Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience.
Santoro G, Castaldi B, Cuman M, Di Candia A, Pizzuto A, Sirico D, Cantinotti M, Garibaldi S, Pak V, Di Salvo G.Int J Cardiol. 2020 Nov 18:S0167-5273(20)34152-8. doi: 10.1016/j.ijcard.2020.11.029. Online ahead of print.PMID: 33220363
Take Home Points:
- The GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) was recently approved by the USA Food and Drug Administration in June 2019 for closure of ostium secundum atrial septal defects (up to 35 mm in diameter).
- This is a Prospective observational study at two Italian Pediatric Cardiology centers (43 patients) using the Gore Cardioform ASD occluder from January to June 2020.
- Device deployment was successful in 97.7% patients with complete closure rate of 92.9% at 1 month follow up (all residual shunt was reported trivial).
Commentary from Dr. Varun Aggarwal MBBS MD (University of Minnesota Masonic Children’s Hospital, Minneapolis, MN), catheterization section editor of Pediatric Cardiology Journal Watch: Transcatheter closure of ostium secundum atrial septal defect is preferred if the defect rims are deemed appropriate for device closure. Till recently, Amplatzer® atrial septal occluder (Abbott Laboratories, IL) is the most commonly used device for secundum atrial septal defect closure in United States. One of the interventionalist nightmare is the (albeit low) risk of erosion of the Amplatzer atrial septal defect occluder leading to pericardial effusion which can be life threatening in some cases. Therefore, some operators prefer to use the (non-self-centering) Gore® Cardioform Septal occluder (WL Gore & Associates, Flagstaff, AZ) approved initially for closure of ASD’s smaller than 17mm in 2015.
The GORE® Cardioform ASD Occluder device (WL Gore & Associates, Flagstaff, AZ) was recently approved by the USA Food and Drug Administration in June 2019 for closure of ostium secundum atrial septal defects, Figure 1. It has as a significant technical innovation in trans-catheter ASD treatment since it combines high softness and anatomic compliance with the potential to close defects as large as 35 mm.
In this prospective observational report by Santoro G et al, 43 patients with hemodynamically significant ASD were evaluated for closure using the Gore Cardioform ASD occluder from January to June 2020. Median age of the cohort was 9.9 years with a median ASD diameter of 10mm (range 10-28mm). Successful device deployment was achieved in 42/43 patients (97.7%). Major adverse events were recorded in 3 patients (7.0%) (one case of early embolization which required emergent cardiac surgery; one case of variable atrio-ventricular block which spontaneously subsided in a few minutes; one case of sustained supra-ventricular tachycardia responsive to antiarrhythmic therapy). Complete ASD closure was found in 78.6% of cases (33/42 pts) at the time of hospital discharge, rising to 92.9% (39/42 pts) at the 1-month follow-up evaluation. Residual shunt was always trivial and intra-prosthetic, even in the patients with multi-fenestrated septum submitted to ASD closure with a single device.
Authors report that the “deployment of this device was somehow technically more challenging than other devices just because of its softness and respectfulness of local anatomy that prevents its self-accommodation inside atrial septum”. In patients with large defects and deficient rims, some variation in delivery technique using a long Mullins sheath (personal experience) has been useful to help align the device parallel to the atrial septum during deployment. Use of both echocardiographic and fluoroscopic guidance is essential during the device deployment. In the study, the rate of complete closure was significantly lower than other reports but significantly improved at the 1-month evaluation, probably due to device endothelial coverage or its slow adaptation to ASD anatomy. No cardiac or extracardiac adverse events were recorded over a short-term follow-up. On-going long-term surveillance with echocardiogram and chest x-ray (for wire frame fracture) is important in the follow up of these patients.
Deployment steps of the Gore Cardioform ASD occluder across the atrial septal defect. The device has a conformable waist and is self-centering in nature. Images were provided courtesy of W. L. Gore & Associates.