d.TRIALING

The TRIALING (Mitralign Inc., Tewksbury, MA, USA) is a direct suture device that reproduces the Kay tricuspid bicuspidization surgical technique leading to the obliteration of the posterior leaflet of the TV. Through a transjugular percutaneous access, two pledgets are inserted in the anteroposterior and posteroseptal commissures. The pledgets are then approximated with a cinching mechanism, bringing both commissures together and obliterating the posterior leaflet. The first published experience corresponds to 14 patients with moderate to severe functional TR, achieving a 51% decrease in EROA and a 34% reduction of the TVA area [46]. The early feasibility SCOUT I trial included 15 patients with functional TR and the device was successfully implanted in all patients [47]. One patient required right coronary angioplasty due to extrinsic compression. At 30-days follow-up, 3 single-pledget annular detachment were documented without reintervention. In the remaining 12 cases, a significant reduction in the TVA area and EROA were observed, together with clinical improvement in functional status [47]. After 12 months, only one patient required surgery. The SCOUT II study is currently ongoing and will include 60 patients [48].
