First experience with a new balloon-expandable and re-collapsible vascular sheath in transfemoral percutaneous aortic valve replacement.

OBJECTIVE: To describe a novel method of transfemoral access via a first generation balloon-expandable and re-collapsible access system.

METHODS: In a patient at very high risk for surgical aortic valve replacement and with a relative contraindication for transapical transcatheter aortic valve implantation (TAVI) (left ventricular ejection fraction = 12%), transfemoral TAVI was performed. Due to compromising peripheral vascular anatomy/disease, a novel balloon-expandable and re-collapsible sheath system (Onset Medical, a subdivision of Terumo Medical Corporation, Irvine, CA) was used to achieve transfemoral access for the implantation of a 31-mm Medtronic CoreValve® prosthesis.

RESULT: The sheath with an initial outer diameter of ~13 French was introduced via the right common femoral artery and advanced into the descending aorta without difficulties and expanded with a pressure of 20 atm for 60 sec. After successful transfemoral TAVI, the sheath was deflated to a size of ~13 French and removed from the vessel. A ProStar® closure device was successfully used to achieve hemostasis. Routine access-site angiography revealed no signs of dissection, stenosis, or extravasation. During the further clinical stay, no further major vascular complication or need for transfusion occurred. The patient was discharged on day 7 after the procedure.

CONCLUSION: The use of a balloon-expandable re-collapsible transfemoral sheath appears to be a promising approach with the potential of less vascular trauma. Further studies will need to evaluate the potential benefit of this novel device in patients with peripheral artery disease and if vascular injury and subsequent access site complications can hereby further be reduced.