Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Intermittent claudication treatment patterns in the commercially insured non-Medicare population.

OBJECTIVE: Despite published guidelines and data for Medicare patients, it is uncertain how younger patients with intermittent claudication (IC) are treated. Additionally, the degree to which treatment patterns have changed over time with the expansion of endovascular interventions and outpatient centers is unclear. Our goal was to characterize IC treatment patterns in the commercially insured non-Medicare population. METHODS: The IBM MarketScan Commercial Database, which includes more than 8 billion US commercial insurance claims, was queried for patients newly diagnosed with IC from 2007 to 2016. Patient demographics, medication profiles, and open/endovascular interventions were evaluated. Time trends were modeled using simple linear regression and goodness-of-fit was assessed with coefficients of determination (R2). A patient-centered cohort sample and a procedure-focused dataset were analyzed. RESULTS: Among 152,935,013 unique patients in the database, there were 300,590 patients newly diagnosed with IC. The mean insurance coverage was 4.4 years. The median patients age was 58 years and 56% of patients were male. The prevalence of statin use was 48% among patients at the time of IC diagnosis and increased to 52% among patients after one year from diagnosis. Interventions were performed in 14.3%, of whom 20% and 6% underwent two or more and three or more interventions, respectively. The median time from diagnosis to intervention decreased from 230 days in 2008 days to 49 days in 2016 (R2 = 0.98). There were 16,406 inpatient and 102,925 ambulatory interventions for IC over the study period. Among ambulatory interventions, 7.9% were performed in office-based/surgical centers. The proportion of atherectomies performed in the ambulatory setting increased from 9.7% in 2007 to 29% in 2016 (R2 = 0.94). In office-based/surgical centers, 57.6% of interventions for IC used atherectomy in 2016. Atherectomy was used in ambulatory interventions by cardiologists in 22.6%, surgeons in 15.2%, and radiologists in 13.6% of interventions. Inpatient atherectomy rates remained stable over the study period. Open and endovascular tibial interventions were performed in 7.9% and 7.8% of ambulatory and inpatient IC interventions, respectively. Tibial bypasses were performed in 8.2% of all open IC interventions. CONCLUSIONS: There has been shorter time to intervention in the treatment of younger, commercially insured patients with IC, with many receiving multiple interventions. Statin use was low. Ambulatory procedures, especially in office-based/surgical centers, increasingly used atherectomy, which was not observed in inpatient settings.

Outcomes for carotid endarterectomy in nonagenarians.

OBJECTIVE: Carotid endarterectomy (CEA) is a well-established procedure with prospective randomized data demonstrating the benefit of stroke prevention. With the aging of the population, there are limited data published for nonagenarians, especially for asymptomatic stenosis. This study investigated 30-day morbidity and mortality as well as late survival in symptomatic and asymptomatic nonagenarians with severe carotid stenosis undergoing CEA. METHODS: A retrospective review was conducted of a single vascular surgery group's registry involving multiple hospitals between November 1994 and June 2017 for all primary CEAs of patients ≥90 years old at the time of surgery. The exclusion criterion was redo surgery or bilateral CEAs. Demographic data, sex, symptoms, risk factors, and postoperative complications were analyzed. Survival analysis was conducted using SPSS software (IBM Corp, Armonk, NY) for the specific end point 30-day morbidity or mortality and late survival. RESULTS: There were 77 patients (44 male [57%]) who underwent CEA for symptomatic (44 [57%]) and asymptomatic (33 [43%]) internal carotid artery stenosis with a median age of 92 years; 23 women were symptomatic compared with 21 men, and 23 men were asymptomatic compared with 10 women. Symptomatic patients included amaurosis fugax (n = 3), stroke (n = 16), and transient ischemic attack (n = 25). CEAs were performed using the eversion technique under cervical block with selective shunting. The 30-day morbidity included one (2.3%) nonfatal myocardial infarction and one (2.3%) ischemic stroke in the symptomatic group compared with one (3%) patient having a nonfatal myocardial infarction and none with ischemic stroke in the asymptomatic group. One patient of the symptomatic group required return to the operating room for hematoma evacuation. The 30-day mortality was 2.3% in the symptomatic group compared with 6.1% in the asymptomatic group. There was no statistical difference in survival based on sex (P = .444). The symptomatic and asymptomatic groups had similar median survival of 27.7 months and 29.4 months (P = .987), respectively. CONCLUSIONS: The aging population adds increasing difficulty in decision-making for surgical intervention on carotid stenosis. CEA in nonagenarians is associated with reasonably low 30-day rates of ischemic stroke and myocardial infarction in our small study. However, enthusiasm for asymptomatic CEA in this population must be tempered by low survival rates.

Regionalization of Emergent Vascular Surgery for Patients With Ruptured AAA Improves Outcomes.

OBJECTIVE: Safe and efficient endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysm (r-AAA) requires advanced infrastructure and surgical expertise not available at all US hospitals. The objective was to assess the impact of regionalizing r-AAA care to centers equipped for both open surgical repair (r-OSR) and EVAR (r-EVAR) by vascular surgeons. METHODS: A retrospective review of all patients with r-AAA undergoing open or endovascular repair in a 12-hospital region. Patient demographics, transfer status, type of repair, and intraoperative variables were recorded. Outcomes included perioperative morbidity and mortality. RESULTS: Four hundred fifty-one patients with r-AAA were treated from 2002 to 2015. Three hundred twenty-one patients (71%) presented initially to community hospitals (CHs) and 130 (29%) presented to the tertiary medical center (MC). Of the 321 patients presenting to CH, 133 (41%) were treated locally (131 OSR; 2 EVAR) and 188 (59%) were transferred to the MC. In total, 318 patients were treated at the MC (122 OSR; 196 EVAR). At the MC, r-EVAR was associated with a lower mortality rate than r-OSR (20% vs 37%, P = 0.001). Transfer did not influence r-EVAR mortality (20% in r-EVAR presenting to MC vs 20% in r-EVAR transferred, P > 0.2). Overall, r-AAA mortality at the MC was 20% lower than CH (27% vs 46%, P < 0.001). CONCLUSIONS: Regionalization of r-AAA repair to centers equipped for both r-EVAR and r-OSR decreased mortality by approximately 20%. Transfer did not impact the mortality of r-EVAR at the tertiary center. Care of r-AAA in the US should be centralized to centers equipped with available technology and vascular surgeons.

Anatomic characteristics of abdominal aortic aneurysms presenting with delayed rupture after endovascular aneurysm repair.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the mainstay of treatment for abdominal aortic aneurysms (AAAs) requiring repair. Delayed rupture after EVAR represents a rare but potentially fatal complication. The purpose of this study was to review the frequency and characteristics of patients presenting with secondary rupture and to define the relationship between rupture after EVAR and initial compliance with instructions for use (IFU). METHODS: This is a retrospective study of a prospectively maintained database. Patients presenting with delayed rupture after EVAR were identified from January 2002 to December 2014. Medical records and imaging were reviewed to define anatomic characteristics and compliance with IFU criteria. Demographics, comorbidities, preoperative imaging, and long-term outcomes were analyzed. Patients were divided into two groups according to compliance with IFU criteria. Outcomes included type of repair (open vs secondary endovascular) as well as perioperative morbidity and mortality. RESULTS: A total of 3081 patients underwent EVAR for AAA from 2002 to 2014. Of the 3081 patients, 45 experienced delayed rupture after EVAR. The mean time interval between initial repair and rupture was 38 months. All patients with delayed ruptures had a type Ia endoleak. Mean follow-up after secondary repair was 44.1 months, and overall mortality was 6.7% (n = 3). Patients were divided in two groups according to compliance with IFU criteria: within the IFU and outside the IFU. There was no significant difference in comorbidities between the two groups except smoking, which was more frequent in the outside the IFU group (25% vs 21%; P = .03). Patients repaired outside the IFU had a higher incidence of type Ia endoleak before presenting with a rupture (44% vs 6%; P = .001), more frequently required open repair (44% vs 12%; P = .002), and had higher perioperative mortality (10.3% vs 0%; P = .01). On review of preoperative computed tomography scans, the outside the IFU group had larger aneurysm sac diameters (7.2 vs 5.6 cm; P = .04), larger proximal neck diameters (28 vs 24 mm; P = .01), shorter proximal necks (12 vs 21 mm; P = .007), and a higher degree of neck angulation >40 degrees (56 vs 11%; P < .001). CONCLUSIONS: Delayed rupture after EVAR is a rare but potentially fatal complication. In patients presenting with secondary rupture, EVAR performed outside the IFU was associated with higher perioperative mortality and need for open repair. Careful selection of patients based on AAA anatomy and adherence to the IFU criteria may reduce the incidence of delayed rupture.

Chronic mesenteric ischemia outcome analysis and predictors of endovascular failure.

OBJECTIVE: Outcomes of open revascularization (OR) and endovascular revascularization (ER) for chronic mesenteric ischemia (CMI) were analyzed to identify predictors of endovascular failure. METHODS: A retrospective study was performed of all consecutive patients with CMI (161 patients, 215 vessels) treated from 2008 to 2012. Demographics, comorbidities, clinical presentation, etiology, and treatment modalities were compared. Outcomes included technical success, restenosis requiring reintervention, complications, mortality, and hospital length of stay. RESULTS: There were 116 patients who were first treated with ER (72%) and 45 patients with OR (28%). Overall mortality was 6.8% (11/161). Among the ER patients, 27 developed restenosis and required OR (23%). Patients treated with ER were older (73 vs 66 years; P = .014), had similar comorbidities, and had higher rate of short lesions (≤2 cm) on preoperative angiograms (23% vs 47%; P = .004). Primary patency at 3 years was higher in the OR group compared with the ER group (91% vs 74%; P = .018). Long-term survival rates were higher in the ER group (95% vs 78%; P = .003). Hospital length of stay and intensive care unit length of stay were shorter in the ER group (<.001). Perioperative mortality (30-day) was not statistically significant between the groups (5.2% vs 11%; P = .165). A subgroup analysis was performed between the patients with successful ER and failure of ER requiring OR. Patients with failure of ER had significantly higher rates of aortic occlusive disease (86% vs 49%; P = .005) and long lesions ≥2 cm on angiography (57% vs 12%; P < .001) that were close to the mesenteric takeoff. Perioperative mortality was higher in the ER failure group (15% vs 2%; P = .009). CONCLUSIONS: ER has similar perioperative mortality and shorter hospitalization but higher rate of restenosis requiring reintervention compared with OR. Patients with ER who required reintervention appear to have longer lesions as well as higher rates of aortic occlusive disease on preoperative angiography. Patients who crossed over from ER to OR had higher perioperative mortality than either primary open or endovascular patients. These findings may guide treatment selection in patients with CMI undergoing ER or OR.