The first patient in the transcatheter arm of a European study has been treated with Micro Interventional Devices’ MIA technology for tricuspid and mitral repair, the company said.
A team at Vilnius University Hospital Santariskiu Clinic (Vilnius, Lithuania) used the 12F MIA (minimally invasive annuloplasty) delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and tricuspid regurgitation (TR) in the patient.
The 61-year-old female was suffering from severe torrential tricuspid regurgitation. The physicians were able to reduce the dilated tricuspid annulus by 29%, from 20.9cm2 to 14.9cm2. MIA also achieved a 36% reduction in effective regurgitant orifice area, from 2.5cm2 to 1.6cm2, a quantitative measure of tricuspid regurgitation. No complications or adverse events were reported.
The image-guided procedure relied on fluoroscopy and 3D echocardiography to place the PolyCor anchors accurately on the tricuspid annulus. MIA’s PolyCor anchoring technology was designed to enable the percutaneous bicuspidization of the tricuspid valve, replicating an open surgical bicuspidization procedure.
“The percutaneous MIA system has the potential to be a safe and effective intervention for patients with moderate to severe tricuspid regurgitation,” said Audrius Aidietis, M.D., chief of cardiology and angiology at Vilnius University Hospital, in a prepared statement. Aidietis and Kestutis Rucinskas, M.D., the hospital’s chief of cardiac surgery, led the team that performed the procedure.
“I expect the reduction in tricuspid regurgitation and annular area achieved during this procedure to improve the patient’s symptoms resulting in favorable right ventricular remodeling,” Rucinskas added.
The woman is the first of 40 patients to be enrolled in the percutaneous arm of the Study of Transcatheter Tricuspid Annular Repair (STTAR) multicenter clinical trial. As of this October, the study’s surgical arm had one-year follow-up data on three patients.