Tricuspid valve repair system shows promising results at one-year
follow-up
Study further validates transcatheter edge-to-edge strategy to treat
tricuspid regurgitation

Date:
April 4, 2022
Source:
American College of Cardiology
Summary:
Patients with tricuspid regurgitation, a common and debilitating
form of valvular heart disease, who received a novel investigational
device intended to repair the defective valve experienced
significant improvements in blood flow through the heart and in
quality of life at one year, according to recent research.



FULL STORY ========================================================================== Patients with tricuspid regurgitation, a common and debilitating
form of valvular heart disease, who received a novel investigational
device intended to repair the defective valve experienced significant improvements in blood flow through the heart and in quality of life at
one year, according to research presented at the American College of Cardiology's 71st Annual Scientific Session.


==========================================================================
"At one year of follow-up, the repair procedure appears to be safe and significantly reduced the severity of patients' tricuspid regurgitation
and improved their ability to function in daily life, maintaining gains
that we previously saw at 30 days of follow-up," said Adam B. Greenbaum,
MD, associate professor of medicine and co-director of the Structural
Heart and Valve Center at Emory University School of Medicine.

Tricuspid regurgitation affects an estimated 1.6 million people in the
U.S. and increases as each generation ages. The study offers further
validation for transcatheter edge-to-edge repair, a minimally invasive
approach to the treatment of patients with the disease, Greenbaum said.

The tricuspid valve, one of four valves in the heart, controls blood
flow between the heart's two right chambers, the right atrium and the
right ventricle. When the right atrium fills with blood, the valve
opens, allowing the blood to flow into the right ventricle. Then, the
valve closes tightly so that no blood flows backward into the right
atrium. Tricuspid regurgitation occurs when the valve doesn't close
tightly, allowing blood to flow backward and causing the heart to pump
harder to push enough blood out into the body.

Patients with tricuspid regurgitation often feel tired and experience
shortness of breath. As the condition worsens over time, it may cause
symptoms such as an enlarged liver, a swishing sound when the heart
beats, a fluttering feeling in the chest and swelling in the abdomen,
legs, ankles or feet.

Patients with tricuspid regurgitation are commonly treated with diuretics, drugs that are also used to treat high blood pressure. Surgery to repair
or replace a poorly functioning tricuspid valve is often done at the
same time a patient undergoes surgery for a problem on the left side of
the heart.

Minimally invasive options are needed to treat tricuspid regurgitation, Greenbaum said, as most patients with the condition are older and may
have other health problems that make them poor candidates for open-heart surgery.

The CLASP-TR study is a feasibility study of an investigational
transcatheter repair system for tricuspid regurgitation. A long, flexible
tube called a catheter is threaded through a vein to insert a tiny device
that resembles a clothespin into the tricuspid valve. The pin grasps
the flaps that open and close the valve, reducing the amount of blood
that flows backward. The study endpoints included a composite of major
adverse events at 30 days (e.g., death due to cardiovascular disease,
heart attack, stroke, kidney failure, severe bleeding); evidence on an echocardiogram of a reduction in backward blood flow; and death from
any cause, distance walked in six minutes and scores on two measures of
heart failure severity.

A preliminary report published in February 2021 found that at 30
days of follow-up, the repair system substantially reduced tricuspid regurgitation, produced few adverse events, and significantly improved patients' ability to function, exercise capacity and quality of life. The current study reports results after one year of follow-up.

A total of 65 patients (average age 77, 55% women) received the
investigational device, 70% of whom had tricuspid regurgitation that was
rated "massive" or "torrential" (the two highest grades of severity on
a five-point scale) despite treatment with diuretics. In addition, most
had other health problems that made them poor candidates for surgery,
including atrial fibrillation (a type of abnormal heart rhythm), liver or kidney disease and pulmonary hypertension (a type of high blood pressure
that affects the right side of the heart and the arteries in the lungs).

The COVID-19 pandemic affected the researchers' ability to obtain one-year follow-up data for all treated patients, Greenbaum said. For example,
some patients completed follow-up questionnaires that could be done
remotely but did not complete tests that had to be done at the hospital,
such as the echocardiogram and six-minute walk test. In addition, several patients died (although none died because of the repair procedure). In a
few patients, the procedure was unsuccessful because the device failed
to attach to the flaps in the tricuspid valve; and a few patients were
lost to follow-up.

Ultimately, one-year follow-up results were available for 49
patients. Seven patients (10.8%) died and 12 (18.5%) were rehospitalized
for heart failure.

These results compare with an expected one-year mortality rate of about
30% for patients with tricuspid regurgitation, Greenbaum said. Among 36 patients with available data at one year, all achieved a reduction of
at least one grade in the severity of their tricuspid regurgitation; 75%
saw a reduction of at least two grades; and 86% achieved an overall grade
of moderate or less. Eleven patients (16.9%) experienced a major adverse
event. Significant improvements were seen in heart failure severity,
the six-minute walk test and patient- reported quality of life.

Longer follow-up is needed to determine how well the device continues to perform and how well patients do at two years or five years of follow-up, Greenbaum said. Limitations of the study include low patient treatment
numbers and an absence of a comparison group. Greenbaum said a randomized
trial is now underway that will compare outcomes for patients treated
with the investigational device and patients who receive optimal medical therapy with diuretics.

The study was funded by Edwards Lifesciences Corporation, maker of the tricuspid valve repair system used in the study.


========================================================================== Story Source: Materials provided by American_College_of_Cardiology. Note: Content may be edited for style and length.


==========================================================================


Link to news story: https://www.sciencedaily.com/releases/2022/04/220404105705.htm

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