Feature | April 08, 2011

Mitral Valve Repair by Catheter Compares Favorably With Open-Heart Surgery

The transcatheter MitraClip mitral valve repair system continues to compare favorably with conventional open-heart surgery for treatment of select patients with mitral regurgitation. The findings come from updated research from the EVEREST II study presented at the American College of Cardiology’s 60th Annual Scientific Session.

Mitral regurgitation (MR) is common in aging hearts, appearing in 20 percent of echocardiograms for people older than 55. A loosely closing mitral valve leaks blood back into the heart, which responds by trying to pump harder. MR is progressive, and over time the overworked heart enlarges and weakens. Each year 250,000 people in the United States learn they have MR, but only 20 percent eventually undergo standard treatment to repair or replace the valve, which is open-heart surgery that puts patients on a heart-lung bypass machine. For many, that procedure poses too great a risk. Instead they rely on medications to reduce MR symptoms, and limit their activities as physical function declines. Symptoms of MR can include palpitations, shortness of breath, fatigue, lightheadedness, cough and swelling in the legs and feet from fluid buildup.

The percutaneous MitraClip involves a minimally invasive procedure that may make valve repair feasible for more people with MR. Cardiologists trained to use this system guide a catheter-mounted device through an incision in the groin, into the femoral artery and on to the heart. When the device is properly placed, it clamps the edges of the faulty valve together like a clothespin. Sometimes a second clip is inserted for better control of MR. Standard MR surgery and device insertion both take about two hours, but their hospitalization and recovery times differ greatly.

“After getting a MitraClip, patients spend one or two nights in the hospital versus five to seven days after open-heart surgery, and they’re back to full activity immediately,” said Ted Feldman, M.D., director of the cardiac catheterization laboratory at NorthShore University HealthSystem, Evanston, Ill., and the study’s co-principal investigator. “Traditional open-heart surgery has a recovery time of one to three months. The contrast is pretty striking.”

This phase II study enrolled 279 patients in 37 North American centers who met criteria for mitral valve surgery: grade 3+ (moderate to severe) or 4+ (severe) MR. All patients had valve anatomy suitable for the procedure and were randomly assigned in a 2-to-1 ratio to the MitraClip or to standard surgery. Both groups were well matched for baseline patient characteristics. Year one data have been published. This presentation reports year two data and patients will be followed for five years.

The effectiveness of the two treatments was measured by a composite of freedom from death, no new mitral valve surgery and MR lower than pretreatment minimum of 3+. In the treatment comparison, 101 patients (62.7 percent) in the percutaneous group met the composite endpoint vs. 66 (66.3 percent) in the surgery group. At two years, 78 percent of patients with the device did not need surgery.

Major adverse events at 30 days were significantly lower in the percutaneous group (15 percent vs. 47.9 percent). Blood transfusions of two units or more account for most of this difference: 13.3 percent in the percutaneous group vs. 44.7 percent for surgery patients.

Durability and anti-clotting drugs are other issues considered in this research. A mechanical heart valve lasts 35 years and requires the patient to take warfarin for life. Valve repair with a MitraClip should last approximately 15 years, and after implant, patients take clopidogrel for just one month and aspirin for six months. Although the procedure’s surgical version has demonstrated durability for more than 12 years, long-term outcomes from MitraClip can be defined only after further study.

“Both procedures reduced mitral regurgitation and produced meaningful clinical benefits, with the MitraClip valve repair increasing safety and surgery decreasing mitral regurgitation more completely,” Feldman said. “Our two-year data indicate that the percutaneous procedure is a therapeutic option for certain patients with significant mitral regurgitation.”

The EVEREST II study (Endovascular Valve Edge-to-Edge REpair STudy) is funded by Evalve, which also provides research funding to NorthShore University HealthSystem. Feldman is a consultant to Abbott, which acquired Evalve in 2009.

These findings will concurrently be published in the New England Journal of Medicine.

For more information: www.cardiosource.org

Related Content

Edwards Intuity aortic valve, surgical aortic valve replacement, PinnacleHealth, first U.S. implants
News | Heart Valve Technology| August 26, 2016
This week, PinnacleHealth, Harrisburg, Pa., became the first hospital in the country to implant the Edwards Intuity...

MRI brain scan of a 26-day-old neonate with Zika virus. It shows septation in the ventricle at the arrow. See more Zika radiology images at http://pubs.rsna.org/doi/full/10.1148/radiol.2016161584.

 

News | Cardiovascular Surgery| August 26, 2016
August 26, 2016 — As a further safety measure against the emerging Zika virus outbreak, the U.S.
cardiac surgery, simulation training, University of Washington, case studies

Multiple repetitions of bypass grafts on a heart, using the Ramphal simulator. Courtesy of the University of Washington in Seattle.

News | Cardiovascular Surgery| August 25, 2016
August 25, 2016 — Simulation training fo
aortic dissection, family history, same age, clinical study, John A. Elefteriades, Annals of Thoracic Surgery
News | Structural Heart| August 25, 2016
People with a family member who had an aortic dissection — a spontaneous tear in one of the body’s main arteries —...
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
TAILOR-PCI study, antiplatelet medication, genotype, NHLBI grant
News | Antiplatelet and Anticoagulation Therapies| August 18, 2016
Researchers at the Peter Munk Cardiac Centre, Toronto, and at Mayo Clinic are leading the Tailored Antiplatelet Therapy...
Overlay Init