Off-pump tricuspid valve repair by automated sutured tricuspid annular plication via transatrial cannulation: preclinical ex vivo and in vivo results

OBJECTIVES: Surgical repair is considered the gold standard treatment for severe symptomatic tricuspid valve (TV) regurgitation. However, patients undergoing isolated surgical tricuspid repair face a high perioperative mortality while long-term data on interventional treatment options are currently missing. We investigated a novel, minimally invasive approach for transatrial off-pump beating-heart tricuspid annular plication based on the surgical Hetzer repair. METHODS: TV annular plication for the creation of a double-orifice valve using novel devices for automated annular suturing was performed in 10 human heart specimens in an ex vivo perfusion model under endoscopic guidance. Additionally, the technique was tested in an in vivo porcine model using the transatrial access under echocardiographic and fluoroscopic guidance. RESULTS: Endoscopically guided conduction of the procedure was successful in all 10 human heart specimens in the ex vivo perfusion model with 1 observed suture pull-through of 60 sutures placed (1.7%). TV measurements yielded significant reductions of the TV septal-lateral diameter (50.9 ± 7.3 vs 42.6 ± 7.9 mm; P = 0.015) and the TV area (1208 ± 399 vs 193 ± 122 mm2; P < 0.0001). TV plication without direct vision using device-embedded intracardiac echocardiography, epicardial echocardiography and fluoroscopy was feasible in both acute animals with no observed device-related adverse events. CONCLUSIONS: Successful plication was completed in 10 ex vivo human hearts, additionally proof-of-concept was conducted in 2 animals. We herein present encouraging early preclinical results of a novel minimally invasive technique for TV repair, which warrants further investigation.