Mitralign presented 30-day data from the SCOUT I study, which designed to evaluate the performance of its Trialign system for tricuspid repair, at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). The data, which were presented by SCOUT I principal investigator Rebecca T Hahn (Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, USA), showed positive data from the study’s first 15 patient cohort.
The results included 100% acute implant success, no deaths and no major adverse events (MAE) through 30 days, as well as statistically significant improvements in tricuspid valve annulus area (from 12.3 ± 3.1cm2 to 11.3 ± 2.7cm2; p=0.019), PISA EROA (from 0.51 ± 0.2cm2 to 0.32±0.2cm2, p=0.020, six-minute walk test (from 236.5m ± 107.4 to 305.1m ± 106.5; p=0.003) and Minnesota Living with Heart Failure Score, Minnesota Living with Heart Failure questionnaire, (from 49.6 ± 15.7 to 18.8 ± 12.0, p<0.001).
Hahn says: “Trialign is the first transcatheter solution that has demonstrated promise in treating tricuspid regurgitation in an early feasibility study. Patients enrolled in this study reported feeling better at the 30 day time point and were able to complete more daily tasks than prior to the treatment, progress that was evidenced by multiple quality of life measures. That Trialign could have a 100% device implantation rate, acute tricuspid regurgitation reduction and no procedure or device related adverse events is a very strong indicator we are on the right track to help address the tremendous interest in transcatheter therapies for direct repair of the tricuspid valve.”
Trialign is designed to provide a non-surgical option for the treatment of tricuspid regurgitation for patients with symptomatic chronic functional tricuspid regurgitation. The device features an implant with a very small footprint designed for a versatile, customizable solution. Following the successful use of its technology in compassionate use cases in Europe, SCOUT I was initiated in the US to demonstrate early feasibility through an Investigational Device Exemption study.