cardiovascular Medicine, Stanford News, Technology

Writing a “very specific sentence” is critical for good biodesign

Writing a "very specific sentence" is critical for good biodesign

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.

1 After several weeks spent following doctors through cardiovascular disease clinics, Debayan Saha, Shashi Ranjan, PhD, and Harsh Sheth, MD, together identified 315 apparent medical needs ranging from better ways of monitoring patients to improvements of existing devices. During the course of their six-month fellowship, they’ll develop a prototype device to solve just one.

The first step toward picking that one is to better define the 315.

This is more complicated than it seems. For example, one of the needs they’d originally written down involved real-time monitoring of certain molecules in the patient’s blood. They revised that phrasing because it defined the solution – real time – rather than the problem, which is the need for doctors to have more accurate information about the patient’s blood so they can make better treatment decisions. “One solution to the problem might be real-time, but there might be another way,” Sheth said.

Similarly, another need they identified had to do with a device that was inconvenient for doctors to use during a medical procedure. Did they need to improve the device to make a procedure more efficient, or was the need specifically for a smaller device? With another device, they debated whether the real need was to reduce the patient’s pain or to reduce the blood loss.

Some of these decisions might sound like splitting hairs – whether the problem is pain or blood loss, there is a clear need for a better device. But the distinction makes a difference down the road. If they chose to focus on the pain rather than the blood loss, that would effect what insurance will pay for its use and intellectual property – factors that make a difference in whether or not a device can get funding and eventually reach patients.

“We need a very specific sentence to make very clear the need we are trying to solve,” Saha said.

Eventually the team will sort through this list of needs to identify the single focus of the remainder of their time.

One thing I found interesting: In fourteen years of the program, each year with several teams working on the same medical field, no two teams have ever developed devices to satisfy the same need.

Previously: Good medical technology starts with patients’ needs and Biodesign program welcomes last class from India
Photo of Shashi Ranjan and Harsh Sheth on a clinical visit by Kurt Hickman

Cardiovascular Medicine, In the News, Medical Apps, Research, Stanford News, Technology

MyHeart Counts app debuts with a splash

MyHeart Counts app debuts with a splash

At Stanford Medicine, we’ve been anticipating the debut of MyHeart Counts, an iPhone app and cardiovascular research study, for some time. The researchers told us it had the potential to be the largest study of measured physical activity and heart health, and we were pretty darn excited. And we were also pleased to see the buzz surrounding Apple’s Monday morning announcement of ResearchKit, the app’s open source software host. Both MyHeart Counts and ResearchKit have been warmly received by both the tech and medical community and, just days after its release, the number of MyHeart Counts users is already in the tens of thousands.

We’re talking about data in medical research that’s never been encountered before

“Following the news, many researchers who spoke to The Huffington Post could barely contain how thrilled they were about the new iPhone feature, calling it ‘revolutionary,’ ‘groundbreaking’ and a ‘new dawn’ when it comes to scientific research,”  wrote on Tuesday. She went on to outline seven ways ResearchKit could change research for the better, and she quoted Stanford’s Alan Yeung, MD, an app architect and medical director of the Stanford Cardiovascular Health:

In most medical studies, 10,000 is a large number, but if we can really hit our mark and have a million people download it, you can do much larger population studies than anything that has been done in the past. So even though we might be slightly restricted in the beginning, we have plans to reach everybody in the world if possible.

This amount of data has never been available before, and if we multiply it by a million, let’s say, we’re talking about data in medical research that’s never been encountered before.

Enrolling 10,000 people in a medical study would normally take a year and the collaboration of at least 50 medical centers, Yeung told Bloomberg. “That’s the power of the phone.”

He said he also believes the app will make it less likely for participants to enter false reports because the device itself will keep track of their exercise. Researchers also plan to test how best to help people modify their behavior.

And the app isn’t just for avid techies or exercise enthusiasts. Physician-blogger Mike Sevilla, MD, wrote earlier this week that ResearchKit has the potential to improve medical care. “Imagine the synergy that will be created with the right app technology, engaged patients and interactive medical teams. Just mind blowing… The potential here is limitless.”

Strong words for a strong app. Check it out for yourself (there’s more info in the video above), because, yes, your heart counts.

Previously: Stanford launches iPhone app to study heart health, Even moderate exercise appears to provide heart-health benefits to middle-aged women and What needs to happen for wearable devices to improve people’s health?
Image by Ken

Cardiovascular Medicine, Research, Stanford News, Technology

Stanford launches iPhone app to study heart health

Stanford launches iPhone app to study heart health

Dr. Alan Yeung,  MD., Chief (Clinical) Division of Cardiovascular Medicine Interventional Cardiology,and Dr Michael McConnell, MD.,  with a new health app for iPhone on Thursday, February 26, 2015. ( Norbert von der Groeben/ Stanford School of Medicine )

A new, first-of-its-kind iPhone app, designed by Stanford Medicine heart experts as a fun way for users to learn about their own heart health while at the same helping to advance the field of cardiovascular medicine, was launched today.

The app, called MyHeart Counts, takes advantage of the iPhone’s built-in motion sensors to collect data on physical activity and other cardiac risk factors for a research study. It’s now available for free in the App Store. As I describe in our press release:

The free app uses the new ResearchKit framework announced today by Apple to present users with a simple way to participate in the study, complete tasks and answer surveys from their iPhone. The app will deliver a comprehensive assessment of each user’s heart health and provide information on how to improve it. It will also be used to study various methods — designed to be both easy and fun — for using smartphones and other wearable devices to enhance heart-healthy habits.

“MyHeart Counts aims to be the largest study of measured physical activity and cardiovascular health to date,” [said Stanford cardiologist Michael McConnell, MD, lead investigator for the study]. “We want people to join in this research effort to give fundamental new insights into how activity helps your heart, across all ages, genders, cultures and countries.”

Users start by providing some basic health information – age, weight, blood pressure – all kept confidential, and are then asked to record a week of activity. The app in return provides the user with a number representing their “heart age.” For example, if you’re 40 years old, and your heart age is reported as 20 years, that’s good news. If those numbers are reversed, there might be something to worry about.

The ultimate goal of the study, McConnell and his collaborator Alan Yeung, MD, told me, is to provide scientific evidence as to the effectiveness of the myriad methods of behavioral motivation techniques marketed through wearable devices to improve health. The idea is to use hard data to find out what really works:

Recently, there has been an explosion in the marketing of wearable devices to record and report information about behaviors, such as physical activity or sleep patterns, to improve health, but there is limited scientific evidence available to show whether they are effective, McConnell said.

As a physician who regularly sees patients in the clinic, McConnell knows first hand how hard it can be to change a patient’s behavior. Physical activity has been shown to be far more effective in improving health than medication, but getting patients to be more active isn’t easy.

“Preventive medicine hasn’t worked by having doctors make to-do lists for their patient, then seeing them six months later and hoping they did everything on the list,” McConnell told me. “The future needs a much more ongoing engagement with people’s health. We need to understand how to reach out to modify behavior long before we end up having to see someone for a heart attack or stroke.”

Previously: Lack of exercise shown to have largest impact on heart disease risk for women over the age of 30
Photo, of Alan Yeung (left) and Michael McConnell, by Norbert von der Groeben

Bioengineering, Cardiovascular Medicine, Medical Education, Research, Technology

Good medical technology starts with patients’ needs

Good medical technology starts with patients' needs

biodesign fellows

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.

The first step in solving a medical challenge is identifying a problem in need of a solution. This seems intuitive, but often people start from the other direction – they’ve developed a technology and go looking for some way to apply it.

Learning that workflow is one thing that brought Shashi Ranjan to the Stanford Biodesign program from Singapore. “I was making devices but didn’t see them going into people,” he told me. “I wanted my technology to go into the real world.”

As the fellows encounter patients and doctors, they are compiling a list of existing medical needs.

Ranjan, along with Harsh Sheth, recently visited the Stanford South Asian Translational Heart Initiative run by Rajesh Dash, MD, PhD, to witness first-hand cardiovascular needs encountered by South Asians in the Bay Area. (The third member of their team, Debayan Saha, was at a different clinic that day.) After observing some patients, what became clear to the two is that lifestyle changes are a major barrier to improving cardiovascular disease risk in South Asians, just like in any other population.

Some of the problems they encountered appear obvious: How do you help people get more exercise and maintain a healthy weight? Develop a device to solve that and the team would help many more people than just patients with cardiovascular disease.

The two had also observed that many people who are overweight have sleep apnea, or short pauses in breathing during sleep, which can contribute to heart disease risk. The devices that exist to help sleep apnea look like cumbersome gas masks and aren’t conducive to a restful slumber. Several patients they observed don’t use the device regularly despite knowing that it could lower their risk of having a heart attack.

After observing patients, the pair added to their growing list of 300 plus medical needs a better air mask for sleep apnea, along with simplified screening for people who are at risk of heart disease. Patients at Dash’s clinic are asked to make routine visits for specialized bloodwork and other screenings. “Can we make the tests simpler but still effective, and available at the point of care?” Sheth asked.

I asked Dash why he wanted to work with Biodesign fellows like Ranjan and Sheth – their presence in the office visit certainly made the room tight and patients perhaps a tad uncomfortable. He told me that training people to make better medical devices is critical to providing good care.

The fellows from India are particularly valuable he said. “They learn how we are approaching the problem here then help find solutions that are effective in India.”

Over the next few weeks, the team will stop visiting clinics and will begin the arduous task of narrowing down their list of more than 300 observed medical needs to the one that will become the focus of their fellowship. (Four other teams are going through a similar process, and they’ll all present their prototypes at a symposium in June.)

Previously: One person’s normal = another person’s heart attack? and Biodesign program welcomes last class from India
Photo, of Shashi Ranjan and Harsh Sheth observing as Rajesh Dash, MD, meets with a patient, by Kurt Hickman

Cardiovascular Medicine, Patient Care

One person’s normal = another person’s heart attack?

One person's normal = another person's heart attack?

Much has been written about calculating your BMI (or body mass index, the relationship between your height to your weight) and what it might indicate about your health.

Similarly, the glucose level in your bloodstream and what it says about your risk of diabetes.

What you don’t hear much about, and what I learned yesterday, is how much the meaning of those numbers can vary between people. A healthy BMI for one person might put another person at risk for heart disease.

I was visiting the Stanford South Asian Translational Heart Initiative run by Rajesh Dash, MD, PhD, along with some Biodesign fellows I’ve been following (more about that in a later post). By way of background on the clinic, Dash explained the high risk of heart disease in the South Asian population. (My colleague Becky Bach blogged about that risk last year.)

Dash said one challenge in helping South Asians avoid heart disease comes from the definitions of “overwieight” and “diabetic”. Dash said that South Asians tend to have more fat per body weight, and so might have an acceptable BMI but still have an amount of fat that puts them at risk for heart disease. Similarly, a South Asian person who is pre-diabetic might benefit from diabetes medication.

“We see a lot of glucose levels that are technically normal but still troubling,” he told me. “Their risk of a cardiovascular event is almost as high as for someone who has diabetes.”

For a population that has four times more heart attacks in California than other ethnic groups, it seemed especially troubling that a mere definition might be preventing them from getting appropriate care.

That got me wondering how those numbers apply to other populations. Or to me.

I had my yearly blood work done recently and was pleased to see that everything was “normal”. I’m curious if in a decade people like Dash and others might have collected enough data to sway the way our values get reported. A set of numbers that is normal for my gender and ethnicity might trigger additional screening in another person, or be considered better than normal for someone else.

Previously: A ssathi (partner) to thwart heart disease in South Asians and Biodesign program welcomes last class from India

Cardiovascular Medicine, Pediatrics, Pregnancy, Surgery

Baby with rare heart defect saved by innovative surgery

Baby with rare heart defect saved by innovative surgery

jackson-lane-stanford-childrens560

Elyse Lane was 20-weeks pregnant when she learned that her unborn son had a rare and severe heart defect. Her baby was missing his pulmonary valve and his pulmonary artery was 10 times the normal size.

The outlook was bleak. The baby’s enlarged artery hampered his blood and oxygen flow, a condition called tetralogy of Fallot, and his missing pulmonary valve made the defect worse.

Fortunately, Lane and her husband, Andy Lane, a former Major League Baseball coach with the Chicago Cubs, were referred to Frank Hanley, MD, a cardiothoracic surgeon at Stanford Children’s Health. Hanley had experience with this kind of heart defect and knew how to perform the delicate surgery needed to repair their baby’s heart.

The Lanes recount the story of their son’s lifesaving surgery on the Lucile Packard Children’s Hospital blog:

When he was just five days old, Jackson underwent a 13-hour operation that would save his life. Hanley and his team did a complex overhaul of Jackson’s heart: they inserted a pulmonary valve, reduced the size of Jackson’s right pulmonary artery, and enlarged his small, disconnected, left pulmonary artery. Hanley also used an innovative and intricate procedure known as the LeCompte maneuver, which altered the pathway of Jackson’s right and left pulmonary arteries from the back of the heart and aorta to the front. This gave his severely compromised bronchial tubes room to grow and remodel after surgery was over.

As the story explains, Jackson’s heart will need some maintenance in the future, but he should live a normal and long life.

“He can now do anything he wants in life,” said Elyse Lane in in the blog piece. “He’s already made it through the biggest challenge.”

Previously: Patient is “living to live instead of living to survive,” thanks to heart repair surgery, A very special small package: Three-pound baby receives pacemaker, Advancing heart surgery for the most fragile babies, and Little hearts, big tools
Photo courtesy of Lucile Packard Children’s Hospital

Cardiovascular Medicine, In the News, Public Health, Research, Women's Health

A look at why young women who have heart attacks delay seeking care

A look at why young women who have heart attacks delay seeking care

317916781_c8bb9b352e_zHeart attacks kill more than 15,000 women in the U.S. each year and are disproportionately deadly for females under the age of 55. Although several studies, including those by Stanford cardiologist Jennifer Tremmel, MD, have investigated the signs and consequences of heart attacks in men and women, relatively little is known about heart disease in women or why it’s so lethal for young females. And according to new research, misconceptions about the risk factors and signs of coronary heart disease may be why young females are less likely to recognize and seek emergency care for a heart attack.

In the study, published yesterday in Circulation: Cardiovascular Quality and Outcomes, a research team led by Judith Lichtman, PhD, MPH, of the Yale School of Public Health, interviewed 30 women between the ages of 30 to 55  who had been hospitalized for a heart attack. The researchers identified five common themes among the symptoms and treatments of the women they interviewed, and one potentially important finding was that women were unsure they’d had a heart attack so they were hesitant to seek medical treatment.

From an NPR story:

A heart attack doesn’t necessarily feel like a sudden painful episode that ends in collapse, [Lichtman] notes. And women are more likely than men to experience vague symptoms like nausea or pain down their arms.

“Women may experience a combination of things they don’t always associate with a heart attack,” Lichtman says. “Maybe we need to do a better job of explaining and describing to the public what a heart attack looks and feels like.”

Tremmel also provided comment on the study, saying it indicates a need to encourage women to seek help for medical concerns. “This is an ongoing issue in the medical field,” she said. “…We all have to empower women patients, so they know that they need to not be so worried about going to the hospital if they’re afraid there’s something wrong.”

Previously: New test could lead to increase of women diagnosed with heart attack, Heart attacks and chest pain: Understanding the signs in young womenAsk Stanford Med: Cardiologist Jennifer Tremmel responds to questions on women’s heart healthPaper highlights major differences in disease between men and women and Gap exists in women’s knowledge of heart disease
Photo by Simon Mason

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