Automated Remote Transapical Wound Closure System Study

Abstract

A readily applied and reliable means to create and close transapical wound access sites through a small intercostal opening could benefit many cardiac patients. Using relevant surgical tissue models, this research evaluated a new approach to enable single-port transapical wound site closure toward the eventual development of safe percutaneous access to the left ventricle. Novel techniques and technologies were developed and successfully tested for remote automated placement of 2 pledgeted horizontal mattress sutures delivered concentrically around a transmural apical guidewire, which provided a tract to enable therapeutic intervention. Mechanical pledgeted knots secured these sutures after cannula removal. Automated transapical closures were created in 47 ex vivo porcine hearts and in 10 human cadavers, 8 through a thoracotomy and 2 thoracoscopically. Automated apical closures achieved hemostasis in an acute beating heart thoracotomy model in 3 anesthetized pigs. An ex vivo porcine heart pressurized infusate model demonstrated the intraventricular pressure tolerated by automated closures (mean, 327 mm Hg) compared with hand-sutured closures (mean, 303 mm Hg). All automated apical closures were effective. Early results encourage further evaluation.