Key result
Suprasternal TAVR shows clinical feasibility in 30 patients with severe aortic stenosis.
Why the study?
Is minimally invasive suprasternal transcatheter aortic valve replacement feasible and safe in patients with symptomatic severe aortic stenosis at high or intermediate risk for surgery?
Observational (n=30)
Yes
Is minimally invasive suprasternal transcatheter aortic valve replacement feasible and safe in patients with symptomatic severe aortic stenosis at high or intermediate risk for surgery?
Suprasternal TAVR using the Aegis Transit System is a feasible alternative access route for patients with severe aortic stenosis and marginal femoral access.
Supports alternative access in select high-risk patients; leaves open comparative safety versus standard routes pending larger trials.
OBJECTIVE: Recently, the PARTNER 2A trial reported results of transcatheter aortic valve replacement versus surgical aortic valve replacement in 2032 intermediate-risk patients at 2 years. Two hundred thirty-six patients (24%) required an access route other than transfemoral. Compared with transfemoral and surgical aortic valve replacement, nontransfemoral transcatheter aortic valve replacement was associated with a numerically higher rate of death and disabling stroke at 30 days. This underscores the need for a better alternative surgical approach for patients with marginal femoral access. We reviewed our multicenter experience with minimally invasive suprasternal transcatheter aortic valve replacement. METHODS: Consecutive patients with symptomatic severe aortic stenosis at high or intermediate risk for surgical aortic valve replacement underwent suprasternal transcatheter aortic valve replacement. A commercially available transcatheter heart valve was deployed under fluoroscopic guidance through the innominate artery or ascending aorta. Using a 3-cm skin incision just above the sternal notch, the Aegis Transit System (Aegis Surgical Ltd, Galway, Ireland) provided illuminated access to the mediastinum without bone disruption. Through a purse-string suture placed in the innominate artery or ascending aorta, transcatheter aortic valve replacement proceeded similarly to the direct aortic approach. RESULTS: Thirty patients at six medical centers successfully underwent suprasternal transcatheter aortic valve replacement. Implanted valves included 2 CoreValve and 12 Evolut-R (Medtronic, Inc, Minneapolis, MN USA), as well as 10 SAPIEN 3 and 6 SAPIEN XT (Edwards Lifesciences, Corp, Irvine, CA USA) with sizes ranging from 23 to 31 mm. Median procedure time was 90 minutes and median hospital stay was 4 days. Postoperatively, new permanent pacemaker (n = 3) was the most common Vascular Academic Research Consortium 2 complication. CONCLUSIONS: These data demonstrate the early clinical feasibility of suprasternal transcatheter aortic valve replacement. Key advantages of this approach include direct access to the innominate artery and ascending aorta, precise sheath control, and confident arterial closure. Additional experience is warranted to confirm these favorable results.
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Kiser et al. (2018) conducted an observational in Symptomatic severe aortic stenosis (n=30). Suprasternal transcatheter aortic valve replacement was evaluated on Procedural success and complications. Suprasternal transcatheter aortic valve replacement was clinically feasible in 30 patients with severe aortic stenosis, with a median procedure time of 90 minutes and 3 new permanent pacemakers.
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