New data presented at the PCR London Valves 2012 meeting has shown a 97% procedural success implantation with the CoreValve System (Medtronic) through a direct aortic approach. One hundred and fifty one patients from 15 centres across Europe and Israel were included in the study. There were no procedural deaths, the overall 30-day mortality rate was 8.6%, and the incidence of stroke was 3.9%.
In the multicentre experience approximately 62% of the patients received the replacement valve through a minithoracotomy, and other patients received the valve through a ministernotomy; both procedures are minimally-invasive and are performed without stopping the heart or penetrating the heart’s ventricular wall. Most patients (86%) in the study had peripheral vascular disease, and the mean logistic EuroSCORE was 26.6 ± 16.
“The growing base of evidence for direct aortic implantation with the CoreValve System shows it is a highly successful and reliable approach for many patients who have a challenging peripheral vascular system and are at high risk for open-heart surgery,” said Giuseppe Bruschi, cardiac surgeon at A De Gasperis Cardiology & Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Milan, Italy, an early contributor to the development of the direct aortic approach, and co-primary investigator in the ADVANCE Direct Aortic study. “These studies are enabling heart teams to collect important information about direct aortic access for the benefit of patients who need aortic valve replacement and are best suited for this increasingly common delivery option.”
Medtronic has announced the start of its international CoreValve ADVANCE Direct Aortic study. The direct aortic approach also is being evaluated in the Medtronic CoreValve US Pivotal trial. The CoreValve System is currently limited to investigational use in the United States. The CoreValve system received the CE mark in November 2011 for patients with severe aortic stenosis.
About the CoreValve ADVANCE Direct Aortic study
Giuseppe Bruschi recently conducted the first procedure in the CoreValve ADVANCE Direct Aortic study, the first prospective clinical study in the world to exclusively explore the safety and efficacy of the direct aortic access approach to transcatheter aortic valve implantation (TAVI). It is a prospective, interventional, single-arm, post-market, multicentre study enrolling and following 100 patients for 12 months at up to 15 investigational sites in Europe.
The primary study objective is to evaluate the safety and performance of the CoreValve System in patients via direct aortic access, with a primary endpoint of all-cause mortality at 30 days. The secondary objective includes assessments of quality of life, therapy clinical benefit and cost-effectiveness.