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Supra-sternal Aortic Valve Implantation For Patients With Marginal Femoral Access
Andy Kiser1, Thomas Caranasos2, Mark Peterson3, Christopher Buller3, David Holzhey4, Philipp Kiefer4, Michael Borger5.
1ECHI, Greenville, NC, USA, 2UNC School of Medicine, Chapel Hill, NC, USA, 3St. Michael's Hospital, Toronto, ON, Canada, 4University of Leipzig Heart Center, Leipzig, Germany, 5Colombia University Department of Surgery, New York, NY, USA.
OBJECTIVE: Recently, the PARTNER 2A trial reported results of TAVR versus surgical AVR (SAVR) in 2,032 intermediate-risk patients at 2 years. The access route was non-TransFemoral (TF) in 236 (24%). Compared to SAVR, non-TF TAVR was associated with a non-inferior rate of all-cause death and disabling stroke. In fact, non-TF TAVR was associated with a numerically higher rate of death and disabling stroke at 30 days. These findings underscore the need for alternative surgical approaches with marginal femoral access. Based on the proven safety record of mediastinoscopy, suprasternal (SS)-TAVR facilitates a minimally invasive, direct innominate arterial or ascending aortic approach without bone disruption.
METHODS: Consecutive patients with severe symptomatic aortic stenosis at high- or intermediate-risk, who were referred for non-TF TAVR, underwent SS TAVR. A commercially available transcatheter heart valve was deployed under fluoroscopic guidance directly through the innominate artery or ascending aorta. With a 3-cm skin incision just above the sternal notch, a novel cannula device provided illuminated, hands-free access to the mediastinum. The cannula device facilitated direct purse-string suture placement on the innominate artery or ascending aorta. Using a similar technique to the direct aortic approach, TAVR was then accomplished.
RESULTS: Thirty patients from six international centers successfully underwent SS-TAVR. The implanted valves included 2 CoreValve and 12 Evolut-R (Medtronic; Minneapolis, MN) and 10 Sapien 3 and 6 Sapien XT (Edwards; Irvine, CA) with sizes ranging from 23 to 31 mm. The table displays demographic characteristics and procedural outcomes. Median procedure time was 90 minutes and median length of stay was 4 days. Postoperatively, new permanent pacemaker (n=3) was the most common VARC-2 complication.
CONCLUSIONS: These data demonstrate the early clinical safety and effectiveness of suprasternal TAVR. Key advantages of this approach include direct access to the innominate artery and ascending aorta, sheath maneuverability, and confident arterial closure. Additional experience is warranted to confirm these favorable results.
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