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.
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
This is a comprehensive review of carotid artery revascularization techniques: Carotid Endarterectomy (CEA), Transfemoral Carotid Artery Stenting (TFCAS), and Transcarotid Artery Revascularization ...(TCAR). CEA is the gold standard and is particularly effective in elderly and high-risk patients. TFCAS, introduced as a less invasive alternative, poses increased periprocedural stroke risks. TCAR, which combines minimally invasive benefits with CEA's neuroprotection principles, emerges as a safer option for high-risk patients, showing comparable results to CEA and better outcomes than TFCAS. The decision-making process for carotid revascularization is complex and influenced by the patient’s medical comorbidities and anatomic factors.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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.
Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates ...after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS.
All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures.
A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval CI, 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio HR, 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033).
In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.
The objective of this study was to report the 5-year outcomes of the Food and Drug Administration investigational device exemption clinical trial of endovascular aneurysm repair (EVAR) with the ...Ovation stent graft (Endologix, Irvine, Calif) for elective treatment of abdominal aortic aneurysm (AAA).
The study comprised 161 patients who underwent EVAR as part of the prospective, international, multicenter pivotal Ovation stent graft trial. The main inclusion criteria were AAA diameter ≥5 cm, proximal neck length ≥7 mm, neck angulation ≤60 degrees, and bilateral iliac fixation length ≥10 mm. The primary end point was a composite outcome of primary clinical success at 5 years. Primary clinical success was defined in accordance with the Society for Vascular Surgery guidelines as successful aneurysm exclusion without aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion, aneurysm rupture, graft migration, or conversion to open repair. Secondary end points included freedom from reintervention, all-cause mortality, and aneurysm-related mortality.
Patients were predominantly male (87.6%) and elderly with a mean age of 73 ± 7.7 years; 66 patients (41%) had challenging anatomy and would be considered outside the instructions for use with other stent grafts, 26 (16.2%) had a proximal neck length <10 mm, and 53 (33%) had a minimum access vessel diameter <6 mm. Technical success was 100%. Of 126 surviving patients, 84 (66.7%) completed 5-year follow-up. The 5-year primary clinical success rate was 78%, aneurysm-related mortality was 1% (one patient), and all-cause mortality was 25%. The AAA-related death resulted from AAA post-EVAR rupture at 49 months in a patient who refused treatment for a type IB endoleak. Freedom from type I or type III endoleak was 95.1%. Freedom from secondary interventions was 80.2%. Most of the reinterventions were performed for type II endoleak (24 63.1%) or for limb thrombosis or stenosis (7 18.4%). There was no graft migration. None of the patients required open conversion.
Five-year results from the Ovation pivotal and continued access investigational device exemption trials demonstrate excellent long-term durability of this endograft despite that 41% of patients had anatomy unfit for other stent grafts. There were no migrations or conversions to open repair and 99% freedom from aneurysm-related mortality. These results suggest a less invasive on-label endovascular option for patients with challenging anatomy who may otherwise require hybrid or open repair.
Carotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, ...there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database.
We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status.
A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio aHR, 0.46; 95% confidence interval CI, 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years.
In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.
OBJECTIVE:To compare the outcomes of TransCarotid Artery Revascularization with flow reversal (TCAR) to the gold standard carotid endarterectomy (CEA) using data from the Society for Vascular Surgery ...Vascular Quality Initiative TCAR Surveillance Project.
SUMMARY BACKGROUND DATA:TCAR is a novel minimally invasive procedure for carotid revascularization in high-risk patients that is associated with significantly lower stroke rates compared with carotid artery stenting via the transfemoral approach.
METHODS:Patients in the United States and Canada who underwent TCAR and CEA for carotid artery stenosis (2016- 2019) were included. Propensity scores were calculated based on baseline clinical variables and used to match patients in the two treatment groups (n=6,384 each). The primary endpoint was the combined outcome of perioperative stroke and/or death.
RESULTS:No significant differences were observed between TCAR and CEA in terms of in-hospital stroke/death TCAR,1·6% vs.CEA,1·6%, RR (95% CI):1·01(0·77–1·33), P=·945, stroke 1·4% vs.1·4%, RR(95%CI):1·02(0·76–1·37), P=·881, or death 0·4% vs.0·3%, RR (95%CI):1·14 (0·64–2·02), P =·662. Compared to CEA, TCAR was associated with lower rates of in-hospital myocardial infarction 0·5% vs. 0·9%, RR (95%CI):0·53 (0·35–0·83), P =·005, cranial nerve injury 0·4% vs.2·7%, RR(95%CI):0·14(0·08–0·23), P<·001, and post-procedural hypertension 13% vs.18·8%, RR(95% CI):0·69(0·63–0·76), P <·001. They were also less likely to stay in the hospital for more than one day 26·4% vs.30·1%, RR (95%CI):0·88(0·82–0·94), P<·001. No significant interaction was observed between procedure and symptomatic status in predicting postoperative outcomes. At one year, the incidence of ipsilateral stroke or death was similar between the two groups HR (95%CI):1·09(0·87–1·36), P=·44.
CONCLUSIONS:This propensity-score matched analysis demonstrated significant reduction in the risk of postoperative myocardial infarction and cranial nerve injury after TCAR compared to CEA, with no differences in the rates of stroke/death.
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.
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.
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.
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.
Preoperative anemia is associated with worse postoperative morbidity and mortality following major vascular procedures. Limited research has examined the optimal method of carotid revascularization ...in anemic patients. Therefore, we aim to compare the postoperative outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid artery revascularization (TCAR) among anemic patients.BACKGROUNDPreoperative anemia is associated with worse postoperative morbidity and mortality following major vascular procedures. Limited research has examined the optimal method of carotid revascularization in anemic patients. Therefore, we aim to compare the postoperative outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid artery revascularization (TCAR) among anemic patients.This is a retrospective review of anemic patients undergoing CEA, TFCAS, and TCAR in the Vascular Quality Initiative database between 2016-2023. We defined anemia as a preoperative hemoglobin level of <13 g/dL in men and <12 g/dL in women. The primary outcomes were 30-day mortality and in-hospital major adverse cardiac events (MACE). Logistic regression models were used for multivariate analyses.STUDY DESIGNThis is a retrospective review of anemic patients undergoing CEA, TFCAS, and TCAR in the Vascular Quality Initiative database between 2016-2023. We defined anemia as a preoperative hemoglobin level of <13 g/dL in men and <12 g/dL in women. The primary outcomes were 30-day mortality and in-hospital major adverse cardiac events (MACE). Logistic regression models were used for multivariate analyses.Our study included 40,383 (59.3%) CEA, 9,159 (13.5%) TFCAS, and 18,555 (27.3%) TCAR cases in anemic patients. TCAR patients were older and had more medical comorbidities than CEA and TFCAS patients. TCAR was associated with decreased 30-day mortality (aOR=0.45,95%CI:0.37-0.59,P<0.001), in-hospital MACE (aOR=0.58,95%CI:0.46-0.75,P<0.001) compared to TFCAS. Additionally, TCAR was associated with 20% reduction in the risk of 30-day mortality (aOR=0.80,95%CI:0.65-0.98,P=0.03), and similar risk of in-hospital MACE (aOR=0.86,95%CI:0.77-1.01, P=0.07) compared to CEA. Furthermore, TFCAS was associated with an increased risk of 30-day mortality (aOR= 2,95%CI: 1.5-2.68,P<0.001), in-hospital MACE (aOR=1.7,95% CI:1.4-2,P<0.001) compared to CEA.RESULTSOur study included 40,383 (59.3%) CEA, 9,159 (13.5%) TFCAS, and 18,555 (27.3%) TCAR cases in anemic patients. TCAR patients were older and had more medical comorbidities than CEA and TFCAS patients. TCAR was associated with decreased 30-day mortality (aOR=0.45,95%CI:0.37-0.59,P<0.001), in-hospital MACE (aOR=0.58,95%CI:0.46-0.75,P<0.001) compared to TFCAS. Additionally, TCAR was associated with 20% reduction in the risk of 30-day mortality (aOR=0.80,95%CI:0.65-0.98,P=0.03), and similar risk of in-hospital MACE (aOR=0.86,95%CI:0.77-1.01, P=0.07) compared to CEA. Furthermore, TFCAS was associated with an increased risk of 30-day mortality (aOR= 2,95%CI: 1.5-2.68,P<0.001), in-hospital MACE (aOR=1.7,95% CI:1.4-2,P<0.001) compared to CEA.In this multi-institutional national retrospective analysis of a prospectively collected database, TFCAS is associated with a high risk of 30-day mortality and in-hospital MACE compared to CEA and TCAR in anemic patients. TCAR was associated with lower risk of 30-day mortality compared to CEA. These findings suggest TCAR as the optimal minimally invasive procedure for carotid revascularization in anemic patients.CONCLUSIONSIn this multi-institutional national retrospective analysis of a prospectively collected database, TFCAS is associated with a high risk of 30-day mortality and in-hospital MACE compared to CEA and TCAR in anemic patients. TCAR was associated with lower risk of 30-day mortality compared to CEA. These findings suggest TCAR as the optimal minimally invasive procedure for carotid revascularization in anemic patients.
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