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Direct aortic approach benefited severe aortic stenosis patients

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Society of Thoracic Surgeons 48th Annual Meeting

Patients with severe aortic stenosis who underwent implantation with the CoreValve System using the direct aortic approach experienced positive outcomes and procedural success, according to two studies presented at The Society of Thoracic Surgeons 48th Annual Meeting.

In a late-breaking session, Neil E. Moat, MBBS, cardiac surgeon and director of the transcatheter valve program at Royal Brompton Hospital in London, said he and colleagues observed procedural success in 92 of 93 patients who underwent implantation of the CoreValve System (Medtronic) using the direct aortic approach. One-third of patients had undergone previous CABG and 83.9% were previously diagnosed with peripheral vascular disease. Study results showed no procedural deaths and a 30-day mortality rate of 9.7%, which decreased to 7% after the researchers gained procedural experience (three procedures).

“We have an increasing body of clinical evidence with regard to the direct aortic approach for transcatheter CoreValve System implantation,” Moat said in a press release. “This minimal-access surgical approach facilitates accurate deployment of the valve, especially in challenging anatomies.”

Giuseppe Bruschi, MD, cardiac surgeon at Niguarda Ca’ Granda Hospital in Milan, Italy, also presented data of 25 patients from a single center in Italy, all previously diagnosed with peripheral vascular disease. Study results showed a 92% survival rate at 30 days after implantation. Pacemakers were implanted in four patients post-procedurally. Researchers found no patients experienced stroke. Mean STS score was 11.4 ± 6.2%.

“The best access approach to TAVI is one that offers the safest conditions and optimal care and recovery for the patient,” Bruschi said in the release. “The clinical results presented today reinforce that direct aortic access using the CoreValve System provides a safe and practical therapy option.”

The CoreValve System is available in 26 mm, 29 mm and 31 mm and is the only transcatheter aortic valve implantation system approved for direct aortic implantation. Although it received the CE mark in 2007 in Europe, the CoreValve System is limited to investigational use in the United States.

For more information:

• Bruschi G. Direct aortic CoreValve implantation through right anterior mini-thoracotomy: single center experience.
• Moat NE. European experience of direct aortic TAVI with a self-expanding prosthesis.
• Both presented at: The Society of Thoracic Surgeons 48th Annual Meeting; Jan. 29-Feb.1, 2012; Fort Lauderdale, Fla.

Disclosure: Dr. Bruschi reports no relevant financial disclosures. Kathleen Janasz is employed at Medtronic. Dr. Moat is on the speakers’ bureau and received honoraria for Abbott, Edwards LifeSciences and Medtronic, and is also a consultant for Medtronic.

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