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OBJECTIVE
A safe and reliable direct percutaneous approach for transapical access to the left ventricle would be a significant advance toward decreasing the invasiveness of intra-cardiac interventions. This report presents initial results from an ongoing healing study in a survivor pig heart model where transapical wounds were closed using an automated suturing technique ultimately intended for percutaneous use.
METHODS
A miniaturized automated suturing and mechanical knot placement technology, which simultaneously places two pledgeted horizontal mattress sutures concentrically around an apical access site, has been demonstrated to provide strong wound closures in previous porcine and human cadaver models. Through an approved protocol including general anesthesia, pig beating hearts were surgically exposed to permit transapical passage of a 0.035” guidewire and 5.5Fr 0.9ml Fogarty balloon catheter. With the balloon pulling the left ventricle anteriorly, the suturing device was passed over the guidewire and Fogarty onto the wound site. Both horizontal mattress sutures were simultaneously placed with a single squeeze of the device’s lever. Next, an 8.3mm dilator was passed into the left ventricle over the guidewire and subsequently removed. The sutures were secured using pledgeted titanium knots. Skin wounds were closed. Pigs recovered from anesthesia and resumed a normal diet.
RESULTS
Under general anesthesia, the transapical wound site of each pig was re-exposed via thoracotomy two weeks post surgery. Hemostasis was complete and all wounds healed well. Pigs were then sacrificed.
CONCLUSIONS
The evaluation of transapical wound closures in this survivor porcine heart model indicates complete hemostasis and excellent healing through use of this miniaturized automated remote suturing technology.