Transcatheter closure of perimembranous ventricular septal defects with the Amplatzer asymmetric ventricular septal defect occluder: preliminary experience in children.

OBJECTIVE: To close perimembranous ventricular septal defects (PMVSDs) in children with the new Amplatzer asymmetric ventricular septal defect occluder (AAVSDO). PATIENTS AND DESIGN: 10 children, aged 1.5-12 years, with PMVSDs underwent transcatheter closure with the AAVSDO. The device consists of two low profile disks made of Nitinol wire mesh with a 1.5 mm connecting waist. The left disk is 5 mm towards the apex and only 0.5 mm towards the aortic valve. The right disk is 4 mm larger than the waist. The prosthesis diameter was chosen to be 1-2 mm larger than the largest diameter of the defect (determined by transoesophageal echocardiography and angled angiocardiography). A 7-8 French gauge sheath was used to deliver the AAVSDO. RESULTS: The PMVSD diameter ranged from 2-8 mm. The device diameter ranged from 4-8 mm. After deployment of the prosthesis there was no residual shunt in 9 of 10 patients (90%). In one patient there was a trivial residual shunt that disappeared at the three month follow up. Three patients developed transient complete left bundle branch block. No other complications were observed. CONCLUSIONS: The AAVSDO appears to be a promising device for transcatheter closure of PMVSDs in children. Further studies are required to document its efficacy, safety, and long term results in a larger patient population.

Transcatheter closure of high pulmonary artery pressure persistent ductus arteriosus with the Amplatzer muscular ventricular septal defect occluder.

BACKGROUND: The design of devices currently used for closure of persistent ductus arteriosus (PDA) with high pulmonary artery pressure is not ideal and there is a risk of embolisation into the aorta. OBJECTIVE: To investigate the use of the Amplatzer muscular ventricular septal defect occluder (AMVSDO) for treatment of PDA with high pulmonary artery pressure. PATIENTS AND DESIGN: Seven patients, aged 5-12 years, with large PDAs and systemic or near systemic pulmonary artery pressure underwent attempted transcatheter closure using the AMVSDO. The device consists of two low profile disks made of a nitinol wire mesh with a 7 mm connecting waist. Balloon occlusion of the duct was performed before closure from the venous side, and prosthesis size was chosen according to the measured diameter of the occluding balloon. A 7 French sheath was used to deliver the device. All patients underwent a complete haemodynamic and angiographic study one year after occlusion. RESULTS: The mean (SD) angiographic PDA diameter was 9.8 (1.7) mm (range 7-13 mm) and the mean AMVSDO diameter was 11.4 (1.8) mm (range 9-16 mm). Q(p)/Q(s) ranged from 1.9-2.2 (mean 2.0 (0.1)). Successful device delivery and complete closure occurred in all patients (100% occlusion rate, 95% confidence interval 59.04% to 100.00%). Mean systolic pulmonary artery pressures were as follows: before balloon occlusion, 106 (13) mm Hg; during occlusion, 61 (6) mm Hg; immediately after the procedure, 57 (5) mm Hg; and at the one year follow up catheterisation, 37 (10) mm Hg. Fluoroscopy time was 10.4 (4.3) min (range 7-18 min). No complications occurred. CONCLUSIONS: AMVSDO is an important adjunct for closure of large PDAs associated with high pulmonary artery pressure. Further studies are required to document its efficacy, safety, and long term results in a larger number of patients.

Patent ductus arteriosus equipment and technique. Amplatzer duct occluder: intermediate-term follow-up and technical considerations.

Between May 1997 and June 2000, 69 patients, ages 0.1 to 34 years, underwent attempted anterograde transcatheter closure of a patent ductus arteriosus (PDA) using the Amplatzer Duct Occluder (ADO). The ADO is a cone-shaped, self-centering, and repositionable occluder made of nitinol wire mesh. A 5Fr to 7Fr sheath was used for the delivery of the device. The mean PDA diameter (at the pulmonary end) was 4.6 +/- 1.9 mm (range 1 mm-8.5 mm). Sixty-seven of the 69 patients had successful device placement. The mean ADO smallest diameter was 6.9 +/- 1.8 mm (range 4 mm-12 mm). Complete angiographic closure occurred in 62 (92.5%) of 67 patients (95% confidence interval, 88.22%-98.77%). In five patients, there was a trivial residual shunt immediately after the procedure. At 24 hours, color Doppler flow imaging revealed complete closure in all 67 (100%) patients. The unsuccessful attempts occurred in two patients with a small, 1-mm diameter native PDA and residual PDA after surgical occlusion. Fluoroscopy time was 7.6 +/- 1.8 minutes (4 min-18 min). No complications were observed. At a median follow-up of 1.5 years (range 0.25 to 3.2 years), all patients had complete closure without complications. We conclude that transcatheter closure using the ADO is a highly effective and safe treatment for most patients with PDA.

Liver and brain mucormycosis in a diabetic patient type II successfully treated with liposomial amphotericin B.

A case of liver and brain mucormycosis in a 73-y-old diabetic patient is described. The patient presented with fever and a moderate, tender hepatomegaly and a C/T scan examination of the abdomen and brain showed multiple hepatic and cerebral nodular lesions. The largest of the liver lesions was aspirated and broad hyphae of mucor were demonstrated in the purulent material obtained. The patient was treated successfully (for 40 d) with intravenous liposomal amphotericin B and then with itraconazole for 3 months. To our knowledge, this is the first case of a diabetic patient with both liver and brain mucormycosis who has been treated successfully.

Stent treatment for coarctation of the aorta: intermediate term follow up and technical considerations.

OBJECTIVE: To report the initial and intermediate term results of stent implantation in children with coarctation of the aorta. PATIENTS AND DESIGN: 17 patients with coarctation of the aorta underwent stent implantation (median age 11 years, range 0.4-15 years); six were treated for isolated coarctation, nine for recurrent coarctation (five after surgical repair and four after balloon dilatation), and two for complex long segment coarctation. INTERVENTIONS: The procedure was guided by a second catheter placed transseptally in the left ventricle or the aorta proximal to the coarctation site, for angiographic and haemodynamic monitoring during the procedure. Twenty two stents were implanted in 17 patients. One of the patients with long segment coarctation received four stents and the other three. Palmaz 4014 stents were placed in 11 patients, Palmaz 308 in five, and Palmaz 154 in one. RESULTS: Immediately after stent implantation the peak systolic gradient (mean (SD)) fell from 50.0 (24.5) to 2.1 (2.4) mm Hg (p < 0.05). The diameter of the stenotic lesion increased from 5.1 (1.5) mm to 13.9 (2.4) mm (p < 0.05). There were no deaths or procedure related complications. At a median follow up of 33 months, no cases of recoarctation were identified, either clinically (0/17; 0%, 95% confidence interval (CI) 0% to 19%) or angiographically (0/13; 0%, 95% CI 0% to 25%). CONCLUSIONS: Stent implantation for the treatment of coarctation of the aorta appears to have very low morbidity and mortality, and reasonable intermediate term results. Long term freedom from recoarctation using this method remains to be determined in comparison with simple balloon dilatation.

Further experience with transcatheter closure of the patent ductus arteriosus using the Amplatzer duct occluder.

OBJECTIVE: The aim of this study was to report further experience with transcatheter closure of the patent ductus arteriosus (PDA) using the Amplatzer duct occluder (ADO). BACKGROUND: The design of previously used devices is not ideal for this purpose, and their use has been associated with several drawbacks, especially in large PDAs. METHODS: Forty-three patients, aged 0.3 to 33 years (mean 6.4+/-6.7 years), with a moderate to large, type A to E PDA, underwent attempted transcatheter closure using the ADO. The device is a plug-shaped repositionable occluder made of 0.004-in. nitinol wire mesh. It is delivered through a 5F to 6F long sheath. The mean PDA diameter (at the pulmonary end) was 3.9+/-1.2 mm (range 2.2 to 8 mm). All patients had color flow echocardiographic follow-up (6 to 24 months) at 24 h, 1 and 3 months after closure, and at 6-month intervals thereafter. RESULTS: The mean ADO diameter was 6.1+/-1.4 mm (range 4 to 10 mm). Complete angiographic closure was seen in 40 of 43 patients (93%; 95% confidence interval [CI] 85.4% to 100%). The remaining three patients had a trivial angiographic shunt through the ADO. At 24 h, color flow mapping revealed no shunt in all patients. A 9F long sheath was required for repositioning of a misplaced 8-mm device into the pulmonary artery. The mean fluoroscopy time was 7.9+/-1.6 min (range 4.6 to 12 min). There were no complications. No obstruction of the descending aorta or the pulmonary artery branches was noted on Doppler follow-up studies. Neither thromboembolization nor hemolysis or device failure was encountered. CONCLUSIONS: Transcatheter closure using the ADO is an effective and safe therapy for the majority of patients with patency of the arterial duct. Further studies are required to establish long-term results in a larger patient population.

Transcatheter closure of atrial septal defects in adults with the Amplatzer septal occluder.

OBJECTIVE: To assess the efficacy and complications of device occlusion of atrial septal defects in adults, using the Amplatzer septal occluder (ASO). DESIGN: A prospective interventional study. SETTING: Paediatric cardiology departments in two European teaching hospitals. PATIENTS: The first 20 patients accepted for atrial septal defect device occlusion, on the basis of transoesophageal echocardiography. Sixteen patients had larger defects with right heart dilatation, while the primary indication for closure in four was a history of early paradoxical embolism. INTERVENTIONS: Transcatheter atrial septal defect occlusions performed under transoesophageal echocardiography and fluoroscopic guidance between December 1996 and June 1998. OUTCOME MEASURES: Success of deployment of ASO devices, procedure and fluoroscopic times, complications, and symptoms. RESULTS: The ASO device was successfully implanted in all 20 patients (14 female), median age 44.2 years, with no complications. Of the 16 patients with right heart dilatation, the median Qp:Qs was 2.5:1. Defects measured 11-22 mm (median 18) on transoesophageal echocardiography, with balloon sized diameter (and device size) of 13-28 mm (median 20). For all 20 patients, the procedure time ranged from 38-78 minutes (median 61), and fluoroscopy 8.4-24.7 minutes (median 15.2). There were residual shunts in three patients at the end of the procedure, which were trivial (

Transcatheter closure of muscular ventricular septal defects with the amplatzer ventricular septal defect occluder: initial clinical applications in children.

OBJECTIVES: The aim of this study was to close muscular ventricular septal defects (MVSDs) in children, with a new device, the Amplatzer ventricular septal defect occluder (AVSDO). BACKGROUND: The design of previously used devices for transcatheter closure of MVSDs is not ideal for this purpose and their use has been limited by several drawbacks. METHODS: Six patients, aged 3 to 10 years, with MVSDs underwent transcatheter closure using the AVSDO. The device is a modified self-centering and repositionable Amplatzer device that consists of two low profile disks made of Nitinol wire mesh with a 7-mm connecting waist. The prosthesis size (connecting waist diameter) was chosen according to the measured balloon stretched VSD diameters. A 6-F or 7-F sheath was used for the delivery of the AVSDO. Fluoroscopy and transesophageal echocardiography were utilized for optimal guidance. RESULTS: The location of the defect was midmuscular in five patients and beneath the pulmonary valve in one. The balloon stretched MVSD diameter ranged from 6 to 11 mm. Device placement was successful in all patients, and complete occlusion occurred in all six patients (95% confidence interval 54.06% to 100%). Two patients developed transient complete left bundle branch block. No other complications were observed. CONCLUSIONS: This encouraging initial clinical success indicates that the AVSDO is a promising device for transcatheter closure of MVSDs in children. Further clinical trials and longer follow-up are needed before the widespread use of this technique can be recommended.

Closure of atrial septal defects with the Amplatzer occlusion device: preliminary results.

OBJECTIVES: This study reports our clinical experience with transcatheter closure of secundum atrial septal defects (ASDs) in children, using the Amplatzer, a new occlusion device. BACKGROUND: None of the devices previously used for transcatheter closure of interatrial communications has gained wide acceptance. METHODS: We examined the efficacy and safety of the Amplatzer, a new self-centering septal occluder that consists of two round disks made of Nitinol wire mesh and linked together by a short connecting waist. Sixteen patients with secundum ASD met established two- and three-dimensional echocardiographic and cardiac catheterization criteria for transcatheter closure. The Amplatzer's size was chosen to be equal to or 1 mm less than the stretched diameter. The device was advanced transvenously into a 7F long guiding sheath and deployed under fluoroscopic and ultrasound guidance. Once its position was optimal, it was released. RESULTS: The mean ASD diameter by transesophageal echocardiography was 14.1+/-2.3 mm and was significantly smaller (p < 0.001) than the stretched diameter of the ASD (16.8+/-2.4 mm). The mean device diameter was 16.6+/-2.3 mm. No complications were observed. After deployment of the prosthesis, there was no residual shunt in 13 (81.3%) of 16 patients. In three patients there was trivial residual shunt immediately after the procedure that had disappeared in two of them at the 3-month follow-up. CONCLUSIONS: The Amplatzer is an efficient prosthesis that can be safely applied in children with secundum ASD. However, a study including a large number of patients and a longer follow-up period are required before this technique can be widely used.

Single-stage balloon valvuloplasty for critical pulmonary valve stenosis in the neonate.

Balloon valvuloplasty (BV) in neonates with critical pulmonary valve stenosis (CPVS) is limited by technical considerations, mainly the difficulty of traversing the stenotic valve. To simplify the procedure we used a 4F Cobra Type I catheter to cross the pulmonary valve (PV) without the aid of a guidewire, and performed single-stage BV, using low-profile balloons, in 12 neonates with CPVS. Procedure and total fluoroscopy times were 69 +/- 33 min (42-125 min) and 34 +/- 19 min (20-58 min), respectively. Following BV, right ventricular systolic pressure (RVSP) decreased from 102 +/- 17 mm Hg to 56 +/- 15 mm Hg (p < 0.001); and the ratio of RVSP to aortic systolic pressure decreased from 1.39 +/- 0.22 to 0.73 +/- 0.21 (p < 0.001). No significant complications were observed. BV failed in two patients, who subsequently had surgery. At follow-up (a mean of 19 months), Doppler gradient was 19 +/- 12 mm Hg (0.50 mm Hg). BV was repeated in one patient. We conclude that in neonates with CPVS, the use of the 4F Cobra type I catheter facilitates crossing of the PV and allows performance of BV in a single stage; this enhances safety and time-efficiency, and shortens exposure to radiation.

Percutaneous balloon pericardiotomy for the treatment of large, nonmalignant pericardial effusions in children: immediate and medium-term results.

To evaluate the safety and efficacy of pericardial window creation by percutaneous balloon dilation in children with recurrent, symptomatic, nonmalignant pericardial effusion, 6 boys and 4 girls, age 5-12 yr, underwent the procedure using the subxiphoid approach. The procedure was successful in 9 patients. There was one case with rupture of the balloon and entrapment of its distal part within the pericardium. During follow-up (mean 14.6 mo) there was reaccumulation of fluid only in the patient in whom rupture of the balloon had occurred. No other complications were noted. Thus, percutaneous balloon pericardiotomy appears to be a safe and effective technique for the creation of a pericardial window in children with nonmalignant pericardial effusions, and may be used as an alternative to surgical window creation.

Percutaneous balloon dilatation of the atrial septum: immediate and midterm results.

OBJECTIVES: To assess the effectiveness of atrial septostomy by percutaneous balloon dilatation in patients with congenital heart defects or primary pulmonary hypertension. PATIENTS AND DESIGN: Twenty three patients (15 boys, eight girls; aged 10 days to 10 years; 17 with congenital heart defects and six with primary pulmonary hypertension), all haemodynamically unstable under optimal medical treatment, underwent atrial septostomy by percutaneous balloon dilatation. INTERVENTIONS: The balloon catheter entered the left atrium through a patent foramen ovale (n = 14) or via transseptal puncture in cases with an intact atrial septum (n = 9). The size of the balloons used ranged from 13 to 18 mm. RESULTS: There were no complications. The interatrial communication (mm) increased (P < 0.05) after dilatation and remained unchanged (P = NS) during a 16.6 (13.8) month follow up (2 (1.7) v 8.8 (1.4) v 8.2 (1.1), respectively). Transatrial gradient (mm Hg) fell and arterial oxygenation (%) improved both in patients with transposition (6.3 (0.8) v 0.8 (1) (P = 0.0001) and 40.6 (4.2) v 76.5 (4.8) (P = 0.0001), respectively) and in those with mitral atresia (13.4 (1.9) v 2 (1.4) (P = 0.0001) and 77.1 (3.9) v 81.5 (4.2) (P = 0.008), respectively). There were two failures, one early and one late, both in the group of patients with mitral atresia or stenosis. A decrease in arterial oxygenation (94.8 (1.5) v 83 (2.4), P = 0.004) and an increase in left atrial pressure (6.8 (0.9) v 8.3 (1.2), P = 0.02) and cardiac index (2.3 (0.2) v 3.1 (0.2) l/min/m2, P = 0.002) was observed in patients with primary pulmonary hypertension. CONCLUSIONS: Percutaneous balloon dilatation is an effective and safe procedure for creating an adequate interatrial communication that can be used as an alternative to blade septostomy.