The Experts below are selected from a list of 1881 Experts worldwide ranked by ideXlab platform
Ziyad M Hijazi - One of the best experts on this subject based on the ideXlab platform.
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atrioventricular block after transcatheter asd closure using the amplatzer Septal Occluder risk factors and recommendations
Catheterization and Cardiovascular Interventions, 2010Co-Authors: Shada J Alanani, Howard S Weber, Ziyad M HijaziAbstract:Transcatheter device closure of atrial Septal defects is now considered an alternative option to open heart surgery with good short-term and long-term results (Du et al., J Am Coll Cardiol 2002;39:1836-1844, Chessa et al., J Am Coll Cardiol 2002;39:1061-1065); in comparison with surgical closure, the complication rate is lower (Du et al., J Am Coll Cardiol 2002;39:1836-1844). Arrhythmias are known infrequent complications of device closure. However, complete heart block is a rare complication of both treatment modalities (Chessa et al., J Am Coll Cardiol 2002;39:1061-1065). We report two patients who developed atrioventricular (AV) block within 48 hr after uncomplicated device closure of ASD using the Amplatzer Septal Occluder (ASO) device. Despite trials of high dose steroids and non-steroidal anti-inflammatory agents in both patients, the response was inadequate and by the end of the first week, both patients were ultimately sent for surgical removal of their devices with complete resolution of their atrioventricular conduction abnormalities. We discuss the possible etiology and risk factors of AV block and propose recommendations for management of such a complication.
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device closure of atrial Septal defects with the amplatzer Septal Occluder safety and outcome in infants
The Journal of Thoracic and Cardiovascular Surgery, 2007Co-Authors: Karim A Diab, Qiling Cao, Emile A Bacha, Ziyad M HijaziAbstract:Objective Device closure of secundum atrial Septal defects is sometimes needed in young children; however, little is known about the safety and outcome of this procedure in infants. In this study, the safety and efficacy of secundum atrial Septal defect closure with the Amplatzer Septal Occluder (AGA Medical Corp, Golden Valley, Minn) was evaluated in patients less than 1 year of age. Methods Between July 1999 and September 2006, atrial Septal defect closure with the Amplatzer Septal Occluder was attempted in 15 infants at our institution. The patients ranged in age from 0.5 to 11.9 months (mean ± standard deviation; 8.2 ± 3.7 months) in the percutaneous group and from 2.2 to 3.4 months (2.9 ± 0.6 months) in the peratrial group. Their weights ranged from 3.8 to 8.3 kg (5.5 ± 1.7 kg) and from 3.0 to 4.0 kg (3.4 ± 0.6 kg) in each group, respectively. The indications for atrial Septal defect closure were failure to thrive, significant chamber enlargement, hemodynamically significant shunts, and prehepatic transplantation. The size of the defect as measured by intracardiac echocardiography (n = 3) or transesophageal echocardiography (n = 12) ranged from 2.0 to 16 mm (8.0 ± 4.4 mm). Results The pulmonary/systemic flow ratio ranged from 1.0 to 9.0 (2.8 ± 2.0).The device was successfully placed in 14 of 15 infants. The size of the Amplatzer Septal Occluder device implanted ranged from 4 to 20 mm (10.1 ± 4.3 mm). It was percutaneously deployed in 11 of 14 patients and by the hybrid or peratrial approach (open chest off-pump) in 3 of 14 infants. In infants who had a successful attempt (n = 14), the complete closure rates at 24 hours and 1 year were 86% and 100%, respectively. In 3 of 15 infants, minor complications occurred: transient arrhythmias (n = 2) and blood transfusion (n = 1). One patient had a major complication (vascular intimal injury with thrombosis of the inferior vena cava). One patient with Down syndrome died 6 weeks later of progressive pulmonary hypertension. The follow-up time ranged from 0.6 to 6.9 years (3.2 ± 1.9 years). At follow-up, clinical development and growth improved in all children with failure to thrive, and all ventilator-dependent children could be weaned shortly after closure of the atrial Septal defect. Conclusion Device closure of atrial Septal defects is an effective and fairly safe alternative to surgery in infants. Hybrid or peratrial closure is also an alternative to percutaneous closure in the very small infant.
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multiple amplatzer Septal Occluder devices for multiple atrial communications immediate and long term follow up results
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Sawsan Awad, Qiling Cao, Francisco Garay, Ziyad M HijaziAbstract:Objectives: We report on the feasibility, effectiveness, and long-term outcome of transcatheter closure of multiple ASD's using multiple ASO devices. Background: Little is known about the use and long-term outcome of multiple Amplatzer Septal Occluder (ASO) devices to close multiple atrial Septal defects (ASD's). Methods: From May 1997 to June 2006, 33 patients (mean age 38.9 years and mean weight 68 kg) underwent transcatheter closure of multiple ASD's under transesophageal (TEE) or intracardiac echocardiographic (ICE) guidance. Results: Unless not available, the device size chosen to be deployed was ±2 mm larger than the stretched diameter or no more than 30–40% larger than the ICE/TEE 2D diameter. Sixty-seven devices were deployed in 33 patients. The mean diameters of the larger and smaller defects were 12.9 and 7.7 mm, and the corresponding mean balloon stretched diameters were 19.2 and 12.0 mm, respectively. The mean larger and smaller device diameters were 19.0 and 13.4 mm, respectively. The mean QP: Qs ratio was 1.8:1. The mean fluoroscopy time, and procedure time were 16.4 and 81.6 min respectively. Immediately after the procedure 15 patients had complete closure, 8 had trivial shunt, 9 had small shunt and one had large shunt. Complications included a device embolization within 24 hr and left atrial-aortic wall erosion and pericardial effusion at 2 years. The mean follow-up interval was 34.8 + 25.7 months. Conclusions: Device closure of multiple ASD's using multiple ASO's is safe and effective. Continued follow-up is important to assess the long-term outcome. © 2007 Wiley-Liss, Inc.
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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
Catheterization and Cardiovascular Interventions, 2005Co-Authors: Ralf J Holzer, Qiling Cao, Ziyad M HijaziAbstract: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.
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novel technique to prevent prolapse of the amplatzer Septal Occluder through large atrial Septal defect
Catheterization and Cardiovascular Interventions, 2003Co-Authors: Abdul H Wahab, Qiling Cao, Amjad R Bairam, Ziyad M HijaziAbstract:We report on a new technique (holding the left atrial disk in the left atrium by a dilator) to prevent prolapse of the left atrial disk of the Amplatzer Septal Occluder during deployment in large atrial Septal defects (ASDs). Two patients underwent successful closure of their ASDs using this new technique. Catheter Cardiovasc Interv 2003;60:543–545. © 2003 Wiley-Liss, Inc.
Larry A Latson - One of the best experts on this subject based on the ideXlab platform.
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results of the u s food and drug administration continued access clinical trial of the gore helex Septal Occluder for secundum atrial Septal defect
Jacc-cardiovascular Interventions, 2014Co-Authors: Evan M Zahn, Alexander J Javois, Thomas K Jones, Craig E Fleishman, Jonathan J Rome, Ricardo H Pignatelli, Larry A LatsonAbstract:Abstract Objectives This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial Septal defect. Background The trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the Pivotal Trial. Devices with hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial. Methods A total of 137 devices were implanted in 137 patients at 13 US institutions. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer term evaluations. Results Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced an erosion or sudden catastrophic event. Conclusions The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the GORE HELEX Septal Occluder is a safe and effective transcatheter Occluder for repair of ostium secundum atrial Septal defect.
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results of the u s multicenter pivotal study of the helex Septal Occluder for percutaneous closure of secundum atrial Septal defects
Journal of the American College of Cardiology, 2007Co-Authors: Thomas K Jones, Larry A Latson, Evan M Zahn, Craig E Fleishman, Joth Jacobson, Robert N Vincent, Kirk R KanterAbstract:Objectives This study sought to compare the safety and efficacy of the HELEX Septal Occluder (HSO) with surgical repair of atrial Septal defect (ASD). Background The HSO is a low-profile, double-disk Occluder device for percutaneous closure of secundum ASD. Methods Patients were enrolled (HSO arm prospectively, surgery arm prospectively/retrospectively) from 14 U.S. sites and followed up for 12 months postprocedure. Investigator-reported outcomes were evaluated, including closure success (no or clinically insignificant residual shunt) and the incidence of adverse events. The first 3 HSO patients at each site were considered training cases and were excluded from analysis. Results Between March 2001 and April 2003, 119 nontraining cases received an HSO and 128 had surgical repair. The groups were similar with statistical but clinically unimportant differences in median age, weight, and preprocedural echocardiographic defect size. Anesthesia time and hospital stay were significantly shorter in the HSO group. Closure success, defined as complete closure or a clinically insignificant residual shunt, was similar in both groups. Major and minor adverse events rates were not statistically different. The most common major adverse events for the HSO group was device embolization requiring catheter retreival (1.7%), and in the surgery group was postpericardiotomy syndrome (6.3%), including one death because of tamponade. The primary end point, clinical success, a composite of closure success and no major adverse events at 12 months, satisfied the noninferiority hypothesis comparing device closure with surgery. Conclusions Closure of ASD with the HELEX Septal Occluder is safe and effective when compared with surgical repair, with reduced anesthesia time and hospital stay. (U.S. Multicenter Pivotal Study of the HELEX Septal Occluder for Percutaneous Closure of Secundum Atrial Septal Defects; this study was approved by the Food and Drug Administration before the National Institutes of Health website was active, so there is not a URL or registration number.)
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analysis of factors related to successful transcatheter closure of secundum atrial Septal defects using the helex Septal Occluder
American Heart Journal, 2006Co-Authors: Larry A Latson, Evan M Zahn, Thomas K Jones, Joth Jacobson, John F RhodesAbstract:Background The HELEX Septal Occluder is a new transcatheter atrial Septal defect occlusion device. This study analyzes the data collected from the first US clinical trials with this device to determine the most significant factors in successful use of the device. Methods Tables of subsets of data were constructed in categories of possibly significant patient and device variables compared with important outcomes. χ 2 analysis was used to determine which variables had significant impact on outcomes. Results The device was successfully implanted in 87% of patients (298/342). A major adverse event occurred in 5.8% (mostly device removal for various reasons). A significant residual leak persisted at 1 year in 2.6%. A fracture of the wire frame occurred in 8%—all were asymptomatic and only 1 required treatment. Overall composite success (no significant leak and no major adverse event) was seen in 91.5%. Patient age, body surface area, and device size had no significant influence on outcomes, except that wire frame fractures were more likely with the 35-mm device. Defect stretch diameter had the largest influence on outcomes, and implantation was possible in only 67% if the stretched diameter of the defect was >20 mm. Device-defect ratio also had a significant effect on delivery success and composite success. Conclusions The HELEX Septal Occluder is best suited for small to moderate atrial Septal defects with a stretch diameter 2 resulted in 95% composite success, and is recommended when possible.
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development and testing of the helex Septal Occluder a new expanded polytetrafluoroethylene atrial Septal defect occlusion system
Circulation, 2001Co-Authors: Evan M Zahn, Warren J Cutright, Neil Wilson, Larry A LatsonAbstract:Background— A variety of transcatheter atrial Septal defect (ASD) Occluders are currently in use around the world. Although for the most part effective, all of these devices lack features that would be desirable in a “perfect” device. The Helex Septal Occluder is a new type of device designed to improve the results of transcatheter ASD closure. This study was designed to examine the effectiveness and safety of this Occluder in an animal model. Methods and Results— The Helex was implanted into 24 dogs with surgically created ASDs. Procedural details focusing on deployment, removal, and early closure rates were examined. Follow-up consisted of sequential transesophageal echocardiography and fluoroscopy as well as epicardial contrast echocardiography and angiography at the time of death. Specimens were examined grossly and histologically, and devices were tested for metal fatigue. All animals had successful ASD closure. Implantation was uncomplicated (mean fluoroscopy time 11.7 minutes), and removal or repos...
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helex Septal Occluder for closure of atrial Septal defects
Current interventional cardiology reports, 2000Co-Authors: Larry A Latson, Evan M Zahn, Nigel WilsonAbstract:The HELEX Septal Occluder (W.L. Gore and Associates, Flagstaff, AZ) is a new device with many desirable characteristics. These include direct placement of the delivery catheter across the Septal defect without the need for a long sheath; rounded, flexible and atraumatic shape; easy deployment while maintaining the ability to withdraw the device back into the delivery system at any time prior to release; safety cord to allow for removal of the device even after release from the formed elements of the delivery system; and highly biocompatible expanded polytetrafluoroethylene (ePTFE) covering. The design of the device has been thoroughly tested by computer modeling, in vitro testing, and in vivo evaluations in an animal model of atrial Septal defect (ASD). Early human experience in Europe for ASD and patent foramen ovale (PFO) indications has been encouraging. Food and Drug Administration (FDA) trials in the United States are anticipated this year.
Evan M Zahn - One of the best experts on this subject based on the ideXlab platform.
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Development and Testing of the Helex Septal Occluder, a New Expanded Polytetrafluoroethylene Atrial Septal Defect Occlusion System
2016Co-Authors: Evan M ZahnAbstract:Background—A variety of transcatheter atrial Septal defect (ASD) Occluders are currently in use around the world. Although for the most part effective, all of these devices lack features that would be desirable in a “perfect ” device. The Helex Septal Occluder is a new type of device designed to improve the results of transcatheter ASD closure. This study was designed to examine the effectiveness and safety of this Occluder in an animal model. Methods and Results—The Helex was implanted into 24 dogs with surgically created ASDs. Procedural details focusing on deployment, removal, and early closure rates were examined. Follow-up consisted of sequential transesophageal echocardiography and fluoroscopy as well as epicardial contrast echocardiography and angiography at the time of death. Specimens were examined grossly and histologically, and devices were tested for metal fatigue. All animals had successful ASD closure. Implantation was uncomplicated (mean fluoroscopy time 11.7 minutes), and removal or repositioning was always possible. Closure rate as judged by transesophageal echocardiography was 88 % initially and 100 % at 2-week follow-up. Devices rapidly became infiltrated with connective tissue without inflammation and were endothelialized over time. There were no instances of thromboembolism. A single wire-frame fracture occurred secondary to a prototype delivery system malfunction. Conclusions—The Helex Septal Occluder proved safe and effective for ASD closure. Several advantages over currently available devices were evident in this model. Controlled prospective clinical trials are needed. (Circulation. 2001;104
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results of the u s food and drug administration continued access clinical trial of the gore helex Septal Occluder for secundum atrial Septal defect
Jacc-cardiovascular Interventions, 2014Co-Authors: Evan M Zahn, Alexander J Javois, Thomas K Jones, Craig E Fleishman, Jonathan J Rome, Ricardo H Pignatelli, Larry A LatsonAbstract:Abstract Objectives This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial Septal defect. Background The trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the Pivotal Trial. Devices with hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial. Methods A total of 137 devices were implanted in 137 patients at 13 US institutions. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer term evaluations. Results Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced an erosion or sudden catastrophic event. Conclusions The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the GORE HELEX Septal Occluder is a safe and effective transcatheter Occluder for repair of ostium secundum atrial Septal defect.
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mid term outcomes of the helex Septal Occluder for percutaneous closure of secundum atrial Septal defects
Congenital Heart Disease, 2013Co-Authors: Rafael Correa, Evan M Zahn, Danyal KhanAbstract:Background The HELEX Septal Occluder (HSO) was approved by the Food and Drug Administration for closure of secundum atrial Septal defects (ASD) in 2006. However, little mid-term follow-up information is available. The object of this study was to examine mid-term outcomes after HSO implantation Methods A retrospective chart review was performed on the first 74 patients who underwent ASD closure with the HSO between 4/00–10/04. Only patients who left the catheterization laboratory after successful implantation and had a minimum follow-up of 5 years were selected for analysis. Results Thirty-three patients met entry criteria. At implantation the mean age was 10.9 years and the median ASD size was 15.1 mm. At a median follow-up of 88 months, 26 patients had complete ASD closure, 6 had trivial left-right shunts, and 1 had a significant residual shunt having a reintervention. Fluoroscopy, performed in 27 patients revealed a frame fracture in 3 patients (9%), all of whom were asymptomatic and had effective ASD closure. All 3 devices were 30 mm or 35 mm HSO and were left in place. One patient developed first-degree heart block and remained asymptomatic with no progression. There were no instances of late device embolization, cardiac perforation, erosion, or death. Conclusions Following successful implantation, HSO results in effective closure of secundum ASD in mid-term follow-up. Late complications appear to be rare with the exception of frame fracture, which in this series did not result in clinical sequelae.
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results of the u s multicenter pivotal study of the helex Septal Occluder for percutaneous closure of secundum atrial Septal defects
Journal of the American College of Cardiology, 2007Co-Authors: Thomas K Jones, Larry A Latson, Evan M Zahn, Craig E Fleishman, Joth Jacobson, Robert N Vincent, Kirk R KanterAbstract:Objectives This study sought to compare the safety and efficacy of the HELEX Septal Occluder (HSO) with surgical repair of atrial Septal defect (ASD). Background The HSO is a low-profile, double-disk Occluder device for percutaneous closure of secundum ASD. Methods Patients were enrolled (HSO arm prospectively, surgery arm prospectively/retrospectively) from 14 U.S. sites and followed up for 12 months postprocedure. Investigator-reported outcomes were evaluated, including closure success (no or clinically insignificant residual shunt) and the incidence of adverse events. The first 3 HSO patients at each site were considered training cases and were excluded from analysis. Results Between March 2001 and April 2003, 119 nontraining cases received an HSO and 128 had surgical repair. The groups were similar with statistical but clinically unimportant differences in median age, weight, and preprocedural echocardiographic defect size. Anesthesia time and hospital stay were significantly shorter in the HSO group. Closure success, defined as complete closure or a clinically insignificant residual shunt, was similar in both groups. Major and minor adverse events rates were not statistically different. The most common major adverse events for the HSO group was device embolization requiring catheter retreival (1.7%), and in the surgery group was postpericardiotomy syndrome (6.3%), including one death because of tamponade. The primary end point, clinical success, a composite of closure success and no major adverse events at 12 months, satisfied the noninferiority hypothesis comparing device closure with surgery. Conclusions Closure of ASD with the HELEX Septal Occluder is safe and effective when compared with surgical repair, with reduced anesthesia time and hospital stay. (U.S. Multicenter Pivotal Study of the HELEX Septal Occluder for Percutaneous Closure of Secundum Atrial Septal Defects; this study was approved by the Food and Drug Administration before the National Institutes of Health website was active, so there is not a URL or registration number.)
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analysis of factors related to successful transcatheter closure of secundum atrial Septal defects using the helex Septal Occluder
American Heart Journal, 2006Co-Authors: Larry A Latson, Evan M Zahn, Thomas K Jones, Joth Jacobson, John F RhodesAbstract:Background The HELEX Septal Occluder is a new transcatheter atrial Septal defect occlusion device. This study analyzes the data collected from the first US clinical trials with this device to determine the most significant factors in successful use of the device. Methods Tables of subsets of data were constructed in categories of possibly significant patient and device variables compared with important outcomes. χ 2 analysis was used to determine which variables had significant impact on outcomes. Results The device was successfully implanted in 87% of patients (298/342). A major adverse event occurred in 5.8% (mostly device removal for various reasons). A significant residual leak persisted at 1 year in 2.6%. A fracture of the wire frame occurred in 8%—all were asymptomatic and only 1 required treatment. Overall composite success (no significant leak and no major adverse event) was seen in 91.5%. Patient age, body surface area, and device size had no significant influence on outcomes, except that wire frame fractures were more likely with the 35-mm device. Defect stretch diameter had the largest influence on outcomes, and implantation was possible in only 67% if the stretched diameter of the defect was >20 mm. Device-defect ratio also had a significant effect on delivery success and composite success. Conclusions The HELEX Septal Occluder is best suited for small to moderate atrial Septal defects with a stretch diameter 2 resulted in 95% composite success, and is recommended when possible.
Neil Wilson - One of the best experts on this subject based on the ideXlab platform.
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fracture of a gore helex Septal Occluder following pfo closure in a diver
Catheterization and Cardiovascular Interventions, 2009Co-Authors: Paul F Scott, Neil Wilson, Gruchen VeldtmanAbstract:Decompression illness (DCI) is more common in divers with a patent foramen ovale (PFO), and transcatheter PFO closure is being increasingly performed in patients with an episode of DCI who want to continue diving. A range of closure devices are available and the choice in an individual case depends on operator preference and PFO anatomy. The GORE HELEX Septal Occluder, introduced in 1999 primarily for secundum atrial defect closure, is a compliant non self-centering device composed of a wire helical framework on which a microporous membrane is mounted. The device is fixed in place by a unique interlocking mechanism that passes through the center of the device from the left to the right atrial disc, thereby securing it onto the interatrial septum. Here, we present a case of a locking loop fracture and review the literature concerning this unusual complication. © 2009 Wiley-Liss, Inc.
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closure of atrial Septal defect with the amplatzer Septal Occluder in adults
American Journal of Cardiology, 2009Co-Authors: Nicolas Majunke, Neil Wilson, Nina Wunderlich, Jacek Bialkowski, Malgorzata Szkutnik, Jacek Kusa, Andreas Baranowski, Corinna Heinisch, Stefan Ostermayer, Horst SievertAbstract:Transcatheter closure of atrial Septal defects (ASDs) was performed mainly in children and adolescents. Information about outcome and complications in adults was limited. From November 1997 to November 2005, percutaneous closure of ASDs using the Amplatzer Septal Occluder was attempted in 650 consecutive adult patients. Median patient age was 45.8 ± 16.2 years (range 18 to 90), mean systolic artery pressure was 33.3 ± 10.6 mm Hg (range 11 to 85), and mean pulmonary and systemic blood flow (Qp/Qs) ratio was 1.9 ± 0.7 (range 0.8 to 6.6). Mean stretched diameter of the ASD was 21.2 ± 5.1 mm (range 3.1 to 43). Seventy-eight patients (12%) had multiple defects. Of 572 patients with a single ASD, device implantation was successful in 563 patients (98%). During follow-up, complete closure could be achieved in 96% of patients with a single ASD and 71% of patients with multiple defects. Mean systolic artery pressure decreased to 28.3 ± 10.1 mm Hg and mean Qp/Qs ratio decreased to 1 ± 0.3. The 3 complications that occurred during the procedure were device embolization (2 patients; 0.3%) and transient ST depression (1 patient; 0.2%). The most common complication immediately after the procedure and during follow-up was new-onset atrial fibrillation (28 patients; 4.3%). Electrical cardioversion was successfully in most. Complications requiring emergency or elective surgery occurred in 6 patients (0.9%; hemopericardium, 2 patients, 0.3%; device embolization, 3 patients, 0.5%, and pericardial tamponade, 1 patient, 0.2%). In conclusion, closure of ASDs using the Amplatzer Septal Occluder in adults was efficient and safe, with excellent long-term success rates. Serious complications were rare.
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development and testing of the helex Septal Occluder a new expanded polytetrafluoroethylene atrial Septal defect occlusion system
Circulation, 2001Co-Authors: Evan M Zahn, Warren J Cutright, Neil Wilson, Larry A LatsonAbstract:Background— A variety of transcatheter atrial Septal defect (ASD) Occluders are currently in use around the world. Although for the most part effective, all of these devices lack features that would be desirable in a “perfect” device. The Helex Septal Occluder is a new type of device designed to improve the results of transcatheter ASD closure. This study was designed to examine the effectiveness and safety of this Occluder in an animal model. Methods and Results— The Helex was implanted into 24 dogs with surgically created ASDs. Procedural details focusing on deployment, removal, and early closure rates were examined. Follow-up consisted of sequential transesophageal echocardiography and fluoroscopy as well as epicardial contrast echocardiography and angiography at the time of death. Specimens were examined grossly and histologically, and devices were tested for metal fatigue. All animals had successful ASD closure. Implantation was uncomplicated (mean fluoroscopy time 11.7 minutes), and removal or repos...
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transcatheter closure of atrial Septal defect and interatrial communications with a new self expanding nitinol double disc device amplatzer Septal Occluder multicentre uk experience
Heart, 1999Co-Authors: K C Chan, Neil Wilson, A Redington, Kevin Walsh, M J Godman, John L GibbsAbstract:OBJECTIVE To review the safety and efficacy of the Amplatzer Septal Occluder for transcatheter closure of interatrial communications (atrial Septal defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)). DESIGN Prospective study following a common protocol for patient selection and technique of deployment in all participating centres. SETTING Multicentre study representing total United Kingdom experience. PATIENTS First 100 consecutive patients in whom an Amplatzer Septal Occluder was used to close a clinically significant ASD or interatrial communication. INTERVENTIONS All procedures performed under general anaesthesia with transoesophageal echocardiographic guidance. Interatrial communications were assessed by transoesophageal echocardiography with reference to size, position in the interatrial septum, proximity to surrounding structures, and adequacy of Septal rim. Stretched diameter of the interatrial communications was determined by balloon sizing. Device selection was based on and matched to the stretched diameter of the communication. MAIN OUTCOME MEASURES Success defined as deployment of device in a stable position to occlude the interatrial communication without inducing functional abnormality or anatomical obstruction. Occlusion status determined by transoesophageal echocardiography during procedure and by transthoracic echocardiography on follow up. Clinical status and occlusion rates assessed at 24 hours, one month, and three months. RESULTS 101 procedures were performed in 100 patients (86 ASD, 7 FF, 7 PFO), age 1.7 to 64.3 years (mean (SD), 13.3 (13.9)), weight 9.2 to 100.0 kg (mean 32.5 (23.5)). Procedure time ranged from 30 to 180 minutes (mean 92.4 (29.0)) and fluoroscopy time from 6.0 to 49.0 minutes (mean 16.1 (8.0)). There were seven failures, all occurring in patients with ASD, and one embolisation requiring surgical removal. Immediate total occlusion rate was 20.4%, rising to 84.9% after 24 hours. Total occlusion rates at the one and three month follow up were 92.5% and 98.9%, respectively. Complications were: transient ST elevation (1), transient atrioventricular block (1), presumed deep vein thrombosis (1), presumed transient ischaemic attack (1). CONCLUSIONS It appears feasible to close interatrial communications and atrial Septal defects up to 26 mm stretched diameter safely with the Amplatzer Septal Occluder. Short term results confirm an early high occlusion rate with no major complications. Careful selection of cases based on the echocardiographic morphology of the ASD and accurate assessment of their stretched diameter is of utmost importance. Further experience with the larger devices and longer term results are required before a firm conclusion regarding its use can be made.
Alexander J Javois - One of the best experts on this subject based on the ideXlab platform.
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use of the gore cardioform Septal Occluder for percutaneous closure of secundum atrial Septal defects results of the multicenter u s ide trial
Catheterization and Cardiovascular Interventions, 2020Co-Authors: Matthew J Gillespie, Phillip Moore, Alexander J Javois, Thomas A Forbes, Joseph PaolilloAbstract:OBJECTIVE To evaluate safety and efficacy of the GORE® CARDIOFORM Septal Occluder for percutaneous transcatheter closure of ostium secundum atrial Septal defects. BACKGROUND The GORE® CARDIOFORM Septal Occluder is a double-disc, low profile, soft, conformable device, with distinct advantages over the GORE® HELEX® Septal Occluder. METHODS Subjects were enrolled in this single arm prospective study from 21 U.S. sites, and followed for 3 years. Primary endpoint was 6 month composite clinical success, comprised of technical success (implantation and retention of device), closure success (normalization of right heart size), no 30 day serious adverse events, and no device embolization or reintervention. Secondary endpoints included technical success, procedure success (technical success and ≤ 2 mm residual shunt at procedure conclusion), closure success (clinically insignificant or no residual shunt), and safety (freedom from 30 day serious adverse events and 6-month device events). RESULTS Between October 2012 and May 2015, 50 pivotal and 350 continued access subjects underwent attempted transcatheter GORE® CARDIOFORM Septal Occluder implantation. Median age was 6.9 years, and mean static defect diameter 9.7 ± 3.1 mm. Device placement was achieved in 93.5% (374/400). Composite clinical success was 90.2% and clinical closure success was 98.8% at 6 months. Freedom from serious adverse events was 98.3% at 30 days, with no device embolizations or reinterventions through 6 months. CONCLUSIONS The GORE® CARDIOFORM Septal Occluder has high composite clinical success and safety, performing well in defects ≤17 mm by stop flow stretched diameter. Single, multifenestrated, and deficient retroaortic tissue defects were well represented and successfully treated.
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results of the u s food and drug administration continued access clinical trial of the gore helex Septal Occluder for secundum atrial Septal defect
Jacc-cardiovascular Interventions, 2014Co-Authors: Evan M Zahn, Alexander J Javois, Thomas K Jones, Craig E Fleishman, Jonathan J Rome, Ricardo H Pignatelli, Larry A LatsonAbstract:Abstract Objectives This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial Septal defect. Background The trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the Pivotal Trial. Devices with hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial. Methods A total of 137 devices were implanted in 137 patients at 13 US institutions. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer term evaluations. Results Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced an erosion or sudden catastrophic event. Conclusions The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the GORE HELEX Septal Occluder is a safe and effective transcatheter Occluder for repair of ostium secundum atrial Septal defect.
