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Monday, May 20, 2024

Edwards, NFL Tackle African American Cardiac Disease

Edwards Lifesciences Corp. may well have saved the life of a former NFL player.

“He had a severe dilated aortic,” recalled Larry Wood, an Edwards executive. “If that ruptures out of the hospital, the mortality rate is very high.”

But Edwards detected the condition in time.

“He had open-heart surgery in less than a week,” Wood recalled.

The NFL veteran’s potentially fatal condition was discovered during a study by Irvine-based Edwards (NYSE: EW) that included screening 498 retired NFL players and their families for hypertension: 84% were positive, while only 47% had self-reported a history of it.

“You’re talking about people who were elite, world-class athletes,” Wood said. “Generally, they think they’re in good health.

“But more than half the people had hypertension and didn’t know they had it.”

Moreover, of all those in the U.S. who received Edwards’ heart valve replacement to remedy the problem, only 3.9% were African American, while African Americans comprised about 14% of the nation’s population in 2022, according to the Pew Research Center.

“It was shocking to me,” said Wood, who heads Edwards’ unit that developed the valve replacement, known as TAVR, for transcatheter aortic valve replacement. “It highlighted the disparity in care.”

Woods said he doesn’t think African Americans suffer fewer heart problems.

Instead, Jerry Abraham, president the Los Angeles County Medical Association and a board member of the California Black Health Network, cites a lack of access to healthcare.

Along with distrust among African Americans of the medical profession, part of a legacy of the infamous Tuskegee experiment, a 40-year study by U.S. public health agencies in which the effects of untreated syphilis on 399 African American men were studied, with most not given penicillin, even after it was discovered as an effective treatment.

Today, Wood said, “It’s tricky to do a study on Black people. It becomes a lightning rod.”

NFL Alumni

Wood, after talking with his friend, former San Diego Charger kicker Rolf Benirschke, came up with the idea of studying former NFL players, about 60% to 70% of whom are African Americans.

“We realized that by working with the NFL Alumni Association and through this unique network of former players, we might be able to gain a greater understanding of how heart disease is impacting underserved populations, and how education, awareness and simple screening tools can save lives in these communities and in the entire nation as a whole,” Wood said.

Edwards said that more than 80% of those with heart valve disease go undiagnosed or untreated, and the undertreatment rate is significantly higher in underserved communities.

Unlike other progressive diseases, such as cancer, there is no age-mandated screening for heart valve failure, Edwards said.

To expand cardiac screenings and heart treatment in minority communities, Edwards has partnered with the Los Angeles Rams in an outreach program called “Off the Sidelines”.

Severe aortic stenosis, a form of heart valve failure, is the most common type of heart valve disease, affecting as many as 1.6 million older Americans.

Though it is deadly—once heart valve disease progresses to heart valve failure, up to 50% of sufferers die within two years—it is also treatable through open-heart surgery or a transcatheter heart valve replacement procedure.

Huddle Up

Edwards began the study, called Huddle, in 2021 by examining the prevalence of heart disease and associated risk factors among members of the NFL Alumni Association and their families.

Conducted across eight U.S. cities in cooperation with NFL Alumni Health, a subsidiary of the NFL Alumni Association, Huddle was a cross sectional study of NFL alumni and their family members aged 50 years and above. The participants were mostly male, 67%, and African American, 63%.

The study participants self-reported their medical histories and participated in heart health education and screenings that included blood pressure, electrocardiogram (EKG) and echocardiogram.

The noninvasive tests could find problems like heart arrhythmia, an irregular heartbeat caused by electrical problems, and hypertension, which can be early signs of stroke and aneurysms.

One participant went straight from the testing to the hospital, Wood said. Another player, about three days after an event, was on a ladder when he noticed symptoms he learned about and immediately identified it as a stroke.

“We detected early stages of heart failures in half of patients,” Wood said. “We’re glad that our study helped people.”

The study didn’t examine whether the athletes were affected by the notorious misuse of steroids, Wood said, adding that the game was much cleaner by the 1980s.

Besides the hypertension results, of all participants screened and found to have an elevated systolic blood pressure, a surprising 74% were also found to have structural heart changes present on a transthoracic echo sonography (TTE).

“These alarming results are a call to action,” said Dr. Michael Amponsah, an interventional cardiologist at the Banner Boswell Medical Center in Peoria, Ariz. “The disparities highlighted in the cohort involved in the Huddle study point to a significant opportunity to examine a greater role for routine age-based screening, and especially for the expanded use of echocardiogram to better identify undetected or undiagnosed heart disease and heart failure.”

The results were presented April 7 during a clinical trials session at the American College of Cardiology and published simultaneously in The Journal of the American College of Cardiology.

Wood said the millions of dollars Edwards spent on the study would not have been justified by an expected return on investment for the company.

“If we detect hypertension early, we may stop people from getting our products,” Wood said. “We’re in the business of helping people, not accelerating heart diseases.

“It’s a real passion project for several of us. Part of our responsibility as a successful company is how to use our resources—to be givers, not just takers.”

Edwards and the Rams

The Los Angeles Rams has teamed up with Edwards Lifesciences Corp. for a new community outreach program for heart testing, “Off the Sidelines.”

Edwards was also the official sponsor of the Rams Legends Community for the 2023 season to raise awareness of heart valve disease and make screening for heart valve failure part of the game plan for everyone 65 and older.

“Off the Sidelines” featured heart valve screening events open to Rams Legends, or former players, to determine if they are at risk for heart valve failure. In addition, the Los Angeles Rams and Edwards Lifesciences brought free heart valve screenings into communities across Southern California.

“The partnership is still in the earlier stages,” said Larry Wood, who heads two of Edwards’ biggest units. “They’ve been spectacular partners. We’re contributing our medical know how to figure out how we can make a difference.”

To kick off the partnership last summer, Edwards hosted a screening for the Rams Legends Community in Irvine prior to the Legends’ Day Training Camp practice.

“Our hope is that this partnership with the Legends community will bring awareness to heart valve failure and encourage people, especially those over 65, to take action,” Wood said.

—Peter J. Brennan

Busy Week at Edwards

Edwards Lifesciences Corp. is busy this week.

Mike Mussallem, who retired as chief executive last year, is also leaving his post as chairman. The company’s annual meeting is scheduled for May 7.

He will be succeeded by independent director Nicholas Valeriani, an Edwards board member since 2014, who has more than 40 years of experience in medtech companies, including as an executive vice president at Johnson & Johnson.

The company is also preparing for its eighth annual event that brings together patients from across the country to meet the Edwards teams that designed, and in some cases, hand-sewed the valves that are in their hearts.

The May 9 event will also feature patient advocacy organizations including the American Heart Association, Aortic Hope, Heart Valve Voice US, Global Heart Hub and the Alliance for Aging Research.

Key to Edward’s Fortunes: Larry Wood

Edwards Lifesciences Corp. has been one of Orange County’s most successful publicly traded companies, having grown from a $1 billion market cap in 2000 when it was spun off from Baxter International, to a $52 billion market cap at press time (NYSE: EW).

Playing a key role has been Larry Wood, who has been running Edwards’ Transcatheter Aortic Valve Replacement unit (TAVR) since its inception in 2007.

The unit, Edwards’ biggest, generated $3.9 billion of the company’s $6 billion in sales in 2023.

Longtime Edwards Chief Executive Mike Mussallem, who retired last year, said Wood started the TAVR business from scratch.

Wood has “dedicated 20 years of his career to create probably one of the greatest innovations in cardiovascular medicine, if not more broadly than any of us has seen,”

Mussallem told investors at the company’s annual meeting last year.

A year ago, Wood took on an expanded role as group president, with additional leadership responsibility for Surgical Structural Heart, which reported $1 billion in 2023 sales, and other key company initiatives.

The company on April 25 reported first-quarter sales rose 10% to $1.6 billion. It also boosted its annual forecast for sales to grow at the high end of its prior guidance of 8% to 10%, $6.3 billion to $6.6 billion. Wood’s TAVR unit boosted sales 6% to $1 billion while the Surgical Structural Heart unit was up 7% to $266 million.

“This encouraging start to the year supports our increased 2024 sales guidance,” CEO Bernard Zovighian said in a statement.

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