Long Term Survival and Limb Salvage in Patients With Non-Revascularisable Chronic Limb Threatening Ischaemia.

OBJECTIVE: The aim of this study was to provide long term survival and limb salvage rates for patients with non-revascularisable (NR) chronic limb threatening ischaemia (CLTI). METHODS: This was a retrospective review of prospectively collected data, derived from a randomised controlled trial (JUVENTAS) investigating the use of a regenerative cell therapy. Survival and limb salvage of the index limb in CLTI patients without viable options for revascularisation at inclusion were analysed retrospectively. The primary outcome was amputation free survival, a composite of survival and limb salvage, at five years after inclusion in the original trial. RESULTS: In 150 patients with NR-CLTI, amputation free survival was 43% five years after inclusion. This outcome was driven by an equal rate of all cause mortality (35%) and amputation (33%). Amputation occurred predominantly in the first year. Furthermore, 33% of those with amputation subsequently died within the investigated period, with a median interval of 291 days. CONCLUSION: Five years after the initial need for revascularisation, about half of the CLTI patients who were deemed non-revascularisable survived with salvage of the index limb. Although the prospects for these high risk patients are still poor, under optimal medical care, amputation free survival seems comparable with that of revascularisable CLTI patients, while the major amputation rate within one year, especially among NR-CLTI patients with ischaemic tissue loss, is very high.

(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment and Comparison with Manufacturer Data.

PURPOSE: Carotid stent (CS) characteristics, such as radial force, scaffolding and flexibility, are continuously modified by stent manufacturers aiming to improve stent performance. Since manufacturers' definitions and assessment methods are not disclosed, it is unknown how characteristics of different CSs relate to each other or to published literature. We examined in vitro methodological techniques used to measure CS characteristics and assessed comparability between published papers and outcomes as provided by the manufacturers. METHODS: A systematic review was conducted in MEDLINE, Embase, Cochrane, and Scopus databases. Studies reporting on in vitro investigations of predefined characteristics of CS used in current everyday clinical practice were included. The predefined characteristics were radial force, scaffolding, flexibility, foreshortening, side-branch preservation and visibility. Eight manufacturers of 10 currently used CS were contacted and data on the predefined device characteristics was requested. RESULTS: 12 published articles were included and six stent manufacturers provided data on six stents (two refused to share data). Used methodologies to measure stent characteristics in published literature and manufacturer data varied greatly for all included characteristics except foreshortening. The number of different units of measurement to express outcomes ranged from two for foreshortening to six for radial force. CONCLUSION: A variety of methodologies and outcome measures is used to quantify CS characteristics, which hampers comparisons between published studies and manufacturer data. Future studies are encouraged to synchronize methodologies and outcome measures. Manufacturers are encouraged up to increase transparency of applied testing methodologies and outcomes.

Applicability of Transcutaneous Oxygen Tension Measurement in the Assessment of Chronic Limb-Threatening Ischemia.

Transcutaneous oxygen tension measurement (TcPO2) is widely applied for the evaluation of chronic limb-threatening ischemia (CLTI). Nevertheless, studies that focused on the clinical value of TcPO2 have shown varying results. We identified factors that potentially play a role in TcPO2 measurement variation such as probe placement, probe temperature, and the use of a reference probe. In this review of the current literature, we assessed the application of these factors. A systematic search was conducted. Parameters that were assessed were probe placement, probe temperature, and mentioning and/or use of a reference probe. In total, 36 articles were eligible for analysis. In 24 (67%) studies, probes were placed on specific anatomical locations. Seven (19%) studies placed probes, regardless of the location of the ulcer, adjacent to an ischemic lesion or ulcer (perilesion). Selected temperature setting of the probe differed; in 18 (50%), a default probe temperature of 44°C was selected, and in 13 (36%), a different temperature was selected. In 31 (84%) studies, the use of a reference probe was not reported. Transcutaneous oxygen tension measurement is applied diversely in patients with CLTI. Homogeneity in TcPO2 protocols is warranted for reliable clinical application and to compare future TcPO2 research.

The impact of race on outcomes after carotid endarterectomy in the United States.

OBJECTIVE: Black patients undergoing carotid endarterectomy (CEA) in the United States are more often symptomatic at presentation and have more comorbidities compared with white patients. However, the impact of race on outcomes after CEA is largely unknown. METHODS: We identified CEA patients in the Vascular Quality Initiative registry (2012-2017) and compared them by race (black vs white). All other nonwhite races (891 [1.4%]) and Hispanics (2222 [3.4%]) were excluded. We used multilevel logistic regression to account for differences in demographics and comorbidities. We assessed long-term survival using multivariable Cox regression. The primary outcome was perioperative stroke/death, with long-term survival as a secondary outcome. RESULTS: We included 57,622 CEA patients; 2909 (5.0%) were black, of whom 983 (34%) were symptomatic. Of the 54,713 white patients, 16,132 (30%) were symptomatic. Black patients, compared with white patients, had a higher vascular disease burden and were less likely to be operated on in a high-volume hospital or by a high-volume surgeon. In addition, black symptomatic patients, compared with white symptomatic patients, were more often operated on <2 weeks after the index neurologic symptom (47% vs 40%; P < .001). Perioperative stroke/death was comparable between black and white patients (symptomatic, 2.8% vs 2.2% [P = .2]; asymptomatic, 1.6% vs 1.3% [P = .2]), as was unadjusted survival at 3 years (93% vs 93%; P = .7). However, after adjustment, black patients did experience better long-term survival compared with white patients (hazard ratio, 0.8; 95% confidence interval, 0.7-0.9; P = .01). On multilevel logistic regression, race was not associated with perioperative stroke/death (odds ratio, 1.0; 95% confidence interval, 0.8-1.3; P = .98). CONCLUSIONS: Despite the greater prevalence of vascular risk factors in black patients and racial inequalities in surgical treatment, rates of perioperative stroke/death and unadjusted survival were similar between white and black patients. Moreover, black patients experienced better adjusted long-term survival after CEA.

Effects of carotid endarterectomy or stenting on arterial diameters in the circle of Willis.

BACKGROUND: In patients with internal carotid artery (ICA) stenosis, the circle of Willis (CoW) is the primary collateral pathway. We compared luminal diameters in the CoW before and after carotid revascularization and compared the effects of carotid endarterectomy (CEA) and stenting on these diameters. METHODS: At a single center in the International Carotid Stenting Study, 139 patients with symptomatic ICA stenosis of 50% or more were randomized to stenting (n = 81) or CEA (n = 58). The diameters of all segments of the CoW were assessed on computed tomography angiography (CTA), before and 30 days after revascularization. All evaluations were performed blinded to treatment allocation and order of CTA. RESULTS: A .10-mm increase (95% confidence interval [CI], .02-.17; 7%; P = .01) in diameter after revascularization occurred in the ipsilateral precommunicating anterior cerebral artery (A1), whereas both the ipsilateral and contralateral posterior communicating arteries decreased in diameter by .12 mm (95% CI, .04-.21; 14%; P = .01) and .08 mm (95% CI, .00-.17; 10%; P = .05), respectively. The increase in diameter of the A1 was larger after stenting (.15 mm; 95% CI, .07-.24; P = .001) than after CEA (.02 mm; 95% CI, -.11 to .15; P = .79). Only in patients treated with CEA, the diameters of the contralateral A1 and ipsilateral precommunicating posterior cerebral artery were reduced after revascularization. CONCLUSIONS: Carotid revascularization improves anterior collateralization and reduces reliance on posterior collateral pathways via the CoW. Carotid stenting and endarterectomy appear to have different early effects on collateralization.

Mechanisms of gender-related outcome differences after carotid endarterectomy.

OBJECTIVE: Large randomized trials have confirmed a difference in outcome after carotid endarterectomy (CEA) between men and women. In this review, we aimed to provide an overview of the gender-specific characteristics causing these perioperative and long-term outcome differences between men and women after CEA. METHODS: A systematic search strategy with the synonyms of 'gender' and 'carotid endarterectomy' was conducted from PubMed and EMBASE databases. Only 11 relevant studies specifically discussing gender-specific related characteristics and their influence on outcome after CEA could be identified. RESULTS: Due to the limited number of included studies, pooling of findings was impossible, and results are presented in a descriptive manner. Each included study described only one possible gender-specific factor. Differences in carotid artery diameter, sex hormones, sensitivity for antiplatelet therapy, plaque morphology, occurrence of microembolic signals, and restenosis rate have all been suggested as gender-specific characteristics influencing outcome after CEA. CONCLUSION: Higher embolic potential in women and relatively stable female plaque morphology are the best-described factors influencing the difference in outcomes between men and women. However, the overall evidence for outcome differences by gender-specific characteristics in the literature is limited.