Closing the gap between acceptable and ideal in catheterisation for paediatric and congenital heart disease-A global view.

In recent issues of the Journal of the Society for Cardiovascular Angiography and Interventions and the Journal of the American College of Cardiology: Cardiovascular Interventions, Holzer and colleagues presented an Expert Consensus Document titled: "PICS / AEPC / APPCS / CSANZ / SCAI / SOLACI: Expert consensus statement on cardiac catheterization for pediatric patients and adults with congenital heart disease." This Expert Consensus Document is a massively important contribution to the community of paediatric and congenital cardiac care. This document was developed as an Expert Consensus Document by the Pediatric and Congenital Interventional Cardiovascular Society, the Association for European Paediatric and Congenital Cardiology, the Asia-Pacific Pediatric Cardiac Society, the Cardiac Society of Australia and New Zealand, the Society for Cardiovascular Angiography and Interventions, and the Latin American Society of Interventional Cardiology, as well as the Congenital Cardiac Anesthesia Society and the American Association of Physicists in Medicine.As perfectly stated in the Preamble of this Expert Consensus Document, "This expert consensus document is intended to inform practitioners, payors, hospital administrators and other parties as to the opinion of the aforementioned societies about best practices for cardiac catheterisation and transcatheter management of paediatric and adult patients with congenital heart disease, with added accommodations for resource-limited environments." And, the fact that the authorship of this Expert Consensus Document includes global representation is notable, commendable, and important.This Expert Consensus Document has the potential to fill an important gap for this patient population. National guideline documents for specific aspects of interventions in patients with paediatric heart disease, including training guidelines, do exist. However, this current Expert Consensus Document authored by Holzer and colleagues provides truly globally applicable standards on cardiac catheterisation for both paediatric patients and adults with congenital heart disease (CHD).Our current Editorial provides different regional perspectives from senior physicians dedicated to paediatric and congenital cardiac care who are practicing in Europe, the Asia-Pacific region, Latin America, Australia/New Zealand, and North America. Establishing worldwide standards for cardiac catheterisation laboratories for children and adults with CHD is a significant stride towards improving the quality and consistency of care. These standards should not only reflect the current state of medical knowledge but should also be adaptable to future advancements, ultimately fostering better outcomes and enhancing the lives of individuals affected by CHD worldwide.Ensuring that these standards are accessible and adaptable across different healthcare settings globally is a critical step. Given the variability in resources and infrastructure globally, the need exists for flexibility and tailoring to implement recommendations.The potential impact of the Expert Consensus Document and its recommendations is likely significant, but heterogeneity of healthcare systems will pose continuing challenges on healthcare professionals. Indeed, this heterogeneity of healthcare systems will challenge healthcare professionals to finally close the gap between acceptable and ideal in the catheterisation of patients with paediatric and/or congenital heart disease.

Sinus node dysfunction during transcatheter assessment and stent correction of sinus venosus atrial septal defects.

Covered stent correction of a superior sinus venosus atrial septal defect is increasingly performed as an alternative to surgical repair. While sinus node dysfunction requiring pacemaker implantation may be required after surgical repair, this has not been previously reported after covered stent implantation. We reviewed the experience in two interventional centers. Balloon inflation in the superior vena cava was used to confirm the anomalous pulmonary vein drainage would be unobstructed after stent implantation. During balloon testing in 62 consecutive patients, we assessed gradients across the pulmonary vein to left atrium while monitoring the rhythm. We observed the outcomes after covered stent correction in 51 patients. In a single patient, significant bradycardia and pauses developed on repeat balloon testing and the procedure was abandoned without stent implantation. In another patient, there was no sign of sinus node dysfunction during balloon testing but several hours after stent implantation, the patient became symptomatic from sinus bradycardia and pauses and had a pacemaker implanted 3 days later. Over a year later there are some signs of improvement in sinus node function. While sinus node dysfunction has not been described previously during balloon testing or after stent implantation, this report demonstrates for the first time that it may occur. Larger registries are therefore required to monitor for this uncommon complication.

Transcatheter Closure of Perimembranous Ventricular Septal Defects Using Different Generations of Amplatzer Devices: Multicenter Experience.

OBJECTIVES: To demonstrate safety and efficacy of using different generations of softer Amplatzer™ devices for ventricular septal defect (VSD) closure to avoid serious complications at follow-up. BACKGROUND: Transcatheter closure of perimembranous ventricular septal defects (PmVSD) is a well-established procedure; however, it is associated with unacceptable incidence of complete heart block. Great advantages have been achieved by using softer devices for VSD transcatheter closure. The first and second generation of Amplatzer™ occluders (AVP II, ADO, and ADO II) seem to offer a safe and attractive alternative for this procedure. These devices can be delivered using either an arterial (retrograde) or venous (prograde) approach. METHODS AND RESULTS: Patients with congenital PmVSD who underwent transcatheter closure using ADO, ADO II, and AVP II devices were included. Primary end point was to determine efficacy and safety of these generations of devices and to determine the incidence of complications at follow-up (complete AV block and aortic/tricuspid/mitral regurgitation). One hundred and nineteen patients underwent VSD closure at a median age of 5 years (8 months-54 years). During the catheterization, there were only minor complications and at follow-up of 36 ± 25.7 months (up to 99 months), the closure rate was high of 98.3% and freedom from AV block was 100%. CONCLUSIONS: The use of softer Amplatzer™ devices is a good alternative to achieve PmVSD closure safely with no risk of AVB during the procedure or at midterm follow-up.

Atrial septal defect closure with the new Cardia Ultrasept II™ device with interposed Goretex patch: Mexican experience - has the perforation of Ivalon's membrane been solved?

OBJECTIVES: The objective of this study was to demonstrate the safety and feasibility of using the new Cardia Ultrasept II™ device with interposed Goretex patch referring to the perforation of polyvinyl alcohol membrane. BACKGROUND: Great advances have been made in the development of devices for closure of atrial septal defect. The Cardia Ultrasept II™ with interposed Goretex patch is the modified last generation of Cardia devices, having the advantage of a super-low profile within the atria and an integral locking delivery-retrieval mechanism that ensures safe deployment. In addition, with the interposition of the Goretex, it has been possible to abolish perforation of Ivalon's membrane as a complication.Methods and resultsPatients with ostium secundum atrial septal defect with surrounding rims with a minimum length of 5 mm and who underwent atrial septal defect closure with the new Ultrasept II™ with Goretex patch were included from two paediatric cardiac centres. Primary end point was to determine perforation of the Goretex membrane at follow-up; secondary end point included right ventricular diastolic diameter. In total, 30 patients underwent atrial septal defect closure at a median age of 6 (1-29) years. At follow-up for 6 (range, 1-15) months, freedom from perforations was 100%. A continuous decrease in right ventricular diastolic diameter was found with an initial median of 30 (25-49) mm and after catheterisation of 27.5 (18-33) mm, p=0.01, and Z-score of 2.6 (1.7-3.6) versus 1.9 (1-2.9) after procedure, p=0.01. CONCLUSIONS: The new modified generation of the Ultrasept II™ device with interposed Goretex patch is a good alternative to achieve atrial septal defect closure safely and feasibly with no membrane perforation at follow-up.

Closure of large patent ductus arteriosus using the Amplatzer Septal Occluder.

BACKGROUND: Percutaneous closure of patent ductus arteriosus has become the treatment of choice in many centres. In patients with large ducts and pulmonary hypertension, transcatheter closure has been achieved with success using the Amplatzer Duct Occluder or even the Amplatzer Muscular Ventricular Septal Defect Occluder. MATERIALS AND METHODS: We present a series of 17 patients with large and hypertensive ductus arteriosus who were treated with an Amplatzer Septal Occluder. The group had 11 female patients (64.7%) and a mean age of 18.6±12.1 years. RESULTS: The haemodynamic and anatomical data are as follows: pulmonary artery systolic pressure 71.3±31.8 mmHg, pulmonary to systemic flow ratio 3.14±1.36, ductal diameter at the pulmonary end 12.5±3.8 mm, and at the aortic end 20.2±7.7 mm; 14 cases (82.3%) had type A ducts. In 11 patients, we began the procedure using a different device - six with duct occluder and five with ventricular septal occluder - and it was changed because of device embolisation in six (35.3%). All septal occluders were delivered successfully. Residual shunt was moderate in six patients (35.3%), mild in eight (47%), trivial in two (11.8%), and no shunt in one (5.9%). Pulmonary systolic pressure decreased to 48.9±10.8 mmHg after occlusion (p=0.0015). Follow-up in 15 patients (88.2%) for 28.4±14.4 months showed complete closure in all cases but one, and continuous decrease of the pulmonary systolic pressure to 31.4±10.5 mmHg. No complications at follow-up have been reported. CONCLUSIONS: The Amplatzer Septal Occluder is a good alternative to percutaneously treat large and hypertensive ductus arteriosus.

Association between Postmortem Kidney Biopsy Findings and Acute Kidney Injury from Patients with SARS-CoV-2 (COVID-19).

BACKGROUND AND OBJECTIVES: AKI in coronavirus disease 2019 (COVID-19) is associated with higher morbidity and mortality. The objective of this study was to identify the kidney histopathologic characteristics of deceased patients with diagnosis of COVID-19 and evaluate the association between biopsy findings and clinical variables, including AKI severity. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Our multicenter, observational study of deceased patients with COVID-19 in three third-level centers in Mexico City evaluated postmortem kidney biopsy by light and electron microscopy analysis in all cases. Descriptive and association statistics were performed between the clinical and histologic variables. RESULTS: A total of 85 patients were included. Median age was 57 (49-66) years, 69% were men, body mass index was 29 (26-35) kg/m2, 51% had history of diabetes, 46% had history of hypertension, 98% received anticoagulation, 66% were on steroids, and 35% received at least one potential nephrotoxic medication. Severe AKI was present in 54% of patients. Biopsy findings included FSGS in 29%, diabetic nephropathy in 27%, and arteriosclerosis in 81%. Acute tubular injury grades 2-3 were observed in 49%. Histopathologic characteristics were not associated with severe AKI; however, pigment casts on the biopsy were associated with significantly lower probability of kidney function recovery (odds ratio, 0.07; 95% confidence interval, 0.01 to 0.77). The use of aminoglycosides/colistin, levels of C-reactive protein and serum albumin, previous use of angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, antivirals, nonsteroid anti-inflammatory drugs, and anticoagulants were associated with specific histopathologic findings. CONCLUSIONS: A high prevalence of chronic comorbidities was found on kidney biopsies. Nonrecovery from severe AKI was associated with the presence of pigmented casts. Inflammatory markers and medications were associated with specific histopathologic findings in patients dying from COVID-19.

[Anomalous origin of the right pulmonary artery and left pulmonary vein stenosis]. / Origen anómalo de la arteria pulmonar derecha y estenosis de vena pulmonar superior izquierda.

We present a case of a 9 month old female with a history of cyanosis. The cardiovascular evaluation included angiocardiogram and magnetic resonance. The diagnosis was: origin of the right pulmonary artery from the ascending aorta, stenosis of the left superior pulmonary vein, patent ductus arteriosus and severe pulmonary hypertension. Surgical treatment consisted in correcting all congenital heart defects. The patient is doing well at home.

Optimización de la protección en radiología y cardiología intervencionista pediatrica en América Latina y el Caribe (OPRIPALC) / Optimization of protection in pediatric interventional cardiology and radiology in Latin America and the Caribbean (OPRIPALC)

El objetivo del presente artículo ha sido describir el programa "Optimización de la Protección en Radiología Intervencionista Pediátrica en América Latina y el Caribe" (OPRIPALC) que nace el año 2018 como respuesta conjunta de la Organización Panamericana de la Salud y la Organización Mundial de la Salud, en cooperación con el Organismo Internacional de Energía Atómica, para colaborar con sus Estados miembros en asegurar que las exposiciones a la radiación de los pacientes pediátricos sean las mínimas necesarias durante los procedimientos intervencionistas. Actualmente, hay 18 centros de los siguientes 10 países que participan: Argentina, Brasil, Chile, Colombia, Costa Rica, Cuba, Ecuador, México, Perú y Uruguay. Para el desarrollo del programa se plantean una serie de objetivos, productos, actividades y resultados esperados. La puesta en marcha de la WEB de OPRIPALC ha significado un instrumento muy válido para seguir la información actualizada del programa. Un programa actualizado de formación en radioprotección para los profesionales implicados en el programa, se está realizando por medio de "webinars". Se deberá seguir actuando en la aplicación del programa de control de calidad básico para los equipos de rayos X participantes y validar los valores de los Niveles de Referencia para Diagnóstico (NRDs). Se propone formar un equipo de trabajo entre los Físicos Médicos y Tecnólogos Médicos participantes de OPRIPALC para implicarse en las pruebas de control básicas que todos los centros debieran realizar. Se han presentado algunos resultados iniciales de OPRIPALC en eventos científicos internacionales. Se está avanzando en proponer unos primeros valores sobre NRDs en procedimientos de intervencionismo cardiológico pediátrico por bandas de edad y peso. OPRIPALC es una de las pocas iniciativas de carácter regional para obtener valores de NRDs en procedimientos intervencionistas pediátricos. Se espera que tanto los valores de referencia como la metodología empleada en OPRIPALC, puedan ser utilizados en otras regiones del mundo.

The objective of this article has been to describe the program "Optimization of Protection in Pediatric Interventional Radiology in Latin America and the Caribbean" (OPRIPALC) that was born in 2018 as a joint response of the Pan American Health Organization and the World Organization of the Health, in cooperation with the International Atomic Energy Agency, to collaborate with its member states in ensuring that radiation exposures of pediatric patients are the minimum necessary during interventional procedures. Currently, there are 18 centers from the following 10 countries participating: Argentina, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, Mexico, Peru and Uruguay. For the development of the program, a series of objectives, products, activities and expected results are proposed. The launch of the OPRIPALC WEBSITE has been a very valid instrument for following up-to-date information on the program. An updated training program in radiation protection for the professionals involved in the program is being carried out through webinars. It should continue acting in the application of the basic quality control program for the participating X-ray equipment and validate the values of the Diagnostic Reference Levels (DRLs). It is proposed to form a work team among the OPRIPALC participating medical physicists to get involved in the basic control tests that all centers should carry out. Some initial results of OPRIPALC have been presented at international scientific events. Progress is being made in proposing first values on DRLs in pediatric cardiac intervention procedures by age and weight bands. OPRIPALC is one of the few regional initiatives to obtain DRLs values in pediatric interventional procedures. It is expected that both the reference values and the methodology used in OPRIPALC can be used in other regions of the world.

Percutaneous interventional closure of large pulmonary arteriovenous fistulas with the amplatzer duct occluder.

Large pulmonary arteriovenous fistulas (PAVFs) are difficult for transcatheter treatment. This report presents 5 patients aged 3 to 73 years with large PAVFs who underwent successful transcatheter closure with the Amplatzer duct occluder (ADO), designed for the occlusion of patent duct arteriosus. The procedures were performed without complications and provided sustained improvement in arterial oxygen saturation and exercise tolerance on follow-up examination in all patients. The transcatheter closure of large PAVFs with the ADO is effective and can eliminate the need for surgical intervention. The newly designed Amplatzer vascular plug is undergoing clinical trials.

[Fontan operation: short- and long-term risk factors]. / Cirugía de Fontan. Factores de riesgo a corto y mediano plazo.

The purpose of this retrospective study was to determine the outcome of patients who underwent a Fontan procedure at National Heart Institute "Ignacio Chávez", Mexico, from January 1989 to December 2003. We had 81 patients with a mean age of 7 years old: 53 with tricuspid atresia, 14 with pulmonary atresia and intact septum, 11 with univentricular atrioventricular connection and 3 with Ebstein's anomaly. An intra-atrial tunnel was performed on 61 patients and an extracardiac conduit on the rest. Of all, 53 underwent a fenestration. The surgical mortality was 13% for tricuspid atresia and 25% for the other diseases. We had an overall mortality of 28.4%, being the main causes cardiogenic shock and arrhythmia. The global survival was 71% in 55 months of following. Takedown was indicated on 5 patients. The patients without fenestration showed to have 2.8 times more risk of death. The mean pulmonary artery pressure > or = 20 mmHg plus the left atrium pressure > or = 10 mmHg increased the death risk 3.6 times. Of the 52% who required readmission, the main causes were hemodynamical failure and infections. The more relevant complications were: arrhythmia (38%), protein-losing enteropathy (8%) and thrombotic cerebral events (1.4%).

[Percutaneous closure of ventricular septal defect by Amplatzer occluder. Immediate and mid-term follow up results]. / Cierre percutáneo de la comunicación interventricular perimembranosa con el dispositivo de Amplatzer: resultados inmediatos y a mediano plazo.

OBJECT: To report the immediate and mid-term follow-up results of the Amplatzer membranous VSD occluder for the percutaneous occlusion of the perimembranous VSD. BACKGROUND: Percutaneous perimembranous VSD occlusion is still considered an experimental method where a variety of devices have been tested. Nowadays, more than 500 membranous Amplatzer devices have been implanted worldwide with encouraging results. METHOD: We included 6 patients (1 man and 5 women) with a mean age of 9.9 years (range, 3 to 17.5) in whom percutaneous perimembranous VSD closure was attempted. RESULTS: In one of the patients, positioning of the device was not possible (intention to treat success rate, 83.3%). In the remaining five patients, there was a single defect. The VSD mean diameter with echo was 7 +/- 1.7 mm (range, 5.1 to 9) and with angio was 6.9 +/- 1 (range, 6 to 8). Mean pulmonary pressure was 20.2 +/- 7.7 mm Hg (range, 12-30) and Qp/Qs was 1.69 +/- 0.65 (range, 1.2-2.8). A single device was use in all cases. Immediate angiographic control showed complete occlusion in two patients, trivial shunt in one, and mild shunt in two. Follow-up was at least 4 months. Only one patient has residual trivial shunt, the rest of the defects are completely closed. CONCLUSION: The special design of the Amplatzer membranous VSD occluder allows percutaneous closure of this defect in a safe and effective way, with good mid-term results. In selected cases, this is a good alternative to surgery in the treatmen of this cardiac defect.

Atrial septal defect in adults > or =40 years old: negative impact of low arterial oxygen saturation.

BACKGROUND: Although good prognosis and clinical long-term outcome have been commonly reported in minimally symptomatic adult patients with ASD, this information has been based on studies with a relatively small number of adult patients. We studied unoperated patients aged over 40 years to define the patterns of presentation, anatomical characteristics, outcome and predictive factors for free-event survival of major cardiovascular and pulmonary events. METHODS AND RESULTS: Two-hundred survivors of atrial septal defect aged over 40-yr attended from 1985 to 1998 were reviewed and followed-up from 1.6 to 22 years. Patients were classified in three groups according to age at entry: Group 1, between 40 and 49; Group 2; 50 and 59; and Group 3, > or =60 years old. The mean age at presentation was 48.8+/-9.2 years, and the most common clinical presentations were arrhythmia and dyspnea (51.4%). There were 37 (18.5%) events: 7 heart failure-related, 5 sudden death, 13 severe pulmonary infections, 5 embolisms, and 4 strokes. According to Cox's regression analysis, predictors of primary end point included age group at presentation (hazard ratio 1.71, 95% confidence limits 1.16 to 2.54), and either pulmonary hypertension (mean pulmonary pressure >35 mmHg; hazard ratio=0.65 (4.6, confidence limits 2.2 to 9.5) or, arterial oxygen saturation <80% (hazard ratio 1.71, 95% confidence limits 1.16 to 2.54). CONCLUSIONS: This study supports that long term outcome of patients aged >40 years with unoperated ASD is importantly determined by the mPAP (>35 mmHg), SaO2% (_80) and the age at diagnosis. Nevertheless we identified an inverse association between the mPAP level and SaO2% (interaction). The event-free survival expectancy may be estimated using the age at diagnosis and either SaO2% or mPAP. This prognostic stratification based on pathophysiological principles, may help in making decisions for therapeutic interventions. SaO2% should always be measured as a part of the initial clinical approach of those patients with atrial septal defect aged over 40 years.

[Therapeutic catheterization in adults with congenital cardiopathy]. / El cateterismo terapéutico en el adulto con cardiopatía congénita.

We report our results with therapeutic cardiac catheterization in adult patients with four of the most frequent congenital heart diseases. 1) Valvular pulmonary stenosis. We treated 20 patients older than 15 years of age and we concluded that anatomy of the valve is the most important variable related to immediate and long-term results. 2) Aortic coarctation. In a group of 54 patients, 32 treated with angioplasty alone and 22 with stent, we concluded that the main determinant for a good long-term result is the residual gradient, which is related to the coarctation anatomy and the use of stent. 3) Patent ductus arteriosus. In 17 adult patients, the ductus was occluded with coils in 5 and with the Amplatzer duct occluder in 12 with complete occlusion of the ductus in all cases followed for a mean period of 18 months and without complications. 4) Atrial septal defect. We treated 39 adult patients using the Amplatzer septal occluder with good results.

[Surgical treatment results of congenital heart defects in children with Down's syndrome]. / Resultados en la corrección quirúrgica de la cardiopatía congénita en el síndrome de Down.

We made a retrospective study of patients with Down's syndrome that were surgically treated for correction or palliation for their congenital heart disease between january 1996 to december of the 2000 in the National Institute of Cardiology "Ignacio Chávez". We analyzed these variables: age at the surgical moment, sex, congenital heart defect, pulmonary arterial pressure, type of surgery, time of stay in the intensive care unit, complications and mortality. In this period they were surgically treated 37 patients. The mean age was of 2 years with 8 months with a range of 2 months to 17 years. The interventricular defect was the most frequent one (35%) and it was associated to persistent ductus arteriosus in the 61% of the cases. Six patients (16%) had atrioventricular septal defect, the half of them type A and other half type C of Rastelli classification. Twelve patients (32%) had one lesion persistent ductus arteriosus. Three patients had tetralogy of Fallot and two atrial septal defect. Pulmonary hypertension was found in 90% of the patients, in 23 was severe (62%), moderate in 5 and slight in 6 (16%). The surgical treatment was corrective in 89% patients and the average time of stay in intensive care unit was of 2.5 days. The most frequent complication was rhythm and conduction disorders, in 8 patients (22%), three with complete AV block and the mortality was of 8%. In the patients with Down's syndrome is important a complete clinical evaluation with an eye toward establishing an opportune surgical treatment.

Patent ductus arteriosus at low and high altitudes: anatomical and haemodynamic features and their implications for transcatheter closure.

BACKGROUND: Living at high altitude increases the prevalence of patent ductus arteriosus (PDA) and may affect its morphology. AIM: To compare the anatomical and haemodynamic features of isolated PDA in patients living at low and high altitudes (1,500-4,200 metres above sea level - m.a.s.l.). METHODS: We studied retrospectively data from 1,404 consecutive patients - 708 living in lowland areas (group L) and 696 in highland areas (group H), in whom transcatheter closure of PDA was attempted. The mean age of the patients in group L was 9.9 ± 13.5 years and in group H it was 8.2 ± 19.7 years. RESULTS: The diameter of PDA in group L was 2.3 ± 1.3 mm and 4.1 ± 1.2 mm in group H (p < 0.001), while the mean pulmonary artery pressure was 17.9 ± 5.9 mm Hg and 25.5 ± 12.3 mm Hg, respectively (p < 0.001). Angiographic PDA type A was more frequently observed in highland patients. In groups L and H, self expanding nitinol occluders (mostly Amplatzer devices) were used in 25.7% vs 92.2% of patients (p < 0.001), whereas coils were used in 69.2% vs 7.5% (p < 0.001), respectively. Double umbrella systems were used in 4.8% of patients in group L. CONCLUSIONS: In catheterised patients with PDA living at high altitude, larger ductal diameter, anatomic type A and higher pulmonary artery pressure were more frequently observed. This finding has important implications for future strategy regarding transcatheter closure in populations living at different altitudes. Kardiol Pol 2011; 69, 5: 431-436.

Percutaneous closure of hypertensive ductus arteriosus.

BACKGROUND: The Amplatzer duct occluder (ADO) has been used with success to close large patent ductus arteriosus (PDA), but some problems exist especially with hypertensive PDAs, such as incomplete closure, haemolysis, left pulmonary artery stenosis, obstruction of the descending aorta and progressive pulmonary vascular disease. METHODS AND RESULTS: We analysed a group of 168 patients with isolated PDA and pulmonary artery systolic pressure (PSAP) > or =50 mm Hg. Mean age was 10.3 +/- 14.3 years (median 3.9), PDA diameter was 6.4 +/- 2.9 mm (median 5.9), PASP was 63.5 +/- 16.2 mm Hg (median 60), Qp/Qs was 2.7 +/- 1.2 (median 2.5), total pulmonary resistance index (PRI) was 3.69 +/- 2.15 (median 3.35) and vascular PRI was 2.73 +/- 1.72 (median 2.37). We used ADOs in 145 (86.3%) cases, Amplatzer muscular ventricular septal defect occluders (AMVSDO) in 18 (10.7%), Amplatzer septal occluders (ASO) in three (1.8%) and the Gianturco-Grifka device in two (1.2%) cases. Device diameter was 106.3% +/- 51% higher than PDA diameter. PASP decreased after occlusion to 42.5 +/- 13.3 mm Hg (p<0.00001). Immediately after closure, no or trivial shunt was present in 123 (74.5%) cases. Immediate complications were device embolisation in five (3%) cases and descending aortic obstruction in one case. The overall success rate was 98.2%. Follow-up in 145 (86.3%) cases for 37.1 +/- 24 months (median 34.1) showed further decrease of the PASP to 30.1 +/- 7.7 mm Hg (p<0.0001). CONCLUSIONS: Percutaneous treatment of hypertensive PDA is safe and effective. ADO works well for most cases, but sometimes other devices (MVSDO or ASO) have to be used. When cases are selected adequately, pulmonary pressures decrease immediately and continue to fall with time.

Transcatheter versus surgical closure of secundum atrial septal defect in adults: impact of age at intervention. A concurrent matched comparative study.

OBJECTIVES: To compare the short- and mid-term outcomes of surgical (SUR) vs. transcatheter closure of secundum atrial septal defect (ASD) using Amplatzer septal occluder (ASO) in adults with a very similar spectrum of the disease; and to identify predictors for the primary end point. DESIGN: Single-center, concurrent comparative study. Surgically treated patients were randomly matched (2:1) by age, sex, date of procedure, ASD size, and hemodynamic profile. SETTING: Tertiary referral center. PATIENTS: One hundred sixty-two concurrent patients with ASD submitted to ASO (n = 54) or SUR closure (n = 108) according with their preferences. MAIN OUTCOME MEASURES: Primary end point was a composite index of major events including failure of the procedure, important bleeding, critical arrhythmias, serious infections, embolism, or any major cardiovascular intervention-related complication. Predictors of these major events were investigated. RESULTS: Atrial septal defects were successfully closed in all patients, and there was no mortality. The primary event rate was 13.2% in ASO vs. 25.0% in SUR (P = .001). Multivariate analysis showed that higher rate of events was significantly associated with age >40 years; systemic/pulmonary output ratio <2.1; and systolic pulmonary arterial pressure >50 mm Hg; while in the ASO group the event rate was only associated with the ASD size (>15 cm(2)/m(2); relative risk = 1.75, 95% confidence interval 1.01-8.8). There were no differences in the event-free survival curves in adults with ages <40 years. CONCLUSIONS: The efficacy for closure ASD was similar in both groups. The higher morbidity observed in SUR group was observed only in the patients submitted to the procedure with age >40 years. The length of hospital stay was shorter in the ASO group. Surgical closure is a safe and effective treatment, especially in young adults. There is certainly nothing wrong with continuing to do surgery in countries where the resources are limited.

Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: immediate and midterm results of an international registry.

OBJECTIVE: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). METHODS: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7-58 years) and the median weight was 27.5 kg (7-121 kg). RESULTS: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5-13 mm), median device size 10 mm (4-16 mm) and median fluoroscopy time 22.1 min (8.9-96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1-763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015). CONCLUSION: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device.