Hartford Hospital Heart Study Helps Push FDA’s MitraClip Approval

Print icon

The good news for people with leaky mitral valves is that the Food and Drug Administration recently approved a device called MitraClip as an effective remedy that does not require open-heart surgery.

The better news for Connecticut residents is that some of the ground-breaking research that prompted the FDA decision in early March was done at the Hartford Healthcare Heart & Vascular Institute, giving patients better access to the physicians most experienced with the technique.

Led locally by site Principal Investigator Dr. Raymond McKay, who is also co-director of the Structural Heart Disease Program, Hartford Hospital participated in the national COAPT trial that compared percutaneous mitral valve repair with MitraClip to medical therapy in high-risk patients who cannot have conventional, open-heart surgery to repair or replace the faulty valve.

“MitraClip was originally approved by the FDA in 2013 only for use in mitral regurgitation patients having structural abnormalities of their mitral valve,” Dr. McKay said, noting that Hartford Hospital physicians have since performed more than 60 MitraClip procedures in patients with intractable congestive heart failure.

In 2018, the hospital was named an investigative site for the landmark COAPT trial, the results of which were simultaneously published in the Journal of the American College of Cardiology and presented at the American College of Cardiology’s Annual Scientific Session in March 2019. A previous presentation of research results prompted the FDA’s approval of MitraClip for high-risk functional mitral regurgitation patients the same month.

In the approximately 2 million Americans with heart failure, most over age 75, the mitral valve often cannot function properly because swelling of the left chamber of the heart prevents the valve from closing properly. This allows blood to backflow through the heart, decreasing the patient’s quality of life while increasing risk of hospitalizations and rate of death. The condition can also cause irregular heartbeats that can lead to stroke and heart failure.

“These are patients who typically find no improvement with other available treatments, yet by implanting MitraClip we are able to improve their daily lives and lower their chance of hospitalization due to the valve defect,” McKay said.

Interventional cardiologists implant the MitraClip through a small incision in a leg artery, avoiding the need for open-heart surgery. The device holds some of the mitral valve sections together to reduce the backflow of blood and allowing the heart to pump more efficiently. COAPT was able to indicate, too, that MitraClip leads to significant improvements in patient quality of life, results that are sustained over the long term, he said.

For more information on MitraClip at the Hartford HealthCare Heart & Vascular Institute, click here.


What's New

Why TAVR Heart-Valve Replacement Is a Medical Breakthrough

By Dr. Raymond G. McKay Co-Director, Hartford HealthCare Heart & Vascular Institute Structural Heart Disease Program at Hartford Hospital Medical breakthroughs that seem to come out of nowhere grab the headlines: cancer vaccines, lab-grown body parts and other developments that almost read like science fiction. But most of medicine’s advancements...


What Causes Peripheral Artery Disease?

What is Peripheral Artery Angioplasty? Risks of Angioplasty for Peripheral Arterial Disease of the Legs For more information about peripheral artery disease at treatment at the Hartford HealthCare Heart & Vascular Institute, click here.

Coronary calcium score.

Hartford Hospital Among Best for Heart Transplants

Hartford Hospital is the number 1 adult heart transplant program in Connecticut based on three-year survival rate data from the national Scientific Registry of Transplant Recipients (SRTR). Hartford Hospital also ranks second highest in the New England-New York-New Jersey region and 11th highest in the nation out of 107 programs....

Stress and Your Heart

Study: Stress-Related Disorder Heightens Heart Risk

People have a 60 percent increased risk of cardiovascular disease within the first year of being diagnosed with any stress-related disorder, according to a new study in Sweden. The results, published April 10 in the British Medical Journal, used data from the Swedish National Patient Register to compare people diagnosed...

Hartford Hospital Celebrates 1,000th ‘TAVR’ Procedure

Method Helps Patients with Aortic Valve Disease On April 5, Hartford Hospital’s structural heart team celebrated its 1,000th Transcatheter Aortic Valve Replacement (TAVR), an achievement reached in January of this year. “It is an honor to celebrate this achievement with our teams and the entire Heart & Vascular Institute,” said...

1,000th TAVR

A TAVR Surgeon Explains Mick Jagger’s Heart Procedure

TAVR, otherwise known as the heart procedure that gave Rolling Stones frontman Mick Jagger a new aortic valve, has become an attractive option for patients with severe aortic stenosis because it does not require conventional open-heart surgery. Dr. Robert Hagberg, chief of cardiac surgery at Hartford Hospital, explains: Q: First,...