Health care giant Abbott (NYSE:ABT) released new study results at this this year’s European Society of Cardiology 2012 Congress in Germany, touting positive outcomes for its MitraClip mitral valve in "real world" patients.
The Access study included more than 560 patients who weren’t good candidates for surgical valve repair, which is still considered the best option for eligible patients suffering from mitral valve regurgitation.
The catheter-based MitraClip device is designed to slip over the mitral valve leaflets of patients without opening their chests, minimizing recovery time drastically compared to traditional open heart surgery.
Performed under general anesthesia, MitraClip’s guide catheter is inserted into the femoral vein to reach the heart, making it ideal for patients unable to undergo surgery.
Unlike Abbott’s previous Everest trial, which showed improved symptoms and reduced mitral regurgitation at 12 months, the Access study, the largest follow-up to date or MitraClip, involved patients who were older and sicker.
"These data give us a picture of how the MitraClip is actually being used in the real world," study author and presenter Dr. Wolfgang Schillinger told ESC 2012 attendees.
Patients in the Access study were, on average, at least 74 years old and had significant co-morbidities, including coronary artery disease in more than half and moderate to severe renal disease in 42%, according to a press release. About 85% of the patient population had moderate to severe mitral regurgitation.
At 1 year of follow-up the survival rate was 82%, 94% had been able to avoid mitral valve surgery and the majority of patients reduced their MR severity to mild.
"It took time to get going, but numbers are now taking off," Schillinger told Heartwire. "There is a large group of patients who may benefit from this procedure, and our data are likely to increase demand in the markets where is it available."
MitraClip, which is not yet cleared in the U.S., has been used in 4,500 procedures worldwide, about half of them in Germany, Heartwire reported.
Based on results from the Access trial, as well as previous MitraClip studies, the European Society of Cardiology decided to include the device in its 2012 ESC Heart Failure Guidelines, as an option for symptom control in patients with severe mitral regurgitation who are not fit for surgery.
The organization added that patient selection is key to success with MitraClip, noting that 20% of patients were left with severe MR and 30% had moderate to severe symptoms despite successful MitraClip implantation.
"This suggests that patient selection could be further improved, both in terms of valve anatomy but also in terms of identifying those individuals who have irreversible ventricular damage or excessive co-morbidity and who are unlikely to derive any benefit," according to the Society’s report.