Search

SCARB1 belongs to class B of Scavenger receptors (SRs) that are known to be involved in binding and endocytosis of various pathogens. SRs have emerging role in regulating innate immunity and host-pathogen interactions by acting in co-ordination with Toll-like receptors. Little is known about the function of SCARB1 in milk-derived mammary epithelial cells (MECs). This study reports the role of SCARB1 in infection and its potential association in TLR4 signaling on bacterial challenge in Goat mammary epithelial cells (GMECs). The novelty in the establishment of MEC culture lies in the method that aims to enhance the viability of the cells with intact characteristics upto a higher passage number. We represent MEC culture to be used as a potential infection model for deeper understanding of animal physiology especially around the mammary gland. On E.coli challenge the expression of SCARB1 was significant in induced GMECs at 6 h. Endoribonuclease-esiRNA based silencing of SCARB1 affects the expression of TLR4 and its pathways i.e. MyD88 and TRIF pathways on infection. Knockdown also affected the endocytosis of E.coli in GMECs demonstrating that E.coli uses SCARB1 function to gain entry in cells. Furthermore, we predict 3 unique protein structures of uncharacterized SCARB1 (Capra hircus) protein. Overall, we highlight SCARB1 as a main participant in host defence and its function in antibacterial advances to check mammary gland infections.

The role of preoperative locoregional therapy (LRT) for hepatocellular carcinoma (HCC) before liver transplantation (LT) remains unclear. Moreover, LRT in the setting of living donor liver transplantation (LDLT) merits further exploration. The objective of the current study was to determine risk factors for poor outcomes after LDLT in patients who received locoregional therapy (LRT). We reviewed patients (n = 46) who underwent LDLT after LRT. Multivariate analysis was performed to determine independent predictors of recurrence-free survival (RFS). Risk scores were developed to define prognostic groups. Median tumor size was 3.7 (1.2–12) cm and tumor number was 1 (1–6). Macrovascular invasion was seen in 10/46 (21.7%) patients. There was a significant difference in 5-year RFS with > 3 tumor nodules (P = 0.005), tumors outside University of California San Francisco criteria (P = 0.03), bilobar disease (P = 0.002), AFP > 600 ng/ml (P = 0.006), and poor response to LRT (P = 0.007). On multivariate analysis, bilobar disease (HR = 2.9, P = 0.01), AFP > 600 ng/ml (HR = 2.3 P = 0.008), and poor response to LRT (HR = 2, P = 0.02) were predictors of 5-year RFS. The 5-year RFS in low risk (score = 0), intermediate risk (score = 1–3), and high risk (score = 4–7) groups was 86%, 76%, and 9% (P

Background The indications for liver transplantation (LT) in patients with hepatocellular carcinoma (HCC) continue to evolve. The aim of this study was to report outcomes in patients who underwent living donor liver transplantation (LDLT) for HCC outside traditional criteria including macrovascular invasion (MVI). Methods We reviewed outcomes in patients who met the University of California San Francisco (UCSF) criteria (n = 159) and our center-specific criteria (UCSF+) (largest tumor diameter ≤ 10 cm, any tumor number, AFP ≤ 1000 ng/ml) (n = 58). We also assessed outcomes in patients with MVI (n = 27). Results The median follow was 28 (10.6–42.7) months. The 5 year overall survival and risk of recurrence (RR) in the UCSF and UCSF + group was 71% vs 69% (P = 0.7) and 13% vs 36% (P = 0.1) respectively. When patients with AFP > 600 ng/ml were excluded from the UCSF + group, RR was 27% (P = 0.3). Among patients with MVI who had downstaging (DS), 4/5(80%) in low-risk group (good response and AFP ≤ 100 ng/ml) and 2/10 (20%) in the high-risk group (poor response or AFP > 100 ng/ml) were alive at the last follow-up. When DS was not feasible, 3/3 (100%) in the low-risk group (AFP ≤ 100 ng/ml + Vp1-2 MVI) and 1/9 (9.1%) in the high-risk group (AFP > 100 or Vp3 MVI) were alive. The 5 year OS in the low-risk MVI group was 85% (P = 0.003). Conclusion With inclusion of AFP, response to downstaging and degree of MVI, acceptable survival can be achieved with LDLT for HCC outside traditional criteria.

Extracorporeal membrane oxygenation complications involving vascular injury or intracardiac thrombosis in neonates are rare. We present a series of unique complications and describe their variable treatments.

Objectives To assess disease-related knowledge of rheumatoid arthritis (RA) patients Patients and methods Consecutive RA patients were invited from the rheumatology departments of BSMM University, Dhaka, Bangladesh. The Bangla version of the Patient Knowledge Questionnaire (B-PKQ) was used. Correlations between the B-PKQ scores and clinical-demographic data were measured using Pearson’s correlation coefficient. Impact of independent variables on the level of knowledge about RA was analyzed through multiple regression analysis. Possible explanatory variables included the following: age, disease duration, formal education level, and Bangla Health Assessment Questionnaire (B-HAQ) score. Analysis of variance (ANOVA) was used to test the difference between demographical, clinical, and socioeconomic variables. For statistical analysis, SPSS statistics version 20 was used. Results A total of 168 RA patients could be included. The mean B-PKQ score was 9.84 (range 1–20) from a possible maximum of 30. The mean time for answering the questionnaire was 24.3 min (range 15–34). Low scores were observed in all domains but the lowest were in medications and joint protection/energy conservation. Knowledge level was higher (15.5) in 6 patients who had RA education before enrollment. B-PKQ showed positive correlation with education level (r = 0.338) and negative correlation with HAQ (r = −0.169). The B-PKQ showed no correlation with age, disease duration, having first degree family member with RA, education from other sources (neighbor, RA patient, nurses), or information from mass media. Conclusions Disease-related knowledge of Bangladeshi RA patients was poor in all domains. Using these findings, improved education and knowledge will result in better disease control.Key Points• Little is known about the knowledge of RA patients regarding their disease and its treatment in Bangladesh and in developing countries in general.• We found that the knowledge of Bangladeshi RA patients regarding their disease was poor in all domains; it correlated positive with education level and negative with function (HAQ), but showed no correlation with age or disease duration.• The findings of this study can be used for improving current patient education programs by health professionals and through mass media.• Better disease control of RA may be achieved by improving patient knowledge in a developing country like Bangladesh, but also in other parts of the world.

Background Variable patent ductus arteriosus (PDA) morphology and the need to close PDAs in small size patients has led physicians to use Amplatzer Vascular Plugs (AVP) and recently available Amplatzer Duct Occluder II - Additional Sizes (ADO II AS). The purpose of this study was to analyze the safety, efficacy, and complication rates of the ADO II AS and AVPs, specifically AVP II. Methods All patients undergoing PDA closure with an AVP or ADO II AS from 2011 to 2016 were included. Clinical, echocardiographic, and angiographic data were collected and reviewed. Results Four hundred and sixty-nine patients were included. Median age was 27 months (0.75-852) and the median weight was 11.4 kg (1-92). There were 51 patients ≤5 kg. Type A PDA was most common in 48% (n = 225), followed by type E (27.5%, n = 129), type D (13%, n = 61), type C (10.2%, n = 48), and type B (1.3%, n = 6). Devices included AVP II (n = 421), ADO II AS (n = 30), and AVP IV (n = 18), left pulmonary artery stenosis occurred in 4.3% (n = 20). One patient required surgery for severe stenosis; the remaining cases were mild and required no intervention. Device embolization occurred in 3 patients (10%) with the ADO II AS. Successful device closure was achieved in 98.9% of cases. Conclusions The AVP II was highly effective for closing PDAs in smaller babies with varying morphologies and is safe when used in small sized patients with relatively low risk of complications. More studies are warranted to clarify the risks of ADO II AS.

Purpose: High-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is used to treat patients with relapsed Hodgkin’s lymphoma. In this retrospective study we report our experience with patients who underwent HDCT and ASCT. Methods: All patients ≥15 years old with relapsed/refractory Hodgkin’s lymphoma who underwent HDCT and ASCT between June 2001 and December 2013 were included. Results: Fifty-four patients were identified. Median age at transplant was 22 years (range 15-49 years); 26 were men and 28 were women. Forty-eight patients (89%) underwent HDCT and ASCT after achieving a radiological response to salvage chemotherapy. The rate of radiological complete response to salvage chemotherapy was 13% and reached 50% within 3 months of ASCT in assessable patients. After a median follow-up of 25 months, 31 patients (57%) were still alive with no evidence of relapse or progression. Median event-free survival (EFS) was 24 months (95% CI 8.7-39.3) and 3-year EFS was 56%. Median overall survival (OS) was not reached and 3-year OS was 82.5%. Bulky mediastinal disease at relapse, hemoglobin level, and number of salvage regimens did not significantly impact EFS in univariate and multivariate analyses. After transplantation there was a trend towards longer EFS (30 vs. 24 months; p = 0.36) in patients with a longer time from the end of first-line treatment until relapse (≥12 vs. Conclusions: HDCT and ASCT for relapsed/refractory Hodgkin’s lymphoma is safe. Our findings are consistent with published phase III results. Longer follow-up is warranted.

We report a case of Figulla-II Occlutech septal occluder malposition with residual shunt at posteriosuperior margin of an atrial septal defect. Improvising its bioptome type delivery cable, same system was used to recapture the device and redeploy it successfully. This report highlights a potential malfunction of Figulla-II Occlutech disc and the advantage of its delivery system for retrieval of the device.

Importance Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Observations Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents. Conclusions and Relevance These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

Traumatic aortic injury (TAI) or aortic transection is the second most common cause of death after blunt trauma. The conventional management approach towards a thoracic aortic injury is open thoracotomy and surgical repair; however, there is a recent increase in the trend towards the use of endovascular approach in this regard, particularly in the developed countries. We here report the cases of two young healthy male patients presenting in emergency department with thoracic aortic injury, following a road traffic accident (RTA). Thoracic endovascular aortic repair (TEVAR) was planned for both patients, as open repair was risky owing to other systemic injuries. Aortic stent graft was deployed just below the origin of the left subclavian artery in one patient, while it partially covered the left subclavian in the other. End runs showed good position of the graft with perfusion of aortic branches and exclusion of flow to the transection. Both patients had an uneventful recovery with no episodes of cerebrovascular accident (CVA) or paraplegia. Our study gives an insight into the recent trends of endovascular aortic repair (EVAR) becoming the mainstay treatment for TAIs. As far as we know this is the first reported successful case series of thoracic endovascular stent graft deployment for blunt thoracic aortic trauma in Pakistan. We recommend education and further teaching of surgeons to acquire expertise in this novel approach.

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high-quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi-disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient-centered care.

This document is 1 of 2 companion appropriate use criteria (AUC) documents developed by the American College of Cardiology, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. This document addresses the evaluation and use of multimodality imaging in the diagnosis and management of valvular heart disease, whereas the second, companion document addresses this topic with regard to structural heart disease. Although there is clinical overlap, the documents addressing valvular and structural heart disease are published separately, albeit with a common structure. The goal of the companion AUC documents is to provide a comprehensive resource for multimodality imaging in the context of valvular and structural heart disease, encompassing multiple imaging modalities. Using standardized methodology, the clinical scenarios (indications) were developed by a diverse writing group to represent patient presentations encountered in everyday practice and included common applications and anticipated uses. Where appropriate, the scenarios were developed on the basis of the most current American College of Cardiology/American Heart Association guidelines. A separate, independent rating panel scored the 92 clinical scenarios in this document on a scale of 1 to 9. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented. Midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is considered rarely appropriate for the clinical scenario. The primary objective of the AUC is to provide a framework for the assessment of these scenarios by practices that will improve and standardize physician decision making. AUC publications reflect an ongoing effort by the American College of Cardiology to critically and systematically create, review, and categorize clinical situations where diagnostic tests and procedures are utilized by physicians caring for patients with cardiovascular diseases. The process is based on the current understanding of the technical capabilities of the imaging modalities examined.

The aim of the study was to evaluate the safety, feasibility, and economic benefit of a high-volume operator performing common interventional procedures in a rural region of the United States (U.S.). Rural areas of the U.S., even with well-equipped cardiac catheterization laboratories, may not have a full-time pediatric interventional cardiologist (PIC); this requires patients to travel out of state even for simple interventions. Since 2005, we have adopted a policy of performing cardiac catheterizations and common interventional procedures with a visiting PIC. We reviewed data of all patients who underwent cardiac catheterizations from May 2005 through March 2015 at our center. Variables analyzed were type of procedure, results, and follow-up six months after procedure. 197 catheterizations were performed, of which 80 were for single atrial septal defect (ASD), 29 for fenestrated ASD, 49 for patent ductus arteriosus (PDA), and 39 for other procedures. Device closure of single ASD was successful in 75 of 79 attempts and in 27 of 28 attempts for fenestrated ASD. PDA closure was successful in 45 of 46 attempts. Follow-up data of 6 months or more were available for 127 patients. All but two patients had no cardiovascular symptoms at 6 months. There were four minor complications and no major complications. With a technical success rate of 94.9% for single ASD closure, 97.8% for PDA closure, and results comparable to those of multi-institutional registries, cardiac catheterization and interventions can be performed safely with excellent results. Performing procedures in such an arrangement is safe, feasible, and economically beneficial.

Percutaneous pulmonary valve placement in patients with an anomalous coronary artery is rare and can be complicated by coronary artery compression. We report successful implantation of a percutaneous pulmonary valve in a patient with an anomalous left anterior descending artery.

Although catheter-based intervention is generally accepted as the treatment of choice for branch pulmonary artery (PA) stenosis, there are no data directly comparing both the need for reintervention and time to reintervention in patients undergoing transcatheter stenting versus surgical arterioplasty. We compared children who underwent surgical branch pulmonary arterioplasty and branch PA stent placement between January 2008 and May 2012 at a single tertiary center. Need for reintervention and mean time to reintervention were assessed using chi-square and independent sample Student t test. Thirty-seven patients were included (surgery n = 18, stent n = 19). Mean weight at initial intervention was 11.3 ± 8.8 kg for surgical and 20.1 ± 15.5 kg for stent (p = 0.041). Intervention was performed on the left PA in 17 patients, the right PA in 12 patients, and both PAs in 8 patients. Five patients had undergone previous intervention. On mean follow-up of 807 ± 415 days, 50 % (9 of 18) of the surgery cohort and 5.3 % (1 of 19) of the stent cohort required reintervention (p = 0.002). In all but one case reintervention was catheter-based. Mean time to reintervention for the surgery cohort was 272 ± 162 days and for the single stent cohort it was 150 days. When comparable age and weight groups were analyzed, reintervention was still more common in the surgery cohort (p = 0.007). Children undergoing surgical branch pulmonary arterioplasty are more likely to require reintervention than those undergoing stent placement.

Perventricular Melody valve placement has been described as a bailout approach or alternative RVOT approach in patients >30 kg. We present three patients

The Amplatzer septal occluder is commonly used to close secundum atrial septal defects (ASDs). Recently, the manufacturer's recommendations have been modified with regard to contraindications for its use. These changes primarily focus on evaluation of the aortic rim (anterio-superior rim) with transesophageal echocardiography (TEE) and intracardiac echocardiography (ICE). In this editorial, we will review systematically all of the sequential views in TEE and ICE that are required for thorough assessment of the aortic rim and provide explanation of what constitutes deficiency of the aortic rim as seen on ICE.

Multiple congenital cardiac defects are usually addressed by cardiac surgery. We present our experience with simultaneous transcatheter treatment of multiple defects in children. Ten children, six females and four males, with multiple defects underwent treatment with interventional technique. The mean age was 4.4 +/- 2.6 years (range, 7 months to 8 years). The cardiac diagnosis was patent ductus arteriosus (PDA) and valvular pulmonary stenosis (PS) in two, atrial septal defect (ASD) and PDA in two, ASD and PS in two, PDA and aortic stenosis (AS) in three (severe left ventricular dysfunction in two), and perimembranous ventricular septal defect (VSD) and valvular PS in one. The ASDs were closed with an Amplatzer septal occluder (mean size, 16 +/- 4 mm), four PDAs were closed with an Amplatzer duct occluder, and three with a Cook's detectable coil. Mean balloon size used to dilate the pulmonary valve was 18 +/- 4 mm, and for the aortic valve this was 12 +/- 2 mm. There was a 70% (+/-15%) postprocedure reduction of gradients across the stenotic valves. The closure rate was 75% for PDAs in the catheterization laboratory, 80% for ASDs, and there was a mild residual intradevice leak in the VSD. In conclusion, interventional technology addressing multiple congenital cardiac defects as a combined procedure in the catheterization laboratory is safe and effective.

Background: We report a multiinstitutional study on intermediate-term outcome of intravascular stenting for treatment of coarctation of the aorta using integrated arch imaging (IAI) techniques. Methods and Results: Medical records of 578 patients from 17 institutions were reviewed. A total of 588 procedures were performed between May 1989 and Aug 2005. About 27% (160/588) procedures were followed up by further IAI of their aorta (MRI/CT/repeat cardiac catheterization) after initial stent procedures. Abnormal imaging studies included: the presence of dissection or aneurysm formation, stent fracture, or the presence of reobstruction within the stent (instent restenosis or significant intimal build-up within the stent). Forty-one abnormal imaging studies were reported in the intermediate follow-up at median 12 months (0.5–92 months). Smaller postintervention of the aorta (CoA) diameter and an increased persistent systolic pressure gradient were associated with encountering abnormal follow-up imaging studies. Aortic wall abnormalities included dissections (n = 5) and aneurysm (n = 13). The risk of encountering aortic wall abnormalities increased with larger percent increase in CoA diameter poststent implant, increasing balloon/coarc ratio, and performing prestent angioplasty. Stent restenosis was observed in 5/6 parts encountering stent fracture and neointimal buildup (n = 16). Small CoA diameter poststent implant and increased poststent residual pressure gradient increased the likelihood of encountering instent restenosis at intermediate follow-up. Conclusions: Abnormalities were observed at intermediate follow-up following IS placement for treatment of native and recurrent coarctation of the aorta. Not exceeding a balloon:coarctation ratio of 3.5 and avoidance of prestent angioplasty decreased the likelihood of encountering an abnormal follow-up imaging study in patients undergoing intravascular stent placement for the treatment of coarctation of the aorta. We recommend IAI for all patients undergoing IS placement for treatment of CoA. © 2007 Wiley-Liss, Inc.

Background: We report a multi-institutional experience with intravascular stenting (IS) for treatment of coarctation of the aorta. Methods and Results: Data was collected retrospectively by review of medical records from 17 institutions. The data was broken down to prior to 2002 and after 2002 for further analysis. A total of 565 procedures were performed with a median age of 15 years (mean = 18.1 years). Successful reduction in the post stent gradient ( 0.8 was achieved in 97.9% of procedures. There was significant improvement (P < 0.01) in pre versus post stent coarctation dimensions (7.4 mm ± 3.0 mm vs. 14.3 ± 3.2mm), systolic gradient (31.6 mm Hg ± 16.0 mm Hg vs. 2.7 mm Hg ± 4.2 mm Hg) and ratio of the coarctation segment to the DAo (0.43 ± 0.17 vs. 0.85 ± 0.15). Acute complications were encountered in 81/565 (14.3%) procedures. There were two procedure related deaths. Aortic wall complications included: aneurysm formation (n = 6), intimal tears (n = 8), and dissections (n = 9). The risk of aortic dissection increased significantly in patients over the age of 40 years. Technical complications included stent migration (n = 28), and balloon rupture (n = 13). Peripheral vascular complications included cerebral vascular accidents (CVA) (n = 4), peripheral emboli (n = 1), and significant access arterial injury (n = 13). Older age was significantly associated with occurrence of CVAs. A significant decrease in the technical complication rate from 16.3% to 6.1% (P < 0.001) was observed in procedures performed after January 2002. Conclusions: Stent placement for coarctation of aorta is an effective treatment option, though it remains a technically challenging procedure. Technical and aortic complications have decreased over the past 3 years due to, in part, improvement in balloon and stent design. Improvement in our ability to assess aortic wall compliance is essential prior to placement of ISs in older patients with coarctation of the aorta. © 2007 Wiley-Liss, Inc.

Background— Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder is generally safe and effective, but erosion into the pericardial space or aorta has been described. Although the absolute risk of this complication is low, there has been no assessment of relative risk factors. Methods and Results— All erosions reported to St. Jude Medical after ASD closure with an Amplatzer septal occluder (cases) were compared with controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002 and 2014, including 95 with an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, Amplatzer septal occluder device size, and device size–ASD diameter difference, and smaller weight:device size ratio were associated with erosion. On multivariable analysis, deficiency of any rim, device >5 mm larger than ASD diameter, and weight:device size ratio were associated with erosion. Conclusions— In addition to aortic rim deficiency, which was almost universal among erosion cases, there were several relative risk factors for erosion after ASD closure with the Amplatzer septal occluder device. To understand the mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.

The hybrid approach to management of hypoplastic left heart syndrome (HLHS) was developed as an alternative to neonatal Norwood surgery, providing a less invasive initial palliation for HLHS. We describe our experience in extending the concept of the hybrid procedure to palliate neonates with anatomically compromised systemic arterial blood flow in a variety of congenital cardiac anomalies and supporting its application as first-line palliation in centers developing their HLHS programs. Retrospective review of patients undergoing therapy for HLHS at a single institution from June 2008 to December 2014 was performed. Subject demographics, clinical and procedural data, along with follow-up, were collected. Thirteen patients had initial hybrid palliation for HLHS during the time frame indicated at a median age of 8 days (range 1-29 days) and median weight of 3.4 kg (range 2.4-4.6 kg). Diagnoses included typical HLHS (n = 6), right-dominant unbalanced atrioventricular septal defect with arch hypoplasia (n = 4), double outlet right ventricle [subpulmonic VSD (n = 1) and intact ventricular septum (n = 1)] with hypoplastic transverse aortic arch and borderline left ventricular dimensions. Standard approach with bilateral pulmonary artery banding and ductal stenting was carried out in all thirteen patients. Two patients required two ductal stents at the time of index procedure. There were no intraprocedural complications. Median intubation length post-procedure was 4 days (range 1-74 days). Median hospital stay post-procedure was 47 days (range 15-270 days). The overall mortality rate on follow-up through comprehensive stage 2 over the 6-year experience was 38 % (5 out of 13). Of note, the mortality rate was significantly lower in the latter 3 years of the study period when the procedure was adopted as a primary palliation for HLHS (14 % or 1 out of 7) compared to the initial 3-year period when it was reserved for higher risk cohorts (67 % or 4 out of 6). Median time to subsequent surgery was 3 months (range 1-4 months). One patient required further ductal stenting on follow-up and developed subsequently airway compression. On median follow-up of 24 months, two patients required pulmonary artery arterioplasty. The hybrid procedure may be used for palliation for a variety of cardiac lesions to avoid high-risk surgery in the neonatal period. This approach may be also an alternative in centers performing lower number of Norwood surgery, which has been associated with higher mortality.

A 7.5-lb female neonate was delivered at term, by means of a caesarian section, to a 26-year-old mother (her 2nd pregnancy). The infant had good Apgar scores but was transferred to the neonatal intensive care unit because of respiratory distress. She was treated for transient tachypnea and for bilateral spontaneous pneumothoraces. She improved with minimal respiratory support. Transthoracic echocardiography (TTE) revealed an aneurysmal ductus arteriosus (DA) with a large thrombus (Fig. 1). The patient was observed clinically and was started on 40 mg/d of aspirin. When the infant was 3 weeks old, TTE showed that the DA lumen was almost completely obliterated by the thrombus (Fig. 2). Two weeks later, TTE revealed complete resolution of the DA aneurysm and no thrombus (Fig. 3). The aspirin therapy was discontinued. Fig. 1. Transthoracic echocardiograms (parasternal short-axis views) show A) the pulmonary branch arteries and an aneurysmal ductus arteriosus with an evident thrombus (arrows); B) in color-flow Doppler mode, continuous flow through the ductus arteriosus into ... Fig. 2. Transthoracic echocardiograms. The parasternal short-axis views reveal A) the organization of the thrombus and almost complete obliteration of the ductus arteriosus lumen, and B) the absence of ductal flow, in color-flow Doppler mode. C) The suprasternal ... Fig. 3. Transthoracic echocardiograms. A) The parasternal short-axis view reveals confluent pulmonary branch arteries with unobstructed flow and complete resolution of the ductus arteriosus aneurysm and thrombus. B) The suprasternal view shows a patent aortic ...

To investigate technical approaches for transcatheter closure of coronary artery fistula based on anatomic type of the fistula.The variability in coronary artery fistulae (CAF) anatomy that necessitates different transcatheter closure (TCC) approaches has not been well documented.Records of patients with CAF who underwent TCC at 2 centers were reviewed for technical details and procedural outcome. CAF were classified as proximal and distal. TCC approaches employed were arterio-venous or arterio-arterial loop, retrograde arterial, and antegrade venous.Eighteen patients with CAF, mean age 12.6 years (0.07-60), 11 male (61%), underwent TCC. All CAF drained predominantly into the right side of the heart. Types of CAF were proximal in 15 and distal in 3 patients. CAF calibers were large in 7, medium in 9, and small in 2 patients. The arterio-venous loop approach was used in the majority of the cases (11 patients) and the CAF size were medium to large. The retrograde arterial approach was used in 4; of these, 3 patients had small to medium sized CAF. In 2 patients with long tortuous CAF an antegrade venous approach was employed. TCC was successful in 17 of the 18 patients (94.4%). There were no peri-procedural deaths or vascular complications.This study documents transcatheter closure approaches for CAF and device selection based on fistula origin. The choices of TCC technique and device selection vary, and are primarily determined by the heterogeneous anatomic characteristics of the fistulae.

In a 4.5-year-old child with refractory pulmonary arterial hypertension, we performed atrial septostomy with the application of an Amplatzer fenestrated device designed to maintain patency. Continuous intravenous epoprostenol infusion was started concomitantly. Forty-two months after the procedure, the patient had no recurrent syncope and remained in New York Heart Association functional class II. Fenestration of the atrial septum is feasible in children with pulmonary artery hypertension. No conclusion regarding the patient's need for an atrial septal defect can be drawn since concomitant prostanoid therapy was administered. The long-term patency of the atrial communication needs further confirmation and the optimal timing for its application has to be determined.

This study evaluated use of Amplatzer fenestrated device to maintain patency of the Fontan fenestration and atrial septal defect. Fenestrations are routinely created in patients with lateral tunnel or extracardiac Fontan. Spontaneous closure of the fenestration can lead to Fontan circulation failure. Other patients without single-ventricle physiology may benefit from a small communication between the left and right atria for decompression if closure of the atrial septal defect leads to failure of a dysfunctional ventricle. Amplatzer septal occluder device was modified to create a fenestration through the disks. Three patients with modified Fontan and one patient with a large atrial septal defect underwent placement of the device by transcatheter technique. The device deployment was guided by transesophageal echocardiography. The procedure was successful in all patients. Contrast injection after placement revealed patent fenestration with free flow. Follow-up ranged from 3 months to 1 year. All devices were patent by transthoracic echocardiography. These preliminary results suggest that the Amplatzer fenestrated device can serve as a valuable tool in failing Fontan circulation and may help to avoid surgical intervention. More studies are needed to assess long-term efficacy of the device.

Coarctation of the aorta (COA) is one of the more common congenital anomalies, occurring in four in ten thousand live births and accounting for five to eight percent of all congenital heart defects. COA lesions can be challenging to treat percutaneously, especially if complex vascular anatomy is a barrier to crossing the lesion. We present two cases of COA that utilized a trans-septal approach to cross the lesion in anterograde fashion, subsequently facilitating retrograde stenting of the lesions after snaring and externalizing the wire. In both cases, the trans-septal approach was employed because traditional femoral and radial approaches failed due to complex anatomy, and the trans-septal approach allowed for effective intervention without the need for surgery.

Background —Pulmonary atresia with ventricular septal defect (VSD) and major aortopulmonary collaterals (MAPCAs) is a complex lesion with marked heterogeneity of pulmonary blood supply. Traditional management has involved staged unifocalization of pulmonary blood supply. Our approach has been to perform early 1-stage complete unifocalization in almost all patients. Methods and Results —Since 1992, 85 patients with pulmonary atresia, VSD, and MAPCAs have undergone unifocalization (median age, 7 months). Complete 1-stage unifocalization and intracardiac repair were performed through a midline approach in 56 patients, whereas 23 underwent unifocalization in a single stage with the VSD left open, and 6 underwent staged unifocalization through sequential thoracotomies. There were 9 early deaths. During follow-up (1 to 69 months), there were 7 late deaths. Actuarial survival was 80% at 3 years. Among early survivors, actuarial survival with complete repair was 88% at 2 years. Reintervention on the neo–pulmonary arteries was performed in 24 patients. Conclusions —Early 1-stage complete unifocalization can be performed in >90% of patients with pulmonary atresia and MAPCAs, even those with absent true pulmonary arteries, and yields good functional results. Complete repair during the same operation is achieved in two thirds of patients. There remains room for improvement; actuarial survival 3 years after surgery is 80%, and there is a significant rate of reintervention. These results must be appreciated within the context of the natural history of this lesion: 65% of patients survive to 1 year of age and slightly >50% survive to 2 years even with surgical intervention.

Background . Our surgical strategy for infant coarctation changed from subclavian flap aortoplasty to resection with extended end-to-end anastomosis in 1991. The purpose of this review was to evaluate the results of that strategy. Methods . From 1991 through 1997, 55 infants underwent repair of coarctation of the aorta using resection with extended end-to-end anastomosis. Isolated coarctation of the aorta was present in 26 patients, 20 patients had a ventricular septal defect, and 9 patients had other associated intracardiac lesions. Mean age at surgery was 0.20 ± 0.24 years (median, 21 days). In 34 patients (62%), arch reconstruction was performed through a left thoracotomy. Twenty patients (36%) had median sternotomy with simultaneous repair of coarctation of the aorta and intracardiac repair of associated lesions. One patient had recoarctation repair through a median sternotomy. All coarctation and ductal tissue was resected and the anastomosis was constructed starting opposite the left carotid artery with running polypropylene suture. Results . There was one early death 26 days after coarctation of the aorta and ventricular septal defect repair in a child on extracorporeal membrane oxygenation for meconium aspiration and 2 late deaths owing to pneumonia and pulmonary hypertension (1) and interventricular hemorrhage (1). There were no instances of paraplegia. Follow-up in survivors ranges from 10 to 76 months (mean, 39.8 ± 17.2 months). Recoarctation has developed in 2 patients, who have had successful balloon dilation 6 and 14 months after the operation. This yields a low recoarctation rate of 3.6%. Conclusions . Resection with extended end-to-end anastomosis yields a low mortality and particularly a low recoarctation rate and is our procedure of choice for infants with coarctation of the aorta.

Blind pouch formation of the pulmonary artery (PA) in patients having undergone a Fontan operation can present a serious risk for thromboembolic events. Either primary or secondary closure of this stump is necessary to reduce this risk. Unfortunately, secondary closure is oftentimes difficult due to the size and anatomy of the presenting patient. We describe the insertion of a muscular ventricular septal defect (VSD) device via a perventricular approach for successful closure of a pulmonary stump in a 3-year old, 16-kg child. To our knowledge, this is the first report of a perventricular approach for successful closure of a PA stump.

The risk of erosion after Amplatzer septal occluder (ASO) device placement in atrial septal defects is well described. Aortic rim deficiency and use of over-sized device increase the risk of erosion. This study attempts to describe device characteristics, anatomical features and echocardiographic predictors that increase the risk of erosion.From 2005 through 2012, 12 new cases, with nine confirmed and three suspected device erosions where pre-procedural, intra-procedural, and/or post-procedural echocardiograms were available and, were reviewed. Following parameters were evaluated: ASD location (high or low), rims deficiency and consistency, septal mal-alignment, dynamic nature of the defect; device edge relationship toward the transverse sinus (TS), atrial free wall tenting and the size of the defect compared with the size of the device used for closure.We found poor posterior rim consistency, aortic rim absence (in multiple views) and absent aortic rim at O degree in 100% of the patients. Septal mal-alignment and dynamic ASD was present in nearly 50% of the cases. The device was over-sized in three patients only. A 26-mm device was the most common device that resulted in erosion. In cases, where patient had experienced bloody pericardial effusion and the device was in place, device tenting in the TS was observed. Surgical explantation of the device confirmed presence of erosion in all cases.Aortic rim absence in multiple views, poor posterior rim consistency, septal mal-alignment, and dynamic ASD appear to be factors where erosion risk increases significantly. A thorough assessment of the device edge by echocardiography in short-axis may show device tenting of the atrial free wall into the TS. This finding should be a strong indictor to recommend surgical removal of device after occurrence of pericardial effusion.

Transcatheter pulmonic valve implantation has emerged as a safe and effective alternative to valve surgery in patients with surgically corrected congenital heart disease. In cases where the transcatheter approach has failed, or was thought to be technically challenging, a hybrid approach to pulmonic valve implantation has been described. This approach involves a small subxyphoid incision made by the cardiac surgeon and implantation of the pulmonic valve through the appropriate delivery sheath through this incision. Here we describe a case of a successful implantation of a Melody valve in a 12 kg child with tetralogy of Fallot. To our knowledge this is the smallest child to have undergone this procedure reported.

Closure of perimembranous ventricular septal defects (PmVSDs) [4] with the original Amplatzer membranous VSD occluder (mVSD1) has been associated with an increased risk of complications, the most notable of which has been complete heart block. This has led to the introduction of a new device to close PmVSDs. The authors describe their experience with the new Amplatzer membranous VSD occluder (mVSD2) in two patients and critique the new device design and delivery system, comparing it with the mVSD1 occluder. Two patients underwent attempted closure of PmVSDs with the new mVSD2 device. One patient had successful closure of the defect with no residual shunt and no evidence of heart block at follow-up evaluation. Trace to mild aortic insufficiency was observed at the time of closure and at the last follow-up visit. The rhythm remained sinus. In the second patient, the device was placed but removed before release because of inability to orient the device in optimal position. Percutaneous closure of PmVSD is feasible with the new mVSD2 occluder. The change in the design may reduce the incidence of complete heart block. It remains to be seen whether the device will be suitable for smaller patients.

Two transcatheter pulmonary valve replacement (tPVR) systems (Edwards SAPIEN and Medtronic Melody) are available; however, comparative studies evaluating outcome data are lacking. The aim of this study was to compare short- with medium-term outcome data of these valves in the pulmonary position from a single institution.Retrospective data analysis of all patients undergoing tPVR from April 2008 until April 2012. Pre-procedural investigations, patient demographics, procedural hemodynamics, and clinical and echocardiographic follow-up data were included. Data are presented as mean ± standard deviation.Thirty-three patients underwent successful tPVR (SAPIEN (S) n = 20, Melody (M) n = 13). Patient age and weight were similar between the two groups. Primary indication included regurgitation (S (n = 2), M (n = 3)), stenosis (S (n = 13), M (n = 7)), or mixed (S (n = 5), M (n = 3)). There was no difference in pre-procedural peak Doppler gradients across the pulmonary outflow (S = 47.73 ± 21.14 mm Hg, M = 42.62 ± 15.59 mm Hg, P = 0.46). All but one patient underwent pre-stenting prior to valve implantation. Immediately following valve deployment, the transvalvar gradient was not statistically different between the two groups (S = 11.5 ± 8.07 mm Hg, M = 8.15 ± 4.56 mm Hg, P = 0.18). There were no procedural deaths. Follow-up mean pulmonary Doppler gradients were higher with the SAPIEN cohort (18.43 ± 9.06 mm Hg (S) and 11.17 ± 5.24 mm Hg (M), P = 0.016); however, no differences were seen when similar procedural epochs were assessed. All but one patient remained with PR grade = 2.In a single-center series, the SAPIEN and Melody valves demonstrated comparable medium-term valve function. Greater residual gradients with the SAPIEN valve may represent a more conservative early pre-stenting approach with this valve.

A 3-month-old male patient was born at 34 weeks’ gestation weighing 1.3 kg with an antenatal diagnosis of severe mitral stenosis, hypoplasia of the left ventricle, juxtaposition of the left atrial appendages, aorta arising anteriorly from the right ventricle, and pulmonary atresia. Following initial palliation with atrial septostomy, he underwent hybrid stenting of the ductus arteriosus. Three days after the stent placement, progressive stenosis of the pulmonary end of the ductus led to a reduction in oxygen saturations and he underwent placement of a 3.5-mm modified right Blalock–Taussig (BT) shunt and partial ligation of the stented patent ductus arteriosus. At discharge, his oxygen saturations were in the upper 80s. He was readmitted 3 days later with a history of lowgrade fever and intermittent oxygen desaturations. Urine cultures grew Candida. Further workup revealed severely enlarged kidneys and, subsequently, the patient underwent right nephrostomy tube placement for partial obstructive uropathy secondary to fungal balls. An echocardiogram revealed patency of the BT shunt, although the proximal area was attenuated with an echogenic mass seen within the lumen of the shunt suggestive of thrombus/vegetation formation (Fig. 1). Emergency catheterization was performed to attempt to reestablish full patency of the BT shunt, as previously reported [1, 2]. The findings identified on echocardiography were confirmed on angiography with distal narrowing of the BT shunt also seen (Fig. 2a). The BT shunt was balloon-dilated with a 5-mm coronary balloon with resolution of the intraluminal mass and improvement in the proximal and distal stenoses as demonstrated by angiography (Fig. 2b) and echocardiography (Fig. 3). Of note, stent placement was not considered, as the narrowing of the BT shunt was at the anastomotic site of the shunt to the brachiocephalic artery and stenting would have compromised the brachiocephalic artery. The infant’s oxygen saturations improved dramatically from 55% preprocedure to 80% following the intervention. This report highlights the benefit of detailed echocardiography in evaluating patients with intermittent oxygen desaturations in the setting of a BT shunt.

We describe our medium-term outcomes for peripheral pulmonary artery stenting in adults with congenital heart disease.Improved outcomes in congenital heart disease have lead to the evolution of transcatheter therapies in adults aimed at maintaining normal hemodynamics. Stenting for pulmonary artery narrowing is effective in children, however little is known about outcomes in adults.Retrospective data analysis and follow-up review of our complete experience with peripheral pulmonary artery stenting in adults.Over a 9-year period we carried out 15 procedures, implanting 23 stents (11-left pulmonary artery) in the pulmonary arteries of 12 adult patients (7 female). Eleven patients had previous cardiac surgery. Median age at implantation was 32.5 years (range, 18.7-56.7 years) with median weight of 71.3 kg (range, 44.5-95 kg). Six patients underwent bilateral pulmonary artery stenting. Median procedure time was 140 minutes (range, 76-263 minutes) and 4 patients had other interventions performed during the same procedure. Median systolic pressure gradient across the narrowing's of 24 mmHg (range, 11-61 mmHg) was reduced to 3 mmHg (range, 0-17 mmHg) postprocedure (P0.001). Three patients had acute stent embolization, one of whom required surgical removal. No aneurysm formation or significant stent fractures have been noted on median follow-up of 27.4 months (range, 1-97 months). Two patients required reintervention with further stent implantation.Pulmonary artery stenting provides effective relief of narrowing in adults with congenital heart disease. Bilateral and/or multiple stenting are often required. Stent embolization may occur particularly in patients with associated significant pulmonary regurgitation. (J Interven Cardiol 2011;24:373-377).

Between November 1978 and May 1991, a two-patch repair with tricuspidization of the left atrioventricular valve was performed in 104 patients with complete atrioventricular canal defect. Mean age was 12 months for the 68 patients who underwent primary repair and 22 months for the 36 patients who had previous pulmonary artery banding. Eleven patients died within 30 days of operation and 4 died late. Reoperation was carried out in 2 patients. Eighty-six patients were in sinus rhythm after operation. One patient required a permanent pacemaker for complete heart block. Follow-up data for 1 to 13 years are available in 80 of 89 survivors (90%). Actuarial survival at 13 years is 81% and event-free survival is 92%. Seventy-six patients are in New York Heart Association class I and 4 in class II. Postoperative echocardiogram of these patients showed minimal or no mitral regurgitation. The advantages of this technique are preservation of valve integrity, durable mitral valve repair, and rare reoperation or heart block even in younger patients.

Stenting of the arterial duct to maintain postnatal communication between the pulmonary and systemic arterial circulations in infants with complex congenital heart disease is an acceptable alternative to a surgically created systemic to pulmonary artery shunt. The procedure, however, can be demanding given the variable anatomy of the patent ductus arteriosus. We report a series of cases of ductal stenting via a range of varying approaches in neonates with complex congenital heart disease, and display the variety of situations in which these approaches may be used.

Muscular ventricular septal defects (MVSDs) account for approximately 20% of all congenital ventricular septal defects. Large defects in infants result in early heart failure, failure to thrive and pulmonary hypertension. Although percutaneous closure of MVSDs has been employed safely and effectively in children, adolescents and adults, its application in the small infant (weight

Transhepatic right heart catheterization is an uncommon procedure for adult interventional cardiologists. We report its successful use for closure of a patent foramen ovale in an elderly patient without femoral vein access. Also described is a novel method of using a vascular plug to achieve hemostasis of the hepatic venous access site. © 2009 Wiley-Liss, Inc.

Objectives: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. Background: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. Methods: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. Results: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). Conclusions: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications. © 2008 Wiley-Liss, Inc.

Isolated muscular ventricular septal defects (VSDs) account for 10% of VSDs. Among these, inlet and midmuscular VSDs are relatively easy to approach surgically, but apical and anterior muscular VSDs can be difficult to visualize during the operation. 2 Intraoperative closure of muscular VSDs with a device during cardiopulmonary bypass (CPB) has been described with good results. The current report describes the use of a new transcatheter device to close muscular VSDs intraoperatively without using CPB in three dogs and later in an 8-month-old girl. Animal studies. The Amplatz VSD device (AGA Medical Corporation, Golden Valley, Minn.) is a modified version of the Amplatz septal occlusion device. It is made of fine nitinol wires that are woven into two discs with a connecting waist. The discs are filled with polyester to enhance thrombogenicity. The device is custom built to correspond to the size of the VSD and thickness of the ventricular septum. It has a screw mechanism on one side for connection to the delivery cable. The device is withdrawn into a loader before introduction into the delivery sheath. All animals received humane care in compliance with the “Guide for the Care and Use of Laboratory Animals” (NIH Publication No. 86-23, revised 1985). The study protocol was approved by institutional animal care committee of the University of Minnesota. To determine the feasibility of intraoperatively closing muscular VSDs, we created an anterior or apical VSD in three dogs with the help of a punch device. The diameter of the punch device was 10 mm. With the animal under general endotracheal anesthesia and aseptic technique, the chest was entered by median sternotomy. The pericardium was opened. Two stay stitches were applied on the right ventricular free wall. A purse-string suture was placed on the left atrial appendage. The index finger of the left hand was inserted in the left atrium and advanced in the left ventricle. A right ventriculotomy was performed and the punch device inserted through the incision in the right ventricle. With a burring action, the septum was traversed until the punch device touched the index finger in the left ventricle. The punch was locked and removed, and the right ventriculotomy was closed with 5-0 running Prolene suture (Ethicon, Inc., Somerville, N.J.). The size of the defect was measured by epicardial echocardiography. In one dog two VSDs were created. An Amplatz VSD device that corresponded to the size of the VSD was screwed onto the delivery cable and withdrawn with the delivery sheath immersed in saline solution to avoid entrapment of air bubbles. The sheath was pushed through the right ventricular free wall. With the aid of epicardial echocardiographic guidance the sheath was aimed toward the muscular VSD. Once the sheath was across the VSD, the left disc was deployed in the left ventricle. The sheath was withdrawn and the right disc deployed in the right ventricle. The device was disconnected from the cable by counterclockwise rotation of the cable. Residual shunt was checked with the help of epicardial echocardiography. Results. A total of four VSDs were created in three dogs. The smallest measured 7 mm and the largest 11 mm. Three muscular VSDs were closed during the operation and the fourth one in the catheterization laboratory. The first dog died 2 hours after the operation because of ventricular fibrillation. Dissection of the heart revealed the device in good position. The second dog was put to death after 3 months. Examination of the heart revealed the device in the optimal location with complete endothelialization. The third dog (with two devices) is still alive. Six months’ follow-up echocardiogram and angiogram revealed no shunt. Muscular VSDs in an 8-month-old baby. The operation was done on the basis of compassionate need. Informed consent and approval of the Institutional Review Board of the University of Minnesota, Minneapolis, were obtained before placement of the device. Baby A was born with multiple muscular VSDs (anterior and apical muscular) and coarctation of aorta. She underwent repair of aortic coarctation and pulmonary artery banding on the fourth day of life. At the age of 8 months she had debanding with closure of large muscular VSDs. Postoperatively a significant residual shunt was identified, but the VSD could not be located during CPB. From the Departments of Cardiology and Cardiovascular Surgery, University of Minnesota, Minneapolis, Minn., and Department of Cardiology, Children’s Memorial Medical Center, Northwestern University Medical School, Chicago, Ill.

This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S.The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality.Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm).The attempt to place a device was successful in 32 patients (91%). The median device size used was 10 mm (range, 6 to 16 mm). The complete closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min). Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up.Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy.

The objectives of this study were to identify possible risk factors that may lead to erosion of the Amplatzer septal occluder (ASO) and recommend ways to minimize future risk. There have been rare occurrences of adverse events with development of pericardial effusion after ASO placement. Identification of high-risk cases, early recognition, and prompt intervention may minimize the future risks of adverse events. In all patients who developed hemodynamic compromise after ASO placement, echocardiograms (pre-, intra-, and postprocedure), atrial septal defect (ASD) size (nonstretched, stretched), size of the device used, cineangiograms, and operative records were reviewed by a panel selected by AGA Medical Corporation. The findings were compared to the premarket approval data obtained from FDA-approved clinical trials that were conducted in the United States, before the device was approved. A total of 28 cases (14 in United States) of adverse events were reported to AGA Medical. All erosions occurred at the dome of the atria, near the aortic root. Deficient aortic rim was seen in 89% and the defect described as high ASD, suggesting deficient superior rim. The device to unstretched ASD ratio was significantly larger in the adverse event group when compared to the FDA trial group. The incidence of device erosion in the United States was 0.1%. The risk of device erosion with ASO is low and complications can be decreased by identifying high-risk patients and following them closely. Patients with deficient aortic rim and/or superior rim may be at higher risk for device erosion. Oversized ASO may increase the risk of erosion. The defect should not be overstretched during balloon sizing. Patients with small pericardial effusion at 24 hr should have closer follow-up.

The objective of this study was to assess the immediate and mid-term results of transcatheter closure of postinfarct muscular ventricular septal defects (VSDs) using the new Amplatzer postinfarct muscular VSD device (PIMVSD). Ventricular septal rupture occurs in 0.2% of myocardial infarcts and remains associated with very high morbidity and mortality. Data were prospectively collected for 18 patients who underwent attempted device closure of postinfarction VSDs between 2000 and 2003. Five patients underwent the closure in the acute phase (within 6 days from the infarct); the remaining patients underwent closure on day 14-95 after the diagnosis of the infarct. Outcome parameters included procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The procedure was successful in deploying a device across the VSD in 16 of 18 patients. The 30-day mortality was 28%. Eleven patients are still alive and have been followed up for a median of 332 days. Two patients required a second procedure to close a residual VSD. At the most recent outpatient follow-up, the VSD was completely closed in two patients, six patients had a trivial or small residual shunt, and two patients had a moderate residual shunt. We conclude that percutaneous device closure of postinfarction VSDs using the Amplatzer PIMVSD occluder appears to be safe and effective. Further trials are required to assess long-term efficacy and compare the results with those of surgical closure.

Placement of intravascular stents that can reach adult size in infants and smaller children has been limited by the large profile and poor flexibility of currently available stents. In vitro and in vivo testing of the Genesis stent was performed to evaluate crimpability, predeployment flexibility, and radial strength. Comparisons were made to the Palmaz iliac and IntraStent (IS) LD stents. Nine physicians placed 30 Genesis stents in swine pulmonary and systemic arteries to evaluate stent deliverability/crimpability. Two swine were recovered and underwent a second catheterization 8 weeks later, where the stents (n = 8) were reexpanded to maximal size. Angiographic and intravascular ultrasound (IVUS) assessments were performed. In vitro testing revealed the Genesis stent to have superior crimpability, flexibility, and comparable radial strength to the Palmaz iliac stent, and superior crimpability and radial strength and comparable flexibility to the IS LD series. During in vivo testing, the physicians graded the Genesis stent superior to the Palmaz stent regarding crimpability and deliverability, and superior to the IS LD stent in regard to crimpability, and comparable to or superior in deliverability. In the chronic animals, the Genesis stent was expanded up to maximal diameter 8 weeks following implantation. Angiographic and IVUS revealed no fractures no in-stent restenosis. The Genesis stent can be easily delivered through smaller sheaths, which will facilitate their use in infants and smaller children with vascular stenosis.

Coronary fistulas can be a source of myocardial Ischemia when they are large. In this case series, we describe four complex coronary fistulas treated by transcatheter occlusion. The first two with Gianturco coils and the other two with an Amplatzer PDA device. Transcatheter closure of coronary fistulas can be accomplished in most cases.