First patient enrolled in STTAR study of MIA—minimally invasive annuloplasty

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Micro Interventional Devices announced the world’s first percutaneous implantation of its MIA, minimally invasive annuloplasty, technology for tricuspid and mitral repair.  This marks the first patient enrolled in the transcatheter arm of the STTAR (Study of transcatheter tricuspid annular repair) trial being conducted in Europe.

The procedure was performed by a team lead by Audrius Aidietis and Kestutis Rucinskas (Vilnius University Hospital Santariskiu Clinic, Vilnus, Lithuania). Proctoring the case were Mathew Williams, and Alan Vainrib (both from NYU Langone Health, New York, USA). A press release reports that a successful outcome was achieved with the 12Fr MIA delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and tricuspid regurgitation in the patient.

The first ever percutaneous bicuspidisation was performed on a 61-year-old female suffering from severe torrential tricuspid regurgitation. Using MIA’s proprietary technology, the physicians were able to reduce the dilated tricuspid annulus by 29%, from 20.9cm2 to 14.9cm2. Additionally, MIA achieved a 36% reduction in effective regurgitant orifice area (EROA), from 2.5cm2 to 1.6cm2, a quantitative measure of tricuspid regurgitation. No complications or adverse events were reported or experienced.  The image-guided procedure relied on fluoroscopy and 3D echocardiography to place the PolyCor anchors accurately on the tricuspid annulus. According to the press release, MIA’s PolyCor anchoring technology enables the percutaneous bicuspidisation of the tricuspid valve, replicating an open surgical bicuspidisation procedure.

The patient was the first of 40 patients to be enrolled in the percutaneous arm of the STTAR multicentre clinical trial. The STTAR study has two arms, a surgical and percutaneous arm.  As of this October, MID now has one-year follow-up data on three patients in the surgical arm, which confirms that the reduction in tricuspid regurgitation and tricuspid annular dimensions observed acutely are maintained at one year.  The team anticipates enrolment in the percutaneous arm will move quickly given the short learning curve associated with the technology.

Rucinskas comments: “I expect the reduction in tricuspid regurgitation and annular area achieved during this procedure to improve the patient’s symptoms resulting in favourable right ventricular remodelling. We look forward to continuing to enrol patients in STTAR to assess the safety and performance of this new therapy.”

 

 

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