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Background The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study, we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO. Methods The study cohort consisted of 1853 pediatric and 2155 adult patients with secundum ASD treated with the CSO. Patients were enrolled retrospectively from 11 international centers and were followed for a mean period of 43 months (range 12–84 months), postprocedural. Clinical, electrocardiographic, echocardiographic, procedural, and follow-up data were collected from each collaborating hospital. Results The CSO was permanently implanted in 3983 patients (99.4%). Echocardiographic evaluation at one month follow-up revealed complete closure in 99.6% of those patients who had a device implanted. Thrombus formation in one adult patient was the only major device related to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. Conclusions Implantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.

Aims The aim of this study was to assess the international procedural and short-term to midterm experience with the new percutaneous Venus P-valve. Methods and results Retrospective data of patient characteristics, clinical and imaging follow-up of Venus P-valve implantation outside China were collected. Thirty-eight patients underwent attempted Venus P-valve implantation between October 2013 and April 2017. Thirty-seven valves were successfully implanted during 38 procedures. There was one unsuccessful attempt and there were two valve migrations, one of which required surgical repositioning. The mean follow-up was 25 months with no short-term or midterm valve failure or deterioration in performance. Frame fractures occurred in 27% of patients. The cohort demonstrated a statistically significant reduction in pulmonary regurgitation fraction and indexed right ventricular diastolic volumes at six and 12 months. Conclusions Implantation of the Venus P-valve has provided satisfactory short-term to midterm results with high success and low complication rates in an inherently challenging patient substrate.

Background Over the years, numerous options have been proposed for surgical management of ascending aorta and aortic arch pathology in an attempt to minimize postoperative morbidity and probability of death. We present a propensity score-matching analysis of 259 patients from a single unit who were operated on under deep hypothermic arrest with retrograde cerebral perfusion (DHCA/RCP) or moderate hypothermic circulatory arrest with selective antegrade cerebral perfusion (via common carotid artery) (MHCA/ACP). Methods Between 2006 and 2014 a total of 259 consecutive patients underwent ascending aorta and hemiarch correction under HCA. DHCA/RCP and MHCA/ACP were performed on 207 and 52 patients, respectively. Baseline patient characteristics accounted for in the propensity matching were age, sex, acute aortic dissection, emergency operation, re-operation, preoperative hemodynamic instability, preoperative kidney injury, and CA time. After propensity scoring 40 pairs (80 patients) were successfully matched ( p = 0.732). Outcomes were defined as the incidence of postoperative neurologic complications, 30-day mortality, and all-cause midterm mortality. Results Surgical procedure that involved the MHCA/ACP technique was associated with 76.5% decreased risk (risk ratio, 0.235; 95% CI, 0.079 to 0.699) of postoperative neurologic complications ( p = 0.009). In addition to MHCA/ACP in surgical procedure for acute aortic dissection a relevant trend was established for 30-day mortality (risk ratio, 0.333; 95% CI, 0.09 to 1.23). For midterm all-cause mortality, MHCA/ACP modestly decreased the number of deaths ( p = 0.0456) in comparison with the DHCA/RCP technique. Conclusions MHCA/ACP in aortic arch surgical procedure is associated with a decreased risk of all types of neurologic complications and a trend toward decreased 30-day and midterm mortality in comparison with DHCA/RCP.

Despite its simplicity, device closure of atrial septal defects is still associated with rare but potentially lethal complications. In this prospective non-randomized multicenter study we investigated the safety and efficacy of the Cocoon septal occluder (CSO) for closure of atrial septal defects (ASDs) in 92 patients. Median age of the patients was 10.5 years (range 3-61 years) and median weight was 25 kg (range 13-65 kg). The device is an improved new generation double disc design made of Nitinol wire mesh that is coated with platinum using NanoFusion technology. The discs are connected by a waist with diameter ranging from 6mm to 40 mm with 2mm increments. All patients completed a 3-month follow-up. Mean ASD diameter was 21 ± 7 mm (range 10-35 mm), while the mean device diameter was 24 ± 8 mm (range 14-40 mm). The CSO was permanently implanted in all 92 patients. Complete echocardiographic closure of the defect immediately after the procedure or at the one month follow-up, was observed in all 92 patients (100%). No device-related complications were observed during the procedure or at short-term follow-up (range 3-12 months). Our preliminary results indicate that CSO is a promising device for transcatheter closure of ASDs. Further studies are required to document its efficacy, safety and long-term results in a larger patient population.

Numerous technical modifications and various complications of the Senning procedure have been described in the literature. We describe the excellent clinical status and anatomic result of a 33-year-old patient who underwent a modified Senning operation using the left atrial appendage for reconstruction more than 30 years prior to presentation.

During cardiac operations, weaning from cardiopulmonary bypass (CPB) may prove challenging as a result of superimposed acute right ventricular dysfunction in the setting of elevated pulmonary vascular resistance (PVR). The aim of this study was to retrospectively evaluate the effect of inhaled milrinone versus inhaled iloprost in patients with persistent pulmonary hypertension following discontinuation of CPB. Eighteen patients with elevated PVR post-bypass were administered inhaled milrinone at a cumulative dose of 50 μg kg−1. These patients were retrospectively matched with 18 patients who were administered 20 μg of inhaled iloprost. Both drugs were administered through a disposable aerosol-generating jet nebulizer device and inhaled for a 15-min period. Hemodynamic measurements were performed before and after cessation of the inhalation period. Both inhaled milrinone and inhaled iloprost induced significant reductions in mean pulmonary artery pressure and PVR and significant increases in cardiac index in patients with post-CPB pulmonary hypertension. The favorable effect of both agents on the pulmonary vasculature was confirmed by echocardiographic measurements. Both agents were devoid of systemic side effects, since mean arterial pressure and systemic vascular resistance were not affected. A decrease in intrapulmonary shunt by inhalation of both agents was also demonstrated. Pulmonary vasodilatation attributed to iloprost seems to be of greater magnitude and of longer duration as compared to that of inhaled milrinone. Both substances proved to be selective pulmonary vasodilators. The greater magnitude and of longer duration vasodilatation attributed to iloprost may be due to its longer duration of action.

The standard technique of catheter closure of patent ductus arteriosus (PDA) may be associated with arterial complications particularly in small pediatric patients. The aim of this study was to evaluate whether catheter closure of PDA in small children using an exclusive venous approach is a safe and effective alternative to closure with the standard technique. One hundred-twelve patients, aged 2 to 24 months, were randomly assigned in a 1:1 ratio to catheter closure of PDA using the standard technique (group 1) and an exclusive venous approach (group 2), respectively. In group 2, the procedure was guided using hand injections of contrast media through the delivery sheath and 2-dimensional and color Doppler echocardiography. Group 1: the PDA diameter ranged from 2 to 5.5 mm and the device diameter ranged from 4 to 8 mm. The PDA occluders were permanently implanted in all patients. Five losses of the arterial pulses that were restored with intravenous infusion of heparin and recombinant tissue plasminogen activator (rtPA), and 4 groin hematomas were the main complications of the procedure. Group 2: the mean PDA diameter ranged from 2.5 to 6 mm and the device diameter ranged from 3 to 8 mm. The PDA occluders were permanently implanted in all but 2 patients. There were no complications. Complete echocardiographic closure of PDA at 1-month follow-up was observed in all 110 patients. Exclusive transvenous PDA occlusion is an effective and safe technique that prevents the arterial complications of the standard approach in small children.

Pulmonary hypertension and right ventricular (RV) dysfunction may complicate the implantation of a left ventricular assist device (LVAD). We examined whether inhaled vasodilators can sufficiently reduce RV afterload, avoiding the need for temporary RV mechanical support.The study includes 7 patients with RV dysfunction after LVAD insertion. Treatment consisted of inotropes, inhaled nitric oxide (10 ppm), and iloprost (10 μg) in repeated doses. Full hemodynamic profile was obtained before inhalation, during administration of inhaled NO alone (before and after iloprost), as well as after the first two doses of inhaled iloprost. Tricuspid annular velocity was estimated at baseline and before and after adding iloprost.There was a statistically significant reduction in pulmonary vascular resistance (PVR), mean pulmonary artery pressure (MPAP), RV systolic pressure, and pulmonary capillary wedge pressure, and a considerable increase in LVAD flow, LV flow rate index, and tricuspid annular velocity at all points of evaluation versus baseline. By the end of the protocol, MPAP/mean systemic arterial pressure, and PVR/systemic vascular resistance ratios were reduced by 0.17±0.03 (95% confidence interval, 0.10 to 0.25, p=0.001) and 0.12±0.025 (95% confidence interval, 0.06 to 0.18; p=0.003), respectively. The tricuspid annular velocity increased by 2.3±0.18 cm/s (95% confidence interval, 1.83 to 2.73 cm/s; p0.001). Pairwise comparisons before and after iloprost showed an important decrease in PVR (p=0.022), MPAP (p=0.001), pulmonary capillary wedge pressure (p=0.002), and RV systolic pressure (p0.001), and a rise in tricuspid annular velocity (p=0.008).Inhaled vasodilators mainly affected the pulmonary vasculature. Combination treatment with inhaled NO and iloprost sufficiently decreased PVR and MPAP on the basis of an additive effect, improved RV function, and avoided the need for RV assist device.

Background Coarctation of aorta (CoA) patients present cardiovascular complications late after repair the causes of which are not fully understood. Our study investigates the neurohormonal and immune activation and the elastic properties of the aorta and peripheral vessels in adult patients with coarctation of aorta (CoA), late after repair. Methods Nineteen adult patients with repaired CoA and 29 matched healthy controls underwent aortic distensibility, stiffness index, a study of the elastic properties of peripheral vessels proximal to the coarctation site and measurement of plasma cytokine and neurohormone levels. Results Distensibility index was reduced (p=0.02) and stiffness index was increased (p=0.005) in CoA patients compared to control. Augmentation index (p=0.0007) and augmented pressure (p=0.001) were higher in CoA patients and Forearm Blood Flow (FBF) index was reduced (p=0.009). Plasma levels of sICAM-1 (p=0.01), sVCAM-1 (p=0.05), E-selectin (p=0.01), sFas-ligand (p=0.02) and IL-10 (p=0.01) were also elevated in CoA patients vs control. TNF-a, IL-6, Endothelin-1 and NT-pro-BNP levels were not. Conclusions Adults with repaired CoA seem to develop a late inflammatory reaction, which reflects a functional problem in all vessels, regardless of the initial lesion. This may explain the late complications of the disease despite early repair and improved surgical procedures.

The aim of the present study was to report our additional experience with transcatheter closure of the patent ductus arteriosus in 65 consecutive patients using the new Amplatzer duct occluder. The median patient age was 3.6 years (range 0.2to 12), and the median weight was 10.5 kg (range 4 to 38). The device was a modified Amplatzer duct occluder made of fabric-free fine Nitinol wire net in to 2 very low profile disks with an articulated connecting waist. It is delivered through a 4Fr to 5Fr delivery sheath. The device was permanently implanted in 62 of 65 patients. The mean patent ductus arteriosus diameter (at the pulmonary end) was 3.6 +/- 1.3 mm (range 0.5 to 5.5). The mean device diameter (waist diameter) was 4.2 +/- 1.5 mm (range 3 to 6). Complete echocardiographic closure of the PDA at 1 month follow-up was observed in 61 (98%) of 62 patients. Immediately after the procedure, mild left pulmonary stenosis (peak pressure gradient of 8, 10, and 12 mm Hg) in 3 of 63 patients. Device embolization in 1 patient was the main complication of the procedure. No other complications were observed. In conclusion, catheter closure using the Amplatzer duct occluder II is an effective and safe therapy for most patients with patent ductus arteriosus. Additional studies are required to document its efficacy, safety, and long-term results in a larger patient population.

The transcatheter closure of certain types of patent ductus arteriosus (PDA) remains a challenge. The investigators report initial clinical experience with 25 patients who underwent PDA occlusion with the use of a swivel-disk device (SDD) or a plug occluder (PO). The patients were divided into 2 groups: in the SDD group, 12 patients aged 1 to 2 years with type A PDA underwent attempted closure using the SDD, a modified Amplatzer duct occluder with a very low profile retention disk that can adapt itself at different PDA insertion angles. The mean PDA diameter was 4.8 +/- 1.5 mm (range 3.8 to 8). In the PO group, 13 patients aged 0.5 to 3 years with type C, D, or E PDA underwent attempted occlusion with the PO, a tubular occluder made of Nitinol wire mesh. The mean PDA diameter was 4.2 +/- 3.5 mm (range 1.2 to 9). The 2 occluders are filled with Dacron patches. The mean device diameters were 6.5 +/- 1.2 and 6.8 +/- 2.2 mm (range 4 to 11) in the SDD and PO groups, respectively. Complete angiographic closure was seen in 24 of 25 patients. The deployment of 4 5-PDA5 coils abolished a residual shunt associated with hemolysis in a 5-month-old patient with a large type C PDA after the implantation of an 11-mm PO. No other complications were observed. In conclusion, the SDD and the PO are promising additions to the armamentarium for PDA closure.

There are very few published reports of the transcatheter closure of perimembranous ventricular septal defects (PMVSDs) using the Amplatzer PMVSD occluder with encouraging initial results. This report presents initial and 1-year results from 54 patients with PMVSDs who underwent transcatheter closure at 5 different institutions with the Amplatzer PMVSD occluder. Sixty-five patients with PMVSDs were enrolled at 5 European centers. Eleven of the 65 patients did not fulfill the patient selection criteria at the initial echocardiographic evaluation or at cardiac catheterization. As a result, a total of 54 patients underwent attempted transcatheter closure using the Amplatzer PMVSD occluder. The median age of the patients was 5.1+/-3.6 years (range 0.3 to 13), and the median weight 18.5+/-10.3 kg (range 5 to 45). Devices were permanently implanted in 49 of 54 patients. Complete occlusion of the communication at 1-year follow-up was observed in 46 of 49 patients (94%). Main early procedural complications included (1) device embolization (2 patients), (2) severe bradycardia with hemodynamic compromise (2 patients), and (3) Mobitz II (2:1) heart block (1 patient). Late procedural complications included complete heart block (1 patient). No other complications were observed during follow-up. In conclusion, the Amplatzer PMVSD occluder is promising device that can be used for transcatheter closure in selected patients with PMVSDs. Further studies and long-term follow-up are required before this technique enters routine clinical practice.

Objectives: The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS). Background: There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS. Methods: We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up. Results: PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001). Conclusions: PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy. © 2006 Wiley-Liss, Inc.

Objectives: To present further experience and intermediate term outcome in 30 patients with single muscular ventricular septal defects (MVSDs) who underwent transcatheter closure with the Amplatzer ventricular septal defect occluder (AVSDO). Patients and design: Thirty patients, aged 4 months to 16 years, with MVSDs underwent transcatheter closure with the AVSDO. The device consists of two low profile disks made of Nitinol wire mesh with a 7 mm connecting waist. The prosthesis size (waist diameter) was selected to be equal to the balloon “stretched” diameter of the defect. A 7–9 French sheath was used to deliver the AVSDO. Fluoroscopy and transoesophageal echocardiography guided the procedure. Results: The stretched diameter of the defects ranged from 6–14 mm. The communication was completely occluded in 28 of 30 patients (93% closure rate). One patient (a 4 month old infant) with sustained complete left bundle branch block after the procedure went on to develop complete heart block one year later. No other complications were observed during a mean follow up of 2.2 years (range 0.25–4.5 years). Conclusions: The AVSDO is an efficient prosthesis that can be safely used in the majority of patients with a single MVSD. Further studies are required to establish long term results in a larger patient population.

The purpose of this study was to estimate the radiation dose to which children are exposed during cardiac catheterizations for the treatment of ventricular and atrial septal defects. Radiation doses were estimated for 46 children aged 1–18 years. These children were treated for secundum atrial septal defects (ASD group) for perimembranous ventricular septal defects (VSD group) or underwent a routine diagnostic catheterization (diagnostic group). Thermoluminescent dosimeters (TLDs) were attached in locations, representing the lateral entrance dose, the posterior entrance dose, the thyroid dose, and the gonad dose, respectively. A dose area product (DAP) meter was also attached externally on the posterior-anterior (PA) tube to give a direct value in cGy cm2 for each procedure. The patient's entrance dose from the PA field ranged from 1.5 to 185.0 mGy for all patients, while the lateral entrance dose varied from 0.9 to 204 mGy. Radiation exposure to the thyroid and the gonads was found to vary from 0.4 to 8.3 and 0.1 to 2.1 mGy, respectively. The DAP meter recorded DAP values for the posterior tube, between 46 and 3,700 cGy cm2. The mean effective dose was found to be 7.7, 16.2, and 33.3 mSv for the diagnostic, the ASD, and the VSD group, respectively. Very strong correlation was found between the DAP values and the entrance radiation dose measured with TLDs. The mean entrance dose received from therapeutic cardiac catheterizations using the Amplatzer devices was found approximately twice the dose received from a diagnostic one. Even for the most complex procedures, the maximum entrance dose was at least 10 times lower than the threshold, associated with skin erythema. © 2005 Wiley-Liss, Inc.

Perimembranous ventricular septal effects (PMVSDs) are the most common congenital cardiac defects of clinical importance. During the last decade, transcatheter closure of PMVSDs has been attempted using various occluders with variable success. This article reviews the existing literature and our experience with transcatheter closure of PMVSDs with the new Amplatzer occluder device.

We appreciate the interest of Dr Heidrich and his colleagues in our recent report.1 We agree overall with their comments, and we think that, until large retrospective or perspective studies clarify this issue, bicuspid aortic valve as opposed to tricuspid …

We report a case of a 12-month-old-infant with double outlet right ventricle and pulmonary stenosis who presented with signs of superior vena cava syndrome secondary to a dysfunctioning bidirectional Glenn shunt. The patient was successfully treated with transcatheter obstruction of an accessory pulmonary blood flow using 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.

Percutaneous pulmonary valve implantation into dysfunctional right ventricular (RV) to pulmonary artery conduits is being increasingly performed in many European and North American centers with satisfactory results and low-complication rates. We report the first application of this elaborate technique in the native RV outflow tract of a young patient who developed severe supravalvular pulmonary stenosis following an arterial switch operation for transposition of the great arteries. The procedure may be used as an alternative to surgical repair for the treatment of selected patients with supravalvular pulmonary stenosis complicating congenital heart surgery. © 2011 Wiley Periodicals, Inc.

The US Food and Drug Administration has alerted providers and patients that the catheter-delivered Amplatzer atrial septal occluder (AGA Medical, Golden Valley, MN) from St. Jude Medical poses a small risk of potentially life-threatening complications.1 According to the agency, the device can erode the surrounding tissue over time and may cause cardiac tamponade or other complications that require immediate surgery. The agency estimates the risk of such emergencies at 1 to 3 per 1000 implanted patients and notes that >230 000 Amplatzer atrial septal occluder devices have been implanted around the world. The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the …

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, I-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. (J Interven Cardiol 2001;14:247–254)

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 (⩽ 1 mm) as assessed by transoesophageal echocardiography, and persisted for more than six months in only one patient. Follow up ranged from 0.1-1.5 years (median 0.7). There have been no late complications. CONCLUSIONS—The ASO device can be used successfully to close selected oval fossa defects in adults, with minimal procedural morbidity and excellent early results. Keywords: atrial septal defect; interventional cardiac catheterisation; Amplatzer septal occluder

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.

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.

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. Cathet. Cardiovasc. Diagn. 40:322–325, 1997. © 1997 Wiley-Liss, Inc.

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.

Objectives We report a modification ("Greek maneuver") of the standard atrial septal defect (ASD) closure technique using the Amplatzer septal occluder (ASO) to facilitate closure of large ASDs with deficient aortic or posterior rims. Methods 185 patients (median 10.8, range 3 to 52years) with large ASDs (mean diameter 26±7mm, range 20–40mm) with a deficient aortic (134 patients) or posterior (51 patients) rim underwent catheter closure with the ASO using the "Greek maneuver" under transesophageal guidance. The Greek maneuver is applied when protrusion of the aortic edge of the deployed left disk of the device in to the right atrium is detected by echo. To circumvent this left disk is recaptured and the whole delivery system is pushed inward and leftward into the left atrium where the left disk and the 2/3 of right disk are simultaneously released. This maneuver forces the left disk to become parallel to the septum preventing the protrusion of the device into the right atrium. Results The ASO was successfully implanted and was associated with complete closure in 175/185 (95%) of the patients. There were no early or late complications related to the procedure during a follow-up period ranging from 6months to 7years. Conclusions The "Greek maneuver" is a simple quite useful trick that facilitates closure of large ASDs associated with or without deficient aortic or posterior rims.

[Figure][1] [Video 1][2] Selective aortography demonstrating a right aortic-atrial tunnel. A stenotic area with a diameter of 4.9 mm (×1) is also shown. ![Figure][1] [Video 2][3] Fluoroscopic image in the anteroposterior view showing a collapsed ADO II within a delivery sheath

The purpose of this study was to evaluate the hemodynamic effects of inhaled nitric oxide (NO) plus aerosolized iloprost in patients with pulmonary hypertension/right ventricular dysfunction after cardiac surgery.A retrospective study.A single center.Eight consecutive patients with valve disease and postextracorporeal circulation (ECC) pulmonary hypertension/right ventricular dysfunction.The continuous inhalation of nitric oxide (10 ppm) and iloprost, 10 μg, in repeated doses.The hemodynamic profile was obtained before inhalation, during the administration of inhaled NO alone (prior and after iloprost), and after the first 2 doses of iloprost. Tricuspid annular velocity and tricuspid annular plane systolic excursion were estimated at baseline and before and after adding iloprost. At the end of the protocol, there were significant decreases in pulmonary vascular resistance (p0.001), the mean pulmonary arterial pressure (p0.001), and the mean pulmonary artery pressure/mean arterial pressure ratio (p = 0.006). Both tricuspid annular velocity (p0.001) and tricuspid annular plane systolic excursion (p0.001) increased. The cardiac index (p0.001) and venous blood oxygen saturation (p = 0.001) increased throughout the evaluation period. Each iloprost dose was associated with further decreases in pulmonary vascular resistances/pressure. By comparing data at the beginning of inhaled NO with those after the second dose of iloprost, the authors noticed decreases in pulmonary vascular resistances (p = 0.004) and the mean pulmonary artery pressure (p = 0.017) and rises in tricuspid annular velocity (p0.001) and tricuspid annular systolic plane systolic excursion (p0.001).Inhaled NO and iloprost significantly reduced pulmonary hypertension and contributed to the improvement in right ventricular function. Inhaled NO and iloprost have additive effects on pulmonary vasculature.

Although stenting has been used as a treatment option for aortic coarctation (CoA) at increasingly younger ages, limited information is available on the long-term follow-up of stent implantation for CoA in pediatric patients. A total of 74 patients with CoA (mean age 8 ± 3 years) underwent stent implantation; 42 were treated for isolated native CoA and 32 for recurrent CoA. A total of 87 stents were implanted (bare metal stents in 71 patients and covered stents in 3 patients). Redilation of a previously implanted stent was performed in 32 patients. Immediately after stenting, the peak systolic pressure gradient decreased from 68 ± 16 mm Hg to 8 ± 5 mm Hg (p0.05), and the CoA diameter increased from 5 ± 3 mm to 16 ± 3 mm (p0.05). The most important procedural complication was aneurysm formation in 1 patient that was successfully treated with implantation of a covered stent. No early or late deaths occurred and no evidence was found of late aneurysm formation during a follow-up period of 6 years. Late stent fracture was observed in 3 patients. At the end of follow-up, no cases of recoarctation were identified on multislice computed tomography or magnetic resonance imaging, and 67 (85%) of the 74 patients were normotensive, receiving no medications. In conclusion, stent implantation is an effective and safe treatment alternative to conventional surgical management for the treatment of CoA in selected pediatric patients.

A 65-year-old woman with a history of multiple (1 to 2/year since 45 years of age) transient ischemic attacks was referred to our department with the multislice computed tomography (MSCT) diagnosis of pulmonary arteriovenous fistula (PAVF) for catheter closure ([Figure 1A][1]). Two weeks prior to

Ascaris infection, when severe, may manifest with constitutional symptoms. The parasites penetrate the intestinal walls, reach the venules and lymphatics and, through the portal circulation, may affect the heart. To the best of our knowledge, involvement of the pericardium has yet to be reported. We describe here a case of severe pericardial effusion and cardiac tamponade in a child with ascariasis.

To the Editor: There is limited information on the late results of stent implantation (SI) for adult coarctation of the aorta (CoA) ([1–3][1]). This study reports the initial and 5-year results in 46 patients who underwent SI for adult CoA. Between April 1999 and November 2002, a total of 46

Background & Aim. Right ventricular failure (RVF) secondary to pulmonary regurgitation (PR) impairs right ventricular (RV) function and interrupts the interventricular relationship. There are few recommendations for the medical management of severe RVF after prolonged PR. Methods. PR was induced in 16 Danish landrace pigs by plication of the pulmonary valve leaflets. Twenty-three pigs served as controls. At re-examination the effect of milrinone, epinephrine and dopamine was evaluated using biventricular conductance and pulmonary catheters. Results. Eighty-one days after PR was induced, RV enddiastolic volume index (EDVI) had increased by 33% (p1⁄40.006) and a severe decrease in the load-independent measurement of contractility (PRSW) (-58%; p1⁄40.003). Lower cardiac index (CI) (-28%; po0.0001), mean arterial pressure (-15%; p1⁄40.01) and mixed venous oxygen saturation (SvO2) (36%; po0.0001) were observed compared to the control group. The interventricular septum deviated towards the left ventricle (LV). Milrinone improved RV-PRSW and CI and maintained systemic pressure while reducing CVP. Epinephrine and dopamine further improved biventricular PRSW and CI equally in a dose-dependent manner. Systemic and pulmonary pressures were higher in the dopamine-treated animals compared to epinephrine-treated animals. None of the treatments improved stroke volume index (SVI) despite increases in contractility. Strong correlation was detected between SVI and LV-EDVI, but not SVI and biventricular contractility. Conclusion. In RVF due to PR, milrinone significantly improved CI, SvO2 and CVP and increased contractility in the RV. Epinephrine and dopamine had equal inotropic, but a greater vasopressor effect was observed for dopamine. SV was unchanged due to inability of both treatments to increase LVEDVI.

From April 1995 until July 2004 in our department we treated 26 patients with 15 days post.-Op. acute mediastinitis after midline sternotomy for cardiac operation. We present our technique and our results in this serious complications after cardiac operation. Resternotomy, full thick debritement of necrotic tissues (skin-subcutaneous-sternum and mediastinum), continuous ½ washing+ with antibiotic solution and long-term drainage of mediastinum, with i.v. antibiotics is our preferable technique (Mean follow-up. 5.8 y), simplicity, non-flaps technique for closure and no-recurrence of the infection is the advantage of our technique.

The aim of this paper is to present the experience and the results of our department in the field of L.V. aneurysm operations. From Febr. 1994 until Dec. 2004 we operated on 57 patients with L.V. aneurysm. The preoperative E.F. was from 15% to 40% and the post.-op. E.F. from 25% to 50%. (Mean follow-up was 4.8 y). The intraoperative mortality was 0%. The 30 days mortality (2/57) 3.5%. Mean age of the patients was 60.5 years. The preoperative NYHA status was III – IV and after the operation I – III with 1y survival rate 96.5% (55/57).

Over the past 10 years a variety of occluding devices has been used for transcatheter closure of ventricular septal defects (VSDs), but none has gained wide acceptance. This article presents the experience of transcatheter closure of muscular and perimembranous VSDs in 22 and 13 patients, respectively, with the new Amplatzer VSD occluders. Overall total occlusion was achieved in 95% and 92.3% of patients with muscular and perimembranous VSDs, respectively. The main complication was embolization of the device in 1/13 (7.6%) patients with perimembranous VSDs. Transcatheter closure of VSDs using the Amplatzer VSD occluders appears to be a safe and effective alternative to the standard surgical treatment.

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 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.

Objective: The standard procedure in percutaneous closure of patent ductus arteriosus (PDA) with Amplatzer duct occluder-I (ADO-I) is transvenous closure guided by aortic access through femoral artery. The current study aims to compare the procedures for PDA closure with ADO-I: only transvenous access with the standard procedure. Methods: This study was designed retrospectively and 101 pediatric patients were included. PDA closure was done by only femoral venous access in 19 of them (group 1), arterial and venous access used in 92 patients (group 2) between 2004 to 2012 years. The position of the device and residual shunt in group1 was evaluated by the guidance of the aortogram obtained during the return phase of the pulmonary artery injection and guidance of transthoracic echocardiography. Shapiro-Wilk’s test, Mann-Whitney U, chi-squared tests were used for statistical comparison. Results: The procedure was successful in 18 (95%) patients in group 1 and 90 (98%) patients in group 2. Complications including the pulmonary artery embolization (n=1), protrusion to pulmonary artery (n=1), inguinal hematoma (n=3), bleeding (n=2) were only detected in group 2. In other words, while complications were observed in 7 (7.2%) patients in group 2, no minor/major complication was observed in group 1. Complete closure in group 1 was: in catheterization room 14 (77.8%), at 24th hour in 2 (11.1%), at first month in 2 (11.1%). Complete closure in group 2 was: 66 (73.4%) patients in the catheterization room, 21 (23.3%) at 24th hour, 3 (3.3%) at first month, complete closure occurred at the end of first month. Conclusion: In percutaneouse PDA closure via ADO-I, this technique can be a choice for patients whose femoral artery could not be accessed, or access is impossible/contraindicated. But for the reliability and validity of this method, randomized multicenter clinical studies are necessary.

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