Original article
Adult cardiac
United States Feasibility Study of Transcatheter Insertion of a Stented Aortic Valve by the Left Ventricular Apex

Presented at the Forty-fourth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2008.
https://doi.org/10.1016/j.athoracsur.2008.04.049Get rights and content

Background

Recent US and European registries have indicated 30% to 60% of patients with critical valvular aortic stenosis (AS) are not treated surgically, usually due to advanced age and comorbidities. We report on a Food and Drug Administration approved feasibility study of a less invasive transcatheter approach to potentially treat these high-risk patients.

Methods

Between December 2006 and February 18, 2008, 40 patients underwent transcatheter insertion of a balloon expandable stainless-steel stent with an internally mounted three-leaflet equine pericardial valve (Edwards Sapien Transcatheter Heart Valve; Edwards Lifesciences, Irvine, CA) into the aortic annulus using a transapical left ventricular insertion (TA-AVI). Patients were inoperable by conventional surgery, or extremely high risk based on Society of Thoracic Surgeons score greater than 15% or other documented risk factors.

Results

All 40 valves were successfully delivered and 35 were successfully seated. Two valves embolized and required open aortic valve replacement (AVR), and one case of severe regurgitation later required AVR. In a further two patients placed on cardiopulmonary support, one valve later embolized and one migrated. There were 7 (17.5%) deaths within 30 days, and a further 2 (5%) deaths before discharge at 42 and 72 days. There were no immediate postoperative strokes after successful deployment. Valve area improved from 0.62 cm2 (SD of 0.13) to 1.61 cm2 (SD 0.37) at 30 days (p = <0.0001), with mean perivalvular regurgitation of 1.19 (SD 0.80). Mean follow-up was 143 days (SD 166 days) with 6 further deaths from comorbid disease, none valve or cardiac related. The Kaplan-Meier survival was 81.8% ± 6.2% at 1 month and 71.7% ± 7.7% at 3 months.

Conclusions

Transapical insertion of a balloon expandable stented valve is feasible but carries considerable risk and will be further evaluated in the PARTNER (Placement of AoRTic traNscathetER valve) randomized trial.

Section snippets

Patients and Methods

Food and Drug Administration approval was obtained in November 2006 for a TA-AVI feasibility study in the US for the study of 20 patients. Subsequently, in October 2007, a further 20 TA-AVI patients were approved for additional inclusion in the feasibility study. The FDA-approved protocol was ratified by the Institutional Review Boards of the participating hospitals, and the first patients underwent study on 4 December 2006. To be included, patients were required to be 70 years of age or older,

Results

In the 40 TA-AVI patients, crossing the aortic valve and deployment was successful in all patients and seating of the valve was successful in all but four patients. In three patients the valve embolized, and in one patient the valve migrated during CPR.

In one patient, in whom the cine was automatically switched off and failed during the critical moment of deployment, the valve embolized distally shortly after deployment. Retrospective analysis revealed the valve became displaced during breath

Comment

Severe comorbid disease and technical reasons, making patients largely inoperable or extremely high risk, has prevented many patients from undergoing aortic valve replacement to improve both quality and duration of life [1, 2, 3, 4, 5]. Indeed, approximately two thirds of these symptomatic patients are likely to die within one year [1, 2, 3, 4, 5]. This early study of a new innovative technology clearly shows TA-AVI is both feasible and durable out to 6 months and may offer an alternative

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