Mean Device Size Research Articles

Echocardiography-guided percutaneous closure of oval-shaped secundum atrial septal defects

BackgroundAn atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of the longest diameter. Research on percutaneous closure of oval-shaped ASDs is limited, with no known reports of non-fluoroscopic closure for this population.ObjectiveTo assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.MethodsThis single-center retrospective study evaluates patients undergoing non-fluoroscopic percutaneous closure of oval-shaped ASDs, defined by the shortest to longest diameter ratio < 0.75, a circular index of 1.33, or ultrasound visualization of an oval shape. Device size was chosen to be 0–4 mm larger than the defect’s longest diameter, based on transthoracic and transesophageal ultrasound measurements.ResultsWe identified 78 patients (33.3% children, 20.5% males) with a mean age of 27.4 ± 16.3 years and a mean weight of 46.8 ± 19.8 kg. The mean longest diameter and mean shortest diameter of ASDs were 23.3 ± 6.8 mm and 15.8 ± 5 mm, respectively. The mean ratio of the shortest to longest diameter was 0.7 ± 0.1. Percutaneous closure was not attempted in 7/78 (9%) patients. Three out of 71 (4.2%) procedures were fluoroscopy-guided upfront due to technical difficulties, and 5/71 (7%) were converted to fluoroscopy-guided closure. Overall procedural success rate was 98.6% (70/71) including 63/71 (88.7%) performed with zero fluoroscopy. Mean device size was 26.5 ± 7.1 mm. Mean procedural time was 45.3 ± 22.6 min. Eleven intraprocedural complications occurred including 6 arrhythmias, 3 pericardial effusions, and 2 device dislodgements.ConclusionTranscatheter closure of oval-shaped ASD is safe and feasible. Echocardiography is adequate for adequate operative guidance.

Utility of 3D Echocardiography for Device Sizing During Transcatheter ASD Closure: A Comparative Study.

Two-dimensional (2D) transesophageal echocardiography (TEE) is commonly used for assessing patients undergoing transcatheter atrial septal defect (ASD) device closure. 3D TEE, albeit providing high resolution en-face images of ASD, is used in only a fraction of cases. We aimed to perform a comparative analysis between 3D and 2D TEE assessment for ASD device planning. This was a prospective, observational study conducted over a period of one year. Patients deemed suitable for device closure underwent 2D and 3D TEE at baseline. Defect characteristics, assessed separately in both modalities, were compared. Using regression analysis, we aimed to derive an equation for predicting device size using 3D TEE parameters. Thirty patients were included in the study, majority being females (83%). The mean age of the study population was 40.5 ± 12.05 years. Chest pain, dyspnea and palpitations were the common presenting complaints. All patients had suitable rims on 2D TEE. A good agreement was noted between 2D and 3D TEE for measured ASD diameters. 3D TEE showed that majority of defects were circular in shape (60%). The final device size used had high degree of correlation with 3D defect area and circumference. An equation was devised to predict device size using 3D defect area and circumference. The mean device size obtained from the equation was similar to the actual device size used in the study population (p = 0.31). Device sizing based on 3D TEE parameters alone is equally effective for transcatheter ASD closure as compared to 2D TEE.

Phase contrast cardiac magnetic resonance imaging versus transoesophageal echocardiography for the evaluation of feasibility for transcatheter closure of atrial septal defects

BackgroundThis prospective study was aimed at comparing phase contrast cardiac magnetic resonance imaging (PC-CMR) with 2D transoesophageal echocardiography (TEE) for determining potential candidature for transcatheter closure in ostium secundum ASD (OS-ASD) patients. We included consecutive adult patients with OS-ASD for the evaluation of feasibility for transcatheter closure using 2D-TEE and PC-CMR over a period of 2 years. Patients who fulfilled the conventional criteria for transcatheter closure, i.e. maximum ASD diameter ≤ 34 mm, adequate rims (≥ 5 mm, except for anterosuperior rim), and normal pulmonary venous drainage on both imaging modalities, were taken for device closure. In patients where there was discrepancy in the measurements of ASD diameter or rim size, making them eligible for device closure on one imaging modality and ineligible on the other hand, provisional device closure was attempted. All patients who underwent transcatheter closure were followed up to 6 months to rule out any complications.ResultsA total of 58 patients (mean age 35.93 ± 10.59 years) were enrolled in the study. Overall, there was significant positive correlation between 2D-TEE and CMR measurements of maximal ASD diameter and rim size (p < 0.001). However, TEE significantly underestimated maximal ASD diameter and posteroinferior rim size in comparison with CMR (p = 0.013 and p = 0.023, respectively). 46 (79.3%) patients were suitable for transcatheter closure on CMR, while 44 (75.9%) were eligible on TEE. Transcatheter closure was attempted in 48 patients based on imaging findings and was successful in 46 (95.8%) patients. Device closure was unsuccessful in 2 patients with defect size < 34 mm on TEE but > 34 mm on CMR. Among 7 patients with deficient posteroinferior rim on TEE, 5 had sufficient rim on CMR and underwent successful transcatheter closure. CMR detected anomalous pulmonary venous drainage in one patient which was missed on TEE, hence excluding the patient from transcatheter closure. Mean device size was 28.3 ± 7.4 mm and correlated more strongly with the defect dimensions on PC-CMR (r = 0.85, p < 0.001) compared to TEE (r = 0.71, p = 0.02).ConclusionsPC-CMR may to be superior to 2D-TEE for the preprocedural planning and feasibility assessment for transcatheter closure in adult patients with ostium secundum ASD.

Percutaneous left atrial appendage occlusion: A South African experience

Background. Atrial fibrillation (AF) is associated with all-cause mortality, heart failure and non-fatal stroke, and thromboprophylaxis is traditionally provided with oral anticoagulants (OACs). Percutaneous left atrial appendage occlusion (LAAO) with a dedicated device is an alternative approach to thromboprophylaxis in patients with AF who are: (i) intolerant to OACs (e.g. life-threatening haemorrhage); (ii) non-adherent to OACs; or (iii) at a high bleeding risk with OACs. Non-inferiority of LAAO compared with OACs was demonstrated in e.g. the WATCHMAN Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation (PROTECT AF) trial. Only very limited data are available on percutaneous LAAO in South Africa (SA), and no local outcome data have been reported. Objectives. To compare the safety and efficacy outcomes of an SA percutaneous LAAO programme with larger international series. Methods. All patients undergoing percutaneous LAAO from 2013 to 2020 at a single centre (SAEndovascular, Kuils River Netcare Hospital, SA) were included from an ongoing registry. Survival analysis was performed with the Kaplan-Meier method. Results. Of 101 LAAO recipients (mean (standard deviation) age 77 (10) years, 64% male) analysed, 90 (90%) had permanent AF, 1 (1%) persistent AF and 9 (9%) paroxysmal AF. The most common indication for LAAO was previous severe bleeding (n=23; 23%). The mean device size was 23 (3) mm and the procedural success rate was 98%. After a median (interquartile range) follow-up of 21 (5 - 41) months, 6 patients (6%) experienced stroke or all-cause mortality. Four patients (4%) had a life-threatening procedural complication (tamponade n=2 (2%) and device embolisation n=2 (2%)). These outcomes are comparable to large international series, e.g. PROTECT AF. Conclusions. The safety and efficacy outcomes of an SA percutaneous LAAO programme were comparable to large international series. A successful percutaneous LAAO programme is feasible in a southern African context

Transcatheter Closure of Residual and Iatrogenic Ventricular Septal Defects: Tertiary Center Experience and Outcome

Abstract Aim This study aimed to review our center experience in transcatheter closure of post-surgical and post-intervention residual and iatrogenic VSDs and to report on their 12-month long-term outcome. Methods All patients who underwent transcatheter closure of residual ventricular septal defects (R-VSDs) and iatrogenic ventricular septal defects (I-VSDs) after either surgical corrections or transcatheter interventions for any congenital heart disease (CHD) between January 2015 and January 2020 were included in the study. Patients' medical records were reviewed and analyzed. Results Twenty-three patients with a mean age of 14.3 ± 8.8 years, a mean weight of 36.2 ± 20.4 Kg, and a mean body surface area of 1.18 ± 0.36 m2 were included. Thirteen (56.5%) patients were males. The VSD was residual in 18 (78.3%) patients and iatrogenic in 5 (21.7%) patients, post-operative in 19 (82.6%) patients and post-transcatheter in 4 (17.4%) patients. The remaining VSD site was peri-membranous in 9 (39.1%) patients, high-muscular in 6 (26.1%) patients, mid-muscular in 4 (17.4%) patients, and Gerbode shunt in 4 (17.4%) patients. The QP/QS ratio was 2.5 ± 0.7, and the VSD diameter was 6.1±2.1 mm with a VSD-aorta rim of 5.4 ± 2.0 mm. Most, 16 (71.43%) patients underwent antegrade device deployment, and 7 (28.57%) patients underwent retrograde transaortic device deployment, with only 3 (13.0%) patients required two devices/patient. Amplatzer™ Muscular VSD devices were used in 16 (69.6%) patients, Amplatzer™ Duct occlude-I devices were used in 4 (17.4%) patients, and Amplatzer™ Duct Occluder-II devices were used in 3 (13.0%) patients with a mean device size of 8.8 ± 2.8 mm. The mean procedural time was 55.1 ± 16.2 minutes, fluoroscopy time was 16.3 ± 4.0 minutes, and the contrast used was 33.8 ± 10.9 ml. Concomitant balloon pulmonary valvuloplasty was done at the same catheterization set in 2 (8.7%) patients. Acute procedural success, satisfactory immediate were achieved in all patients. During follow-up (23.3 ± 15.9 months), no patient required re-intervention or exhibited mortality. Conclusions Transcatheter closure of post-operative, and post-intervention residual and iatrogenic VSDs represents an attractive therapeutic approach. This approach is safe, feasible, effective, and less invasive alternative treatment option for such remaining VSDs.

Transcatheter Closure of Residual and Iatrogenic Ventricular Septal Defects: Tertiary Center Experience and Outcome.

Residual or iatrogenic ventricular septal defects (VSDs) may result in significant hemodynamic effect. This study aimed to review our center experience in transcatheter closure of post-surgical and post-intervention residual and iatrogenic VSDs and to report on their 12-month long-term outcome. All patients who underwent transcatheter closure of residual/iatrogenic VSDs after surgical or transcatheter CHD interventions between January-2015 and January-2020 were included. Patients' medical records were reviewed and analyzed. Twenty-three patients with a mean age of 14.3 ± 8.8years were included. The VSD was residual in 18 (78.3%) patients and iatrogenic in 5 (21.7%) patients, post-operative in 19 (82.6%) patients and post-transcatheter in 4 (17.4%) patients. The VSD site was peri-membranous in 9 (39.1%) patients, high-muscular in 6 (26.1%) patients, mid-muscular in 4 (17.4%) patients, and Gerbode shunt in 4 (17.4%) patients. The QP/QS ratio was 2.5 ± 0.7, and the VSD diameter was 6.1 ± 2.1mm. Most, 16 (71.43%) patients underwent antegrade device deployment, and 7 (28.57%) patients underwent retrograde transaortic device deployment with 3 (13.0%) patients required two devices. Amplatzer™ Muscular VSD devices were used in 16 (69.6%) patients, Amplatzer™ Duct occlude-I devices were used in 4 (17.4%) patients, and Amplatzer™ Duct Occluder-II devices were used in 3 (13.0%) patients with a mean device size of 8.8 ± 2.8mm. Procedural and fluoroscopy times were 55.1 ± 16.2 and 16.3 ± 4.0min respectively. During follow-up (23.3 ± 15.9months), no patient required re-intervention or exhibited mortality. Transcatheter closure of post-operative and post-intervention residual/iatrogenic VSDs represents a safe, feasible, and effective therapeutic approach.

Impact of atrial septal defect device size on biventricular global and regional function: a two-dimensional strain echocardiographic study.

In this study, we assessed the acute changes in biventricular longitudinal strain after atrial septal defect transcatheter closure and its relation to the device size. Hundred atrial septal defect patients and 40 age-matched controls were included. Echocardiography and strain study were performed at baseline and 24 hours and 1 month after the intervention. The study group was divided into two subgroups; group 1: smaller devices were used (mean device size = 1.61 ± 0.05 cm, n = 74) and group 2: larger devices were used (mean device size = 2.95 ± 0.07 cm, n = 26). At baseline, there was a significant difference between the study group and controls as regards right ventricular global longitudinal strain with significant hyperkinetic apex (p = 0.033, p = 0.020, respectively). There was a significant immediate reduction in right ventricular global longitudinal strain (from -24.43 ± 0.49% to -21.62 ± 0.47%, p < 0.001), which showed insignificant improvement after 1-month follow-up. While only left ventricular global longitudinal strain increased after 1 month. Within 24 hours of device closure, all the basal- and mid-lateral segments strains and apical right ventricular strains showed a significant reduction. There was a significant negative correlation between the indexed large device size and an immediate change in the right ventricular global longitudinal strain (r = -0.425, p = 0.034). Significant right ventricular global longitudinal strain reduction starts as early as 24 hours after transcatheter closure, irrespective of the device size used. The rapid impact of closure was mainly on the biventricular basal and lateral segments and right ventricular apical ones, especially with the large sized atrial septal defect.

Transcatheter closure of ventricular septal defect from retrograde transarterial approach: immediate and long-term outcome

Background: Ventricular septal defect (VSD) is a commonly encountered congenital heart defect. The aim of this study was to analyze five years’ experience with patients who had undergone transcatheter closure of VSD using retrograde transarterial approach.Methods: It was a retrospective study conducted from December 2014 to December 2019. Cases planned for VSD closure in retrograde approach were included. A total of 147 cases fulfilled the criteria after left ventricular angiography and procedure was performed without forming arteriovenous loop. Follow up was planned at 1, 3, 6, 12 months and yearly thereafter.Results: The mean age of the patients was 5.94±4.67 years and mean weight was 17.93±8.26 kg. Perimembranous VSD was present in 70.06% cases and the size of the VSD was 5.5±1.8 mm. Amplatzer duct occluder II was the commonest device used (55.24%). Mean device size was 6.2±1.8 (5-8 mm). Complete occlusion was achieved immediately in 94.56% cases, and after one month in 99.36% cases. Four (2.78%) cases were postponed for malpositioning and encroachment of aortic valve. One patient (2.22%) had tiny residual VSD up to 3 years follow up. Bacterial endocarditis was noticed in one patient (0.80%) at one year follow up. No evidence of complete heart block was encountered in follow up period of six to 60 months.Conclusions: This study recommends that retrograde transarterial approach for closure of moderate to small VSD is safe, effective, and minimally invasive, can be performed in short time with less radiation hazard and less trauma to conducting tissues.

Venous flow patterns after percutaneous atrial septal defect closure: Does the mechanical device decrease right atrial compliance?

Systemic venous flow patterns become abnormal and restrictive after surgical closure of ostium secundum atrial septal defect (ASD) but rarely studied after percutaneous device closure. From January 2017 to January 2018, systemic venous Doppler flow patterns were documented prospectively in 50 subjects who underwent percutaneous closure of ASD, prior to, after procedure, and at 6-month follow-up and correlated with defect size and device size. In hepatic veins and superior venacava post device-closure closure, the velocity time integral (VTI) of forward flow in both systole (S) and diastole (D) increased. Overall S was higher than D, and D/S ratio was <1. The D/S ratio increased after device closure significantly reflecting that the improvement in atrial filling increase in diastolic flow more than the increase in systolic flow. Increase in flow velocities was more prominent at 6months with further increase in D/S VTI ratios. When correlated with the defect size, in those with defect size less than 15mm/sq.m (mean device size 13.05±3.21mm), the changes in S- or D-wave, D/S ratio were less prominent and statistically not significant, while in subjects with defect size≥15mm/sq.m (mean device size 23.02 (±4.77mm), these changes were greater and statistical significant. Residual filling defects with restriction of systolic venous flow were observed in subjects after device closure, correlating with larger device sizes, implying the compliance abnormality conferred by them which progresses at 6months. Subjects with persistent abnormalities would need careful follow up for incomplete remodeling and increase in atrial size related arrhythmias.

The efficacy and safety of using amplatzer for transcatheter closure of atrial septal defect in small children with less than 10 kg.

BACKGROUNDAtrial septal defect (ASD) accounts for about 10% of congenital heart diseases (CHDs). Self-closure of these defects in patients with defects less than 8 mm has been reported in several studies. In children, transcatheter closure of the ASD is suggested for asymptomatic patients older than two years and with weight > 15 kg. The purpose of this study was to show that transcatheter closure of ASD in small children with body weight less than 10 kg is an effective and safe method.METHODSBetween July 2016 and September 2018, 35 children with body weight less than 10 kg underwent percutaneous closure of ASD using amplatzer. All patients had minimum defect size of 6 mm, pulmonary blood flow (Qp) to systemic blood flow (Qs) ratio above 1.5, right atrial and ventricular dilation, symptoms of delayed growth, and recurrent respiratory infections in their evaluation and had acceptable rims for intervention. Follow-up evaluations were done 1 day, 1 week, 1 month, 6 months, and yearly after discharge with transthoracic echocardiography (TTE) and electrocardiography (ECG).RESULTSThe mean age of patients at procedure was 12.06 ± 4.47 months (range: 6 to 14 months), mean weight was 8.32 ± 0.72 kg (range: 7.5 to 9.8 kg). The mean defect size was 10.00 ± 2.32 mm (range: 6-13 mm). The mean device size used was 10.57 ± 2.57 mm (range: 7.5 to 15 mm). Mean duration of follow-up was 16.66 ± 6.93 months (range: 1-29 months). Respiratory rate, heart rate, pulmonary stenosis (PS), and Qp to Qs ratio had significant difference before and after procedure during the follow up (P < 0.001).CONCLUSIONTranscatheter closure of ASD with amplatzer in symptomatic small children and infants is a safe and effective treatment associated with excellent success, but long-term follow-up in a large number of patients would be warranted.

Feasibility of percutaneous closure of atrial septal defects in adults under transthoracic echocardiography guidance using the Figulla atrial septal defect occluder device

BackgroundClosure of atrial septal defect (ASD) among adults under transthoracic echocardiography (TTE) guidance using devices other than the Amplatzer Septal Occluder has not been extensively tested. Aim of workAssessment of the safety and efficiency of secundum ASD closure using the Occlutech Figulla ASD Occluder under TTE guidance in adult patients with hemodynamically significant secundum ASD. MethodsTwenty patients (mean age, 32.9±9.7, 75% of them females) were enrolled in the study. All patients underwent TTE and transoesophageal echocardiography (TEE) to assess the characteristics of the ASD prior to percutaneous closure. Procedures were performed using the Figulla Occluder device under both fluoroscopic and TTE guidance. Follow-up clinical and TTE examinations were done at 1, 3, and 6 months following the procedure. ResultsTTE estimated mean ASD size was 21.7±7.3 mm with adequate rims except for the aortic rim (deficient in one third of cases). Mean device size was 28.1±8.6 mm with mean procedure and fluoroscopic times of 46.2±16.4 and 15.7±5.4minutes respectively. ASD was successfully closed in all patients. Two patients showed a small residual shunt immediately after the device placement that disappeared by the end of the 2nd followup TTE examination. Transient complications were detected in 2 patients. All patients were asymptomatic during the follow-up period. ConclusionTranscatheter closure of secundum ASD in adults under TTE guidance using the Occlutech Figulla ASD occluder device is safe and effective when performed in a tertiary center and by expert echocardiographers and interventional cardiologists.

Transcatheter closure of atrial septal defect in children using the Occlutech Figulla occluder device

Background Percutaneous transcatheter closure of atrial septal defect (ASD) among children using devices other than the Amplatzer septal occluder has not been extensively tested. Objectives We evaluated the efficiency and safety of secundum ASD closure using the Occlutech Figulla ASD occluder in children and the efficiency and safety of secundum ASD closure under transthoracic echocardiography (TTE) guidance in children with less than 12 kg body weight. Patients and methods Forty-two patients (19 girls and 23 boys; mean age 4.8±2.0 years) were enrolled in a prospective cohort study. All patients underwent TTE and transesophageal echocardiography (TEE) to assess the characteristics of the ASD before transcatheter closure. Procedures were performed under fluoroscopic and TTE or TEE guidance. Follow-up was done at 1, 3, and 6 months following the procedure by clinical and TTE examination. Results The mean defect size was 14.9±4.2 mm on TTE and 16.1±4.7 mm on TEE. The mean device size was 17.9±4.9 mm (range 10.5–27 mm). The mean procedure time was 59.6±19.5 min. Thirty-one cases were performed under general anesthesia and TEE guidance, whereas the other 11 cases were performed under general anesthesia and TTE guidance. The device was placed successfully in all 42 patients. A small residual flow was seen immediately after device placement in three (7.1%) patients, which disappeared at 6 months. No complications occurred during the procedure. All patients were asymptomatic during the follow-up period. Conclusion Transcatheter closure of secundum ASD is generally safe and efficient in children younger than 12 years old, and ASD closure under TTE guidance in children less than 12 kg body weight is considered safe and efficient when performed in a tertiary center in the presence of an expert echocardiographer and interventional cardiologist.

Changes in Strain Pattern and Exercise Capacity after Transcatheter Closure of Atrial Septal Defects.

Background and ObjectivesAssessment of left ventricle (LV) function by using strain and strain rate is popular in the clinical setting. However, the use of these echocardiographic tools in assessing right ventricle (RV) failure, and the manner in which they both reflect the functional capacity of the patient, remains poorly understood. This study aimed to investigate the change in exercise capacity and strain between before and (1 month) after the transcatheter closure of atrial septal defects (ASDs).Subjects and MethodsThirty patients who underwent transcatheter closure of ASD between May 2014 and June 2015 at the Division of Pediatric Cardiology, Severance Cardiovascular Hospital, were enrolled. We compared and analyzed the results of the following examinations, before and (1 month) after the procedure: echocardiography, cardiopulmonary exercise test (CPET), and N-terminal pro-brain natriuretic peptide level.ResultsThere were no mortalities, and the male-to-female ratio was 1:2. The mean defect size was 22.3±4.9 mm; the mean Qp/Qs ratio, 2.1±0.5; and the mean device size, 22.3±4.9 mm. Changes in global RV longitudinal (GRVL) strain and LV torsion were measured echocardiographically. Exercise capacity improved from 7.7±1.2 to 8.7±1.8 metabolic equivalents (p=0.001). These findings correlated to the change in GRVL strain (p=0.03).ConclusionThe average exercise capacity increased after device closure of ASD. The change in strain was evident on echocardiography, especially for GRVL strain and LV torsion. Further studies comparing CPET and strain in various patients may show increased exercise capacity in patients with improved RV function.

Percutaneous Transcatheter Closure of Ruptured Sinus of Valsalva Aneurysm: Immediate Result and Long-Term Follow-Up.

There is scarcity of data on closure and long-term follow-up of percutaneous treatment of ruptured sinus of Valsalva aneurysm (RSOVA). In this article, we present our experience in percutaneous closure of this defect. Between December 2009 and July 2014, 11 cases of RSOVA were referred to our hospital. Eight of the 11 cases (72.7%) were considered for percutaneous closure. Seven of the eight (87.5%) patients underwent successful percutaneous closure. There were four females and three males in the age group of 16 to 48 years (mean 24.7 ± 6.1 years). Associated defects were bicuspid aortic valve in one patient, mild preexisting aortic regurgitation in two patients, and healed infective endocarditis in one patient. Echocardiography revealed RSOVA from right coronary sinus (RCS) to right atrium (RA) in one patient (14.3%), RCS to right ventricular outflow in three patients (42.8%), and noncoronary sinus ruptured into RA in three patients (42.8%). All patients were symptomatic in New York Heart Association (NYHA) class II to IV. The defect size ranged from 7 to 10 mm (mean 8.4 ± 1.3 mm). The defects were closed from the venous side with device selection 2 to 4 mm higher than the defect size under fluoroscopy and transesophageal echocardiography guidance. Technical success was 87.5%. The mean device size was 12.0 ± 1.6 mm/10.0 ± 1.6 mm. Six out of seven patients (85.7%) had complete disappearance of shunt before discharge. During 1 to 55 months follow-up, all patients were in NYHA class I. There was no residual shunt, progression of AR or new AR, infective endocarditis or device embolization. Percutaneous closure of RSOVA appears to be a safe alternative to surgical therapy, with high technical success and excellent long-term outcome.

Transcatheter closure of perimembranous ventricular septal defect with the Amplatzer® membranous VSD occluder 2: Initial world experience and one‐year follow‐up

To describe the initial world experience and mid-term follow-up of perimembranous ventricular septal defect (pmVSD) closure with a newly designed occluder. Transcatheter closure of pmVSDs has been associated with a substantial risk of complete heart block, prompting many centers to abandon this intervention. A prospective multicenter cohort study was conducted on patients with pmVSD undergoing catheter closure using the Amplatzer(®) Membranous VSD Occluder 2 in the initial 4 pilot centers. Nineteen patients, median age 6 years (range 1.4-62 years), were enrolled and followed for 14 ± 3 months (range 8-20 months). The median weight was 26 kg (range 9.3-96 kg) and the mean Qp/Qs ratio was 1.8 ± 0.7. The defect on left ventricular side measured 9.9 ± 3.5 mm and the orifice on right ventricular side was 8.1 ± 2.8 mm by echocardiography. Mean device size was 9.4 ± 2.4 mm (range 5-14 mm). An eccentric device was employed in 9 patients (47%) and a concentric device in 10 (53%). Overall, 18 patients (95%) had successful device implants. Procedural time was 122 ± 39 min. There were no procedural complications. Mild residual shunting was initially observed in 14 (78%) patients. At last follow-up, mild residual shunting persisted in only 3 (17%) patients. There was no significant increase in aortic or tricuspid regurgitation. No patient had any degree of AV block, although one developed a transient left anterior fascicular block. Holter evaluation, obtained in all patients, was unremarkable in all. This early cohort experience using a novel adapted transcatheter closure device for pmVSD suggests that the procedure is feasible, safe, and effective.

Transcatheter closure of perimembranous ventricular septal defect with a new occluder: one-year follow-up

Purpose: Transcatheter closure of peri-membranous ventricular septal defects (pmVSDs) has been associated with a significant risk of complete heart block, leading most groups to abandon the technique. We describe the initial world experience of pmVSD closure with a newly designed occluder. Methods: Patients with pmVSD underwent catheter closure using the Amplatzer® Membranous VSD Occluder 2 (St. Jude Medical, MN, USA). Results: Nineteen patients from the 4 centers initially involved worldwide were prospectively included and followed for a 12±3 months. Patients ranged in age from 1.4 to 62 years (median 6 years) and in weight from 9.3 to 96 kg (median26 kg). The Qp/Qs ratio was (mean ± SD) 1.9±1.6. The size of the defect on left ventricular side was (mean ± SD) 9.9±3.5 mm (range 4.6 – 16 mm) and the orifice on right ventricularside was 8.1±2.8 mm (range 3.9 – 14 mm) by echocardiography. Mean device size was 9.4±2.4 mm (range 5 – 14 mm). An eccentric device was used in 9 patients (47%) and a concentric device in 10 (53%). A device was successfully implanted in 18 patients (95%). Procedural time was 122±39 min (range 60 – 207 min). There were no significant procedural complications. Mild (0-2 mm) residual shunt was initially observed in 14 patients (78%). At last follow-up, mild residual shunt was still observed in only 3 patients (17%). There was no significant increase of aortic or tricuspid regurgitation, compared to pre-catheterization levels. No patient showed conduction abnormalities on the ECG, and 17 out of 18 had a Holter evaluation, which was normal in all. Conclusions: Transcatheter closure of pmVSD with the Amplatzer pmVSD Occluder 2 is safe and effective. No conduction abnormalities or any other complications were observed on short and one-year follow of this initial human series.

Transcatheter Interatrial Septal Defect Closure in a Large Cohort: Midterm Follow-up Results

We evaluated immediate and midterm results of transcatheter closure of atrial septal defects (ASDs) and patent foramen ovale (PFO) using various closure devices. The study included four hundred fourteen patients (one hundred eighty-two men, two hundred thirty-two women; mean age 39 ± 12.3 years; range 17-67 years) who underwent transcatheter closure of secundum ASD (n = 193) or PFO (n = 221). All the patients were evaluated by transthoracic echocardiography and transesophageal echocardiography before the procedure. Transcatheter closure was performed by using Amplatzer (n = 184), Occlutech Figulla (n = 209), or BioSTAR (n = 21) devices. Closure of ASDs was performed under general anesthesia with transesophageal echocardiography guidance, and closure of PFOs was performed under local anesthesia with transthoracic echocardiography guidance. Follow-up controls were at 1, 6, and 12 months and annually thereafter. The median follow-up periods of ASD and PFO patients were 43 and 30 months. The mean device size was 19.3 ± 6.2 mm for ASD patients and 24.6 ± 2.6 mm for PFO patients. The mean procedural and fluoroscopy times were 22.3 ± 4.7 and 4.1 ± 1.9 minutes for ASD closure and 12.4 ± 3.2 and 3.1 ± 1.2 minutes for PFO closure, respectively. Procedural device embolization occurred in only two patients (0.48%). During follow-up, recurrent embolic events occurred in four patients (1.8%) after PFO closure, and no residual shunts were seen after ASD closure. Device thrombosis developed in two ASD patients during the procedure and in one PFO patient at 12th month of the follow-up (0.72%). Transcatheter closure of PFOs and secundum-type ASDs using the Amplatzer, Occlutech Figulla, and BioSTAR devices is an efficacious and safe therapeutic option.

Perventricular Device Closure of Perimembranous Ventricular Septal Defect in Pediatric Patients: Technical and Morphological Considerations

We report our experience of using perventricular device closure (PVDC) in treating perimembranous ventricular septal defect (pm-VSD) with emphasis on technical and morphological considerations. Thirty-one pediatric patients with pm-VSD who underwent successful PVDC were enrolled in this study. The pm-VSDs were divided into three different types (type I: tunnel shape; type II: with subaortic rim < 2 mm; type III: membranous aneurysm formation). Four closure strategies were utilized, corresponding to the morphology of the pm-VSD. Mean age of the patients was 2.1 years with mean VSD diameter 5.8 mm. Seven patients had type I VSD, nine presented with type II, and 15 had type III. Twenty-two concentric and nine eccentric devices were used with mean device size 7.3 mm. Complete closure was achieved in 97% of cases during follow-up. Procedure-induced tricuspid regurgitation (TR) was noted in nine patients at discharge; four resolved. Multivariable analysis showed that the procedure-induced TR was associated with the device size (odds ratio = 5.059; 95% confidence interval = 1.431-17.880). Different closure strategies allow for PVDC of various types of pm-VSDs in selected pediatric patients.

A new “tool” for transcatheter atrial defect closure: The St. Jude SL2™ sheath

Orienting the left atrial disc of an atrial septal defect (ASD) closure device parallel to the septum is important, particularly in cases of ASD with deficient retroaortic rim. Standard vascular sheaths can make this challenging. We report the use of an electrophysiologic sheath, the SL2™ St. Jude Vascular sheath (St. Jude Medical, St. Paul, MN) for closure of ASD. All patients undergoing ASD closure between July 2010 and February 2011 at The Children's Hospital at Montefiore in which the SL2 sheath was used were reviewed. Nine patients underwent transcatheter ASD or PFO (1/9) closure with the SL2 sheath. Mean age was 22.7 years (range, 3-58); weight was 46.5 kg (range, 14.7-78.6). The Amplatzer ASD Occluder (AGA Medical Corp., Plymouth, MN) was used in all cases. The mean measurement of the ASDs via "stop-flow" technique was 13.3 mm (range, 4-19). The mean device size was 13.9 mm (range, 5-20) or 105% the size of the defect. The retroaortic rim was deficient (<2 mm) in 3 of 9. ASD closure was achieved in 9 of 9. In all, the left atrial disk was brought toward the atrial septum parallel to the atrial septum, and repositioning or recapturing of the device was unnecessary in any case. Mean fluoroscopy time was 9.3 min (range, 2.2-18). No significant complications. The SL2 sheath was useful to position the ASD device parallel to the atrial septum, eliminating the need for redeployment during the procedure. This sheath was useful in those cases of deficient retroaortic rim in this study.

Percutaneous closure of the left atrial appendage: a new option for the prevention of thromboembolic stroke

Percutaneous left atrial appendage (LAA) closure is an important therapeutic option for prevention of thromboembolic stroke in patients with atrial fibrillation (AF), especially when contraindications exist for oral anticoagulation. We aimed to evaluate our short-term results of LAA closure (initial experience) using the WATCHMAN LAA system. Eleven patients (8 men, 3 women; mean age 68.4±7.0 years) with nonvalvular AF, a high risk for cardioembolic stroke (mean CHADS2 score 2.6±1.2, mean CHA2DS2-VASc score 4.0±1.5), and contraindications to oral anticoagulation underwent percutaneous LAA closure using the WATCHMAN LAA system. All the procedures were performed under general anesthesia and fluoroscopy and transesophageal echocardiography (TEE) guidance. The patients were evaluated clinically (at 45 days and 6 months) and by TEE (at 45 days). The LAA was successfully occluded in all the patients (100%). The mean procedural and fluoroscopy times were 58.6±8.1 and 19.1±5.2 minutes, respectively. The mean diameter of the LAA ostium was measured as 20.4±3.8 mm by TEE. The mean device size was 24.6±3.8 mm. The mean hospital stay was 1.7±0.9 days. Follow-up TEE showed closure of all LAA orifices without device-related thrombus formation. Two patients (18.2%) had minimal peri-device leaks (<3 mm). None of the patients experienced major adverse events during a median follow-up of 90 days (interquartile range 60-185 days). Our initial experience suggests that percutaneous LAA closure with the WATCHMAN LAA system is safe and feasible, with favorable short-term clinical outcomes.