CoreValve Safe and Effective for Direct Aortic Approach

Medtronic, Inc. points us at data from nine European centres in a study of the direct aortic approach with the CoreValve® TAVI System. The positive outcomes in the CoreValve ADVANCE Direct Aortic (DA) study of 100 patients demonstrated low rates of mortality, stroke and paravalvular leak (PVL) at 30 days, the conclusion being that it is a safe and effective alternative for aortic stenosis patients at increased risk for surgery who are not suitable for transcatheter aortic valve implantation (TAVI) via the standard transfemoral approach.

Background

For some severe aortic stenosis patients who are at increased risk for surgical valve implantation, the standard transfemoral approach with TAVI may not be an option due to a number of anatomical limitations, such as heavy vascular calcification, peripheral artery disease and small iliofemoral vessel diameter.

The ADVANCE DA Study is 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 and following them 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.

Presented during a late-breaking clinical session at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS 2014) in Milan, the primary endpoint of all-cause mortality at 30 days was 4.4 percent with the CoreValve System. Stroke rates were among the lowest reported to date for the CoreValve System, with no occurrences of disabling stroke and only one non-disabling stroke observed. Overall valve hemodynamic performance was strong, with mean gradients of 8.4 ± 3.7 mmHg at discharge. PVL rates were exceptionally low, with 98.7 percent of patients free from moderate or severe PVL (1.3 percent moderate, 0 percent severe), as confirmed by an independent echocardiography core lab. Additionally, the permanent pacemaker implantation rate for patients in this study was 14.5 percent.

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 percent of patients.

Investigator comments

“These data further support the strong valve performance we’ve come to expect from the CoreValve System,” said Giuseppe Bruschi, M.D., 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.”

Source: Medtronic, Inc.

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