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Rates of stroke, death and myocardial infarction post-TCAR do not differ by patient sex
While sex disparities regarding the outcomes of carotid revascularization have “long been a concern,” new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid artery…
Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
[vc_row][vc_column][vc_column_text] In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data…
FDA seeks to ‘modernize’ clinical trials with new draft guidance
The Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials. In a statement, the regulator said that the updates are intended to…
Interim data find ‘no evidence of benefit’ for carotid revascularization additional to optimized medical therapy
Interim results from the ECST-2 randomized controlled trial (RCT) have shown no evidence that carotid stenosis patients with a low-to-intermediate stroke risk, treated with optimized medical therapy, will benefit from additional carotid revascularization via carotid endarterectomy (CEA) or carotid artery…
EndoAVF found usually less cost effective compared with sAVF
The Society for Clinical Vascular Surgery (SCVS) 50th Annual Symposium (25–29 March, Miami) hosted a series of abstract presentations. Among them was one by Bianca Mulaney, MD and colleagues including Elizabeth George, MD, Stanford University, Stanford, on the cost effectiveness…
A call to arms: Reuse of mature venous conduits urged
“Recycle that vein!”—that was the appeal from the authors of a new study that trialled the explantation of mature arteriovenous fistulas (AVFs) from patients with venous outflow obstruction in one extremity and translocation of them to the contralateral extremity. Led…
Study highlights need for ‘continuous comparative assessments’ to guide endograft treatment decisions
A recent study comparing outcomes of endovascular aneurysm repair (EVAR) patients has reported no statistically significant differences in mortality or secondary rupture rates between standard Cook, Medtronic and Gore endografts, suggesting similar safety in a real-world setting. Michael O. Falster,…
Distal embolic protection linked to significantly better outcomes in carotid stenting
Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection during…
EU ministers approve changes to MDR transition timetable
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). Producers of medical devices will have until Dec. 31, 2027, for higher risk…
Equivalency to clinical practice ‘varies considerably’ across recent carotid intervention trials
The transferability to real-world clinical practice of contemporary randomized controlled trials (RCTs) investigating carotid artery stenosis interventions “varies considerably,” according to a recent analysis published in the European Journal of Vascular and Endovascular Surgery (EJVES) by senior author Hans-Henning Eckstein,…