Structural Heart Disease: The Rapid Pace of Advances in Replacing, Treating Heart Valves

Most everyone understands that heart disease, or coronary artery disease, remains the No. 1 cause of death in the U.S. But as the elderly population grows, so do defects or disease associated with the structure of the heart.

Pivotal advances in treating or replacing heart valves, many of them initiated as part of national and international clinical trials, have taken place at Baptist Health Miami Cardiac & Vascular Institute over the past two decades. And they continue at a very steady pace.

Typically diagnosed in people 65 or older, valvular heart disease can produce symptoms which could be dismissed as signs of typical aging or other easily manageable conditions – but could signal something potentially much more serious, explains Nish Patel, M.D., an interventional cardiologist at the Institute who specializes in catheter-based therapies for valvular heart disease. Those symptoms could include fatigue, shortness of breath, dizziness or an irregular heartbeat.

Nish Patel, M.D., interventional cardiologist at Baptist Health Miami Cardiac & Vascular Institute.

“At this point, the cardiologist and our community of structural heart specialists are focused on those fatigue symptoms where the patient may just blame it on their age,” said Dr. Patel. “But the symptoms may be associated with underlying valvular heart disease. So, anytime a patient 65 and above have these symptoms, they should seek cardiology evaluation. And, if the cardiologist or other primary care physician finds something unusual, such as a murmur, then they will arrange an echocardiogram for the patient, and the echocardiogram would give us information if there's any issues with any of the valves. That's how we would find the valvular heart disease.”

A heart murmur is an unusual sound in your heartbeat that may sound like a whooshing or swishing noise. The extra noise occurs when the blood doesn’t flow smoothly through your heart. The murmur could be harmless, or it could signal a problem with the heart valves.

Everyone’s heart pumps with the vital help of four valves that direct blood in and out of each chamber – the aortic, mitral, tricuspid and pulmonary valves. When the valves are diseased or structurally deficient, the result can be critical or even deadly for patients. Advances in treating valves have focused on minimally invasive, catheter-based procedures that generally ensure quick and smoother recoveries compared to outright surgeries. A

Aortic stenosis is one of the most common and serious valve disease conditions. It refers to the narrowing of the aortic valve opening, and is sometimes referred to as a failing heart valve. Aortic stenosis restricts the blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium.

“The incidence of aortic stenosis is 1 percent after 65 years of age; it's 3 percent after 75 years of age, and it's 10 percent after 85 years of age,” said Dr. Patel. “So, as you age, the risk of aortic stenosis goes up, and that's essentially due to wear and tear of the valve because imagine that your body is just doing its own thing while you're living your life.

“With every single heartbeat, those valves are opening and closing. And those valves, with just constant opening and closing, and dealing with the high pressures of the heart chambers, they go through wear and tear. And where there's wear and tear, there are calcium deposits. And those calcium deposits can restrict the opening of the heart valve in the aortic valve condition and would cause the aortic stenosis.”

Replacing the Aortic Valve and Repairing the Mitral Valve

Many more advances have been linked to replacing the aortic valve via a minimally invasive procedure called TAVR, or “transcatheter aortic valve replacement.” The aortic valve is not as complex as the much more intricate mitral valve, which can present more critical issues, even for young heart patients. In 2019, TAVR exceeded all forms of surgical aortic valve replacement (SAVR) for the first time.

Now, more patients than ever can undergo TAVR and avoid SAVR. Since the first TAVR device was approved in 2011, access has been extended from patients considered inoperable or at extreme risk (2011), at high-risk (2012), intermediate-risk (2016) and low-risk (2019) for SAVR.

Baptist Health Miami Cardiac & Vascular Institute has taken part in many of the national clinical trails involving the advancement of TAVR, led by Ramon Quesada, M.D., medical director of Structural Heart and Complex Percutaneous Coronary Intervention at the Institute.

The Institute is now taking part in the clinical trial, Complete TAVR, that focuses on patients who about to undergo TAVR but are also diagnosed with coronary artery disease. The trial will help determine if revascularization before TAVR is necessary and determine the optimal timing of treating the coronary artery disease – if necessary at all.

Heart valve disease occurs if one or more of the heart valves — the tricuspid, pulmonary, mitral, and aortic valves — do not open fully or they allow blood to leak back into the chambers. Heart valves can have three basic kinds of problems: regurgitation, stenosis (narrowing), and atresia (lacking an opening for blood to flow through).

The mitral valve is more challenging to treat, but the Institute has been involved in clinicals trials that have led to approvals of devices to treat the most common issue: Mitral regurgitation, which refers to leakage of blood backward through the mitral valve each time the left ventricle contracts. Some blood flows from the ventricle through the aortic valve — as it should — and some blood flows back into the atrium.

Along with aortic stenosis, the most common valvular heart disease in the United States is mitral regurgitation, said Dr. Patel. The Institute’s structural heart team uses minimally invasive procedures and the latest devices to stop the mitral valve leakages. For example, in the MitraClip procedure, a surgeon places a catheter into the femoral vein in the leg and threads it through to the heart. When the catheter is inside the heart’s left atrium, the doctor moves the clip through the catheter and positions it above the leak in the mitral valve. The clip grasps both leaflets of the valve to help them close properly.

“There are numerous devices out there under research,” explains Dr. Patel. “We have a solution called Pascal. And there are other solutions which are still under the research phase for the mitral valve replacement, which would represent the next major milestone.”

The PASCAL implant was approved in 2022 by the U.S. Food and Drug Administration (FDA). The implant clips the two flaps together to reduce MR, or the backflow of blood through the valve.

Dr. Patel emphasize that Baptist Health Miami Cardiac & Vascular Institute is unique in South Florida because it has a team of structural heart specialists that make up a Valve Clinic where patients have access to a multi-disciplinary team once they are diagnosed with severe valvular heart disease.