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Objective We compared 5-year outcomes of transcatheter pulmonary valve (TPV) replacement with the Melody TPV in the post-approval study (PAS) and the investigational device exemption (IDE) trial. Background As a condition of approval of the Melody TPV after the IDE trial, the Food and Drug Administration required that a PAS be conducted to evaluate outcomes of TPV replacement in a "real-world" environment. The 5-year outcomes of the PAS have not been published, and the IDE and PAS trials have not been compared. Methods The cohorts comprised all patients catheterized and implanted at 5 IDE sites and 10 PAS sites. Differences in trial protocols were detailed. Time-related outcomes and valve-related adverse events were compared between the two trials with Kaplan-Meier curves and log-rank testing. Results 167 patients (median age, 19 years) were catheterized and 150 underwent TPV replacement in the IDE trial; 121 were catheterized (median age, 17 years) and 100 implanted in the PAS. Freedom from hemodynamic dysfunction (p = .61) or any reintervention (p = .74) over time did not differ between trials. Freedom from stent fracture (p = .003) and transcatheter reintervention (p = .010) were longer in PAS, whereas freedom from explant (p = .020) and TPV endocarditis (p = .007) were shorter. Clinically important adverse events (AEs) were reported in 14% of PAS and 7.2% of IDE patients (p = .056); the incidence of any particular event was low in both. Conclusions Hemodynamic and time-related outcomes in the PAS and IDE trials were generally similar, confirming the effectiveness of the Melody TPV with real-world providers. There were few significant complications and limited power to identify important differences in AEs. The lack of major differences in outcomes between the two studies questions the usefulness of mandated costly post-approval studies as part of the regulatory process for Class III medical devices.

BACKGROUND Since FDA approval of the Melody valve, transcatheter pulmonary valve replacement (TPVR) has been offered to an expanding population. Limited data exist regarding the safety and feasibility of TPVR in smaller patients. METHODS All patients weighing

Background: Secundum atrial septal defect (ASD) closure devices were granted approval based on industry-sponsored, prospective, nonrandomized, single device studies, demonstrating acceptable efficacy and safety in selected patients. We sought to report community practice and outcomes. Methods and Results: Procedure specific data was collected on cases considered for ASD closure in the congenital cardiac catheterization project on outcomes (C3PO) between February 1, 2007 and June 31, 2010. Eight centers contributed data during this time period. All adverse events (AE) were independently reviewed and classified by a five level severity scale. In 40 months (2/07–6/10), 653 of 688 ASDs were occluded with a single device using an AMPLATZER® Septal Occluder (ASO) in 566 (87%), GORE® HELEX® Septal Occluder (HSO) in 33 (5%), and a CardioSEAL® or STARFlex™ device (CSD) in 54 (8%). Most patients had an isolated ASD (93%). 85% were >2 years of age. The ASD median diameter was 12 mm [8,16] for ASO, with smaller diameters in HSO 8 mm [7,10] and CSD 8 mm [5,10] (P

BACKGROUND: Quantitative assessment of right ventricular (RV) function is important for the management of patients with congenital heart disease. Tissue Doppler (TDI)-derived myocardial acceleration during isovolumic contraction (IVA) is an echocardiographic measure of contractility that is independent of loading conditions. The aim of this study was to establish normative data for IVA at the lateral tricuspid valve annulus (RV IVA).METHODS: This is a retrospective study of 340 children who had normal echocardiograms. We analyzed RV IVA in relation to age, body surface area (BSA), gender, heart rate (HR), tricuspid annular plane systolic excursion (TAPSE), and TDI-derived S' (RV S').RESULTS: RV IVA showed a positive correlation with HR (r = 0.58, P 160 bpm. When RV IVA was corrected for HR (RV IVAc), it became independent of HR, age, BSA, and gender. The mean RV IVAc was 2.3 m/sec(1.5) (±2 SD: 1.1-3.6 m/sec(1.5) ). There was a correlation of normalized RV IVAc with normalized TAPSE and RV S'.CONCLUSION: RV IVA, a marker of RV contractility, shows a strong dependence on HR. HR corrected RV IVA (RV IVAc) is independent of age, BSA, gender, and HR. We suggest measuring RV IVAc routinely in patients at risk for RV dysfunction. (Less)

Trans-catheter balloon angioplasty is a well-established treatment modality for pulmonary artery (PA) stenosis in children with congenital heart disease. We report a case of an unusual complication where a fistula developed between the left PA and the left atrium during balloon angioplasty in a patient with history of tetralogy of Fallot. This was successfully treated with placement of a covered stent.

A covered stent was used for percutaneous closure of an unroofed coronary sinus in an infant with congestive heart failure secondary to increased pulmonary flow. Prior to the stent deployment, the location of the entrance of the coronary vein into the coronary sinus was demonstrated with a selective left coronary artery angiogram to facilitate placement of the stent. The procedure was well tolerated without complications. The infant's symptoms improved significantly after the procedure.

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.

Early spontaneous closure of a fenestration following Fontan palliation may complicate the postoperative management of such patients. The creation of a fenestration in the catheterization laboratory with an intravascular stent may improve these patients' hemodynamic status. The aim of this study is to present a new technique to reduce the diameter of stented Fontan fenestrations in those patients in whom the stent diameter is functionally made too large.

Objective: The purpose of this study is to evaluate the recently FDA-approved AMPLATZER® Vascular Plug in the embolization of vascular lesions associated with congenital heart disease (CHD). Background: Fistulas and arteriovenous malformations have been occluded using various devices. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device, used for embolization in the peripheral vasculature. Methods: A total of 84 vessels in 52 patients with CHD from 11 centers were occluded with 89 AMPLATZER Vascular Plugs, delivered through a coronary guide catheter in various vascular sites, including collaterals, pulmonary arterio-venous and coronary artery fistulas, transhepatic tracts, central shunts, patent ductus arteriosus (PDA), and excluded hepatic vein. Complete vessel occlusion was demonstrated within 10 min in 94% of patients. Results: There was no device embolization, vascular disruption, or procedure-related complication. One vascular plug implanted in a large type C PDA required surgical removal followed by PDA ligation, after 5 weeks from successful implant because of significant residual flow through the device. Conclusions: The AMPLATZER Vascular Plug is an effective transcatheter occlusion device in the embolization of a wide variety of vascular lesions associated with CHD. Based on our early experience, caution should be used when considering the Vascular Plug as a closure device for large PDA. © 2005 Wiley-Liss, Inc.

Survival following cardiac transplantation in children and adults, including the group with complex congenital heart disease, has improved over the last decade secondary to medical and surgical advances in management. There have been rare reports of superior vena cava obstruction at anastomotic sites following transplantation. In patients following heart transplantation, venous stenosis can limit the ability to perform endomyocardial biopsies. We reviewed our experience in three patients who underwent cardiac transplantation and developed significant venous stenosis requiring intervention. All three were successfully treated by transcatheter implantation of endovascular stents. Endovascular stent implantation for venous obstruction in patients following cardiac transplantation was safe and effective, allowing improved ease of catheterization for future posttransplantation monitoring and surveillance.

Endovascular stent implantation for pulmonary artery stenosis requires the use of a long, large-bore vascular sheath to insure precise implantation without embolization or malposition. A long vascular sheath may be difficult to position and usage may be associated with vascular compromise and/or hemodynamic embarrassment, especially in infants and small children. We report a new technique for pulmonary artery endovascular stent implantation without the use of a long sheath. From December 2000 to May 2001, 10 patients underwent implantation of 13 Palmaz Corinthian premounted biliary transhepatic stents for pulmonary artery stenosis. Median age was 0.8 years (range, 0.5-18.5) and median weight was 11.8 kg (range, 4.6-65). Patient diagnoses were tetralogy of Fallot (five), double outlet right ventricle (three), branch peripheral pulmonary artery stenosis (two), single ventricle s/p cavopulmonary shunt (one), and truncus arteriosus (one). All Palmaz Corinthian stents were delivered uncovered on Cordis Opta LP balloon catheters via short sheaths (6-7 Fr); super-stiff guidewires were not always necessary. These stents, with a maximal expanded diameter of 12 mm, were placed for peripheral pulmonary artery stenosis as a definitive procedure or at the pulmonary artery bifurcation in patients who were expected to undergo future open heart surgery. The stents were initially implanted on 4, 6, or 8 mm balloon catheters and further expanded if needed. Stents were placed in the right pulmonary artery alone in three patients, left pulmonary artery alone in four patients, and side-by-side stents were implanted simultaneously in three patients. All thirteen stents were implanted successfully in the desired location without stent malposition or embolization. Mean angiographic diameter increased from 2.5 +/- 1.5 to 5.7 +/- 1.4 mm (P < 0.01) and peak systolic ejection gradients decreased from 44 +/- 22 to 14 +/- 11.6 mm Hg (P < 0.01). The uncovered delivery of the premounted Palmaz Corinthian stent allowed for precise and safe endovascular stent implantation without the hemodynamic and technical problems associated with long vascular sheath usage. This technique is useful for the palliation of proximal pulmonary artery stenosis and is effective definitive treatment for peripheral pulmonary artery stenosis in small infants and children.

Deep vein thrombosis, pulmonary embolism, and pulmonary thrombosis in situ are rare in childhood and adolescence [1,2]. Unfortunately, these diagnoses may be unsuspected in a pediatric patient with dyspnea and chest pain. This article illustrates the diagnostic and therapeutic challenges that arose from unrecognized chronic thrombotic disease in an adolescent.

This study was performed to evaluate the efficacy of transcatheter coil closure of the patent ductus arteriosus in comparison to our experience with the Rashkind umbrella device. Transcatheter coil closure of the patent ductus arteriosus has been reported with encouraging results. We present our experience with ducti up to 5.0 mm in diameter and report the short-term follow-up. We compare the results with our previous experience with the Rashkind umbrella device. Seventy-one patients underwent transcatheter coil closure. Median age was 3.1 years, and median weight was 13.6 kg. Mean ductus diameter was 2.0 +/- 1.1 mm. These were compared with 105 patients who underwent transcatheter closure using a single Rashkind umbrella device. The median age was 3.2 years and the median weight was 14.0 kg. The mean ductus diameter for this group was 2.1 +/- 0.6 mm. The ductus murmur in the coil group disappeared in all patients. Immediate ( or = 3.0 mm required two or more coils. Eleven coils in six patients embolized to the pulmonary arteries. All coils except one were retrieved with subsequent successful foil placement. Sixty-seven patients (94%) in the coil group were discharged in < or = 24 h. Transcatheter closure of the patent ductus arteriosus using multiple coils is a more effective technique than the Rashkind umbrella closure and has excellent short-term results. This can be performed safely as an outpatient procedure.

We report the immediate results and the short-term follow-up in a group of selected patients with coarctation of the aorta who underwent endovascular stent implantation. Balloon-expandable stents were implanted in 6 patients (mean age 19.8 ± 5.1 years) with coarctation of the aorta (4 recurrent and 2 native) who underwent a total of 7 procedures (6 implantation and 1 further expansion). The systolic peak pressure gradient was decreased from 36.7 ± 16.9 to 13.3 ± 23.2 mm Hg (P < 0.005). There was a 66% increase in the mean coarctation diameter from 9.3 ± 1.7 to 15.6 ± 3.1 mm (P = 0.001) with the ratio of the coarctation to descending aorta diameter, measured at the level of the diaphragm, increasing from 0.49 ± 0.1 to 0.81 ± 0.2 (P < 0.005). The dilatation was successful in expanding the stent to an acceptable diameter in 5 of 6 patients. One patient underwent successful further expansion of a stent implanted 22 months previously. There were no immediate complications during balloon expansion and stent implantation. One patient suffered a femoral arterial bleed requiring surgical repair. There was one unrelated death. All patients were hypertensive (systolic blood pressure >140 mm Hg) prior to stent implantation. At mean follow-up of 8 months, 3 patients are normotensive. There was no recurrence of coarctation, aortic dissection, or aneurysm formation in the patients in whom stent implantation was successful. These findings indicate that balloon-expandable stent implantation for coarctation of the aorta in selected patients is a safe and effective alternative approach for relieving the obstruction with a low complication rate and no recoarctation at short-term follow-up. © 1996 Wiley-Liss, Inc.

This report presents a case of pulmonary atresia/intact ventricular septum with right ventricular-dependent coronary circulation. At 7 months of age, the infant underwent coil embolization of the connection between the right ventricle and the coronary circulation. The child is currently well following surgical decompression of the right ventricle.

Successful stent implantation for conduit stenosis has been described; however, this procedure may be complicated by compression of adjacent structures during expansion. We report on a rare case of a single right coronary artery system complicating stent implantation for relief of homograft stenosis in tetralogy of Fallot.