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1.
J Immunol ; 2020 Mar 30.
Artigo em Inglês | MEDLINE | ID: mdl-32229536

RESUMO

Cytotoxic CD4 T cells are linked to cardiovascular morbidities and accumulate in both HIV and CMV infections, both of which are associated with increased risk of cardiovascular disease (CVD). In this study, we identify CMV coinfection as a major driver of the cytotoxic phenotype, characterized by elevated CD57 expression and reduced CD28 expression, in circulating CD4 T cells from people living with HIV infection, and investigate potential mechanisms linking this cell population to CVD. We find that human CD57+ CD4 T cells express high levels of the costimulatory receptor CD2 and that CD2/LFA-3 costimulation results in a more robust and polyfunctional effector response to TCR signals, compared with CD28-mediated costimulation. CD57+ CD4 T cells also express the vascular endothelium-homing receptor CX3CR1 and migrate toward CX3CL1-expressing endothelial cells in vitro. IL-15 promotes the cytotoxic phenotype, elevates CX3CR1 expression, and enhances the trafficking of CD57+ CD4 T cells to endothelium and may therefore be important in linking these cells to cardiovascular complications. Finally, we demonstrate the presence of activated CD57+ CD4 T cells and expression of CX3CL1 and LFA-3 in atherosclerotic plaque tissues from HIV-uninfected donors. Our findings are consistent with a model in which cytotoxic CD4 T cells contribute to CVD in HIV/CMV coinfection and in atherosclerosis via CX3CR1-mediated trafficking and CD2/LFA-3-mediated costimulation. This study identifies several targets for therapeutic interventions and may help bridge the gap in understanding how CMV infection and immunity are linked to increased cardiovascular risk in people living with HIV infection.

2.
J Vasc Surg ; 2020 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-32201007

RESUMO

These Society for Vascular Surgery Clinical Practice Guidelines describe the care of patients with aneurysms of the visceral arteries. They include evidence-based size thresholds for repair of aneurysms of the renal arteries, splenic artery, celiac artery, and hepatic artery, among others. Specific open surgical and endovascular repair strategies are also discussed. They also describe specific circumstances in which aneurysms may be repaired at smaller sizes than these size thresholds, including in women of childbearing age and false aneurysms. These Guidelines offer important recommendations for the care of patients with aneurysms of the visceral arteries and long-awaited guidance for clinicians who treat these patients.

3.
J Vasc Surg ; 2020 Mar 04.
Artigo em Inglês | MEDLINE | ID: mdl-32145991

RESUMO

OBJECTIVE: Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. METHODS: A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. RESULTS: CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance <5 cm (n = 17), common carotid artery diameter <6 mm (n = 3), or significant plaque at the TCAR sheath access site (n = 20), yielding 368 arteries (85.0%) that were eligible for TCAR. CONCLUSIONS: A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

4.
J Vasc Surg ; 2020 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-32035784

RESUMO

OBJECTIVE: Previous data showed superior outcomes of carotid endarterectomy (CEA) compared with transfemoral carotid artery stenting (TFCAS) in elderly patients because of an increased stroke risk in TFCAS-treated patients. Transcarotid artery revascularization (TCAR) with flow reversal was developed to mitigate the maneuvers at highest risk for causing stroke during TFCAS, such as manipulation of a diseased aortic arch and crossing of the carotid lesion before deployment of an embolic protection device. This study aimed to compare the association between age and outcomes after TCAR, TFCAS, and CEA. METHODS: All patients undergoing carotid procedures in the Society for Vascular Surgery Vascular Quality Initiative database between 2015 and November 2018 were included. Patients were divided into three different age groups (≤70 years, 71-79 years, and ≥80 years). In-hospital outcomes after TCAR vs TFCAS and after TCAR vs CEA were compared in each age group by introducing an interaction term between treatment type and age in the logistic regression analysis after adjustment for patients' preoperative characteristics. RESULTS: The study cohort included 3152 TCAR, 10,381 TFCAS, and 61,650 CEA cases. The absolute and adjusted in-hospital outcomes after TCAR did not change across the different age groups. The rates of in-hospital stroke/death after TCAR were 1.4% in patients ≤70 years vs 1.9% in patients 71 to 79 years and 1.5% in patients ≥80 years (P = .55). Comparison of TCAR to CEA across different age groups showed no significant differences in outcomes, and no interaction was noted between treatment and age in predicting in-hospital stroke/death (P = .80). In contrast, TCAR was associated with a 72% reduction in stroke risk (4.7% vs 1%; odds ratio [OR], 0.28; 95% confidence interval [CI], 0.12-0.65; P < .01), 65% reduction in risk of stroke/death (4.6% vs 1.5%; OR, 0.35; 95% CI, 0.20-0.62; P < .001), and 76% reduction in the risk of stroke/death/myocardial infarction (5.3% vs 2.5%; OR, 0.24; 95% CI, 0.12-0.47; P < .001) compared with TFCAS in patients ≥80 years. Moreover, compared with TCAR, the odds of stroke/death after TFCAS doubled at 77 years (OR, 2.0; 95% CI, 1.4-3.0; P < .01) and tripled at 90 years (OR, 3.0; 95% CI, 1.6-5.8; P < .01; P value for the interaction = .08). CONCLUSIONS: TCAR is a relatively safe procedure regardless of the patient's age. The advantages of TCAR become more pronounced in elderly patients, with significant reductions in in-hospital stroke compared with TFCAS in patients ≥77 years old, independent of symptomatic status and other medical comorbidities. These findings suggest that TCAR should be preferred to TFCAS in elderly patients who are at high surgical risk.

5.
J Vasc Surg ; 2020 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-32037083

RESUMO

OBJECTIVE: The neutrophil-lymphocyte ratio (NLR) is an inexpensive and useful inflammatory marker that incorporates the balance of the innate (neutrophil) and adaptive (lymphocyte) immune responses. Data exist on the association between NLR and mortality in various coronary diseases and in cancer surgery, but there is a paucity of data on the impact of preoperative NLR on vascular surgical outcomes. The aim of this study was to evaluate the relationship between preoperative NLR and elective endovascular aortic aneurysm repair (EVAR) outcome. METHODS: A retrospective review of all patients who underwent elective EVAR at a single institution between 2010 and 2018 was conducted (n = 373). Only patients who had a preoperative complete blood count with differential within 30 days of their operation were included. The NLR was computed by dividing the absolute neutrophil count by the absolute lymphocyte count. A receiver operating characteristic curve was used to determine the optimal cutoff value of NLR with the strongest association with mortality. NLR was dichotomized so that patients with NLR above the threshold were at increased risk of mortality compared with those below it. Continuous variables were analyzed using Wilcoxon nonparametric signed-rank test and categorical variables with the Fisher exact test. A comparison of NLR and mortality was completed using Kaplan-Meier survival analysis. Cox regression analysis was used to evaluate factors associated with mortality through 5-year follow-up. RESULTS: Overall, 108 patients were included in this study. An NLR ≥ 4.0 was found to be associated with mortality (P < .0001). Thirty-two patients composed the High-NLR (NLR ≥ 4.0) group and the remaining 76 patients formed the Low-NLR (NLR < 4.0) group. Baseline characteristics were similar between groups, except that the High-NLR group was older (77.9 vs 74.4; P = .047). At a mean of 36.4 months follow-up, the overall mortality rate was 32.4%. Although there were no differences in the perioperative period, the Kaplan-Meier estimates of mortality were significantly greater in the High-NLR group at 1, 2, and 5 years postoperatively (P < .0001). The mean preoperative NLR of the deceased was higher (5.94 ± 5.20; median, 4.75; interquartile range, 3.17-7.83) than those who survived (2.87 ± 1.61; median, 2.53; interquartile range, 1.97-3.49) (P < .0001). Secondary interventions and sac enlargement rates were similar between groups. On univariable analysis, NLR (hazard ratio [HR], 1.17; 95% confidence interval [CI], 1.10-1.23; P < .0001), age (HR, 1.06; 95% CI, 1.02-1.11; P = .004), and aneurysm diameter (HR, 1.04; 95% CI, 1.01-1.07; P = .003) were associated with mortality. On multivariable analysis, NLR (HR, 1.19; 95% CI, 1.12-1.27; P < .0001), age (HR, 1.06; 95% CI, 1.01-1.11; P = .026), and aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.07; P = .003) were associated with mortality. CONCLUSIONS: Patients with an elevated preoperative NLR, irrespective of other comorbidities, may represent a previously unrecognized subset of patients who are at heightened risk of mortality after elective EVAR. A complete blood count with differential is an inexpensive test that may be used as a prognostic indicator for outcome after EVAR. Further research is warranted to identify clinical, pathological, or anatomical factors associated with an elevated NLR and to determine modifiable factors, which may help improve long-term survival.

6.
J Vasc Surg ; 2020 Jan 24.
Artigo em Inglês | MEDLINE | ID: mdl-31987668

RESUMO

OBJECTIVE: The incidence of perigraft hygroma (PGH) development after aortic reconstruction remains poorly defined and its clinical relevance is questionable. This study was designed to establish the incidence of and determine the risk factors associated with PGH formation and its outcomes. METHODS: Patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease with an expanded polytetrafluoroethylene (ePTFE) or polyester graft from 2004 to 2018 were retrospectively reviewed (n = 262). Only those who had follow-up imaging 3 or more months after repair were included. Patients with mixed graft types were excluded. PGH was defined as a perigraft fluid collection of 30 mm or greater in diameter with a radiodensity of 30 or fewer Hounsfield units on computed tomography at a minimum of 3 postoperative months. Analysis was conducted between patients with and without PGH. RESULTS: One hundred forty patients met the inclusion criteria: 88 were treated with ePTFE and 52 with polyester grafts. Twenty-three patients (16.4%) were found to have radiologic evidence of PGH. PGH developed more frequently in patients with ePTFE (21/88 [23.9%]) compared with those with polyester grafts (2/52 [3.8%]) (P = .002). Mean PGH size was 63.5 ± 36.4 mm (range, 33-153 mm) and the average time to PGH detection 27.7 months (range, 3-112 months). Baseline characteristics were similar between the groups. Patients who developed PGH had larger aneurysms, more often received ePTFE grafts, had larger graft diameters, and had bifurcated grafts. The overall mortality was 32.1% at a mean follow-up of 5.2 years. The 5-year mortality rates were similar between patients with and without PGH (26.1% vs 18.8%; P = .41). Of the 23 patients with PGH, 4 (all with ePTFE) presented with symptoms related to the PGH. The average size of symptomatic and asymptomatic PGH were 11.5 and 4.8 cm, respectively. Mortality rates overall were similar between those with and without symptoms (50.0% vs 36.8%; P = .99). CONCLUSIONS: Nearly one-quarter of aortic reconstructions with ePTFE are associated with PGH formation compared with 4% with polyester. Clinically significant PGH-related symptom development occurs in 20%. Patient education and close surveillance are warranted. Manufacturer's device modification is needed.

7.
J Vasc Surg ; 2020 Jan 06.
Artigo em Inglês | MEDLINE | ID: mdl-31917036

RESUMO

OBJECTIVE: Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality. METHODS: We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ2 analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis. RESULTS: Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality. CONCLUSIONS: The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality.

8.
J Vasc Surg ; 71(1): 87-95, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31227410

RESUMO

OBJECTIVE: Transcarotid artery revascularization (TCAR) with flow reversal offers a less invasive option for carotid revascularization in high-risk patients and has the lowest reported overall stroke rate for any prospective trial of carotid artery stenting. However, outcome comparisons between TCAR and carotid endarterectomy (CEA) are needed to confirm the safety of TCAR outside of highly selected patients and providers. METHODS: We compared in-hospital outcomes of patients undergoing TCAR and CEA from January 2016 to March 2018 using the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project registry and the Society for Vascular Surgery Vascular Quality Initiative CEA database, respectively. The primary outcome was a composite of in-hospital stroke and death. RESULTS: A total of 1182 patients underwent TCAR compared with 10,797 patients who underwent CEA. Patients undergoing TCAR were older (median age, 74 vs 71 years; P < .001) and more likely to be symptomatic (32% vs 27%; P < .001); they also had more medical comorbidities, including coronary artery disease (55% vs 28%; P < .001), chronic heart failure (20% vs 11%; P < .001), chronic obstructive pulmonary disease (29% vs 23%; P < .001), and chronic kidney disease (39% vs 34%; P = .001). On unadjusted analysis, TCAR had similar rates of in-hospital stroke/death (1.6% vs 1.4%; P = .33) and stroke/death/myocardial infarction (MI; 2.5% vs 1.9%; P = .16) compared with CEA. There was no difference in rates of stroke (1.4% vs 1.2%; P = .68), in-hospital death (0.3% vs 0.3%; P = .88), 30-day death (0.9% vs 0.4%; P = .06), or MI (1.1% vs 0.6%; P = .11). However, on average, TCAR procedures were 33 minutes shorter than CEA (78 ± 33 minutes vs 111 ± 43 minutes; P < .001). Patients undergoing TCAR were also less likely to incur cranial nerve injuries (0.6% vs 1.8%; P < .001) and less likely to have a postoperative length of stay >1 day (27% vs 30%; P = .046). On adjusted analysis, there was no difference in terms of stroke/death (odds ratio, 1.3; 95% confidence interval, 0.8-2.2; P = .28), stroke/death/MI (odds ratio, 1.4; 95% confidence interval, 0.9-2.1, P = .18), or the individual outcomes. CONCLUSIONS: Despite a substantially higher medical risk in patients undergoing TCAR, in-hospital stroke/death rates were similar between TCAR and CEA. Further comparative studies with larger samples sizes and longer follow-up will be needed to establish the role of TCAR in extracranial carotid disease management.

9.
J Am Coll Surg ; 230(1): 113-120, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31672680

RESUMO

BACKGROUND: Transcarotid artery revascularization (TCAR) with flow reversal was recently introduced as a novel technique for carotid artery stenting (CAS). We examined the learning curve of surgeons adopting TCAR based on data from the Vascular Quality Initiative (VQI-TCAR Surveillance Project; TSP). STUDY DESIGN: We identified all patients in the TSP who underwent TCAR from September 2016 to December 2018. Cases were numbered in chronological order for each unique surgeon. Patients were then divided into 4 levels based on surgeon case number for comparison: cases 1 to 5 (novice), cases 6 to 20 (intermediate), cases 20 to 30 (advanced), and cases >30 (expert). RESULTS: During the study period, 3,456 TCAR procedures were performed by 417 unique surgeons from 178 centers. Of all procedures, 1,426 (41%) were performed at the novice level, 1,375 (40%) at the intermediate level, 307 (8.9%) at the advanced level, and 348 (10%) at the expert level. Cases performed at more advanced levels had lower operative times (novice 82 vs intermediate 73 vs advanced 62 vs expert 60 minutes, p < 0.001), fluoroscopy time (7 vs 6 vs 5 vs 5 minutes, p < 0.001), and flow reversal time (12 vs 11 vs 10 vs 10 minutes, p < 0.001). Cases done at more advanced levels had decreases in bleeding (3.9% vs 3.4% vs 1.6% vs 1.2%, p = 0.03). No differences in major in-hospital outcomes were found regardless of experience level including stroke (p = 0.99), death (p = 0.39), and composite stroke/death/myocardial infarction (p = 0.84). CONCLUSIONS: Transcarotid artery revascularization is being performed with excellent stroke and mortality rates in the TSP, even in the early stages of the surgeons' learning curve. Bleeding complications, operative, fluoroscopy, and flow reversal times all decrease with increasing TCAR experience.

10.
J Vasc Surg ; 71(1): 350, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31864655
11.
JAMA ; 322(23): 2313-2322, 2019 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-31846015

RESUMO

Importance: Several trials have observed higher rates of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. Transcarotid artery revascularization with flow reversal was recently introduced for carotid stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized. Objective: To compare outcomes associated with transcarotid artery revascularization and transfemoral carotid artery stenting. Design, Setting, and Participants: Exploratory propensity score-matched analysis of prospectively collected data from the Vascular Quality Initiative Transcarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transcarotid artery revascularization and transfemoral carotid artery stenting for carotid artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. Exposures: Transcarotid artery revascularization vs transfemoral carotid artery stenting. Main Outcomes and Measures: Outcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality. Results: During the study period, 5251 patients underwent transcarotid artery revascularization and 6640 patients underwent transfemoral carotid artery stenting. After matching, 3286 pairs of patients who underwent transcarotid artery revascularization or transfemoral carotid artery stenting were identified (transcarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). Transcarotid artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.1%; absolute difference, -1.52% [95% CI, -2.29% to -0.75%]; relative risk [RR], 0.51 [95% CI, 0.37 to 0.72]; P < .001), stroke (1.3% vs 2.4%; absolute difference, -1.10% [95% CI, -1.79% to -0.41%]; RR, 0.54 [95% CI, 0.38 to 0.79]; P = .001), and death (0.4% vs 1.0%; absolute difference, -0.55% [95% CI, -0.98% to -0.11%]; RR, 0.44 [95% CI, 0.23 to 0.82]; P = .008). There was no statistically significant difference in the risk of perioperative myocardial infarction between the 2 cohorts (0.2% for transcarotid vs 0.3% for the transfemoral approach; absolute difference, -0.09% [95% CI, -0.37% to 0.19%]; RR, 0.70 [95% CI, 0.27 to 1.84]; P = .47). At 1 year using Kaplan-Meier life-table estimation, the transcarotid approach was associated with a lower risk of ipsilateral stroke or death (5.1% vs 9.6%; hazard ratio, 0.52 [95% CI, 0.41 to 0.66]; P < .001). Transcarotid artery revascularization was associated with higher risk of access site complication resulting in interventional treatment (1.3% vs 0.8%; absolute difference, 0.52% [95% CI, -0.01% to 1.04%]; RR, 1.63 [95% CI, 1.02 to 2.61]; P = .04), whereas transfemoral carotid artery stenting was associated with more radiation (median fluoroscopy time, 5 minutes [interquartile range {IQR}, 3 to 7] vs 16 minutes [IQR, 11 to 23]; P < .001) and more contrast (median contrast used, 30 mL [IQR, 20 to 45] vs 80 mL [IQR, 55 to 122]; P < .001). Conclusions and Relevance: Among patients undergoing treatment for carotid stenosis, transcarotid artery revascularization, compared with transfemoral carotid artery stenting, was significantly associated with a lower risk of stroke or death.


Assuntos
Estenose das Carótidas/cirurgia , Cateterismo Periférico/efeitos adversos , Stents , Acidente Vascular Cerebral/etiologia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Idoso , Estenose das Carótidas/complicações , Estenose das Carótidas/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Pontuação de Propensão , Sistema de Registros
13.
Eur J Vasc Endovasc Surg ; 57(5): 619-625, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30940430

RESUMO

OBJECTIVES: Stroke after carotid endarterectomy (CEA) has been assessed widely. However, factors enhancing non-ipsilateral stroke risk are poorly defined. The aim of this study was to identify drivers of 30 day non-ipsilateral stroke after CEA in the Vascular Quality Initiative (VQI) and assess long-term survival based on laterality of post-operative stroke. METHODS: The VQI was queried between April 1, 2003, and March 31, 2017, for all CEA. Bilateral carotid procedures within 30 days were excluded. Thirty day non-ipsilateral strokes were identified. Factors were examined to discriminate between patients with and without non-ipsilateral stroke. Univariable analysis followed by multivariable logistic regression was performed. Kaplan-Meier and log rank methods were used to estimate and compare survival. RESULTS: During this 14 year period, 80,230 CEA in 74,928 patients met the criteria. The average age was 70.3 ± 9.3 years. Most were male (48,506; 60%), Caucasian (73,967; 92%), smokers (60,543; 76%), and asymptomatic (43,074; 54%). Contralateral stenosis ≥70% was present in 8033 (10%) with 2239 (3%) having contralateral occlusion. In 491 (0.6%) patients, peri-operative non-ipsilateral stroke occurred. After characterising univariable associations, logistic regression identified independent drivers of non-ipsilateral stroke after CEA. Operative urgency (p = .001), symptomatic disease (p < .001) and contralateral occlusion (p = .001) were pre-operative drivers. Operative predictors included shunt use (p = .008), CEA with cardiac surgery (p = .013), and CEA with concomitant proximal ipsilateral endovascular intervention (p = .01). Use of dextran (p = .005) and anti-angiotensin therapy (p = .03) were protective. Reperfusion syndrome (p < .001), re-exploration (p < .001), myocardial infarction (p < .001), and intravenous treatment of hypotension (p < .001) or hypertension (p < .001) were post-operative correlates. Non-ipsilateral stroke 30 day mortality was less than ipsilateral stroke (6.1% vs. 10.3%; p = .007). Five year survival after non-ipsilateral stroke was 73%, and no different from ipsilateral stroke 76% (p = .16). Both were worse than without stroke (88%; p < .001). CONCLUSION: Non-ipsilateral stroke after CEA is rare. Features driving risk surround global disease burden, combined procedures, and haemodynamic fluctuations. Contralateral occlusion independently increases non-ipsilateral stroke risk. Regardless of laterality or location, effects of stroke after CEA on long-term survival are similar.


Assuntos
Procedimentos Cirúrgicos Cardiovasculares/efeitos adversos , Estenose das Carótidas/fisiopatologia , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Acidente Vascular Cerebral/etiologia , Idoso , Angiotensinas/antagonistas & inibidores , Anticoagulantes/uso terapêutico , Dextranos/uso terapêutico , Feminino , Hemodinâmica , Humanos , Estimativa de Kaplan-Meier , Masculino , Complicações Pós-Operatórias , Indicadores de Qualidade em Assistência à Saúde , Análise de Regressão , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/fisiopatologia , Acidente Vascular Cerebral/prevenção & controle
14.
J Vasc Surg ; 70(2): 516-521, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30718112

RESUMO

BACKGROUND: In the pivotal U.S. Food and Drug Administration approval trial, ROADSTER, transcarotid artery revascularization (TCAR) using the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical Inc, Sunnyvale, Calif) was shown to have one of the lowest reported complication rates, not only for carotid artery stent placement, but also for any carotid intervention, including endarterectomy. The number of cases required for a surgeon to gain the proficiency to realize these outcomes has not been studied. Our objective was to determine the learning curve for vascular surgeons performing the TCAR procedure. We examined the effect of surgeon procedural experience on intraoperative data and postoperative outcome. METHODS: This retrospective review analyzed data from a prospectively maintained database of 188 consecutive patients from three large academic centers who underwent TCAR. Procedures were ordered chronologically for each surgeon and grouped into bins of five. Operative times and flow reversal times were analyzed by analysis of variance. Results led to comparison of surgeons' early experience (cases 1-15) with their later experience (cases 16-50). The primary outcome was postoperative stroke and death. RESULTS: The mean procedural time for all cases was 75.0 ± 23.8 minutes. When the procedural time of cases 1 through 15 (mean, 79.0 ± 28.3 minutes) were compared with cases 16 through 50 (mean, 71.8 ± 19.0 minutes), a significant difference was noted (P = .02). The mean flow reversal time was 10.6 ± 6.8 minutes. When flow reversal times were compared using analysis of variance testing, cases 1 through 15 were statistically similar and cases 11 through 50 were also similar, but the two groups differed from each other (P < .001). For flow reversal, cases 1 through 15 had mean reversal times of 13.3 ± 8.8 minutes compared with 8.5 ± 3.5 minutes for cases 16 through 50 (P < .001). Postoperative stroke rates were similar in the 1 through 15 and 16 through 50 case groups (2.4% vs 1.0%; P = .59), as were death rates (0.0% vs 1.0%; P > .99). The combined stroke/death rates were also comparable at 2.4% in the early cohort vs 1.9% in the late cohort (P > .99). CONCLUSIONS: There seems to be a relatively short learning curve for the TCAR procedure. After 15 cases, surgeons are able to reduce procedural decrease by 10% (from 79.0 to 71.8 minutes), and flow reversal times by an average of 40% (from 13.3 to 8.5 minutes). More important, the rates of stroke and death do not differ between early and late experience with TCAR. The TCAR procedure may be quickly and safely adopted by vascular surgeons for carotid intervention.


Assuntos
Doenças das Artérias Carótidas/terapia , Competência Clínica , Endarterectomia das Carótidas , Procedimentos Endovasculares , Curva de Aprendizado , Idoso , Idoso de 80 Anos ou mais , Doenças das Artérias Carótidas/mortalidade , Bases de Dados Factuais , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Stents , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
15.
J Vasc Surg ; 70(1): 123-129, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30622007

RESUMO

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a novel approach to carotid intervention that uses a direct carotid cut-down approach coupled with cerebral blood flow reversal to minimize embolic potential. The initial positive data with TCAR indicates that it may be an attractive alternative to trans-femoral carotid artery stenting and possibly carotid endarterectomy (CEA) for high-risk patients. The purpose of this study was to present 30-day and 1-year outcomes after treatment by TCAR and to compare these outcomes against a matched control group undergoing CEA at the same institutions. METHODS: A retrospective review of all patients who underwent TCAR at four institutions between 2013 and 2017 was performed to evaluate the use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Inc, Sunnyvale, Calif). TCAR patients had high-risk factors and were either enrolled in prospective trials or treated with a commercially available TCAR device after US Food and Drug Administration approval. Contemporaneous patients undergoing CEA at each institution were also reviewed. Patients were propensity matched in a 1:1 (CEA:TCAR) fashion with respect to preoperative comorbidities. Data were analyzed using statistical models with a P value of less than .05 considered significant. Individual and composite stroke, myocardial infarction, and death at 30 days and 1 year postoperatively were assessed. RESULTS: Consecutive patients undergoing TCAR or CEA were identified (n = 663) and compared. Patients undergoing the TCAR procedure (n = 292) had higher rates of diabetes (P = .01), hyperlipidemia (P = .02), coronary artery disease (P < .01), and renal insufficiency (P < .01) compared with unmatched CEA patients (n = 371). Stroke rates were similar at 30 days (1.0% TCAR vs 1.1% CEA) and 1 year (2.8% TCAR vs 3.0% CEA) in the unmatched groups. After propensity matching by baseline characteristics including gender, age, symptom status (36.3%, 35.3%) and diabetes, 292 TCAR patients were compared with 292 CEA patients. TCAR patients were more likely to be treated preoperative and postoperatively with clopidogrel (preoperatively, 82.2% vs 39.4% [P < .01]; postoperatively, 98.3% vs 36.0% [P < .01]) and statins (preoperatively, 88.0% vs 75.0% [P < .01]; postoperatively, 97.8% vs 78.8% [P < .01]). Stroke (1.0% TCAR vs 0.3% CEA; P = .62) and death (0.3% TCAR vs 0.7% CEA; P = NS) rates were similar at 30 days and comparable at 1 year (stroke, 2.8% vs 2.2% [P = .79]; death 1.8% vs 4.5% [P = .09]). The composite end point of stroke/death/myocardial infarction at 1 month postoperatively was 2.1% vs 1.7% (P = NS). TCAR was associated with a decreased rate of cranial nerve injury (0.3% vs 3.8%; P = .01). CONCLUSIONS: These early data suggest that patients undergoing TCAR, even those with high-risk comorbidities, achieve broadly similar outcomes compared with patients undergoing CEA while mitigating cranial nerve injury. Further comparative studies are warranted.


Assuntos
Doenças das Artérias Carótidas/cirurgia , Endarterectomia das Carótidas , Procedimentos Endovasculares , Idoso , Doenças das Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/mortalidade , Doenças das Artérias Carótidas/fisiopatologia , Circulação Cerebrovascular , Endarterectomia das Carótidas/efeitos adversos , Endarterectomia das Carótidas/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Stents , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
16.
J Vasc Surg ; 69(1): 92-103.e2, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29941316

RESUMO

BACKGROUND: Recent evidence from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial in high-risk patients undergoing transcarotid artery stenting with dynamic flow reversal reported the lowest stroke rate compared with any prospective trial of carotid artery stenting. However, clinical trials have selection criteria that exclude many patients from enrollment and are highly selective of operators performing the procedures, which limit generalizability. The aim of this study was to compare in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) as reported in the Vascular Quality Initiative (VQI). METHODS: The Society for Vascular Surgery VQI TCAR Surveillance Project (TSP) was designed to evaluate the safety and effectiveness of TCAR in real-world practice. Data from the initial 646 patients enrolled in the TSP from March 2016 to December 2017 were analyzed and compared with those of patients who underwent TFCAS between 2005 and 2017. Patients with tandem, traumatic, or dissection lesions were excluded. Multivariable logistic regression and 1:1 coarsened exact matching were used to analyze neurologic adverse events (stroke and transient ischemic attacks [TIAs]) and in-hospital mortality. Patients in the two procedures were matched on age, ethnicity, coronary artery disease, congestive heart failure, prior coronary artery bypass graft or percutaneous coronary intervention, chronic kidney disease, degree of ipsilateral stenosis, American Society of Anesthesiologists class, symptomatic status, restenosis, anatomic and medical risk, and urgency of the procedure. RESULTS: Compared with patients undergoing TFCAS (n = 10,136), those undergoing TCAR (n = 638) were significantly older, had more cardiac comorbidities, were more likely to be asymptomatic, and were less likely to have a recurrent stenosis. The rates of in-hospital TIA/stroke as well as of TIA/stroke/death were significantly higher in TFCAS compared with TCAR (3.3% vs 1.9% [P = .04] and 3.8% vs 2.2% [P = .04], respectively). In both procedures, symptomatic patients had higher rates of TIA/stroke/death compared with asymptomatic patients (TCAR, 3.7% vs 1.4% [P = .06]; TFCAS, 5.3% vs 2.7% [P < .001]). After multivariable adjustment, there was a trend of increased stroke or death rates in TFCAS compared with TCAR, but it was not statistically significant (2.5% vs 1.7%; P = .25; odds ratio, 1.75, 95% confidence interval, 0.85-3.62). However, TFCAS was associated with twice the odds of in-hospital adverse neurologic events and TIA/stroke/death compared with TCAR (odds ratio, 2.10; 95% confidence interval, 1.08-4.08; P = .03), independent of symptom status. Coarsened exact matching showed similar results. CONCLUSIONS: Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.


Assuntos
Estenose das Carótidas/cirurgia , Cateterismo Periférico , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Stents , Procedimentos Cirúrgicos Vasculares/instrumentação , Idoso , Idoso de 80 Anos ou mais , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Artéria Femoral/diagnóstico por imagem , Mortalidade Hospitalar , Humanos , Ataque Isquêmico Transitório/etiologia , Ataque Isquêmico Transitório/mortalidade , Masculino , Pessoa de Meia-Idade , Punções , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade
17.
J Vasc Surg ; 69(4): 1102-1110, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30553728

RESUMO

OBJECTIVE: Adding ipsilateral, proximal endovascular (IPE) intervention to carotid endarterectomy (CEA) for the treatment of tandem bifurcation and supra-aortic trunk disease is controversial. Some suggest that this combined strategy (CEA + IPE) confers no risk over isolated CEA (ICEA). Others disagree, reserving CEA + IPE for symptomatic patients. Using the Vascular Quality Initiative (VQI), this study assessed the effect of adding IPE to CEA on stroke and death risk. We further weighed CEA + IPE outcomes in the context of symptomatic status and Society for Vascular Surgery guidelines. METHODS: All CEAs in the VQI database from 2003 to 2017 were reviewed. Urgent and redo CEAs were excluded. CEA + IPE procedures were identified. To isolate the effect of IPE, patients undergoing other concurrent procedures were removed, providing an ICEA cohort. Primary end points were perioperative (30-day) stroke and death. Univariate and logistic regression analyses were performed. RESULTS: After exclusion and identification of CEA + IPE, 66,519 procedures were available for analysis. Of these, 66,115 represented ICEA and 404 represented CEA + IPE. Most patients (60%) were male, 93% were white, and 41% were symptomatic. Average age was 70 ± 9 years. Those undergoing CEA + IPE were more likely to be female (50% vs 40%; P < .001) and smokers (87% vs 76%; P < .001), and they were more likely to have coronary artery disease (32% vs 27%; P = .04), congestive heart failure (14% vs 10%; P = .01), and chronic obstructive pulmonary disease (30% vs 22%; P < .001). ICEA patients were more likely to have severe ipsilateral stenosis (86% vs 80%; P = .002) and to undergo intraoperative shunting (53% vs 49%; P = .05). There was no difference in 30-day mortality between cohorts (1% vs 1%; P = .23). However, CEA + IPE had higher rates of perioperative stroke (3.0% vs 1.4%; P = .01) and combined 30-day stroke and death (3.5% vs 1.8%; P = .02). When patients were stratified by symptomatic status, there were no differences in primary end points between cohorts in asymptomatic patients. In symptomatic patients, CEA + IPE carried significantly higher stroke (4.9% vs 1.9%; P = .002) and stroke and death risk (6.0% vs 2.4%; P = .002). After risk adjustment, predictors of stroke and death were diabetes (odds ratio [OR], 1.2; P = .001), symptomatic status (OR, 1.7; P < .001), and CEA + IPE (OR, 1.9; P = .02). CONCLUSIONS: The addition of IPE to CEA confers increased stroke and death risk over ICEA. Risk is largely in symptomatic patients. Although CEA + IPE increases risk compared with ICEA, overall risk remains low. Based on this VQI analysis, CEA + IPE outcomes for asymptomatic patients fall within Society for Vascular Surgery guidelines for ICEA. Those for symptomatic patients do not, and consideration should be given to other surgical bypass, cerebral protection, and staged strategies.


Assuntos
Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Acidente Vascular Cerebral/etiologia , Idoso , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Terapia Combinada , Bases de Dados Factuais , Endarterectomia das Carótidas/mortalidade , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento
18.
J Vasc Surg ; 2019 Dec 31.
Artigo em Inglês | MEDLINE | ID: mdl-31901361

RESUMO

OBJECTIVE: Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events. METHODS: There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ2 analysis. RESULTS: There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups. CONCLUSIONS: The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.

19.
J Vasc Surg ; 68(5): 1621-1622, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-30360859
20.
J Endovasc Ther ; 25(6): 773-778, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30191765

RESUMO

PURPOSE: To evaluate any intraoperative electroencephalographic (EEG) changes accompanying reversed flow with the ENROUTE Transcarotid Neuroprotection System during transcarotid artery revascularization (TCAR). METHODS: A post hoc analysis was performed of the first 81 consecutive lead-in patients (mean age 72.8±8 years; 61 men) enrolled in the ROADSTER 1 trial at 5 participating institutions. All patients had high-grade carotid artery stenosis [53 (59.3%) left sided; 12 (14.8%) contralateral occlusions] and high-risk criteria for carotid endarterectomy. A third had symptoms of either stroke (13, 16.0%) or transient ischemic attack (14, 17.3%). This subset of early patients underwent EEG monitoring to detect any cerebral changes during reversed flow as an added safety measure mandated by the ROADSTER 1 trial protocol. RESULTS: Mean flow reversal time was 12.9±8.2 minutes. The goal mean arterial pressure during reversed flow was 100 mm Hg, but 7 (8.6%) patients suffered hypotension. One (1.2%) patient had slight EEG changes secondary to blood pressure fluctuation; these resolved with blood pressure elevation. No other EEG changes were noted. One (1.2%) patient had a postoperative stroke and another (1.2%) had postoperative myocardial infarction (MI), leading to 2.5% 30-day stroke/death/MI rate. CONCLUSION: Temporary reversal of blood flow during TCAR is a safe maneuver and does not cause cerebral ischemia in the vast majority of patients, including those with contralateral carotid occlusion. Carotid stenting performed with reversed blood flow mitigates cerebral embolization and periprocedural stroke without concern for brain ischemia.


Assuntos
Ondas Encefálicas , Encéfalo/fisiopatologia , Estenose das Carótidas/cirurgia , Circulação Cerebrovascular , Dispositivos de Proteção Embólica , Procedimentos Endovasculares/instrumentação , Idoso , Idoso de 80 Anos ou mais , Estenose das Carótidas/complicações , Estenose das Carótidas/fisiopatologia , Ensaios Clínicos como Assunto , Eletroencefalografia , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Monitorização Neurofisiológica Intraoperatória/métodos , Ataque Isquêmico Transitório/etiologia , Ataque Isquêmico Transitório/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
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