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Novel percutaneous LV repair system shows promise in systolic HF
SAN FRANCISCO — Early clinical data suggest that an investigational percutaneous device designed to directly repair the left ventricle is feasible and safe in patients with HF and functional mitral regurgitation. Data on the first 31 patients enrolled in the CorCinch FMR early feasibility study who were treated with the AccuCinch ventricular repair system at U.S. centers through July were presented at TCT 2019.
“AccuCinch is a novel device for heart failure that directly impacts the left ventricle. Early data demonstrate improved overall ventricular function, with reduced volume and dimensions and reduced mitral regurgitation,” Satya Shreenivas, MD, interventional cardiologist at The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati, said during a presentation. Shreenivas is co-principal investigator for the CorCinch FMR study along with Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center.
The AccuCinch system (Ancora Heart) works by accessing the LV via the femoral artery with an 18F guide catheter through the aortic valve and navigating a guidewire behind the chordae. Next, the TracCath is advanced over the guidewire and the AccuCinch device is implanted in the LV. Then, the AccuCinch implant is completed by cinching and locking the cable, Shreenivas said during his presentation. Once cinched, the implant is intended to reduce the size of the LV and support and strengthen the heart wall.
According to the interim safety analysis, the rate of freedom from device-related major adverse events at 30 days was 97%. There were no deaths, MIs, emergent conversions to surgery, strokes, major cardiac structure complications or major vascular complications related to the device, according to Shreenivas. Two HF-related hospitalizations were reported.
“As far as the device itself is concerned, this is a very safe procedure,” he said.
Shreenivas presented preliminary efficacy data on nine patients who had adjudicated core lab data available through 6 months. Results demonstrated a 27% improvement in ejection fraction, 23% reduction in LV end-systolic volume index and 31% reduction in effective regurgitant orifice area. At screening, most patients had moderate to severe or severe mitral regurgitation (grade 3+/4+), with 50% improving to mild or moderate (grade 1+/2+) at 6 months. Six-month data also highlighted improvements in quality of life, with an average increase of 30% on the Kansas City Cardiomyopathy Questionnaire.
Of note, Shreenivas said these changes improved over time, from 1 month to 3 months to 6 months.
Mean age of the patients enrolled was 67 years, and 20 patients were men. At screening, two-thirds had NYHA class III HF and nearly half had mitral regurgitation grade 3+. The average LVEF at screening was 32%.
Enrollment in the CorCinch FMR study recently concluded, with 35 patients treated with the AccuCinch system at 15 centers. The primary safety endpoint of the study is device-related or procedure-related major adverse events through 30 days. Secondary exploratory endpoints include technical success, device and procedural success, as well as other observational endpoints measuring heart function, HF symptoms and changes in quality of life, according to a company press release.
“Additional studies of AccuCinch in heart failure populations independent of mitral regurgitation are ongoing,” Shreenivas said. “All early feasibility study data will further inform future AccuCinch pivotal studies.” – by Katie Kalvaitis
Reference:
Shreenivas S. TCT-88. Session II: Heart Failure Therapies. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Disclosure: Shreenivas is co-principal investigator of the CorCinch FMR Study (Ancora Heart).