Underwent Device Closure Research Articles

Outcome of pregnancy in women with unrepaired atrial septal defect - study of a single tertiary centre

Abstract Background Patients with unrepaired atrial septal defect (ASD) are prone to develop arrhythmia, right heart failure and to suffer paradoxical embolism. The risk might be even bigger during pregnancy due to the hemodynamic changes combined with the hypercoagulable state. Purpose To evaluate maternal, foetal, and neonatal outcome of pregnancy in women with unrepaired ASD. Methods A retrospective study of 43 pregnancies in 24 women with unrepaired ASD was performed in our tertiary centre from 2004. Previous maternal cardiovascular events and events during pregnancy (maternal, neonatal, and obstetric) were documented. Results 24 women with unrepaired ASD (median age: 27.5 ± 6.2) had 43 pregnancies resulting in one termination, 4 miscarriages and 38 live births. 55% were primigravida and 2 twin pregnancies were documented. At baseline 2 women (10.5%) were in NYHA functional class II and signs of right ventricle (RV) volume overload were detected on echocardiography in 18 cases (47%). 2 women had a history of supraventricular tachycardia. Median gestation at delivery was 39 ± 2.6 weeks. No thromboembolic events, pulmonary hypertension, or desaturation occurred during pregnancy. However maternal cardiovascular complications all affected women with RV volume overload: 2 cases (5.2%) of supraventricular tachycardia, 2 (5.2%) cases with NYHA functional class deterioration and 1 case (2.6%) of syncope were documented. Only one obstetric event; preeclampsia occured. Neonatal complications were as follows: premature delivery in 3 cases (7.9%) and recurrence of congenital heart disease (CHD) in 4 pregnancies (10.5%). After the pregnancy device or surgical closure of the ASD was indicated for 11 women (45.8%). Since then, five already underwent device closure, one had surgical repair, while five women are still waiting for intervention. Conclusions Our results align with the mWHO classification. Pregnancy with an unrepaired ASD is well tolerated and has a low risk of neonatal and maternal cardiovascular events. However, women with right ventricle volume overload are prone to develop arrhythmia or right heart failure during pregnancy. Therefore, cardiology follow-up during pregnancy should be decided on an individual basis. In our cohort no thromboembolic events were documented during pregnancy, however the prevalence of congenital heart disease in the foetus was higher compared to the literature.

Transcatheter closure of atrial septal defect (ASD) in adult and paediatric population without transoesophageal echocardiography/general anaesthesia

Abstract Background Transcatheter device closure is the preferred therapeutic option for ostium secundum atrial septal defect(OS-ASD). Standard practice is to perform it under transoesophageal echocardiography(TEE) guidance. However, TEE is performed under general anaesthesia (GA) and leads to increases in cost, procedural duration, ICU stay, total hospital stays, risk of oesophageal injury and complications of GA. Transthoracic echocardiography(TTE) is an excellent alternative and prior studies have shown it to be a safe alternative in paediatric population. In current study we analysed safety and efficacy of TTE-guided device closure of OS-ASD in all comer population irrespective of age, weight, defect size. Methods The study enrolled all patients who underwent device closure of OS-ASD between March 2017 and December 2023. All procedures were performed under LA for adults and conscious sedation for children. The device was placed under fluoroscopy guidance and position were confirmed on TTE. Procedural success, device, defect size ratio, procedural time, fluoroscopy time, complications, intensive care unit/hospital stay duration were analysed and compared with our own experience of 125 patients with TEE-guided closures before switching to complete TTE-guided procedure(before 2017). Results 340 patients underwent TTE-guided device closure of ASD. Procedure success was 97.4% with acceptable risk of major complications. Three(0.8%) had embolization into pulmonary artery, successfully operated surgically. Two had tamponade requiring drainage. In 9 patients, device could not be deployed despite multiple attempts and approaches. All of these had defect size of > 34mm and deficient IVC rim along with shorter (other than aortic) rim. Findings were compared with our own previous experience of TOE guided closure (practised before 2017). Compared to TOE group, TTE group had significantly lower total procedural duration (75±4 vs. 28 ±1 min; p < 0.01), intensive care unit stay (24±10 vs. 10.5±1 h; p < 0.01), and hospital (48±12 vs. 25.5±4h; p < 0.01) stay duration. Fluoroscopic time was similar in both. There was no mortality in either group. Major complications were comparable, TTE-guided group had less post-procedure complications of vomiting and headache. Additional findings of less pre-procedure fasting duration and early commencement of post procedure oral intake were noted in TTE group. Conclusion TTE-guided device closure of OS-ASD is a safe and feasible in all-comer population in experienced hands. It can definitely negate the use of TEE except in very poor echo window. The added advantages include utilization of physiological variations in PV/LV pressure during cough, Valsalva manoeuvres in awake patients. It definitely reduces the procedural duration, cost of procedure and dependence on GA and trained transoesophageal echocardiographer.

Transcatheter closure of perimembranous ventricular septal defect using the cocoon membranous VSD occluder

BackgroundTranscatheter device closure is a well-established treatment for suitable ventricular septal defects (VSDs). The Cocoon Membranous VSD Occluder is a relatively new device specifically designed for perimembranous VSDs. Existing research on the Cocoon Membranous VSD Occluder for closing PM VSD is limited. ObjectiveThis study aimed to describe a single-center experience using the Cocoon Membranous VSD Occluder for perimembranous VSD. MethodsWe retrospectively analyzed data from patients who underwent device closure of perimembranous VSD using the Cocoon occluder between May 2023 and April 2024. Procedural success, complications, and short-term outcomes were evaluated. ResultsBetween May 2023 and April 2024, 13 patients with perimembranous VSD and left-to-right shunt underwent device closure with the Cocoon Membranous VSD Occluder. Twelve patients (92.3 %) achieved successful VSD closure. The mean age was 8.06 years with standard deviation (SD) of 7.24 years. The mean weight was 11.98 kg with SD of 18.93 kg. The mean VSD size was 4.96 mm with SD of 0.92 mm. The VSD was crossed from the right ventricle in 5 patients and from the left ventricle in 9 patients. All patients had successful device placement from the right ventricle approach. The Cocoon Membranous VSD device size ranged from 6 to 4 mm to 12–4 mm. In one smaller patient, the device was electively removed due to significant flow through an additional exit, and the patient subsequently underwent surgery. Another patient developed hemoglobinuria on the fourth day, which resolved by the tenth day with hydration therapy. Two patients experienced trivial to mild aortic regurgitation, and one had Wenckebach phenomenon that resolved the next day. In the short-term follow-up (mean duration of 4.33 months), all patients were doing well, had good device performance, and showed no evidence of heart block. ConclusionsDevice closure of perimembranous VSD in infants with the Cocoon Membranous VSD Occluder appears to be safe and effective in carefully selected patients during short-term follow-up. Larger studies with long-term data are necessary for future recommendations.

Perventricular device closure of the ventricular septal defects in children-first experience in the United Arab Emirates

BackgroundVentricular septal defect (VSD) is the most common congenital cardiac malformation, accounting for approximately 30% of congenital heart defects. Conventional surgical repair using cardiopulmonary bypass is invasive and associated with morbidities and prolonged hospital stay. With the advent of interventional approaches and availability of different occluding devices, the technique of perventricular device closure is evolving and being implemented successfully in larger groups of patients. We present herein, our initial experience of perventricular device closure for the ventricular septal defects in children to assess risks and benefits.MethodsFrom March, 2023 to February, 2024, we have performed perventricular closure of ventricular septal defects in 13 children, under guidance of transesophageal echocardiography without cardiopulmonary bypass support. The median age at operation was 2 year (range 1.3–10 years) with the median body weight 11 kg (range 8.7–16.6 kg). Sixty-nine percent were males. The ventricular septal defect sizes ranged from 2.7 to 6 mm (mean 4.7 mm). Seven defects were perimembranous, four sub-aortic and two were muscular. One patient also underwent pulmonary artery de-banding with pulmonary artery balloon angioplasty and other one patent ductus arteriosus ligation, concomitantly. For defect closure, we used ventricular septal defect occlusion device (MemoPart™, Lepu Medical Technology Company, China) through a 3-cm skin incision in the lower- third of the sternum. The device sizes ranged from 5 to 8 mm (mean 6.9+-1.8 mm) and all patients except for two required symmetrical devices.ResultsAll patients underwent device closure successfully. The procedural duration ranged between 32 and 52 min. None of the patients required cardiopulmonary bypass. The mean ventilation time and intensive care unit stay was 3 and 24 h, respectively. None of the patients required inotropic support or blood transfusions. Moreover, no patients developed any arrhythmias including heart block. The average length of hospital stay was 4.4 days. At the latest follow up, there were no residual shunts, conduction disturbances, device dislodgement or major aortic or tricuspid valve complications seen in any patients. There was no mortality.ConclusionsPerventricular device closure of ventricular septal defects is a less invasive, extremely safe and effective method in children. It is associated with very fast recovery, shorter hospitalization time and better cosmetic incision. Moreover, it avoids cardiopulmonary bypass. The modifications and refinements in the design, material and implantation techniques will help in expanding the indications and prevent complications in the long-term.

Clinical Presentation, Echocardiographic Findings, Treatment Options Available for Ventricular Septal Defect in Children: A Study in a Tertiary Care Military Hospital

Introduction: Ventricular Septal Defect (VSD) is the most common congenital heart defects. Early diagnosis, appropriate treatment and transcatheter VSD closure with newer devices in favorable cases, decrease the need for surgical interventions and mortality. Objectives: To determine the clinical presentation, echocardiographic findings and the treatment options available for VSD in Paediatric Cardiology Department, Combined Military Hospital (CMH) Dhaka. Methods: It was a cross sectional observational study carried out in the department of Paediatric Cardiology, CMH Dhaka. Forty six isolated ventricular septal defect cases were diagnosed by echocardiography. Clinical features, echocardiographic findings and treatment options of all 46 cases were observed and recorded in pre formed data sheet and statistical analysis was done in statistical software SPSS version 25. Results: Among the 46 patients of VSD, majority 20(43.48%) were in age group 0-6 months. Most of them were male 24(52%). Common presenting features were dyspnea on exertion 23(50%), cough 30(65.20%), head sweating 23(50%), and feeding problem in 34(73.91%). VSD in 27(58.6%) patients were <5mm, 15(32.6%) were 5-10mm and 4(8.7%) had size >10mm. Most of the VSDs were perimembranous 31(67.39%). Among the 46 cases medical management was given to 20(43.5%), device closure was done in 10(21.7%) patients and surgical interventions done in 16(34.8 %) patients. Conclusion: Most of the VSD patients presented at an earlier age some of them were undergone device closure and some require surgical interventions that were not suitable for device closure. Patients those presented lately developed pulmonary hypertension. JAFMC Bangladesh. Vol 19, No 1 (June) 2023: 22-26

Complications Associated with Transcatheter Device Closure of Atrial Septal Defect Cases in Pediatric Cardiology Center of Combined Military Hospital Dhaka, Bangladesh

Background: In Bangladesh, ASD device closure has been started in various centers for about a decade. Still, to date, few studies concern the complications associated with transcatheter device closure of ASD. Material & Methods: From January 2016 to December 2016, patients with suspected and confirmed ASD cases reported to the Department of Paediatric Cardiology Center of Combined Military Hospital, Dhaka, Bangladesh were evaluated. Osteum second ASD cases that were suitable for device closure were selected. Data of patients who underwent device closure were recorded in a predesigned data collection sheet. Results: During the study period, a total of 48 patients were found with second ASD and tried for transcatheter device closure, and 46 (95.83%) were successfully closed. There were 6/46 (13.04%) complications, of which 2 were major, and 4 were minor. The only major complication was device embolization occurring in 2/46 (4.37%) cases; 1 (2.1%) required surgical retrieval, while in the remaining case, the device was retrieved by catheter technique. Another important complication is the formation of a thrombus on the device. Among minor complications, arrhythmia was most common and occurred in 2/46 (4.34%) of cases. In one of these 2, atrial fibrillation required electrical cardioversion, and the other one recovered spontaneously. Post-procedural lower respiratory tract infection occurred in 1/46 (2.17%) patients, for which no apparent reason was found. Transient hypoxemia occurred in one case, 1/46 (2.17%), which also recovered spontaneously. Conclusion: In summary, it is stated that transcatheter ASD device closure is a safe and effective procedure.

The Risk of Heart Failure Progression in Patients With Patent Foramen Ovale: Differential Risk Associated With Device Closure

A patent foramen ovale (PFO) can unload left atrial pressure via an interatrial shunt. We investigated whether device closure of PFO is associated with a subsequent risk of heart failure (HF), particularly in patients with structural heart disease or atrial fibrillation (AF). We enrolled 4,804 consecutive patients who underwent transesophageal echocardiography at tertiary medical centers in Korea between 2007 and 2019. The primary outcome was the 4-year risk of HF hospitalization. Underlying structural heart disease was determined by echocardiography. A PFO was observed in 981 (20.4%) patients, where 161 underwent device closure. During follow-up (median, 3.5 [1.4-6.4] years), the primary outcome was lower in patients with PFO than in those without (2.6% vs 4.0%; adjusted hazard ratio [aHR], 0.65; 95% CI, 0.45-0.94; P=.021). Among the patients with PFO, the primary outcome was higher in the device closure group than in the no-closure group (5.5% vs 1.2%; aHR, 5.59; 95% CI, 4.26-7.34; P<.001). A consistent result was found in patients with structural heart disease or AF (9.6% vs 3.9%; aHR, 2.55; 95% CI, 1.95-3.33; P<.001), demonstrating an increased risk of the primary outcome proportionate to the number of combined structural abnormalities. However, no significant association was observed between the primary outcome and PFO closure in those without structural heart disease or AF (1.7% vs 1.5%; aHR, 1.22; 95% CI, 0.99-1.50; P=.054). Patients with underlying structural heart disease or AF may be predisposed to symptomatic HF progression after PFO closure. Therefore, careful medical surveillance with optimal risk management is needed in these patients.

Fungal Infective Endocarditis Post Device Occlusion in Perimembranous Ventricular Septal Defect

Recent increase in deployment of trans-catheter devices such as septal or ductal occluding coils and devices has been a possible risk factor for infective endocarditis, predominantly in the initial post deployment period before endothelialization has ensued. Though a long-term study of trans-catheter Atrial Septal Defect (ASD) closure revealed no cases of Infective Endocarditis, some case reports of endocarditis in trans-catheter device closure of ASD, VSD and Patent ductus arteriosus(PDA) advocate that residual defect after device occlusion may be a factor in the risk for Infective Endocarditis. We herein describe the case of a 9-month-old female patient who underwent device closure for peri-membranous ventricular septal defect (VSD) and developed fungal infective endocarditis in early post occlusion period which was confirmed on blood culture. Despite treatment with appropriate antifungal as per sensitivity, clinical condition of the patient deteriorated and it was decided to manage her with surgical explanation of device and closure of defect.

Abstract 9538: Impact of Device Closure on Heart Failure Progression in Patients With Patent Foramen Ovale

Background: Patent foramen ovale (PFO) can unload left atrial pressure via interatrial shunt. We evaluated whether device occlusion of PFO is associated with subsequent risk of heart failure (HF). Methods: We enrolled 4,804 consecutive patients (median age: 68 years, 62.4% male) who underwent transesophageal echocardiography at tertiary medical centers in Korea between 2007 and 2019. The primary outcome was the 4-year risk of HF. The independent association of PFO closure with HF was evaluated using the Cox regression hazard model after multivariate adjustment for demographics, clinical risk factors, and echocardiographic parameters. Additional subgroup analysis was performed according to the presence structural heart disease defined as left ventricular (LV) ejection fraction &lt; 55%, left atrial (LA) size &gt; 35ml or LA volume ≥ 40ml/m 2 , LV mass index ≥ 115g/m 2 , E/e' ≥ 15, or presence of atrial fibrillation. Results: In total, PFO was observed in 981 (20.4%) patients, where 161 (16.4%) of them underwent device closure. Patients with PFO showed a lower risk of HF than those without (2.6 vs. 4.0%, adjusted hazard ratio [HR]: 0.65, 95% confidence interval [CI] 0.45-0.94, p=0.021). PFO closure group showed a significantly higher risk of HF than no closure group (5.5 vs. 1.2%, adjusted HR: 5.59, 95% CI 4.26-7.34, p&lt;0.001) (Figure). In subgroup analysis, PFO closure was significantly associated with HF risk in patients with underlying structural heart disease (9.6 vs. 3.9%, adjusted HR: 2.55, 95% CI 1.95-3.33, p&lt;0.001), demonstrating an increasing trend in proportion to the number of structural abnormalities. However, PFO closure showed no significant association with HF risk in patients without structural heart disease (1.7 vs. 1.5%, adjusted HR: 1.22, 95% CI 0.99-1.50, p=0.054). Conclusion: PFO closure may increase the risk of HF. Therefore, careful patient selection is needed, especially among those with underlying structural heart disease.

Routine use of 3-dimensional zoom modality with 2-dimensional transesophageal echocardiography to decide the candidacy for transcatheter device closure of atrial septal defect

Abstract Background 2-dimensional transesophageal echocardiography (2D-TEE) and balloon sizing are commonly used for assessment of Ostium secundum atrial septal defect (OS-ASD) prior to device closure but complications do occur. Therefore, assessment of accurate morphology and anatomy of the defect in three-dimensional plane is essential for transcatheter device closure to be successful, which the 2D TEE fails to reveal. Purpose 2D TEE has long been used to decide size of the device required for transcatheter closure of OS-ASD and the appropriate candidates. However, complications like inadequate closure, leaving behind residual defect or device embolization often come into picture. The reason behind this is complex anatomy of some defects in the three-dimensional plane. Purpose of this study was to see if the routine use of 3D zoom with 2D TEE can better help to select the appropriate patients for device closure than that by 2 TEE alone. Methods We enrolled 71 OS-ASD patients from October 2020 to December 2021. All the patients underwent transesophageal echocardiography (TEE). Assessment of quantitative (number, shape and size of defect and size of residual rims) and qualitative (aneurysm, malalignment, fenestration) parameters was done by both 2D and 3D zoom. The measurements by 2D and 3D TEE clips were done by different operators. Transcatheter device closure was done for the patients with defect morphology and residual rims amenable for the same, with acceptable pulmonary pressure. Patients found to be adequate for the device closure by 2D TEE, when further found to have an unfavorable morphology by 3D TEE, were referred for surgical management. Follow up transthoracic echo was done after 1 month. Results Of the 71 patients, 65% were females and mean age was 26.23±10.75 years. By 3D TEE, 66% had circular defect,19% had oval defect and 14% had complex defect. 2 patients had spiral defect. Malalignment of the septum was seen in 4 (5.6%) patients by 2D TEE whereas in 13 (18.3%) patients by 3D TEE. Septal aneurysm was seen in 1 (1.4%) by 2D TEE whereas in 3 (4.2%) patients by 3D TEE. Mean largest size obtained by 2D was 24.82±9 mm and that by 3D was 26.23±8.42. By 3D TEE, 37 patients had at least one rim deficient (&amp;lt;5 mm). 3D Maximal diameter strongly correlated with 2D Maximal diameter (correlation coefficient 0.860; p&amp;lt;0.01). 9 (12.6%) patients found adequate for the device closure by 2D TEE were further found to have an unfavorable morphology by 3D TEE. 38 (53.5%) patients underwent device closure and 20 (28.2%) patients underwent surgical patch closure. At 1 month follow up all the 38 patients had device in-situ and had no residual shunt. Conclusions In OS-ASD patients, routine use of 3D zoom modality can complement 2D TEE in deciding appropriate patients for transcatheter device closure and help prevent many unforeseeable complications. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Jawaharlal Institute of Postgraduate Medical Education and Research

A prospective study of various anesthetic techniques in patients with acyanotic congenital heart diseases undergoing device closure.

Transcatheter device closure of congenital heart defects (CHD) has recently gained popularity. As limited literature exists regarding the ideal anesthetic technique for these procedures, we studied the perioperative anesthetic management and its effects on hemodynamics and complication rate in patients undergoing device closure. In this prospective observational study, all patients of 1 month to 50 years of age with acyanotic congenital heart diseases undergoing device closure were included. The anesthesia technique, i.e., general anesthesia with endotracheal tube (GETA)/supraglottic airway device (SGD) or conscious sedation with face mask (S-FM), and intravenous induction agent used was noted. Intraoperatively vital parameters, use of transesophageal echocardiography (TEE), and perioperative complications if any, were noted. Descriptive statistical analysis was done using a statistical package for the social sciences (SPSS) version 15. GETA was used in the atrial septal defect (ASD) (62.8%), patent ductus arteriosus (PDA) (66.7%), ventricular septal defect (VSD) (65%) patients, SGD in ASD (6.3%), PDA (16.7%), and VSD (13.3%) patients. S-FM in ASD (31.3%), PDA (16.7%) and VSD (21.7%) patients. Etomidate was used as an induction agent in 30.61% of the patients and propofol in 69.39% of the patients. The mean arterial pressure (MAP) in the etomidate and propofol groups was statistically insignificant while decreased heart rate was noted in both groups. Complications like SGD dislodgement, supraventricular tachycardia, and device dislodgements were seen. In PDA device closure patients, GETA should be preferred. Patients for VSD device closure should receive general anesthesia as complications are common. In ASD device closure, patients without TEE use can be done under general anesthesia with SGD.

Balloon Interrogation of Intervening Tissue: A Novel Method to Decide Strategy for Closing Multiple Atrial Septal Defects.

Two separate ostium secundum atrial septal defects are a challenging substrate for device closure due to lack of a well-described strategy or an adequately evaluated protocol. This is a prospective study comprising 20 patients with 2 atrial septal defects who underwent device closure. All of them underwent balloon interrogation (BI) of the intervening tissue to decide 1- versus 2-device strategy. During BI, if the flow through both the defects could be stopped completely implying adequate mobility of the separating tissue, a single device strategy was used. The size of the device in this subset was determined by BI diameter. In case the flow persisted, 2 devices were used to close the defects separately. The mean age was 24±17 years. The main defect size was (mean 14.5 mm±SD 2.69 mm), whereas the second defect measured (mean 8.5±SD 3.02 mm). The tissue separating the 2 defects was measured (mean 6.1±SD 2.6 mm). In 15 of them, based on the BI results, a single device was used successfully to close both the defects without a residual shunt. In the remaining 5 patients, 2 devices were used. There were no complications during the procedure or at follow-up period of 41.9±16.9 months. BI in patients with 2 atrial septal defects is helpful in defining 1- versus 2-device strategies and in choosing the size of the device to be used. Nearly 3/4 of the patients may get away with a single device for closing both the defects successfully thereby decreasing the cost and complexity of the procedure.

Transcatheter closure of secundum atrial septal defect using Cocoon septal occluder: immediate and long-term results

BackgroundAtrial septal defect (ASD) is one of the common congenital heart defects. Its management has transformed dramatically in the last 4 decades with the transition from surgical to percutaneous transcatheter closure for most secundum-type ASDs. Various devices are available for transcatheter closure of ASD with Amplatzer atrial septal occluder being most commonly used worldwide. Cocoon septal occlude has a nanocoating of platinum using nano-fusion technology over nitinol framework that imparts better radiopacity and excellent biocompatibility and prevents leaching of nickel into circulation, and by smoothening nitinol wire makes this device very soft and smooth. The aim of this study was to evaluate feasibility, effectiveness, safety, and long-term outcome of transcatheter closure of ASD using Cocoon septal occluder (Vascular Innovation, Thailand).ResultsAll patients undergoing transcatheter closure of hemodynamically significant ASD between September 2012 and July 2019 in our institute were included into this single-center, prospective study. Exclusion criteria were defect > 40 mm, unsuitable anatomy, Eisenmenger syndrome, and anomalous pulmonary venous return. Three hundred and twenty patients underwent device closure, of which 238 (74%) were female. The mean age was 14.6 years (range 6–29), and the median weight was 30.2 kg (range 10–53 kg). Procedure was performed under fluoroscopy using transthoracic and transesophageal echocardiography in 298 (93.1%) and 22(6.9%) patients, respectively. Balloon-assisted technique was used, when septal defect was ≥ 34 mm, in 9 (2.8%) patients. The mean diameter of defect and device was 21.4 mm (range 12–36 mm) and 26.9 mm (range 14–40 mm), respectively. Aortic rim was absent in 11 (3.4%) patients. Primary success was achieved in 312 (97.5%) patients. Early embolization to right ventricle was noted in 2 (0.6%) patients. In both cases, 40-mm device was attempted for defect of 36 mm with inadequate aortic rim using balloon-assisted technique. One (0.3%) patient developed perforation of right atrium. All were surgically repaired. Three (0.9%) patients developed complete heart block following device deployment requiring device retrieval. Two patients had had moderate residual shunt at 6 months of follow-up. After mean follow-up of 50.92 months (range 12.5–89 months), no erosion, allergic reactions to nickel, or other major complications were reported.ConclusionsPercutaneous transcatheter closure of ASD by Cocoon septal occluder (up to 36 mm) is safe and feasible with high success rate and without any significant device-related major complications over long-term follow-up. With unique device design and excellent long-term safety, it could be preferred dual-disk occluder for transcatheter closure of atrial septal defect. In most of the patients, ASD device can be safely deployed under transthoracic echocardiographic guidance.

Atrial arrhythmias in patients beyond 40 Years of age post atrial septal defect device closure

BackgroundPatients >40 years with an atrial septal defect (ASD) may have atrial arrhythmia which warrants treatment. It is unclear whether preventive left atrial appendage (LAA) occlusion should be performed simultaneously during ASD closure in these patients. ObjectiveThis study aimed to examine the incidence of de novo atrial arrhythmia in patients >40 years old post transcatheter closure of ASD. MethodsThis was a single-center, retrospective study involving all consecutive patients who have undergone device closure of ASDs at age >40 years. Standard 12-lead ECGs were performed pre-procedure and during every clinic follow-up. Ambulatory monitors were applied when indicated. ResultsEighty-eight patients (mean age: 51.81 ± 8.01 years; male: 22.7%) were recruited and followed up over a median duration of 3.6 years (range: 1–6.5). Seven patients (8%) had documented atrial arrhythmia (AA) pre and post ASD closure. Two patients (2.5%) developed de novo atrial fibrillation and one patient (1.2%), ectopic atrial rhythm during follow-up. In univariate analyses, age >61.3 years (p < 0.001), a history of palpitation (p = 0.006), right atrial area >25.15cm2 pre-closure (p = 0.004); dilated right and left atrium immediately post ASD closure (p = 0.016 & 0.001) and pulmonary vascular resistance >1.31Woods unit (p = 0.036) were associated with increased risk of AA. However, on multivariate analyses, none were significantly associated with AA. ConclusionsDe novo atrial arrhythmia after ASD device closure is uncommon.

Outcomes After Transcatheter Closure of Atrial Septal Defect Without Using a Balloon-Sizing Technique: A Randomized Controlled Comparison with Closures Using a Balloon-Sizing Technique.

The transcatheter closure of atrial septal defect could be completed without the balloon-sizing technique, so we evaluated long-term outcomes compared with closure using balloon sizing, which was the conventional method. Even without using the balloon-sizing technique, transcatheter closure of atrial septal defect might be safe and effective. We included 124 patients with isolated atrial septal defects who underwent device closure without balloon sizing between 2012 and 2016, and we further included 257 patients as a control group. Patients who received closure with multiple devices or who experienced postoperative residual defects were excluded. Immediate procedural results, as well as long-term outcomes for closure without balloon sizing, were investigated and compared with the control group. The procedural success rate was 96.7%, and there were no mortalities. No embolization or cardiac erosions were observed; however, one patient experienced residual shunt, and another developed progressed mitral regurgitation during the follow-up period (983±682 days). Newly onset persistent atrial fibrillation developed in one patient (1.0%). There were no significant differences in procedures or follow-up between the study and control groups. Despite the shorter procedural time in the study group, fluoro time was not different. Atrial arrhythmias were more frequently observed in the control group, but the difference was not significant. Persistent atrial fibrillation was observed in two patients in the control group (0.8%). Transcatheter closure of atrial septal defect can be performed safely and effectively without using the balloon-sizing technique. The long-term outcomes were similar to outcomes with balloon sizing.

Complications of trans-catheter closure of atrial septal defects.

Trans-catheter device closure of atrial septal defects (ASD) is considered to be safe with minimal complications. But, there are certain complications that arise after these device closures which might require urgent or late surgical intervention. We have retrospectively analysed our experience. Out of 780 patients who underwent device closure, 11 (1.4%) patients required urgent surgical intervention to retrieve the embolized device. The size of the ASD, expertise of the cardiologist and the type of the device directly impacted the rate of device embolization. Early diagnosis and prompt surgical retrieval is paramount before any life threatening complications arise due to the embolized device. One patient developed infective endocarditis later, which required surgery. Regular long term follow up is needed after these procedures to diagnose the complications earlier so that prompt surgical intervention could be done.

Perimembranous ventricular septal defect closure in infants with KONAR-MF occluder

BackgroundVentricular septal defect (VSD) with significant left to right shunt requires closure. Device closure in Infants with perimembranous VSD and moderate left to right shunt is emerging as an indication in selective cases. ObjectiveAnalysis of infants with moderate perimembranous VSD closed with new KONAR MF occluder. MethodsInfants with perimembranous VSD and moderate left to right shunt who underwent device closure with KONAR MF device (Lifetech Inc., Shenzhen, China) in a tertiary care setup were analyzed retrospectively. ResultsFive infants had perimembranous VSD with moderate left to right shunt. They underwent device closure with a KONAF MF device. The mean age was 7.8 months and the mean defect size was 4.3 mm. The VSD was crossed antegradely in two patients and retrogradely in three patients. All but one patient had an antegrade deployment. The KONAR MF device size ranged from 6–4 mm to 10–8 mm. The device was deployed with either Launcher guiding catheter (Medtronic AVE, Santa Rosa, CA) 5F and 6F or 5F Lifetech delivery system. Successful deployment was possible in all patients. One patient had tilting of the device 3 h after the procedure with significant residual flow. The patient was sent for surgery after combined cardiology and surgical discussion. All other infants had stable device positions. There was no residual flow and no significant aortic regurgitation or any hemolysis. In the mean follow up of 15 months, they were all doing well, had good device performance with no evidence of heart block. ConclusionsDevice closure of moderate sized perimembranous VSD in infants with KONAR MF occluder appeared to be safe and effective in short term follow up. Larger studies with long term data will help with future recommendations.

Individualized strategy of minimally invasive cardiac surgery in congenital cardiac septal defects

BackgroundIntracardiac septal defect is repaired using median sternotomy in most centers; however, there are several reports using minimally invasive surgery in both children and adults. This study summarized our strategy of minimally invasive therapy using various lateral mini-thoracotomies in patients with congenital septal defect.MethodsIn this study, 472 patients who underwent minimally invasive repair of intracardiac septal defects (atrial septal defect, (ASD), ventricular septal defect, (VSD), and atrioventricular septal defect, (AVSD)) from January 2012 to June 2020 were retrospectively reviewed. Those who underwent device closure were excluded. The minimally invasive strategy included three groups: the right sub-axillary vertical incision (RSAVI) group (N = 335, including192 ASDs, 135 VSDs and 8 AVSDs); the right anterolateral thoracotomy (RALT) group (N = 132, including 77 ASDs, 51 VSDs and 4 AVSDs); and the left anterolateral thoracotomy (LALT) group (N = 5, all subpulmonary VSDs).ResultsConcomitant surgeries included nine cases of right ventricular outflow tract obstruction relief, nine cases of mitral repairs and 37 cases of tricuspid repairs. There was one transition from thoracotomy to sternotomy. Three patients required second pump run for residual lesions (two residual VSD shunts and one mitral regurgitation). The age and body weight of the RSAVI group were significantly lower than those of the RALT and LALT groups (all P < 0.01). No postoperative death was observed. Postoperative complications included one case of chest exploration for bleeding, one case of reoperation due to patch dehiscence during the same admission, one case of transient neural dysfunction, three cases of diaphragmatic paresis and 13 cases of atelectasis. The median stay in the intensive care unit was two days, while the median postoperative hospitalization duration was six days. The echocardiography results before discharge indicated no significant residual lesions. No reoperation, no new onset of chest deformities and no sclerosis were observed during the follow-up.ConclusionsIntracardiac septal defects can be safely and effectively repaired by minimally invasive surgery with good cosmetic results. RSAVI is suitable in infants and children, while RALT is more commonly used in adolescents and adults. LALT is an alternative incision to repair subpulmonary VSD.

Mapping the Conduction System in Patients Undergoing Transcatheter Device Closure of Perimembranous Ventricular Septal Defect: A Proof-of-Concept Study.

Earlier studies that investigated the relation of atrioventricular (AV) conduction system to perimembranous ventricular septal defect (pmVSD) were based on cardiopathological specimens. To study the relationship of conduction system to pmVSD using 3-dimensional electroanatomic mapping system (EAMS) in patients undergoing device closure. Fifteen consecutive cases of pmVSD from January 2014 to July 2017 (age > 2years and weight > 8kg) were included in the study. The course of conduction system and its relationship with the pmVSD was mapped before and after device closure, with the use of EAMS. Median age and weight of the cohort was 10years (range 4-21years) and 25kg (range 13-55) respectively. Device implantation was successful in all patients except 1. The course and relation of the conduction system were posteroinferior to the pmVSD in all cases (100%), and away from the defect in 67% (10/15). In patient with baseline RBBB, the right-sided conduction system was in close proximity to the pmVSD. Two patients had part of left-sided conduction system in close proximity to pmVSD or device edges. Two patients developed RBBB following device deployment, which reverted to normal on follow up. No patient developed high grade AV block during the median follow-up of 34months (range 24-62). This experimental study has shown the feasibility of 3D EAM of conduction system during device closure of pmVSD. This novel concept can be utilized to understand the anatomy of conduction system in other congenital heart diseases.

Transient Complete Heart Block after Percutaneous Transcatheter ASD Device Closure

Transcatheter device closure of atrial septal defect (ASD) is associated with increased complications in small children in device size ≥ 19mm or indexed size ≥ 0.18 mm/cm and weight≤ 15 kg. Complete atrioventricular heart block (CHB) is reported as a rare complication of ASD device closure. We report the case of a 7year-old boy, 23kg weight, underwent device closure of ASD and subsequently developed CHB next day after the procedure which was completely resolved by day 3 with steroid treatment. Similar case reports were rarely reported in the literature. Keywords: atrial septal defect, complete heart block, device/height ratio.