Abstract 4431: Limitations in the Wide-Spread Application of Transfemoral Aortic Valve Replacement for the Treatment of Aortic Stenosis in the United States
Background: Despite improvements in procedural technique and valve technology, many high risk surgical or non operable patients (pts) are ineligible for transfemoral aortic valve replacement (TFAVR) to treat aortic stenosis (AS). We hypothesize that vascular acess and inadequate catheter valve sizes has limited the use of TFAV in the United States.
Methods: We reviewed patients records that were referred for TFAVR that failed screening from October 2006 to May 2009.
Results: 267 pts were referred for TFAVR; 178 pts (67%) were deemed not suitable candidates, Table 1⇓. High risk surgical candidates were 102/178 pts (57%) and 76/178 pts (43%) were non-operable. Pts were deemed non-operable secondary to advanced age (n=35;46%), multiple comorbidities (n=22;29%), frailty (n=49; 64%), porcelain aorta (n=18;29%), severe lung disease (n=12;16%), chest wall deformity or prior chest irradiation (n=4;5%), and poor LV function (n=8;10%). 46 pts (61%) had >1 reason cited for inoperability. Reasons for TFAVR ineligibility was inadequate vascular access measured by lower extremity angiogram and comptued tomography angiogram of <8mm (n=95;53%), low surgical risk score (STS score <10%, n=28;16%), left ventricular outflow tract (LVOT) >24mm by TEE (n=18;10%), multi-valve disease or bicuspid aortic valve n=16;9%), refused participation after screening (n=14;8%), end-stage renal failure (creatinine >3.0 mg/dL, n=7;4%). Of those pts with inadequate leg acess, 81% (n=77) measured between 6 – 8mm while 19% (n=18) measured <6mm at the narrowest region.
Conclusion: >60% of pts are ineligible for TFAVR predominantly due to inadequate vascular access and enlarged LVOT size. Further development in smaller delivery devices to accomadate >6 mm leg vessels, and larger catheter valves sizes should significantly broaden the application of TFAVR use in high risk surgical and non-operable pts in the United States.