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.
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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.
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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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Recent studies have demonstrated that transcarotid artery revascularization (TCAR) has comparable outcomes to the surgical gold standard, carotid endarterectomy (CEA). However, few studies have ...analyzed the cost of TCAR, and no study has evaluated its cost-effectiveness. The purpose of this study is to conduct a cost-effectiveness analysis comparing TCAR with CEA for carotid artery stenosis.
We built a Markov microsimulation using transition probabilities and utilities from existing literature for symptomatic patients undergoing TCAR or CEA. Costs were derived from literature then converted to 2019 dollars. The model included six health states with monthly cycle lengths: surgery, death, alive after surgery, alive after myocardial infarction, alive after stroke, and alive after stroke and death. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness.
For symptomatic patients, CEA cost $7821 for 2.85 QALYs, whereas TCAR cost $19154 for 2.92 QALYs, leading to an ICER of $152,229 per QALY gained in the TCAR arm. Sensitivity analysis demonstrated that our model was most sensitive to probability of restenosis, costs of TCAR, and costs of CEA. Probabilistic sensitivity analysis demonstrated TCAR would be considered cost-effective in 49% of iterations.
This study found that, although 5-year costs for TCAR were greater than CEA, TCAR afforded greater QALYs than CEA. TCAR became cost-effective at 6 years of follow-up.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
Evidence for benefit of endovascular aneurysm repair (EVAR) over open surgical repair for de novo infrarenal abdominal aortic aneurysms (AAAs) in younger patients remains conflicting because of ...heterogeneous study populations and small sample sizes. The objective of this study was to compare perioperative and short-term outcomes for EVAR and open surgery in younger patients using a large national disease and procedure-specific data set.
We identified patients 65 years of age or younger undergoing first-time elective EVAR or open AAA repair from the Vascular Quality Initiative (2003-2014). We excluded patients with pararenal or thoracoabdominal aneurysms, those medically unfit for open repair, and those undergoing EVAR for isolated iliac aneurysms. Clinical and procedural characteristics were balanced using inverse propensity of treatment weighting. A supplemental analysis extended the study to those younger than 70 years.
We identified 2641 patients, 73% (n = 1928) EVAR and 27% (n = 713) open repair. The median age was 62 years (interquartile range, 59-64 years), and 13% were female. The median follow-up time was 401 days (interquartile range, 357-459 days). Unadjusted perioperative survival was 99.6% overall (open repair, 99.1%; EVAR, 99.8%; P < .001), with 97.4% 1-year survival overall (open repair, 97.3%; EVAR, 97.4%; P = .9). Unadjusted reintervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years (P = .8). After propensity weighting, the absolute incidence of perioperative mortality was <1% in both groups (open repair, 0.9%, EVAR, 0.2%; P < .001), and complication rates were low. Propensity-weighted survival (hazard ratio, 0.88; 95% confidence interval, 0.56-1.38; P = .6) and reintervention rates (open repair, 6; EVAR, 8; reinterventions per 100 person-years; P = .8) did not differ between the two interventions. The analysis of those younger than 70 years showed similar results.
In this study of younger patients undergoing repair of infrarenal AAA, 30-day morbidity and mortality for both open surgery and EVAR are low, and the absolute mortality difference is small. The prior published perioperative mortality and 1-year survival benefit of EVAR over open AAA repair is not observed in younger patients. Further studies of long-term durability are needed to guide decision-making for open repair vs EVAR in this population.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Restenosis after carotid endarterectomy (CEA) is associated with an increased risk of ipsilateral stroke. The optimal procedural modality for this indication has yet to be determined. Here, we ...evaluate the in-hospital outcomes of transcarotid artery revascularization (TCAR), redo-CEA, and transfemoral carotid artery stenting (TFCAS) in a large contemporary cohort of patients who underwent treatment for restenosis after CEA.
We performed a retrospective analysis of all patients in the vascular quality initiative database who underwent TCAR, redo-CEA, or TFCAS after ipsilateral CEA between September 2016 and April 2020. Patients with prior ipsilateral CAS were excluded from this analysis. In-hospital outcomes following TCAR versus CEA and TCAR versus TFCAS were evaluated using multivariate logistic regression analysis.
A total of 4425 patients were available for this analysis. There were 963 (21.8%) redo-CEA, 1786 (40.4%) TFCAS, and 1676 (37.9%) TCAR. TCAR was associated with lower odds of in-hospital stroke/death (odds ratio OR, 0.41 95% CI, 0.24–0.70, P=0.021), stroke (OR, 0.46 95% CI, 0.23–0.93, P=0.03), myocardial infarction (MI; OR, 0.32 95% CI, 0.14–0.73, P=0.007), stroke/transient ischemic attack (OR, 0.42 95% CI, 0.24–0.74, P=0.002), and stroke/death/MI (OR, 0.41 95% CI, 0.24–0.70, P=0.001) when compared with redo-CEA. There was no significant difference in the odds of death between the 2 groups (OR, 0.99 95% CI, 0.28–3.5, P=0.995). TCAR was also associated with lower odds of stroke/transient ischemic attack (OR, 0.37 95% CI, 0.18–0.74, P=0.005) when compared with TFCAS. There was no significant difference in the odds of stroke, death, MI, stroke/death, or stroke/death/MI between TCAR and TFCAS.
TCAR was associated with significantly lower odds of in-hospital stroke, MI, stroke/transient ischemic attack, stroke/death, and stroke/death/MI when compared with redo-CEA and lower odds of in-hospital stroke/transient ischemic attack when compared with TFCAS. Additional long-term studies are warranted to establish the role of TCAR for the treatment of restenosis after CEA.
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