Studies have suggested that there is increased risk of thromboembolism (TE) associated with coronavirus disease 2019 (COVID-19). However, overall arterial and venous TE rates of COVID-19 and effect ...of TE on COVID-19 mortality is unknown.
We did a systematic review and meta-analysis of studies evaluating TE in COVID-19. We searched PubMed, Cochrane, and Embase for studies published up to June 12, 2020. Random effects models were used to produce summary TE rates and odds ratios (OR) of mortality in COVID-19 patients with TE compared to those without TE. Heterogeneity was quantified with I2.
Of 425 studies identified, 42 studies enrolling 8271 patients were included in the meta-analysis. Overall venous TE rate was 21% (95% CI:17–26%): ICU, 31% (95% CI: 23–39%). Overall deep vein thrombosis rate was 20% (95% CI: 13–28%): ICU, 28% (95% CI: 16–41%); postmortem, 35% (95% CI:15–57%). Overall pulmonary embolism rate was 13% (95% CI: 11–16%): ICU, 19% (95% CI:14–25%); postmortem, 22% (95% CI:16–28%). Overall arterial TE rate was 2% (95% CI: 1–4%): ICU, 5% (95%CI: 3–7%). Pooled mortality rate among patients with TE was 23% (95%CI:14–32%) and 13% (95% CI:6–22%) among patients without TE. The pooled odds of mortality were 74% higher among patients who developed TE compared to those who did not (OR, 1.74; 95%CI, 1.01–2.98; P = 0.04).
TE rates of COVID-19 are high and associated with higher risk of death. Robust evidence from ongoing clinical trials is needed to determine the impact of thromboprophylaxis on TE and mortality risk of COVID-19.
None.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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).
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.
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.
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.
Display omitted
The evidence supporting management decisions of visceral artery aneurysms (VAAs) is sparse. Practice guidelines are needed to help patients and surgeons choose between endovascular and open surgery ...approaches.
We searched MEDLINE, EMBASE, Cochrane databases, and Scopus for studies of patients with VAAs. Studies were selected and appraised by pairs of independent reviewers. Meta-analysis was performed when appropriate.
We included 80 observational studies that were mostly noncomparative. Data were available for 2845 aneurysms, comprising 1279 renal artery, 775 splenic artery, 359 hepatic artery, 226 pancreaticoduodenal and gastroduodenal arteries, 95 superior mesenteric artery, 87 celiac artery, 15 jejunal, ileal and colic arteries, and 9 gastric and gastroepiploic arteries. Differences in mortality between open and endovascular approaches were not statistically significant. The endovascular approach was used more often by surgeons. The endovascular approach was associated with shorter hospital stay and lower rates of cardiovascular complications but higher rates of reintervention. Postembolization syndrome rates ranged from 9% (renal) to 38% (splenic). Coil migration ranged from 8% (splenic) to 29% (renal). Otherwise, access site complication were low (<5%). Pseudoaneurysms tended to have higher mortality and reintervention rates.
This systematic review provides event rates for outcomes important to patients with VAAs. Despite the low certainty warranted by the evidence, these rates along, with surgical expertise and anatomic feasibility, can help patients and surgeons in shared-decision making.
We report the 1-year outcomes of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial. This trial introduced a novel transcarotid ...neuroprotection system (NPS), the ENROUTE transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif). Postoperative results demonstrated that the use of the ENROUTE transcarotid NPS is safe and effective. The aim of this study was to evaluate the safety of transcarotid artery revascularization (TCAR) and to present the 1-year outcomes.
This study is a prospective, single-arm clinical trial. Current enrollment occurs in 14 centers. Primary end points were incidence rates of ipsilateral stroke at 1 year after TCAR. Occurrence of stroke was ascertained by an independent Clinical Events Committee. Patients with anatomic or medical high-risk factors for carotid endarterectomy (CEA) were eligible to be enrolled in the ROADSTER trial.
Overall, 165 patients were included in the long-term follow-up (112 of 141 patients from the pivotal phase and 53 of 78 patients from the extended access). Mean age was 73.9 years (range, 42.1-91.3 years). Patients aged 75 years and older were 43.3% of the cohort. The majority of patients were white (92.7%) and male (75.2%). Most patients were asymptomatic (79.9%). Anatomic risk factors were distributed as follows: contralateral carotid artery occlusion (11.0%), tandem stenosis of >70% (1.8%), high cervical carotid artery stenosis (25.0%), restenosis after CEA (25.6%), bilateral stenosis requiring treatment (4.3%), and hostile neck (14.6%). Medical high-risk criteria included two-vessel coronary artery disease (14.0%) and severe left ventricular dysfunction with ejection fraction <30% (1.8%). In general, 43.3% of patients had at least one anatomic high-risk factor, whereas 29.9% of patients had medical high-risk factors. Both subsets of factors were present simultaneously in 26.8% of the cohort. At 1-year follow-up, ipsilateral stroke incidence rate was 0.6%, and seven patients (4.2%) died. None of the deaths were neurologic in origin.
TCAR with dynamic flow reversal had previously shown favorable 30-day perioperative outcomes. This excellent performance seems to extend to 1 year after TCAR as illustrated in this analysis. The promising results from the ROADSTER trial likely stem from the novel cerebral protection provided through the ENROUTE transcarotid NPS in comparison to distal embolic protection devices as well as the transcarotid approach's circumventing diseased aortic arch manipulation and minimizing embolization. TCAR offers a safe and durable revascularization option for patients who are deemed to be at high risk for CEA.
Background Patient frailty has been implicated as a predictor of poor patient outcomes; however, there is no consensus on how to define or quantify frailty to assess perioperative risk. A previously ...described modified Frailty Index (mFI) has been shown to predict adverse outcomes after selected vascular surgical procedures, but no studies to date have compared its utility against other recognized risk indices in specific populations of vascular surgery patients. Methods National Surgical Quality Improvement Program data were reviewed for all patients undergoing carotid revascularization, abdominal aortic aneurysm (AAA) repair, and lower extremity revascularization for peripheral arterial disease (PAD) from 2006 to 2012. Patients were then further stratified into “open” and “endovascular” cohorts. The mFI was compared with the Lee Cardiac Risk Index (LCRI) and the American Society of Anesthesiologists (ASA) Physical Status Classification using a receiver operating characteristic area under curve (AUC). The primary end point was 30-day mortality, with a secondary end point of Clavien-Dindo class IV complications. Results A total of 72,106 patients were identified in the study period, with 40,931 (56.8%), 20,975 (29.1%), and 10,200 (14.1%) in the carotid, AAA, and PAD populations, respectively. For carotid endarterectomy, mFI demonstrated better discrimination regarding mortality than LCRI and ASA, with an AUC of 0.66 (95% confidence interval CI, 0.63-0.70; P < .01 vs P = .65 and P = .60, respectively). The open AAA cohort had similar findings, with an AUC of 0.63 (95% CI, 0.59-0.67; P = .02 vs P = .58, and P = .58, respectively). In open PAD patients, mFI was comparable to ASA (AUC, 0.64 95% CI 0.60-0.69 vs 0.65), with a trend toward better discrimination compared with the 0.60 AUC of LCRI ( P = .08). The mFI was a better discriminator of class IV complications than LCRI and ASA after open AAA (AUC for mFI, 0.59 vs 0.56 and 0.55; 95% CI, 0.57-0.61; P < .01) and endovascular AAA repair (AUC for mFI, 0.60 vs 0.59 and 0.57; 95% CI, 0.58-0.62; P = .01). There were no significant differences in discrimination of class IV complications after open or endovascular PAD or carotid endarterectomy. Conclusions The mFI was a better discriminator of mortality than other risk indices; however this was only significant for the open cohort. The mFI was also a better discriminator of class IV complications for the open and endovascular AAA repair groups. These data suggest that mFI should be used in place of previously recognized risk indices to define perioperative mortality after open vascular surgery and risk of major complications after aneurysm repair.
Management of carotid bifurcation stenosis in stroke prevention has been the subject of extensive investigations, including multiple randomized controlled trials. The proper treatment of patients ...with carotid bifurcation disease is of major interest to vascular surgeons and other vascular specialists. In 2011, the Society for Vascular Surgery published guidelines for the treatment of carotid artery disease. At the time, several randomized trials, comparing carotid endarterectomy (CEA) and carotid artery stenting (CAS), were reported. Since the 2011 guidelines, several studies and a few systematic reviews comparing CEA and CAS have been reported, and the role of medical management has been reemphasized. In the present publication, we have updated and expanded on the 2011 guidelines with specific emphasis on five areas: (1) is CEA recommended over maximal medical therapy for low-risk patients; (2) is CEA recommended over transfemoral CAS for low surgical risk patients with symptomatic carotid artery stenosis of >50%; (3) the timing of carotid intervention for patients presenting with acute stroke; (4) screening for carotid artery stenosis in asymptomatic patients; and (5) the optimal sequence of intervention for patients with combined carotid and coronary artery disease.
A separate implementation document will address other important clinical issues in extracranial cerebrovascular disease. Recommendations are made using the GRADE (grades of recommendation assessment, development, and evaluation) approach, as was used for other Society for Vascular Surgery guidelines. The committee recommends CEA as the first-line treatment for symptomatic low-risk surgical patients with stenosis of 50% to 99% and asymptomatic patients with stenosis of 70% to 99%. The perioperative risk of stroke and death in asymptomatic patients must be <3% to ensure benefit for the patient. In patients with recent stable stroke (modified Rankin scale score, 0-2), carotid revascularization is considered appropriate for symptomatic patients with >50% stenosis and should be performed as soon as the patient is neurologically stable after 48 hours but definitely <14 days after symptom onset. In the general population, screening for clinically asymptomatic carotid artery stenosis in patients without cerebrovascular symptoms or significant risk factors for carotid artery disease is not recommended. In selected asymptomatic patients with an increased risk of carotid stenosis, we suggest screening for clinically asymptomatic carotid artery stenosis as long as the patients would potentially be fit for and willing to consider carotid intervention if significant stenosis is discovered. For patients with symptomatic carotid stenosis of 50% to 99%, who require both CEA and coronary artery bypass grafting, we suggest CEA before, or concomitant with, coronary artery bypass grafting to potentially reduce the risk of stroke and stroke/death. The sequencing of the intervention depends on the clinical presentation and institutional experience.
Transcarotid artery revascularization (TCAR) with the ENROUTE transcarotid neuroprotection and stent system (Silk Road Medical, Inc, Sunnyvale, Calif) combines surgical principles of neuroprotection ...with less invasive endovascular techniques to treat high grade stenosis in the carotid artery. The ENROUTE Neuroprotection System allows the surgeon to directly access the common carotid artery to initiate high rate temporary blood flow reversal to protect the brain while performing carotid angioplasty and stenting. Unprotected catheterization of the arch and lesion is, thus, avoided. Pivotal data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) study of high-risk patients undergoing TCAR have showed a low stroke rate compared with other prospective trials of endovascular carotid intervention. The aim of this article is to provide specific technical details of TCAR.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
The Centers for Medicare and Medicaid Services (CMS) now approve reimbursement for Transfemoral Carotid Artery Stenting (TFCAS) in the treatment of standard-risk patients with carotid artery ...occlusive disease. TFCAS in patients with complex aortic arch anatomy is known to be challenging with worse outcomes. Transcarotid Artery Revascularization (TCAR) could be a preferable alternative in these patients owing to avoiding the aortic arch and using flow reversal during stent deployment. We aim to compare the outcomes of TCAR versus TFCAS across all aortic arch types and degrees of arch atherosclerosis.
All patients undergoing Carotid Artery Stenting (CAS) between September 2016 and October 2023 were identified in the VQI database. Patients were stratified into four groups: Group-A (Mild Atherosclerosis and Type I/II Arch), Group-B (Mild Atherosclerosis and Type III Arch), Group-C (Moderate/Severe Atherosclerosis and Type I/II Arch), Group-D (Moderate/Severe Atherosclerosis and Type III Arch). The primary outcome was in-hospital composite stroke or death. ANOVA and χ2tests analyzed differences for baseline characteristics. Logistic regression models were adjusted for potential confounders, and backward stepwise selection was implemented to identify significant variables for inclusion in the final models. Kaplan Meier survival estimates, Log Rank test, and multivariable Cox regression models analyzed hazard ratios for one-year mortality.
A total of 20,114 patients were included Group-A:12,980 (64.53%); Group-B: 1,175 (5.84%); Group-C: 5,124 (25.47%); Group-D: 835 (4.15%). TCAR was more commonly performed across the four groups (72.21%, 67.06%, 74.94% 69.22%; p<0.001). Compared to patients with mild arch atherosclerosis, patients with advanced arch atherosclerosis in Group-C and Group-D were more likely to be female, hypertensive, smokers, and have CKD. Patients with Type-III arch in Group-B and Group-D were more likely to present with stroke preoperatively. On multivariable analysis, TCAR had less than half the risk of stroke/death and one-year mortality compared to TFCAS in the patients with the mildest atherosclerosis and simple arch anatomy (group A) (OR=0.43,95%CI:0.31-0.61, p<0.001; HR=0.42,95%CI:0.32-0.57, p<0.001). Group-B patients with similar atherosclerosis but more complex arch anatomy had 70% lower odds of stroke/death with TCAR compared to TFCAS (OR=0.30,95%CI:0.12-0.75, p=0.01). Similar findings were also evident in patients with more severe atherosclerosis and simple arch anatomy (OR=0.66,95%CI:0.44-0.97, p=0.037). There was no significant difference in odds of stroke/death in patients with advanced arch atherosclerosis and complex arch (Group-D) (OR=0.91,95%CI:0.39-2.16, p=0.834).
TCAR is safer than TFCAS in patients with simple and advanced arch anatomy. This could be related to the efficiency of flow reversal vs distal embolic protection. Current CMS decision will likely increase stroke and death outcomes of carotid stenting nationally if multidisciplinary approach and appropriate patient selection are not implemented.
Type of research: Multicenter retrospective analysis of prospectively collected Vascular Quality Initiative data.Key Findings: Analysis of 14,579 transcarotid artery revascularization (TCAR) and 5,535 transfemoral carotid artery stenting (TFCAS) procedures revealed that TCAR had less than half the risk of stroke/death compared to TFCAS in the patients with the mild atherosclerosis and simple arch anatomy. Patients with more complex arch anatomy had 70% lower odds of stroke/death with TCAR. Similar findings were also evident in patients with more severe atherosclerosis with 34% lower odds of stroke/death.Take Home Message: TCAR being safer than TFCAS in patients with simple and complex arch configuration. This can be explained by better neurological protection using flow reversal compared to distal embolic protection. Proper patient selection and adequate preoperative imaging is important for patient selection and planning before carotid artery stenting.
AbstractObjectiveBowel ischemia (BI) is a serious complication after abdominal aortic aneurysm (AAA) repair. We sought to identify the incidence and risk factors associated with the development of ...postoperative BI and the post-BI outcomes for patients undergoing open aortic repair (OAR) and endovascular aortic repair (EVAR) of AAAs. MethodsA retrospective analysis was conducted for all patients who had undergone OAR or EVAR from 2003 to 2017 using the Vascular Quality Initiative database. Univariate (Student's t test, χ2, median) and multivariable (logistic regression) analyses were used to identify independent factors associated with postoperative BI and compare the post-BI in-hospital outcomes and mortality. ResultsWe identified 45,474 patients who had undergone infrarenal AAA repair (OAR, 21.5%; EVAR, 78.5%). The overall incidence of postoperative BI was 1.9% (OAR, 6.2% vs EVAR, 0.8%; P < .001). OAR was associated with a threefold increased odds of BI compared with EVAR (adjusted odds ratio aOR, 3.24; 95% confidence interval CI, 2.49-4.22; P < .001). The independent factors associated with BI after OAR included older age (aOR per year of age, 1.02; 95% CI, 1.00-1.03), congestive heart failure (aOR, 1.44; 95% CI, 1.05-1.98), and ruptured aneurysm (aOR, 4.16; 95% CI, 2.98-5.81; P < .01 for all). We also found that transfusion ≥1 U (aOR, 1.69; 95% CI, 1.30-2.20), a transperitoneal approach (aOR, 2.13; 95% CI, 1.03-1.87), supraceliac clamping (aOR, 1.58; 95% CI, 1.08-2.33), and inferior mesenteric artery reimplantation (aOR, 1.41; 95% CI, 1.06-1.89) were associated with greater odds of BI after OAR ( P < .01 for all). Similarly, we found that ruptured aneurysms, a longer operative time, and transfusion of ≥1 U of blood were associated with BI after EVAR ( P < .001 for all). For both OAR and EVAR, the postoperative stay (median, 13 days interquartile range (IQR), 7-26 days vs 7 days IQR, 5-10 days and 11 days IQR, 4-23 days vs 1 day IQR, 1-3 days, respectively) and 30-day mortality (35.0% vs 6.4% and 40.5% vs 1.9%, respectively) were significantly higher for patients with BI ( P < .001 for all). The predictors of mortality for patients with BI were surgical management (aOR, 2.05; 95% CI, 1.28-3.30), older age (aOR, 1.05; 95% CI, 1.02-1.07), symptomatic aneurysm (aOR, 1.26; 95% CI, 0.60-2.62), ruptured aneurysm (aOR, 2.23; 95% CI, 1.43-3.48), longer operative time (aOR, 1.11; 95% CI, 1.01-1.22), and postoperative renal complications (aOR, 2.98; 95% CI, 1.80-4.96; P < .05 for all). ConclusionsConfirming the results from previous studies, we found that BI is more common after a ruptured aneurysm and OAR. Other associated intraoperative factors included a transperitoneal approach, supraceliac clamping, and a reimplanted inferior mesenteric artery. More than one third of patients who developed postoperative BI in our cohort had died within 30 days after AAA repair. The factors associated with mortality after BI included surgical management and postoperative renal failure. A high index of suspicion for the signs and symptoms of BI should be maintained postoperatively for patients presenting with the risk factors identified.
Adequate proximal and distal seal zones are necessary for successful thoracic endovascular aortic repair (TEVAR). Often, the achievement of an adequate distal seal zone requires celiac artery (CA) ...coverage by endograft with or without preservation of CA blood flow. The outcomes of CA coverage without its flow preservation were studied only in small case series. This study aims to determine the difference in outcomes between CA coverage with vs without preservation of CA blood flow during TEVAR using a multi-institutional national database.
The Vascular Quality Initiative database was reviewed for all TEVAR patients distally landing in zone 6. The cohort was divided into TEVAR with vs without CA flow preservation. Demographic, clinical, and perioperative characteristics, as well as postoperative mortality, morbidities, and complications, were compared between the groups. Univariate and multivariate regression analyses were performed.
Of 25,549 reviewed patients, 772 had a distal landing in Zone 6, 212 of which (27.5%) had TEVAR without CA flow preservation, whereas 560 (72.5%) underwent TEVAR with CA flow preservation. Indications for TEVAR were aneurysm in 431 (55.8%), dissection in 247 (32.0%), or other in 94 (12.2%) cases. Patients who underwent TEVAR without CA flow preservation had statistically significantly higher rates of 30-day mortality (11.3% vs 5.9%; P = .010), 30-day disease/treatment-related mortality (8.0% vs 4.3%; P = .039), as well as a tendency of increased intestinal ischemia requiring intervention (1.9% vs 0.5%; P = .077). After adjusting for potential confounders, CA coverage without flow preservation was associated with more than a two-fold increase in the overall 30-day mortality (odds ratio OR, 2.83; 95% confidence interval CI, 1.35-5.92; P = .006) and 30-day disease/treatment-related mortality (OR, 2.72; 95% CI, 1.11-6.72; P = .029). In a sub-group analysis based on disease pathology, these results persisted only in the aneurysm group (30-day mortality OR, 2.36; 95% CI, 1.01-5.48; P = .047; 30-day disease/treatment-related mortality OR, 2.88; 95% CI, 1.08-7.67; P = .034), whereas there was no significant association between CA flow preservation status and the endpoints in the dissection subgroup (30-day mortality OR, 1.16; 95% CI, 0.22-6.05; P = .856, 30-day disease/treatment-related mortality OR, 0.90; 95% CI, 0.16-5.19; P = .911).
CA coverage during TEVAR without preservation of its blood flow is associated with significantly higher mortality in patients with aortic aneurysm, but not dissection. In patients with aortic aneurysm, CA flow should be preserved during TEVAR whenever feasible, whereas in patients with dissection, it may be safe to cover CA without preservation of its flow. Prospective studies should be done to confirm these findings and compare the open vs endovascular revascularization techniques on outcomes.
PDF
