Sharpened Focus: A Vision For Improved Clinical Trials

Dr. Lyssa Ochoa is bringing a fresh perspective and greater inclusion to community-based cardiovascular research

Healthy Heart|Jul.25, 2022

One does not have to look at Dr. Lyssa Ochoa’s optometry records to know she has extraordinary vision, possessing a unique ability to focus on objects near and far, small and large.

Even as a young girl, the board-certified vascular surgeon and clinical investigator for LIFE-BTK could see the power of education and had a vision for helping large numbers of people who needed her expertise the most.

This vision was a gift she clearly inherited from her parents, both born to families without benefit of formal education. “My father was a farm worker, and my mother was a migrant laborer who met in high school, before they became the first members of their families to graduate from college,” Ochoa said.

Understanding that their educations had allowed them to advance beyond the opportunities afforded many of their neighbors from Mission, Texas, the pair initially became teachers and were none-too-subtle in their insistence that their children attend college.

Loud and Clear

Lyssa got the message.

So loudly and clearly, in fact, that it echoed for eight years.

The first wave was a scholarship to her parents’ alma mater (now the University of Texas-Pan American), followed by a second wave that carried to the Baylor College of Medicine.

As one of the scholarship winners from the Rio Grande Valley, she traveled (as echoes do) a great distance to a faraway land: Houston, a six-hour drive from Mission.

After finishing medical school, she stayed on for her general surgery residency at Baylor, before taking her father’s suggestion to practice in San Antonio, which had the dual advantages of being a large city with a small city feel, and being considerably closer to her hometown.

“I started working as the only woman at a peripheral vascular practice with 20 other doctors, eventually becoming their first female full partner. But I came to realize that their goals weren’t really in line with what I wanted to do.”

Location, Location, Location

Ochoa had a vision that far outstripped the confines of her private practice.

She not only took on all the challenges that came with serving vascular patients in her practice but was also determined to make substantive changes to impact the communities she embraced.

“Having been on call at hospitals located on both the north side of the city, where our practice was, and the south side, it didn’t take long to realize there was not only disparate care being given depending on location, but there were different types of patients and even different outcomes,” Ochoa said.

“I was seeing younger and younger patients with uncontrolled type 2 diabetes and more diabetic amputations, heart attacks and patients on dialysis. I would see patients with diabetic ulcers on the north side, but not as many, and the patients weren’t as young.

“A lot of it didn’t seem to make strict medical sense. Surprisingly, private practice patients being seen on the south side of San Antonio were even sicker and had more uncontrolled diabetes, with worse complications, than uninsured patients I had seen in the Houston area public hospitals.”

Where Medicine and Geography Meet

Dr. Ochoa found herself asking the age-old question: Why?

“I needed to know why patients on the south side were experiencing worse outcomes than those on the north,” Ochoa said. “I ended up meeting several key leaders in San Antonio. Not medical doctors, but experts who could shine some light on this situation.”

One sociology professor, Christine Drennon, explained the history of segregation in San Antonio, how brown and black people were not allowed to buy homes in certain areas, which led to wealth and health disparities.

“She told her story using maps, showing the areas starting in the 1930s where these people were limited in where they could buy homes. What was shocking to me, as I was looking at the redline map, was that it looked exactly like a map I had made setting out diabetic amputation rates in different San Antonio zip codes.

“That’s when I asked myself how is it that what was intentional segregation and racism back then, with its resulting lack of investment in infrastructure, could still influence healthcare outcomes today?

“I think that was the most eye-opening part for me.”

Taking a New Look at the Healthcare Landscape

Never one to identify a problem without working intently to resolve it, Ochoa again reached out to other professionals to learn more.

Ochoa began meeting with local public health professors who taught her about the social determinants of health. She was shocked that over 50% of one’s health care outcome is based on social determinants, with less than 20% resulting from actual care received.

“I trained 15 years to only affect 20% of a patient’s outcome in a community? Ochoa said. “It was truly eye-opening that everything else: transportation, lack of access to healthy foods, sidewalks, health literacy, air quality – all these things – affect one’s health care outcome more than the actual care people receive.

“But it also helped explain why in San Antonio we had seen an increasing diabetic amputation rate over many years, despite the fact that we have more than enough vascular surgeons and interventionalists to treat these patients.”

Seeking a New Path

Ochoa’s vision of impacting these social health determinants required leaving her large group practice on the north side and starting her own practice, the San Antonio Vascular and Endovascular (SAVE) Clinic, that focused on those zip codes with the highest diabetic amputation rates. Their main clinic opened on the southeast side of the city, adding satellite clinics throughout the south side.

“We are acknowledging one big social determinant of health, transportation, because when we are physically closer to the patients, they are more likely to get to us.”

Determined to increase the scope of her vision, she will have the SAVE clinics collaborate with all appropriate entities – hospitals, other physicians, non-profits, academic centers, city leaders – to figure out how best to influence as many social determinants as possible, because, “Ultimately, it’s your neighborhood that predicts what your health outcomes will be.”

Navigating a Troublesome Past and a Complex Future

Ochoa knows the path forward is challenging and complex due to the many different factors that can impact a community. She also understands that one cannot look to improve the future without understanding the past.

“We need to acknowledge that there is a disparity born of segregation and that it was intentional at one point, if no longer. But until we have the same force of intention in eradicating the impact of that disparity as was originally put into the cause of that disparity, we will just continue the status quo.

“And the status quo is not enough.”

Ochoa was determined to open the eyes of others. She saw the severe cases on the south side that she hadn’t seen before – the end-stage diabetic complications like amputations, heart attacks, strokes, and dialysis – and knew she had to be part of a solution.

“I can’t just see there’s a problem and not do anything about it,” Ochoa said. “And that’s how I kind of transitioned into doing more than just surgery.”

Seeing Oneself as a Clinical Investigator

So how does one transition into, “doing more than just surgery,” while aiming to better the lives of large numbers of previously under-represented patients?

One answer for Ochoa was to become a principal investigator for Abbott’s LIFE-BTK clinical trial, part of a larger initiative to make research more inclusive and better represent the broad diversity of patients impacted by any number of medical conditions.

The LIFE-BTK clinical trial is designed to test an investigational device that treats blocked arteries in Peripheral Artery Disease (PAD), a condition in which blood vessels, especially in the legs, narrow or become blocked and can lead to amputation.

PAD disproportionately impacts African American, Hispanic and Native American patients. Yet these communities remain drastically under-represented in clinical research, making up less than 15% of participants in cardiovascular clinical trials from 2015 to 2019.

PAD is the buildup of calcium plaque inside the blood vessel and it can block blood flow to the lower extremities, including feet. Diabetes is a highly inflammatory condition, like high blood pressure, high cholesterol and smoking, that induces this accumulation, so when one has PAD it makes a person vulnerable to diabetic foot ulcers that won’t heal.

PAD usually first presents as a diabetic foot ulcer, rather than pain, and these ulcers are associated with increased amputation and mortality rates, meaning that by the time the person knows there is an issue they are already far down the severity scale.

First Step Down This Path

“This is my very first clinical trial,” Ochoa said. “We know that my demographic of patients is usually not represented in most clinical trials, but they are going to be the people with the potential to benefit the most. It’s bringing something completely new, leading edge and exciting to a population that would never expect to see that.

“To me it fulfills the same mission of what I’m trying to accomplish in healthcare equity. It means we can get better data and information about this previously overlooked population, so we can figure out how to better treat this group. We all now know that different races, genders and ages respond differently to different treatments, and how do we find out how if they’re not also included in these clinical trials?”

Looking for a New Type of Clinical Trial

In the not-too-distant past, clinical trials were primarily conducted by large, academic-based medical institutions that had the necessary resources and experience, using white, male subjects. This approach, however, limited the number and types of investigators, subjects, approaches, and innovation, necessarily limiting the value of the findings reached.

Ochoa is part of an evolving system determined not just to change, but substantially improve this structure. “We understand that if we really want this broad diversity of patients in trials, we’re going to have to open up and put more resources into physicians that serve these populations conducting clinical trials.

“If we want the rewards of better, more applicable research, we have to work a little harder to get there.”

Investments that Pay Off

Ochoa and the sponsors of these clinical trial are very aware of the challenges and the ongoing investments of effort and money required to make these studies more inclusive. “It requires more staff, spending more time to help us collect data, and so many additional resources,” Ochoa said.

Ochoa knows there are many steps in this process, including building infrastructure that will provide patient transportation and community outreach to build understanding and enhance trust. Perhaps most importantly, “We need to be available so that people know who we are and will believe us when we say we are going to do the right thing by them.”

As the trust is building, the education is introduced. “We want them to know about, and benefit from, the newest technologies, that will not only help them, but the surrounding community of people who are suffering like they are,” Ochoa said. “Once we have established that patient-physician relationship, most people are willing to proceed with the trial.

“We are really trying to individualize the care of each patient and assure them that we will overcome whatever challenges they have in getting the care they need.”

Looking Into the Future

This is Ochoa’s first clinical trial, but it’s unlikely to be her last.

Her exceptional vision can’t help but take in a future where her research helps improve and extend the lives of innumerable patients. She believes her work puts her in a unique position to help those who need it most.

“I feel that those of us who bear witness to the very damage that is done — whether it is diabetic amputation, heart attack, stroke, dialysis — are among the best people to serve that role as advocates, to educate on diabetes control, diabetes prevention and education. Ultimately, I believe it’s my responsibility as a vascular surgeon to be at the forefront of this type of care.”

From Mission to Houston to San Antonio, Lyssa Ochoa’s extraordinary vision has never failed her. She has never lost sight of her goal to help the most people facing the greatest medical challenges, nor had her focus stray from the under-represented patients needing her skills and compassion.

She has looked through massive amounts of data that represent individual lives with highly specific challenges, caring for each patient she sees while analyzing the macro impact of the research she conducts.

And she understands that who she is, and what she sees in the mirror, can be pretty important in all the best ways:

“Something that speaks to my heart is when I hear of little girls who look like me say, ‘I can do that. I can be like her. So, yes, I am willing to speak up and be an advocate for this.”

We see. And agree.