Mario Carminati

Early and late complications associated with transcatheter occlusion of secundum atrial septal defect

OBJECTIVES The goal of this study was to report the early and late complications experienced in atrial septal defect (ASD) transcatheter closure. BACKGROUND Atrial septal defect transcatheter occlusion techniques have become an alternative to surgical procedures. A number of different devices are available for transcatheter ASD closure. The type and rate of complications are different for different devices. METHODS Between December 1996 and January 2001, 417 patients (mean age: 26.6 +/- 19 years) underwent transcatheter occlusion of secundum type ASD. Complications were categorized into major and minor. Two different devices were used: the CardioSEAL/STARFlex in 159 patients and the Amplatzer septal occluder in 258 patients. RESULTS Thirty-four patients experienced 36 complications during the hospitalization (8.6%, 95% confidence interval: 6.1% to 11.1%). Ten patients underwent elective surgical repair because of device malposition (three patients) or device embolization (seven patients). Twenty-four patients experienced 25 minor complications: unsatisfactory device position or embolization. Devices were retrieved using a gooseneck snare and/or a basket; 11 patients experienced arrhythmic problems. Other complications were: pericardial effusion, thrombus formation on the left atrial disc, right iliac vein dissection, groin hematoma, hemorrhage in the retropharynx and sizing balloon rupture. Two patients had late complications: peripheral embolization in the left leg one year after implantation of an Amplatzer device and sudden death 1.5 year later. CONCLUSIONS Our series of patients with ASD by transcatheter occlusion shows that the procedure is safe and effective in the vast majority of cases. To further reduce the complications rate, the criteria of device selection according to ASD morphology and some technical tips during implantation are discussed.

Transcatheter closure of perimembranous ventricular septal defects. Early and long-term Results

OBJECTIVES We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmVSD). BACKGROUND Results of pmVSD transcatheter closure have been reported in the literature; however, follow-up data are still limited. METHODS Between January 1999 and June 2006, 104 patients underwent percutaneous closure of a pmVSD at our institution. An Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, Minnesota) was used in all subjects. RESULTS The mean age at closure was 14 years (range 0.6 to 63 years). The attempt to place a device was successful in 100 patients (96.2%). The median device size used was 8 mm (range 4 to 16 mm). No deaths occurred. Total occlusion rate was 47% at completion of the procedure, rising to 84% at discharge and 99% during the follow-up. A total of 13 early complications occurred (11.5%), but in all but 2 subjects (1.9%) these were transient. The median follow-up was 38.5 months. The most significant complication was complete atrioventricular block (cAVB), which required pacemaker implantation in 6 subjects (5.7%; 2 in the early phase and 4 during the follow-up). Cox proportional hazards regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.028; relative risk 0.25). All subjects experiencing this problem were <6 years old. CONCLUSIONS In the current era and in experienced hands, pmVSD closure can be performed safely and successfully. The major concern is the occurrence of cAVB; therefore, very careful monitoring of rhythm is mandatory during follow-up.

Clinical ResearchCongenital Heart DiseaseTranscatheter Closure of Perimembranous Ventricular Septal Defects: Early and Long-Term Results

OBJECTIVES We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of perimembranous ventricular septal defects (pmVSD). BACKGROUND Results of pmVSD transcatheter closure have been reported in the literature; however, follow-up data are still limited. METHODS Between January 1999 and June 2006, 104 patients underwent percutaneous closure of a pmVSD at our institution. An Amplatzer VSD device (muscular or eccentric) (AGA Medical Corp., Golden Valley, Minnesota) was used in all subjects. RESULTS The mean age at closure was 14 years (range 0.6 to 63 years). The attempt to place a device was successful in 100 patients (96.2%). The median device size used was 8 mm (range 4 to 16 mm). No deaths occurred. Total occlusion rate was 47% at completion of the procedure, rising to 84% at discharge and 99% during the follow-up. A total of 13 early complications occurred (11.5%), but in all but 2 subjects (1.9%) these were transient. The median follow-up was 38.5 months. The most significant complication was complete atrioventricular block (cAVB), which required pacemaker implantation in 6 subjects (5.7%; 2 in the early phase and 4 during the follow-up). Cox proportional hazards regression analysis showed that the only variable significantly associated with the occurrence of this complication was age at the time of the procedure (p = 0.028; relative risk 0.25). All subjects experiencing this problem were <6 years old. CONCLUSIONS In the current era and in experienced hands, pmVSD closure can be performed safely and successfully. The major concern is the occurrence of cAVB; therefore, very careful monitoring of rhythm is mandatory during follow-up.

Initial human experience with the Amplatzer perimembranous ventricular septal occluder device

Transcatheter closure of perimembranous ventricular septal defects with coils or devices designed to close other lesions may be complicated by embolization or aortic insufficiency. A new asymmetric Amplatzer perimembranous ventricular septal occluder and delivery system was specifically designed for perimembranous defects. This report describes the first use of this device in 27 patients. Implantation was successful in 25 (93%), with 1 removed for device‐related aortic insufficiency and inability to position the delivery sheath in another. Device orientation was excellent when the device was initially advanced through a standard delivery sheath positioned in the left ventricular apex. Twenty‐three had complete occlusion within 1 week (92%), with a tiny (< 2 mm) residual shunt in the other two. In the 25 subjects with the device left in place, device‐related aortic or tricuspid insufficiency, arrhythmias, and embolization were not observed. These excellent acute results need to be confirmed by long‐term follow‐up. Cathet Cardiovasc Intervent 2003;58:238–245.

Melody transcatheter pulmonary valve implantation. Results from the registry of the Italian society of pediatric cardiology

Percutaneous implantation of pulmonary valve has been recently introduced in the clinical practice. Our aim was to analyze data of patients treated in Italy by using the Melody Medtronic valve.

Transcatheter closure of atrial septal defect in young children: Results and follow-up

OBJECTIVES This study sought to analyze the safety, efficacy, and follow-up results of percutaneous closure of secundum atrial septal defect (ASD) in young children. BACKGROUND Results of ASD transcatheter closure in adults are widely reported but there are no large published series concerning young children. METHODS Between December 1996 and February 2002, 48 of 553 patients percutaneously treated at our institution were children age <or=5 years. Indications for closure were: elective closure in 32 patients; frequent respiratory infections in 8; failure to thrive in 2; liver transplantation in 5; and a fenestrated Fontan in 1. The procedure was carried out under general anesthesia with fluoroscopy and transesophageal control. Two different devices were used: 1) the CardioSEAL/StarFLEX (CS/SF) and 2) the Amplatzer septal occluder (ASO). Basal physical examinations and echocardiograms were performed prior to the procedure and at follow-ups (1, 6, and 12 months, and yearly thereafter). RESULTS The mean age at closure was 3.6 +/- 1.3 years. A CS/SF was used in 10 subjects; an ASO was used in 38 patients. No deaths or immediate major complications occurred. The total occlusion rate was 87% at procedure, rising to 94% at discharge. The mean follow-up was 18 +/- 14 months. No midterm major or minor complications occurred. The occlusion rate rose to 100% at 12 months of follow-up. Symptomatic patients improved significantly. CONCLUSIONS In the current era and in experienced hands, ASD closure can be performed safely and successfully, even in very young children.

Treatment of isolated secundum atrial septal defects: Impact of age and defect morphology in 1,013 consecutive patients

BACKGROUND Percutaneous closure of atrial septal defect (ASD) is a valid alternative to surgical approach. Current device has significantly improved the success rate also in complex cases. The aim of this study is to assess the impact of age, defect size, and morphologic features on successfully percutaneous ASD closure. METHODS Between January 2000 and September 2004, 1,013 consecutive patients underwent closure of an isolated type II ASD at our institution. The following outcomes have been evaluated: (1) role of percutaneous ASD closure as alternative to surgical repair, in current daily practice; (2) impact of age on the selected closure approach; (3) analysis of morphologic variety of ASD and its effect on the closure technique; (4) possible role of specific device selection according to ASD morphology to improve procedural success. RESULTS During the study period, up to 80% of secundum ASDs were suitable for percutaneous closure with the currently available devices. Need for surgical ASD closure was more common in pediatric patients, likely reflecting the more frequent diagnosis of larger and complex defects at a young age. Accurate ADS morphology assessment and appropriate device selection are key elements to obtain procedural success. In particular, among all the ASD characteristics, the rim absence is the main limiting factor to a successful percutaneous ASD closure. A trend of reduction in peri-procedural adverse events was observed during the study period, with complications needing immediate cardiac surgery occurred only in 1% of cases. CONCLUSIONS Percutaneous ASD closure is feasible and associated with low complication rate. A thorough analysis of morphologic aspects is mandatory in order to select the appropriate device and the optimal approach. Surgical closure remains the treatment of choice in selected patients.

A new 2D-based method for myocardial velocity strain and strain rate quantification in a normal adult and paediatric population: assessment of reference values

BackgroundRecent advances in technology have provided the opportunity for off-line analysis of digital video-clips of two-dimensional (2-D) echocardiographic images.Commercially available software that follows the motion of cardiac structures during cardiac cycle computes both regional and global velocity, strain, and strain rate (SR).The present study aims to evaluate the clinical applicability of the software based on the tracking algorithm feature (studied for cardiology purposes) and to derive the reference values for longitudinal and circumferential strain and SR of the left ventricle in a normal population of children and young adults.Methods45 healthy volunteers (30 adults: 19 male, 11 female, mean age 37 ± 6 years; 15 children: 8 male, 7 female, mean age 8 ± 2 years) underwent transthoracic echocardiographic examination; 2D cine-loops recordings of apical 4-four 4-chamber (4C) and 2-chamber (2C) views and short axis views were stored for off-line analysis.Computer analyses were performed using specific software relying on the algorithm of optical flow analysis, specifically designed to track the endocardial border, installed on a Windows™ based computer workstation. Inter and intra-observer variability was assessed.ResultsThe feasibility of measurements obtained with tissue tracking system was higher in apical view (100% for systolic events; 64% for diastolic events) than in short axis view (70% for systolic events; 52% for diastolic events). Longitudinal systolic velocity decreased from base to apex in all subjects (5.22 ± 1.01 vs. 1.20 ± 0.88; p < 0.0001). Longitudinal strain and SR significantly increased from base to apex in all subjects (-12.95 ± 6.79 vs. -14.87 ± 6.78; p = 0.002; -0.72 ± 0.39 vs. -0.94 ± 0.48, p = 0.0001, respectively). Similarly, circumferential strain and SR increased from base to apex (-21.32 ± 5.15 vs. -27.02 ± 5.88, p = 0.002; -1.51 ± 0.37 vs. -1.95 ± 0.57, p = 0.003, respectively).Values of global systolic SR, both longitudinal and circumferential, were significantly higher in children than in adults (-1.3 ± 0.2, vs. -1.11 ± 0.2, p = 0.006; -1.9 ± 0.6 vs. -1.6 ± 0.5, p = 0.0265, respectively). No significant differences in longitudinal and circumferential systolic velocities were identified for any segment when comparing adults with children.ConclusionThis 2D based tissue tracking system used for computation is reliable and applicable in adults and children particularly for systolic events. Measured with this technology, we have established reference values for myocardial velocity, Strain and SR for both young adults and children.

Percutaneous versus surgical closure of secundum atrial septal defects: a systematic review and meta-analysis of currently available clinical evidence

AIMS To summarise data from studies comparing surgical (SC) versus percutaneous closure (PC) of atrial septal defects (ASDs). METHODS AND RESULTS Electronic databases, journals and major international conference proceedings were systematically searched for pertinent clinical studies comparing the two methods of closure (percutaneous and surgical) published up to December 2008, including only those reporting on more than 20 patients. Primary endpoints: occurrence of death and of total and major early complications. Thirteen original studies (3,082 patients) were included. All studies were non-randomised. One death was reported in the surgical group (0.08%; 95% C.I. 0-0.23%). Analysis of postprocedural complications showed a 31% rate (95% CI 21-41%) in SC patients and a 6.6% rate (95% CI 3.9-9.2%) in PC subjects. The adjusted OR for SC vs. PC total complications was 5.4 (95% CI 2.96-9.84; p<0.0001), significantly in favour of PC. The postprocedural major complication rate was 6.8% (95% CI 4-9.5%) in SC patients and 1.9% (95% CI 0.9-2.9%) in PC patients. The adjusted OR for SC vs. PC major complications was 3.81 (95% CI 2.7-5.36; p=0.006), again favouring PC. CONCLUSIONS The largest cohort to date of patients with secundum ASD shows that treatment by a percutaneous approach has a significantly lower rate of either total or major early postprocedural complications compared to surgery.

Transcatheter closure of persistent ductus arteriosus with the Amplatzer duct occluder in very young symptomatic children

Objectives: To analyse safety, efficacy, and follow up results of percutaneous closure of persistent ductus arteriosus (PDA) in very young symptomatic children. Patients and design: Between March 2000 and March 2003, of 197 patients treated at the authors’ institution 18 were symptomatic children aged ⩽ 3 years old. Seven of these children were ⩽ 1 year old. Indications for closure were failure to thrive (12 patients) and frequent respiratory infections (six patients). The procedure was carried out under heavy sedation with fluoroscopic control. The Amplatzer duct occluder device was used. Basal physical examinations and echocardiograms were performed before the procedure and at follow up (three, six, and 12 months and yearly thereafter). Results: Mean (SD) age was 18.3 (10) months and mean (SD) weight at closure was 9.1 (2.2) kg. Neither death nor any major complications occurred. Complications occurred in three patients aged ⩽ 1 year. Two patients had a mild inguinal haematoma. One patient had femoral artery thrombosis that was successfully treated by intravenous urokinase. The mean (SD) follow up was 12.8 (8.5) months. No problems occurred. Patients with recurrent respiratory infections had no significant recurrences and children who had failed to thrive had significantly increased growth. Conclusions: In experienced hands, percutaneous closure of moderate to large PDA in very young symptomatic children is safe, effectively closes the PDA, and solves clinical problems.