Data from a late-breaking trial (ADVANCE Direct Aortic) presented at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; 11–15 October, Milan, Italy) indicate that the direct aortic approach with the CoreValve transcatheter aortic valve implantation (TAVI) system is safe and effective for aortic stenosis patients at who are not suitable for the transfemoral approach.
The outcomes in the CoreValve ADVANCE Direct Aortic study of 100 patients demonstrated low rates of mortality, stroke and paravalvular leak at 30 days. The primary endpoint of all-cause mortality at 30 days was 4.4% with the CoreValve system (Medtronic).
According to a company press release, stroke rates were among the lowest reported to date for the CoreValve system, with no occurrences of disabling stroke and one non-disabling stroke observed (1%). Overall valve haemodynamic performance was strong, with mean gradients of 8.4 ± 3.7mmHg at discharge. Paravalvular leak rates were exceptionally low, with 98.7% of patients free from moderate or severe paravalvular leak (1.3% moderate, 0% severe), as confirmed by an independent echocardiography core lab. Additionally, the permanent pacemaker implantation rate for patients in this study was 14.5%.
The study also found that CoreValve patients experienced significant improvements in quality of life, with patients gaining 18 ± 28 points at 30 days as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) 100-point scale, where five points is considered an improvement, and 20 points is considered a large, clinically important improvement. Additionally, a majority of patients experienced substantial improvements in heart failure symptoms following the procedure, as shown by an improvement of at least one New York Heart Association (NYHA) class in 73.5% of patients.
“These data further support the strong valve performance we’ve come to expect from the CoreValve system,” said Giuseppe Bruschi, cardiac surgeon at A De Gasperis Cardiology & Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Milan, Italy, and co-primary investigator in the ADVANCE DA Study who presented the data. ”It’s particularly compelling to have demonstrated comparable positive outcomes with the direct aortic approach, since patients who are not candidates for TAVI via the standard transfemoral approach have typically demonstrated poorer outcomes.”
The press release reports that the ADVANCE Direct Aortic Study, a first-of-its-kind prospective, multi-centre clinical study to exclusively evaluate the safety and efficacy of the direct aortic access approach to TAVI, enrolled 100 patients across nine European centres, who will be followed for one year. The study leveraged best practice implantation technique including CT-based sizing in addition to an independent core laboratory analysis of all MSCT and echocardiographic data.