AccuCinch ventricular repair system associated with favourable safety profile at 30 days
Data from an interim analysis of heart failure patients treated in the CorCinch FMR study show, a press release reports, that the AccuCinch ventricular repair system (Ancora Heart) is associated with a favourable safety profile, with 97% freedom from device-related major adverse events at 30 days.
The findings from the first 31 heart failure patients with functional mitral regurgitation treated with the AccuCinch system at heart centres across the USA were presented by Satya Shreenivas (The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, USA) at the Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2019; 25–29 September, San Francisco, USA).
The transcatheter AccuCinch therapy, the press release states, is designed to complement and enhance existing care to manage symptoms and slow, or stop, the progression of heart failure. In some patients, AccuCinch may have the potential to reverse enlargement of the left ventricle. For patients in whom heart failure has progressed beyond the ability for medications and pacemakers to manage symptoms, non-surgical percutaneous device therapy with AccuCinch may provide an effective treatment option. The AccuCinch system is designed to directly repair the left ventricle of the heart, addressing the progression of systolic heart failure.
The primary safety endpoint of the study CorCinch FMR study is device-related or procedure-related major adverse events through 30 days. Secondary exploratory endpoints include technical success, and device and procedural success, as well as other observational endpoints measuring heart function, heart failure symptoms, and changes in quality of life.
Preliminary efficacy data from the first nine patients treated with the latest implantation technique and with adjudicated core lab data available through six months demonstrated an average reduction in left ventricular volume of 23%. Ejection fraction improved on average from 31% to 39% over the same period. Additionally, Kansas City Cardiomyopathy Questionnaire scores increased by an average of 30%, suggesting that reducing the left ventricular volume resulted in improved quality of life and reduced heart failure symptoms for this group. Further, mitral regurgitation grades and regurgitant volumes were both substantially reduced across this cohort.