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Biomedical subjects

Ziyad M Hijazi

Publications and source records attributed to Ziyad M Hijazi.

At least 19 recordsLinked to original sources
PubMed2006

Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: results of the U.S. phase I trial.

OBJECTIVES: This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S. BACKGROUND: The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality. METHODS: Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm). RESULTS: The attempt to place a device was successful in 32 patients (91%). The median device size used was 10 mm (range, 6 to 16 mm). The complete closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min). Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up. CONCLUSIONS: Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy.

Adolescent↗
PubMed2006

Cardiac conduction disturbances seen after transcatheter device closure of muscular ventricular septal defects with the Amplatzer occluder.

This study examined the incidence of cardiac conduction abnormalities and ventricular arrhythmias after the transcatheter closure of muscular ventricular septal defects (MVSDs) using the Amplatzer device occluder. From the records of 27 patients who underwent 33 consecutive MVSD device closures, a low incidence of permanent and transient cardiac conduction disturbances was observed. Heart rate variability was less after the closure of multiple MVSDs compared with single MVSDs.

Adolescent↗
PubMed2006

Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: immediate and midterm results of an international registry.

OBJECTIVE: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). METHODS: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7-58 years) and the median weight was 27.5 kg (7-121 kg). RESULTS: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5-13 mm), median device size 10 mm (4-16 mm) and median fluoroscopy time 22.1 min (8.9-96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1-763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015). CONCLUSION: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device.

Adolescent↗
PubMed2006

Percutaneous replacement of pulmonary valve using the Edwards-Cribier percutaneous heart valve: first report in a human patient.

We report on the use of the Edwards-Cribier percutaneous heart valve (PHV) in a stenotic right ventricle to pulmonary artery homograft in a 16-year old patient who underwent the Ross operation. Initially, the homograft was stented and at the same procedure, the PHV was deployed inside it. This is the first human case of the application of this valve in the pulmonary valve position.

Adolescent↗
PubMed2006

Intracardiac echocardiography to guide closure of atrial septal defects in children less than 15 kilograms.

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly replacing transesophageal echocardiography (TEE) as the primary imaging technique to guide device closure of atrial septal defects (ASD). Owing to the length of the procedure, the use of TEE requires general anesthesia. Investigators have reported the usefulness of ICE in adults and children. However, little is known about the use of ICE in children whose weight is <15 kg. Therefore, this study examines the use of ICE guided secundum ASD closure in children <15 kg. METHODS: Nineteen patients with a median age of 3.1 years (range 1.8-4.8), and median weight of 13.2 kg (range 8.0-14.4) underwent transcatheter occlusion (Amplatzer occluder) of a secundum ASD using ICE guidance. ICE was performed using an Acunav catheter. The ICE catheter (10 F shaft) was introduced into an 11 F sheath in a contralateral femoral vein. Diagnostic as well as periprocedure imaging was obtained. RESULTS: Sixteen patients had single, and three had multiple defects. Median defect size as measured by ICE was 16 mm (range 2.5-25). The median balloon stretched diameter (obtained in eight patients) was 18 mm (range 10-21); the median size of the defect for these eight patients was 15 mm (range of 8-20). Both techniques for measuring the defect correlated well with r = 0.94. The ASD occluder size ranged from 7 to 26 mm with a median of 18 mm. The procedure was successful in 16 patients who had a device implanted and no residual shunt. ASD occlusion was not attempted in two patients due to deficient rims and in one patient, the attempt failed due to left atrial disk prolapse through the ASD. Four patients experienced transient complications during the catheter procedure, including supra ventricular tachycardia, sinus bradycardia, and two with complete heart block (resolving with device removal); all had subsequent successful device placement. No complications were attributed to the use of ICE and specifically, no vascular injury was noted. CONCLUSIONS: Comparable to results with larger patients, ICE provides adequate imaging (preprocedure diagnosis and periprocedure guidance) during device occlusion of secundum ASDs with no significant complications. Thus, ICE can successfully be used in the closure of ASD in smaller patients (<15 kg) and eliminate the need for endotracheal intubation.

Body Weight↗
PubMed2005

Single-ventricle palliation for high-risk neonates: the emergence of an alternative hybrid stage I strategy.

BACKGROUND: Survival after stage I palliation for hypoplastic left heart syndrome or related anomalies remains poor in high-risk neonates. We hypothesized that a less invasive hybrid approach would be beneficial in this patient population. METHODS: The hybrid stage I procedure was performed in the catheterization laboratory. Via a median sternotomy, both branch pulmonary arteries were banded, and a ductal stent was delivered via a main pulmonary artery puncture and positioned under fluoroscopic guidance. RESULTS: Between October 2003 and June 2005, 14 high-risk neonates underwent a hybrid stage I procedure. Eleven of 14 had hypoplastic left heart syndrome. Two also underwent peratrial atrial septal stenting, and 5 required percutaneous atrial stenting later. Two neonates with an intact or highly restrictive atrial septum had emergency percutaneous atrial stent placement. Hospital survival was 11 (78.5%) of 14. One patient required extracorporeal membrane oxygenation support for intraoperative cardiac arrest. He underwent cardiac transplantation but died later of sepsis. One patient died of ductal stent embolization, and a third died of progressive cardiac dysfunction. The first 4 patients required pulmonary artery band revisions. There were none after we modified our technique and added branch pulmonary artery angiograms. There were 2 interstage deaths from atrial stent occlusion and from preductal retrograde coarctation. Eight patients underwent stage II procedures, consisting of aortic arch reconstruction, atrial septectomy, and cavopulmonary shunt. Two patients died after stage II. One patient is awaiting stage II. CONCLUSIONS: The hybrid stage I palliation is a valid option in high-risk neonates. As experience is accrued, it may become the preferred alternative. However, in aortic atresia, the development of preductal retrograde coarctation is a significant problem.

Cardiac Surgical Procedures↗
PubMed2005

Closure of a moderately large atrial septal defect with a self-fabricated fenestrated Amplatzer septal occluder in an 85-year-old patient with reduced diastolic elasticity of the left ventricle.

Percutaneous closure of an atrial septal defect (ASD) in the elderly with reduced diastolic elasticity of the left ventricle poses a significant management challenge. We report on the case of an 85-year-old patient who was admitted for percutaneous device closure of a moderately large secundum atrial septal defect. Hemodynamic evaluation documented an increase in left atrial pressure from a mean of 12 mm Hg to a mean of 32 mm Hg after balloon test occlusion of the ASD. Two months later, after adequate pretreatment with diuretics and afterload-reducing substances, he underwent successful closure of the ASD using a self-fabricated fenestrated Amplatzer septal occluder, which resulted in a postimplantation left atrial pressure of a mean of 18 mm Hg. Recovery was unremarkable and the fenestration has remained patent for 3 months since implantation of the device. This unique case highlights the feasibility of using a self-fabricated fenestrated Amplatzer septal occluder to close interatrial communications in elderly patients with diastolic dysfunction of the left ventricle.

Aged↗
PubMed2005

Initial clinical experience with intracardiac echocardiography in guiding transcatheter closure of perimembranous ventricular septal defects: feasibility and comparison with transesophageal echocardiography.

Over the last several years, intracardiac echocardiography (ICE) has been employed successfully in guiding transcatheter device closure of a secundum atrial septal defect (ASD) or patent foramen ovale (PFO). Nothing is known regarding the use of ICE to guide catheter device closure of a perimembranous ventricular septal defect (PMVSD). Twelve patients (seven female/five male) who had a PMVSD (among them, three patients with associated atrial communications: two with an ASD and one with a PFO) underwent attempts at transcatheter device closure using the Amplatzer membranous VSD device of their defects, using sequential transesophageal echocardiography (TEE) and ICE guidance with general endotracheal anesthesia (five patients) and using ICE alone with conscious sedation (seven patients). The mean age of patients was 16.9 +/- 3.7, and their mean weight was 42.4 +/- 6.6. Their mean left ventricular end-diastolic dimension preclosure was 45.7 +/- 2.5. The Qp/Qs ratio ranged from 1.0 to 1.8:1. During the procedure, the ICE catheter was positioned in the right atrium (RA) in all 12 patients and the ICE catheter was advanced to the left atrium to obtain a view of the ventricular septum in 3. Both TEE and ICE provided similar anatomical views of the position of the PMVSD. Furthermore, the relationship of the defect to the aortic valve and tricuspid valves, the measured size of defect, and the guidance of various stages of device deployment were comparable by TEE and ICE. There were no complications encountered during or after closure. We conclude that ICE provides unique images of the PMVSD and measurements similar to those obtained by TEE. ICE potentially could replace TEE in most patients as a guiding imaging tool for PMVSD device closure, thus eliminating the need for general endotracheal anesthesia.

Adolescent↗
PubMed2005

Transcatheter closure of large secundum atrial septal defects using the 40 mm Amplatzer septal occluder: results of an international registry.

Little is known about the efficacy and safety of the 40 mm Amplatzer septal occluder (ASO). Thirty-three patients (22 female, 11 male) with a large secundum atrial septal defect (ASD) underwent attempted device closure using the 40 mm ASO at a median age of 40 years (range, 14-81 years) and median weight of 65 kg (range, 48-98 kg). The median size of the ASD measured on 2D transesophageal echocardiography (27 patients) or intracardiac echocardiography (6 patients) was 30.5 mm (range, 24-39 mm) and the median balloon-stretched diameter was 37.7 mm (range, 32-43.7 mm). The median Qp:Qs ratio was 3.2:1 (range, 1.4-6.2). The attempt was unsuccessful in five patients; two had device embolization and one had left atrial wall perforation due to the sheath; all three required emergent surgery. The attempt was successful in the 28 remaining patients, resulting in complete immediate closure in 14 and a trivial residual shunt in 14. Fluoroscopy time ranged from 8.6 to 37.8 min (median, 12.2 min). At 24-hr follow-up, 2D transthoracic echocardiography with color flow Doppler revealed complete closure in 23 patients, and 5 had a trivial residual shunt. There were no complications encountered in patients who received the device. On follow-up, all patients are doing well. We conclude that the 40 mm ASO is safe and effective in most patients with a large ASD up to a diameter of 39 mm. However, the use of this device requires careful attention as the procedure may be unsuccessful or the device may embolize.

Adolescent↗
PubMed2005

Heart block and empirical therapy after transcatheter closure of perimembranous ventricular septal defect.

Two patients with perimembranous ventricular septal defects (VSDs) and inlet extension have undergone uncomplicated transcatheter device closure using the Amplatzer membranous VSD device. Both patients developed complete heart block 2-4 days from the closure. Both patients responded well to high-dose intravenous therapy with steroids and high-dose oral anti-inflammatory aspirin. Both patients remain in normal sinus rhythm 8 weeks and 10 months, respectively, from the episode.

Aspirin↗
PubMed2005

Transcatheter placement of a low-profile biodegradable pulmonary valve made of small intestinal submucosa: a long-term study in a swine model.

OBJECTIVE: We sought to investigate a placement of a percutaneous low-profile prosthetic valve constructed of small intestinal submucosa in the pulmonary position in a swine model. METHODS: Twelve female farm pigs were stented at the native pulmonary valve to induce pulmonary insufficiency. Once right ventricular dilation occurred, the small intestinal submucosa valve was implanted. The pigs were followed up with transthoracic echocardiographic Doppler scanning. One animal died of heart failure before valve replacement. Animals were euthanized at 1 day, 1 month, 3 months, 6 months, and 12 months after valve implantation. RESULTS: The small intestinal submucosa pulmonary valve showed effective reversal of pulmonary regurgitation. There were no misplacements during deployment. There were no embolizations. One-year echocardiographic follow-up showed minimal regurgitation and no stenosis for a valve/vessel ratio of 0.78 or greater. Histologic examination demonstrated intensive remodeling of the small intestinal submucosal valve. Within 1 month, the surface was covered by endothelium, and fibroblasts invaded the interior. Over the following months, the small intestinal submucosal valve remodeled without apparent graft rejection. CONCLUSION: The small intestinal submucosa valve has the potential for graft longevity without the need for anticoagulation or immunosuppression. Histologic remodeling of the valve tissue provides a replacement capable of resembling a native valve that can be placed percutaneously with low-profile delivery systems.

Absorbable Implants↗
PubMed2005

Hybrid procedures in pediatric cardiac surgery.

Hybrid pediatric cardiac surgery is an emerging field that combines skills and techniques used by pediatric cardiac surgeons and interventional pediatric cardiologists. This article describes the emerging indications and techniques in hybrid pediatric cardiac surgery and discusses potential future applications. It focuses on peratrial and perventricular septal defect closure, intraoperative stenting, hybrid stage I palliation for hypoplastic left heart syndrome, and percutaneous valve implantation.

Cardiac Surgical Procedures↗
PubMed2005

Pediatric catheter interventions: a year in review 2004-2005.

PURPOSE OF THE REVIEW: The fields of pediatric and congenital cardiac interventions continue to expand at a rapid pace. The last few years have witnessed a tremendous explosion in procedures such as the transcatheter closure of secundum atrial septal defects, patent foramen ovale, patent ductus arteriosus, stent placement for pulmonary artery stenosis, and coarctation of the aorta. The purpose of this review is to highlight important publications in the last year and the direction the field is taking. RECENT FINDINGS: Research data over the last year has concentrated on six main themes: (a) mid-to-long-term data for device closure of atrial septal defects, the incidence of late cardiac erosions, thrombus formation and heart block; (b) the transcatheter closure of muscular ventricular septal defects; (c) the transcatheter closure of perimembranous ventricular septal defects; (d) the placement of bioprosthetic valves in the pulmonary and aortic positions; (e) the 'hybrid' approach that combines surgical and interventional techniques in the management of various congenital cardiac defects; and (f) fetal interventions. SUMMARY: This review outlines the key data presented in the literature involving interventional cardiology for pediatric and congenital cardiac defects over the last year. It illustrates that in close collaboration with industry, together with bioengineers and cardiothoracic surgeons, adult cardiac interventionists and perinatologists should continue to expand the role of pediatric catheter interventions. Fetal interventions have the potential to alter the natural history of abnormal cardiac development.

Adult↗