A prospective, multicentre clinical trial to evaluate the BioSTAR bioabsorbable septal repair implant for the closure of atrial level shunts: The BEST study

Mullen, Michael; Duke, Abdul; Giovanni, Joseph De; Hildick‐Smith, David; Hillis, Stewart; Morrison, Lindsay

doi:10.1016/j.ijcard.2007.03.025

Cited by 47 publications

(80 citation statements)

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“…RLS is also one of a myriad of risk factors which both migraine and stroke might share [3]. The closure of RLS reduced the number of migraine attacks and stroke recurrence, although it did not completely prevent migraine attacks in randomized trials [3,11,23,25,29]. These studies suggest that a high prevalence of dWMLs in migraineurs seems to be related to RLS-related ischemic insult.…”

Section: Introductionmentioning

confidence: 95%

“…Numerous abnormalities have been reported in migraineurs involving blood components, circulating endothelial progenitor cells, blood enzymes such as increased elastase activity, and cardiac abnormalities such as right-to-left shunt (RLS) and cerebral white matter lesions (WMLs) on magnetic resonance (MR) scans [19,22,23]. Compared with healthy controls, the prevalence of deep WMLs (dWMLs), but not periventricular WMLs (pvWMLs), was higher in migraineurs [16].…”

Section: Introductionmentioning

confidence: 99%

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Small deep white matter lesions are associated with right-to-left shunts in migraineurs

et al. 2010

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The right-to-left shunts (RLS) and white matter lesions (WMLs) are frequently observed in migraineurs and in patients with ischemic stroke. Previous studies have reported that the burden of WMLs did not increase with the intracardiac right-to-left shunt (RLS) in migraineurs. However, some types of WMLs are known to be associated with RLS in patients with stroke and dementia. The aim of the study was to demonstrate the difference in the size and location of WMLs, according to the existence of RLS in patients with headache. From the prospective headache registry, a total of 425 subjects (age, 30.8 ± 5.1 years; 303 women; 242 migraineurs; 183 patients with tension-type headache (TTH)) were retrospectively reviewed and evaluated for RLS and WMLs using M-mode power transcranial Doppler sonography (mTCD) and brain magnetic resonance imaging scans. We scored WMLs, according to the Rotterdam Scan Study, and assessed the association between RLS presence and the location and size of WMLs. The number of small deep WMLs (dWMLs) and the prevalence of RLS, defined as microembolic signals (MES) ≥ 11, were higher in patients with migraine (small dWMLs, 6.23 vs. 4.05; RLS, 36.8% vs. 10.9%), compared to patients with TTH. There was no significant difference in the sum of periventricular WML grades or the total volume of dWMLs between TTH and migraine patients. Among the migraineurs, the patients with RLS more frequently had small dWMLs, aura, and heart disease compared to those without RLS. In addition, RLS were also independent predictors for the presence of small dWMLs from the multivariate binary regression analysis (p < 0.01; OR = 3.24; 95%CI 1.56-6.72). Small dWMLs are associated with RLS in young migraineurs. These results imply that paradoxical embolism may cause the small WMLs in some migraineurs.

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Section: Introductionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 99%

Small deep white matter lesions are associated with right-to-left shunts in migraineurs

et al. 2010

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“…Previous studies 13,15 have shown that after a variable period of time, the implanted devices become encapsulated by fibrous tissue, which effectively seals the defect, thereafter rendering the implant redundant. The experimental result in this study shows that the biodegradable PCL occluders combining PLGA/collagen nanofibers can indeed provide an effective closure of the orifice in vitro.…”

Section: Discussionmentioning

confidence: 99%

“…Their results showed that PHB might be a potential material for making biodegradable occlusion devices. Mullen et al 15 were able to close ASDs using a bioabsorbable device, consisting of nitinol microsprings and an acellular porcine intestinal collagen layer. Their preliminary experimental results suggested this device is feasible and effective in humans.…”

Section: Introductionmentioning

confidence: 99%

Novel Biodegradable Polycaprolactone Occlusion Device Combining Nanofibrous PLGA/Collagen Membrane for Closure of Atrial Septal Defect (ASD)

et al. 2011

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The purpose of this report was to develop novel biodegradable occlusion devices for closure of atrial septal defects (ASD). To manufacture the biodegradable occluders, polycaprolactone (PCL) components were first fabricated by a lab-scale micro-injection molding machine. They were then assembled and hot-spot welded into double umbrella-like devices of 50 mm in diameter. A special mechanism at the axis of the occluder was designed to self-lock the occluder after the two umbrellas were expanded. Furthermore, a nanofibrous matrix of poly-D-L-lactide-glycolide (PLGA)/type I collagen blend was produced via electrospinning to develop biodegradable and biomimetic anti-shunt membranes for the occluders. Characterization of the biodegradable PCL occluders was carried out. PCL occluders exhibited mechanical properties comparable to that of commercially available Amplatzer occluders. The sealing capability of biodegradable occluders was found superior to that of Amplatzer occluders. In addition, the cell attachment and spreading of endothelial cells seeded on the PLGA/collagen nanofibrous matrix and the interaction between cells and PLGA/collagen nanofibers were studied. The nanofibrous membranes made of PLGA/collagen were very effective in promoting cell proliferation during culture.

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“…Das CardioSEAL/ STARflex-Doppelschirmsystem kann als direkter Nachfolger dieses Systems angesehen werden [15]. Eine weitere Entwicklung ist das BioSTAR-System, dessen Membranen aus bioabsorbierbarem Kollagen bestehen [17]. Diese Systeme können im Allgemeinen für Defekte bis zu einer Größe von 20 mm eingesetzt werden.…”

Section: Reduktion Oder Verschluss Von Kurzschlussverbindungenunclassified

Katheterinterventionelle Therapie angeborener Herzfehler

Krasemann

2008

Herz

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Interventional catheterization for congenital heart disease has rapidly developed over the last 2 decades. The role of interventions has evolved from replacing surgery altogether in some cases to complementing surgery in others. The most commonly used approaches to common cardiac lesions such as persistent arterial duct, atrial and ventricular septal defects, valvar stenosis, coarctation of the aorta and pulmonary artery stenosis are discussed.

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A prospective, multicentre clinical trial to evaluate the BioSTAR bioabsorbable septal repair implant for the closure of atrial level shunts: The BEST study

Cited by 47 publications

References 0 publications

Small deep white matter lesions are associated with right-to-left shunts in migraineurs

Small deep white matter lesions are associated with right-to-left shunts in migraineurs

Novel Biodegradable Polycaprolactone Occlusion Device Combining Nanofibrous PLGA/Collagen Membrane for Closure of Atrial Septal Defect (ASD)

Katheterinterventionelle Therapie angeborener Herzfehler

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