Background-Associations between hospital volume and the risk of stroke or death following carotid endarterectomy (CEA) and carotid artery stenting (CAS) on a national level in Germany were analyzed. Methods and Results-Secondary data analysis using microdata from the nationwide statutory German quality assurance database on all surgical or endovascular carotid interventions on the extracranial carotid artery between 2009 and 2014. Hospitals were categorized into empirically determined quintiles according to the annual case volume. The resulting volume thresholds were 10, 25, 46, and 79 for CEA and 2, 6, 12, and 26 for CAS procedures. The primary outcome was any stroke or death before hospital discharge. For risk-adjusted analyses, a multilevel regression model was applied. The analysis included 161 448 CEA and 17 575 CAS procedures. In CEA patients, the crude risk of stroke or death decreased monotonically from 4.2% (95% confidence interval, 3.6%-4.9%) in low-volume hospitals (first quintile 1-10 CEA per year) to 2.1% (2.0%-2.2%) in hospitals providing ≥80 CEA per year (fifth quintile; P<0.001 for trend). The overall risk of any stroke or death in CAS patients was 3.7% (3.5%-4.0%), but no trend on annual volume was seen (P=0.304). Riskadjusted analyses confirmed a significant inverse relationship between hospital volume (categorized or continuous) and the risk of stroke or death after CEA but not CAS procedures. Conclusions-An inverse volume-outcome relationship in CEA-treated patients was demonstrated. No significant association between hospital volume and the risk of stroke or death was found for CAS. (Circ Cardiovasc Interv. 2016;9:e004171.
Local anesthesia, patch plasty compared with primary closure, intraoperative completion studies by duplex ultrasound or angiography, and perioperative antiplatelet medication were independently associated with lower in-hospital stroke or death rates after carotid endarterectomy.
BackgroundGuideline recommendations on carotid endarterectomy are based predominantly on randomized, controlled trials, in which women or elderly patients are often under‐represented. This study analyzed the association of age and sex with the risk of in‐hospital stroke or death following carotid endarterectomy under routine conditions in Germany.Methods and ResultsSecondary data analysis using the Statutory German Quality Assurance Database on all carotid endarterectomy procedures (n=142 074) performed between 2009 and 2014. Primary outcome was any stroke or death until discharge; secondary outcomes were any in‐hospital stroke (alone), and death (alone). Descriptive statistics and multilevel multivariable regression analyses were applied. Patients were predominately male (68%), with mean age 71 years. Carotid stenosis was symptomatic in 40%. Primary outcome occurred in 1.8% of women and 1.9% of men. Multivariable regression analysis revealed that more‐advanced age was associated with a higher primary outcome rate (relative risk [RR] per 10‐year increase: 1.19; 95% CI, 1.14–1.24). Risk of death (alone) was associated with age (RR, 1.68; 95% CI, 1.54–1.84). Age was associated with the risk of stroke (alone; RR, 1.05; 95% CI, 1.00–1.11). Sex was not associated with primary outcome rate (1.01; 95% CI, 0.93–1.10), nor did it significantly modify the age effect.ConclusionsThis study shows that increasing age, but not sex, is associated with a higher risk of in‐hospital stroke or death following carotid endarterectomy under everyday conditions in Germany. Whereas the risk of death (alone) is significantly associated with age, the association between age and the risk of stroke (alone) can be considered of minor importance.
The use of an embolic protection device was independently associated with lower in-hospital risk for stroke or death, major stroke or death, and stroke.
Collecting biological tissue samples in a biobank grants a unique opportunity to validate diagnostic and therapeutic strategies for translational and clinical research. In the present work, we provide our long-standing experience in establishing and maintaining a biobank of vascular tissue samples, including the evaluation of tissue quality, especially in formalin-fixed paraffin-embedded specimens (FFPE). Our Munich Vascular Biobank includes, thus far, vascular biomaterial from patients with high-grade carotid artery stenosis (n = 1567), peripheral arterial disease (n = 703), and abdominal aortic aneurysm (n = 481) from our Department of Vascular and Endovascular Surgery (January 2004–December 2018). Vascular tissue samples are continuously processed and characterized to assess tissue morphology, histological quality, cellular composition, inflammation, calcification, neovascularization, and the content of elastin and collagen fibers. Atherosclerotic plaques are further classified in accordance with the American Heart Association (AHA), and plaque stability is determined. In order to assess the quality of RNA from FFPE tissue samples over time (2009–2018), RNA integrity number (RIN) and the extent of RNA fragmentation were evaluated. Expression analysis was performed with two housekeeping genes—glyceraldehyde 3-phosphate dehydrogenase (GAPDH) and beta-actin (ACTB)—using TaqMan-based quantitative reverse-transcription polymerase chain reaction (qRT)-PCR. FFPE biospecimens demonstrated unaltered RNA stability over time for up to 10 years. Furthermore, we provide a protocol for processing tissue samples in our Munich Vascular Biobank. In this work, we demonstrate that biobanking is an important tool not only for scientific research but also for clinical usage and personalized medicine.
This study shows that the risk of stroke or death was significantly higher in patients without any perioperative antiplatelet therapy. In contrast, dual antiplatelet therapy vs aspirin monotherapy was associated with a lower risk only of perioperative death but with a higher risk of neck bleeding until discharge. Perioperative antiplatelet therapy was significantly associated with a decreased in-hospital stroke and death risk. Further studies are needed to evaluate the risk-benefit ratio of single vs dual antiplatelet therapy.
Rationale: To evaluate the repurposing of lenvatinib, a multi tyrosine kinase inhibitor, in limiting experimental abdominal aortic aneurysm (AAA) growth.Objective: AAA is a disease with high morbidity and mortality, especially in case of rupture. No pharmacologic treatment is currently available. Novel therapeutic strategies are targeting vascular smooth muscle cells (VSMC) and angiogenesis.Repurposing of clinically available drugs has proven its benefit to extend treatment strategies and may be suited to halt aortic dilatation.Findings: Porcine pancreatic elastase (PPE) was used to induce murine AAAs.Systemic and local lenvatinib forms of treatment were evaluated, and RNA profiling identified myosin heavy chain 11 (Myh11) as the most deregulated transcript. Daily oral treatment significantly reduced aneurysm formation in two independent mouse models. In addition, a novel large animal aneurysm model in hypercholesterolemic low-density lipoprotein receptor knockout (LDLR -/-) Yucatan minipigs was applied to endovascularly deliver lenvatinib via drug-eluting balloons (DEB). Here, a single local endovascular delivery blocked AAA progression successfully compared to a DEBdelivered control treatment when reaching 28 days post aneurysm induction.Reduced VSMC proliferation and a restored contractile phenotype were observed in animal tissues (murine and porcine), as well as AAA patient-derived cells. Apart from increasing MYH11 levels, lenvatinib reduced downstream ERK signaling.
Conclusion:Lenvatinib is a promising new therapy to limit aortic aneurysm expansion upon local endovascular delivery. The tyrosine kinase inhibitor was able to positively affect pathways of key relevance to human AAA disease. The novel endovascular local delivery using DEBs offers new treatment strategies for additional therapies capable of slowing down aneurysm expansion.
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