Extended EVEREST II Data Examine Safety, Efficacy of MitraClip as Well as Cost Effectiveness

MIAMI BEACH, FLA.—Three-year data from the EVEREST II trial confirm the clinical benefits and improved safety of the MitraClip system compared with surgery in the treatment of severe mitral regurgitation. In addition, a cost-effectiveness analysis indicates that costs related to the percutaneous clip technology are equal to or less than those that accompany surgery, particularly when data are confined to patients with acute procedural success.

Ted E. Feldman, MD, of Evanston Northshore Healthcare, Evanston, Ill., and colleagues presented 3-year outcomes from EVEREST II, a prospective multicenter randomized trial that compared the safety and efficacy of the MitraClip System (Abbott Vascular) to that of traditional mitral valve surgery in patients with severe mitral valve regurgitation.

According to previously reported data, at 1 and 2 years postprocedure, about 80% of patients who were treated initially with the MitraClip still had durable results. Follow-up of 258 patients to 3 years confirms sustained reductions in mitral regurgitation and sustained improvements in left ventricular volumes and NYHA functional class (see Table). In addition, the 22% rate of surgery seen within 6 months of the percutaneous procedure remained stable at 3 years.

Because the device is currently the only one to accumulate significant clinical experience as a percutaneous therapy for mitral regurgitation, every year showing durability of the results represents an important milestone, Feldman told TCT Daily.

Cost-effectiveness data

The cost-effectiveness analysis of the MitraClip was conducted by Matthew R. Reynolds, MD, of Harvard Clinical Research Institute, Boston, and colleagues. This analysis took 12-month data on the MitraClip from EVEREST II and estimated indexed admission costs, costs for follow-up hospitalizations, and resource-based costs including rehabilitative and long-term care services. These were compared with expenses associated with conventional mitral valve surgery.

Researchers used the assumed price of the MitraClip ($18,000) in the United States, where the system is still not commercially available, and the European sales price of about $26,200. At the U.S. price, use of the system reduced overall costs by $2,200 per patient, indicating that this method is economically dominant. However, at the European price, overall costs were $6,192 higher than conventional surgery with a cost >$400,000 per quality-adjusted life year (QALY) gained.

When the results were limited to only those patients with acute procedural success, the QALYs gained from receiving the MitraClip were even greater, even with the higher assumed European MitraClip price where the cost per QALY was reduced to $54,000.

Sustained benefit

“What we can say at 3 years is that the outcomes seen initially remain true,” said Feldman. “Patients who get beyond the first 6 months appear to have results that are the same as surgery in terms of the need for additional surgery or other major endpoints.”

According to Feldman, many lessons have been learned to date from this randomized controlled trial and the ongoing registry of patients who have had MitraClip procedures.

“It would seem that the major lesson from the randomized trial was that the best results, or those most similar to conventional surgeries, were in patients who were older, had poorer LV function and who had functional rather than degenerative mitral valve regurgitation,” Feldman said. “The current emphasis for the procedure is higher in patients with predominantly functional mitral regurgitation.”

In addition, he added, although a high percentage of EVEREST II patients who underwent percutaneous treatment later required surgery, physicians’ ability to select patients and successfully perform the procedure has improved substantially since the trial began.

Procedural success improves, cost improves

When discussing cost, Reynolds said that in addition to the shorter hospital stay and a quality of life advantage seen at 1 month post-procedure, results indicated that depending on the exact price point of the device, the admission costs for clip procedures were close to or even lower than those for mitral valve surgery. And results appeared even better when confined to patients with acute procedural success.

Reynolds said that in the near term, it appears that the MitraClip will mainly be targeted for inoperable patients, and if that is the case, then cost will have to be examined in this specific patient population.

“But taking a longer view, our analysis suggests that the economics of a minimally invasive therapy for mitral regurgitation could be feasible as an alternative to mitral valve surgery if the right ingredients in terms of procedural success, clinical effectiveness, and price come together,” Reynolds said.