Howaida G. El-Said

Fulminant myocarditis associated with pandemic H1N1 influenza A virus in children.

To the Editor: Acute myocarditis is a well-recognized, albeit rare, manifestation of numerous viral infections ([1][1]) with a broad spectrum of symptoms and clinical features ([2][2]). Fulminant myocarditis may present with fatal arrhythmias, atrioventricular block, and/or varying degrees of

Transcatheter Device Closure of Atrial Septal Defects: A Safety Review

This review discusses the current safety issues related to U.S. Food and Drug Administration approved atrial septal defect devices and proposes a potential avenue to gather additional safety data including factors, which may be involved in device erosion.

Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations?

Background: Device erosion is a very rare but potentially fatal complication of ASD occlusion by the Amplatzer Septal Occluder (ASO). After reviewing cases of device erosion, recommendations for ASD sizing and device selection were revised by a small group of “experts” and adopted by the device manufacturer in 2004. These revisions, which recommend use of smaller devices, which do not straddle the aorta, remain controversial. Objective: The aim of our study is to help define an expanded expert consensus with respect to the causes and preventive strategies for erosions. Methods: We report a case of device erosion in which the 2004 revisions were carefully followed; and a survey of the members of the Congenital Cardiovascular Interventional Study Consortium (CCISC) soliciting experiences with and opinions about device erosion. Results: In our case, the device disk appeared to protrude into the aortic root but not straddle, and had motion independent of cardiac movement. Of 57 survey responders having a total experience of 12,006 ASO implants, 12 members reported 14 erosions among 3,010 implants. Ninety percent of erosions occurred in patients with deficit aortic rim. Of 53 patients, 38 (71.7%) responded that devices, which are undersized and do not straddle the aorta are at highest risk of erosion. Of 52 patients, 44 (84%) responded that motion of the device relative to the heart may cause erosion. Conclusion: Both the survey results and our single case experience suggest that operator opinions (and perhaps also device sizing practices) are at odds with the 2004 revisions. Further study and focus on this issue is needed.

Device therapy for atrial septal defects in a multicenter cohort: Acute outcomes and adverse events

Background: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry‐sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. Methods and Results: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07–6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER® Septal Occluder (ASO) in 566 (87%), GORE® HELEX® Septal Occluder (HSO) in 33 (5%), and a CardioSEAL® or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P < 0.001). AE (n = 82) were recorded in 76 cases, 11.5% (95% CI 9.2%, 14.1%) and classified as high severity in 4.7% (95% CI 3.2%, 6.5%), with no mortality. A new conduction abnormality was detected during 15 cases and did not resolve in one. Transcatheter device retrieval was possible in 7 of 10 device embolizations. Device erosion occurred in 3 of 566, 0.5% (95% CI 0.1%, 1.5%), ASO implants. Conclusion: Although device closure of ASDs is associated with low morbidity and rare mortality, ongoing assessment of device safety profiles are warranted, and registries offer opportunities to facilitate the required surveillance.

Safety of Percutaneous Patent Ductus Arteriosus Closure: An Unselected Multicenter Population Experience

Background The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences. Methods and Results Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) <6 months old. Median minimum PDA diameter was 2.5 mm (range 1 to 12 mm; IQR 2 to 3 mm) for device closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P<0.001). A device rather than coil was used in patients <3 years, weight <11 kg, and with a PDA minimum diameter >2 mm (all P<0.001). Three of 8 centers exclusively used a device for PDAs with a diameter >1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil‐related AEs were more common than device‐related AEs (10% versus 2%, P<0.001). Conclusions PDA closure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention‐related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist.

Stenting of stenosed aortopulmonary collaterals and shunts for palliation of pulmonary atresia/ventricular septal defect

Patients with unrepaired pulmonary artery atresia and ventricular septal defect (PA/VSD) depend on aortoplumonary collaterals and surgically created shunts for pulmonary blood flow. These vessels frequently develop stenoses with time, leading to hypoperfusion of lung segments and systemic hypoxemia. The purpose of this article is to describe catheter palliation of hypoxemic patients with PA/VSD who were not candidates for surgical repair. We present our experience with stent implantation for stenosis of aortopulmonary collaterals and shunts in these patients. Three patients with hypoplastic pulmonary arteries underwent stent placement in aortopulmonary collateral arteries (APCAs) or their shunts. Technical aspects of the interventional catheterization procedure are discussed in detail. Case 1 underwent placement of five stents in collateral vessels and one stent in the Blalock‐Taussig shunt (BT) with dramatic increase in vessel size and improvement in saturations from 70% to 89%. Case 2 underwent placement of two overlapping stents in a collateral vessel with an increase in diameter of the collateral vessel from 2.3 to 6 mm and an improvement in saturation from 68% to 88%. Case 3 underwent placement of three overlapping stents in a BT shunt with an increase in diameter of the shunt from 2.2 to 6.6 mm and an improvement in saturation from 71% to 89%. All three patients had excellent clinical improvement and stable saturation at follow‐up. Stent placement for maintaining patency of APCAs and aortopulmonary shunts is feasible and safe. Cathet. Cardiovasc. Intervent. 49:430–436, 2000.

Is cardiac catheterization a prerequisite in all patients undergoing bidirectional cavopulmonary anastomosis

Traditionally, all patients undergo cardiac catheterization before bidirectional cavopulmonary anastomosis (BCPA). The purpose of this study was to determine if preoperative catheterization is necessary when echocardiographic parameters appear favorable. A retrospective review was performed of all patients who underwent BCPA (n = 142) between February 1996 and May 2001. Echocardiographic criteria defining a favorable BCPA candidate included good ventricular function, moderate or less atrioventricular and semilunar valve regurgitation, absence of ventricular outflow tract obstruction, normal proximal branch pulmonary artery (PA) size, and low PA pressures estimated by PA band gradient or systemic PA shunt velocity. The median age at operation was 7 months (range: 2-11) and weight was 6.2 kg (range: 2.7-7.1). There were 73 unfavorable candidates. Patients with hypoplastic left heart syndrome (n = 23) and pulmonary atresia with intact septum (n = 15) predominated among the unfavorable group. All patients were catheterized. This provided additional information on PA pressures in 3 patients in the favorable group but did not defer operation or influence outcome (no mortality, prolonged pleural drainage, or longer intensive care department stay). All 3 patients are alive at a mean follow-up of 51 months. The 30-day mortality was 2% (4 of 151 patients), all in the unfavorable group. Overall, 20 patients (13%) required arterioplasty of PAs at the time of BCPA. BCPA can be performed with a low risk of morbidity and mortality in a wide range of patients. By using commonly acquired echocardiographic parameters, a low-risk subgroup of patients can be identified who can safely avoid preoperative cardiac catheterization.

Low weight as an independent risk factor for adverse events during cardiac catheterization of infants.

Studies have documented the importance of procedure type and hemodynamic variables on the incidence of procedure related adverse events (AE) after cardiac catheterization. However, little is known about the impact of low weight on the incidence and severity of AE. Methods: Data were prospectively collected using a multicenter registry (C3PO). Infants <1 year were divided into four weight categories: <2 kg, 2–3 kg, 3–5 kg, ≥5 kg. AE severity was classified as level 1–5 (none, minor, moderate, major, death).

Left main coronary artery compression from right pulmonary artery stenting

Complications related to pulmonary artery stenting include stent migration, jailing of vessels, vessel rupture, and compression of surrounding structures. Compression of the left main coronary artery (LMCA) as a result of stent placement in the right pulmonary artery (RPA) is extremely rare. We present two patients post repair of congenital heart disease who suffered LMCA compression following RPA stenting. The first patient experienced acute coronary insufficiency in the cardiac catheterization laboratory, whereas the second patient had a more chronic course. We also present a third patient who had a CT angiogram that demonstrated a close spatial relationship between the RPA and the LMCA. Based on our previous experiences, we felt that this patient was at significant risk for LMCA compression if the RPA were stented. Coronary compression is rare complication of pulmonary artery stenting but should be considered in cases with history of repaired congenital heart disease.

Comparison of ductal stenting versus surgical shunts for palliation of patients with pulmonary atresia and intact ventricular septum

We sought to compare ductal stenting (DS) to systemic‐pulmonary artery shunt (SPS) in a contemporary cohort of patients having pulmonary atresia with intact ventricular septum (PAIVS).