Main navigation is closed
Sentara patients receive first TricValve heart implants in Hampton Roads
Breakthrough device treats form of heart valve disease as part of a national clinical trial. Below: Dr. Matthew Summers (left), Karen Bellemare (center), and Nurse Practitioner and Valve Coordinator Sarah Kennedy
Karen Bellemare had a severe leakage in the heart’s tricuspid valve, which helps blood flow in the right direction.
Her physician estimated her vital organs were receiving only twenty percent of the normal blood flow. For Karen, that meant exhaustion, shortness of breath, and dizzy spells. She also experienced swelling in her legs and abdomen.
“I couldn’t do normal things around the house,” said Karen, 74, a retired special education teacher. “I couldn’t vacuum. I was getting up in the morning, throwing in a quick load of laundry, and then going for a nap.”
Her care team attempted minimally invasive repair with clips, but these were unsuccessful given her anatomy. Then they told her of a clinical trial for a new valve implant that held promise for patients with severe cases of tricuspid regurgitation. Karen was interested.
In October, Karen and another Sentara patient became the first two people in Virginia’s Hampton Roads region to receive the TricValve system, which the FDA has designated a breakthrough device.
Karen said she feels “blessed” to be able to receive the new treatment.
“It’s like winning the lottery.”
Her exhaustion has lessened, her swelling is gone, and now she is able to do things around the house. She is planning to go on a cruise in January.
“I am feeling very good,” Karen said.
The Sentara Heart Hospital is one of only 36 hospitals around the country that offer the TricValve implantation as part of an ongoing clinical trial, according to cardiologist Matthew Summers, M.D., director of Sentara's Structural Heart Center, who performed Karen’s surgery. Sentara is considered a national leader in heart valve care.
The new device treats severe tricuspid regurgitation, where blood leaks backward through the heart valve. Moderate to severe tricuspid regurgitation affects around 4% of people over age 75, according to Dr. Summers. The condition can lead to heart failure and death.
While other treatments are available for this form of heart disease, anatomic issues mean that they are unsuitable for 5-10% of people.
“Before this past year, tricuspid regurgitation had no treatment options,” said Dr. Summers. “This was a large treatment gap and patients in our community suffered. Now we have three excellent options for people with all types of severe tricuspid regurgitation."
To qualify for the new device, patients must meet study criteria. Afterward, clinical team members monitor the patient closely for a year, with data collected for up to five years.
The trial is one of hundreds in which Sentara participates through the Sentara Health Research Center, offering patients access to cutting-edge care in areas like cancer, neurology, cardiology, and vascular surgery.
Both Karen and the other patient who received a TricValve implant now have normal heart function and no significant leaks, said Dr. Summers.
“They’re both doing really well,” he said.
Decades ago, when Karen’s grandmother was diagnosed with leukemia, she was told she only had a few months to live. Then her grandmother learned of a clinical trial for a new treatment. She enrolled.
“She ended up living two and a half years,” Karen said. “So the study helped her.”
Later, when Karen's cousins were diagnosed with leukemia, treatments for cancer had improved, and they lived for many years afterward. This made an impression on her. Her grandmother had helped advance care, and she wanted to do her part, too.
“If it helps me, that’s great. But it will also help someone else down the road. That’s why I said yes.”
To learn more about Sentara’s heart valve care, see our Heart Valve Center page.
Her physician estimated her vital organs were receiving only twenty percent of the normal blood flow. For Karen, that meant exhaustion, shortness of breath, and dizzy spells. She also experienced swelling in her legs and abdomen.
“I couldn’t do normal things around the house,” said Karen, 74, a retired special education teacher. “I couldn’t vacuum. I was getting up in the morning, throwing in a quick load of laundry, and then going for a nap.”
Her care team attempted minimally invasive repair with clips, but these were unsuccessful given her anatomy. Then they told her of a clinical trial for a new valve implant that held promise for patients with severe cases of tricuspid regurgitation. Karen was interested.
In October, Karen and another Sentara patient became the first two people in Virginia’s Hampton Roads region to receive the TricValve system, which the FDA has designated a breakthrough device.
Karen said she feels “blessed” to be able to receive the new treatment.
“It’s like winning the lottery.”
Her exhaustion has lessened, her swelling is gone, and now she is able to do things around the house. She is planning to go on a cruise in January.
“I am feeling very good,” Karen said.
A cutting-edge treatment for heart valve disease
The Sentara Heart Hospital is one of only 36 hospitals around the country that offer the TricValve implantation as part of an ongoing clinical trial, according to cardiologist Matthew Summers, M.D., director of Sentara's Structural Heart Center, who performed Karen’s surgery. Sentara is considered a national leader in heart valve care.
The new device treats severe tricuspid regurgitation, where blood leaks backward through the heart valve. Moderate to severe tricuspid regurgitation affects around 4% of people over age 75, according to Dr. Summers. The condition can lead to heart failure and death.
While other treatments are available for this form of heart disease, anatomic issues mean that they are unsuitable for 5-10% of people.
“Before this past year, tricuspid regurgitation had no treatment options,” said Dr. Summers. “This was a large treatment gap and patients in our community suffered. Now we have three excellent options for people with all types of severe tricuspid regurgitation."
To qualify for the new device, patients must meet study criteria. Afterward, clinical team members monitor the patient closely for a year, with data collected for up to five years.
The trial is one of hundreds in which Sentara participates through the Sentara Health Research Center, offering patients access to cutting-edge care in areas like cancer, neurology, cardiology, and vascular surgery.
Both Karen and the other patient who received a TricValve implant now have normal heart function and no significant leaks, said Dr. Summers.
“They’re both doing really well,” he said.
Advancing care through clinical trials
Decades ago, when Karen’s grandmother was diagnosed with leukemia, she was told she only had a few months to live. Then her grandmother learned of a clinical trial for a new treatment. She enrolled.
“She ended up living two and a half years,” Karen said. “So the study helped her.”
Later, when Karen's cousins were diagnosed with leukemia, treatments for cancer had improved, and they lived for many years afterward. This made an impression on her. Her grandmother had helped advance care, and she wanted to do her part, too.
“If it helps me, that’s great. But it will also help someone else down the road. That’s why I said yes.”
To learn more about Sentara’s heart valve care, see our Heart Valve Center page.
By: Clancy McGilligan