Objectives To compare transesophageal echocardiography (TOE) findings after patent foramen ovale (PFO) closure by BioSTAR (NMT Medical Inc, Boston, MA) and Amplatzer PFO occluders (Abbott Vascular, Plymouth, MN). Background PFO closure with a biodegradable device represents an attractive alternative to permanent devices. Long‐term effectiveness and morphology after biodegradation remain unknown. Methods Between February 2008 and June 2014, 49 patients received BioSTAR and 48 Amplatzer PFO occluder. TOE was performed after closure, at 6 months and beyond 2 years. Results PFO features were comparable between the groups. Immediate effective closure (<5 bubbles on Valsalva) was obtained in 96% by BioSTAR and 88% by Amplatzer PFO occluder (p = .16). Except for transient fever after BioSTAR (10.8 vs. 0%; p = .08), there was no adverse events. TOE at 6 months revealed comparable effective closure (93 vs. 89%; p = .74), all devices in correct position and no thrombus/pericardial effusion. In the BioSTAR group, a peri‐device left‐to‐right color Doppler shunt was documented in one patient (2.2%), protrusion of the nitinol framework strut(s) into the atrial cavity in two patients (4.3%), and both events in one patient (2.2%). TOE beyond 2 years showed comparable effective closure (92 vs. 96%; p = 1.00) and again BioSTAR‐associated peri‐device left‐to‐right shunt and metal framework strut(s) protrusion. There was no stroke or peripheral embolization in either group while TIA was numerically greater in BioSTAR patients (6.8 vs. 2.5%; p = .61). Conclusion BioSTAR provided similar PFO closure rate as Amplatzer PFO occluder. As yet unreported BioSTAR‐associated peri‐device left‐to‐right shunt and metal framework strut(s) protrusion may have practical implications for further development of biodegradable devices.
Background: COVID-19 infection has been associated with paradoxical thromboembolism through a patent foramen ovale (PFO) and ischaemic stroke. Such events have not been reported after COVID-19 vaccination. The aim of the present study was to investigate PFO-associated stroke during the mass COVID-19 vaccination in Slovenia. Methods: This prospective study, conducted between 26 December 2020 and 31 March 2022, enrolled consecutive patients (≥18 years) with PFO-associated stroke referred for a percutaneous closure to a single interventional facility in Slovenia. Results: A total of 953,546 people aged between 18 and 70 years received at least one dose of a COVID-19 vaccine approved by the European Medicines Agency. Of the 28 patients presenting with PFO-associated stroke, 12 patients (42.9%) were vaccinated prior to the event, of whom nine were women and three were men, aged between 21 and 70 years. Stroke occurred within 35 days after vaccination in six patients (50%). Clinical presentation included motor dysphasia, paresis, vertigo, ataxia, paraesthesia, headache, diplopia and hemianopia. At hospital discharge, 11 patients (91.6%) had at least one residual ischaemic lesion. Conclusion: A temporal coincidence of COVID-19 vaccination and PFO-associated stroke has been described. A potential cause–effect relationship may only be hypothesised.
The current study was designed to reveal possible associations between the angiotensin-converting-enzyme (ACE) gene polymorphisms (rs4646994 and rs4341) with markers of carotid atherosclerosis in patients with type 2 diabetes mellitus (T2DM) in a 4-year-long follow-up study. Five hundred and ninety-five T2DM subjects and 200 control subjects were enrolled. Genotyping of ACE polymorphisms was performed using KASPar assays, and ultrasound examinations were performed twice (at the enrollment and at follow-up). With regard to the progression of atherosclerosis in subjects with T2DM, statistically significant differences were demonstrated in the change of the sum of carotid plaques thickness for the rs4646994 polymorphism. We did not demonstrate an association between the tested polymorphisms (rs4646994 and rs4341) and either carotid intima media thickness (CIMT) or CIMT progression in a 3.8-year period. In our study, we demonstrated that subjects with T2DM with the DD genotype of the rs4646994 [ACE insertion/deletion (I/D)] polymorphism had faster progression of atherosclerosis in comparison to subjects with other genotypes.
Metode: Opravili smo retrospektivno raziskavo na zaporednih bolnikih, ki smo jih uvrstili v register PCI. Poleg splošnih značilnosti bolnikov in koronarne anatomije so nas zanimale značilnosti PCI, uporaba žilnih opornic, uspeh PCI in zapleti. Posebej smo obdelali bolnike s PCI na nezaščitenem deblu leve koronarne arterije, ki smo ga opredelili kot pomembno stenozo ob odsotnosti vsaj enega prehodnega kirurškega obvoda.Izsledki: V opazovanem obdobju smo opravili 1.981 PCI. Med bolniki so prevladovali moški (73 %), povprečna starost je bila 65+10 let, večina bolnikov (94 %) pa je imela stabilno koronarno bolezen z večžilno prizadetostjo (62 %). PCI smo opravili na 2.978 stenozah (1,50 stenoze/bolnika) s povprečno zožitvijo 85+10 %. Tarčna sprememba je bila bodisi na levi descendentni koronarni arteriji (42,9 %), desni koronarni arteriji (32,4 %), levi cirkumfleksni arteriji (18,4 %), deblu leve koronarne arterije (3 %), na kirurških obvodih (2,3 %) ali na intermediarni arteriji (1 %). Samo balonsko dilatacijo smo uporabili v 9,6 %, pri ostalih bolnikih pa smo vstavili 1-7 kovinskih žilnih opornic (1,44+0,86/ bolnika). Do leta 2009 je delež žilnih opornic, prevlečenih s citostatikom (DES), znašal 20-30 %, v letu 2012 je porastel na 80 %, v letu 2015 pa na 100 %. PCI je angiografsko uspela v 95,2 %. Zaradi zapleta so 4 bolniki (0,2 %) potrebovali urgentno srčno operacijo, 4 bolniki (0,2 %) pa operacijo na vbodnem mestu. Bolnišnična umrljivost je znašala 0 %. Trombozo žilne opornice v prvih 30 dneh smo ugotovili pri 6 bolnikih (0,3 %). V podskupini 58 bolnikov s PCI nezaščitene stenoze debla leve koronarne arterije smo v 88 % uporabili tehniko s samo eno žilno opornico. Delež DES je bil 94 %. PCI je uspela pri vseh bolnikih. Bolnišnična in 30-dnevna umrljivost sta bili 0 %, enoletna 1,7 % (95-odstotni interval zaupanja 0-11 %), 5-letna pa 13,8 % (95-odstotni interval zaupanja 7-33 %). Potreba po ponovni revaskularizaciji v 5-letnem obdobju je znašala 3,5 % (95-odstotni interval zaupanja 0-23 %).Sklep: PCI pri bolnikih s pretežno stabilno koronarno boleznijo je v Medicorju učinkovita in varna metoda revaskularizacije, kar velja tudi za poseg na nezaščitenem deblu leve koronarne arterije. AbstractBackground: Medicor was established as the third cardiovascular center in Slovenia and started with percutaneous cardiovascular interventions in 2005. The purpose of our study was to describe the features and results of percutaneous coronary intervention (PCI) performed between 2005 and 2015.
A 67-year old man with a hemodynamically significant type secundum atrial septal defect (ASD), large patent foramen ovale (PFO) and significant septal aneurism presented with shortness of breath and limited exercise tolerance. There was no evidence of additional structural abnormalities nor significant coronary artery disease. Simultaneous percutaneous closure of both defects was planned. Since the wire could have been passed only through PFO and the second wire not through the ASD, only PFO was closed with 35 mm Amplatz PFO occluder. After 3 months, which served for tissue ingrowth of Amplatz PFO occluder and aneurism stabilization, ASD located in posterior-inferior part of fossa ovalis documented by three-dimensional transesophageal echocardiography (3D-TEE) was easily crossed and successfully closed with a 12 mm Amplatz ASD occluder. Stable position without unwanted interference between the devices was obtained. There was noresidual shunting on color Doppler and no bubble shunting during Valsalva maneuver. Within 6 months after the procedure, symptoms significantly improved and right heart chambers decreased. 3D-TEE revealed both devices in good position with only trivial shunting through PFO occluder documented by color Doppler.
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