Transfemoral-Venous Transcatheter Access To Left Ventricle Through The Created Communication Of Inter-Ventricular Septum With The Assistance Of Arterio-Venous Circuit

Abstract Background During transcatheter aortic/mitral valve replacement (TA/MVR), current available routes are limited due to unfavorable entry-angle, vessel-anatomy or mini-thoracotomy. Through created communication of inter-ventricular septum (C-IVS), transfemoral venous transcatheter access to left ventricle becomes feasible with the assistance of arterio-venous circuit. Purpose The study was conducted to investigate the feasibility and safety of transfemoral-venous transcatheter access to left ventricle through the created C-IVS in a swine model. Methods Via femoral artery, transcatheter puncture of mid-IVS was performed with the custom-made nickel-titanium needle (0.038-inch, needle-tip bent 60 degrees automatically associated with increased hardness when temperature was above 30°C) and 6F-sheath in 20 healthy Chinese mini-swine. Then femoral arterio-venous circuit was established through created C-IVS with hydrophilic guidewire in all swine, and femoral veno-venous circuit was further created through C-IVS and atrial septum in 4 swine. After pre-dilation of C-IVS, a 20F-sheath was introduced into left ventricle transvenously over the guidewire. Furthermore, transfemoral-venous TAVR was attempted with this approach in one swine. C-IVS was evaluated postoperatively and was further confirmed pathologically 2 months later. Results All transcatheter puncture of IVS was performed successfully in left ventricle and the thickness of mid-IVS was 7.67±0.98 mm. During the puncture, ventricular fibrillation occurred in one swine (successfully defibrillation) and only isolated ventricular premature beats/non-sustained ventricular tachycardia were observed in other swine. In all swine, femoral arterio-venous/veno-venous circuit was established via C-IVS, and the 20F-sheath was introduced into left ventricle safely through femoral vein and C-IVS. With the aid of vessel circuit, the 20F-sheath was further advanced into aorta in 16 swine (the entry-angle was 145.3±12.2 degrees) and into left atrium in 4 swine. After the procedure, there was one swine with moderate tricuspid regurgitation and 5 swine with mild residual shunt (2.6±0.7 mm). In addition, epicardial coronary arteries were normal in all swine. Two months later, residual shunt was still detected in 3 swine and the communication was confirmed pathologically. In other swine, there was no defect of IVS and mild replacement-scar was identified along C-IVS. In the swine underwent transfemoral-venous TAVR, prosthetic valve was deployed successfully with good function. Conclusions With the aid of vessel circuit, transfemoral-venous transcatheter access to left ventricle is feasible and safe via C-IVS, and transfemoral-venous TAVR was achieved successfully using this novel approach with favorable entry-angle. Figure 1 Funding Acknowledgement Type of funding source: Other. Main funding source(s): National Natural Science Foundation of China