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Biomedical subjects

T R Lloyd

Publications and source records attributed to T R Lloyd.

At least 37 records · Page 2Linked to original sources

Stent redilation in canine models of congenital heart disease: pulmonary artery stenosis and coarctation of the aorta.

In a canine puppy model, pulmonary artery stenosis was created by banding the left pulmonary artery to 30-40% of its original diameter. Animals underwent right heart catheterization and angiography 1-2 mo later, and Palmaz P308 stents were implanted. Stent redilation was performed 3-5 mo later. One mo postredilation, the animals were restudied and sacrificed. Coarctations of the aorta were created by transverse aortic incision and longitudinal repair. P308 stent implantation was performed 2-3 mo later. Stent redilation was performed after 6-10 mo, and the animals were restudied and sacrificed 1-2 mo later. Stent implantation was performed in 6 puppies with pulmonary artery stenosis, as 2 animals developed postoperative pulmonary arterial hypoplasia, precluding stenting. The stenosis diameter increased from 4.8 +/- 0.5 mm to 7.4 +/- 0.6 mm (mean +/- SE) following stenting (P = 0.005), and increased further to 9.2 +/- 0.7 mm following redilation (P < 0.001). There were no significant vessel tears or ruptures. Coarctation stenting was performed in 8 animals. The coarctation was dilated from 5.8 +/- 0.9 mm to 9.8 +/- 0.6 mm (P < 0.001), and to 13.5 +/- 0.5 mm at redilation (P = 0.002). Redilation could not be performed in 1 animal. Aortic rupture and death occurred in 2 of 7 animals at redilation. Stent implantation and redilation in experimental pulmonary artery stenosis appears safe and effective. Though stent implantation for coarctation of the aorta appears safe, there was a 28% aortic rupture rate at stent redilation in this model.

Angioplasty, Balloon↗

Hemolysis following coil embolization of a patent ductus arteriosus.

We describe the development of hemolysis from moderate residual shunting across a patent ductus arteriosus following coil embolization. The fall in hemoglobin levels from 11.6 to 6.0 gm/dl necessitated a second coil procedure which resulted in complete closure of the residual shunting and resolution of hemolysis. Therefore, appearance of anemia following coil embolization of patent ductus arteriosus should be monitored closely; however, repeat coil embolization with elimination of residual shunt will lead to prompt recovery of normal hemoglobin levels.

Anemia, Hemolytic↗

Follow-up of coil occlusion of patent ductus arteriosus.

OBJECTIVE: We sought to determine the prevalence and fate of residual ductal shunting following coil occlusion of patent ductus arteriosus. BACKGROUND: Although transcatheter coil occlusion of patent ductus arteriosus has gained popularity, few follow-up data have been reported. METHODS: A review of 75 patients who underwent coil occlusion was performed. Residual shunting was investigated by Doppler echocardiography in follow-up. Angiograms were reviewed to obtain minimal ductal diameter and ductal angiographic type. RESULTS: Residual shunts were found in 31 patients (41%) on the day of the procedure, and of these, spontaneous closure was noted in 17 (55%) at 2 weeks to 20 months of follow-up. Of the 75 patients studied, 5 (7%) required a second coil procedure, and 10 (13%) remained with persistent residual shunts at most recent follow-up. Actuarial analysis estimated a 6 +/- 5% prevalence of residual shunts 20 months after a single coil procedure and 3 +/- 3% after all coil procedures. Minimal ductal diameter was associated with immediate complete ductal occlusion by a single coil. These patients had significantly smaller (p = 0.003) minimal ductal diameters (1.2 +/- 0.7 mm) than those who required two coils during their initial procedure to achieve immediate occlusion (1.9 +/- 0.7 mm), those who required a second coil procedure (2.0 +/- 0.9 mm), those who had spontaneous closure of residual shunts (1.9 +/- 0.7 mm) and those with persistent residual shunts (2.0 +/- 0.9 mm). No association was identified between ductal angiographic type and outcome of coil occlusion. No late adverse clinical events of coil occlusion or evidence of recanalization was found. CONCLUSIONS: Small residual shunts are common after coil embolization of patent ductus arteriosus, but most close spontaneously. Actuarial analysis estimates complete closure in 94% at 20 months, and reintervention was required in only 7% of patients.

Actuarial Analysis↗

Transcatheter closure with single or multiple Gianturco coils of patent ductus arteriosus in infants weighing < or = 8 kg: retrograde versus antegrade approach.

Experience with transcatheter closure (TCC) of patent ductus arteriosus (PDA) in small infants is limited. Our goals were to evaluate the immediate and short-term results of TCC of PDA in small infants (< or = 8 kg) as attempted with single or multiple Gianturco coils and to compare results for PDA < or = 2.5 mm versus PDA > 2.5 mm. Twenty-four infants underwent an attempt at TCC of PDA at a median age of 0.7 years (range 2 weeks to 1.5 years) and median weight of 6.5 kg (range 2.3 to 8 kg). Coils were placed by the transvenous route in 14 patients and by the transarterial route in 10 patients. The median PDA diameter was 2.7 mm (range 0.4 to 5.2 mm). Ten patients had PDA diameters < 2.5 mm and all had complete closure, 9 with a single coil and 1 with two coils. Fourteen patients had PDA diameters > or = 2.5 mm; closure was complete in 10 patients, 9 of whom required multiple coils. There was a trend toward improved results with multiple coils delivered transvenously. There was immediate complete closure of the PDA with a diameter as large as 5.2 mm that persisted at a median follow-up period of 1.2 year. Closure was unsuccessful in 4 patients, each of whom required multiple coils. The median fluoroscopy time was 19 minutes. Complications included transient loss of femoral pulse in 2 infants, mild left pulmonary artery obstruction in 2, and nonretrievable coil migration to the right lung in one. We conclude that TCC is effective therapy for small infants with a PDA of diameter < or = 5.2 mm by the single-or multiple-coil technique on an outpatient basis and that TCC can be performed in neonates as small as 2.3 kg.

Cardiac Catheterization↗

Acute results of balloon angioplasty of native coarctation versus recurrent aortic obstruction are equivalent. Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry Investigators.

OBJECTIVES: This study sought to compare the immediate results and risk factors for suboptimal outcomes of percutaneous balloon angioplasty for native versus recurrent aortic obstruction. BACKGROUND: Some cardiology centers have been reluctant to adopt balloon angioplasty for treatment of native aortic coarctation, while advocating balloon angioplasty over an operation for treatment of postsurgical or recurrent aortic obstruction. METHODS: Acute results were analyzed from 970 procedures (422 native and 548 recurrent lesions) performed between 1982 and 1995 in 907 patients from 25 centers. An acute suboptimal outcome was defined as one or more of the following: residual systolic pressure gradient > or = 20 mm Hg, residual proximal to distal systolic pressure ration > or = 1.33 or a major complication (death, aortic transmural tear, stroke). RESULTS: Bal loon angioplasty significantly (p = 0.0001) increased lesion diameter fo r both native (mean [+/= SD] 128 +/= 94%) and recurrent aortic obstruction (97 +/= 87%), with a significantly greater increase in the native group (p = 0.0001). A reduction in systolic pressure gradients was significant in both groups (p = 0.0001), but slightly higher (p = 0.01) for native (-74 +/- 24%) versus recurrent obstruction (-70 +/- 31%). Death associated with angioplasty was reported in 0.7% of patients with native and in 0.7% of patients with recurrent lesions (p = 1.00). An acute suboptimal outcome was noted with angioplasty in 19% of native and in 25% of recurrent lesions (p = 0.04). Significant independent risk factors included higher preangioplasty systolic gradient (odds ratio [OR] 1.39/10-mm Hg increment; 95% confidence interval [CI] 1.28 to 1.50, p = 0.0001), earlier study date (OR 0.92/1-year increment, 95% CI 1.02 to 1.26, p = 0.02) and recurrent obstruction (OR 1.39 vs. native lesions, 95% CI 1.00 to 1.94, p = 0.05). CONCLUSIONS: Acute results and complications of balloon angioplasty of native coarctation appear to be equivalent or slightly superior to those of recurrent aortic obstructions.

Adolescent↗

Staged reconstruction for hypoplastic left heart syndrome. Contemporary results.

OBJECTIVE: The authors review their experience with staged reconstructive surgery for hypoplastic left heart syndrome (HLHS) and assess current outcome for this condition. SUMMARY BACKGROUND DATA: Once considered a uniformly fatal condition, the outlook for newborns with HLHS has been altered dramatically with staged reconstructive procedures. Refinements in operative technique and perioperative management have been largely responsible for this improved outlook. METHODS: The authors reviewed their experience with 158 consecutive patients undergoing stage 1 reconstruction with a Norwood procedure from January 1990 to August 1995. All patients had classic HLHS, defined as a right ventricular dependent circulation in association with atresia or severe hypoplasia of the aortic valve. RESULTS: There were 120 hospital survivors. Among the 127 patients considered at standard risk, survival was significantly higher than that for the 31 patients with important risk factors. Adverse survival was associated most strongly with significant associated noncardiac congenital conditions and severe preoperative obstruction to pulmonary venous return. Second-stage reconstruction with the hemi-Fontan procedure was performed in 106 patients, with 103 hospital survivors and one late death. Three of the late survivors were not considered candidates for the Fontan procedure. To date, the Fontan procedure has been completed in 62 patients, with 53 survivors. Deaths after the Fontan procedure occurred early in our experience and were mostly secondary to left pulmonary artery stenosis or hypoplasia. Significant or potentially significant morbid conditions were noted in 25 of the 120 hospital survivors. Neurologic conditions were found in 6% and cardiovascular conditions in 10%, including dysrhythmia, left pulmonary artery thrombosis, and chronic pleural effusions. Among the patients considered at standard risk with typical anatomy, actuarial survival was 69 +/- 8% at 5 years. Survival was 71 +/- 17% at 5 years for standard risk patients with variant anatomy and 58 +/- 9% for the entire cohort of 158 patients. The largest decrease in survival occurred in the first month of life and late deaths primarily affected those patients in the high-risk group. CONCLUSIONS: Staged reconstruction has significantly improved the intermediate-term outlook for patients with HLHS. Factors addressing improvements in early (< 1 month) first-stage survival would be expected to add significantly to an overall improved late outcome. Currently employed refinements in operative technique are associated with eliminating or reducing pulmonary artery distortion and dysrhythmia.

Cardiac Surgical Procedures↗

Transhepatic cardiac catheterization in children. Evaluation of efficacy and safety.

BACKGROUND: In some children with congenital heart disease, conventional venous access is unavailable for cardiac catheterization. This study investigates a novel transhepatic venous approach to cardiac catheterization in children and evaluates its efficacy and safety. METHODS AND RESULTS: Percutaneous transhepatic puncture was performed using a 22-gauge Chiba needle under fluoroscopic guidance. After wire exchanges were performed, a 5F to 8F sheath was positioned in the low right atrium and cardiac catheterization was performed. On completion of the catheterization, the sheath was withdrawn and a 3-mm steel coil was placed in the parenchymal tract between the hepatic vein and liver capsule. Liver enzyme studies were obtained before and after transhepatic catheterization, and an abdominal ultrasound was performed to evaluate the liver 24 hours after the procedure. Percutaneous transhepatic cardiac catheterization was performed successfully in 17 of 18 children in whom it was attempted. Patient age was 30 +/- 8 months (mean +/- SEM; range, 1 day to 9 years), weight was 10.5 +/- 1.5 kg (3.1 to 27.5 kg), and mean right atrial pressure was 10 +/- 1 mm Hg (5 to 19 mm Hg). Time from initial needle puncture to right atrial entry was 6.2 +/- 1.2 minutes. Diagnostic catheterization was performed successfully in all 17 children, and additional interventional procedures were performed in 5 children. The total catheterization time was 2.0 +/- 0.2 hours. Serum aspartate aminotransferase increased from 57 +/- 15 to 78 +/- 8 IU/L (P = .06), but alanine aminotransferase and gamma-glutamyl transpeptidase did not change. Ultrasound was performed 24 hours after transhepatic catheterization, and no evidence was found in any patient of hemorrhage or subcapsular hematoma. CONCLUSIONS: These data suggest that this novel transhepatic approach provides an effective and safe route for diagnostic and interventional cardiac catheterization in children.

Cardiac Catheterization↗

Effectiveness of balloon valvuloplasty in the young adult with congenital aortic stenosis.

The objective of this study was to assess the effectiveness of balloon valvuloplasty in the young adult with congenital aortic stenosis and to compare its effectiveness with children. Percutaneous balloon valvuloplasty is effective in children with congenital aortic stenosis, but not in adults with acquired calcific aortic stenosis. Because effectiveness of balloon valvuloplasty in young adults with congenital aortic stenosis is not well defined, we evaluated the outcome in 15 patients aged 16-24 years (18 +/- 0.6; mean +/- SEM) who underwent balloon valvuloplasty from 1985 to 1993. The aortic valve annulus diameter ranged from 18.5 to 30 mm (24 +/- 0.9). The aortic valve was bicuspid in 12 and tricuspid in 3 patients, and calcification was present in one patient. Balloon valvuloplasty was performed using a double balloon technique in 12 patients and a single balloon technique in three patients. Three patients had inadequate relief of gradient with a residual peak systolic gradient > or = 70 mm Hg. Three patients required valve replacement-two patients for a residual gradient > or = 70 mg Hg, and one patient 4 years later for severe aortic valve regurgitation. Eight of the remaining 12 have undergone elective follow-up catheterization 1.2-2.5 years (1.5 +/- 0.1) later. The peak systolic aortic valve gradient decreased by 55% from 73 +/- 5.8 mm Hg to 35 +/- 5.4 mm Hg immediately postvalvuloplasty, and was 30 +/- 4.4 mm Hg at follow-up (P < 0.001). The left ventricular systolic pressure decreased from 179 +/- 7.5 to 147 +/- 6.5 mm Hg immediately postvalvuloplasty and was 147 +/- 4 mm Hg at follow-up. Aortic insufficiency was unchanged after valvuloplasty in 9, increased by 1+ in 4, and by 2+ in 2 patients. Balloon valvuloplasty was as effective in these young adults as in 70 children (age 6 +/- 0.7 years) with congenital aortic stenosis (peak systolic gradient pre- 79 +/- 3 mm Hg versus post- 34 +/- 2 mg Hg; at 1-2 years follow-up 34 +/- 4 mm Hg). Balloon valvuloplasty provides effective treatment in most young adults with congenital aortic stenosis, without early restenosis. Balloon valvuloplasty is as effective in young adults as in children, where it is currently the treatment of choice.

Adolescent↗

Determinants of successful balloon valvotomy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum.

OBJECTIVES: This study reviewed our experience with percutaneous balloon valvotomy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum and defined the anatomic and hemodynamic characteristics of infants in whom this procedure is successful and provides definitive therapy. BACKGROUND: Unlike children with valvular pulmonary stenosis, the follow-up of infants with critical pulmonary stenosis undergoing percutaneous balloon valvotomy is limited. METHODS: Between December 1987 and August 1992, percutaneous balloon valvotomy was attempted in 12 infants with critical pulmonary stenosis (n = 10) or pulmonary atresia with intact ventricular septum (n = 2). Two outcome groups were identified: Group A patients are acyanotic, have mild residual pulmonary stenosis and have not required operation; Group B patients have required operation. RESULTS: Of the 12 infants, 11 had a successful balloon valvotomy procedure. Group A patients (n = 7) have a residual gradient of 22 +/- 18.7 mm Hg (mean +/- SD) at follow-up of 3.2 years (range 1.2 to 5.0). In Group B (n = 5), operation was required for inability to cross the pulmonary valve (n = 1) or persistent severe hypoxemia for > or = 2 weeks after valvotomy (n = 4). Significant differences (p < or = 0.01) between the two groups (Group A vs. Group B) were identified in pulmonary valve annulus (Z value) 8.1 mm (-1.1) versus 5.5 mm (-3.4); tricuspid valve annulus (Z value) 14.0 mm (0.8) versus 8.8 mm (-1.8); right ventricular volume 65 versus 29 ml/m2; and Lewis index 10.9 versus 8.9. CONCLUSIONS: Percutaneous balloon valvotomy is effective and likely to provide definitive therapy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum who have a tricuspid valve annulus > 11 mm, pulmonary valve annulus > or = 7 mm and right ventricular volume > 30 ml/m2.

Catheterization↗

The management of tetralogy of Fallot with pulmonary atresia and diminutive pulmonary arteries.

Since September 1991, 14 consecutive patients with tetralogy of Fallot, pulmonary atresia, and diminutive pulmonary arteries have undergone staged repair. All patients had multiple aortopulmonary collateral arteries and the ductus arteriosus was absent in 11. Mean sizes of the right and left pulmonary arteries were 2.2 +/- 0.7 mm and 1.9 +/- 0.8 mm, respectively (range 0.5 to 3.0 mm). Eight patients (57%) have subsequently received complete repair. Age at initial procedure (shunt, right ventricle-pulmonary artery conduit, or direct aorta-pulmonary artery anastomosis) in this group was 5.3 +/- 6.8 months. The number of operative procedures to achieve complete repair was 2.9 +/- 0.8 per patient (range 2 to 4). Intraoperative postrepair peak right ventricle-left ventricle pressure ratio was 0.57 +/- 0.17. Six of 8 patients (75%) required additional interventional procedures (mean 1.5 +/- 1.2 per patient) for angioplasty of peripheral pulmonary artery stenoses, coil embolization of aortopulmonary collateral arteries, or intra-operative insertion of intravascular pulmonary artery stents. Mean follow-up from complete repair was 8.7 +/- 8.3 months (range 0.5 to 23.8 months) and is complete. There was one in-hospital death at 45 days, and one late cardiac death at 20.3 months. Six patients had initial palliative operations (unifocalization, right ventricle-pulmonary artery conduit, direct aorta-pulmonary artery anastomosis, or transannular outflow patch) but have not undergone complete repair. Age at initial procedure in this group was 27.9 +/- 56.9 months (range 0.27 to 155 months), and mean follow-up from initial procedure was 10.9 +/- 11.2 months (range 0 to 31.4 months). The operative mortality rate was 33% (2 of 6 patients). There was one late noncardiac death at 5.3 months. Three patients are awaiting further intervention or repair. This experience suggests that complete repair is feasible even in patients with extremely diminutive pulmonary arteries (< or = 3.0 mm). Pulmonary artery growth is facilitated by early (3 to 6 month) establishment of central pulmonary artery flow by right ventricle-pulmonary artery conduit (pulmonary arteries > 1.5 mm) or by direct ascending aorta-pulmonary artery anastomosis (pulmonary arteries < 1.5 mm). Subsequent interventional catheterization and operative procedures as required for pulmonary artery stenoses and coil embolization of collateral arteries allow continued recruitment of central pulmonary arteries and may obviate or minimize the need for unifocalization procedures.

Angioplasty↗

Transcatheter closure of atrial septal defects.

The first transcatheter closure of an atrial septal defect (ASD) was performed by King and Mills in 1976. The Lock Clamshell occluder and the buttoned device are the latest devices to undergo clinical trials. Successful transcatheter closure has been possible with minimal morbidity and mortality. Small residual shunts may remain, however, in up to 20% of patients 1 year after the procedure. The clinical significance and natural history of these small residual atrial communications remains to be determined. This article reviews the history and development of the current ASD closure techniques, with emphasis on the experience with the Lock Clamshell occluder and the buttoned device.

Cardiac Catheterization↗

Embolization therapy in pediatric cardiology.

Transcatheter embolization therapy has assumed an important role in the management of patients with congenital heart disease. A variety of embolization materials, most commonly steel coils, is available to treat or palliate patients with aortopulmonary collateral vessels or surgical shunts, arteriovenous malformations, and anomalous venovenous connections (common after surgical intervention for the univentricular heart). At many centers, coil occlusion has recently become the treatment of choice for patients with a restrictive patent ductus arteriosus (PDA). This article describes the materials and techniques of embolization therapy, as well as the common indications encountered in the practice of pediatric interventional cardiology.

Angiography↗

Ontogeny of rat myocardial A1 adenosine receptors.

Adenosine functions as a counterregulatory hormone in the myocardium by decreasing work and thereby protecting the myocardium against ischemia. Functional adenosine A1 receptors could serve as an important regulatory system in the developing preinnervated heart by balancing the humoral sympathetic input to the heart. The aims of this study were to determine if A1 adenosine receptors were functionally coupled to their Gi protein in the immature preinnervated heart and to determine if A1 adenosine receptors were present in greater numbers in the immature heart. One- to 3-day-old rat ventricular cardiomyocyte cultures were exposed to (1) control conditions; (2) isoproterenol, a beta-receptor agonist, (3) R-PIA, an A1 agonist, or (4) isoproterenol and R-PIA, cAMP levels were determined by RIA in each group. Adenosine A1 receptor density and the equilibrium dissociation constant were determined by binding of an adenosine A1 receptor antagonist in newborn, 1-week-old, 2-week-old, and adult rat hearts. A1 stimulation decreased the isoproterenol-induced increase in cAMP by 30%, demonstrating functional A1 receptors in immature preinnervated myocytes. The A1 receptor density in the newborn age group was twice the adult and 2-week-old level. We conclude that A1 receptors in the immature heart are functionally coupled to their effector and that A1 receptors are present in greater numbers in the immature heart.

Adrenergic beta-Agonists↗

Late follow-up of balloon angioplasty in children with a native coarctation of the aorta.

Between May 1984 and April 1993, 59 children underwent balloon angioplasty of a native coarctation at our institution. The follow-up protocol included a cardiac catheterization 1 to 2 years after angioplasty, which was performed in 90% of patients with > or = 2 years follow-up. Angioplasty caused an acute decrease in peak systolic gradient from 46 +/- 2 to 15 +/- 2 mm Hg, without early aneurysm or emergent surgical intervention in any patient. Based on follow-up data, a satisfactory result was obtained in 38 patients (64%; 70% confidence limit: 58% to 71%), defined as a residual systolic gradient < 20 mm Hg and no aneurysm. In these patients the gradient decreased acutely from 43 +/- 2 to 9 +/- 1 mm Hg, was 6 +/- 1 mm Hg at follow-up catheterization, and 9 +/- 2 mm Hg by clinical evaluation 4.4 +/- 0.3 years after angioplasty. Twenty-one patients (36%; 70% confidence limit: 29% to 42%) had an unsatisfactory result due to a residual gradient > or = 20 mm Hg (n = 19) or aneurysm formation (n = 3), or both. Restenosis occurred in 6 patients, and occurred more in infants than in children > or = 12 months of age (3 of 5 infants vs 3 of 41 children, p = 0.01). Thus, balloon angioplasty provides an effective initial treatment strategy for native coarctation in most children aged > 12 months.

Adolescent↗

Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial).

A clinical trial was conducted of the buttoned device for transcatheter closure of ostium secundum atrial septal defect. Occlusion was attempted in 57 patients aged 1 to 62 years (median 5). The procedure was abandoned in 7 patients after 1 or more unsuccessful attempts, and devices were released in 50 patients. Urgent surgical retrieval was necessary in 4 patients because of unstable device position: 3 devices "unbuttoned," with migration of the counteroccluder to the pulmonary artery or inferior vena cava, and 1 intact device embolized to the main pulmonary artery. All patients remained stable and underwent successful operation. Successful device implantation was therefore achieved in 46 patients, with immediate reduction in Qp/Qs from 1.8 +/- 0.6 to 1.1 +/- 0.2 (mean +/- SD, p < 0.0001). At most recent follow-up (1 to 20 months), 45 of 46 patients (98%) have no shunt or a trivial residual shunt. The prevalence of residual shunts declined from 65% at 1 month to 19% at 12 months after the occlusion procedure (p < 0.0001). Complications included unbuttoning of a fourth device, transient tricuspid regurgitation in 2 patients, and transient mitral regurgitation in 2 patients. An episode of asymptomatic atrial flutter was noted in a 46-year-old patient which may have been related to device implantation, but which has not recurred. There have been no cases of endocarditis or thromboembolism in 350 patient-months of follow-up. The buttoned device provided effective closure of the atrial septal defect in 45 of 57 patients (79%) in whom implantation was attempted and in 45 of 46 patients (98%) in whom device implantation was successfully accomplished.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

International experience with secundum atrial septal defect occlusion by the buttoned device.

Several devices are available for transcatheter occlusion of atrial septal defect. This report describes the international experience with the buttoned device. During a 4.5-year period ending in February 1993, 180 transcatheter atrial septal defect occlusions were performed with the buttoned device. Patient age varied between 0.6 and 76 years and stretched atrial defect diameter between 5 and 25 mm. The defects were closed with 25 to 50 mm devices delivered through 8F (148 patients) or 9F (32 patients) sheaths. Twelve patients were adults whose defects were closed to prevent recurrence of cerebrovascular accidents caused by presumed paradoxic embolism. In the remaining patients the atrial defect was closed to treat the left-to-right shunt. The atrial septal defects were effectively occluded as demonstrated by (1) decrease in pulmonary-to-systemic flow ratio from 2.1 +/- 0.6 (mean +/- SD) to 1.05 +/- 0.1 (p < 0.01) by oximetry; (2) normalized S2 and disappearance of the diastolic murmur by auscultation; and (3) improvement in right ventricular volume overloading by echocardiogram. However, trivial to small shunts could be detected by color Doppler studies in 76 (45%) of 168 patients in whom such data are available. Complications included unbuttoning in 13 and whole-device embolization in 1. All patients remained stable, and retrieval of the device and surgical closure of the atrial septal defect were accomplished in 10 patients. Transcatheter retrieval was used in the remaining 4 patients. The incidence of unbuttoning, a major complication of the procedure, appeared to decrease with the increasing experience of the investigators and with device modification (third-generation). The follow-up duration varied between 1 month and 4 years. Six patients required surgery during the follow-up period. In the remaining patients (n = 160), clinical examination did not reveal signs of atrial shunts. Color Doppler studies revealed either complete disappearance of the previously demonstrated shunts or further diminution of their size. The results indicate that transcatheter occlusion of the atrial septal defects with buttoned devices is feasible, relatively safe, and effective, and it appears to be a viable alternative to surgery for some patients with secundum atrial septal defect. Complications are infrequent and should improve with experience.

Cardiac Catheterization↗