November

Trans-catheter atrial septal defect closure with the new GORE® Cardioform ASD occluder: First European experience

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.   FIGURE 1   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.   

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Single center experience of pediatric percutaneous balloon pericardiotomy

Single center experience of pediatric percutaneous balloon pericardiotomy. Herron C, Forbes TJ, Kobayashi D.Cardiol Young. 2020 Nov 3:1-4. doi: 10.1017/S1047951120003686. Online ahead of print.PMID: 33140718   Take Home Points: Percutaneous balloon pericardiotomy is a feasible alternative to surgical pericardial window creation in the pediatric population. Although technical success was excellent in this manuscript, re-interventions were common and some patients did require subsequent surgical pericardial window creation.   Commentary from Dr. Arash Salavitabar (Ann Arbor MI, USA), catheterization section editor of Pediatric Cardiology Journal Watch: The authors report on a retrospective single-center experience with percutaneous balloon pericardiotomy (PBP) in children with the goal of creating a non-surgical pericardial window, a relatively unique procedure in the pediatric population. Technical success was defined as achievement of a pericardial window by this technique, judged by identification of the balloon waist at the parietal pericardium and following disappearance of this balloon waist. Procedural success was defined as resolution of the pericardial effusion without need of subsequent surgical pericardial window.   The technique described by the authors was performed in 11 patients with a median age of 12 years (range 1.8-19) and median weight of 50kg (12-.3-122). The approach involves a standard pericardiocentesis with subsequent placement of a 0.035” Rosen wire (Cook Medical, Bloomington, IN) into the pericardial space. The skin tract is dilated with an 8-10Fr dilator, and then serial dilation is performed with balloons situated across the pericardium. A mid-balloon waist is observed via gentle inflation and by fluoroscopy to confirm position and the ultimate balloon diameter is chosen based on the goal diameter. Some patients required two simultaneous balloon catheter inflations to achieve that goal diameter. Contrast injections were used to visualize the pericardial space and margin of the parietal pericardium. A pericardial drain was left in most patients.       Four of the 11 patients were post-pericardiotomy syndrome patients at a median 58 days (39-88) post-cardiac surgery and 4 required percutaneous re-interventions (4 pericardiocentesis in 3 patients and 2 PBPs in 2 patients) due to re-accumulation of the pericardial effusion. Three of those patients who required percutaneous re-interventions also required subsequent surgical pericardial window creation. The majority of PBPs were performed with compliant balloons (e.g., Tyshak II, Z-Med), however two received PBP using relatively non-compliant balloons (e.g., Atlas, Powerflex). The largest balloon diameter used ranged from 8 to 20mm; 20mm was the final dilation diameter in most older children. Echocardiography was used to confirm improvement in pericardial effusion.   Based on these results, the authors reported a technical success of 100% with no acute complications, an overall procedural success of 73%, and 45% re-intervention rate. Of note, 4/11 patients showed development of a left pleural effusion post-PBP, but did not require chest tube placement. The authors describe that this procedural success rate and re-intervention rate may be explained by the fact that a “torn” pericardium by PBP is not a permanent anatomic solution. The other possible contributing factors described were final balloon size, inability to completely expand the balloon based on position against chest wall, residual waist, or the etiology of the underlying effusion.   The approach of percutaneous balloon pericardiotomy is certainly an enticing alternative to surgical pericardial window creation and the authors describe a technique that is certainly plausible in many patients with pericardial effusions. Based on these results, the care team and proceduralist must understand that re-interventions are relatively common with this procedure, but may preclude the need for more invasive surgical interventions in some patients. Given the heterogeneity in their reported patient population and the potential for variable results, larger studies will be of benefit to better understand its utility, as well as risk factors for procedural failure and complications.    

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