Abbott Vascular has announced the publication of two European post approval studies for its transcatheter device, MitraClip, for mitral regurgitation. ACCESS-EU, which was published in the Journal of American College of Cardiology, and the Transcatheter mitral valve interventions (TRAMI) registry, which was published in EuroIntervention, both show positive outcomes for the device.
ACCESS-EU, a European prospective study that enrolled 567 patients at 14 sites, demonstrated that in real-world, post approval experience in Europe, patients undergoing the MitraClip therapy are predominantly high surgical risk, elderly patients who are mainly affected by functional mitral regurgitation. It showed that in this patient population, the MitraClip procedure demonstrated low rates of hospital mortality and adverse events and provided significant improvements in day-to-day quality of life at one year following treatment.
Findings of the ACCESS-EU study included:
• No incidence of death or stroke during the MitraClip procedure and in the immediate post-operative period.
• A majority of patients (91.2%) achieved MR reduction to MR grade of 2+ or less (on a scale of 1+ [mild MR] to 4+ [severe MR]) at discharge (p<0.0001).
• At one year following the procedure, 78.9% of patients were free from MR severity of 2+ or more (p<0.0001), and 71.4% of patients were in NYHA Functional Class II or Class I compared to 15 percent at baseline (p<0.0001).
• A large majority of patients (79.2%) were discharged to home rather than to a skilled nursing facility.
• Significant improvements in quality of life. At one year, six-minute walk test results improved by a mean of 59.5 meters (p<0.0001). Minnesota Living With Heart Failure results, which measure the effects of symptoms, functional limitations and psychological distress on an individual’s quality of life, improved by a mean 13.5 points (p<0.0001).
“I am impressed by the excellent outcomes observed in real-world patients with the MitraClip therapy. The procedure proved safe and effective even in patients who are at high risk for complications from mitral valve surgery,” said Francesco Maisano, director of Transcatheter Valve Therapies at San Raffaele Hospital in Milan, Italy, lead author of the ACCESS-EU data publication and co-principal investigator of the study. “In my experience, the MitraClip therapy has a definite role for patients who are not candidates for surgery. I have treated many patients who have experienced a dramatic improvement in quality of life. Relief from the symptoms of mitral regurgitation has allowed many bedridden patients to return to normal day-to-day activities.”
Results of the TRAMI registry, which enrolled 1,064 patients at 20 German sites, showed similar benefits for the MitraClip therapy in both elderly and younger patients. To evaluate the influence of age, patients were divided into two subgroups: patients 76 years old and above, and patients younger than 76 years of age. The procedure proved to be safe in both groups. Hospital mortality was 2.9% in elderly patients and 2.8% in younger patients (p=0.96). Major adverse cardiovascular or cerebrovascular events (MACCE), defined as a composite endpoint of death, myocardial infarction or stroke, was 3.5% vs. 3.4%.