🔒Hartford docs helping study pros, cons of heart valve replacement breakthrough

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The options for treating heart ailments that arise in old age have taken a big leap forward in recent years.

One of the more significant developments has been a minimally invasive valve replacement procedure approved by the U.S. Food & Drug Administration about seven years ago.

Area doctors say transcatheter aortic valve replacement, known by its acronym TAVR, has prolonged older patients' lives and become a significant line of business for larger hospitals.

“It represents a major market going forward for healthcare systems and a major way of helping a lot of people who would otherwise be dying from their heart condition,” says Dr. Raymond G. McKay, co-director of the Heart & Vascular Institute structural heart program at Hartford Hospital, which has performed nearly 900 TAVR procedures since 2012.

The pace of surgeries could increase if and when the FDA approves the procedure — each of which brings in $50,000 to $60,000 to Hartford Hospital — for additional types of patients.

TAVR allows interventional cardiologists and cardiothoracic surgeons to replace the crucial and hardworking aortic valve without the use of open-heart surgery.

Instead, doctors guide a metal-mesh enclosed replacement valve made from a pig or cow heart through a key artery, most often from the groin up to the heart. The replacement valve fits snugly within the existing worn out or calcified valve, which is not removed during the procedure.

The increasing use of TAVR doesn't mean open-heart surgery is falling out of favor. For many patients with worn-out valves (a condition known as aortic stenosis) it's been the clear choice for decades and will have its place for years to come.

But surgery isn't an option for roughly two-thirds of patients with severely worn-out valves, largely those who are older — typically in their late 70s or 80s — and frailer. That leaves those patients — particularly individuals showing severe symptoms that could lead to death — with few options.

That “extreme-risk” population is the biggest beneficiary of TAVR.

The survival rate for high-risk patients who had a transcatheter aortic valve replacement was 70 percent a year after surgery, according to one trial. That was better than the 50 percent survival rate for high-risk patients who received non-surgical medical therapy like diuretics — a heart failure medication.

That death rate is still quite high, according to Dr. Francis Kiernan, who holds an identical title to McKay at Hartford Hospital. But the highest-risk patients are often very frail and sick.

“Usually, most medical trials show a relatively small overall benefit in terms of survival, but this one showed a huge benefit,” Kiernan said of the comparison between TAVR and non-surgical options.

Hartford Hospital has been involved in TAVR trials with the two companies that make approved valves, Edwards Life Sciences and Medtronic, registering more than 120 patients over the past six years.

“We've been involved in this from the very beginning as early adopters,” said Dr. Robert Hagberg, Hartford Hospital's chief of cardiothoracic surgery, who performs open-heart surgery.

Participating in trials is a lot of work, but it allows the hospital to offer new options to patients, and raises the institution's overall profile, McKay said.

Yale New Haven Health, too, has been involved in TAVR trials since the early days, and continues to study medical devices that would reduce the procedure's stroke risk, according to Dr. John Forrest, director of interventional cardiology and the structural heart disease program at YNNH. He said the system is now doing upwards of 250 procedures a year.

Forrest says the improved quality of life that frailer patients can achieve through TAVR should not be overlooked.

“They just want to be able to play with their grandkids without not being able to breathe,” Forrest said.

Proof is in the pudding

An estimated 2.5 million people over the age of 75 have aortic stenosis, and the large majority are male.

Depending on the patient, TAVR could be a better choice than surgery.

While doctors now know quite a bit about the procedure and its pros and cons, there's plenty left to learn before it can be adequately compared to open-heart surgery.

For one, doctors can't say for certain yet if TAVR valves will last as long as those used in open-heart procedures. While the valves appear identical to the untrained eye, the TAVR process requires the valve to be crimped and compressed, which could have structural implications down the line.

“There are early studies showing that longevity could be good, but all surgeons know you don't look at any valve durability data until it hits 10 years,” Hagberg said.

He said medical-device companies have been known to be aggressive in touting valve durability in their sales efforts.

His mantra is: “Sounds good, show me the data.”

Hartford Hospital doctors and staff are playing a continuing role in getting that data.

Since the FDA first approved TAVR for extreme-risk patients seven years ago, it has also approved the procedure for high and intermediate-risk patients.

A new patient population

The next frontier for TAVR is low-risk patients, for which a trial has already been completed. Study results for those patients are expected to be published in the first quarter of 2019.

Hartford Hospital participated in that trial and continues to offer TAVR to low-risk patients using the Edwards valve, as permitted by the FDA, along with 34 other hospitals.

McKay thinks that, as well as the public becoming increasingly informed about TAVR, will create a surge in patients asking for it.

”A smart, low-risk person who wanted to avoid open-heart surgery would wait until this registry came online and could just come in and get a TAVR,” he said.

He's hoping the data next year show that TAVR has an equivalent or improved one-year mortality and stroke rate compared to surgery. He also hopes data will bear out that TAVR is a lower-cost option.