Patient Stories: Heart

Heart & Vascular Institute-Texas Medical Center

Cardiologist Performs Innovative Mitral Valve Repair During
Phase II Evalve Trial

Retired schoolteacher Leona is the first of many Gulf Coast residents who will benefit from a Phase II follow-up trial currently under way at Memorial Hermann Heart & Vascular Institute-TMC and The UT Medical School at Houston. The trial, known as EVEREST II, is investigating the Evalve® Cardiovascular Valve Repair System for the treatment of mitral valve regurgitation (MR).

It was initiated last year following the release of initial results with six months' follow-up from the Phase I trial, the Endovascular Valve Edge-to-Edge Repair Study or EVEREST I.

Leona was identified as a candidate for the procedure last fall by cardiologist Richard Smalling, M.D., after she was transported from her home in Angleton during the Hurricane Rita evacuation and treated for a stress-related heart condition. She recovered quickly with no damage to her heart, but it was evident to physicians treating Leona that the 73-year-old suffered from severe mitral valve regurgitation.

MR, a progressive disorder, affects about 4 million people in the United States, with about 250,000 new diagnoses each year. The disorder results from dysfunction of the mitral valve leaflets, which causes backflow of blood into the left atrium and reduced cardiac output. If left untreated, MR can lead to congestive heart failure.
   

Approximately 50,000 patients undergo open heart surgery for MR annually, involving sternotomy, cardiopulmonary bypass and valve repair or replacement with a tissue or mechanical substitute. Patients who undergo surgery face a 2.3 percent mortality rate for repair or a 5.6 percent rate for replacement.

"The traditional mitral valve repair involves cutting out a section of the valve leaflet and suturing it together to cinch the valve opening," says Smalling, who is the J. Brent Sterling Professor of Cardiovascular Medicine at The UT Medical School at Houston.

"It's a fairly complicated surgery, performed by a relatively small number of surgeons. The alternative is an artificial valve, which affects the architecture and, therefore, the function of the heart."

During Leona's procedure, Smalling repaired the valve by clipping its two leaflets together with a tiny MitraClip™ device, delivered and deployed by a catheter threaded through the femoral vein to the heart. The procedure requires a team, including Catalin Loghin, M.D., an expert in transesophageal echocardiography, which is required to precisely place the clip in the leaky portion of the valve.

"Typically, surgery is the only option for patients with significant mitral regurgitation. While medication can address some of the symptoms, it can't treat the underlying physiological problems," says Smalling, "With this new approach, we hope to give patients an effective, minimally invasive option that may also speed recovery."

Data reported from the EVEREST I trial showed that out of 47 patients treated at various centers around the country, only 4 percent experienced significant adverse events at 30 days post procedure. Evalve repair prevented invasive surgery in 75 percent of patients at the six month post-procedure mark.

To date, Leona's December 2005 procedure has proven effective. She's back on the dance floor enjoying a favorite pastime and, on quieter days, honing her skills as a watercolorist.

"I'd been putting off valve replacement because I didn't want to be on medication for the rest of my life to avoid rejection," she says. "The Evalve procedure gave me a better option."

Currently, patients can only be candidates for the Evalve procedure by participating in the clinical study.