Impact of routine surveillance duplex ultrasound and subsequent reintervention after superficial femoral artery stenting.

OBJECTIVE: Superficial femoral artery (SFA) stenting is a common treatment for peripheral artery disease. It is effective in the short term; however, in-stent restenosis (ISR) limits long-term success. Surveillance with duplex ultrasound (DUS) can identify patients who develop ISR leading to early reintervention, but data to support this practice is sparce. The purpose of this study was to evaluate whether surveillance and subsequent reintervention improves outcomes in patients with SFA stents. METHODS: A single-center, retrospective study was performed with patients undergoing SFA stenting between 2005 and 2020 who had a follow-up with DUS. Five groups were identified based on the presence of ISR on DUS (ISR vs no ISR [NISR]), recurrence of symptoms (symptomatic [SX] vs asymptomatic [ASX]), and if any reintervention was performed (reintervention [R] vs no reintervention [NR]): (1) ISR+SX+R; (2) ISR+SX+NR; (3) ISR+ASX+R; (4) ISR+ASX+NR; and (5) NISR+NR. The primary endpoint was amputation-free survival, and the secondary endpoint was patency. Predictors of mortality and surveillance were identified by multivariable logistic regressions and Cox multivariate regression models. Survival curves were presented as Kaplan-Meier plots using log-rank test for subgroup comparison. RESULTS: Two hundred fifty-seven patients were included in the analysis. The indication for intervention was claudication in 28% and chronic limb-threatening ischemia in 72%. A total of 161 patients (63%) underwent reintervention for ISR. Of patients who had restenosis on DUS, those who were symptomatic and did not undergo reintervention (ISR+SX+NR) did the worst, with 50% amputation rate. In contrast, those who were asymptomatic but did undergo reintervention (ISR+ASX+R) had the lowest amputation rate of 13%. Active smoking was a predictor of both loss of patency and amputation (1.72; 95% confidence interval [CI], 1.00-2.98; P = .050; 3.55; 95% CI, 1.53-8.25; P = .003). Post procedure dual antiplatelet therapy had a positive association with limb salvage (hazard ratio [HR], 0.23; 95% CI, 0.09-0.58; P = .001), whereas diabetes (HR, 2.61; 95% CI, 1.21-6.01; P = .019), stent occlusion (HR, 17.0; 95% CI, 5.93-63.1; P < .001), and chronic limb-threatening ischemia presentations (HR, 4.31; 95% CI, 1.86-11.7; P=.002) were negatively associated with limb salvage. CONCLUSIONS: Routine surveillance DUS and subsequent reintervention on ISR after SFA stenting is associated with improved patency and amputation-free survival. Surveillance DUS should be routine for patients after stenting, with reintervention strongly considered if ISR is identified for both symptomatic and asymptomatic.

The addition of a leaded arm sleeve to leaded aprons further decreases operator upper outer quadrant chest wall radiation dose during fluoroscopically guided interventions.

OBJECTIVE: Breast cancer most commonly occurs in the upper outer quadrant (UOQ) chest wall (CW). The effectiveness of routine leaded aprons to protect this region of the body in interventionalists during fluoroscopically guided interventions (FGIs) is unknown. Given the high lifetime attributable risks of prolonged occupational exposure to ionizing radiation and the increasing number of practicing female vascular surgeons and interventionalists, we sought to determine if the use of a leaded arm shield would offer additional protection to the lateral CW and axilla in operators compared with routine leaded aprons. METHODS: Effectiveness of leaded sleeves in attenuating radiation dose to the axilla and UOQ was evaluated in clinical practice and simulated scenarios. In the clinical setting, optically stimulated luminescence nanoDot detectors were placed at the UOQ lateral CW position, both over and under a standard leaded apron vest with and without the addition of an antimony/bismuth Enviro-Lite sleeve on two vascular surgeons performing FGIs. In the simulation, nanoDots were similarly placed on an anthropomorphic phantom positioned to represent a primary operator performing right femoral access. Fluorography was performed on 12-inch-thick acrylic scatter phantom at 80 kVp for an exposure of 3 Gy reference air kerma. Experiments were done with and without the sleeve. Paired Wilcoxon and χ2 tests were performed to identify the statistical significance of radiation attenuation. RESULTS: Operator UOQ CW dose was measured during 61 FGIs: 33 cases (54%) with and 28 cases (46%) without the sleeve. Median procedure reference air kerma and fluoroscopy time was 180 mGy (interquartile range [IQR], 85-447 mGy) and 21 minutes (IQR, 11-39 minutes) when the sleeve was worn vs 100 mGy (IQR, 67-270 mGy) and 11 minutes (IQR, 6.3-25 minutes) without the sleeve. Radiation dose to the operator's UOQ was reduced by 96% (IQR, 85%-96%) when the sleeve was present and by 62% (IQR, 44%-82%; P < .001) without the sleeve. In the simulated setting, the sleeve reduced the radiation dose to the UOQ compared with the apron alone (96% vs 67%; P < .001). CONCLUSIONS: Routine leaded aprons do attenuate the majority of UOQ chest wall radiation dose; however, the addition of a lead-equivalent sleeve further significantly reduces this dose. Because this area of the body has a high incidence of cancer formation, additional protection, especially to female interventionalists, seems prudent. Vascular surgeons should consider using a protective sleeve with their personal protective equipment when performing complex fluoroscopically guided procedures.

Impact of head and neck radiation on long-term outcomes after carotid revascularization.

OBJECTIVE: Radiation-induced carotid artery stenosis (RICS) is a well-described phenomenon seen after head and neck cancer radiation. Previously published literature suggests that, compared with atherosclerotic disease, RICS may result in worse long-term outcomes and early restenosis. This study aims to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques using a multi-center registry database. METHODS: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry for carotid artery intervention (carotid endarterectomy [CEA]; transfemoral carotid artery stenting [CAS]; transcarotid artery revascularization [TCAR]), who are 65 years or older were included in the study. VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Medicare-linked database was used to obtain long-term procedure-specific outcomes. Primary endpoints were 3-year death, stroke, and reintervention. We performed propensity matching between patients with prior radiation and those without. Kaplan-Meier analysis and a multivariate logistic regression model were used to analyze the outcome variables. RESULTS: A total of 56,472 patients had undergone carotid revascularization (CEA, n = 48,307; TCAR, n = 4593; CAS, n = 3572), 1244 patients with prior radiation and 54,925 patients without prior radiation. The prior radiation group was more likely to be male (71.9% vs 60.3%; P < .01), to receive a stent (47.5% vs 13.5%; P < .01), and to be on P2Y12 inhibitor (55.2% vs 38.3%; P < .01). Propensity matching was performed on 1223 patients (CEA, n = 655; TCAR, n = 292; CAS, n = 287). There were no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events for all three procedures. The prior radiation group had higher rates of cranial nerve injury (3.7% vs 1.8%; P = .04) and 90-day readmission (23.5% vs 18.3%; P = .01) after CEA. For long-term outcomes, prior radiation significantly increased mortality risk for CEA and CAS (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.38-2.27 and HR, 1.56; 95% CI, 1.02-2.36, respectively). The 3-year risk of stroke for CEA in radiated patients was also significantly higher (HR, 1.47; 95% CI, 1.03-2.09) compared with non-radiated patients. Prior radiation did not significantly affect death and stroke in patients undergoing TCAR. Prior radiation also did not impact the rates of short and long-term reintervention after CEA, CAS, or TCAR. CONCLUSIONS: Prior head and neck radiation significantly increases the risk for mortality and stroke for CEA and the risk for mortality after CAS. Long-term outcomes for TCAR are not significantly affected by prior radiation. TCAR may be the preferred treatment modality for patients with radiation-induced carotid stenosis.

Impact of chronic kidney disease and end-stage renal disease on outcomes after complex endovascular and open aortic aneurysm repair.

OBJECTIVE: Chronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular aortic repair (EVAR) and open aneurysm repair (OAR) of abdominal aortic aneurysms (AAAs). However, there needs to be more data on complex AAA repair involving the aorta's visceral segment. This study stratifies complex AAA repair outcomes by CKD severity and dialysis dependence. METHODS: All patients undergoing elective OAR and fenestrated/branched EVAR (F-BEVAR) for complex AAA with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: normal/mild (CKD 1 and 2), moderate (CKD class 3a), moderate to severe (CKD 3b), severe (CKD class 4 and 5), and dialysis. Only patients with clamp sites above one of the renal arteries were included for complex OAR. For F-BEVAR, patients with proximal landing zones below zone 5 (above celiac artery) were included, and distal landing zones between zones 1 and 5 were excluded. Primary outcomes were perioperative and 1-year mortality. Predictors of mortality were identified by Cox multivariate regression models. RESULTS: We identified 7849 elective complex AAA repairs: 4230 (54%) complex OARs and 3619 (46%) F-BEVARs. Most patients were White (89%) and male (74%), with an average age of 72 ± 8 years. The patients who underwent F-BEVAR were older and had more comorbidities. Elective F-BEVAR for complex AAA started in 2012 and increased from 1.4% in 2012 to 58% in 2020 (P < .001). The OAR cohort had more perioperative complications, but less 1-year mortality. The normal/mild CKD cohort had the highest 1-year survival compared with other groups after both complex OAR and F-BEVAR. On Cox regression analysis, when compared with CKD 1-2, worsening CKD stage (CKD 3b: hazard ratio [HR], 2.5; 95% confidence interval [CI], 1.82-3.40; P < .001; CKD 4-5: HR, 1.9; 95% CI, 1.16-3.26; P = .011; and dialysis: HR, 4.4; 95% CI, 2.53-7.72; P < .001) were independently associated with 1-year survival after F-BEVAR. After complex OAR, worsening CKD stage but not dialysis was associated with 1-year mortality compared with CKD 1-2 (CKD 3b: HR, 1.6; 95% CI, 1.13-2.35; P = .009; CKD 4-5: HR, 3.4; 95% CI, 2.03-5.79; P < .001). CONCLUSIONS: CKD severity is an essential predictor of perioperative and 1-year mortality after complex AAA repair, irrespective of the treatment modality, which may reflect the natural history of CKD. Consideration should be given to raising the threshold for elective AAA repair in patients with moderate to severe CKD and end-stage renal disease, given the high 1-year mortality rate.

Outcomes of carotid stenting in patients with fibromuscular dysplasia.

OBJECTIVE: Fibromuscular dysplasia (FMD) is a noninflammatory arterial disease that affects the extracranial carotid arteries in young patients. The ideal treatment of FMD has continued to be debated, and the role of carotid artery stenting (CAS) is controversial. The aim of the present study was to assess the feasibility and outcomes of CAS for patients with FMD. METHODS: A retrospective analysis of patients who had undergone CAS was performed using the Vascular Quality Initiative database from December 2012 to May 2021. Patients who had undergone CAS for atherosclerosis and FMD were included and matched 1:1 by age, gender, and clinical presentation. The demographics, clinical parameters, and procedural data were analyzed. The end points included postoperative stroke and transient ischemic attack (TIA), and adverse events (perioperative and 1-year mortality, neurologic changes, access site complications, hematoma or bleeding, infection, congestive heart failure, arrhythmia, myocardial infarction, reperfusion symptoms), and hospital length of stay. RESULTS: After matching, 55 patients had undergone CAS for FMD (mean age, 58.7 ± 14 years; 62% women; 69% White; mean body mass index, 28 ± 6 kg/m2). Most of these procedures (69%) were elective. The FMD group had had a lower rate of hypertension (55% vs 82%; P = .002), smoking (35% vs 80%; P < .001), diabetes (13% vs 45%; P < .001), and coronary artery disease (9% vs 45%; P < .001) compared with the non-FMD group. In the FMD group, prior TIA and stroke was identified in 39 (71%) and 31 (57%) patients, respectively. The mean interval from a prior stroke or TIA to the index surgery was 160 days. Additionally, 23 patients (42%) had had anatomically high lesions above the level of the second cervical vertebra. In the FMD group, the transfemoral approach was used for 43 patients (78%), with distal embolic protection used for 40 patients (93%). Flow reversal was used for nine patients (23%). Most cases were performed with local anesthesia (58%). Three patients (6%) in the FMD group had had access site complications that were managed nonoperatively. No differences were found between the FMD and non-FMD groups in perioperative stroke, TIA, or 30-day mortality. The length of stay was similar between the two groups, and the 1-year survival was 100% for both groups. All the patients in the FMD group were discharged without neurologic complications, and 50 patients (91%) were receiving dual antiplatelet therapy. The median follow-up was 328 days (interquartile range, 1-732 days) with no mortality or reinterventions during follow-up. CONCLUSIONS: CAS for FMD is a feasible and safe procedure with favorable technical success, a low incidence of neurologic complications, and good clinical outcomes at 1 year of follow-up.

Chronic kidney disease impacts outcomes after abdominal aortic aneurysm repair.

OBJECTIVE: Chronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular and open repair of abdominal aortic aneurysm (AAA). This study stratifies outcomes of AAA repair by approach, CKD severity, and dialysis dependence. METHODS: All patients undergoing elective infrarenal open aneurysm repair (OAR) and endovascular aortic repair (EVAR) with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: CKD stages 1 and 2, CKD stage 3a, CKD stage 3b, CKD stages 4 and 5, and dialysis. Primary outcomes were perioperative and 1-year mortality. Predictors of survival were identified by Cox multivariate regression models. RESULTS: In total, 53,867 elective AAA repairs were identified: 5396 (10%) OARs and 48,471 (90%) EVARs. Most patients were White (90%) and male (81%), with a mean age of 73 ± 9 years. Patients who underwent EVAR were older and had more comorbidities. The use of elective EVAR for AAA increased from 52% in 2003 to 91% in 2020 (P < .001). The OAR cohort had more perioperative complications and short-term mortality. The CKD 1 and 2 group had the highest 1-year survival compared with the other groups after both OAR and EVAR. On Cox regression analysis, after EVAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.68; P = .13; CKD 3b: HR, 1.74; 95% CI, 1.23-2.45; P < .050; CKD 4-5: HR, 3.23; 95% CI, 2.13-4.88; P < .001), and dialysis (HR, 4.48; 95% CI, 1.90-10.6; P < .001) were independently associated with worse 1-year survival rates. After OAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: HR, 1.08; 95% CI, 0.96-1.20; P = .20; CKD 3b: HR, 1.60; 95% CI, 1.41-1.81; P < .001; CKD 4-5: HR, 2.85; 95% CI, 2.39-3.41; P < .001), and dialysis (HR, 3.79; 95% CI, 3.01-4.76; P < .001) were independently associated with worse 1-year survival rates. CONCLUSIONS: Regardless of the treatment approach, CKD severity is an important predictor of perioperative and 1-year mortality rates after infrarenal AAA repair and may reflect the natural history of CKD. Open repair is associated with high perioperative mortality risk in patients with CKD stages 4 and 5, as well as end-stage renal disease. Individualization of patient decision-making is especially important in patients with a glomerular filtration rate of less than 45 and perhaps consideration should be given to raising the threshold for elective AAA repair in these patients. Further studies focusing on appropriate size threshold for repair in these patients may be warranted.

Redo Fenestrated-Branched Endovascular Aortic Repair (F-BEVAR) for Failed F-BEVAR.

Failed fenestrated-branched endovascular aortic repair (F-BEVAR) requiring a redo F-BEVAR is a rare event. In this study, we report 2 cases of a failed F-BEVAR secondary to a type IIIb endoleak from tears on the fabric graft successfully treated with redo F-BEVAR. This is a technically challenging procedure that requires meticulous planning, advanced imaging technologies and experienced operators. Redo F-BEVAR appears to be a feasible and safe treatment option. However, larger series and long-term follow-up are needed to confirm effectiveness and durability.

Operator Lower Leg Radiation Dose during Fluoroscopically Guided Interventions is Effectively Reduced by Wearing Lead-Equivalent Leg Wraps.

BACKGROUND: The intensity of radiation scatter that emanates from the X-ray beam during fluoroscopically guided interventions is greater below the fluoroscopy table than above. Yet interventionalists' lower legs are typically unshielded and table skirts are often positioned incorrectly. We sought to characterize the efficacy of the leg protector wraps (Leg Wraps, Burlington Medical Inc.) in reducing the radiation dose to the operator's lower leg during fenestrated and branched endovascular aneurysm repair (F-BEVAR). METHODS: A prospective cohort study was performed evaluating the lower leg radiation dose reduction of one vascular surgeon during F/BEVAR using antimony/bismuth Enviro-Lite leg wraps (0.35 mm lead equivalency, 99.7% attenuation at 50 kVp; Burlington Medical, Hampton Roads, Virginia). Optically Stimulated Luminescence nanoDot detectors (microSTARii System, LANDAUER, Inc., Glenwood, Illinois) were placed over and under the left leg wrap at the anterior tibial tuberosity position to compare operator leg dose with and without this additional protection. The table-mounted lead skirt was used consistently in all cases. The nanoDot detectors were cross-calibrated with a survey meter (RaySafe X2 survey sensor, Fluke Biomedical, Cleveland, Ohio) by measuring scattered radiation at a position equivalent to an operator's mid-tibia while performing digital acquisitions of a 25-cm thick, 30 cm × 30 cm acrylic phantom with a Philips FD20 fluoroscope (Philips Healthcare, Best, The Netherlands) with the table skirt removed. The measured radiation doses were converted to a Hp (0.07) skin dose, assuming an RQR6 beam spectrum (IEC-61267). Paired Wilcoxon test was performed to identify significant attenuation of radiation exposure. RESULTS: Leg dose measurements from 40 F-BEVARs were analyzed. The patients had a median (interquartile range) body mass index of 27 (24-32) kg/m2. Median procedure reference air kerma was 1,100 (728-1,601) mGy, kerma-area product was 127 (73-184) Gycm2, and fluoroscopy time was 69 (54-86) min. The median skin dose Hp (0.07) over the leg wraps (n = 40) was 54.2 (24-100) µSv and under the leg wraps (n = 40) was 2.7 µSv (1.0-5.8). The leg wraps attenuated the radiation dose by 95% (89-98%) (P < 0.001). The unprotected, Hp (0.07) per kerma-area product was determined to be 0.38 (0.30-0.55) µSv/Gycm2. CONCLUSIONS: The 0.35-mm lead-equivalent leg wraps significantly decreased scattered radiation to the lower leg during F-BEVAR. Protective leg wraps should be recommended to operators performing complex fluoroscopically guided procedures.

Disposable, lightweight shield decreases operator eye and brain radiation dose when attached to safety eyewear during fluoroscopically guided interventions.

OBJECTIVE: Long-term radiation exposure from fluoroscopically guided interventions (FGIs) can cause cataracts and brain tumors in the operator. We have previously demonstrated that leaded eyewear does not decrease the operator eye radiation dose unless lead shielding has been added to the lateral and inferior portions. Therefore, we have developed a disposable, lightweight, lead-equivalent shield that can be attached to the operator's eyewear that conforms to the face and adheres to the surgical mask. In the present study, we evaluated the efficacy of our new prototype in lowering the operator brain and eye radiation dose when added to both leaded and nonleaded eyewear. METHODS: The attenuating efficacy of leaded eyewear alone, leaded eyewear plus the prototype, and nonleaded eyewear plus the prototype were compared with no eyewear protection in both a simulated setting and clinical practice. In the simulation, optically stimulated, luminescent nanoDot detectors (Landauer, Inc, Glenwood, Ill) were placed inside the ocular, temporal lobe, and midbrain spaces of a head phantom (ATOM model-701; CIRS, Norfolk, Va). The phantom was positioned to represent a primary operator performing right femoral access. Fluorography was performed on a plastic scatter phantom at 80 kVp for an exposure of 3 Gy reference air kerma. In the clinical setting, nanoDots were placed below the operator's eye both inside and outside the prototype during the FGIs. The median and interquartile ranges were calculated for the dose at each nanoDot location for the phantom and clinical studies. The average dose reduction was also recorded. RESULTS: Wearing standard leaded eyewear alone did not decrease the operator ocular or brain radiation dose. In the phantom experiment, the leaded glasses plus the prototype reduced the radiation dose to the lens, temporal lobe, and midbrain by 83% (P < .001), 78% (P < .001), and 75% (P < .001), respectively. The nonleaded glasses plus the prototype also reduced the dose to the lens, temporal lobe, and midbrain by 85% (P < .001), 81% (P < .001), and 71% (P < .001), respectively. A total of 15 FGIs were included in the clinical setting, with a median reference air kerma of 98.4 mGy. The use of our prototype led to an average operator eye dose reduction of 89% (P < .001). CONCLUSIONS: Attaching our prototype to both leaded and nonleaded glasses significantly decreased the eye and brain radiation dose to the operator. This face shield attachment provided meaningful radiation protection and should be considered as either a replacement or an adjunct to routine eyewear.

A single-center experience on the management of pediatric blunt aortic injury.

OBJECTIVE: Blunt abdominal aortic injury in children is a rare clinical entity with which most vascular surgeons have minimal experience. The evidence for management recommendations is limited. We have reported a single institution's experience in the care of pediatric abdominal aortic injuries. METHODS: We performed a retrospective review of consecutive pediatric patients who had been diagnosed with blunt traumatic abdominal aortic injury at our institution from 2008 to 2019. RESULTS: A total of 16 pediatric patients (50% male) were identified. They ranged in age from 4 to 17 years. All had been involved in motor vehicle collisions and had been restrained passengers with a seatbelt in use. Five patients (31%) were hypotensive en route or on arrival. Seven patients (44%) had been transferred from another hospital. The median injury severity score was 34 (interquartile range, 19-35). The infrarenal aortic injuries were stratified using the aortic injury grading classification (five, two, seven, and two with grade 1, 2, 3, and 4, respectively). Concurrent nonaortic injuries included solid organ (63%; n = 10), hollow viscus (88%; n = 14), brain (25%; n = 4), hemothorax or pneumothorax (25%; n = 4), spine fractures (81%; n = 13), and nonspine fractures (75%; n = 12). Of the 16 patients, 9 (56%) had required aortic repair. Three had required immediate revascularization for distal ischemia. The remaining six patients (38%) had undergone delayed repair, with a median interval to repair of 52 days (range, 2-916 days). One half of the delayed repairs were performed during the index hospitalization. On repeat axial imaging, the three patients who had undergone delayed repair were found to have enlarging pseudoaneurysms or flow-limiting dissections and had subsequently undergone repair during the index hospitalization. Only one patient had undergone endovascular repair. No deaths occurred, and the median follow-up was 7 months (interquartile range, 3-28 months) for our study population. All postoperative patients demonstrated stable imaging findings without requiring further intervention. Seven patients, whose injury grades had ranged from 1 to 3, were observed. Their repeat imaging studies demonstrated either stability or resolution of their aortic injury. However, one half of the patients had been lost to follow-up after discharge or after their first postoperative clinic visit. CONCLUSIONS: Delayed aortic intervention can be safely performed for most pediatric patients with blunt abdominal aortic injuries with preserved distal perfusion to the lower extremities. This finding suggests that transfer to a tertiary center with vascular expertise is a safe and feasible management strategy. However, the progression of aortic injuries was seen as early as within 48 hours and as late as 30 months after injury, underscoring the importance of long-term surveillance. However, in our cohort, 50% of the children were lost to follow-up, highlighting the need for a more structured surveillance strategy.

New imaging technology system reduces patient radiation dose during peripheral arterial endovascular interventions.

BACKGROUND: Radiation exposure and imaging quality are among the main concerns in endovascular procedures. The Clear VD11 PURE platform technology system (Siemens Healthineers, Erlangen, Germany) has been reported to lower the radiation dose and improve image quality. In the present study, we evaluated whether the radiation dose during peripheral arterial endovascular procedures had decreased after implementation of this new imaging system. METHODS: The patient characteristics (age, gender, body mass index [BMI]), procedure type (diagnostic, balloon angioplasty, atherectomy, stenting), body location (aortoiliac, superficial femoral artery, tibial artery), reference air kerma (RAK), kerma area product (KAP), and fluoroscopy time (FT) were recorded during peripheral artery interventions performed 1 year before (group A) and 1 year after (group B) the CLEAR system upgrade. The procedures were performed in an Artis zeego hybrid room (Siemens Healthineers) with the same providers. A general linear model was used to estimate the average difference between groups adjusted by procedure type and patient age, gender, and BMI. Additionally, to control for variations in case complexity, groups A and B were matched by age, gender, BMI, lesion location, and intervention type. Propensity score matching and a paired t test were used to compare the KAP, RAK, and FT stratified by single intervention procedures. RESULTS: A total of 487 endovascular procedures were performed: 209 in group A and 278 in group B. A total of 111 single intervention procedures from each group were matched (1:1), with a mean age of 61 ± 8 years and a BMI of 26.5 ± 4 kg/m2. The median KAP, RAK, and FT for group A were 28.8 Gy · cm2 (interquartile range [IQR], 24-34 Gy · cm2), 146 mGy (IQR, 123-173 mGy), and 12 minutes (IQR, 10-14 minutes), respectively. The median KAP, RAK, and FT for group B were 18.3 Gy · cm2 (IQR, 16-22 Gy · cm2), 71.2 mGy (IQR, 60-85 mGy), and 10.4 minutes (IQR, 9-12 minutes), respectively. The KAP, RAK, and FT were significantly decreased in group B by 24% (P = .005), 41% (P < .001), and 22% (P = .002), respectively, compared with the values for group A. Stratified by single intervention procedures, the KAP and RAK had decreased significantly in group B (36% [P = .002] and 51% [P < .001], respectively) compared with group A. The FT decrease of 13% in group B was not statistically significant (P = .20). CONCLUSIONS: Use of the Clear VD11 PURE platform system (Siemens Healthineers) reduced the patient radiation dose by 51% during endovascular peripheral interventions. The similar FTs for the matched single intervention procedures before and after the upgrade indicated consistent case complexity and surgeon practice. This platform appears to be an effective system for lowering the radiation dose.

Perioperative neurologic outcomes of right versus left upper extremity access for fenestrated-branched endovascular aortic aneurysm repair.

OBJECTIVE: Upper extremity (UE) access is frequently used for fenestrated-branched endovascular aortic aneurysm repair (F-BEVAR), particularly for complex repairs. Traditionally, left-side UE access has been used to avoid crossing the arch and the origin of the supra-aortic vessels, which could potentially result in cerebral embolization and an increased risk of perioperative cerebrovascular events. More recently, right UE has been more frequently used as it is more convenient and ergonomic. The purpose of this study was to assess the outcomes and cerebrovascular events after F-BEVAR with the use of right- vs left-side UE access. METHODS: During an 8-year period, 453 patients (71% male) underwent F-BEVAR at a single institution. UE access was used in more complex repairs. Left UE access was favored in the past, whereas right UE access is currently the preferred UE access side. Brachial artery cutdown was used in all patients for the placement of a 12F sheath. Outcomes were compared between patients undergoing right vs left UE access. End points included cerebrovascular events, perioperative mortality, technical success, and local access-related complications. RESULTS: UE access was used in 361 (80%) patients. The right side was used in 232 (64%) and the left side in 129 (36%) patients for the treatment of 88 (25%) juxtarenal, 135 (38%) suprarenal, and 137 (38%) thoracoabdominal aortic aneurysms. Most procedures were elective (94%). Technical success was achieved in 354 patients (98%). In-patient or 30-day mortality was 3.3%. Five (1%) perioperative strokes occurred in patients undergoing right UE access, of which three were ischemic and two were hemorrhagic. No transient ischemic attacks occurred perioperatively. Two hemorrhagic strokes were associated with permissive hypertension to prevent spinal cord ischemia. No perioperative strokes occurred in patients undergoing left UE access (P = .16). Overall, perioperative strokes occurred with similar frequency in patients undergoing UE (5, 1%) and femoral access only (1, 1%) (P = .99). Arm access-related complications occurred in 15 (5%) patients, 11 (4.8%) on the right side and 4 (6%) on the left side (P = .74). CONCLUSIONS: Right UE access can be used for F-BEVAR with low morbidity and minimal risk of perioperative ischemic stroke or transient ischemic attacks. In general, UE access is not associated with an increased risk of perioperative stroke compared with femoral access only. Tight blood pressure control is, however, critical to avoid intracranial bleeding related to uncontrolled hypertension.

Endovascular Aortic Repair in Patients of Advanced Age.

PURPOSE: Treatment decisions for the elderly with abdominal aortic aneurysms (AAAs) are challenging. With advancing age, the risk of endovascular aneurysm repair (EVAR) increases while life expectancy decreases, which may nullify the benefit of EVAR. The purpose of this study was to quantify the impact of EVAR on 1-year mortality in patients of advanced age. MATERIALS AND METHODS: The 2003-2020 Vascular Quality Initiative Database was utilized to identify patients who underwent EVAR for AAAs. Patients were included if they were 80 years of age or older. Exclusions included non-elective surgery or missing aortic diameter data. Predicted 1-year mortality of untreated AAAs was calculated based on a validated comorbidity score that predicts 1-year mortality (Gagne Index, excluding the component associated with AAAs) plus the 1-year aneurysm-related mortality without repair. The primary outcome for the study was 1-year mortality. RESULTS: A total of 11 829 patients met study criteria. The median age was 84 years [81, 86] with 9014 (76.2%) being male. Maximal AAA diameters were apportioned as follows: 39.6% were <5.5 cm, 28.6% were 5.5-5.9 cm, 21.3% were 6.0-6.9 cm, and 10.6% were ≥7.0 cm. The predicted 1-year mortality rate without EVAR was 11.9%, which was significantly higher than the actual 1-year mortality rate with EVAR (8.2%; p<0.001). The overall rate of perioperative MACE was 4.4% (n = 516). Patients with an aneurysm diameter <5.5cm had worse actual 1-year mortality rates with EVAR compared to predicted 1-year mortality rates without EVAR. In contrast, those with larger aneurysms (≥5.5cm) had better actual 1-year mortality rates with EVAR. The benefit from EVAR for those with Gagne Indices 2-5 was largely restricted to those with AAAs ≥ 7.0cm; whereas those with Gagne Indices 0-1 experience a survival benefit for AAAs larger than 5.5 cm. CONCLUSION: The current data suggest that EVAR decreases 1-year mortality rates for patients of advanced age compared to non-operative management in the elderly. However, the survival benefit is largely limited to those with Gagne Indices 0-1 with AAAs ≥ 5.5 cm and Gagne Indices 2-5 with AAAs ≥ 7.0 cm. Those of advanced age may benefit from EVAR, but realizing this benefit requires careful patient selection.

Renal Artery Aneurysms in the Inpatient Setting.

BACKGROUND: The risk of rupture of renal artery aneurysms (RAAs) remains undefined. A recent paper from the Vascular Low-Frequency Disease Consortium (VLFDC) identified only 3 ruptures in 760 patients. However, over 80% of patients in the VLFDC study were treated at large academic centers, which may not reflect the pattern of care of RAAs nationwide. Thus, the purpose of this study was to evaluate the pattern of nonelective versus elective surgery requiring inpatient admission for RAAs, including nephrectomies, and their outcomes using a national database. METHODS: The National Inpatient Sample (NIS) database from 2012 to 2018 was utilized. Patients with a primary diagnosis of RAAs were identified using ICD-9 and ICD-10 codes. Ruptured RAAs (rRAAs) were identified utilizing surrogate ICD codes. The primary outcome variables for this study were proportion of RAAs requiring non-elective surgery and in-hospital mortality. RESULTS: A total of 590 inpatient admissions for RAA were identified with 554 procedures at 467 hospitals across the country. Of the 590 inpatient admissions, 380 (64.4%) admissions were deemed nonelective. There was an increasing proportion of nonelective admissions over the study period. The overall rate of nephrectomies was 7.1% (n = 42). In-hospital mortality rate for the cohort was 1.4% (n = 8) with no differences in in-hospital mortality in the elective versus nonelective setting (1.0% vs. 1.6%; P = 0.718). In the nonelective setting, patients requiring a nephrectomy (n = 23) had significantly higher rates of in-hospital mortality compared those not requiring a nephrectomy (8.7% vs. 1.1%, P = 0.045). rRAA (n = 50) patients had significantly higher in-hospital mortality compared to the remainder of the cohort (6.0% vs. 0.9%, P = 0.024). rRAA patients were also more likely to undergo a nephrectomy compared to the remainder of the cohort (16.0% vs. 6.3%, P = 0.019). CONCLUSIONS: These data demonstrate that treatment of RAAs are primarily done in the nonelective setting with a high proportion of ruptures, which could continue to rise as the threshold for repair has decreased.

Dual fluoroscopy with live-image digital zooming significantly reduces patient and operating staff radiation during fenestrated-branched endovascular aortic aneurysm repair.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (F/B-EVAR) is a complex procedure that generates high radiation doses. Magnification aids in vessel cannulation but increases radiation. The aim of the study was to compare radiation doses to patients and operating room staff from two fluoroscopy techniques, standard magnification vs dual fluoroscopy with live-image digital zooming during F/B-EVAR. METHODS: An observational, prospective, single-center study of F/B-EVAR procedures using Philips Allura XperFD20 equipment (Philips Healthcare, Amsterdam, The Netherlands) was performed during a 42-month period. Intravascular ultrasound, three-dimensional fusion, and extreme collimation were used in all procedures. Intraoperative live-image processing was performed with two imaging systems: standard magnification in 123 patients (81%) and dual fluoroscopy with live-image digital zooming in 28 patients (18%). In the latter, the live "processed" zoomed images are displayed on examination displays and live images are displayed on reference displays. The reference air kerma was collected for each case and represents patient dose. Operating staff personal dosimetry was collected using the DoseAware system (Philips Healthcare). Patient and staff radiation doses were compared using nonparametric tests. RESULTS: Mean age was 71.6 ± 11.4 years. The median body mass index was 27 kg/m2 (interquartile range [IQR], 24.4-30.6 kg/m2) and was the same for both groups. Procedures performed with dual fluoroscopy with digital zooming demonstrated significantly lower median patient (1382 mGy [IQR, 999-2045 mGy] vs 2458 mGy [IQR, 1706-3767 mGy]; P < .01) and primary operator radiation doses (101 µSv [IQR, 34-235 µSv] vs 266 µSv [IQR, 104-583 µSv]; P < .01) compared with standard magnification. Similar significantly reduced radiation doses were recorded for first assistant, scrub nurse, and anesthesia staff in procedures performed with dual fluoroscopy. According to device design, procedures performed with four-fenestration/branch devices generated higher operator radiation doses (262 µSv [IQR, 116.5-572 µSv] vs 171 µSv [IQR, 44-325 µSv]; P < .01) compared with procedures with three or fewer fenestration/branches. Among the most complex design (four-vessel), operator radiation dose was significantly lower with digital zooming compared with standard magnification (128.5 µSv [IQR, 70.5-296 µSv] vs 309 µSv [IQR, 150-611 µSv]; P = .01). CONCLUSIONS: Current radiation doses to patients and operating personnel are within acceptable limits; however, dual fluoroscopy with live-image digital zooming results in dramatically lower radiation doses compared with the standard image processing with dose-dependent magnification. Operator radiation doses were reduced in half during procedures performed with more complex device designs when digital zooming was used.

Effects of preoperative visceral artery stenosis on target artery outcomes after fenestrated/branched endovascular aortic aneurysm repair.

OBJECTIVE: Target artery stenosis might affect the outcomes of fenestrated/branched endovascular aortic aneurysm repair (F-BEVAR). The aim of the present study was to assess the effects of preoperative stenosis of the celiac artery (CA) and superior mesenteric artery (SMA) on the target artery outcomes after F-BEVAR. METHODS: During a 4-year period, 287 consecutive patients, 204 men (71%) and 83 women (29%), had undergone F-BEVAR using fenestrated (83%), fenestrated-branched (4.5%), branched (3.5%), and off-the-shelf t-Branch (9%) devices (Cook Medical Inc, Bloomington, Ind). Preoperative SMA and CA significant stenosis was defined as a computed tomography angiography-based intraluminal diameter reduction >50%. The primary endpoints included primary patency, freedom from target vessel instability, and patient survival. RESULTS: The median patient age was 71 years (interquartile range, 67-77 years). Suprarenal (36%), juxtarenal (25%), and thoracoabdominal (39%) aortic aneurysms were treated. The technical success rate was 99%. The 30-day survival was 97%. Among 981 stented vessels, 179 (18%) were CAs and 270 (27.5%) were SMAs. Significant preoperative CA stenosis was identified in 39 patients (22%) and SMA stenosis in 24 (9%). The median follow-up was 29.9 months. The primary patency rates at 12, 36, and 60 months were 98%, 92%, and 92% for the CA and 99%, 98%, and 98% for the SMA, respectively. Primary patency was significantly lower in the patients with previous significant CA stenosis than in those without stenosis (83%, 83%, and 76% vs 100%, 100%, and 97% at 12, 36, and 60 months, respectively; P < .01). Freedom from celiac branch instability was also significantly lower among patients with significant stenosis (84%, 84%, and 76% vs 100%, 93%, and 93% at 12, 36, and 60 months; P < .01). The presence of significant SMA stenosis did not affect either primary patency or freedom from target vessel instability. The survival rates at 12, 36, and 60 months were significantly lower for the patients with CA stenosis than for those without stenosis (67%, 61%, and 55% vs 90%, 84%, and 82%, respectively; P < .01). Similarly, lower survival rates were observed for patients with significant SMA stenosis (70%, 60%, and 60% vs 87%, 79%, and 78% at 12, 36, and 60 months, respectively; P = .04). CONCLUSIONS: F-BEVAR was associated with overall primary patency rates >90% for the CA and SMA. Preoperative CA stenosis was associated with lower primary patency and freedom from target vessel instability. In contrast, neither SMA branch primary patency nor freedom from target vessel instability were affected by preoperative SMA stenosis. We found visceral artery stenosis was a marker of atherosclerosis burden associated with reduced mid- and long-term patient survival.

Impact of dual antiplatelet therapy after lower extremity revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke. METHODS: We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT). RESULTS: From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS. CONCLUSIONS: In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS.

Effect of Abdominal Aortic Aneurysm Size on Mid-Term Mortality After Endovascular Repair.

BACKGROUND: Previous studies have suggested that large preoperative AAA size may impact late survival after elective EVAR. It is unclear, however, whether this association applies to patients with smaller AAA between 5.0-5.5 cm, who constitute a substantial portion of patients undergoing elective EVAR. The purpose of this study was to delineate the effect of AAA size between 5.0 and 5.5 cm on mid-term mortality after EVAR by analyzing a large national cohort, the Vascular Quality Initiative (VQI) database. METHODS: Using the Vascular Quality Initiative (VQI) national database, patients who underwent EVAR for intact AAA between 2003 and 2018 were identified and stratified based on maximal AAA diameter into 3 groups: Group 1 (4.0 cm ≤ AAA <5.0 cm); Group 2 (5.0 cm ≤ AAA < 5.5 cm); and Group 3 (AAA ≥ 5.5 cm). Cox proportional hazard model and propensity score matching method were used to estimate AAA size effect on all-cause mortality at 1, 3, and 5 years after EVAR while adjusting for potential confounders. RESULTS: The study included 32,398 patients, of whom 81% were men with a mean age of 74. The most common group who underwent EVAR was Group 2 (5.0 cm ≤ AAA < 5.5 cm). Larger AAA size was associated with male sex (75% versus 79% versus 84%, for Groups 1, 2, and 3 respectively; P < 0.0001) and with coronary artery disease (27% versus 29% versus 31%, for Groups 1, 2, and 3 respectively, P< 0.0001); but was negatively associated with active smoking (33% versus 31% versus 30%, for Groups 1, 2, and 3, respectively, P< 0.001). While 10% of the largest and smallest AAA groups (Groups 3 and 1, respectively) were symptomatic, only 5% of patients in Group 2 were symptomatic (P < 0.01). Adjusted Cox proportional hazard modeling revealed that patients in Group 2 were at significantly lower risk of 5-year mortality when compared to patients in Group 3 (HR 0.66, 95% CI 0.61-0.72, P< 0.01), while similar in risk when compared to patients in Group 1 (HR 1.11, 95% CI 0.93-1.32, P= 0.26). CONCLUSION: Our analysis found that over 40% of EVAR in the national VQI cohort were performed for AAA < 5.5 cm, with the greatest number of patients undergoing EVAR at AAA size 5.0-5.5cm. Patients with AAA size 5.0-5.5 cm had better 5-year survival outcomes than patients with AAA ≥ 5.5 cm, and similar survival to patients with small AAA between 4.0-5.0 cm.

Novel modification to leaded eyewear results in significant operator eye radiation dose reduction.

OBJECTIVE: Ocular radiation exposure from fluoroscopically guided interventions (FGIs) can cause cataracts. Standard lead eyewear may not significantly reduce eye radiation dose as the majority of scattered radiation penetrates the operator's eye obliquely. Our aim was to evaluate the efficacy of standard leaded eyewear and a customized eyewear design in lowering eye radiation dose to vascular surgeons. METHODS: The attenuating efficacy of three forms of leaded eyewear (standard eyewear, eyewear with built-in leaded side shields, and our modified eyewear) was tested in both a simulated setting and clinical practice. The modified design consisted of safety eyewear with 0.75 mm of added lead shielding attached to the lateral and inferior borders of the eyewear frame to attenuate oblique radiation. We performed simulated experiments using an anthropomorphic head phantom (ATOM model 701; CIRS, Norfolk, Va) positioned to represent a primary operator performing right femoral access. Optically stimulated, luminescent nanoDot detectors (Landauer, Glenwood, Ill) were placed inside the phantom's ocular spaces and at the surface of the left eye within and outside the leaded glasses to measure the eye radiation dose reduction provided by each eyewear type. All three eyewear types were also tested during clinical FGIs by placing nanoDots below the operator's left eye, inside and outside of the eyewear coverage. Means and standard errors were calculated using a pooled linear mixed model with repeated measurements. RESULTS: This prospective, single-center study included 60 FGIs, 30 with traditional eyewear and 30 with our modified design. There was no significant eye radiation dose reduction (P > .05) with the standard eyewear or leaded side shield eyewear in both the simulated and clinical settings. In the simulated environment, our modified design resulted in an 86% radiation dose reduction to the surface of the left eye and an 80% reduction in left lens radiation dose (P < .0001). In the clinical FGIs, the modified eyewear led to a 62% left ocular radiation dose reduction (P < .0001). CONCLUSIONS: Standard lead-equivalent glasses are ineffective at reducing ocular radiation dose during FGIs. Eyewear modification with lateral and inferior lead shielding molded to the operator's face significantly decreases radiation exposure to the eye closest to the X-ray source.

Defining the threshold surgeon volume associated with improved patient outcomes for carotid endarterectomy.

OBJECTIVE: The outcomes for common vascular operations, such as carotid endarterectomy (CEA), are associated with surgeon volume. However, the number of operations associated with an improved stroke or death rate for CEA is not known. The objective of the current study was to define the annual surgeon volume of CEAs that is associated with a lower risk of stroke or death rate. METHODS: The Nationwide Inpatient Sample was analyzed to identify patients undergoing CEA between 2003 and 2009. Annual surgeon volume was correlated with a composite end point of in-hospital stroke or death. Mixed linear regression analyses were conducted to determine if annual surgeon volume of CEAs is independent predictor of the composite outcome. Receiver operating characteristic curves were constructed from the regression models and used to calculate the Youden Index, which defined the optimal cutoff point of annual surgeon volume of CEAs in predicting in-hospital stroke and death. This cutoff point was further assessed using Chi square analyses to determine whether incremental increases in the annual volume of CEAs were associated with a lower in-hospital stroke or death rate. RESULTS: A total of 104,918 CEA cases with surgeon identifiers were included in the analysis. The crude in-hospital stroke or death rate for CEA was 1.26 %. As expected, the stroke or death rate after CEA was higher for symptomatic patients, compared to asymptomatic patients (6.46 % vs 0.72%; P < .0001). For symptomatic patients, the relationship between surgeon volume and the composite end point was not significant (P = .435). In contrast, there was a strong relationship between surgeon volume and outcomes for asymptomatic patients undergoing CEA with a stroke/death rate of 1.66%, 0.91%, and 0.65% for low-, moderate-, and high-volume surgeons (P < .0001). Multivariate analysis identified age, African-American race, Charlson Comorbidity Index, and surgeon volume as independent predictors of stroke/death after CEA for asymptomatic carotid stenosis. For asymptomatic patients, the optimal cutoff number of CEAs to predict stroke/death rate was 19.4 CEAs per year (sensitivity = 74.9%, specificity = 72.6%, Youden index = 0.475). Analyses of outcomes at different cutoff points of surgeon volume revealed that the rate of crude complications and the adjusted probability of stroke or death was higher with case numbers less than 20 CEAs per year and lower with case numbers of 20 CEA or higher per year. Cutoff points above 20 cases were year did not yield a stroke/death rate that was significantly lower than the stroke/death rate at 20 CEAs per year, which confirmed the cutoff point of 20 CEAs per year. Only 16% of surgeons in the database achieved the threshold of 20 CEAs per year. CONCLUSIONS: Higher surgeon volume is associated with improved outcomes for CEAs performed in patients with asymptomatic carotid disease, but not for symptomatic carotid disease. For asymptomatic carotid disease, the probability of stroke or death was no longer reduced significantly at cutoff points of 20 or more CEAs per year. There are a number of other variables that may impact the clinical outcomes for CEA, so it is premature at this time to restrict privileges based on surgeon volume criteria.