Clinical research expands treatment for heart valve disease

December 4, 2023

Swedish Heart & Vascular Team

[4 MIN READ]

Results from several clinical research studies in which Swedish is a participant show positive results, leading to improved care and increased options for people with heart valve disease.
Clinical research provides access to next-generation technology for people who might not be able to get that type of treatment otherwise.
Swedish’s commitment to excellence and innovation is saving lives.

Researchers at Swedish understand that tomorrow’s treatment breakthroughs often come from today’s clinical research. And it drives their efforts daily.

“Swedish has a long-standing track record of excellence and quality in research and patient care,” says Sameer A. Gafoor, M.D., Medical Director of Structural Heart Disease at Swedish. “Clinical trials allow the next-generation technology to be accessible to patients. And it’s all done with the highest levels of safety and efficacy to get the best outcomes.”

Dr. Gafoor works closely with a heart team of cardiac interventionalists, cardiac imagers, surgeons, and other specialists to create a multidisciplinary approach for these patients. Two close members of the heart team include his partners Sidakpal Panaich, M.D., and Santanu Biswas M.D.

Three ongoing studies recently published results that could be game changers for people with heart valve disease.

Understanding heart valve disease

A healthy heart has four chambers: the right and left atria and the right and left ventricles. Four valves link the chambers and open and shut with every heartbeat. This keeps your blood moving in the right direction as it goes to and from your heart.

“Valves can fail in one of two ways. They can either be overly tight, called stenosis, or leaky, called regurgitation. The cause of heart valve disease varies and may include infection, age or congenital issues. Some people have no symptoms, but others may experience excessive fatigue, difficulty breathing, chest pressure or passing out,” explains Dr. Gafoor.

Treatment for heart valve disease includes medication and surgery to repair or replace the valve, depending on the patient’s health history and physical condition. If medication is ineffective or surgery is not a viable choice, it may leave patients with no other care options.

Treating aortic stenosis

Aortic stenosis occurs when your aortic valve becomes too narrow and tight for blood to flow freely from your heart. At least half of the people with aortic stenosis pass away within two years of their diagnosis, according to Dr. Panaich

Traditionally, open heart surgery has been the primary treatment for aortic stenosis. Patients who were not good candidates for surgery often had minimal care options. The use of transcatheter aortic valve replacement (TAVR) expanded their choices and increased their chances of a successful outcome, according to Dr. Panaich.

TAVR is a minimally invasive procedure that replaces the aortic valve without opening the patient’s chest. The diseased or defective valve is replaced with an aortic valve made from animal tissue. The procedure can be a good alternative for people who are not good candidates for surgery. Swedish is the only program in the region to offer conscious or light sedation for TAVR.

For several years, Swedish has been a major participant in a clinical trial comparing the effectiveness of transcatheter aortic valve replacement (TAVR) with surgery. Researchers recently released five-year and longer results that show the procedure is a good choice for many participants, with outcomes just as good as surgery, and sometimes better. Swedish was the state leader in one of the two major trials, which only selected national sites with the highest quality and track record of outstanding care.

“They found that TAVR allowed great recovery and outcomes compared to surgery when it came to valve function, as well as quality of life and survival. This is an important trial because it shows there are multiple options open to patients,” explains Dr. Panaich.

Enrollment has closed for this study and no new patients will be included. Researchers will continue to gather data by following participating patients for up to 10 years from the study’s start. What they find could expand the choices for people with heart valve disease and positively impact countless lives.

Tricuspid valve repair and replacement

Your tricuspid valve is the first valve blood meets when it enters your heart’s right side. Tricuspid valve regurgitation occurs when your tricuspid valve fails to close properly, allowing blood to leak backward causing a “leaky” heart. Recent data on the repair and replacement of the tricuspid valve shows both can be viable treatment alternatives, according to Dr. Biswas.

“Swedish led the way with both of these opportunities for patients,” says Dr. Biswas. “We have seen people come from Puget Sound as well as across the Pacific Northwest to participate in this next-generation technology here at Swedish.”

TRISCEND II Pivotal Clinical Trial

The TRISCEND II Pivotal Clinical Trial is designed to assess the effectiveness of a tricuspid valve replacement system marketed under the brand name. The minimally invasive valve replacement procedure uses a small incision in your leg to access your heart and replace the faulty valve. Patients typically go home the next day. Swedish had multiple patients participate in this study, which was the first of its kind in the country and the world.

Based on the excellent outcomes, the device is anticipated to receive FDA approval next year.

“The trial showed that patients improved their quality of life and functional status,” he explains. “This study shows that patients feel better and can do more with this type of care.”

TRILUMINATE Trial

The TRILUMINATE Trial was the first major study to compare the effectiveness and safety of a device called a TriClip™ to repair the tricuspid valve. Swedish was the lead enroller in Washington State and the Pacific Northwest, according to Dr. Gafoor. The TriClip™ is expected to receive FDA approval next year.

“This study showed that patients can achieve a significant reduction of the leak in their tricuspid valve, which gave them improved health and better quality of life,” says Dr. Gafoor.

Mitral valve regurgitation

The mitral valve is located between the two chambers on the left side of your heart. When the valve doesn’t close all the way, your blood flows backward and reduces the amount of blood circulating throughout your body. This forces your heart to work harder to circulate your blood and may lead to congestive heart failure if left untreated.

The Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial examined the safety and effectiveness of the PASCAL system compared with the MitraClip system. Results indicate the system is a good option for patients with significant valve disease and significant surgical risks. The device has been approved by the FDA, adding another option to the physician’s arsenal of tools.

“Having more options to care for patients helps us tailor their treatment according to their anatomy and needs to get the best outcome,” says Dr. Panaich. “We would like to thank the patients at Swedish who participated in these trials. By being part of this type of research, our patients were not only able to access next-generation technology themselves, they also gave us information that will shape medicine for years to come. Many of the ways we’ll be able to treat patients in the future are thanks to fantastic cardiology research teams and the amazing patients who gave up their time to participate.”

“As researchers, we understand that advances like these in technology and treatment are game changers for people with heart valve disease,” adds Dr. Biswas. “We always remember that behind the numbers, graphs and devices are real people hoping for a better future. At Swedish, we know one way to make that dream a reality is through cutting-edge research. We are indebted to our patients who changed not only their own reality, but also medical history.”

Learn more and find a provider

The team of specialists at the Swedish Heart & Vascular Institute have access to the latest treatments and technology and the expertise to know how to use it safely and effectively. Call 206-320-4100 to learn more about the cardiac care we offer.

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