Abstract 2535: Modernized Off-Pump, Closed, Beating Intracardiac Surgery: A Feasibility Study. I: Cardiac Access And Manipulation Of Devices
Introduction: We have modernized the off-pump closed beating intracardiac approach, with the view of developing a less invasive alternative to open heart techniques or support to catheter techniques.
The purpose of the study was to demonstrate its safety using a versatile, multi-tool Universal Cardiac Introducer® (UCI) and the feasibility using image-guidance to substitute for the absence of direct vision.
Method. The Universal Cardiac Introducer was attached to the left atrial appendage. It was tested on 13 acute porcine experiments by introducing a Flex 10® microwave probe, with its loop holder into the left atrium. Navigating and positioning of instruments were tested by using overlapping applications of a Surgifrost® probe for exclusion of the pulmonary vein region (AF surgery) in 7 acute pigs. The feasibility of introducing and positioning a bulky device was tested by inserting an mitral valve prosthesis (Mosaic porcine heart valve®) in 9 acute pig studies.
Results: There were no complications associated with cardiac access. Introduction of the Flex10® established the safety of the UCI. The UCI did not hinder the manipulation and positioning of tools and allowed appropriate freedom of motion. Using the Surgifrost® cryo-probe, we demonstrated that precise positioning was feasible with ultrasound image-guidance. Exclusion was obtained in 6 of 7 animals. Transmural exclusion was documented by two-way electrical isolation and pathological examination. The last group showed that a 27 to 29 mm prosthesis (35 mm total diameter with the cuff) could be introduced into the left atrium, directed into the mitral valve orifice, precisely positioned. Tools for attachment of the valve could be simultaneously introduced and positioned.
Conclusion: We have demonstrated that the off-pump, closed, beating intracardiac surgery is a valid and practical concept when the two major problems are solved: Cardiac access with the UCI® and substitution of direct vision with ultrasound imaging readily available in clinical operating rooms while multimodality imaging and virtual reality are making rapid progress. Concurrent studies have shown that all intracardiac targets are accessible and new technology is being developed in preparation for clinical application.