Outcome after transcatheter occlusion of patent ductus arteriosus in infants less than 6 kg: A national study from United Kingdom and Ireland.

OBJECTIVES: This study aimed to report our national experience with transcatheter patent ductus arteriosus (PDA) occlusion in infants weighing <6 kg. BACKGROUND: The technique of transcatheter PDA closure has evolved in the past two decades and is increasingly used in smaller patients but data on safety and efficacy are limited. METHODS: Patients weighing < 6 kg in whom transcatheter PDA occlusion was attempted in 13 tertiary paediatric cardiology units in the United Kingdom and Ireland were retrospectively analyzed to review the outcome and complications. RESULTS: A total of 408 patients underwent attempted transcatheter PDA closure between January 2004 and December 2014. The mean weight at catheterization was 4.9 ± 1.0 kg and mean age was 5.7 ± 3.0 months. Successful device implantation was achieved in 374 (92%) patients without major complication and of these, complete occlusion was achieved in 356 (95%) patients at last available follow-up. Device embolization occurred in 20 cases (5%). The incidence of device related obstruction to the left pulmonary artery or aorta and access related peripheral vascular injury were low. There were no deaths related to the procedure. CONCLUSIONS: Transcatheter closure of PDA can be accomplished in selected infants weighing <6 kg despite the manufacturer's recommended weight limit of 6 kg for most ductal occluders. The embolization rate is higher than previously reported in larger patients. Retrievability of the occluder and duct morphology needs careful consideration before deciding whether surgical ligation or transcatheter therapy is the better treatment option.

Transcatheter Retrieval of Cardiovascular Foreign Bodies in Children: A 15-Year Single Centre Experience.

There has been a rapid increase in the practice of interventional catheter treatment of congenital heart disease. Catheter retrieval of embolized cardiac devices and other foreign bodies is essential, yet no large studies have been reported in the paediatric population. Retrospective 15-year review of all children who underwent transcatheter foreign body retrieval in a tertiary cardiac centre from January 1997 to September 2012. Transcatheter retrieval of foreign bodies from the cardiovascular system was attempted in 78 patients [median age 4 (0.02-16) years and median weight 15 (1.7-74) kg] including 46 embolized devices. Transcatheter retrieval was successful in 70/78 (90%), surgical retrieval was required in 6. In two patients, small embolized coils were left in situ. Gooseneck snare was the most commonly used retrieval device. Median procedure and screening times were 90 (15-316) and 31 (2-161) min, respectively. There were no procedural deaths. Transient loss of foot pulses occurred in 5 and 2 patients required blood transfusion. Transcatheter retrieval of cardiovascular foreign bodies can be performed safely in the majority of children thus obviating the need for surgery. It is essential to have a comprehensive inventory of retrieval equipment and interventional staff conversant with its use.

Percutaneous Device Closure of Paravalvular Leak: Combined Experience From the United Kingdom and Ireland.

BACKGROUND: Paravalvular leak (PVL) occurs in 5% to 17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery. METHODS: All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. RESULTS: Three hundred eight PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67±13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches. Nineteen percent of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved postprocedure (P<0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association class improved from 2.7±0.8 preprocedure to 1.6±0.8 (P<0.001) after a median follow-up of 110 (7-452) days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (P<0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; P=0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; P=0.037), New York Heart Association class (HR, 2.00; P=0.015) at follow-up and baseline creatinine (HR, 8.19; P=0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; P=0.002). CONCLUSION: Percutaneous closure of PVL is an effective procedure that improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.

Permanent trans-venous pacing in an extra-cardiac Fontan circulation.

AIMS: In patients with an extra-cardiac Fontan circulation, there is no direct access to the heart. The insertion of a permanent pacemaker requires surgery to insert epicardial pacing wires. We present the implantation of a permanent endocardial pacing lead from the superior vena cava (SVC) into the atrium via direct passage from the right pulmonary artery (RPA). METHODS AND RESULTS: A permanent pacing lead was passed directly from the SVC to the RPA and then into the atrial mass. Direct passage from the RPA (attached directly to the right SVC) into the atrial mass was achieved using a trans-septal puncture needle. CONCLUSION: This novel technique is an alternative to epicardial pacing in patients with an extra-cardiac Fontan circulation, thus avoiding the need for surgical intervention. It may also be applied to gain access to the atrial mass for arrhythmia ablation therapy.

Twenty-year outcome of anomalous origin of left coronary artery from pulmonary artery: management of mitral regurgitation.

BACKGROUND: This study is a single-center experience with surgical repair of anomalous origin of left coronary artery from pulmonary artery (ALCAPA) with focus on the management of associated mitral regurgitation (MR). METHODS: We performed a retrospective analysis of cases presenting to a quaternary referral center between November 1990 and October 2011. RESULTS: In all, 25 patients (18 female) presented with a diagnosis of ALCAPA at a median age of 5 months (range, 1.5 to 102). Twenty-one patients (84%) had moderate to severe impairment of left ventricular function with median fractional shortening of 14% (range, 2% to 33%), and 19 patients (76%) had moderate to severe MR. Surgery was performed with direct coronary reimplantation in 16 patients (64%) and intrapulmonary tunnel (Takeuchi repair) in 9 (36%). Four patients had mitral valve repair at time of surgery, all for structural anomalies. Functional MR with a structurally normal mitral valve was not repaired. The median duration of postoperative follow-up was 93 months (range, 9 to 240). There were no early or late deaths, and no patient required mechanical support. Four patients (16%) required surgical or catheter reintervention. At last follow-up, 24 of 25 patients were asymptomatic; the left ventricular function was normal in 22 patients. Moderate MR was present in 4 patients. There was significant improvement in left ventricular function and MR (p < 0.01) during follow-up. CONCLUSIONS: Surgical repair of ALCAPA has good long-term results with low mortality and reintervention rates. The majority of MR is functional and will improve with reperfusion, but structural mitral valve abnormalities should be repaired at the time of surgery.

Catheter interventions in the staged management of hypoplastic left heart syndrome.

AIM: To analyse the current practice and contribution of catheter interventions in the staged management of patients with hypoplastic left heart syndrome. METHODS: This study is a retrospective case note review of 527 patients undergoing staged Norwood/Fontan palliation at a single centre between 1993 and 2010. Indications and type of catheter interventions were reviewed over a median follow-up period of 7.5 years. RESULTS: A staged Norwood/Fontan palliation for hypoplastic left heart syndrome was performed in 527 patients. The 30-day survival rate after individual stages was 76.5% at Stage I, 96.3% at Stage II, and 99.4% at Stage III. A total of 348 interventions were performed in 189 out of 527 patients. Freedom from catheter intervention in survivors was 58.2% before Stage II and 46.7% before Stage III. Kaplan-Meier freedom from intervention post Fontan completion was 55% at 10.8 years of follow-up. Post-stage I interventions were mostly directed to relieve aortic arch obstruction--84 balloon angioplasties--and augment pulmonary blood flow--15 right ventricle-to-pulmonary conduit interventions; post-Stage II interventions centred on augmenting size of the left pulmonary artery--73 procedures and abolishing systemic venous collaterals--32 procedures. After Stage III, the focus was on manipulating the size of the fenestration--42 interventions--and the left pulmonary artery -31 procedures. CONCLUSION: Interventional cardiac catheterisation constitutes an integral part in the staged palliative management of patients with hypoplastic left heart syndrome. Over one-third (37%) of patients undergoing staged palliation required catheter intervention over the follow-up period.

Stenting of the right ventricular outflow tract.

OBJECTIVE: To assess the indication, technical aspects, and outcome of stenting of the right ventricular outflow tract (RVOT) in the management of symptomatic patients with severely limited pulmonary blood flow. METHODS: Retrospective case note and procedure review of patients undergoing stenting of the RVOT over an 8 year period. PATIENTS: Between 2005 and 2012, 52 selected patients underwent percutaneous stent implantation into a very narrow RVOT to improve pulmonary blood flow. Median age at stent implantation was 63 (range 4-406) days and median weight was 3.8 (1.7-12.2) kg. RESULTS: 52 patients underwent stent implantation. Median procedure time was 57 (24-260) min and fluoroscopy time 16 (5.5-73) min. There was one procedural death (1.9%) and one emergency surgery (1.9%). Saturations increased from 71% (52-83%) to 92% (81-100%) (p<0.001). Two patients required early shunts due to inadequate palliation and two died from non-cardiac causes. Sixteen further catheter interventions were undertaken (balloon in 7, further stent in 9). Twenty-nine patients underwent delayed surgery (complete repair in 26, palliative in 3) at a median of 172 (52-758) days post-stenting. Left pulmonary artery Z score increased from a pre-interventional value of -1.75 (-4.96 to 0.67) to a pre-surgical value of -0.55 (-4.12 to 1.97), (p<0.01). Median right pulmonary artery Z score increased from -2.63 (-7.70 to 0.89) to -0.75 (-6.69 to 1.18) (p<0.01) . Seventeen patients remain well palliated after a median of 122 (40-286) days. CONCLUSIONS: Stenting of the RVOT is an effective treatment option in the initial management of selected patients with very reduced pulmonary blood flow.

Surgery following primary right ventricular outflow tract stenting for Fallot's tetralogy and variants: rehabilitation of small pulmonary arteries.

OBJECTIVES: Primary surgical repair of Tetralogy of Fallot (ToF) in small infants with small pulmonary arteries (PAs) or complex anatomies can be hazardous. We assessed the effect of right ventricular outflow tract (RVOT) stenting on subsequent surgical intervention with attention to growth of the PAs. METHODS: Primary RVOT stenting was performed in 32 symptomatic patients with ToF physiology. Twenty patients had surgical intervention, with 15 undergoing complete repair to date. Median age at stenting was 61 (range 8-406) days, and median weight, 3.9 (range 1.8-12.2) kg. RESULTS: Stenting improved saturations from 72 ± 8 to 92 ± 2% (P < 0.001). Four patients required early surgical palliation for persistent desaturation (within 4 weeks). Twenty patients went on to have surgical intervention at a median time of 220 days after stenting. There was no operative mortality after complete repair. Removing the stent lengthened the procedure time and 86% required transannular patch (TAP; bypass time 109 ± 42 min, cross clamp 68 ± 29 min). Median intensive therapy unit stay was 2 days. There was 1 late death at 3 months due to chronic lung disease. The median left PA Z-score increased from a preinterventional value of -1.27 (-0.19 to -2.87) to a presurgical value of +0.11 (-4.12 to +1.97). The median right PA Z-score increased from -2.02 (-1.77 to -4.68) to -0.65 (-0.29 to -2.04) over the preinterventional and presurgical time intervals. Growth was greatest in the right PA. CONCLUSIONS: Primary RVOT stenting facilitates staged palliation for ToF in small infants and complex anatomies. Improved PA blood flow generated by the stent leads to growth of the branch PAs and may improve the substrate for subsequent surgical repair. Surgery is safe; however, the majority will require a TAP.

Percutaneous radiofrequency septal reduction for hypertrophic obstructive cardiomyopathy in children.

OBJECTIVES: The aim of this study was to assess the efficacy of radiofrequency catheter ablation (RFCA) in the treatment of hypertrophic obstructive cardiomyopathy in children. BACKGROUND: Hypertrophic obstructive cardiomyopathy is an uncommon cause of left ventricular outflow tract obstruction in children. In symptomatic patients, open heart surgical myectomy has hitherto been the only therapeutic option. METHODS: In 32 children, at a median age of 11.1 (range 2.9 to 17.5) years and weight of 31 (15 to 68) kg, ablation of the hypertrophied septum was performed using a cool-tip ablation catheter via a femoral arterial approach. The median number of lesions was 27 (10 to 63) and fluoroscopic time was 24 (12 to 60) min. RESULTS: The majority of patients demonstrated an immediate decrease in the catheter pullback gradient (mean 78.5 ± 26.2 mm Hg pre-RFCA versus mean 36.1 ± 16.5 mm Hg post-RFCA, p < 0.01) and a further reduction in the Doppler echocardiographic gradient (mean 96.9 ± 27.0 mm Hg pre-RFCA versus 32.7 ± 27.1 mm Hg post-RFCA, p < 0.01) at follow-up. One patient died due to a paradoxical increase in left ventricular outflow tract obstruction, and another had persistent atrioventricular block that required permanent pacing. Six patients required further procedures (surgery, pacing, or further RFCA) during a median follow-up of 48 (3 to 144) months. CONCLUSIONS: The preliminary results of RFCA for septal reduction in children with hypertrophic cardiomyopathy are promising and merit further evaluation.

The role of echocardiography in percutaneous left atrial appendage occlusion.

Percutaneous device closure of the left atrial appendage (LAA) has been introduced in the last decade as a minimally invasive alternative treatment to long-term anticoagulation to reduce the risk of thrombo-embolism in patients with atrial fibrillation. Echocardiography is an essential tool at all stages of the procedure. Pre-procedural echocardiography is used to screen suitable candidates and to define LAA morphology and dimension; peri-procedural transoesophageal or intracardiac echocardiography has a major role in guiding, delivery, and deployment of the device, for screening of procedural complications and for assessing procedural success; and post-procedural echocardiography is important in the surveillance and monitoring of long-term outcome. This article aims to outline the role of echocardiography at each stage of LAA occlusion.

Transcatheter interventions in the early postoperative period after the Fontan procedure.

OBJECTIVE: To analyze the safety and clinical impact of interventional cardiac catheter procedures in the management of early postoperative problems after completion of an extracardiac Fontan procedure. BACKGROUND: The mortality after Fontan procedure has consistently decreased over the last decade. The role of interventional catheterization to address early postoperative problems in this setting has not been studied systematically. METHODS: Over a 9.7-year period, 289 patients underwent an extracardiac fenestrated Fontan procedure with two early deaths (0.7%) and takedown in four (1.4%). Twenty-seven patients (9.3%) underwent 32 interventional cardiac catheter procedures at a median interval of 12.2 (1-30) days. The median weight was 14.5 (13.5-25) kg. The case notes and procedure records were reviewed retrospectively. RESULTS: Fontan pathway obstructions were treated in 11 patients with stent implantation with good results and no complications. Stent fenestration of the Fontan circulation was performed in 16 patients with one episode of transient hemiparesis and one episode of pericardial effusion. Three patients underwent initial balloon dilatation of branch pulmonary arteries or fenestration with little effect and underwent stent treatment 6 (5-9) days later. One patient had device closure of a large atrial fenestration. In one patient, residual anterograde pulmonary blood flow was occluded using a device. There were no deaths and in-hospital course was improved in all. CONCLUSION: Interventional cardiac catheter procedures can be performed safely and effectively in the early postoperative period after Fontan completion to address hemodynamic problems. These techniques contribute significantly to achieve a very low mortality and address morbidity after Fontan completion.

Rapid ventricular pacing for catheter interventions in congenital aortic stenosis and coarctation: effectiveness, safety, and rate titration for optimal results.

INTRODUCTION: Infants and children with congenital aortic stenosis and coarctation of the aorta can be treated by catheter intervention. There are several pharmacological and mechanical techniques described to overcome the balloon movement; none, however, have proved entirely satisfactory. An alternative method to achieve balloon stability is the use of rapid ventricular pacing. We describe our experience with titrating the pacing rate and the use of this technique. METHODS: A retrospective review of database was performed, to identify patients who underwent transcatheter intervention with rapid ventricular pacing. Invasive systemic pressures were documented with a catheter in the aorta. Rapid ventricular pacing was initiated at the rate of 180 per minute and increased by increments of 20 per minute to a rate required to achieve a drop in systemic pressure by 50% and a drop in pulse pressure by 25%. The balloon was inflated only after the desired pacing rate was reached. Pacing was continued until the balloon was completely deflated. RESULTS: Thirty patients were identified, 29 of whom had interventions with rapid ventricular pacing. Balloon valvuloplasty of aortic valve was performed on 25 patients while 4 patients had stenting for coarctation by this technique. The rate of ventricular pacing required ranged from 200 to 260 per minute with a median rate of 240. Balloon stability at the time of intervention was achieved in 27 patients. CONCLUSION: Rapid ventricular pacing is a safe and effective method to provide transient decrease in cardiac output at the time of transcatheter interventions to achieve balloon stability.

Treatment of dynamic subvalvar muscular obstruction in the native right ventricular outflow tract by percutaneous stenting in adults.

Percutaneous techniques are being increasingly used in adult congenital heart disease but there is limited experience in the treatment of native nonvalvar right ventricular outflow tract obstruction. We describe two cases of percutaneous stenting of the subpulmonary region where surgery was not an option.

Acquired thoracic aortic interruption: percutaneous repair using graft stents.

Two adult patients with isolated, aortic interruption were successfully treated by percutaneous insertion of graft stents. Prior to the intervention, both patients were hypertensive and on medication. In both cases, an ascending aortogram demonstrated a blind ending of the thoracic aorta distal to the left subclavian artery with a large gradient across the interruption and with multiple collaterals. A graft stent was successfully deployed across the interrupted segment in both cases. We believe that this is one of the first reported cases of percutaneous stenting of aortic interruption and represents a promising new therapeutic option for these adult patients.

Surgical management of hypoplastic left heart syndrome at the Birmingham Children's Hospital.

Currently, a three-stage surgical palliation remains the treatment of choice at Birmingham Children's Hospital. After initial introduction of the classical Norwood with pulmonary blood flow provided by a modified Blalock-Taussig shunt, a right ventricular to right pulmonary artery conduit at stage 1 Norwood palliation is now used in most cases, a bi-directional 'Glenn' shunt at second stage and an extra-cardiac Fontan completion at third stage. Mortality and morbidity has improved after modification of the technique. Thirty-day mortality was 32.4% (79/244) for the 'classical' Norwood procedure, 25.0% (7/28) for the left-sided RV-PA conduit and 12.7% (22/173) for the right-sided RV-PA conduit. Interstage mortality was 8.6% (21/244) for the 'classical' Norwood procedure, 14.3% (4/28) for the left and 10.1% (15/148) for right-sided RV-PA conduit. After stage II, 30-day mortality was 3.0% (10/335) for all groups. Stage III 30-day mortality was 0.9% (1/115) for all groups.

Transvenous pacing via a disconnected superior vena cava in a patient with transposition of the great arteries.

We describe successful implantation of a permanent pacemaker via the right subclavian vein in a 28-year-old man with operated transposition of the great arteries where the superior vena cava is completely disconnected from the systemic venous atrium following a previous Glenn procedure.

Femoral vascular access complications in adult congenital heart disease patients: audit from a single tertiary center.

OBJECTIVE: To determine the rate of vascular access complications in patients with adult congenital heart disease (ACHD). BACKGROUND: Complications of femoral access following coronary angiography or percutaneous coronary intervention have been studied extensively, but the complication rate following catheterization and intervention in ACHD patients is poorly documented. DESIGN, SETTING, AND OUTCOME MEASURES: We present a retrospective audit of vascular access complications in a large tertiary ACHD center over a 12-month period. Complications were defined as any clinically significant hematoma, pseudoaneurysm, arteriovenous fistula, or bleeding resulting in the need for imaging, transfusion, vascular or radiological intervention, or delayed discharge. RESULTS: Of 197 procedures (102 interventions and 95 cardiac catheterizations), a complication rate of 3.6% was identified, comparable to that of coronary angiography and percutaneous coronary intervention. The main complications were femoral artery pseudoaneurysm and hematoma resulting in delayed discharge by a mean of 2(2/3) days (range 1-4 days). Predictors of risk for vascular complications include female sex, history of diabetes, and anticoagulation; larger sheath sizes and obesity were not associated with higher complication rate. CONCLUSIONS: Adult congenital heart disease patients represent a unique and ever-growing population with a higher incidence of catheterization as children, surgical cut-down scars and anatomical variants. We present a low incidence of femoral access complications in interventional and diagnostic procedures in a large series of ACHD patients over a 12-month period. Patients with risk factors for vascular complications may be considered for device closure of the venous access site.

The morphologic left ventricle that requires training by means of pulmonary artery banding before the double-switch procedure for congenitally corrected transposition of the great arteries is at risk of late dysfunction.

OBJECTIVE: The aim of this study was to compare the outcome of the double-switch procedure for congenitally corrected transposition of the great arteries for patients completing morphologic left ventricle training by means of pulmonary artery banding with the outcome of patients whose morphologic left ventricle did not require training. METHODS: A retrospective study of all patients undergoing the double-switch procedure from 1991 through 2004 was performed. Patients were divided into 2 groups: those not requiring morphologic left ventricle training (n = 33) and those completing morphologic left ventricle training by means of pulmonary artery banding (n = 11). RESULTS: The time spent with the morphologic left ventricle conditioned at systemic pressures was longer for the group not requiring morphologic left ventricle training (median, 730 days; interquartile range, 399-1234 vs median, 436 days; interquartile range, 411-646; P = .19). The overall mortality (not requiring morphologic left ventricle training, 12.1%; requiring morphologic left ventricle training, 9.1%; P = 1) and rate of death/transplantation, development of moderate-to-severe morphologic left ventricle dysfunction, or both (not requiring morphologic left ventricle training, 21.2%; requiring morphologic left ventricle training, 45.5%; P = .14) were similar between groups. Actuarial freedom from death/transplantation with good morphologic left ventricular function was superior for patients whose morphologic left ventricle did not require training (P = .04). The follow-up was not different between groups (not requiring training: median, 1435 days [interquartile range, 285-2570 days]; requiring morphologic left ventricle training: median, 568 days [interquartile range, 399-1465 days]; P = .14). On multivariate analysis, the completion of morphologic left ventricle training predicted death/transplantation, development of moderate-to-severe morphologic left ventricle dysfunction, or both (P = .02). CONCLUSIONS: The early results of the double-switch procedure in patients whose morphologic left ventricle required training compare favorably with those of patients whose morphologic left ventricle required no training. There is an increased risk of deterioration of morphologic left ventricle function over time in patients whose morphologic left ventricle requires training, and these patients need to be followed up regularly to detect this.

Migraine Intervention With STARFlex Technology (MIST) trial: a prospective, multicenter, double-blind, sham-controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache.

BACKGROUND: Patent foramen ovale (PFO) is prevalent in patients with migraine with aura. Observational studies show that PFO closure resulted in migraine cessation or improvement in approximately 80% of such patients. We investigated the effects of PFO closure for migraine in a randomized, double-blind, sham-controlled trial. METHODS AND RESULTS: Patients who suffered from migraine with aura, experienced frequent migraine attacks, had previously failed > or = 2 classes of prophylactic treatments, and had moderate or large right-to-left shunts consistent with the presence of a PFO were randomized to transcatheter PFO closure with the STARFlex implant or to a sham procedure. Patients were followed up for 6 months. The primary efficacy end point was cessation of migraine headache 91 to 180 days after the procedure. In total, 163 of 432 patients (38%) had right-to-left shunts consistent with a moderate or large PFO. One hundred forty-seven patients were randomized. No significant difference was observed in the primary end point of migraine headache cessation between implant and sham groups (3 of 74 versus 3 of 73, respectively; P=0.51). Secondary end points also were not achieved. On exploratory analysis, excluding 2 outliers, the implant group demonstrated a greater reduction in total migraine headache days (P=0.027). As expected, the implant arm experienced more procedural serious adverse events. All events were transient. CONCLUSIONS: This trial confirmed the high prevalence of right-to-left shunts in patients with migraine with aura. Although no significant effect was found for primary or secondary end points, the exploratory analysis supports further investigation. The robust design of this study has served as the model for larger trials that are currently underway in the United States and Europe.

Transcatheter closure of congenital ventricular septal defects: results of the European Registry.

AIM: To report the experience of 23 tertiary referral European Centres on transcatheter closure of congenital ventricular septal defects (VSD). METHODS AND RESULTS: Implantation of transcatheter devices was attempted in 430 patients (pts) with congenital VSDs until July 2005. The following anatomic types were present: 119 muscular, 250 perimembranous, 16 multiple, 45 residual post-surgery. Median VSD size was 7 mm (range 3-22), fluoroscopy time 33 min (range 3-146). Devices implanted were Amplatzer muscular or membranous devices in 364, PDA devices in 12, ASD devices in seven, Starflex in seven, and coils in nine patients. Procedure was successful in 410 cases (95%). COMPLICATIONS: device embolization in five cases (surgery in two, catheter retrieval in three), aortic regurgitation in 14 cases (two of which requiring surgery), tricuspid regurgitation in 27 cases (no surgery was necessary), minor rhythm disturbances in 10 pts, death in one patient, complete heart block (cAVB) in 16 pts [perimembranous 12 of 250 (5%), muscular one of 119 (0.8%), residual post-surgery VSD three of 45 (6.7%)]. CAVB was transient in six patients, requiring permanent pace-makers in 10 cases (3.8%) (six early, four late). In the multivariate analysis, the only variable associated with a risk of the occurrence of complication was age (P=0.012) and weight (P=0.0035). In the univariate analysis, risk factors for the development of cAVB were, device type (P=0.03) and VSD location (P=0.05). After the multivariable Cox proportional hazards analysis, no risk factor was found. CONCLUSION: Transcatheter closure of congenital VSDs offers encouraging results. COMPLICATIONS are limited; the most relevant one seems to be the device related to cAVB in perimembranous VSD. More experience and long-term follow-up are mandatory to assess safety and effectiveness of this procedure as an alternative to conventional surgery.