Brigham and Women’s Hospital (BWH) interventional cardiologists, in collaboration with their surgical colleagues, are among only a few programs in the nation in early-phase clinical trials for pioneering catheter-based mitral valve repair techniques that may prove to be valuable therapies for a diverse set of patients with mitral valve regurgitation.
Andrew Eisenhauer, MD, Director of the Interventional Cardiovascular Medicine Service at BWH, says, “The search for percutaneous mitral valve repair solutions is driven not only by the trend to do procedures in a less invasive way, but also by a growing body of information suggesting that mitral regurgitation (MR) may be dangerous in and of itself—not solely because of factors such as coronary artery disease that are often associated with MR —and that earlier intervention to prevent long-term consequences may be beneficial.”
Campbell Rogers, MD, Director of BWH’s Cardiac Catheterization Laboratory, says, “We are poised to begin offering two repair systems, each designed for a specific subset of patients with mitral valve regurgitation (MR). Our physicians and scientists have been active in the preclinical development of percutaneous mitral valve repair devices. Thus we have great familiarity with them and are ideally positioned to conduct clinical trials to demonstrate their safety and efficacy.”
EVEREST I
Dr. Eisenhauer is site investigator for EVEREST I (Endovascular Valve Edge-to-Edge Repair Study), a trial designed to test a mitral valve repair system for patients with isolated mitral valve disease due to a flail segment who are eligible for surgery. Patients with severe annular dilatation are not appropriate candidates for this trial. Under fluoroscopic and transesophageal echocardiographic (TEE) guidance, a catheter is advanced from the groin into the right heart, through the interatrial septum, and into the left atrium. A small clip introduced through the catheter is positioned in the mitral valve and deployed to grasp the anterior and posterior leaflets and pull them together, thereby creating a competent dual-orifice valve.
Results of the repair are assessed on the table by echocardiography and contrast ventriculography. Echocardiographic follow-up will occur at 30 days, six months, and 12 months. The protocol calls for reduction in MR of at least one grade, and physicians hope for even more improvement, leaving the patient with only trace amounts of MR.
The Everest Mitral Repair System is made by Evalve, Inc., the sponsor of the trial. Dr. Eisenhauer expects to enroll about a dozen patients in EVEREST I before it evolves into EVEREST II, which will involve randomizing patients to either this catheter-based approach or surgical repair. Dr. Eisenhauer says, “We hope that catheter-based strategies for amelioration of MR, used earlier in the course of the disease, will prove to reduce the adverse consequences of MR and improve long-term outcomes. This is not a ‘bridge-burning’ therapy – the patient can still undergo conventional surgical repair, if necessary, in subsequent years.”
COMPETENT
The COMPETENT (Coronary Sinus-Based Mitral Percutaneous Annuloplasty) trial is designed to test a repair system for MR of functional origin, in which the mitral valve annulus has become dilated. Again under fluoroscopic and TEE guidance, a catheter is advanced from the groin into the coronary sinus, which encircles the mitral valve from the outside. The repair device is introduced through the catheter, positioned in the coronary sinus, and deployed, allowing the clinician to create a “purse string.” When the string is tightened, it tightens the mitral valve annulus as well, thereby restoring competency and reducing regurgitation. The clinician is able to modulate the degree of correction by monitoring the valve fluoroscopically and making appropriate adjustments. The device, the Carillon Mitral Contour System, is made by Cardiac Dimensions, Inc., the study sponsor. Dr. Rogers is the principal investigator for this national trial.
For both trials, all candidates will be evaluated for suitability by echocardiography and reviewed by a team of BWH cardiac specialists that will include both interventionalists and surgeons. Dr. Rogers concludes, “We believe that percutaneous mitral valve repair has tremendous potential to improve patient outcomes in a less invasive way. Much research remains to be done to determine which device is best for which patient, but we are excited to offer this modality as part of a comprehensive medical, catheter-based, and surgical program for our patients with mitral valve disease.”
For more information on these trials, please contact:
Campbell Rogers, MD (617) 732-8136
Andrew Eisenhauer, MD (617) 732-8898
Donald Baim, MD (617) 732-8335
Cardiovascular Center Resources
On-line Information
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www.brighamandwomens.org/cvcenter/medical/presentations.asp
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