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  • Oxford University Press (OUP)  (7)
  • Grygier, Marek  (7)
  • 1
    In: Europace, Oxford University Press (OUP)
    Abstract: A significant proportion of patients who suffer from atrial fibrillation and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well-known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with atrial fibrillation. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
    detail.hit.zdb_id: 2002579-8
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  • 2
    In: European Heart Journal: Acute Cardiovascular Care, Oxford University Press (OUP), Vol. 12, No. 9 ( 2023-09-25), p. 584-593
    Abstract: High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR pulmonary embolism (PE) treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population. Methods and Results This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, CA, USA) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-h after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the right-to-left ventricular (RV/L) ratio assessed in the imaging 24–48 h after the CDMT. 71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 h. CDMT was complicated by major bleeding in 1.8%, pulmonary artery injury in 1.8%, and ischaemic stroke in 0.9%. Immediate haemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (P & lt; 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (P & lt; 0.0001). Conclusion These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.
    Type of Medium: Online Resource
    ISSN: 2048-8726 , 2048-8734
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2663340-1
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  • 3
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2021
    In:  EP Europace Vol. 23, No. 11 ( 2021-11-08), p. 1867-1868
    In: EP Europace, Oxford University Press (OUP), Vol. 23, No. 11 ( 2021-11-08), p. 1867-1868
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2002579-8
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  • 4
    In: EP Europace, Oxford University Press (OUP), Vol. 25, No. 3 ( 2023-03-30), p. 914-921
    Abstract: The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting. Methods and results Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-up, core-lab adjudicated complete seal was 88.2% (149/169), 9.5% (16/169) had leak & lt;3 mm, 2.4 (4/169) had leak ≥3 mm to ≤5 mm, and 0% had & gt;5 mm leak. At 1 year, 93.3% (280/300) had final follow-up; 60.5% of patients were on a single antiplatelet medication, 21.4% were on DAPT, 5.6% were on direct oral anticoagulation, and 12.1% were not taking any antiplatelet/anticoagulation medication. Adverse event rates through 1 year were: all-cause death 10.8% (32/295); CV/unexplained death 5.1% (15/295); disabling and non-disabling stroke each 1.0% (3/295, all non-fatal); pericardial effusion requiring surgery or pericardiocentesis 1.0% (3/295); and device-related thrombus 2.4% (7/295). Conclusion The WATCHMAN FLX device had excellent procedural success rates, high LAA seal rates, and low rates of thromboembolic events in everyday clinical practice.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
    detail.hit.zdb_id: 2002579-8
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  • 5
    In: EP Europace, Oxford University Press (OUP), Vol. 23, No. 11 ( 2021-11-08), p. 1787-1794
    Abstract: The number of cardiovascular procedures using the coronary sinus (CS) as a gateway is constantly increasing. The present study aimed to define specific structures within CS, which could potentially complicate CS cannulation and to develop a new Thebesian valve (TV) classification system. Methods and results The study was performed on 560 consecutive unfixed cadaveric hearts during routine autopsy examination (1–3 days post-mortem). Basic CS dimensions were measured and the presence and dimensions of the TV and the Vieussens valve (VV) were assessed. Thebesian valves were classified according to their morphology into six main types: remnant fold, semilunar, fenestrated, chord, fused strands, and mixed shaped. The median age of hearts was 48 years (range 16–95 years), and 38.9% were female. Thebesian valve was present in 79.5%. The most common TV type was semilunar (54%) followed by fenestrated (8.2%), remnant fold (5.5%), fused strands (4.8%), chord (4.0%), and mixed shaped (3.0%). In 1.1% of hearts, TV totally covered the coronary sinus ostium (CSO). The VV was detected in 67.9%. Potentially occlusive VV was found in 1.1% hearts and in all of which it coexisted with obstructive TV. The median CSO area was 87.9 mm2 [interquartile range (IQR): 56.5–127.1 mm2] and median CS length was 38 mm (IQR: 29.5–45 mm). The CSO area and CS length correlated with each other and with the right atrium’s dimensions. Conclusion We identified six types of TVs, among which only 1.1% TVs caused total occlusion of CSO. The obstructive TV co-existed with potentially occlusive VV what might hinder CS cannulation.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2002579-8
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  • 6
    In: European Heart Journal - Cardiovascular Imaging, Oxford University Press (OUP), Vol. 22, No. 6 ( 2021-05-10), p. 626-635
    Abstract: We aimed to investigate the role of aortic valve tissue composition from quantitative cardiac computed tomography angiography (CTA) in patients with severe aortic stenosis (AS) for the differentiation of disease subtypes and prognostication after transcatheter aortic valve implantation (TAVI). Methods and results Our study included 447 consecutive AS patients from six high-volume centres reporting to a prospective nationwide registry of TAVI procedures (POL-TAVI), who underwent cardiac CTA before TAVI, and 224 matched controls with normal aortic valves. Components of aortic valve tissue were identified using semi-automated software as calcific and non-calcific. Volumes of each tissue component and composition [(tissue component volume/total tissue volume) × 100%] were quantified. Relationship of aortic valve composition with clinical outcomes post-TAVI was evaluated using Valve Academic Research Consortium (VARC)-2 definitions. High-gradient (HG) AS patients had significantly higher aortic tissue volume compared to low-flow low-gradient (LFLG)-AS (1672.7 vs. 1395.3 mm3, P  & lt; 0.001) as well as controls (509.9 mm3, P  & lt; 0.001), but increased non-calcific tissue was observed in LFLG compared to HG patients (1063.6 vs. 860.2 mm3, P  & lt; 0.001). Predictive value of aortic valve calcium score [area under the curve (AUC) 0.989, 95% confidence interval (CI): 0.981–0.996] for severe AS was improved after addition of non-calcific tissue volume (AUC 0.995, 95% CI: 0.991–0.999, P = 0.011). In the multivariable analysis of clinical and quantitative computed tomography parameters of aortic valve tissue, non-calcific tissue volume [odds ratio (OR) 5.2, 95% CI 1.8–15.4, P = 0.003] and history of stroke (OR 2.6, 95% CI 1.1–6.5, P = 0.037) were independent predictors of 30-day major adverse cardiovascular event (MACE). Conclusion Quantitative CTA assessment of aortic valve tissue volume and composition can improve detection of severe AS, differentiation between HG and LFLG-AS in patients referred for TAVI as well as prediction of 30-day MACEs post-TAVI, over the current clinical standard.
    Type of Medium: Online Resource
    ISSN: 2047-2404 , 2047-2412
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2042482-6
    detail.hit.zdb_id: 2647943-6
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  • 7
    In: EP Europace, Oxford University Press (OUP), Vol. 22, No. 7 ( 2020-07-01), p. 1036-1043
    Abstract: Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. Methods and results A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan–Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. Conclusions Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.
    Type of Medium: Online Resource
    ISSN: 1099-5129 , 1532-2092
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
    detail.hit.zdb_id: 2002579-8
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