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Biomedical subjects

E B Sideris

Publications and source records attributed to E B Sideris.

32 records · Page 2Linked to original sources
PubMed1994

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↗
PubMed1994

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↗
PubMed1993

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.

Cardiac Catheterization↗
PubMed1992

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.

Catheterization↗
PubMed1991

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.

Cardiac Catheterization↗
PubMed1991

[Non-surgical repair of atrial septal defect by "buttoned" double disk device in children. First results in 3 children].

Transcatheter closure of ostium secundum atrial septal defect (ASD) with a "buttoned" double-disk device was attempted in 5 children aged 14 months to 12 years, with success in 3 cases. The diameter of the ASD was 15 to 20 mm. The occluding devices were chosen with sizes 12-15 mm greater than those of the ASDs. There were no operative complications: the ASD was practically completely occluded in 2 children and left a very small shunt in a third case. Those three patients are doing well, 8 to 9 months after the procedure. In the other two cases, the device fell into the right atrium and had to be removed surgically without any complications. The "buttoned" double-disk device seems to be relatively simple and easy to insert through an 8F catheter. Additional technical improvements should enable more complete occlusion of ASD and easier retrieval by the transvenous route when incorrectly inserted. Further experimental and clinical studies are required to assess the results and to compare them with those of the other teams.

Cardiac Catheterization↗
PubMed1990

Transvenous atrial septal defect occlusion in piglets with a "buttoned" double-disk device.

The feasibility and safety of transvenous closure of atrial septal defects by a new device was tested in 20 piglets, in which atrial septal defects were created by foramen ovale dilatation with angioplasty balloons. The device was small enough to be introduced in a 7F or 8F sheath, and it measured 20-25 mm. It has no hooks and consists of a foam occluder from the left atrium and a counter-occluder from the right atrium, buttoned independently. The animals were observed by angiography and color flow mapping, and they were electively killed at various intervals up to 2 months after occlusion. The device was not thrombogenic and had endothelialized by 2-3 weeks. All atrial defects were found to be completely occluded. Complications occurred only with the first three prototype devices, including counter-occluder detachment, right atrial perforation, and need for double occlusion and pulmonary artery embolization. No such complications occurred in the last 17 experiments because of modifications of the device and operator experience. These observations showed the feasibility of occlusion of moderate-size atrial septal defects in piglets by a new device introduced through a small sheath. The method appears promising for potential human application.

Angiography↗
PubMed1988

Axillary vein approach for pulmonic valvuloplasty in infants with iliac vein obstruction.

Repeated pulmonic balloon valvuloplasty from the axillary vein was performed in two infants with initial transvalvular gradients of 131 and 162 mm Hg. The first angioplasty was performed through the femoral vein and improved the valve gradient in both patients. Because of obstruction of the iliac system the axillary vein approach was used for the second angioplasty. The transaxillary pulmonic valvuloplasty decreased the gradient to acceptable levels, and no complications were noticed. The axillary vein approach can be the alternative to the femoral one in cases with obstructed iliac system or interrupted inferior vena cava.

Axillary Vein↗
PubMed1985

Prostaglandins and fetal cardiac output distribution in the lamb.

With the use of a triple thermodilution technique in 17 fetal lambs, combined with microsphere estimations in 7, the effects of indomethacin prostaglandin (PG) I2 and PGE2 on cardiac output and its distribution were measured. Indomethacin (0.2 mg/kg) induced a main pulmonary artery-to-aorta pressure gradient, which peaked within 45-60 min and persisted for 2-3 h. PGE2 abolished this gradient (threshold 50 ng X kg-1 X min-1), while PGI2 in doses up to 100 ng X kg-1 X min-1 increased it. Indomethacin did not change total cardiac output but altered its distribution (right ventricular output, left ventricular output) and increased the percentage of right ventricular output flowing to the lungs. Ductal flow decreased concomitantly. After indomethacin, PGI2 further decreased ductal flow, increased pulmonary flow, and decreased pulmonary vascular resistance. PGE2 restored the original right ventricular-to-total cardiac output ratio, although ductus flow did not return to base-line levels. Pulmonary resistance increased slightly, reflecting decreased pulmonary flow, associated with decreased right ventricular output. Thus PGE2 was more effective on the ductus than on the pulmonary circulation. PGI2 did not relax the ductus but was a potent pulmonary vasodilator. Neither PGI2 nor PGE2 nor indomethacin changed total cardiac output but all altered its distribution.

Animals↗
PubMed1982

Ventricular diastolic pressure-volume relations after the intra-atrial baffle operation for transposition of the great arteries.

Right and left ventricular diastolic pressure-volume (P-V) relations were assessed in 30 patients approximately 2 years after the Mustard operation. The overall distensibility index (delta V/ delta P), the compliance index at end-diastole (dv/dp), and the modulus of ventricular stiffness (Kp) were calculated in all, as well as the half-time of early diastolic pressure fall (T) in 10 cases. Transducer-tipped catheters were used in 15 patients and biplane cineangiography was employed in all. Values for the above indices equal to 2 standard deviations below the mean, obtained from five postoperative Mustard patients with no residual defects, were used as "normals." Seven patients with pulmonary hypertension (PH) and six with pulmonic stenosis (PS) were found to have impaired P-V relations. The impairment was more profound in the PH group. Delta v/delta p and dv/dp were abnormal in six of seven patients for both ventricles and T was abnormal in two of five. Kp was abnormal for the LV, and the RV ejection fraction was diminished. In the PS group (nine patients) the impairment was milder, affecting more than LV and end-diastole (dv/dp). Compliance studies might be useful in patients with LV afterload problems following the Mustard operation.

Cardiac Catheterization↗
PubMed1982

Left ventricular function and compliance in pulmonary atresia with intact ventricular septum.

Left ventricular systolic function and compliance were assessed in 15 cases of pulmonary atresia with intact ventricular septum. The left ventricular ejection fraction measured from cineangiography was used for the evaluation of the systolic function. The end-diastolic pressure (EDP), left ventricular compliance index at end-diastole (dv/dp), and left ventricular stiffness constant K were used as compliance indices. The mean left ventricular ejection fraction was slightly diminished. The right ventricular end diastolic pressures (RVEDPs) correlated significantly (r = 0.90) with the left ventricular end diastolic pressure (LVEDP). On the basis of left ventricular compliance, two distinctive groups of patients could be identified: Group I consisted of Patients 1 to 7, all with impaired left ventricular compliance. A shunt operation was the basic palliation in this group. None of these patients survived infancy. Group II consisted of Patients 8 to 15, all with normal left ventricular compliance. Pulmonary valvotomy as well as aortopulmonary shunts were the basic palliative procedures in this group. Six of eight patients in this group are long-term survivors. No difference was found in right ventricular size, tricuspid valve size, presence of tricuspid insufficiency, presence of a patent ductus arteriosus, postoperative oxygen saturations, and atrial pressure gradients between the two groups. Evaluation of the left ventricular compliance in patients with pulmonary atresia and intact ventricular septum might be of significant prognostic valve for their early survival.

Blood Pressure↗