Closure Of Secundum Atrial Septal Defect Research Articles

Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts

BackgroundThe GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure. ObjectivesThis study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months. MethodsThis prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated. ResultsOf 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae). ConclusionsIn this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684)

Intracardiac Echocardiography-Guided Transseptal Puncture Invisible by Transesophageal Echocardiography After Secundum Atrial Septal Defect Closure

Intracardiac Echocardiography-Guided Transseptal Puncture Invisible by Transesophageal Echocardiography After Secundum Atrial Septal Defect Closure

Complications and Efficacies of Surgical Versus Transcatheter Closure for Pediatric Ostium Secundum Atrial Septal Defect: A Meta-Analysis.

The optimal approach for pediatric ostium secundum atrial septal defect (ASD) closure remains uncertain. This study aims to assess complications and efficacies of surgical and transcatheter closures. Systematic search in Medline, Cochrane, and EMBASE databases identified cohort studies until July 2023. Complications, length of hospital stay, and efficacy outcomes were evaluated. Subgroup analyses considered ethnicity, ASD size, age, and rim deficiency involvement. Fourteen cohort studies involving 9695 patients were comprehensively analyzed. Regarding complications, the pediatric patients in the surgery group exhibited higher occurrences of cardiac arrhythmia (odds ratio [OR]: 1.87, 95% confidence interval [CI]: 1.22-2.87, p=0.004), pericardial effusion (OR: 14.80, 95% CI: 6.97-31.43, p<0.00001), and pulmonary complications (OR: 2.58, 95% CI: 1.73-3.85, p<0.00001) compared with those in the transcatheter group. However, no significant difference in fever incidence was observed (OR: 2.57, 95% CI: 0.90-7.34, p=0.08). Furthermore, length of hospital stay was notably shorter in the pediatric transcatheter group (mean difference [MD]: 4.00, 95% CI: 1.71-6.29, p=0.0006). Regarding efficacies, both groups demonstrated similar rates of successful closure (OR: 1.97, 95% CI: 0.56-6.92, p=0.29) and residual shunting (OR: 0.55, 95% CI: 0.17-1.77, p=0.31) in the pediatric cohort. Subgroup analyses revealed that surgical residual shunting was notably lower in the European pediatric population (OR: 0.18, 95% CI: 0.07-0.45, p=0.0002), in cases with ASD size exceeding 15 mm (OR: 0.19, 95% CI: 0.08-0.49, p=0.0006), and in pediatric patients younger than 8 years (OR: 0.33, 95% CI: 0.12-0.92, p=0.03). Interestingly, residual shunting involving complex ASD with rim deficiency was more pronounced in the surgery group (OR: 2.66, 95% CI: 1.33-5.32, p=0.006). Both surgical and transcatheter closures are equally effective, with transcatheter closure showing significantly fewer complications. This meta-analysis offers pivotal insights for clinicians grappling with the optimal approach to pediatric ostium secundum ASD closure. The observed higher incidence of cardiac arrhythmias, pericardial effusions, and pulmonary complications in surgical closures underscores the challenges associated with this modality. In contrast, transcatheter closure, with its comparable efficacy and shorter hospital stays, emerges as an appealing and less invasive alternative. These findings equip clinicians with evidence to make informed decisions, optimizing patient outcomes. Subgroup analyses further refine recommendations, emphasizing tailored considerations for European pediatric patients, larger ASDs, and those under 8 years old, ultimately fostering personalized and improved care strategies.

Percutaneous Secundum Atrial Septal Defect Closure: Failure Rate and Procedural Predictors

Background: Percutaneous atrial septal defect (ASD) closure is one of therapeutic options for patients with a suitable ASD anatomy, however in developing countries, the exact figure and procedural characteristics remain unknown. Therefore, this study was conducted to identify the failure rate and procedural predictors of the percutaneous ASD closure.Materials and methods: A retrospective study using a database of all patients undergoing percutaneous ASD closure was conducted between March 2010 to November 2023. Patients who developed a pulmonary hypertensive crisis during the procedure were excluded. Procedural and echocardiographic parameter were measured and analyzed.Results: A total of 112 samples were included in this study, 74.1% were female and 55.36% were pediatric patients. The failure rate was 12.5% (n=14) with diameter index was higher in the failed group. Unpaired T-test revealed that ASD size was one of the predictor failure in pediatric patients (mean diameter: 24.7±6.46 mm vs. 16.36±5.94 mm, p=0.001). There were no statistically significant variations in rim diameters, while compared with all patients with appropriate rims (rim ≥7mm), the failure rate was higher in patients with two rims measuring between 5.9 and 6.9 mm and rims less than 5 mm. Two patients presented with device embolization and required surgical device removal.Conclusion: The failure rate of percutaneous ASD closure was 12.5%. A larger ASD increases the risk of failure of percutaneous closure in pediatric patients. Furthermore, patient with 5-6.9 mm on two or more rims as well as those with rim less than 5 mm, have a higher failure rate.Keywords: secundum atrial septal defect, percutaneous closure, failure rate

Secundum atrial septal defect closure in adults in the UK.

To examine determinants of access to treatment, outcomes and hospital utilization in patients undergoing secundum atrial septal defect (ASD) closure in adulthood in England and Wales. Large retrospective cohort study of all adult patients undergoing secundum ASD closures in England and Wales between 2000/01 and 2016/17. Data were from population-based official data sets covering congenital heart disease procedures, hospital episodes and death registries.Out of 6541 index closures, 79.4% were transcatheter (median age 47 years, IQR 34-61) and 20.6% were surgical (40 years, 28-52). The study cohort was predominantly female (66%), with socio-ethnic profile similar to the general population.Mortality in hospital was 0.2% and at one year 1.0% (95%CI 0.8%-1.2%). Risk of death was lower for transcatheter repairs, adjusting for age, sex, year of procedure, comorbidities and cardiac risk factors (in-hospital adjusted-OR 0.09, 95%CI 0.02-0.46, one-year adjusted-HR 0.5, 0.3-0.9). There was excess mortality one year after ASD closure compared to matched population data.Median (IQR) peri-procedural length of stay was 1.8 (1.4-2.5) and 7.3 (6.2-9.2) days for transcatheter and surgical closures, respectively. Hospital resource use for cardiac reasons started the year before repair (median 2 inpatient and 2 outpatient-only days) and decreased post-repair (zero inpatient and one outpatient days during the first two years). This national study confirms that ASD closure in adults, by surgical or transcatheter methods, is provided independently of ethnic or socioeconomic differences, it is low (but not no) risk and appears to reduce future cardiac hospitalisation even in older ages.

The Risk Factors of Mitral Regurgitation Deterioration After Secundum Atrial Septal Defect Closure.

Association between secundum Atrial Septal Defect (ASD) and mitral valve (MV) disease has been recognized for decades. Secundum ASD closure can reduce mitral regurgitation (MR) degree. However, in some patients, deterioration of MR after ASD closure has been observed. We aimed to identify the risk factors of MR deterioration after ASD closure. This was an observational retrospective cohort study. Data were collected from the registry and echocardiogram report. We evaluated all patients with ASD closure by surgery and transcatheterization without MR intervention from January 2012 until June 2021 at Dr. Sardjito General Hospital, Yogyakarta. We excluded patients with multiple ASD and ASD with severe MR requiring MV intervention. Risk factors for MR deterioration were evaluated using multivariate logistic regression. A total of 242 patients who underwent post-secundum ASD closure were included. In multivariate analysis, ASD closure by surgery, large left atrial (LA) diameter (>40 mm), low left ventricular ejection fraction (LVEF; <55%), and MV regurgitation degree were significant risk factors for MR worsening after ASD closure, with OR of 2.103 (95% CI 1.124-3.937); 2.871 (95% CI 1.032-7.985); 5.531 (95% CI 1.368-22.366); and 2.490 (95% CI 1.339-4.630) respectively. ASD closure by surgery, large LA diameter (>40 mm), low LVEF (<55%), and MV regurgitation degree are independent significant risk factors for MR deterioration in post-secundum ASD closure patients. In adult ASD patients with reduced LV function, it is recommended to perform balloon testing and consider fenestrated closure, as low LVEF <55% has the highest risk of causing new or deteriorating MR.

Feasibility of transcatheter device closure of secundum atrial septal defect under transthoracic echocardiography guidance.

Objective: To determine the usefulness and safety of transthoracic echocardiography (TTE) imaging for real time guidance in transcatheter device closure of atrial septal defect (ASD) secundum. Study Design: Cross-sectional study. Setting: Department of Paediatric Cardiology, CPEIC, Multan, Pakistan. Period: January 2022 to December 2023. Material &amp; Methods: Patients of both genders aged above 3 years with clinical and echocardiographic evidence of ASD secundum with significant left to right shunt were analysed. All cases had morphologically suitable margins of defect confirmed on TTE. Usefulness and safety of intra-procedure and immediate post-procedure transcatheter device closure of secundum ASD were noted. Results: In a total of 34 patients, 20 (58.8%) were female and 14 (41.2%) male. The mean age was 21.32±17.21 years. The TTE findings revealed that the mean ASD side was 17.47±4.32 mm. Aortic margins were deficient among 28 (82.4%) cases. The mean fluoroscopy and procedure time were 9.29±6.98 minutes and 49.91±39.76. Residual leak was noted in one (2.9%) cases while none of the cases were observed to have superior vena cava, inferior vena cava or pulmonary vein obstructions. Post-procedure, transient supraventricular tachycardia (SVT) arrhythmia was the most common type of complication reported among 2 (5.9%) cases. None of the cases needed any kind of emergency surgical exploration. No cases of pericardial effusion were found. No mortality was reported. Conclusion: Transcatheter device closure of secundum atrial septal defect was found to be effective and safe using TTE.

Single tertiary center experience using Gore Cardioform Atrial Septal Defect Occluder for secundum atrial septal defect closure with a focus on deficient rims.

The data on the use of Gore Cardioform Septal Occluder (GCA; W. L. Gore and Associates, Inc.) for atrial septal defect (ASD) with deficient rims is limited. All patients evaluated by transesophageal echocardiogram (TEE) for ASD occlusion were included. TEE planes at 35°, 0°, and 90° were assessed for anterior-superior (AS) and posterior (P), anterior-inferior (AI) and posterior-superior (PS), as well as superior (S) and inferior (I) rims. ASD size >20 mm, and rims less than 5 mm were defined as large and deficient, respectively. We included patients who had a procedural failure along with the patients in whom the procedure was not attempted after echocardiogram in the unsuccessful group. In 148 patients, the median weight, age, and ASD size were 36 kg (range, 8-60 kg), 11.8 years (range, 1-60 years), and 14.2 ± 8.28 mm, respectively. One or more deficient rims were noted in 112 of 148 (75.7%): 99 (67%) AS, 36 (24%) P, 17 (11%) AI, 30 (20%) PS, 26 (18%) S, and 33 (22%) I. ASD closure was performed in 115 (78%) patients. The procedure was successful in 111 (96.5%) patients with procedural failure in 4 (3.4%) patients. Multiple deficient rims were associated with reduced procedural success (OR 0.36, 95% CI, 0.25-0.56). On multivariate analysis deficient P, PS, and I rims were associated with an unsuccessful group (P = .001, .046, and .005, respectively). Complications included 1 device embolization, 1 vascular injury, and 5 arrhythmias. Transcatheter closure of ASDs with deficient rims is feasible using GCA. Large ASDs with deficient P, PS, and I rims were associated with unsuccessful closure. Risk stratification and comprehensive evaluation of ASD rims is vital for the use of GCA.

Transcatheter closure of large ostium secundum atrial septal defects in symptomatic small children: A single-center retrospective study.

In general, the risks associated with transcatheter atrial septal defect (ASD) device closure are reported to be relatively low, but the evidence stems from trials involving adults and older children. Current guidelines do not recommend ASD device closure in children with defect sizes >20 mm due to limited data available in this group of patients. This retrospective study sought to determine the clinical and procedural characteristics of successful transcatheter ASD device closure in small children with large defects and assess the complication rates and reasons for unsuccessful device closure. We retrospectively reviewed the data of all patients who underwent elective transcatheter closure of ostium secundum ASD in our department between September 2013 and February 2022. All children weighing <20 kg, requiring a device of size 20 mm or greater, were included. Major and minor complications were predefined and indications for referral were evaluated. Echocardiogram reports were reviewed from the time of referral, postcatheterization day 1, and at 1-year follow-up. We identified 40 patients meeting inclusion criteria with a median (interquartile range [IQR]) procedural age of 5 (4-7) years and median (IQR) weight of 14 (12-18) kg. Successful device closure was achieved in 39 patients with a success rate of 97.5%. The total complication rate was 2.5% (95% confidence interval: 0.44%- I2.8%) with only 1 major complication. All children had right heart enlargement and exertional dyspnea, 30% of patients had recurrent lower respiratory tract infections, and 10% had failure to thrive. At 1-year follow-up, a transthoracic echocardiogram showed a well-endothelialized device in a stable position in all the patients, and none of the patients had a residual shunt. In experienced centers, percutaneous ASD closure of large defects in symptomatic small children can be done effectively and safely with a great degree of predictability and a low complication rate.

Atrial septal defect closure is associated with improved clinical status in patients ≤ 10 kg with bronchopulmonary dysplasia.

Patients with bronchopulmonary dysplasia (BPD) have shown clinical improvement after secundum atrial septal defect (ASD) closure. We sought to determine if this post-ASD closure improvement is secondary to the expected course in BPD patients or related to the closure itself. A novel BPD-ASD score was created to assess patients' clinical status (higher score = worse disease) and applied to 10 BPD-ASD inpatients weighing ≤ 10 kg who underwent ASD closure. The score and its subcomponents were retrospectively calculated serially ranging from 8 weeks pre- to 8 weeks post-intervention, and pre- and post-intervention score slopes were created. These slopes were compared using mixed regression modeling with an interaction term. There was a significant difference in pre- versus post-intervention slope with the most score drop the first week post-intervention (-2.1 + /- 0.8, p = 0.014). The mean score also dropped through weeks 2 (slope -0.8 + /- 0.8, p = 0.013) and 4 (slope -1.0 + /- 0.5, p = 0.001) post-intervention. There was a significant difference in pre- and post-intervention slopes for diuretics (p = 0.018) and the combined score of respiratory support, FiO2 need, and respiratory symptoms (p = 0.018). This study demonstrated significant improvement in BPD-ASD score, diuretic need, and respiratory status after ASD closure in BPD-ASD patients ≤ 10 kg that was outside of the natural course of BPD. Our study was limited by its small, single-center, retrospective nature. Future studies should be performed in a larger multicenter population to both validate the scoring system and compare to non-intervention infants.

Effective and aesthetic results of horizontal right axillary minithoracotomy for congenital heart defects repair in children

Background: horizontal right axillary minithoracotomy is one of the treatment options for many simple congenital heart defects. This approach shows many aesthetic advantages besides effectiveness and safety. This study aims to: comment on the technical characteristics and early results of horizontal right axillary minithoracotomy in children at Hanoi Heart Hospital.&#x0D; Methods: a descriptive cross-sectional study. We retrospectively reviewed 156 patients who underwent horizontal right axillary minithoracotomy at Hanoi Heart Hospital from January 2022 to December 2022.&#x0D; Results: horizontal axillary approach could be applied even for children with low weight, average weight was 12.22 ± 8.67 kg, the lowest was 2.6 kg and the highest was 51.0 kg. A wide range of congenital heart defects were repaired, including ventricular septal defect closure (84 patients), secundum atrial septal defect closure (22 patients), ventricular septal defect with stenosis repair (31 patients), partial atrio-ventricular septal canal repair (6 patients), repair of atrial septal defect with partial abnormal return of the pulmonary veins (3 patients), repair of ventricular septal defect and atrial septal defect (4 patients), Cor triatriatum sinister repair (4 patients), mitral valve repair (1 patient), atrial septal defect and pulmonary valve stenosis repair (1 patient). Cannulation of the aorta and vena cavae was performed through the main incision, whose size ranged from 3.5 to 5.5cm. The average postoperative hospital stay was 7.34 ± 2.16 days, the rate of severe complications and hospital mortality were 0%.&#x0D; Conclusion: horizontal right axillary minithoracotomy was a good approach to correct many simple congenital heart defects in children. This technique is being applied at Hanoi Heart Hospital safely and provided outstanding advantages in terms of aesthetics.

Comparison of Short-Term Outcomes of Transcatheter versus Surgical Closure of Atrial Septum Defect at a Tertiary Cardiac Care Facility

Objective: To compare the short-term outcomes of transcatheter versus surgical closure of atrial septal defect (ASD) at a tertiary cardiac care facility in South Punjab, Pakistan.&#x0D; Study Design: Prospective comparative study.&#x0D; Place and Duration of the Study: Department of Paediatric Cardiology and Paediatric Cardiac Surgery, Chaudhary Pervez Elahi Institute of Cardiology, Multan Pakistan, from Jul 2019 to Jun 2021.&#x0D; Methodology: A total of 110 patients with moderate to large isolated secundum ASDs without severe pulmonary hypertension and planned to undergo closure of secundum ASD by either surgical approach or device closure were included. All surgical and transcatheter procedures were performed adopting standard techniques. Intra-procedural or post-procedural outcomes were noted.&#x0D; Results: In a total of 110 patients, 59(53.6%) underwent transcatheter closure of ASD, while surgical closure was done in the remaining 51(46.4%) patients. Post-procedural complications were significantly more in the Surgical Closure Group in comparison to the Transcatheter Closure Group, [14(27.5%) vs 5(8.5%) (p=0.026)]. None of the cases in the Transcatheter Closure Group required inotropes in the post-procedure period in comparison to 24(47.1%) cases (p&lt;0.001). The total cost of treatment was significantly higher in transcatheter closure patients compared to surgical closure patients (1504±60.4 US$ versus 1448±75.4 US$, p&lt;0.001). Overall, successful closure was noted in 108(98.2%) cases. No mortality was recorded.&#x0D; Conclusion: Overall, short-term outcomes of transcatheter ASD closure were comparable to the surgical approach, but patients with transcatheter ASD closure had significantly less duration of hospitalization and low rates of post-procedural complications.Keywords: Atrial septum defect, Mortality, Surgical closure, Transcatheter closure.

Evaluation of Arrhythmia Prevalence, Management, and Risk Factors in Patients with Transcatheter and Surgically Closed Secundum Atrial Septal Defects.

Atrial septal defect (ASD) accounts for 6-10% of all congenital heart disorders. Secundum ASD closure can be performed surgically or percutaneously. We aimed to identify the various arrhythmias that occur before, during, and after the procedure and evaluate their management. The study included a total of 427 patients aged 0-18 years who underwent transcatheter or surgical closure of isolated secundum ASD between January 2008 and January 2020. Postoperative electrocardiogram (ECG) traces, intraoperative arrhythmias, and treatments were recorded for both groups. Echocardiography and ECG were evaluated at postoperative 1 week, 1, 3, and 6 months, and annually thereafter. After transcatheter closure, follow-up basal ECG showed incomplete right bundle branch block pattern in 21 patients and sinus rhythm in 229 patients. After surgical closure, incomplete right bundle branch block pattern was detected in 23 patients, complete right bundle branch block in 3 patients, and complete AV-block (Atrioventricular Block) pattern in 1 patient. The other 150 patients showed sinus rhythm. At least one postoperative follow-up Holter ECG record could be obtained for 104 patients in the transcatheter group and 96 patients in the surgical group. Of 104 patients who underwent transcatheter closure, 97 (93.3%) had normal Holter ECG findings and 7 (6.7%) had arrhythmia. Of the 96 patients who underwent surgical closure, 85 (88.5%) had normal Holter ECG traces and 11 (11.5%) had arrhythmia. There was no statistically significant difference in the frequency of arrhythmia (P = 0.164). The higher frequency of arrhythmia in adult studies compared to the pediatric age group once again demonstrates the importance of early diagnosis and treatment of ASD in childhood. The similar incidence of arrhythmia in both groups supports the safety and effectiveness of both closure methods in eligible patients.

Usefulness of perioperative transesophageal echocardiography during pediatric cardiac surgery

Pediatric transesophageal echocardiography (TEE) probes allow perioperative evaluation during pediatric congenital heart disease (CHD) surgery. To determine the usefulness of perioperative TEE for evaluation of residual lesions severity according to the type of repaired CHD. Retrospective review of patients who underwent a perioperative TEE study during open-heart surgery (excluding ostium secundum atrial septal defect closure) over 4 consecutive years in our center. Residual lesions were rated as mild, moderate or severe. Among 291 interventions (which may include multiple gestures) in 280 patients (pts), no complications related to TEE study occurred. Median weight was 8,1 kg (range 2–96) and size of probe (micro 2D TEE, mini-multi 2D TEE or 3D TEE) adapted to the weight. Twenty-one (7.2%) severe residual lesions required immediate reintervention. Eleven pts (9.7%) had severe residual stenosis and required immediate reintervention out of 113 right ventricular outflow tract obstruction (RVOTO) surgeries. Three pts (3.5%) required immediate reintervention for aortic regurgitation and two (2.3%) for mitral residual lesions out of 86 left heart surgeries. Two pts (1.1%) required immediate reintervention for severe residual VSD out of 188 ventricular shunt surgeries. Two pts (4.2%) required immediate reintervention for superior vena cava stenosis following Warden procedure out of 47 pretricuspid shunt surgeries. One immediate reintervention occurred after a “Cone surgery” for severe right ventricle dysfunction. Use of perioperative TEE is safe and provides accurate information of residual lesions leading to several immediate intervention. RVOTO, left valvular and shunt closure surgeries could most likely benefit of its use.

Transcatheter closure of secundum atrial septal defects in Egyptian centers: immediate and short-term outcomes

Considered is the Atrial Septal Defect (ASD), with secundum ASDs being the most frequent. As known, in comparison to surgical approach, device closure of secundum ASD is less invasive, has few post-procedural complications, reduced anaesthesia risks, and has early hospital discharge. The present observational study discusses the outcome of the transcatheter closure of secundum ASD in Egyptian cardiac centres. The outcome included immediate and short-term results (up to one-year of intervention date).

Usefulness of perioperative transesophageal echocardiography during pediatric cardiac surgery

Pediatric transesophageal echocardiography (TEE) probes allow perioperative evaluation during pediatric congenital heart disease (CHD) surgery. The aim of the study was to determine the usefulness of perioperative TEE for evaluation of residual lesions severity according to the type of repaired CHD. Retrospective review of patients who underwent a perioperative TEE study during open-heart surgery (excluding ostium secundum atrial septal defect closure) over 4 consecutive years in our center. Residual lesions were rated as mild, moderate or severe. Among 291 interventions (which may include multiple gestures) in 280 patients (pts), no complications related to TEE study occurred. Median weight was 8.1 kg (range 2–96) and size of probe (micro 2D TEE, mini-multi 2D TEE or 3D TEE) adapted to the weight. Twenty-one (7.2%) severe residual lesions required immediate reintervention. Eleven pts (9.7%) had severe residual stenosis and required immediate reintervention out of 113 right ventricular outflow tract obstruction (RVOTO) surgeries. Three pts (3.5%) required immediate reintervention for aortic regurgitation and two (2.3%) for mitral residual lesions out of 86 left heart surgeries. Two pts (1.1%) required immediate reintervention for severe residual VSD out of 188 ventricular shunt surgeries. Two pts (4.2%) required immediate reintervention for superior vena cava stenosis following Warden procedure out of 47 pretricuspid shunt surgeries. One immediate reintervention occurred after a “Cone surgery” for severe right ventricle dysfunction. Use of perioperative TEE is safe and provides accurate information of residual lesions leading to several immediate intervention. RVOTO, left valvular and shunt closure surgeries could most likely benefit of its use.

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects.

BackgroundThe last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlexTM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU).MethodsProcedure specific data was collected on patients considered for ASD closure with the CeraFlexTM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU.ResultsThe primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlexTM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle.ConclusionsCatheter interventional closure of secundum ASDs with the CeraFlexTM ASD occluder was feasible, safe and effective in this study.

Feasibility of Transcatheter Closure of Large Secundum Atrial Septal Defect with Absent Superior or Inferior Rim.

Introduction Surgical closure of a large secundum atrial septal defect (ASD) with an absent superior or inferior rim is the standard method of management, but transcatheter closure of such a defect is possible and feasible. Objectives To evaluate the feasibility, effectiveness, and safety of transcatheter closure of large secundum ASD with an absent superior or inferior rim through implantation of a cheatham platinum (CP) stent at the entrance of the superior vena cava (SVC) or inferior vena cava (IVC) into the right atrium (RA) to create a suitable rim for subsequent complete closure of the defect using a septal occluder. Patients and Methods. This case series was carried out at Ibn Al-Bitar Center for Cardiac Surgery, Baghdad, Iraq from 2014 to 2019, five patients underwent such transcatheter approach for closure of large secundum ASD with the absent superior or inferior rim by implantation of CP stent at the entrance of vena cave into the RA. Result The ages and weights of patients who were enrolled in this study ranged from 9–31 years (15.2 ± 9 years) and 31.5–62 kg (42.6 ± 12 kg). Three patients had absent superior rims, and the other two had absent inferior rims. The Qp/Qs was ranged from 1.9–3.2 (2.78 ± 0.29), and the mean pulmonary arterial pressure ranged from 22–29 mmHg (25.4 ± 3 mmHg). The defects with an absent superior rim were closed successfully by implantation of CP stents of 45, 45, and 39 mm to create a rim which supported the left atrial disc of 30, 38, and 32 mm atrial septal occluder (ASO), respectively, while large secundum ASD with an absent inferior rim could be effectively closed by implantation of two overlapping bare CP stents of 45 mm to create an IVC rim that supported 34 mm and 30 mm atrial septal occluder. Conclusion and recommendation. Transcatheter closure of large secundum ASD with absent superior or inferior rim is possible and effective by implantation of covered and bare CP stents at the entrance of SVC and IVC, respectively. Although these procedures are relatively difficult and challenging, especially in the closure of large defects associated with absent inferior rim, they carry a high risk of stent migration (8 zig, 45 mm), so we recommend using a CP-stent (10 zig, 60 mm).

TCTAP A-039 Bi-atrial Geometrical Changes Following Secundum Atrial Septal Defect Closure Using Magnetic Resonance Imaging and Their Effect on Electrical Changes

TCTAP A-039 Bi-atrial Geometrical Changes Following Secundum Atrial Septal Defect Closure Using Magnetic Resonance Imaging and Their Effect on Electrical Changes

Atrial Septal Defect Repair in Adolescent and Adult Patients, a Cross Sectional Study at Jordan University Hospital, a Tertiary Hospital in a Developing Country

ObjectiveWe aim to report our heart team's experience in repair of Secundum atrial septal defect (ASD) in adolescent and adult patients at Jordan University Hospital (JUH).MethodologyA retrospective observational study of 44 patients who underwent secundum ASD closure by transcatheter closure (TCC) or Minimally Invasive Cardiac Surgery (MICS) at JUH. Patients who were treated at an age of 14 years or older regardless of the age of diagnosis were included. SPSS and Microsoft Excel were used to analyze the data.ResultsA total of 44 patients with secundum ASD were treated during the period of (January 2015 and December 2019). The mean age was 34.1 (±14.3) years. Thirty-four patients underwent TCC, 9 underwent surgical closure and one had a hybrid procedure. We had no mortality and 2 minor morbidities. After a mean follow-up period of 13.2-/+13.6 months, most patients experienced improved symptoms, and there was a significant reduction of right ventricular dimension from 33.1 (±8.74) to 24 (±4.67) mm (p=0.0001).ConclusionASD closure whether TCC or MICS is a safe procedure with very low morbidity. A heart team approach is a necessity in the era of advances in both MICS surgery and TCC approach. A heart team provides the patients with a variety of safe and cosmetic solutions that allow the patients to have a fast management and recovery phase in rapid time through providing the merits and avoiding the complications of each modality, the team allows low volume centers in developing countries to achieve an excellent outcome.