Biomedical subjects
E B Sideris
Publications and source records attributed to E B Sideris.
Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices.
Detachable balloon devices were applied in the occlusion of experimental ASDs in 20 piglets. The detachable balloons were made from Latex; the occluder balloon was placed on the left atrial side and required a floppy disk and counter-occluder(s) support from the right atrial side (17 experiments), or a second detachable balloon from the right side (3 experiments). Full occlusion was noticed in all cases. There was one device embolization in the descending aorta (device with a regular floppy disk and no counter-occluder). The device was covered by tissue in 3 to 4 weeks with the balloon flat on the septum in approximately 2 months; it required minimal rim and no wires in the left atrium. The double balloon model was wireless. The balloon detachable device was found effective and safe in the occlusion of experimental ASDs in piglets.
Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devices. International Buttoned Device Trial Group.
OBJECTIVES: The purpose of this study was to assess safety and effectiveness of the fourth generation buttoned device in dosing atrial septal defects (ASDs) and to test the hypothesis that introduction of double button reduces unbuttoning rate without reducing effectiveness. BACKGROUND: Because of the high unbuttoning rate (7.2%) with first, second and third generation buttoned devices, the device was modified (fourth generation) so that there were two radiopaque spring buttons 4 mm apart on the button loop attached to the occluder. METHODS: During a four-year period ending in September 1997, 423 patients, ages 1.5 to 80 years (median 16 years), underwent closure of ASD at 40 medical centers around the world. RESULTS: The ASD size varied between 5 and 30 mm (median 17 mm). The device size varied between 25 and 60 mm. Unbuttoning occurred in 4 (0.9%) of 423 patients. Effective occlusion, defined as no (n = 343) or trivial (n = 34) residual shunt on echo-Doppler studies performed within 24 h of the procedure, was demonstrated in 377 patients (90%). Thus, the unbuttoning rate (0.9 vs. 7.2%) decreased (p<0.01) while effective occlusion rate (90 vs. 92%) remained unchanged (p>0.1) with this device, compared with earlier generation devices. During follow-up from one month to five years (23+/-15 months), 21 (5%) of 417 patients required surgical (n = 12) or transcatheter (n = 9) reintervention, mostly to treat significant residual shunt. In the remaining patients there was gradual reduction and disappearance of the residual shunt. No wire integrity problems were observed. CONCLUSIONS: These data suggest that the fourth generation buttoned device is as effective as earlier generation devices, but without significant unbuttoning. Follow-up results remained good, with a reintervention-free rate of 89% at five years.
Follow-up results of transvenous occlusion of patent ductus arteriosus with the buttoned device.
OBJECTIVES: The purpose of this presentation is to document results of buttoned device (BD) occlusion of patent ductus arteriosus (PDA) in a large number of patients with particular emphasis on long-term follow-up in an attempt to provide evidence for feasibility, safety and effectiveness of this method of PDA closure. BACKGROUND: Immediate and short-term results of BD occlusion of PDA have been documented in a limited number of children. METHODS: During a six-year period ending August 1996, transcatheter BD closure of PDA was attempted in 284 patients, ages 0.3 to 92 years (median 7) under a protocol approved by the local institutional review boards and FDA with an investigational device exemption in U.S. cases. RESULTS: The PDAs measured 1 to 15 mm (median 4) at the narrowest diameter; 20 were larger than 8 mm and 10 larger than 10 mm. They were occluded with devices measuring from 15 to 35 mm delivered via 7F (N = 140) or 8F (N = 144) sheaths. Successful implantation of the device was accomplished in 278 (98%) of 284 patients. The Qp:Qs decreased from 1.8+/-0.6 (mean+/-SD) to 1.09+/-0.19 (p < 0.001). Effective occlusion defined as no (N = 167 [60%]) or trivial (N = 79 [28%]) residual shunt was achieved in 246 (88%) patients. All types of PDAs, irrespective of the shape (conical, tubular or short), size (small or large) or length (short or long) of the PDA and previously implanted Rashkind devices, could be occluded. Follow-up data, 1 to 60 months (median 24) after device implantation, were available in 234 (84%) patients. Seven (3%) patients required reintervention to treat residual shunt with (N = 2) or without (N = 5) hemolysis. Actuarial reintervention-free rates were 95% at 1 and 5 years. There was gradual reduction of actuarial residual shunts and were 40%, 28%, 21%, 14%, 11%, 10%, 6% and 0% respectively at 1 day, 1, 6, 12, 24, 36, 48 and 60 months after device implantation. Incorporation of folding plug over the button loop in 10 additional patients produced immediate and complete occlusion of PDA. CONCLUSIONS: This large multiinstitutional experience confirms the feasibility, safety and effectiveness of buttoned device closure of PDAs. All types of PDAs irrespective of the shape, length and diameter can be effectively occluded. Incorporation of folding plug over the button loop produces complete PDA occlusion at the time of device implantation.
Transcatheter closure of atrial septal defects.
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Results of transvenous buttoned device occlusion of patent ductus arteriosus in adults. International Buttoned Device Trial Group.
Examination of the immediate and follow-up results of transvenous buttoned device occlusion of patent ductus arteriosus suggests that the method is feasible, safe, and effective irrespective of the size and shape of the ductus. Although residual shunts are present, they tend to disappear during follow-up, and complete occlusion at the time of implantation may be achieved by incorporation of a folding plug over the button loop of the device.
Intermediate-term results of Phase I Food and Drug Administration Trials of buttoned device occlusion of secundum atrial septal defects.
OBJECTIVES: This study was conducted to evaluate the intermediate-term results of the multi-institutional U.S. trial of the buttoned device for transcatheter closure of atrial septal defects (ASDs). BACKGROUND: The trial was conducted in three centers (University of Arizona, University of Michigan and University of Wisconsin) under a Food and Drug Administration (FDA)-approved clinical trial with investigational device exemption. Only short-term follow-up is known. METHODS: All 46 patients who had successful implantation of the device were prospectively followed up. Patients were evaluated at 1, 6 and 12 months after device occlusion and yearly thereafter. RESULTS: This cohort was followed up from 51 to 68 months (mean 60.8, median 62). Patient ages ranged from 1 to 62 years (median 4); weights ranged from 10 to 105 kg (median 18); and stretched ASD sizes were 14 +/- 4 mm (left to right shunts) and 10 +/- 3 mm (right to left shunts). Of the 46 patients, 45 (98%) had effective occlusion of their ASD, and 34 (74%) had complete ASD closure. The incidence of residual shunts decreased from 65% (30 of 46 patients) at 1 month after device placement to 27% (12 of 45 patients) at last follow-up. All residual shunts were quantitated as trivial. Only two patients (4%) required reintervention for significant residual defects. There were no cases of endocarditis or thromboembolism in 224 patient-years of follow-up. CONCLUSIONS: In up to 5.5 years of follow-up, the buttoned device provided effective closure in 98% of patients in whom the device was successfully implanted. The incidence of residual shunts decreased during follow-up, and no instances of endocarditis or thromboembolism were observed.
Role of inverted buttoned device in transcatheter occlusion of atrial septal defects or patent foramen ovale with right-to-left shunting associated with previously operated complex congenital cardiac anomalies.
Feasibility, safety, and effectiveness of transcatheter occlusion of atrial septal defect (ASD) with the buttoned device has been demonstrated. Despite its effectiveness in occluding secundum ASD with left-to-right shunt and patent foramina ovalia, presumably responsible for paradoxic embolism, it has limitations in effectively occluding ASD with evident right-to-left shunts. Therefore, the device was modified so that the square-shaped occluder component of the device is on the right atrial side, the inverted buttoned device. This study determines the feasibility, safety, and effectiveness of inverted buttoned device occlusion of atrial defects with right-to-left shunts. During a 17-month period ending August 1996, 12 patients, aged 1.6 to 39.0 years, underwent occlusion of residual ASD after repair of pulmonary atresia/stenosis with intact ventricular septum (n = 5), modified or fenestrated Fontan for tricuspid or pulmonary atresia (n = 5), and double-inlet left ventricle (n = 2). The systemic arterial oxygen saturation increased (p <0.001) from 82 +/- 7% (range 72% to 90%) to 94 +/- 3% (range 88% to 98%). There was no change in heart rate or cardiac index measured by Fick. Right atrial pressure increased by 1 to 4 mm in 5 of 12 patients (42%). There was trivial (n = 5) or no (n = 7) residual shunt by color Doppler study. Six- to 18-month (median 12) follow-up in all 12 patients revealed stable oxygen saturations (92 +/- 3%) by pulse oximetry. Color Doppler studies revealed small (n = 1), trivial (n = 1), or no (n = 10) residual shunt at follow-up. Based on these data, it is concluded that transcatheter occlusion of ASD with right-to-left shunts with inverted buttoned device is feasible in relieving arterial hypoxemia. Further clinical trials in a larger number of patients and careful evaluation of follow-up results are indicated to examine its safety and longer term effectiveness.
Occlusion of congenital ventricular septal defects by the buttoned device. "Buttoned device" Clinical Trials International Register.
OBJECTIVES: To study the feasibility of congenital ventricular septal defect occlusion by the buttoned device and to establish guidelines for its safe and effective application. DESIGN: A descriptive study of all patients with a congenital ventricular septal defect undergoing transcatheter occlusion with the buttoned device, from March 1994 to May 1995. These patients were otherwise candidates for elective surgery at their institutions because they had persistence of a significant shunt (Qp:Qs = 1.5-2.1:1, median = 1.7), with left ventricular enlargement and/or symptoms, although their systolic pulmonary artery pressure was invariably normal (20-28 mm Hg, median = 25). The angiographic diameter of the defect ranged from 2.5 to 14 mm (median 6 mm). SETTING: A multi-institutional study. PATIENTS: Out of 25 cases attempted, 18 children and adults aged 4-35 years had devices implanted. Fifteen of these patients had membranous ventricular septal defects and three had muscular defects. All patients with a membranous ventricular septal defect had an associated aneurysm of the membranous septum. INTERVENTIONS: The buttoned device was introduced either directly or, in the last 12 cases, over a wire bridging the femoral artery and the femoral or jugular vein; the devices were delivered through 7-9 French (F) long sheaths. A membranous defect was regarded as suitable for device closure if the distance from the centre of the defect to the insertion of the right coronary aortic valve leaflet was more than 50% of the size of the required device. The device was guided by echocardiography and fluoroscopy. All muscular defects were corrected through the right jugular vein and all membranous ones through the femoral vein. RESULTS: All 18 patients underwent initial successful implantation of the device. In thirteen patients the shunts were completely occluded and in the remaining five there were trivial residual shunts. In two patients with membranous ventricular septal defects a change from the original position was noticed at two weeks; mild aortic regurgitation developed in one and the murmur recurred in the other; the devices had to be removed surgically. One patient developed transient third degree atrioventricular block during implantation; no tricuspid regurgitation was observed. CONCLUSION: Clinical occlusion of congenital ventricular septal defects was achieved in 16 out of the 18 attempted cases (13 full occlusions). Membranous ventricular septal defect occlusion can be effective and safe if patients and device sizes are carefully selected.
Occlusion of large atrial septal defects with a centering buttoned device: early clinical experience.
A feasibility clinical study was conducted for the transcatheter occlusion of large ostium secundum atrial septal defects with the centering buttoned device. The centering buttoned device is a modification of the regular buttoned device in which a centering counter-occluder is sutured at the central 40% portion of the occluder. During centering it is stretched, forming a parachute-shaped structure and pulling the occluder over the center of the defect. During buttoning, the counter-occluder forms a double figure eight, opposing the right atrial side of the atrial septum. Occlusion was performed in 12 patients aged 6 to 56 years. All had been rejected for transcatheter occlusion by the regular buttoned device, because of either their defect size or the lack of adequate septal rim. The defect size varied between 23 and 31 mm, and the device size varied between 45 and 60 mm. Nine had immediate effective occlusions of their defects and three residual shunts. One patient with unbuttoning had hemolysis at 2 weeks and underwent surgery. Early results of the transcatheter occlusion of large atrial septal defects are promising, and larger clinical trials are justified.
Transcatheter occlusion of cardiac defects.
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Use of the reversed button device to treat an atrial septal aneurysm associated with a patent foramen ovale.
An atrial septal aneurysm may be associated with a patent foramen ovale. When paradoxical emboli result, the shunt must be closed and the atrial septal aneurysm excised. A reversed buttoned occluder device was successfully used for the transcatheter treatment of this condition.
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)
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.
Transcatheter occlusion of patent ductus arteriosus with adjustable buttoned device. Initial clinical experience.
BACKGROUND: Several devices are available for transcatheter occlusion of patent ductus arteriosus. Most of these devices either require complicated intracardiac maneuvering, have not been tried in humans, or need a large-sized sheath for implantation of the device. METHODS AND RESULTS: During a 26-month period ending November 1992, 14 patients underwent transcatheter closure of patent ductus arteriosus with an adjustable buttoned device delivered via a 7F sheath under an institutional review board-approved custom-made device protocol. The children were 15 months to 8 years of age with weight range of 7.2 to 19 kg. The patent ductus arteriosus measured from 2 to 7.5 mm (median, 3 mm) at the narrowest diameter and was conical, short, or tubular. They were occluded with devices measuring 15 to 20 mm. The ratio of pulmonary to systemic flow decreased (P < .01) from 1.9 +/- 0.6 (mean +/- SD; range, 1.3 to 3.2) to 1.05 +/- 0.1 (1 to 1.3). Continuous murmur of patent ductus arteriosus disappeared in all except 1 patient. Small residual shunts were detected by color Doppler studies in 4 of 14 patients (29%). All patients were followed for 1 to 24 months (mean, 6 +/- 7 months). The device was intact in all patients, and no breakage of the wires was noted. No shunts were seen in 12 of 14 patients (86%), and minute residual shunts were seen in 2 children. No major complications were encountered. CONCLUSIONS: It is concluded that transcatheter closure of patent ductus arteriosus with the adjustable buttoned device is feasible and effective and can be accomplished via small 7F sheaths; a 7F sheath is adequate for all ductal sizes; and the adjustable length of the loop accommodated all types of patent ductus arteriosus. Clinical trials on a larger number of patients are warranted.
Echocardiographic estimation of balloon-stretched diameter of secundum atrial septal defect for transcatheter occlusion.
Stretched diameter of the atrial septal defect (ASD), determined by balloon sizing at cardiac catheterization, is commonly used to select the sizes of the devices used for transcatheter closure of the secundum ASD. We have previously evaluated the utility of pulmonary/systemic flow ratio and angiographic and echocardiographic (echo) sizes of the ASD in estimating stretched ASD diameter in a group of 16 patients and determined that echo diameter had the best correlation with stretched diameter (r = 0.82; p less than 0.001). The stretched diameter can be estimated: 1.05 x echo diameter in millimeters + 5.49. In this study we have prospectively evaluated this formula in estimating the stretched ASD diameter by two-dimensional echo measurements obtained in two (long and short-axis) subcostal views in another group of 21 patients aged 2.5 to 29 years (median 4.5 years). The echo size of the ASD was 9.7 +/- 3.0 mm, whereas the measured stretched diameter was 15.3 +/- 4.0 mm. The predicted stretched ASD diameter was calculated according to the above formula and was 15.7 +/- 3.1 mm, not significantly different (p greater than 0.1) from the measured stretched diameter. The correlation between predicted and measured stretched ASD sizes was excellent (r = 0.9; p less than 0.001). The mean squared error was 2.4. The differences between measured and predicted values were within 2 mm in all but three patients. It is concluded that stretched ASD diameter can be estimated accurately by two-dimensional subcostal echo measurements, which in turn could be used for selection of device size for occlusion of the ASD.
Transcatheter closure of patent ductus arteriosus with buttoned device: first successful clinical application in a child.
Several devices are available for transcatheter closure of PDA. Most of the available devices either require complicated intracardiac maneuvering or need a large-sized sheath for implantation of the device. A recently described "buttoned" device developed by Sideris et al. that can be delivered across the ductus via a 7F sheath had undergone successful trials in animal models. Because of the ease of device implantation and the requirement for a smaller-sized sheath for delivery than that used with other devices, we have used this custom-made double-disc device in a 5-year-old child and have shown successful closure of the ductus by angiography and by color Doppler studies. Further clinical trials with this device seem warranted.
Catheter closure of atrial septal defect: successful use in a 3.6 kg infant.
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