Gene therapy for rhesus monkeys heterozygous for LDL receptor deficiency by balloon catheter hepatic delivery of helper-dependent adenoviral vector.

Autosomal dominant familial hypercholesterolemia (FH) is a monogenic life-threatening disease. We tested the efficacy of low-density lipoprotein receptor (LDLR) gene therapy using helper-dependent adenoviral vector (HDAd) in a nonhuman primate model of FH, comparing intravenous injection versus intrahepatic arterial injection in the presence of balloon catheter-based hepatic venous occlusion. Rhesus monkeys heterozygous for mutant LDLR gene (LDLR+/-) developed hypercholesterolemia while on a high-cholesterol diet. We treated them with HDAd-LDLR either by intravenous delivery or by catheter-based intrahepatic artery injection. Intravenous injection of ⩽1.1 × 10(12) viral particles (vp) kg(-1) failed to have any effect on plasma cholesterol. Increasing the dose to 5 × 10(12) vp kg(-1) led to a 59% lowering of the plasma cholesterol that lasted for 30 days before it returned to pre-treatment levels by day 40. A further increase in dose to 8.4 × 10(12) vp kg(-1) resulted in severe lethal toxicity. In contrast, direct hepatic artery injection following catheter-based hepatic venous occlusion enabled the use of a reduced HDAd-LDLR dose of 1 × 10(12) vp kg(-1) that lowered plasma cholesterol within a week, and reached a nadir of 59% pre-treatment level on days 20-48 after injection. Serum alanine aminotransferase remained normal until day 48 when it went up slightly and stayed mildly elevated on day 72 before it returned to normal on day 90. In this monkey, the HDAd-LDLR-induced trough of hypocholesterolemia started trending upward on day 72 and returned to pre-treatment levels on day 120. We measured the LDL apolipoprotein B turnover rate at 10 days before, and again 79 days after, HDAd-LDLR treatment in two monkeys that exhibited a cholesterol-lowering response. HDAd-LDLR therapy increased the LDL fractional catabolic rate by 78 and 50% in the two monkeys, coincident with an increase in hepatic LDLR mRNA expression. In conclusion, HDAd-mediated LDLR gene delivery to the liver using a balloon catheter occlusion procedure is effective in reversing hypercholesterolemia in a nonhuman primate FH model; however, the unsustainability of the hypocholesterolemic response during 3-4 months of follow up and heterogeneous response to the treatment remains a challenge.

Long-term follow-up of the STARFlex device for closure of secundum atrial septal defect.

BACKGROUND: There is limited published outcome data on the STARFlex device for transcatheter closure of atrial septal defects (ASD). AIM: To contribute to the long term outcomes of ASD device closure with the STARFlex device. METHODS: Results of a prospective FDA approved clinical trial (1999-2001) from a single institution of the STARFlex device for simple ASD was reviewed. The inclusion criteria included age >or=2 years, isolated secundum ASD, evidence of right ventricular volume overload, and maximum stretched diameter <22 mm. A retrospective review of the original study data with most recent follow-up was performed. Clinical success in the trial was defined as complete closure or residual leak

Prevalence of additional cardiovascular anomalies in patients referred for transcatheter closure of patent ductus arteriosus.

Catheter closure of the patent ductus arteriosus is now a reality. The purpose of this study was to establish the prevalence of associated cardiovascular defects and the accuracy of echocardiography in patients referred for transvenous ductal closure. This study reviewed 146 patients seen from 1981 to 1988: 126 with only a patent ductus arteriosus (Group I) and 20 with additional cardiovascular anomalies (Group II). Groups I and II did not differ significantly in age, gender or physical examination except for the presence of a continuous murmur (Group I 100% versus Group II 80%, p less than 0.001). A left patent ductus arteriosus was visualized by two-dimensional echocardiography in 96% of patients and was evident by Doppler study in 100%. A patent ductus arteriosus was not seen in six patients including a patient who was found to have only a collateral network from the aorta to the main pulmonary artery. The 12 patients with noncardiovascular abnormalities such as Down's syndrome were more likely than the overall group to have additional cardiovascular anomalies (6 of 12, p = 0.001). The cardiovascular anomalies encountered were varied. Eight of the 20 patients with such anomalies had only a restrictive ventricular septal defect in addition to the patent ductus arteriosus. Significant anomalies found at catheterization included two thoracic arteriovenous malformations and an isolated right carotid artery draining into the right pulmonary artery by way of a right ductus arteriosus. This study indicates that echocardiography is an effective diagnostic technique in this patient group. A thorough cardiac catheterization with angiography should be performed before implantation of a ductal device.

Intracardiac undifferentiated sarcoma in infancy.

A rare case of an intracardiac undifferentiated sarcoma in a 3 month old infant is described together with the clinical, angiographic, echocardiographic, surgical and histopathologic findings. The tumor was successfully removed surgically, and monthly echocardiographic follow-up is being performed.

Balloon angioplasty of native coarctation of the aorta: midterm follow-up and prognostic factors.

UNLABELLED: OBJECTIVES, This retrospective analysis was designed to examine the intermediate and long-term effects of balloon angioplasty for native coarctation of the aorta and to determine whether any factors are predictive of outcome. BACKGROUND: Balloon angioplasty for native coarctation of the aorta is controversial. Concerns exist over lack of long-term follow-up and possible formation of aneurysms. The role of transverse arch and isthmus hypoplasia after balloon dilation is unknown. METHODS: Included in the study were all patients 3 days to 29 years old (mean age 4.6 years) referred for possible balloon dilation to the pediatric cardiac catheterization laboratory with evidence of a discrete coarctation of the aorta. The hemodynamic data, angiograms and clinical records of 102 patients were examined, with follow-up data from 2 to 117 months (median 36.2) available in 92 patients. RESULTS: Immediate success with balloon angioplasty was achieved in 93 (91.2%) of the 102 patients. Seventy-one patients (77.2%) with intermediate follow-up data (range 12 to 117 months) available are asymptomatic and normotensive, with insignificant arm to leg blood pressure gradients (< or = 20 mm Hg). Twenty-one patients (22.8%) with an initial successful result developed an increase in gradient 2 at 86 months after angioplasty, requiring reintervention in 18. Follow-up > 72 months is available in 17 patients, 16 of whom are normotensive and have not required additional intervention. No additional intervention was needed in 88.4% of older children and infants > 7 months old. Ten of the 13 surviving neonates who initially had a successful dilation required reangioplasty or operation 14 days to 10 months (median 4.6 months) after angioplasty. Transverse arch hypoplasia had minimal effect on follow-up blood pressure gradient, whereas isthmic hypoplasia was associated with reintervention in 50%. A small aneurysm was noted in 2 (1.9%) of 102 patients. CONCLUSIONS: Balloon angioplasty of native aortic coarctation is effective in infants and older children. In neonates, balloon angioplasty provides effective palliation only. Aneurysm formation is rare; however, lifetime follow-up is warranted.

Atrioventricular valve abnormalities in infancy: two-dimensional echocardiographic and angiocardiographic comparison.

The results of two-dimensional echocardiography and biplane angiocardiography from 47 infants with congenital atrioventricular (AV) valve abnormalities were compared. Eleven patients had atresia of the right AV valve, 10 had atresia of the left AV valve, 4 had hypoplasia of the right AV valve and 5 had hypoplasia of the left AV valve. Twelve patients had endocardial cushion defect, three had single ventricle and two had straddling of the left AV valve. There was agreement between the two techniques as to the number of AV valves present in each patient. The echocardiographic estimate of valve anular diameter was below normal in seven of the eight patients thought to have a hypoplastic anulus by angiocardiography. In 10 of the 12 patients with endocardial cushion defect, there was agreement between the two techniques as to the presence or absence of atrial and ventricular septal defect. The chordal attachments of straddling valves were better visualized by echocardiography; flow patterns and effective orifice size were better demonstrated by angiocardiography. The subcostal four chamber echocardiographic views and cranially angulated oblique angiocardiographic views were comparable and provided the best images for determination of the size and number of AV valves and their relation to the atrial and ventricular septa.

Balloon dilation of unoperated coarctation of the aorta: short- and intermediate-term results.

Balloon dilation is effective in the immediate relief of obstruction due to unoperated coarctation of the aorta. However, the long-term benefits and complications of this procedure have not been established. Thirty-three patients underwent balloon dilation of unoperated coarctation using a percutaneous technique from November 1983 to December 1985. High quality biplane angiography was performed before and after dilation. Follow-up was obtained in 20 patients from 6 to 31 months following dilation. Angiography was performed at follow-up in 10, nuclear magnetic resonance (NMR) imaging in 10 and both NMR imaging and angiography in 3. Balloon dilation was successful in 31 of the 33 patients with a decrease in average systolic pressure gradient from 46 to 8 mm Hg. There was no significant change in gradient on follow-up physical examination and at recatheterization in 10 patients. In addition, there was no evidence of restenosis on follow-up angiography and NMR imaging. In two patients, a small aneurysm formed at the site of balloon dilation. Balloon dilation of unoperated coarctation is effective, providing lasting relief of coarctation gradient and no evidence of restenosis. However, because of the uncertain natural history of aneurysms after dilation, this procedure should be considered investigational until further follow-up on patients with and without an aneurysm is available.

Re-expansion of balloon-expandable stents after growth.

OBJECTIVES: The purpose of this study was to evaluate the feasibility of re-expansion of balloon expandable intravascular stents and to examine the gross and histologic effects of re-expansion on vascular integrity. BACKGROUND: Intravascular stents have been used successfully as an adjunct to balloon dilation of congenital pulmonary artery branch stenosis and postoperative stenosis of the pulmonary arteries in children. However, use of rigid stents in children could result in development of relative stenosis at the site of stent implantation with subsequent growth of the child. METHODS: Stainless steel "iliac" stents were placed in the thoracic aorta of 10 normal juvenile swine by a transcatheter technique. Angiography and re-expansion were performed at a mean of 11 weeks (n = 9) and again at 18 weeks (n = 5). After euthanasia, the aortic specimens were removed for gross and histologic examination. RESULTS: Stents were successfully implanted in 10 swine. Re-expansion was successfully performed in each animal at 11 weeks and at 18 weeks. Aortic growth produced a relative constriction of the aorta of 20% +/- 10% (mean +/- SD) at the site of stent implantation at both 11 and 18 weeks. Re-expansion produced a significant increase in mean stent diameter from 10.1 +/- 1 mm to 12.3 +/- 1.2 mm at 11 weeks and from 11.2 +/- 0.7 to 13.5 +/- 1.1 mm at 18 weeks after implantation (p < 0.001). Balloon dilation produced a relative increase in stent diameter of 21% +/- 7% at 11 weeks and 18% +/- 4% at 18 weeks. Stent re-expansion was accompanied by plastic deformation of the neointima without neointimal dissection. Where neointima was thick, there was no evidence of neointimal abrasion, but where neointima was thin, areas of localized neointimal abrasion were observed with focal fibrin and platelet adherence to the stent struts. There was no evidence of medial or adventitial hemorrhage or dissection produced by re-expansion. CONCLUSIONS: Re-expansion of intravascular stents is feasible after growth in juvenile swine without significant injury to neointima, media or adventitia. The results of this study support careful and selective use of intravascular stents as an adjunct to balloon dilation of congenital stenoses in children.

Reconstruction of stenotic or occluded iliofemoral veins and inferior vena cava using intravascular stents: re-establishing access for future cardiac catheterization and cardiac surgery.

OBJECTIVES: The study evaluated the safety and efficacy of stent reconstruction of stenotic/occluded iliofemoral veins (IFV) and inferior vena cava (IVC). BACKGROUND: Patients with congenital heart defects and stenotic or occluded IFV/IVC may encounter femoral venous access problems during future cardiac surgeries or catheterizations. METHODS: Twenty-four patients (median age 4.9 years) underwent implantation of 85 stents in 22 IFV and 6 IVC. Fifteen vessels were severely stenotic and 13 were completely occluded. Although guide wires were easily passed across the stenotic vessels, occluded vessels required puncture through the thrombosed sites using a stiff wire or transseptal needle. Once traversed, the occluded site was dilated serially prior to stent implantation. RESULTS: Following stent placement, the mean vessel diameter increased from 0.9 +/- 1.6 to 7.4 +/- 2.6 mm (p < 0.05). Twenty-one of 28 vessels had long segment stenosis/occlusion requiring two to seven overlapping stents. Repeat catheterizations were performed in seven patients (9 stented vessels) at mean follow-up of 1.6 years. Seven vessels remained patent with mean diameter of 6.4 +/- 2.0 mm. Two vessels were occluded, but they were easily recanalized and redilated. Echocardiographic follow-up in two patients with IVC stents demonstrated wide patency. In four additional patients, a stented vessel was utilized for vascular access during subsequent cardiac surgery (n = 3) and endomyocardial biopsy (n = 1). Therefore, 13 of 15 stented vessels (87%) remained patent at follow-up thus far. CONCLUSIONS: Stenotic/obstructed IFV and IVC may be reconstructed using stents to re-establish venous access to the heart for future cardiac catheterization and/or surgeries.

Double balloon technique for dilation of valvular or vessel stenosis in congenital and acquired heart disease.

Despite the generally excellent success with balloon dilation for the stenotic lesions of congenital and acquired heart disease, technical difficulties sometimes prevent satisfactory results. Such technical difficulties include: a large diameter of the anulus of the stenotic lesion relative to available balloon diameter, difficulty in the insertion or removal of the larger balloon catheters, and permanent damage to or obstruction of the femoral vessels by the redundant deflated balloon material of the large balloons. A double balloon technique was initiated to resolve these difficulties. With this method, percutaneous balloon angioplasty catheters were inserted in right and left femoral vessels, placed side by side across the stenotic lesion and inflated simultaneously. Dilation procedures using the two balloon technique were performed in 41 patients: 18 with pulmonary valve stenosis, 14 with aortic valve stenosis, 5 with mitral valve stenosis, 3 with vena caval obstruction following the Mustard or Senning procedure and 1 with tricuspid valve stenosis. Patient ages ranged from 1 to 75 years (mean 17.8) and patient weights ranged from 8.9 to 89 kg (mean 42.3). Balloon catheter sizes ranged from 10 to 20 mm in diameter. Average maximal pressure gradient in mm Hg before dilation was 61 in pulmonary stenosis, 68 in aortic stenosis, 21 in mitral stenosis, 12 in tricuspid stenosis and 25 in vena caval stenosis. Average maximal valvular pressure gradient after dilation was 13 in pulmonary stenosis, 24 in aortic stenosis, 4 in mitral stenosis, 0 in tricuspid stenosis, and 1 in vena caval stenosis. No major complications were encountered with the procedures.(ABSTRACT TRUNCATED AT 250 WORDS)

Results of balloon valvuloplasty in typical and dysplastic pulmonary valve stenosis: Doppler echocardiographic follow-up.

To assess the usefulness of balloon valvuloplasty in patients with a dysplastic pulmonary valve, the files of 36 patients (aged 1 day to 18.5 years) who had two-dimensional echocardiography before and continuous wave Doppler echocardiography late after balloon valvuloplasty (balloon diameter greater than or equal to 20% anulus diameter) were reviewed. Results of relief of pulmonary stenosis were graded by catheter gradient in the catheterization laboratory and compared with Doppler echocardiographic findings at follow-up. There were 32 patients with typical pulmonary stenosis and 4 with a dysplastic valve. In the 32 patients with typical pulmonary stenosis, transvalvular gradient changed from a mean of 67 +/- 32 to 20 +/- 20 mm Hg (p less than 0.0001, mean reduction 72.6%). The gradients at follow-up by Doppler echocardiography averaged 20 mm Hg including 15 that increased, 3 that were unchanged and 14 that decreased. Only 3 (9%) of 32 patients had a gradient greater than 25 mm Hg at follow-up and only one gradient was greater than 35 mm Hg. All four patients with a dysplastic valve had a gradient that decreased with valvuloplasty from a mean of 85 +/- 33 to 33 +/- 20 mm Hg (p less than 0.05); gradient reduction in this group ranged from 40 to 85% (mean 57.5%). The gradient at follow-up increased in three of these four patients and decreased in one (the only late gradient less than 25 mm Hg). Late gradient was less than 35 mm Hg in two of the four patients and was reduced by 43 and 57%, respectively, in the other two.(ABSTRACT TRUNCATED AT 250 WORDS)

Redilation of endovascular stents in congenital heart disease: factors implicated in the development of restenosis and neointimal proliferation.

OBJECTIVES: We sought to determine the incidence of and risk factors for the development of restenosis and neointimal proliferation after endovascular stent implantation for congenital heart disease (CHD). BACKGROUND: Risk factors for the development of restenosis and neointimal proliferation are poorly understood. METHODS: This was a retrospective review of patients who underwent endovascular stent redilation between September 1989 and February 2000. RESULTS: Of 368 patients who had 752 stents implanted, 220 were recatheterized. Of those 220 patients, 103 underwent stent redilation. Patients were classified into three groups: 1) those with pulmonary artery stenosis (n = 94), tetralogy of Fallot/pulmonary atresia (n = 72), congenital branch pulmonary stenosis (n = 9), status post-Fontan operation (n = 6), status post-arterial switch operation (n = 7); 2) those with iliofemoral venous obstruction (n = 6); and 3) those with miscellaneous disorders (n = 3). The patients' median age was 9.9 years (range 0.5 to 39.8); their mean follow-up duration was 3.8 years (range 0.1 to 10). Indications for stent redilation included somatic growth (n = 67), serial dilation (n = 27) and development of neointimal proliferation or restenosis, or both (n = 9). There was a low incidence of neointimal proliferation (1.8%) and restenosis (2%). There were no deaths. Complications included pulmonary edema (n = 1), hemoptysis (n = 1) and contralateral stent compression (n = 2). CONCLUSIONS: Redilation or further dilation of endovascular stents for CHD is effective as late as 10 years. The risk of neointimal proliferation (1.8%) and restenosis (2%) is low and possibly avoidable. Awareness of specific risk factors and modification of the stent implantation technique, including avoidance of minimal stent overlap and sharp angulation of the stent to the vessel wall and avoidance of overdilation, have helped to reduce the incidence of restenosis.

Intravascular stents in congenital heart disease: short- and long-term results from a large single-center experience.

OBJECTIVES: This report describes the results of the Food and Drug Administration's phase 1 and 2 clinical trials of intravascular stents at Texas Children's Hospital. BACKGROUND: Since the late 1980s, intravascular stent implantation for the treatment of arterial and venous stenoses in congenital heart disease has been highly successful. METHODS: Stents were placed in postoperative pulmonary artery (PA) stenoses, congenital PA stenoses or stenoses of systemic veins/venous anastomoses. Prospective collection of data according to protocol was done before intervention, after stent implantation and at follow-up catheterization. RESULTS: At stent implantation, pressure gradients decreased significantly in all three groups (mean +/- SD): from 46 +/- 25 to 10 +/- 13 mm Hg in postoperative PA stenoses (p < 0.001); from 71 +/- 45 to 15 +/- 21 mm Hg in congenital PA stenoses (p < 0.001); and from 7 +/- 6 to 1 +/- 2 mm Hg in stenoses of systemic veins/venous anastomoses stenoses (p < 0.001). Vessel diameters markedly increased: from 6 +/- 3 to 12 +/- 3 mm in postoperative PA stenoses (p < 0.001); from 3 + 1 to 9 + 1 mm in congenital PA stenoses (p < 0.001); and from 3 +/- 4 to 12 +/- 4 mm in stenoses of systemic veins/venous anastomoses (p < 0.001). In the postoperative and congenital PA stenoses groups, right ventricular pressure decreased (right ventricular pressure indexed to femoral artery pressure ratio): from 0.63 +/- 0.2 to 0.41 +/- 0.02 (p < 0.001) and from 0.71 +/- 0.3 to 0.55 +/- 0.35 (p = 0.04), respectively. Perfusion to a single affected lung increased from 31 +/- 17% to 46 +/- 14% (p < 0.001). On recatheterization (mean 14 months), results varied minimally. Repeat angioplasty of residual stent stenoses was safe and effective. Complications included four early patients with stent migration, three with stent thrombosis and two deaths. There were no late complications. Significant restenosis occurred in only three patients. CONCLUSIONS: Intravascular stents for the treatment of vascular stenoses in congenital heart disease provide excellent immediate and long-term results.

Thoracoabdominal ectopia cordis with mosaic Turner's syndrome: Report of a case.

A child was treated for thoracoabdominal ectopia cordis and an associated chromosomal defect. Contrary to most cases in which death is due to the externally situated heart and abdominal viscera, this patient died from congenital heart disease.

Congenital and surgical atrioventricular block within the His bundle.

In three patients with congenital heart disease the site of atrioventricular (A-V) block was localized within the His bundle with the aid of His bundle electrograms. In one patient with first degree A-V block and normal QRS configuration, electrophysiologic studies revealed "split" His potentials. The other two patients had complete A-V block, and their His bundle electrograms revealed His spikes both proximal and distal to the site of block. One of the two patients, who had a pattern of left bundle branch block in the electrocardiogram, had surgically induced complete A-V block after repair of an ostium primum atrial septal defect. The other patient with congenital A-V block had a narrow QRS complex and, in addition to complete block within the His bundle, prolonged A-V nodal conduction time but no associated cardiac anomaly. Both patients with complete heart block required pacemaker insertion. The natural history of intra-H-is bundle block is not known, and it is difficult to recommend appropriate therapy. More electrophysiologic studies are needed in patients with A-V block to determine the prognostic significance of such block or conduction delay in the His bundle.

Congenital stenosis of individual pulmonary veins: clinical spectrum and unsuccessful treatment by transvenous balloon dilation.

Congenital stenosis of the pulmonary veins is a rare but frequently lethal congenital cardiac abnormality. Eight patients with this malformation were diagnosed, evaluated and treated. All eight patients had associated congenital cardiac defects. Two of the eight died, one of sepsis and one after operative pulmonary venoplasty. In three patients who underwent transvenous balloon catheter dilation of the stenosis the procedure provided immediate but transient relief of the stenosis. The prognosis for symptomatic infants with pulmonary vein stenosis is poor and its treatment an enigma.

Pulmonary artery sling.

Pulmonary artery "sling" indicates the vascular anomaly wherein the left pulmonary artery arises from the right pulmonary artery and traverses between the esophagus and trachea to enter the left lung. Respiratory symptoms may result from compression of the trachea and right mainstem bronchus by the anomalous vessel as well as by associated tracheobronchial defects. Six cases are described. The distinctive radiologic features include anterior indentation of the barium esophagogram and a characteristic pulmonary angiogram. Surgery is the usual recommended treatment for life-threatening airway obstruction, but results are often poor. In patients with less severe symptoms the physician's approach may be modified by the presence of associated intracardiac defects and intrinsic airway disease.

Unilateral pulmonary vein atresia: Diagnosis and treatment.

The clinical, hemodynamic, angiographic and pathologic features of unilateral pulmonary vein atresia in a 16 month old boy are described. The relevant findings were symptoms and signs of influenza, roentgenographic evidence of unilateral diffuse interstitial edema, prominent interlobar fissures and pleural effusion, absence of abnormal cardiac structure and prominent unilateral bronchial circulation. Angiocardiography was necessary for a definitive diagnosis and revealed the lack of a site of entry for venous blood from the right lung into the circulation. The patient was treated successfully by a right pneumonectomy. The histologic hallmark in this case was extensive intimal fibrosis of the pulmonary veins.

Transcatheter occlusion of patent ductus arteriosus in adults.

This study examines whether transcatheter closure of a patent ductus arteriosus (PDA) using a Rashkind PDA occluder device is safe and effective in adults, or if adults have complications not sited in children owing to prolonged aorticopulmonary communication, high surgical risks or calcified PDAs. Fifteen patients aged 22 to 76 years (mean 42 +/- 14) were referred for transcatheter PDA occlusion. Exercise intolerance was the most frequent clinical manifestation. Eleven of 15 patients had surgical risk factors that included left ventricular failure (n = 10), biventricular failure (n = 1), elevated pulmonary pressures (n = 1), and a calcified PDA (n = 5). Twelve millimeter devices were placed in 4 PDAs < or = 3 mm in diameter; 17 mm devices were placed in 11 PDAs 3 to 6 mm in diameter. Seven (47%) were occluded angiographically shortly after device placement; another 5 PDAs (33%) were occluded echocardiographically within 24 hours of the procedure. Completed occlusion in this time interval was more likely to occur in PDAs < 5 mm in diameter (p = 0.0009). Of the 3 remaining PDAs with follow-up ranging from 9 to 38 months, 2 have demonstrated gradual diminution of shunting and have trivial leaks by color/Doppler flow. The other patient with a residual PDA has no ductal flow after placement of a second device. No complications related to device implantation or closure of the PDA occurred in any patient. No complications were reported in the follow-up patients who received evaluation (14 of 15 patients; range 1 to 38 months).(ABSTRACT TRUNCATED AT 250 WORDS)

Balloon dilation of miscellaneous lesions: results of Valvuloplasty and Angioplasty of Congenital Anomalies Registry.

Data on 111 lesions, in addition to pulmonary valve, aortic valve, branch pulmonary stenosis, native coarctation and recoarctation, were submitted to the Valvuloplasty and Angioplasty of Congenital Anomalies Registry. Because there was a very heterogenous group of lesions both in types of lesions and techniques of dilation, only minimal data can be offered concerning the efficacy of the dilation of any or all of these lesions. The registry data do, however, demonstrate the safety of these dilations compared to alternative surgical therapy.