Safety of Occlutech Septal Occluder ACCELL Flex II for Transcatheter Closure of Secundum Atrial Septal Defects in Children: A Long-Term Follow-Up

Objectives. To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background. Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods. Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain chest radiograph, and full 2D transthoracic echocardiography (TTE) were performed at discharge, at one month, six months, and yearly thereafter. Results. The mean age of the study group at the last follow-up was 10.4 ± 4.6 years, with 63.3% (nineteen patients) females. There were no residual shunts or complications encountered immediately after the procedure and at the latest follow-up. Conclusion. This study confirmed the transcatheter closure (TCC) of secundum ASDs using the Occlutech® ACCELL® Flex II device to be safe and effective with no complications detected in children and adolescents.

Association of atrial septal defect and Brugada syndrome in a young woman

We report a 25-year-old woman who was diagnosed with atrial septal defect (ASD). An ECG showed only first-degree atrioventricular block and incomplete right bundle branch block. One day after the percutaneous ASD closure, she had a slight fever and an ECG showed a type 1 Brugada pattern. ECG characteristics of ASD are similar to those of a Brugada ECG. This case is rare combination of Brugada syndrome with ASD.

Long-Term Outcomes in Adult Patients With Pulmonary Hypertension After Percutaneous Closure of Atrial Septal Defects

Background: Pulmonary hypertension (PH), recently redefined as mean pulmonary arterial pressure >20 mm Hg (PH 20 ), may be observed in patients with atrial septal defects (ASD). We aimed to determine the effect of preprocedural PH 20 status on outcomes among patients undergoing ASD closure. Methods: Study population was selected from a retrospective registry of adult patients who underwent percutaneous ASD closure from 1998 to 2016 from a single center and had right heart catheterizations during the procedure. The clinical registry was linked to administrative databases to capture short- and long-term outcomes. Results: We included a total of 632 ASD closure patients of whom 359 (56.8%) had PH 20 . The mean follow-up length was 7.6±4.6 years. Patients with PH 20 were older (mean age 56.5 versus 43.1 years, P <0.001) and a higher prevalence of comorbidities including hypertension (54.3% versus 21.6%, P <0.001) and diabetes (18.1% versus 5.9%, P <0.001) than those without PH. In a Cox proportional hazards model after covariate adjustment, patients with PH had a significantly higher risk of developing major adverse cardiac and cerebrovascular events (heart failure, stroke, myocardial infarction, or cardiovascular mortality), with hazards ratio 2.45 (95% CI, 1.4–4.4). When applying the prior, mean pulmonary arterial pressure ≥25 mm Hg (PH 25 ) cutoff, a significantly higher hazard of developing major adverse cardiac and cerebrovascular events was observed in PH versus non-PH patients. Conclusions: ASD patients with PH undergoing closure suffer from more comorbidities and worse long-term major adverse cardiac and cerebrovascular events outcomes, compared with patients without PH. The use of the new PH 20 definition potentially dilutes the effect of this serious condition on outcomes in this population.

Transcatheter Closure of Atrial Septal Defect

Background: Over the past decade, percutaneous atrial septal defect (ASD) closure has been the preferred treatment option in many clinical programs for ASD. Percutaneous ASD closures with advanced device architecture and distribution have established user experience and process security. The ability to diagnose has also improved. The devices have evolved from the larger fixtures to the reset zone, being easily eliminated with little residual mesh material and comfortable fitting with the surrounding structures. Biodegradable technology has been introduced and will be considered as a future option. The emergence of the use of the ASD closure device over the last forty years includes improvements that reduce the incidence of adverse effects reported over the years. Issues reported in the literature include thrombus formation, air tightness, device insertion, abrasion, residual shunts and nickel hypersensitivity. Modern tools hold medium and long-term data with excellent results. Multi-sized devices securely close simple and complex ASDs that can re-scan, reset, and detect percutaneous advanced delivery procedures. In this review, the most widely used tools and distribution processes are discussed and the tools that show promise for the future. Conclusion: As the field of transcatheter treatment of atrial septal defects (TC-ASD) and congenital interventional cardiology develops, real-world design studies provide valuable developmental information on aspects of care where there is disagreement about best practices and more research is needed.

Safety and Cost Implications of Same-Day Discharge Following Elective Percutaneous Closure of Patent Foramen Ovale and Atrial Septal Defects in Australia

Background: Percutaneous closure of patent foramen ovale (PFO) and atrial septal defects (ASD) is being more commonly performed due to changes in international guidelines supporting its use. This study was performed to determine the clinical outcomes, safety and cost implications of same-day discharge (SDD) following such procedures and place this in an Australian context. Methods: This was a retrospective, observational study of patients undergoing elective percutaneous PFO or ASD closure at St. George Hospital, Australia between January 2011 and January 2020. Primary outcomes included 30-day major adverse cardiovascular endpoints (MACE) and readmission to hospital within 30 days. Results: Twenty-four patients were included in the primary analysis. Ten (41.7%) patients underwent elective ASD closure while 14 (58.3%) underwent PFO closure. Among the 24 patients who underwent elective percutaneous closure of structural heart disease, 23 patients (95.8%) were managed with SDD. There were no MACE outcomes at 30 days. No patients were re-admitted to hospital at 30 days following these procedures. When compared to overnight admission to hospital post-elective percutaneous structural heart condition closure, SDD yielded a cost saving of AUD 5999 per case. Conclusion: SDD following elective percutaneous closure of ASD and PFO was demonstrated to be a safe and effective strategy for managing patients. With more widespread use, it can lead to significant cost savings for hospitals without compromising patient care.

Echocardiographic Evaluation of Changes in Cardiac Hemodynamics, Loading Conditions, and Atrial Function after Transcatheter Closure of Atrial Septal Defect

Background The changes in loading conditions, atrial function, and the different echocardiographic parameters before and after transcatheter atrial septal defect (ASD) closure are still under study. So we felt the need to evaluate the echocardiographic changes that occur and detect the timing after closure at which the right-sided heart hemodynamics, and measurements are back to normal. Objectives To evaluate the changes in cardiac hemodynamics, loading conditions, and atrial function after percutaneous closure of ASD using echocardiography. Patients and Methods The study included 30 patients referred to percutaneous closure of ASD in Ain Shams University hospital we performed echocardiography before, 1 week, and 3 months after closure. Results The study showed that RV dimensions and volumes decreased significantly 1 week, and 3 months after ASD closure (p &lt; 0.001). RA dimensions and volumes decreased significantly 1 week, and 3 months after ASD closure (p &lt; 0.001). RA peak systolic strain, and strain rate increased significantly 1 week, and 3 months after ASD closure (p &lt; 0.001). LA dimensions and volumes increased significantly 1 week, and 3 months after ASD closure (P &lt; 0.001). LA peak systolic strain showed no significant difference before, 1week, and 3 months after ASD closure (P = 0.063), and strain rate showed no significant difference before, 1week, and 3 months after ASD closure (P = 0.207). Conclusion In our study, we have concluded that RV dimensions and volumes decreased significantly 1 week, and 3 months after ASD closure. RA dimensions and volumes decreased significantly 1 week, and 3 months after ASD closure. RA peak systolic strain, and strain rate increased significantly 1 week, and 3 months after ASD closure, as a result of improvement of the RA wall velocity, due to relief of the volume overload after closure of the shunt. LA peak systolic strain, and strain rate showed no significant difference before, 1week, and 3 months after ASD closure. Abbreviations list ASD (atrial septal defect), RV (right ventricle), RA (right atrium), LA (left atrium).

Secundum Type Atrial Septal Defect in Patients with Trisomy 21—Therapeutic Strategies, Outcome, and Survival: A Nationwide Study of the German National Registry for Congenital Heart Defects

(1) Secundum type atrial septal defect (ASD II) is usually considered a relatively benign cardiac lesion amenable to elective closure at preschool age. Patients with trisomy 21 (T21), however, are known to have a higher susceptibility for pulmonary vascular disease (PVD). Therefore, T21 children may present with clinical symptoms earlier than those without associated anomalies. In addition, early PVD may even preclude closure in selected T21 patients. (2) We performed a retrospective analysis of the German National Register for Congenital Heart Defects including T21 patients with associated isolated ASD II. We report incidence, demographics, therapeutic strategy, outcome, and survival of this cohort. (3) Of 46,628 patients included in the registry, 1549 (3.3%) had T21. Of these, 156 (49.4% female) had an isolated ASD II. Fifty-four patients (34.6%) underwent closure at 6.4 ± 9.9 years of age. Over a cumulative follow-up (FU) of 1148 patient-years, (median 7.4 years), only one patient developed Eisenmenger syndrome and five patients died. Survival of T21 patients without PVD was not statistically different to age- and gender-matched controls from the normal population (p = 0.62), whereas children with uncorrected T21/ASD II (including patients with severe PVD, in whom ASD-closure was considered contraindicated) showed a significantly higher mortality. (4) The outcome of T21-patients with ASD II and without PVD is excellent. However, PVD, either precluding ASD-closure or development of progressive PVD after ASD-closure, is associated with significant mortality in this cohort. Thus T21 patients with ASD II who fulfill general criteria for closure and without PVD should be offered defect closure analogous to patients without T21.

Fluid challenge and balloon occlusion testing in patients with atrial septal defects

IntroductionCareful, stepwise assessment is required in all patients with atrial septal defect (ASD) to exclude pulmonary vascular or left ventricular (LV) disease. Fluid challenge and balloon occlusion may unmask LV disease and post-capillary pulmonary hypertension, but their role in the evaluation of patients with ‘operable’ ASDs is not well established.MethodsWe conducted a prospective study in three Italian specialist centres between 2018 and 2020. Patients selected for percutaneous ASD closure underwent assessment at baseline and after fluid challenge, balloon occlusion and both.ResultsFifty patients (46 (38.2, 57.8) years, 72% female) were included. All had a shunt fraction >1.5, pulmonary vascular resistance (PVR) <5 Wood Units (WU) and pulmonary arterial wedge pressure (PAWP) <15 mm Hg. Individuals with a PVR ≥2 WU at baseline (higher PVR group) were older, more symptomatic, with a higher baseline systemic vascular resistance (SVR) than the lower PVR group (all p<0.0001). Individuals with a higher PVR experienced smaller increases in pulmonary blood flow following fluid challenge (0.3 (0.1, 0.5) vs 2.0 (1.5, 2.8) L/min, p<0.0001). Balloon occlusion led to a more marked fall in SVR (p<0.0001) and a larger increase in systemic blood flow (p=0.024) in the higher PVR group. No difference was observed in PAWP following fluid challenge and/or balloon occlusion between groups; four (8%) patients reached a PAWP ≥18 mm Hg following the addition of fluid challenge to balloon occlusion testing.ConclusionsIn adults with ASD without overt LV disease, even small rises in PVR may have significant implications on cardiovascular haemodynamics. Fluid challenge may provide additional information to balloon occlusion in this setting.

“The Effect of Atrial Septal Defect Closure on Cardiac Volumetric Changes in Adults, Transcatheter Versus Surgical Closure, and the Outcome of Tricuspid Regurgitation, a Pilot Cmr Study”

BackgroundClosure of an atrial septal defect (ASD) reduces right heart volumes by eliminating shunting while improving left ventricle (LV) filling and function due to ventricular interdependence, thereby improving symptoms. Furthermore, studies on atrial volume changes following ASD closure are paucity. Functional tricuspid regurgitation (TR) is frequently seen in adult patients with ASD as a consequence of right ventricle (RV) dilatation. Cardiac magnetic resonance (CMR) is widely accepted as the gold standard method for measuring cardiac volume and mass.ObjectiveWe aimed at studying the cardiac volumetric changes preclosure and 6 months after transcatheter and surgical closure, as well as fate of TR, using CMR analysis. MethodsWe prospectively enrolled 30 adult patients with isolated secundum ASD who were referred for ASD closure. CMR evaluates the right and left atrial volumes, as well as the ventricular end diastolic and end systolic volume indexes (EDVI and ESVI), function, the mass index, and tricuspid regurgitant fraction.ResultsRV volumes decreased in both groups when compared to baseline (P value 0.001), with the device group experiencing more reduction in volumes and improvement in RV function after closure (P 0.001). In each group, the absolute value of RV mass decreased significantly from the baseline (P value (0.001)), but with no difference between groups (P value 0.31). Improvement in functional TR occurred in both groups. LVEDVI increased significantly in both groups (P values 0.001 and 0.005, respectively), with a significant improvement in the LV mass index (P value = 0.01) and a non-significant difference in LVESVI. Only device closure resulted in an improvement in LV function (63.53 ± 3.85 versus 67.13 ± 4.34, P value =0.01). There was a significant reduction in right atrial (RA) volume (P value = 0.5), with a trend to decrease in left atrial (LA) volume but it was insignificant, with no difference between groups.ConclusionOur findings revealed that both procedures resulted in normalization of ventricular volume and reduction of RA volumes, with only the device group showing improvement in ventricular function. Functional TR improved after closure with either a device or a surgical approach.

The Efficacy, Safety, and Side Effects of Intrapericardial Triamcinolone Treatment in Children with Post-surgical Pericardial Effusion: A Case Series

Intrapericardial triamcinolone can be used to treat chronic pericardial effusion (PE) in adults; however, pediatric data are lacking. In this case series we aim to evaluate the efficacy, safety, and side effects of intrapericardial triamcinolone in children with PE. The incidence and treatment of post-surgical PE from 2009 to 2019 were determined using the institutional surgical database and electronic patient records. Furthermore, a retrospective analysis of efficacy, safety, and side effects of intrapericardial triamcinolone treatment for chronic post-surgical PE was performed. The incidence of postoperative PE requiring treatment was highest after atrial septal defect (ASD) closure when compared to other types of cardiac surgery (9.7% vs 4.3%). Intrapericardial treatment with triamcinolone resolved pericardial effusion in 3 out of 4 patients. All patients developed significant systemic side effects. Surgical ASD closure is associated with an increased risk of development of PE requiring treatment. Intrapericardial triamcinolone is an effective treatment for chronic postoperative PE in children, but is always associated with significant systemic side effects. Close monitoring and treatment of adrenal insufficiency are mandatory in these cases.