A Pediatric Cardiologist from West Virginia Practices Rural Medicine in China

I first met Dr. Lee Pyles on the airplane on our trip from Minneapolis to Lanzhou, China in 2008. Lee carried a giant suitcase, a roller bag and a big backpack. Lee grew up in West Virginia, and just moved back there recently after 15 years working with the University of Minnesota. In the nine years after that initial trip, Lee and I have traveled together to Lanzhou, Huining and Linxie in Gansu, Kunming and Xixuanbanna China.

Dr. Pyles is a pediatric cardiologist. During the training visits, Dr. Pyles performed echocardiograms (or “echo” for short) to verify diagnostics and confirm the plan for each surgery that the Children’s HeartLink team would work on with the local team. These patient exams were like a live classroom. Lee loved to teach. No detail was too small where it was critical.

It is a constant challenge for an echo doctor in China to see up to 100 patients a day, which is easily five times the volume in the US. It is a balance of serving a high volume of patients and maintaining the quality of diagnosis for each. Lee taught from his experience of understanding physiology to help the local team improve efficiency and quality.

On the first day of each training visit, members of both teams gather for a case conference to review all candidates for surgeries during the visit. Lee and I noticed the high percentage of pulmonary hypertension among children that were initially selected by the local team. Pulmonary hypertension in children with congenital heart disease (CHD) is caused by the high-pressured blood from the left ventricle of the heart that flows through an opening that called ventricular septal defect, to the right ventricle then into the lung. A prolonged high pressure can cause irreversible damage to the lung and the heart. When diagnosed early, closing the ventricular septal defect can avoid the permanent damage to the heart and lung with a curable outcome. When not diagnosed in time, pulmonary hypertension associated with the damaged heart and lung function increases the risk during surgery and recovery and may mean the patient has missed the window for treatment altogether.

It is rare to see pulmonary hypertension among children with CHD in the U.S. and other developed countries these days. The murmurs generated by the heart defect are recognized by trained pediatricians during early childhood checkups. In a place like Gansu and Yunnan province in China, however, many children from rural areas may not see a doctor for years after birth. Lee and I have visited several rural counties in Gansu and Yunnan working with local doctors to find these children and help improve the diagnosis of CHD in rural communities. We have developed a telemedicine system for a health workers to record and transmit heart murmurs via smartphone for review and consultation by a heart specialist in another location.

Many of the children Lee and I met in China had not seen a U.S. doctor before in their lives. Doing echo exams with their cooperation was no small feat. The young ones might bite their tongue, staring at Lee’s big nose. The infants and toddlers could cause riots. Lee could always see the trouble ahead and went to his big suitcases to fetch a toy. These made-in-China toys were big hits with the babies. Their moms were also impressed when they heard the toys were all the way from America.  Lee still travels with all his suitcases whenever we go to China.

Note: Thank you, Ryn W, for helping with the editing. 

On Inspire 10th Anniversary

The Inspire team celebrated our 10th anniversary this year. My reflection with a few quotes heard during this journey:

"It will get complicated very quickly." - Kingman Strohl, our trusted advisor since the first study planning meeting in May 2008.

"Always remember to put the patient first; rest will be easy." - Glen Nelson, Inspire first board chairman, who was an inspiration for the team.

"That is a cardinal grade of a palate." - Jerry Griffin after seeing the first CT scan of feasibility study patient.

"So you think there is a chance." - Ed Schuck, our beloved board member, who had always believed in us.

"The only thing we don't do is the ordinary." - Paul van de Heyning, the surgeon performed the first hypoglossal nerve stimulation implant with Medtronic in the 90s then with Inspire on Feb 20, 2009.

"It is always possible, Quan." - Marc Willems, sleep lab manager at University Hospital Antwerp, helped us titrate therapy.

“You get my best work on the July 4^th weekend.” – Pat Strollo after finishing the first STAR trial manuscript later published on New Engl J Med in 2014.

"We not only do good clinical practice, we do great clinical practice." - Saf Badr after hearing our requirement of GCP in clinical trials.

“It is white on rice.” – Tim liked to say when the going gets tough and used many times during the first 10 years of Inspire.

"It worked!" - Mark after trying the cuff electrode and an external stimulation on the deer hunting opener in 2008.

"We are not out of the woods yet." - Darrell used many times during late night sleep studies.

"Do or do not, there is no try." - John quoted from the Star War.

"I got a letter from the FDA." - Joel received the FDA approval letter on April 30, 2014.

"Presence, action, and belief." - Randy on the art of selling.

"Know who is who in the zoo." - Ivan on the practice of selling.

"All night, every night." - Luke on keeping the Inspire therapy on.

"Sleep Well, Have a Better Tomorrow."

A Perfusionist Who Cannot Carry His Bag

"Passion is a Pursuit of Happiness through Suffering". When I read this interpretation of passion as a pursuit of happiness through suffering, I remembered a few medical volunteers of Children’s HeartLink during our trips to China over the past 13 years.

A Perfusionist Who Cannot Carry His Bag

Kris Nielsen is a perfusionist from the Twin Cities. His job in the OR is to keep the patient alive on a heart-and-lung machine while the surgeon operates on the stopped heart. His work is nothing short of magic.

During our first trip together to Lanzhou, China in 2010, Kris explained that the protocol for heart-and-lung bypass was largely standardized, so he was pleased to see a familiar set up in the OR where we would work the next day at the First Affiliate Hospital of Lanzhou University. The first day of surgery was a success. The medical team from the University of Minnesota and the local team bonded quickly. Kris observed closely, kept his surgeon informed, and shared his observations with his counterpart from Lanzhou. After discussing some ideas with his new partner, Kris helped implement a few changes during the next day of surgeries. It was amazing to see them chit-chat with only one or two words in English and a lot of nodding.

At first, Kris dealt with his jet-leg with an early morning run to the Yellow River. He was full of energy. Kris and Raj, the anesthesiologist on the team, spent a lot of time together. Naturally, they joked with each other inside and outside the OR all the time. Kris teased Raj mercilessly after Raj had been schooled on how to gracefully put a needle in the tiny vein of a Chinese baby by the local staff on the first day.

But on the third day of the trip, Kris became quiet in the OR. He asked for a blanket and wrapped it around himself. His responses to the surgeon were down to one or two words. By the late afternoon, I found him lying down to rest in the break room. It looked like the jet-leg had finally taken a toll. Kris missed our group dinner, and then he missed our breakfast, too.

It was the Montezuma’s revenge that punishes travelers in the middle kingdom just as in the Aztec empire, regardless of the purpose of the mission. Kris had struggled for two days without telling most of the team. It pained Kris so immensely that Raj had to carry Kris’ backpack as they walked together from the hotel to the hospital the next morning. Raj had his revenge as well.

I shared Kris’ story a few times with other volunteers on their first trips to China, and I no longer laugh some of them favor KFC over the handmade noodles or other street food that I couldn’t resist on the streets of Lanzhou.  

Kris Nielsen and his fellow perfusionist from Lanzhou First Affiliate Hospital, 2010.

Note: Thank you Ryn W for the editing. 

A Journey of a Biomedical Engineer

I was excited to prepare for a seminar at the Biological Engineering Department at the University of Minnesota. It has been 30 years since I began my journey in the field of biomedical engineering when I enrolled in Shanghai Jiaotong University in 1987.

At that time, I did not know any other biomedical engineer in my life. I was attracted by the description of “biomedical engineering”. Solving medical problems with the knowledge of biology and tools of engineering appealed to me as a promising field. Biomedical Engineering was a newly created department at Chinese Universities. We went to many other departments on-campus or off-campus for classes. We rubbed shoulders with other students in electrical engineering and mechanical engineering classes. We rode bikes to anatomy and physiology classes at a nearby medical college. Our own professors taught us computer programming, ultrasound and medical instrumentation.

By the end of the four-year college in 1991, most of us got jobs in the instrumentation department at a hospital or at a few medical companies in China which manufactured x-rays and other medical equipment. Many graduates of my college had left China to study abroad. The opportunities for admission to a US university and obtaining a student visa were rare in the early 90s in China. For many, it was a path to a bright future.

I was admitted to the University of California, San Diego. The Bioengineering program at UCSD was founded by Professor YC Fung, and chaired by Shu Chien at the time. Professor Fung initiated the field of research on biomechanics, which studies tissue properties of muscles and circulation. In an outing with new students, Professor Fung recalled how he got his start in biomedical engineering. He had been an aeronautics professor at Caltech. When he found that his mother was developing an acute glaucoma, he began to immerse himself in the medical literature to learn about it, and sent his notes to his mom’s physician in China. The intense learning led him to a close collaboration with a medical doctor, and later, with many other physicians in areas of heart and lung mechanics.  Professor Fung no longer taught classes in the department, but told me the first real-life story of a biomedical engineer.

Dr. Chien took me into his laboratory research in cell mechanics. I studied the aggregation of red blood cells, a phenomenon that occurs in life but with little understanding of why and how. I spent countless hours in a dark room with a powerful electron microscope, but was unable to find what bound these cells together. To this day, I still remember what Dr. Chien said, “You are going to be a scientist. You want to learn everything there is to learn on your project.”

My learning continued at the University of Utah, where I decided to pursue a PhD in its Bioengineering Department. My growing interests in the electrical system of the heart found a home with two mentors at the Cardiovascular Research and Training Institute. Bruno Taccardi was studying how heart muscles affected electrical wave propagation in each heartbeat. He devised systems with hundreds of electrodes that placed directly in a beating heart to measure electrical field during propagation. Rob MacLeod, my PhD advisor, had developed computer programs for visualization and simulation of these complex systems based on some of Bruno’s measurements.

Bruno was in his late 60s at the time. He “retired” from his institute in Parma Italy, where he was the director, and came to Utah to continue his research. Bruno wanted to know everything about electrical propagation in the heart.  He only wrote a few papers in his career, but one of them was read by nearly every researcher in the field. Rob MacLeod was a young faculty member and I was lucky to be his first student. I could not have asked for a better mentor. Rob recognized my challenges with scientific writing. He gave me a list of classic papers on cardiac electrophysiology, and critiqued my review summary of each paper. The exercise went on for a few years, and ended with our first paper together on interpolation of electrical potentials in the heart.  After six years, I finished my PhD in biomedical engineering. I was ready and anxious to solve problems in the real-world.

It was an exciting time in implanted device industry with recent introduction of cardiac resynchronization therapy, a new therapy for patients with heart failure due to an electrical conduction problem in the heart. I was impressed by the enthusiasm of scientists I met during the interview with Guidant Corporation, one of the three companies that manufactured cardiac pacemakers and defibrillators. I decided to join them after the interview and hoped one day to work on a new therapy myself.

I was open to work on any problems. The first problem I worked on was a condition called chronotropic incompetence. With aging, many of us lose the ability to regulate heart rate with increasing metabolic demand, for example, during exercise. In traditional cardiac pacemakers, an algorithm increased heart rate based on body motion detected by an accelerometer sensor. This had limitations, for example, an accelerometer would not determine the different metabolic demand between climb upstairs versus downstairs. I started with a project to measure respiration using an implanted respiration sensor in a cardiac pacemaker. This was a new feature in the pacemaker to provide heart rate support during patients’ exercise. The pacemaker can sense the increase of respiration with an impedance sensor and changes of motion with an accelerometer. The combined information would improve the algorithm to regulate heart rate with the metabolic demand during the exercise.

The ability to monitor respiration in an implanted device soon led me to a discovery that many cardiac pacemaker patients stopped breathing frequently during sleep, a disorder called obstructive sleep apnea. In a collaborative study with a cardiac electrophysiologist doctor and a pulmonary doctor in Pittsburgh, we found nearly half of his VA pacemaker patients had undiagnosed sleep apnea. We formed a new team in 2001, the apnea team, which included original team members of Kent Lee, Jess Hartley and Jeff Stahmann. Our goal was to detect and monitor sleep apnea with a cardiac pacemaker and explore new treatment options. Boston Scientific, which bought Guidant, now produces pacemakers that can monitor sleep apnea status every night for this chronic condition based on our original work.

Once diagnosed, sleep apnea treatment is another major clinical challenge. The standard of care is positive airway pressure delivered by a mask placed over the nose and mouth during sleep. I made a good effort trying the treatment myself for two weeks and I had a very hard time to get to sleep. So it was not a surprise that nearly half of the patients with sleep apnea do not use any treatment.

My opportunity to work on a solution for sleep apnea treatment came in 2008. Tim Herbert, Mark Christopherson and others had worked on an implanted neuromodulation approach for treating sleep apnea while at Medtronic in the 1990’s. The idea was based on the finding that tongue relaxation during sleep was causing airway obstruction, and the tongue could be controlled via the hypoglossal nerve. The Medtronic team developed an implanted device to stimulate this nerve, and demonstrated in a small study that hypoglossal nerve stimulation would stiffen and move the tongue forward and could resolve upper airway obstruction. Medtronic did not continue this project, as it was not in their core therapy areas. In 2007, as a true entrepreneur, Tim quit his job in Medtronic, licensed the technology from them, and recruited Mark to join him to start Inspire Medical Systems, whose singular goal would be to develop and commercialize a neurostimulation therapy for obstructive sleep apnea. During one of our conversations before joining them, I asked Tim what made him believe they could accomplish what Medtronic could not in developing this new therapy. Tim put a children’s book in front of me, and asked if I remembered reading A Little Engine that Could. I told Tim that I grew up in China and had not heard of the book. After finding the book at a bookstore, I liked the attitude of “I think I can”.

In April 2008, I left my job at Boston Scientific and joined the Inspire team and began the next chapter of my journey as a biomedical engineer in finding a solution to help people sleep better.

Letter to Congressman Paulsen on Immigration

Dear Congressman Paulsen

You visited us when we were a company of 10 people in a small office in Brooklyn Park, Minnesota. Inspire Medical Systems was just spun out of Medtronic in our mission to develop a new treatment for sleep apnea. You asked us why we felt we could accomplish what Medtronic had given up. I jumped on like a good student who felt I had the best answer. That was the same question that I asked our CEO, Tim Herbert, during the job interview a few months earlier. Tim pulled out a little book with the title of “The Little Engine that Could”, and asked me if I knew the book. I told him that I grew up in China, and had not read children’s books for some time. The story of “I think I can” from the book impressed me so much, I signed on shortly after. So I responded to you, “Congressman, have you ever read a book called The Little Engine that Could?”  

“I think I can” is my story as an immigrant American. I left China in 1991 right after finishing college with the fresh memory of the student movement in 1989. My search for a better life was blessed by an opportunity to study in America, and the help from a caring sister, who was studying in California. My mentors in graduate schools shaped my skills as a biomedical engineer. They also formed my desire to improve lives. My job in the medical device industry is fulfilling as reflected in one of my employers’ motto “When you have the power to save lives, share it”. After eight years in America, I received one of the most treasured privileges in my life, a green card, the right to live in America permanently. I became a US citizen after 18 years in this country. I was attracted by our democracy and kindness and fairness of our people. I wanted to participate as a citizen.  

Our recent immigration policy changes related to travel ban make me think about my fellow immigrant Americans. I think about my friend from Egypt. He is a VA doctor, who received the Chief of Staff Clinical Excellence award last year. I think about a collaborator in Detroit, who grew up in Syria and trained in the US. He is one of the most respected doctors in sleep medicine today. I think about a young surgeon, who was born in Iran. He lost his Dad last year, who worked until his last day in Minnesota, as a family doctor. I hear the story of a fellow engineer, who grew up in Ethiopia, and came to America when he was young. He tells me the fear of watching what happens after the recent policy and wondering his belonging.

The task of fighting terrorists is as hard as fighting other violent crimes. We need to be resolute and be determined. We cannot, however, harm innocent people in our response. Over the last two hundred years, people came to this country to search for better lives. It was not an easy journey for most of us, including the separation from the home country often with families behind. We travel back when there is a parent who needs care, or when there is a niece who gets married. The travel ban harms immigrants from the seven countries included. It also affected me because of the concern of our policy maker's willingness to overlook the harm for fellow immigrants. We cannot have policies that erode the principle of our country of immigrants.

When I am reflecting today on who we are, and what I want to be, I am reminded by a former coworker who told me to choose work that is life giving. I am reminded by my CEO, and his mentor, the late Dr. Glen Nelson, who told us to put patient first. I am reminded by our celebration of 1,200 treated lives at the recent holiday party of our company now of 80 employees, where Dr. Nelson’s widow, Marilyn Carlson Nelson told us to do work that is good and to help people. I am reminded by what my Dad taught us at his 80th birthday, to be kind, be sincere, be informed and think independently.

Congressman Paulsen, you have a great responsibility representing Minnesotans in Washington. There are complex issues about which you will make decisions that will impact lives in the coming days, months and years. I hope you will represent us with kindness to others, support work that to be life giving, be informed and think independently.

Quan Ni

An Immigrant American

"You are not perfect, you have flaws."

I found out from Gale today that my first dental cleaning from her was 16 years ago. 

I marveled, "Your kids were babies then". Gale became a grandma last year. 

"They are still babies."

I chuckled after a few seconds. Gale was not happy with my response. 

"It took you that long!"

Gale and I have bonded over the last 16 years in keeping my teeth. I have a unique set of teeth from the overuse of tetracycline and the lack of dental care growing up. Back in the 70s’ China, tetracycline was a go-to antibiotic for every bacterial infection including common cold, gonorrhea, which I had plenty. The “tetracycline teeth” kids, as many of us being called while growing up, would not like to show the jarring teeth in dark and brown color when take selfies today.

Gale was protective of the bond, after my initial dental exam. She always apologized after the first exam of each new dentist in the office we broke in together over the years.

“I am sorry you have to go through that, Quan, but you are unique.”

After examining the dental x-rays today, Gale was seemly satisfied. Then she added,

"But you are not perfect, you have flaws,".

Feeling my dental homework un-appreciated, I responded, 

"I do floss." 

Nashville and the New Year Resolution

On my way to Nashville, I recalled a passenger I met a few years ago on a long haul flight to Shanghai. He grew up a surf boy in San Diego, and later found home in Nashville. He owned a company making hunting gears. Using his product catalog, he proudly showed me hundreds of different shooting targets that he designed. He was fit, even though he seemed to be chewing tobacco during the entire trip. After several hours of friendly conversations, he told me to stay away from the dessert. “No sugar, my friend”. Finally, I decided to put less sugar on the resolution for the new year.   

The Uber driver who picked me up in the Nashville airport was also from California. He followed his children and their mom here after the divorce. After learning this was my first trip to Nashville, he got excited. “Are you ready for some honky-tonk, my friend?”. Honky-tonk? I had to google it quickly, and was excited too. New adventure and new learning every day, that is the second resolution on the new year list. 

My colleague told me he would have a surprise for me in Nashville. After searching what was around the hotel that he recommended in the Gulch neighborhood, I found that the Station Inn seemed to be the place to be for live Bluegrass music. I felt sorry that I apparently ruined his surprise. The Bluegrass musicians played in the Station Inn were surprisingly good. The Tuesday night band was a collection of professional and amateur musicians. The two guitar players took turn at the mic. One of the young guitar player looked like about 15. Later on, he had to leave early for school tomorrow. We sit close to the fiddle player. He just kept blown us away. The bass player was the proprietor of the place in the last four decades. Then there were mandolin, banjo, and Dobro.

Dobro is a guitar with a metal plate which creates amazing resonant sound. I found more about it on youtube by Jerry Douglas, the best Dobro player according to my friend.

The players took turns for a half step up to do their highlight of a song. The rest of the band would look him on, nodding in support. They were having a good time. We were having a good time. It was a harmony of collaboration, inclusion, appreciation, patience and calm. Those, of course, are the rest of the new year resolution for 2017.