Patent Foramen Ovale Using the Premere Device: The Results of the CLOSEUP Trial

Büscheck, Franziska; Sievert, Horst; Kleber, Franz X.; Tiefenbacher, Christiane; Krumsdorf, Urilke; Windecker, S.; Uhlemann, Frank; Wahr, Dennis

doi:10.1111/j.1540-8183.2006.00154.x

Cited by 51 publications

(31 citation statements)

References 13 publications

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“…The BioSTAR septal repair implant used in the present study demonstrated closure rates superior to those reported previously with conventional synthetic devices 4,5,7 and is the first bioabsorbable device for the treatment of structural heart defects in humans.…”

Section: Discussionmentioning

confidence: 44%

“…In the majority of cases, this can now be achieved by percutaneous transcatheter placement of a permanent synthetic implant to occlude the defect through a combination of mechanical closure and fibrous encapsulation of the device. [3][4][5][6] This process is not always fully achieved, and residual leaks are common after implantation. 4,5,7 In addition, late complications, including arrhythmia, 8 -11 erosions, [12][13][14] thrombus formation, 15 and allergic reactions, have been reported.…”

mentioning

confidence: 99%

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BioSTAR Evaluation STudy (BEST)

Mullen

Hildick‐Smith²,

Giovanni³

et al. 2006

Circulation

131

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Background-The use of permanent synthetic implants to close atrial septal defects (ASD) and patent foramen ovale (PFO) has a number of limitations, including late complications and the limiting of transeptal access to the left heart should it be required for the later treatment of acquired heart disease. BioSTAR is a novel, bioabsorbable, atrial septal repair implant. This phase I pilot study evaluates the feasibility, safety, and effectiveness of BioSTAR for the first time in humans. Methods and Results-We conducted a prospective, open-label, multicenter clinical study in 58 patients aged 28 to 68 years who had a clinically significant ASD or PFO. Percutaneous shunt closure was undertaken with the BioSTAR septal repair implant. Successful device implantation was achieved in 57 (98%) of 58 patients. Closure at 30 days and 6 months, assessed by contrast transthoracic echocardiography, was 48 (92%) of 52 and 54 (96%) of 56, respectively. There was no evidence of a clinically significant response to the device. Transient atrial arrhythmia occurred in 5 patients after implantation. No major safety issues were observed. Conclusions-This study demonstrates the feasibility, safety, and effectiveness of BioSTAR for the closure of ASD and PFO in humans with a high rate of early and complete shunt closure. BioSTAR is a novel septal repair implant designed to provide biological closure of atrial-level defects using the patient's natural healing response. Because 90% to 95% of the implant is absorbed and replaced with healthy native tissue, future access to the left atrium may be achieved.

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Section: Discussionmentioning

confidence: 44%

mentioning

confidence: 99%

BioSTAR Evaluation STudy (BEST)

Mullen

Hildick‐Smith²,

Giovanni³

et al. 2006

Circulation

131

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“…Vast majority of the devices described in the ASD section, as and when they became available, were used to close PFOs. Existing ASD closure devices were modified or new devices designed to address the anatomic features of the foramen ovale and these include, Amplatzer PFO occluder [180], Cardia devices (PFO-Star and several of its subsequent generations) [172,181], Premere occluder [182], Occlutech septal occluder [183], Coherex Flat stent [184], pfm PFO-R [173], Solysafe PFO occluder [168] and others. Some of these devices are in clinical trials in and/or outside the US, and none are currently approved by FDA for general clinical use.…”

Section: Patent Foramen Ovalementioning

confidence: 99%

Historical Aspects of Transcatheter Treatment of Heart Disease in Children

Rao¹

2012

Pediat Therapeut

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The very first transcatheter intervention to treat congenital cardiac defects was reported by Rubio-Alvarez et al. [1] in 1953, when they performed pulmonary valvotomy using a modified ureteral catheter. A decade later Dotter, Rashkind, Porstmann and their associates described progressive dilatation of peripheral arterial stenotic lesions, balloon atrial septostomy and transcatheter occlusion of patent ductus arteriosus, respectively. The purpose of this review is to present these and other historical developments of catheter-based interventions in the treatment of heart disease in children. Historical aspects of 1. balloon angioplasty/valvuloplasty of valvar pulmonary stenosis, valvar aortic stenosis, fixed subaortic stenosis, native aortic coarctation, postsurgical aortic recoarctation, branch pulmonary artery stenosis, mitral stenosis, cyanotic heart defects with pulmonary oligemia, stenotic bioprosthetic valves, congenital tricuspid and mitral stenosis, truncal valve stenosis, subvalvar pulmonary stenosis, supravalvar pulmonary stenosis (congenital membranous or postoperative), stenosis of the aorta (Leriche syndrome, atherosclerotic and Takayasu's arteritis), baffle obstruction following Mustard or Senning procedure (both systemic and pulmonary venous obstructions), superior and inferior vena caval obstructions, pulmonary vein stenosis, pulmonary veno-occlusive disease, vertical vein stenosis in total anomalous pulmonary venous connection, pulmonary venous obstruction following repair of total anomalous pulmonary venous obstruction, specially designed pulmonary artery bands, cor triatriatum, cor triatriatum dexter, and coronary artery stenotic lesions that develop after Kawasaki disease; 2. stents to enlarge stenotic lesions of branch pulmonary arteries, systemic veins, systemic and pulmonary venous pathways after Mustard procedure, aorta, right ventricular outflow conduits, pulmonary veins and native right ventricular outflow tract or to keep the ductus arteriosus open in patients with pulmonary atresia and hypoplastic left heart syndrome and maintaining patency of stenosed aorto-pulmonary collateral vessels, surgically created but obstructed shunts or acutely thrombosed shunts as well as covered stents; 3. transcatheter occlusion of cardiac defects comprising of atrial septal defect, patent foramen ovale, patent ductus arteriosus, ventricular septal defect and aortopulmonary window and 4. catheter-based atrial septostomy such as Rashkind balloon atrial septostomy, Park's blade atrial septostomy, balloon angioplasty of the atrial septum, trans-septal puncture and atrial septal stents were presented.

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“…The sheath was withdrawn into the heart, and the patent foramen ovale closure device was placed through the guidewire as previously described for patent foramen ovale closure. 14 …”

Section: Transatrial Access With Closure Devicementioning

confidence: 99%

Percutaneous Transatrial Access to the Pericardial Space for Epicardial Mapping and Ablation

Scanavacca

Venâncio

Pisani

et al. 2011

Circ: Arrhythmia and Electrophysiology

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Background— Puncture of the atrial appendage may provide access to the pericardial space. The aim of this study was to evaluate the feasibility of epicardial mapping and ablation through an endocardial transatrial access in a swine model. Methods and Results— An 8-F Mullins sheath was used to perforate the right (n=16) or left (n=1) atrial appendage in 17 pigs (median weight, 27.5 kg; first and third quartiles [Q1, Q3], 25.2, 30.0 kg). A 7-F ablation catheter was introduced into the pericardial space to perform epicardial mapping and deliver radiofrequency pulses on the atria. The pericardial space was entered in all 17 animals. In 15 (88%) animals, there was no hemodynamic instability (mean blood pressure monitoring, initial median, 80 mm Hg; Q1, Q3, 70, 86 mm Hg; final median, 88 mm Hg; Q1, Q3, 80, 96 mm Hg; P =0.426). In these 15, a mild hemorrhagic pericardial effusion was identified and aspirated (median, 20 mL; Q1, Q3, 15, 30 mL) during the procedure, and postmortem gross analysis revealed that the atrial perforation was closed in these animals. In 2 (12%) of the 17 animals, there was major pericardial bleeding with hemodynamic collapse. On gross examination, it was found that pericardial space was accessed through right ventricular perforation in 1 animal and the tricuspid annulus in the other. After the initial study, we used an occlusion device in 3 other animals to attempt to seal the puncture (2 at the right atrial appendage and 1 at the right ventricle). These 3 animals had no significant pericardial bleeding. Conclusions— Transatrial endovascular right atrial appendage puncture may provide a potential alternative route for pericardial access. Further studies are needed to evaluate its safety with longer and more-complex procedures before being applied in clinical settings.

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Patent Foramen Ovale Using the Premere Device: The Results of the CLOSEUP Trial

Abstract: These data demonstrate that the Premere device can safely and effectively close PFO. Additional studies should be undertaken to demonstrate the effectiveness of PFO closure in reducing thrombo-embolic events such as stroke.

Cited by 51 publications

References 13 publications

BioSTAR Evaluation STudy (BEST)

BioSTAR Evaluation STudy (BEST)

Historical Aspects of Transcatheter Treatment of Heart Disease in Children

Percutaneous Transatrial Access to the Pericardial Space for Epicardial Mapping and Ablation

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