The researchers at Rush are taking part in the national EVEREST II trial, a prospective, multi-center, phase II clinical study comparing the effectiveness of the eValve MitraClip device to standard open heart surgery. The tiny clip, which is placed using a catheter, holds the flaps of the mitral valve together to prevent leaking.
In normal hearts, the flaps of the valve between the left atrium and the left ventricle come back together after each heartbeat. With mitral regurgitation, the valve does not seal completely and blood leaks back into the left atrium. This reverse flow forces the heart to work harder to circulate the blood and can result in shortness of breath, fainting, low blood pressure, fluid retention, fatigue, loss of appetite, and a hacking cough that worsens when lying down.
If left untreated, patients with mitral regurgitation can suffer serious complications.
“Patients can develop heart rhythm disorders which can cause blood clots and strokes. The heart muscle gets worse and worse function, so by the time symptoms develop, patients have lost critical heart function,” said Dr. Ziyad M. Hijazi, study investigator and director of the Center for Congenital and Structural Heart Disease at Rush.
This new procedure is performed under general anesthesia and is far less complex than the standard method of correcting mitral regurgitation – open heart surgery, which requires a sternum splitting operation, use of a heart-lung machine and stopping the heart to repair or replace the valve.
“Until now, open heart surgery was the only option for patients with severe mitral regurgitation,” said Cliff Kavinsky, MD, study co-investigator and a cardiologist in the Center for Congenital and Structural Heart Disease at Rush. “Instead, we can use a catheter to reach the heart valve.”
With a small puncture in the groin area of the leg, a catheter is threaded through the leg vein up into the heart. This allows doctors to manipulate a tiny clip, which can bring the mitral leaflets together to help control or cure the mitral regurgitation and stop the leak.
Because the procedure is minimally invasive, patients usually spend one night in the hospital compared to about five nights with open heart surgery.
Preliminary results from the phase I trial, known as EVEREST I, show that the vast majority of mitral regurgitation patients who had successful results with the MitraClip device did not need mitral valve surgery three years after their procedure and many benefited from significantly improved function of the left ventricle. At 36-months follow-up, 82 percent of patients who had a successful result with the MitraClip device remain free from surgery. Seventy-four percent of patients with one or more clips implanted experienced significant improvement in the leak. Also, 12 months after the procedure, the shape of the left ventricle has improved. This was based on five echocardiographic measures, including left ventricular end-systolic dimension.
“There are no drugs that specifically treat or cure mitral regurgitation,” said Hijazi. “This procedure may allow us to stave surgery safely and manage patients’ symptoms effectively.”
For more information about mitral regurgitation or the EVEREST II REALISM trial, please contact Catherine Glase, clinical research nurse at Rush, at 312-942-9398.
Enrollment in the study is open to range of patients:
- Patients must be 18 years or older.
- Patients with either degenerative or functional mitral regurgitation
- Patients who are good surgical candidates and are open to the option of a less invasive approach.
- High-risk patients who are not good candidates for surgery.
About EVEREST II
The EVEREST II (Endovascular Valve Edge-to-edge REpair STudy) clinical research study is evaluating the safety and efficacy of the MitraClip device compared to traditional surgical mitral valve repair or replacement. This prospective, randomized, multi-center study will enroll 279 patients at up to 42 sites in the United States and Canada. Patients are randomized 2:1 to receive the MitraClip device. The same sites are also enrolling patients into a High Risk Registry.
About Rush University Medical Center
Rush University Medical Center includes the 674-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).
Rush is currently constructing a 14-floor, 806,000-square-foot hospital building at the corner of Ashland Avenue and Congress Parkway. The new hospital, scheduled to open in 2012, is the centerpiece of a $1 billion, ten-year campus redevelopment plan called the Rush Transformation, which also includes a new orthopedics building (to open in the Fall 2009), a new parking garage and central power plant completed in June 2009, renovations of selected existing buildings and demolition of obsolete buildings The new hospital is being designed and built to conserve energy and water, reduce waste and use sustainable building materials. Rush is seeking Leadership in Energy and Environmental Design (LEED) gold certification from the U.S. Green Building Council. It will be the first full-service, “green” hospital in Chicago.
Rush’s mission is to provide the best possible care for our patients. Educating tomorrow’s health care professional, researching new and more advanced treatment options, transforming our facilities and investing in new technologies—all are undertaken with the drive to improve patient care now, and for the future.