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This study was undertaken to elicit the opinion of experts regarding the management of iatrogenic injury to the carotid artery. A text questionnaire was transmitted by electronic mail to members of the Western Vascular Society concerning management of iatrogenic injury to the cervical carotid artery. Participants were asked to submit information regarding practice status and their preferred choices for the management of different clinical scenarios. The scenarios were: (1) large bore sheath (> 8.5F) cannulation of the carotid artery in anesthetized patients, (2) large bore sheath cannulation of the carotid artery in an awake patient, (3) delayed recognition of a misplaced sheath by > 4 hours, and (4) arterial puncture was recognized after only the entry needle (16-gauge) was introduced but before sheath insertion. Finally, the members were asked to comment on the management of abnormal findings on duplex scanning, such as intimal flap or pseudoaneurysm. A response rate of 42% was obtained (45/106 active members). Eighty-two percent of respondents had been in practice for longer than 10 years. Eighty-nine percent had seen this complication and 29% had cared for patients in whom subsequent neurologic deficit developed. The institutional incidence of such injury was 1-5 cases per year for 82% of respondents. Sixteen-gauge needle injury was managed by immediate removal and applied pressure by 98% of respondents. When large-bore sheath injury is recognized within 1 hour of insertion, 62% of respondents would remove the sheath and hold pressure, with or without obtaining a duplex ultrasound examination. However, if injury recognition was delayed for > 4 hours, 82% would proceed to surgery. Only 26% operated on asymptomatic carotid flap found on ultrasound, while the remaining 74% would base their decision on size and flow characteristics on ultrasound. The management of pseudoaneurysm differed significantly. Whereas 31% of respondents would manage this finding expectantly, 69% would proceed to surgery regardless of size or symptoms. Despite awareness of iatrogenic injury to the cervical carotid artery, the institutional incidence remains high. Two thirds of respondents would manage a misplaced sheath in the carotid artery nonoperatively if the injury was recognized immediately. However, if injury recognition was delayed for > 4 hours, the majority of respondents would remove the sheath surgically. While the management of intimal flap largely depended on size and flow characteristics, 69% of respondents would operate on a pseudoaneurysm regardless of size or symptoms. The results of this survey may serve as a guideline for the management of this potentially devastating injury. [ABSTRACT FROM AUTHOR]

The arterial and venous volume blood flow in the dominant and nondominant upper extremities of five male pitchers, ages 16 to 21, was measured using color flow duplex ultrasound. Blood-flow measurements were obtained at baseline, after warmup, and after each sequence of 20 pitches until 100 pitches were thrown. Blood flow was additionally determined 1 hour after the last pitch. The velocity of each pitch was recorded with a speed gun. Anthropomorphic measurements of the upper extremity were obtained at baseline and immediately after Pitch 100 using a standard measuring tape. The highest average arterial volume flow in the pitching arm occurred after 40 pitches, reaching a peak of 549 ml/min (56% increase from baseline). Thereafter, the average arterial blood flow steadily declined, reaching an average of 402 ml/min after the 100th pitch (14% increase from baseline). In contrast, the arterial blood flow in the nonpitching arm increased only slightly from baseline, reaching a maximal volume flow of 448 ml/min immediately after the warm-up period (10% increase from baseline). The volume flow then persistently fell to a level 30% below baseline after the 100th pitch. Although this small pilot study does not demonstrate causation between a decline in pitching performance and arterial blood flow, it suggests arterial flow in the dominant extremity falls as the pitch count increases. [ABSTRACT FROM AUTHOR]

Background: Treatment of iliac artery aneurysms (IAAs) with the iliac branch endoprosthesis (IBE) during endovascular repair of infrarenal abdominal aortic aneurysm (endovascular aortic repair (EVAR)) has been well-documented as effective. However, limited data exist evaluating the safety and efficacy of treating complex abdominal (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) with associated IAA with combined physician-modified fenestrated-branched EVAR (PM-FBEVAR) and IBE. Moreover, limited studies exist assessing the impact of adding IBE on the outcomes following PM-FBEVAR. Therefore, we compared the clinical outcomes of patients who underwent PM-FBEVAR with and without IBE for the treatment of cAAA and TAAA., Methods: A single-institution retrospective review of consecutive patients who underwent PM-FBEVAR between September 2015 and February 2021 was conducted. Patients with both unilateral and bilateral IBE implantation were included. Infected aneurysms and pseudoaneurysms were excluded. Demographics, technical success, and operative factors were analyzed. Primary outcomes were incidence of pelvic ischemia including buttock and thigh claudication, bowel and spinal cord ischemia, patency of internal and external limbs of IBE, and target vessel instability. Secondary outcomes included technical success, 30-day major adverse events, 30-day and all-cause mortality, and endoleaks., Results: Among 183 patients identified who underwent PM-FBEVAR, 22 patients underwent PM-FBEVAR and IBE with 3 patients treated with bilateral IBEs. There was no pelvic ischemia in the PM-FBEVAR and IBE group. Technical success, fluoroscopy time, and procedure time were comparable between the 2 groups. Contrast usage was higher in the PM-FBEVAR and IBE group (P = 0.01). Thirty-day major adverse event and mortality were not statistically different between the 2 groups. At a mean follow-up of 23 months, all-cause mortality was similar for both groups (21% vs. 27%; P = 0.47). Patency of internal iliac artery limb and external iliac artery limb of the IBE were 96% (24 of 25) and 100%, respectively, during mean follow-up of 23 months. The patient with occlusion of internal iliac limb was asymptomatic and received no reintervention., Conclusions: Treatment of cAAA and TAAA associated with IAA using combined PM-FBEVAR and IBE is feasible with high efficacy and safety, and without adverse effect on outcomes. Long-term follow-up is planned to assess durability of repair with PM-FBEVAR and IBE., (Published by Elsevier Inc.)

Objective: Penetrating cerebrovascular injuries (PCVI) are associated with a high incidence of mortality and neurological events. The optimal treatment strategy of PCVI, especially when damage control measures are required, remains controversial. The aim of this study was to describe the management of PCVI and patient outcomes at a level 1 trauma center where vascular injuries are managed predominantly by trauma surgeons., Methods: An institutional trauma registry was queried for patients with PCVI from 2011 to 2021. Patients with common carotid artery (CCA), internal carotid artery (ICA), or vertebral artery injuries were included for analysis. The primary outcome was in-hospital stroke. The secondary outcomes were in-hospital mortality and in-hospital stroke or death. A subgroup analysis was completed of arterial repair (primary repair or interposition graft) vs ligation or embolization vs temporary intravascular shunting at the index procedure., Results: We analyzed 54 patients with PCVI. Overall, the in-hospital stroke rate was 17% and in-hospital mortality was 26%. Twenty-one patients (39%) underwent arterial interventions for PCVI. Ten patients underwent arterial repair, six patients underwent ligation or embolization, and five patients underwent intravascular shunting as a damage control strategy with a plan for delayed repair. The rate of in-hospital stroke was 30% after arterial repair, 0% after arterial ligation or embolization, and 80% after temporary intravascular shunting. There was a significant difference in the stroke rate between the three subgroups (P = .015). Of the 32 patients who did not have an intervention to the CCA, ICA, or vertebral artery, 1 patient with ICA occlusion and 1 patient with CCA intimal injury developed in-hospital stroke. The mortality rate was 0% after arterial repair, 50% after ligation or embolization, and 60% after intravascular shunting. The rate of stroke or death was 30% in the arterial repair group, 50% in the ligation or embolization group, and 100% in the temporary intravascular shunting group., Conclusions: High rates of stroke and mortality were seen in patients requiring damage control after PCVI. In particular, temporary intravascular shunting was associated with a high incidence of in-hospital stroke and a 100% rate of stroke or death. Further investigation is needed into the factors related to these finding and whether the use of temporary intravascular shunting in PCVI is an advisable strategy., Competing Interests: Disclosures G.A.M. is a consultant for W. L. Gore & Associates and Silk Road Medical., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The technical aspects of thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection (TBAD), specifically the location of proximal seal zone (PSZ) (need to cover the left subclavian artery [LSA]), distal seal zone (DSZ) (length of aortic coverage), benefit of LSA revascularization, and prophylactic lumbar drainage are still debated. Each of these issues has potential benefits but also has known risks. This study aims to identify factors associated with reintervention and spinal cord ischemia (SCI) following TEVAR for acute TBAD with a zone 3 entry tear., Methods: The Vascular Quality Initiative was queried for TEVARs performed for acute TBAD with zone 3 entry tear, zone 3 proximal zone of disease, treated with TEVAR extending between zone 2 and zone 5. The primary outcomes were SCI and related reintervention. Secondary outcomes were stroke, arm ischemia, and retrograde type A dissection (RTAD). The exposure variables were PSZ 2 vs 3, DSZ 4 vs 5, prophylactic lumbar drain, and LSA revascularization. Univariate analyses were conducted with χ 2 analysis, and multivariable logistic regression was used to evaluate association with outcomes., Results: Of 583 patients who met inclusion criteria, 266 had PSZ 2 and 317 had PSZ 3. On univariate analysis, PSZ 2 was associated with a higher rate of reintervention, but PSZ2 was not significant on multivariable analysis after accounting for age, sex, race, smoking, PSZ, DSZ, prophylactic lumbar drain, and LSA patency. PSZ 2 was not associated with SCI, arm ischemia, or RTAD. PSZ 2 was associated with a trend towards a higher rate of stroke. DSZ 4 and DSZ 5 were performed in 161 and 422 TEVARs, respectively, and DSZ 5 was associated with a higher rate of SCI on univariate (3 [1.9%] vs 39 [9.2%]; P = .01) and multivariable (odds ratio, 7.384; 95% confidence interval, 2.193-24.867; P = .001) analyses. Prophylactic lumbar drain placement was not statistically significantly associated with SCI, but lack of postoperative LSA patency was associated with SCI (odds ratio, 2.966; 95% confidence interval, 1.016-8.656; P = .05)., Conclusions: This study found that PSZ 2 was not associated with lower reinterventions or higher rates of SCI but trended towards a higher rate of stroke than PSZ 3. Additionally, DSZ 5 was strongly associated with SCI when compared with DSZ 4, highlighting the importance of limiting aortic coverage to coverage of the proximal entry tear when possible., Competing Interests: Disclosures G.A.M. is a consultant for W.L. Gore and Cook. S.M.H. is a consultant for WL Gore, Cook, and Terumo. L.D. is supported by grants UL1TR001855 and UL1TR000130 from the National Center for Advancing Translational Science (NCATS) of the United States National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution., Methods: A retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared., Results: A total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157)., Conclusions: At experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG., Competing Interests: Disclosures G.M. is a consultant for W. L. Gore & Associates, Cook Medical, and Silk Road Medical. S.H. is a consultant for W. L. Gore & Associates, Terumo, and Vestek, and is on the board for W. L. Gore & Associates and Vestek., (Copyright © 2024 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: Carotid baroreflex activation therapy (BAT) restores baroreflex sensitivity and modulates the imbalance in cardiac autonomic function in patients with heart failure with reduced ejection fraction (HFrEF). We tested the hypothesis that treatment with BAT significantly reduces cardiovascular mortality and heart failure morbidity and provides long-term safety and sustainable symptomatic improvement., Methods and Results: BeAT-HF was a prospective, multicentre, randomized, two-arm, parallel-group, open-label, non-implanted control trial. New York Heart Association (NYHA) class III subjects, ejection fraction ≤35%, previous heart failure hospitalization or N-terminal pro-B-type natriuretic peptide (NT-proBNP) >400 pg/ml, no class I indication for cardiac resynchronization therapy and NT-proBNP <1600 pg/ml were randomized to BAT plus optimal medical management (BAT group) or optimal medical management alone (control). The primary endpoint was cardiovascular mortality and HF morbidity; additional pre-specified endpoints included durability of safety, quality of life (QOL), exercise capacity (6-min hall walk distance [6MHWD]), functional status (NYHA class), hierarchical composite win ratio, freedom from all-cause death, left ventricular assists device (LVAD) implantation, heart transplant. Overall, 323 patients had 332 primary events, median follow-up was 3.6 years/patient. Both primary endpoint (rate ratio 0.94, 95% confidence interval [CI] 0.57-1.57; p = 0.82) and components of the primary endpoints were not significantly different between BAT and control. The system- and procedure-related major adverse neurological and cardiovascular event-free rate remained 97% throughout the trial. Symptom improvement (QOL, 6MHWD, NYHA class, all nominal p < 0.001) in the BAT group was durable in time, sustainable in extent. Win ratio (1.26, 95% CI 1.02-1.58) and freedom from all-cause death, LVAD implantation, heart transplant (hazard ratio 0.66, 95% CI 0.43-1.01) favoured the BAT group but did not reach statistical significance., Conclusion: The BeAT-HF primary endpoint was neutral; however, BAT provided safe, effective, and sustainable improvements in HFrEF patient's functional status, 6MHWD and QOL., (© 2024 CVRx and The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Introduction: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up., Methods: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test., Results: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm 2 , P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm 2 , P = .6)., Conclusions: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline., Competing Interests: Disclosures S.M.H. is a consultant for W. L. Gore & Associates, Cook Medical, Terumo Aortic, and on the scientific advisory board for W. L. Gore & Associates, Cook Medical, Viz AI, and Vestek. G.A.M. is a consultant for W. L. Gore & Associates and Cook Medical., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Thoracic endovascular aortic repair (TEVAR) involving the aortic arch is increasingly being performed and novel endografts have been developed for this procedure, but the association of stroke and relative risk of procedural techniques remains unclear. This study evaluates the procedural risk factors for stroke and mortality with zone 0-2 TEVAR., Methods: The Society for Vascular Surgery Vascular Quality Initiative registry was queried for patients who underwent TEVAR with proximal landing in zone 0-2 from 2013 to 2022. Emergent and ruptured cases were excluded. Primary exposure variables included proximal seal zone (0-2) and branch vessel revascularization technique: open debranching/bypass, total endovascular incorporation, or combination (at least 1 branch open and 1 branch endovascular). The primary outcome was perioperative inhospital stroke and the secondary outcome was inhospital mortality. Univariable and multivariable regression analyses were performed., Results: In total, 4,355 cases were analyzed with 350 in zone 0 (8%), 513 in zone 1 (12%), and 3,492 in zone 2 (80%). For zone 0, 1, and 2, the stroke rates were 11.1%, 5.3% and 4.7% (P < 0.0001) and inhospital mortality rates were 6.9%, 5.3% and 3.5% (P = 0.002), respectively. Branch vessel revascularization technique was associated with stroke in zone 0 with a 3-fold higher stroke rate for total endovascular incorporation of branches compared to combination and open techniques (P = 0.002). On multivariable analysis, zone 0 was independently associated with a greater than 2-fold increased odds of stroke compared to zone 2 (95% CI 1.4-3.2, P = 0.0008)., Conclusions: Stroke rate was 2-3 times higher for zone 0 TEVAR compared to zones 1 and 2. Within zone 0, total endovascular branch incorporation was associated with a 3-fold higher stroke rate than open and combination techniques. Future device design modifications and novel endovascular strategies for stroke prevention are required to make total endovascular repair of the aortic arch an acceptable alternative to combination and open debranching/bypass techniques., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Cerebral hyperperfusion syndrome (CHS) is a rare but known complication of carotid revascularization that can result in severe postoperative disability and death. CHS is a well-described sequela of carotid endarterectomy (CEA) and, more recently, of transfemoral carotid artery stenting (TFCAS), but its incidence after transcarotid artery revascularization (TCAR) has not been delineated. The aims of this study were to determine the impact of procedure type (CEA versus TCAR versus TFCAS) on the development of CHS as well as to identify perioperative risk factors associated with CHS., Methods: The Society for Vascular Surgery Vascular Quality Initiative was queried for patients aged ≥18 years who underwent CEA, TCAR, or TFCAS from 2015-2021. Emergent procedures were excluded. The primary outcome was postoperative development of CHS, defined as the presence of postoperative seizures, intracerebral hemorrhage due to hyperperfusion, or both. Bivariate and multivariable logistic regression analyses were performed to identify factors associated with CHS., Results: 156,003 procedures were included (72.7% CEA, 12.4% TCAR, and 14.9% TFCAS). The incidence of CHS after CEA, TCAR, and TFCAS were 0.15%, 0.18%, and 0.53%, respectively. There was no significant difference in risk of CHS after TFCAS compared to CEA (odds ratio [OR]: 1.21; 95% confidence interval [CI] 0.76-1.92; P = 0.416), nor was there a difference between TCAR and CEA (OR: 0.91; 95% CI 0.57-1.45; P = 0.691). Perioperative risk factors associated with an increased risk of CHS included previous history of transient ischemic attack or stroke (OR: 2.50; 95% CI 1.69-3.68; P < 0.0001), necessity for urgent intervention within 48 hr (OR: 2.03; 95% CI 1.43-2.89; P < 0.0001), treatment of a total occlusion (OR: 3.80; 95% CI 1.16-12.47; P = 0.028), and need for postoperative intravenous blood pressure medication (OR: 5.45; 95% CI 3.97-7.48; P < 0.0001). Age, preoperative hypertension, degree of ipsilateral stenosis less than or equal to 99%, and history of prior carotid procedures were not statistically associated with an increased risk of CHS. Discharging patients on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker was associated with a decreased risk of developing CHS (OR: 0.47; 95% CI 0.34-0.65; P < 0.0001)., Conclusions: Compared with CEA, TCAR and TFCAS were not statistically associated with an increased risk of postoperative CHS. Patients with a previous history of transient ischemic attack or stroke, who require urgent intervention or postoperative intravenous blood pressure medication, or who are treated for a total occlusion are at a higher risk of developing CHS. Using an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker on discharge appears to be protective against CHS and should be considered for the highest risk patients., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Penetrating carotid artery injuries (PCAI) are significantly morbid and deadly, often presenting in extremis with associated injuries and central nervous system deficit. Repair may be challenging with arterial reconstruction vs ligation role poorly defined. This study evaluated contemporary outcomes and management of PCAI., Methods: PCAI patients in the National Trauma Data Bank from 2007 to 2018 were analyzed. Outcomes were compared between repair and ligation groups after additionally excluding external carotid injuries, concomitant jugular vein injuries, and head/spine Abbreviated Injury Severity score of ≥3. Primary end points were in-hospital mortality and stroke. Secondary end points were associated injury frequency and operative management., Results: There were 4723 PCAI (55.7% gunshot wounds, 44.1% stab wounds). Gunshot wounds more frequently had associated brain (73.8% vs 19.7%; P < .001) and spinal cord (7.6% vs 1.2%; P < .001) injuries; stab wounds more frequently had jugular vein injuries (19.7% vs 29.3%; P < .001). The overall in-hospital mortality was 21.9% and the stroke rate was 6.2%. After exclusion criteria, 239 patients underwent ligation and 483 surgical repair. Ligation patients had lower presenting Glasgow Coma Scale (GCS) than repair patients (13 vs 15; P = .010). Stroke rates were equivalent (10.9% vs 9.3%; P = .507); however, in-hospital mortality was higher after ligation (19.7% vs 8.7%; P < .001). In-hospital mortality was higher in ligated common carotid artery injuries (21.3% vs 11.6%; P = .028) and internal carotid artery injuries (24.5% vs 7.3%; P = .005) compared with repair. On multivariable analysis, ligation was associated with in-hospital mortality, but not with stroke. A history of neurological deficit before injury lower GCS, and higher Injury Severity Score (ISS) were associated with stroke; ligation, hypotension, higher ISS, lower GCS, and cardiac arrest were associated with in-hospital mortality., Conclusions: PCAI are associated with a 22% rate of in-hospital mortality and a 6% rate of stroke. In this study, carotid repair was not associated with a decreased stroke rate, but did have improved mortality outcomes compared with ligation. The only factors associated with postoperative stroke were low GCS, high ISS, and a history of neurological deficit before injury. Beside ligation, low GCS, high ISS, and postoperative cardiac arrest were associated with in-hospital mortality., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Fenestrated-branched endovascular repair has become a favorable treatment strategy for patients with complex abdominal aortic aneurysms (cAAAs) and thoracoabdominal aortic aneurysms (TAAAs) who are high risk for open repair. Compared with degenerative aneurysms, post-dissection aneurysms can pose additional challenges for endovascular repair. Literature on physician-modified fenestrated-branched endovascular aortic repair (PM-FBEVAR) for post-dissection aortic aneurysms is sparse. Therefore, the aim of this study is to compare the clinical outcomes of patients who underwent PM-FBEVAR for degenerative and post-dissection cAAAs or TAAAs., Methods: A single-center institutional database was retrospectively reviewed for patients that underwent PM-FBEVAR between 2015 and 2021. Infected aneurysms and pseudoaneurysms were excluded. Patient characteristics, intraoperative details, and clinical outcomes were compared between degenerative and post-dissection cAAAs or TAAAs. The primary outcome was 30-day mortality. The secondary outcomes included technical success, major complications, endoleak, target vessel instability, and reintervention., Results: Of the 183 patients who underwent PM-FBEVAR in the study, 32 had aortic dissections, and 151 had degenerative aneurysms. There was one 30-day death (3.1%) in the post-dissection group and eight 30-day deaths (5.3%) in the degenerative aneurysm group (P = .99). Technical success, fluoroscopy time, and contrast usage were similar between the post-dissection and degenerative groups. Reintervention during follow-up (28% vs 35%; P = .54) and major complications were not statistically significantly different between the two groups. Endoleak was the most common reason for reintervention, with the post-dissection group having a higher rate of type IC, II, and IIIA endoleaks (31% vs 3%; P < .0001; 59% vs 26%; P = .0002; and 16% vs 4%; P = .03). During the mean follow-up of 14 months, all-cause mortality was similar between the groups (12.5% vs 21.9%; P = .23)., Conclusions: PM-FBEVAR is a safe treatment for post-dissection cAAAs and TAAAs with high technical success. However, endoleaks requiring reintervention were more frequent in post-dissection patients. The impact of these reinterventions on long-term durability will be assessed with continued follow-up., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Endovascular aortic repair (EVAR) is the preferred method of repair for abdominal aortic aneurysms (AAAs). However, patients with advanced chronic kidney disease (CKD) are a high-risk group, and it is unknown which patients with CKD benefit from EVAR vs continued surveillance. The purpose of this study was to identify which patients with advanced CKD may benefit from EVAR., Methods: The Vascular Quality Initiative Database was utilized to identify elective EVARs for AAAs. Patients were excluded if they underwent urgent or emergent repairs. CKD stages were categorized based on preoperative estimated glomular filtration rate (eGFR) and dialysis status. Predicted 1-year mortality of untreated AAAs was calculated by modifying a validated comorbidity score that predicts 1-year mortality (Gagne Index) without repair. The primary outcome was actual 1-year mortality, which was compared with the predicted 1-year mortality without repair., Results: A total of 34,926 patient met study criteria. There were differences in Gagne Indices among the varying classes of CKD. Patients with CKD 4 and CKD 5 had the highest 1-year mortality rates, followed by CKD 3b, which was significantly higher than those with CKD 1 and CKD 2. Patients with CKD 4 had no differences between actual 1-year mortality with EVAR and predicted 1-year survival without EVAR across all AAA sizes. Those with CKD 5 had worse actual 1-year survival with EVAR than predicted 1-year survival without EVAR for AAAs <5.5 cm. Patients with CKD 5 only experienced an actual mortality benefit with EVAR compared with predicted 1-year mortality without EVAR for AAAs ≥7.0 cm., Conclusions: The current data suggest that patients with CKD 3b, 4, and 5 represent a high-risk group who may not benefit from elective EVAR utilizing traditional size criteria. Patients with CKD 4 and 5 with AAAs <5.5 cm do not benefit from elective EVAR. In patients with CKD 5, elective EVAR may need to be reserved for AAAs ≥7.0 cm unless there are other concerning anatomic characteristics., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The study objective was to analyze the outcomes of thoracic endovascular aortic repair performed for complicated and uncomplicated acute type B aortic dissections., Methods: Patients from WL Gore's Global Registry for Endovascular Aortic Treatment who underwent thoracic endovascular aortic repair for acute type B aortic dissections were included, and data were retrospectively analyzed., Results: Of 5014 patients enrolled in the Global Registry for Endovascular Aortic Treatment, 172 underwent thoracic endovascular aortic repair for acute type B aortic dissections. Of these repairs, 102 were for complicated acute type B aortic dissections and 70 were for uncomplicated acute type B aortic dissections. There were 46 (45.1%) procedures related to aortic branch vessels versus 15 (21.4%) in complicated type B aortic dissections and uncomplicated type B aortic dissections (P = .002). The mean length of stay was 14.3 ± 10.6 days (median, 11; range, 2-75) versus 9.8 ± 7.9 days (median, 8; range, 0-42) in those with complicated type B aortic dissections versus those with uncomplicated acute type B aortic dissections (P < .001). Thirty-day mortality was not different between groups (complicated type B aortic dissections 2.9% vs uncomplicated acute type B aortic dissections 1.4%, P = .647), as well as aortic complications (8.8% vs 5.7%, P = .449). Aortic event-free survival was 62.9% ± 37.1% versus 70.6% ± 29.3% at 3 years (P = .696)., Conclusions: In the Global Registry for Endovascular Aortic Treatment, thoracic endovascular aortic repair results for complicated type B aortic dissections versus uncomplicated acute type B aortic dissections showed that 30-day mortality and perioperative complications were equally low for both. The midterm outcome was positive. These data confirm that thoracic endovascular aortic repair as the first-line strategy for treating complicated type B dissections is associated with a low risk of complications. Further studies with longer follow-up are necessary to define the role of thoracic endovascular aortic repair in uncomplicated acute type B dissections compared with medical therapy. However, in the absence of level A evidence from randomized trials, results of the uncomplicated acute type B aortic dissection patient cohort treated with thoracic endovascular aortic repair from registries are important to understand the related risk and benefit., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Preservation of antegrade flow to the left vertebral artery (LVA) is often achieved by transposition or bypass to the left subclavian artery during zone 2 thoracic endovascular aortic repair. An anomalous LVA (aLVA) originating directly from the aortic arch is a common arch variant with a reported incidence of 4% to 6%. In addition, 6% to 10% of vertebral arteries terminate in a posterior inferior cerebellar artery, increasing the risk of stroke if not revascularized. Few series of aLVA to carotid transposition have been reported. The aim of this study was to evaluate the outcomes of patients who underwent aLVA to carotid transposition for the management of aortic disease., Methods: A retrospective review of all aLVA-carotid transpositions performed for the management of thoracic aortic dissection or aneurysm at a single center from 2018 to 2021 was performed. The primary outcomes were postoperative stroke and patency of the transposed aLVA. Secondary outcomes were spinal cord ischemia, postoperative cranial nerve injury, and Horner's syndrome., Results: Seventeen patients underwent aLVA to carotid transposition as an adjunct to management of aortic disease during the study period. Most were men (n = 14) and the mean age was 54 ± 16 years. The primary indication for aortic repair was dissection in 10, aneurysm in 6, and Kommerell diverticulum in 1. Nine patients underwent zone 2 thoracic endovascular aortic repair, seven received open total arch repair, and there was one attempted total endovascular arch repair that was aborted owing to unfavorable anatomy. Twelve transpositions were performed before or concomitant with planned aortic repair owing to high-risk cerebrovascular anatomy (three posterior inferior cerebellar artery termination, six dominant aLVA, four intracranial LVA stenosis), and two were performed postoperatively for treatment of type II endoleak. LVA diameter ranged from 2 to 6 mm (mean, 3.3 mm). The mean operative time for transposition was 178 ± 38 minutes, inclusive of left subclavian artery revascularization, and the mean estimated blood loss was 169 ± 188 mL. No patients experienced 30-day postoperative spinal cord ischemia, stroke, or mortality. There were two cases of postoperative hoarseness, presumably owing to recurrent laryngeal nerve palsy, both of which resolved within 4 months. There were no cases of Horner's syndrome. At follow-up (mean, 306 days; range, 6-714 days), all transpositions were patent., Conclusions: Vertebral-carotid transposition is a safe and effective adjunct in the management of aortic disease with anomalous origin of the LVA., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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., (Published by Elsevier Inc.)

Purpose: To analyze differences in baseline characteristics, overall mortality, device-related mortality, and re-intervention rates in patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) with atherosclerotic/degenerative cause or acute aortic syndrome (AAS), using the Global Registry For Endovascular Aortic Treatment (GREAT)., Materials and Methods: Patients submitted to TEVAR for AAS or DTAA, included in GREAT, were eligible for this analysis. Primary outcome was 30-day all-cause mortality rate. Secondary outcomes were 30-day aorta-related mortality and re-intervention rate, 1-year and 3-year all-cause mortality, aorta-related mortality and re-intervention rate., Results: Five-hundred and seventy-five patients were analyzed (305 DTAA and 270 AAS). Thirty-day mortality rate was 1.3% and 1.8% for DTAA and AAS, respectively (p=0.741). One-year and 3-year mortality rates were 6.2% versus 9.3 and 17.3% versus 15.9% for DTAA and AAS, respectively (p=0.209 and p=0.655, respectively). Aorta-related mortality rates at 30 days, 1 year and 3 years were 1.3%, 1.3%, and 2.6% for DTAA, 1.8%, 4.2%, and 4.2% for AAS (p=ns). Re-intervention rates at 30 days, 1 year, and 3 years were 1.3%, 4.3%, and 7.5% for DTAA, 3.3%, 8.1%, and 10.7% for AAS (p=ns). Furthermore, a specific analysis with similar outcomes was performed dividing follow-up in 3 periods (1-30 days, 31-365 days, 366-1096 days) and describing mutual differences between 2 groups and temporal trends in each group., Conclusion: Patients who underwent TEVAR for DTAA or AAS experienced different mortality and re-intervention rates among years during mid-term follow-up. Although all-cause related deaths within 30 days were TEVAR-related, aorta-related deaths were more common for AAS patients within 1 year. A greater re-intervention rate was described for AAS patients, although only 1 year after TEVAR.

Introduction: Emergent endovascular repair of suprarenal (SRAAAs) and thoracoabdominal aortic aneurysms (TAAAs) poses a significant challenge due to the need for branch vessel incorporation, time constraints, and lack of dedicated devices. Techniques to incorporate branch vessels have included parallel grafting, physician-modified endografts, double-barrel/reversed iliac branch device, and in situ fenestration (ISF). This study describes a single-center experience and the associated outcomes when using these techniques for ruptured SRAAAs and TAAAs., Methods: A retrospective review of patients who underwent endovascular repair of ruptured SRAAAs and TAAAs from July 2014 to March 2021 with branch vessel incorporation was performed. Clinical presentation, intraoperative details, and postoperative outcomes of those who underwent ISF were compared with those who underwent repair using non-ISF techniques. The primary outcome of interest was in-hospital mortality. Secondary outcomes were major adverse events including myocardial infarction, respiratory failure, renal dysfunction, new onset dialysis, bowel ischemia, stroke, and spinal cord ischemia., Results: Forty-two patients underwent endovascular repair for ruptured SRAAAs and TAAAs, 18 of whom underwent ISF repair. Seventy-two percent of ISF patients were hypotensive before surgery, compared with 46% of the patients who underwent repair using non-ISF techniques (physician-modified endografts, parallel grafting, or double-barrel/reversed iliac branch device). The total procedural and fluoroscopy times were similar between the two groups despite a greater mean number of branch vessels incorporated with the ISF technique (3.1 vs 2.2 per patient, P = .015). In-hospital mortality was 19% for all ruptures and 25% for ruptures with hypotension. Compared with the non-ISF group, in-hospital mortality trended lower in the ISF group (11% vs 25%, P = .233), reaching statistical significance when comparing patients who presented with hypotension (8% vs 45%, P = .048). The rate of major adverse events was 57% across all techniques and did not significantly differ between the ISF and non-ISF groups, with postoperative renal dysfunction being the most frequent complication (48%). Overall, ISF became the most commonly used technique later in the study period., Conclusions: Although emergent endovascular repair of ruptured SRAAAs/TAAAs remains a challenge, a number of techniques are available for expeditious treatment. In this series, ISF was associated improve survival, including a fivefold reduction in mortality in patients presenting with hypotension, and has now become the dominant technique at our center. Despite these advantages, postoperative complications and reinterventions are common. Further experience and longer-term follow-up are needed to validate these initial results and assess durability., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Aims: Heart failure with reduced ejection fraction (HFrEF) remains associated with high morbidity and mortality, poor quality of life (QoL) and significant exercise limitation. Sympatho-vagal imbalance has been shown to predict adverse prognosis and symptoms in HFrEF, yet it has not been specifically targeted by any guideline-recommended device therapy to date. Barostim™, which directly addresses this imbalance, is the first Food and Drug Administration approved neuromodulation technology for HFrEF. We aimed to analyse all randomized trial evidence to evaluate the effect of baroreflex activation therapy (BAT) on heart failure symptoms, QoL and N-terminal pro-brain natriuretic peptide (NT-proBNP) in HFrEF., Methods and Results: An individual patient data (IPD) meta-analysis was performed on all eligible trials that randomized HFrEF patients to BAT + guideline-directed medical therapy (GDMT) or GDMT alone (open label). Endpoints included 6-month changes in 6-min hall walk (6MHW) distance, Minnesota Living With Heart Failure (MLWHF) QoL score, NT-proBNP, and New York Heart Association (NYHA) class in all patients and three subgroups. A total of 554 randomized patients were included. In all patients, BAT provided significant improvement in 6MHW distance of 49 m (95% confidence interval [CI] 33, 64), MLWHF QoL of -13 points (95% CI -17, -10), and 3.4 higher odds of improving at least one NYHA class (95% CI 2.3, 4.9) when comparing from baseline to 6 months. These improvements were similar, or better, in patients who had baseline NT-proBNP &lt;1600 pg/ml, regardless of the cardiac resynchronization therapy indication status., Conclusion: An IPD meta-analysis suggests that BAT improves exercise capacity, NYHA class, and QoL in HFrEF patients receiving GDMT. These clinically meaningful improvements were consistent across the range of patients studies. BAT was also associated with an improvement in NT-proBNP in subjects with a lower baseline NT-proBNP., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objective: The new Society for Vascular Surgery/Society for Thoracic Surgery reporting standards for type B aortic dissection (TBAD) categorize clinical presentations of aortic dissection into uncomplicated, high-risk features (HRF), and complicated groups. Although it is accepted that complicated dissections require immediate repair, the optimal timing of repair for HRF has yet to be established. This study aims to identify the ideal timing of thoracic endovascular aortic repair (TEVAR) for HRF, as well as outcomes associated with specific HRF., Methods: The Vascular Quality Initiative was queried for TEVARs performed for acute and subacute TBAD with HRF from 2014 to 2020. Rupture, malperfusion, and uncomplicated patients were excluded. HRF were defined per the guidelines as refractory hypertension, pain, or rapid expansion/aneurysm of more than 40 mm. The primary outcomes were in-hospital/30-day mortality and 1-year survival with primary exposure variables being days from symptoms to repair and number of HRFs. Secondary outcomes were spinal cord ischemia, stroke, and retrograde type A dissection (RTAD)., Results: Of the 1100 patients who met inclusion criteria, 811 had one HRF, 249 had two, and 40 had three. There were no significant differences in primary or secondary outcomes based on number of HRFs. There were 309 patients who underwent repair at 0 to 2 days, 262 at 3 to 6 days, 270 at 7 to 14 days, and 259 at 15 days or more. TEVAR performed at 15 days or more was independently associated with lower in-hospital/30-day mortality (odds ratio, 0.38; P = .0388) and improved 1-year survival. Postoperative stroke was associated with earlier repair (0-2 days). There was no association of timing of repair with spinal cord ischemia, retrograde type A dissection or reintervention., Conclusions: TEVAR for TBAD with HRF delayed at least 15 days from symptom onset is associated with improved survival, supporting the theory that it is best to delay TEVAR until the subacute phase. Additionally, TEVAR delayed at least 3 days is associated with a decrease in stroke. Having more than one HRF was not associated statistically with worse outcomes. Because the classification of HRF is relatively new and without guidelines for repair, this study highlights the risks of early intervention for HRF and suggests that these patients seem to benefit from at least a short stabilization period before TEVAR., (Copyright © 2022. Published by Elsevier Inc.)

Background: Concomitant iliac artery aneurysms can pose challenges during repair of complex abdominal and thoracoabdominal aortic aneurysms. In fenestrated aortic aneurysm repairs (FEVAR), preservation of internal iliac perfusion is important to minimize risk of spinal cord ischemia. Currently, most commonly used fenestrated stent grafts and the only approved iliac branch devices are manufactured by different companies in the United States. We report our experience with combining Iliac Branch Endoprosthesis (IBE) (W.L. Gore and Associates, Flagstaff, AZ) and fenestrated stent grafts, using the Zenith platform (Cook Medical, Bloomington, IN)., Methods: Retrospective review of consecutive patients who underwent FEVAR at a single institution from September, 2015 to June, 2020 was performed. Patients were deemed high-risk for open repair. Fenestrated aortic components implanted were either physician-modified or custom manufactured. Cases in which IBEs were deployed during FEVAR were specifically reviewed. Anatomic details were obtained from preoperative CT scans. Postoperative outcomes such as mortality, technical success, major adverse events, limb patency, limb-related endoleaks and re-intervention rates were assessed., Results: During the study period, 171 patients underwent FEVAR at our institution. Among those, 15 patients had unilateral IBE implantation during FEVAR, while one received bilateral IBE implantation. Fourteen cases involved physician-modified fenestrated endograft, and Zenith Fenestrated (Cook Medical, Bloomington, IN) in combination with Excluder bifurcated main body and IBE (W.L. Gore and Associates, Flagstaff, AZ). Mean operative, and fluoroscopy times were 340.2 minutes, and 65.4 minutes respectively. A total of 67 viscerorenal target vessels (mean = 3.9, range =&#95;3-5) and 15 internal iliac arteries were incorporated, with a mean of 160 cc contrast used. Completion angiograms were free of type 1 and type 3 endoleaks. Technical success was 100%. There was no perioperative mortality. One patient developed spinal cord ischemia post-operative day two with neurological recovery. At mean follow-up of 430 days, overall survival was 100% with no aneurysm-related mortalities. Limb patency remained 100%. There were no type 3 endoleaks while one patient had a type 1B endoleak that is currently being monitored. There was one re-intervention for type 1C renal branch graft endoleak., Conclusion: Combining IBE with FEVAR allows internal iliac preservation during endovascular repair of complex abdominal aortic aneurysms, with encouraging early results., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Current management of small abdominal aortic aneurysms (AAAs) primarily involves serial imaging surveillance of maximum transverse diameter (MTD) to estimate rupture risk. Other measurements, such as volume and tortuosity, are less well-studied and may help characterize and predict AAA progression. This study evaluated predictors of AAA volume growth and discusses the role of volume in clinical practice., Methods: Subjects from the Non-invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (baseline AAA MTD, 3.5-5.0 cm) with ≥2 computed tomography scans were included in this study (n = 250). Computed tomography scans were conducted approximately every 6 months over 2 years. MTD, volume, and tortuosity were used to model growth. Univariable and multivariable backwards elimination least squares regressions assessed associations with volume growth., Results: Baseline MTD accounted for 43% of baseline volume variance (P < .0001). Mean volume growth rate was 10.4 cm 3 /year (standard deviation, 8.8 cm 3 /year) (mean volume change +10.4%). Baseline volume accounted for 30% of volume growth variance; MTD accounted for 13% of volume growth variance. More tortuous aneurysms at baseline had significantly larger volume growth rates (difference, 32.8 cm 3 /year; P < .0001). Univariable analysis identified angiotensin II receptor blocker use (difference, -3.4 cm 3 /year; P = .02) and history of diabetes mellitus (difference, -2.8 cm 3 /year; P = .04) to be associated with lower rates of volume growth. Baseline volume, tortuosity index, current tobacco use, and absence of diabetes mellitus remained significantly associated with volume growth in multivariable analysis. AAAs that reached the MTD threshold for repair had a wide range of volumes: 102 cm 3 to 142 cm 3 in female patients (n = 5) and 105 cm 3 to 229 cm 3 in male patients (n = 20)., Conclusions: Baseline AAA volume and MTD were found to be moderately correlated. On average, AAA volume grows about 10% annually. Baseline volume, tortuosity, MTD, current tobacco use, angiotensin II receptor blocker use, and history of diabetes mellitus were predictive of volume growth over time., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Patients who present with lower extremity ischemia are frequently anemic and the optimal transfusion threshold for this cohort remains controversial. We sought to evaluate the impact of blood transfusion on postoperative major adverse cardiac events (MACE), including myocardial infarction, dysrhythmia, stroke, congestive heart failure, and 30-day mortality for these patients., Methods: All consecutive patients who underwent infra-inguinal bypass at our institution from 2011 to 2020 were included. Perioperative red blood cell transfusion was the primary exposure, and the primary outcome was MACE. Univariate and multivariable analyses were performed to assess the impact of patient and procedural variables, including red blood cell transfusion, stratified by hemoglobin (Hgb) nadir: <7, 7-8, and >8 g/dL., Results: Of the 287 patients reviewed for analysis, 146 (50.9%) had a perioperative transfusion (mean: 1.6 ± 3 units). Patients who received a transfusion had a mean nadir Hgb of 8.3 ± 1.0 g/dL, compared to 10.1 ± 1.7 g/dL without a transfusion. The overall incidence of MACE was 15.7% (45 of 287 patients). Univariate analysis demonstrated that MACE was associated with blood transfusion (P = 0.009), lower Hgb nadir (P = 0.02), and higher blood loss (P = 0.003). On multivariate analysis, transfusion was independently associated with MACE for patients with a Hgb nadir >8 g/dL (OR: 3.09; P = 0.006), but not for patients with Hgb nadir 7-8 g/dL (OR: 0.818; P = 0.77). Additionally, patients with MACE had significantly longer length of hospital stay than for patients without (13 vs. 7.7 days, P = 0.001)., Conclusions: For patients undergoing infra-inguinal bypass, receiving a red blood cell transfusion with a Hgb nadir >8 g/dL was associated with a 3-fold increase in MACE, with nearly twice the length of stay. For patients with a Hgb 7-8 g/dL, transfusion did not increase or reduce the incidence of MACE. These findings suggest no benefit of blood transfusion for patients with Hgb nadir >7 g/dL and harm for Hgb >8 g/dL, however causation cannot be proven due to the retrospective nature of the study and randomized studies are needed to confirm or refute these findings., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: Endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms have been performed widely in an increasing number of centers, utilizing custom-manufactured or physician-modified stent grafts containing fenestrations and side-arm branches for visceral and renal artery incorporation. Alternatively, inner branch configurations may be useful in complex anatomy, where application of fenestrations or side-arm branches can be challenging. Our study aims to evaluate the incidence of target vessel instability when incorporated with inner branch configurations, and report clinical outcomes of patients who underwent fenestrated/branched endovascular aortic repairs (F-BEVAR) containing one or more inner branches., Methods: We reviewed patients who underwent F-BEVAR with at least one inner branch configuration for complex abdominal or thoracoabdominal aortic aneurysms at Keck Hospital of University of Southern California from 2014 to 2020. Endpoints were mortality, major adverse events (MAE), technical success, and target vessel instability. Target vessel instability was assessed using follow-up computed tomography (CT) and duplex imaging., Results: Out of the 175 patients who underwent F-BEVAR for complex abdominal and TAAA during the study period, 17 patients had at least one inner branch configuration. All were deemed high-risk for open repair with multiple cardiovascular and/or pulmonary comorbidities. Eight (47%) patients had extent I, II, III thoracoabdominal aortic aneurysms, and 10 (59%) had prior aortic repairs. A total of 68 target vessels were incorporated (mean = 4 vessels/patient, range=1~6), of which 40% were inner branch configurations, most commonly for renal arteries. Technical success was 94.1%. There was one perioperative mortality due to massive myocardial infarction, as well as one patient who needed temporary hemodialysis. No device-related mortalities were observed. At 30 days, primary inner branch patency was 100% with no target vessel instability or reintervention. At mean follow-up of 5.8 months, the overall survival was 94% with one patient who expired from unknown cause. Overall primary inner branch patency was 96.3%, due to occlusion of a long lumbar artery branch with no clinical sequelae., Conclusion: Inner branch configurations can provide a safe alternative technique of branch incorporation during complex endovascular aortic repair., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Endovascular abdominal aortic repair can involve the incorporation of renal arteries. Revascularization after intentional or unintentional renal artery (RA) coverage is not always technically successful, and the loss of a single RA may result in the need for postoperative dialysis. Thus, we compared the outcomes after endovascular aneurysm repair (EVAR) stratified by RA involvement (RAI)., Methods: Patient data from the Vascular Quality Initiative from 2009 to 2018 registry were analyzed. The exclusion criteria were preoperative dialysis, missing RAI data, and repair above the superior mesenteric artery. The repair type cohorts were defined as (1) no RAI (NRAI), (2) RAI with revascularization (RAI-R), and (3) RAI with no revascularization (RAI-NR). A sensitivity analysis was performed by excluding ruptured presentations. The primary outcome was the need for postoperative dialysis. The secondary outcomes were 30-day mortality, dialysis at follow-up, postoperative renal function, and 2-year survival. Multivariate analysis was used to determine the independent predictors for postoperative dialysis. The 2-year survival analysis was performed using Kaplan-Meier log-rank test., Results: Of 54,020 patients in the EVAR and TEVAR (thoracic EVAR)/complex EVAR modules in the Vascular Quality Initiative, 25,724 met the criteria for inclusion (NRAI, n = 24,879; RAI-R, n = 733; RAI-NR, n = 112). The demographics and comorbidities were similar among the three groups. The RAI-NR group had more frequently had ruptured or symptomatic aneurysms. The postoperative dialysis requirement was higher in the RAI-NR group (NRAI, 0.7%; RAI-R, 2.2%; RAI-NR, 17%; P < .0001), as were the 30-day mortality and dialysis requirement at follow-up. On multivariate analysis, RAI-R (odds ratio [OR], 2.2; P = .03) and RAI-NR (OR, 5.9; P < .0001) were independent predictors of postoperative dialysis and remained so after excluding ruptured presentations (RAI-R: OR, 3; P = .003; RAI-NR: OR, 22.3; P < .0001). Other independent predictors of the need for postoperative dialysis were worse preoperative renal function, a symptomatic presentation, any preoperative or intraoperative blood transfusion, and larger blood loss (≥200 mL). Excluding those with rupture, the overall survival at 2 years on Kaplan-Meier analysis was lower for the RAI-NR group (NRAI, 92%; RAI-R, 89%; RAI-NR, 80%; P = .004)., Conclusions: RAI is highly predictive of the need for postoperative and permanent dialysis after EVAR. RAI-NR was associated with lower overall survival. These risks should be considered when planning and performing EVAR and should be weighed against the risks of open repair when considering the treatment options., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We investigated the association of tunneling technique on patency and amputation in patients undergoing lower extremity bypass for limb ischemia., Methods: The National Vascular Quality Initiative database infrainguinal bypass module from 2008 to 2017 was queried for analysis. We excluded cases with non-great saphenous vein grafts, grafts using multiple segments, aneurysmal disease indications, bypass locations outside the femoral to below the knee popliteal artery or tibial arteries, and missing data on tunneling type and limb ischemia. The main exposure variable was the tunneling type, subcutaneously vs subfascially. Our primary outcomes were primary patency and amputation. The secondary outcomes included primary-assisted patency and secondary patency. Univariate and multivariate logistic regression models were used., Results: A total of 5497 bypass patients (2835 subcutaneous and 2662 subfascial) were included. Age, race, graft orientation (reversed vs not reversed), bypass donor and recipient vessels, harvest type, end-stage renal disease, smoking, coronary artery bypass graft, congestive heart failure, P2Y12 inhibitor at discharge, surgical site infection at discharge, and indication (rest pain vs tissue loss vs acute ischemia) were analyzed for an association with the tunneling technique (P < .05). Multivariate analyses demonstrated that the tunneling type was not associated with primary patency, primary-assisted patency, secondary patency, or major amputation (P > .05)., Conclusions: Compared with subfascial tunneling, the superficial tunneling technique was not associated with primary patency or major amputation in limb ischemia patients undergoing infrainguinal bypass with a single-segment great saphenous vein., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Despite the increasing use of endovascular therapy for traumatic arterial injuries, little is known about the outcomes of endovascular repair of superficial femoral artery (SFA) and popliteal artery (PA) injuries. In the present study, we compared the characteristics and outcomes of endovascular vs open repair of traumatic SFA and PA injuries., Methods: We performed a retrospective National Trauma Data Bank analysis of trauma patients with a blunt or penetrating injury of the SFA and/or PA who had undergone endovascular or open repair from 2007 to 2014. Multivariate logistic regression was used to compare the outcomes, with propensity score matching used for sensitivity analysis., Results: The incidence of SFA and PA injuries was 0.2%, with an overall increase in the annual use of endovascular stent repair from 3.2% in 2007 to 7.6% in 2014 (P = .002). A total of 2,873 patients with an isolated SFA and/or PA injury were included in the present study, of whom 163 (5.7%) had undergone endovascular repair. SFA injuries were more frequently treated with endovascular repair (70% vs 27%) and PA injuries were more often associated with open repair (41.1% vs 54.7%). Open repair was more frequently associated with a concomitant femur fracture or knee dislocation (30.7% vs 38.8%; P = .039). Endovascular repair was not associated with worse in-hospital amputation-free survival (AFS) compared with open repair on univariate analysis (91.1% vs 89.7%; P = .573) or multivariate logistic regression (odds ratio [OR], 1.053; 95% confidence interval [CI], 0.551-2.012; P = .876). Propensity score matching revealed that in-hospital mortality was higher (OR, 3.69; 95% CI, 1.37-9.82; P = .01) and fasciotomy was lower (OR, 0.23; 95% CI, 0.14-0.37; P < .001) in the endovascular repair group, with no significant differences in AFS (OR, 0.86; 95% CI, 0.48-1.67; P = .65)., Conclusions: Endovascular repair of SFA and PA injuries has in-hospital AFS comparable to that for open repair, supporting the increasing use of endovascular repair for traumatic SFA and PA injuries in appropriately selected cases. Given the unexpected finding of increased in-hospital mortality after endovascular repair, further studies are necessary to determine the appropriate patient selection and the durability of endovascular repair., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: We reviewed the complications associated with perioperative lumbar drain (LD) placement for endovascular aortic repair., Methods: Patients who had undergone perioperative LD placement for endovascular repair of thoracic and thoracoabdominal aortic pathologies from 2010 to 2019 were reviewed. The primary endpoints were major and minor LD-associated complications. Complications that had resulted in neurological sequelae or had required an intervention or a delay in operation were defined as major. These included intracranial hemorrhage, symptomatic spinal hematoma, cerebrospinal fluid (CSF) leak requiring intervention, meningitis, retained catheter tip, arachnoiditis, and traumatic (or bloody) tap resulting in delayed operation. Minor complications were defined as a bloody tap without a delay in surgery, asymptomatic epidural hematoma, and CSF leak with no intervention required. Isolated headaches were recorded separately owing to the minimal clinical impact., Results: A total of 309 LDs had been placed in 268 consecutive patients for 222 thoracic endovascular aortic repairs, 85 complex endovascular aortic repairs (EVARs; fenestrated branched EVAR/parallel grafting), and 2 EVARs (age, 65 ± 13 years; 71% male) for aortic pathology, including aneurysm (47%), dissection (49%), penetrating aortic ulcer (3%), and traumatic injury (0.6%). A dedicated neurosurgical team performed all LD procedures; most were performed by the same individual, with a technical success rate of 98%. Radiologic guidance was required in 3%. The reasons for unsuccessful placement were body habitus (n = 2) and severe spinal disease (n = 3). Most were placed prophylactically (96%). The overall complication rate was 8.1% (4.2% major and 3.9% minor). Major complications included spinal hematoma with paraplegia in 1 patient, intracranial hemorrhage in 2, meningitis in 2, arachnoiditis in 3, CSF leak requiring a blood patch in 3, bloody tap delaying the operation in 1, and a retained catheter tip in 1 patient. Patients who had undergone previous LD placement had experienced significantly more major LD-related complications (12.2% vs 3%; P = .019). The rate of total LD-associated complications did not differ between prophylactic and emergent therapeutic placements (8.1% vs 7.7%; P = 1.00) nor between major or minor complications. On multivariate analysis, previous LD placement and an overweight body mass index were the only independent predictors of major LD-related complications., Conclusions: The complications associated with LD placement can be severe even when performed by a dedicated team. Previous LD placement and overweight body mass index were associated with a significantly greater risk of complications; however, emergent therapeutic placement was not. Although these risks are justified for therapeutic LD placement, the benefit of prophylactic LD placement to prevent paraplegia should be weighed against these serious complications., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

We previously described a transfemoral antegrade in situ laser fenestration technique (in situ fenestrated endovascular abdominal aortic aneurysm repair) for ruptured thoracoabdominal aortic aneurysms. In the present report, we have described an alternative technique of caudally directed in situ fenestrated endografts using upper extremity access for branch vessel incorporation. This technique involves partial deployment of the aortic stent graft in the thoracic aorta to achieve proximal control, followed by sequential branch incorporation using a laser probe through a steerable sheath, from the upper extremity access. The advantages of the technique include rapid proximal aortic control before branch incorporation without target vessel prestenting and separation of in situ fenestration from the target branch vessel origin, facilitating cannulation of angulated branch vessels., (© 2021 The Authors.)

Objective: Revascularization of the left subclavian artery (LSA) during zone 2 thoracic endovascular aortic repair (TEVAR) maintains collateral circulation to decrease ischemic complications, including stroke, spinal cord ischemia, and upper extremity ischemia. Both open surgical and endovascular LSA revascularization techniques have been described, each with unique risks and benefits. We describe our "periscope sandwich" technique for the LSA during zone 2 TEVAR, which maintains antegrade access to the distal abdominal aorta if subsequent interventions are necessary. Technical results and short-term outcomes are compared with LSA open surgical debranching., Methods: A single-institution retrospective review was performed for patients requiring zone 2 TEVAR with LSA revascularization by periscope sandwich technique or open surgical debranching with subclavian to carotid transposition (SCT) or carotid-subclavian bypass (CSB). The presenting aortic disease and perioperative details were recorded. Intraoperative angiography and postoperative computed tomography images were reviewed for occurrence of endoleak and branch patency., Results: Between January 2013 and December 2018, the LSA was revascularized by periscope sandwich in 18 patients, SCT in 22 patients, and CSB in 13 patients. Compared with open surgical debranching, periscope sandwich had a lower median estimated blood loss (100 mL vs 200 mL for pooled SCT and CSB; P = .03) and lower median case duration (133.5 minutes vs 226 minutes; P < .001). Contrast material volume (120 mL vs 120 mL; P = .98) and fluoroscopy time (13.1 minutes vs 13.3 minutes; P = .92) did not differ significantly between the groups. There was no difference in aorta-related mortality (P = .14), and LSA patency was 100%. Median follow-up for the periscope sandwich group was 11 months, with an overall estimated 91% freedom from gutter leak at 6 months., Conclusions: LSA periscope sandwich technique provides safe and effective LSA revascularization during zone 2 TEVAR. LSA periscope sandwich can be used emergently with off-the-shelf endovascular components and facilitates future branched-fenestrated endovascular repair of thoracoabdominal aortic diseases., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Thoracic endovascular aortic repair (TEVAR) for type B aortic dissections is used to promote false lumen (FL) thrombosis and favorable aortic remodeling, but its impact on occlusion of FL origin branch vessels has not been widely described. We compare FL versus true lumen (TL) branch vessel patency after TEVAR., Methods: Patients treated by TEVAR for type B aortic dissection in zones 2-5 in the Vascular Quality Initiative from 2009 to 2018 were evaluated. The primary outcome was postoperative branch patency. Secondary outcomes were need for branch vessel intervention, preoperative origin, and postoperative patency of individual branch vessels (celiac, superior mesenteric artery, renal arteries, and iliac arteries). A subset analysis was performed comparing acute and chronic dissections., Results: Of 11,774 patients, 1,484 met criteria for analysis. The left renal was the most common to have FL origin (21.6%), whereas right and left common iliac arteries were the most likely to originate off both lumens (BLs; 22% and 24%). Branch vessels that originated from the TL, FL, BLs, or were obstructed had postoperative patency rates of 99%, 99%, 99%, and 87% (P < 0.0001). Branch vessel treatment was performed in 5% of patients. The right (2.5%) and left (2.8%) renal arteries were the most frequently obstructed branches postoperatively. On multivariate analysis, preoperatively obstructed branches (odds ratio 0.03, P < 0.0001) were negatively associated with postoperative branch patency and branch vessel treatment (odds ratio 3.8, P = 0.004) was positively associated with postoperative patency. FL or BL origin, number of zones covered by TEVAR, urgency, dissection chronicity (acute versus chronic), and demographics were not independently associated with patency. These findings remained unchanged in the subset analysis of only acute dissections., Conclusions: Branch vessel patency rates after TEVAR for a type B aortic dissection are high and are not significantly different for FL or BL origin vessels compared with TL vessels. Branches that are patent before TEVAR almost always remain patent after TEVAR, but branch vessel stenting may be required in less than 5%., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: Aberrant subclavian artery (aSCA) is a rare anatomic variant whose association with other aortic branch variations and aortic pathology has yet to be established. Knowledge of such an association could be relevant to recommendations for screening and awareness as associated variations are important for operative planning. We describe the incidence of aSCA variations, its association with aortic pathology, and a proposed classification system., Methods: The thoracic cross-sectional imaging database at Keck Hospital of the University of Southern California from 2006 to 2018 was queried for presence of aSCA. Studies were evaluated for aSCA laterality, variant anatomy, and aortic and branch vessel disease. Medical records were reviewed for associated symptoms and diagnoses. The primary outcome was association of aSCA with aortic pathology (aneurysm or dissection). Secondary outcomes were comparison of right and left aSCA, comparison between the sexes, and creation of a proposed classification system., Results: Of 98,580 axial imaging studies, 810 studies (0.82%) were identified with aSCA in 312 unique patients. Right aSCA made up the majority of cases (90.1%). All aSCAs had a retroesophageal course. Kommerell's diverticulum (KD) was present in 184 (59%) with an average diameter of 1.67 cm (range, 1.2-3.3 cm). KD was more frequent (84% vs 56%; P = .0003) and larger (2.05 cm vs 1.61 cm; P < .0001) in left aSCA patients. When present, KD was more often symptomatic in left aSCA compared with right aSCA (77.4% vs 49.1%; P = .005). Dysphagia, chest pain, reflux, and asthma were all more common in left aSCA patients. KD was also more common in men (73.3% vs 50%; P < .0001) and larger in men (1.81 cm vs 1.54 cm; P < .0001) but with no difference in symptoms between sexes. Our proposed classification system based on aortic arch branching is as follows: type 1, left arch with right aSCA (59.9%); type 2, left arch with common carotid trunk and right aSCA (30.1%); type 3, right arch with left aSCA (9.6%); and type 4, right arch with common carotid trunk and left aSCA (0.3%). Subtypes describe the right vertebral artery (RVA) and left vertebral artery (LVA) origin: subclavian (s, RVA 90.1%, LVA 96.8%), carotid (c, RVA 9.6%, LVA 0.3%), or arch (a, RVA 0.3%, LVA 2.9%). Overall, 9.9% (31/312) had associated aortic pathology, although the study was underpowered to detect a difference between right aSCA and left aSCA (9.3% vs 16.1%; P = .213). Type 3 and type 4 arches more often have associated aortic pathology, KD, and symptoms., Conclusions: aSCAs are frequently symptomatic and commonly associated with aortic dissection and aneurysm. Our proposed classification scheme depicts all four aSCA arch variants and accounts for vertebral artery origin variation. These variants are common, and vertebral anatomy can differ greatly. Knowledge of these anatomic variations is critical to planning for endovascular and open repair of aortic arch pathology., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Upper extremity and neck access is commonly used for complex endovascular aortic repairs. We sought to compare perioperative stroke and other complications of (1) arm/neck (AN) and femoral or iliac access versus femoral/iliac (FI) access alone, (2) right- versus left-sided AN, and (3) specific arm versus neck access sites., Methods: Patients entered in the thoracic endovascular aortic repair/complex endovascular aortic repair registry in the Vascular Quality Initiative from 2009 to 2018 were analyzed. Patients with a missing access variable and aortic arch proximal landing zone were excluded. The primary outcome was perioperative in-hospital stroke. Secondary outcomes were other postoperative complications and 1-year survival. Kaplan-Meier curves and log-rank test were used for survival analysis., Results: Of 11,621 patients with 11,774 recorded operations, 6691 operations in 6602 patients met criteria for analysis (1418 AN, 5273 FI). AN patients had a higher rate of smoking history (83.6% vs 76.1%; P < .0001), and prior stroke (12.6% vs 10.1%; P = .01). Operative time (280 ± 124 minutes vs 157 ± 102 minutes; P < .0001), contrast load (141 ± 82 mL vs 103 ± 67 mL; P < .0001), and estimated blood loss (300 mL vs 100 mL; P < .0001) were larger in the AN group, indicative of greater complexity cases. Overall, AN had a higher rate of stroke (3.1% vs 1.8%; P = .003) compared with FI and on multivariable analysis AN access was found to be an independent risk factor for stroke (odds ratio, 1.97; P = .0003). There was no difference in stroke when comparing right- and left-sided AN access (2.8% vs 3.2%; P = .71). Stroke rates were similar between arm, axillary, and multiple access sites, but were significantly higher in patients with carotid access (2.6% vs 3.5% vs 13% vs 3.7%; P = .04). AN also had higher rates of puncture site hematoma, access site occlusion, arm ischemia, and in-hospital mortality (7.1% vs 4.2%; P < .0001). At 1 year, AN had a lower survival rate (85.1% vs 88.1%; P = .03)., Conclusions: Upper extremity and neck access for complex aortic repairs has a higher risk of stroke compared with femoral and iliac access alone. Right-sided access does not have a higher stroke rate than left-sided access. Carotid access has a higher stroke rate than axillary, arm, and multiple arm/neck access sites., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial, failed to demonstrate a benefit of renal artery stenting (RAS) over medical therapy in patients with renal artery stenosis and hypertension. However, there are patients for whom RAS is a consideration because of failure of medical therapy. Unfortunately, selection of patients for RAS is complicated by a lack of validated predictors of blood pressure (BP) response. A previous single-center study identified three preoperative markers of BP response to RAS: requirement for four or more antihypertensive medications, preoperative diastolic BP >90 mm Hg, and preoperative clonidine use. To date, these markers of outcome have not been independently validated. The aim of this study was to validate these markers using data from the CORAL trial., Methods: All patients randomized in the CORAL trial to RAS were included. American Heart Association guidelines were used to categorize patients as BP responders or nonresponders to RAS. BP responders were defined by a postoperative BP <160/90 mm Hg with a reduced number of antihypertensive medications or a reduction in diastolic BP to <90 mm Hg with the same medications after RAS. Patients with stable or worsened BP were labeled nonresponders. Variables associated with a favorable BP response were identified by multivariable logistic regression analysis., Results: There were 436 patients who underwent RAS with a median age of 70 years (interquartile range [IQR], 63-76 years). The median systolic and diastolic BPs of the stented cohort at baseline were 149 mm Hg (IQR, 132-164 mm Hg) and 78 mm Hg (IQR, 70-87 mm Hg), respectively. A positive BP response occurred in 284 of 436 (65.1%) stented patients. Multivariable logistic regression analysis identified three independent markers of a positive BP response: requirement for four or more medications (odds ratio, 5.9; P < .001), preoperative diastolic BP >90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008). The percentage of patients with a positive BP response increased incrementally as the number of markers per patient increased, based on the Cochran-Armitage test for trend (P < .0001)., Conclusions: In patients from the CORAL trial who underwent RAS, the previously reported clinical markers of BP response were validated. A prospective trial to validate their utility as predictors of BP response to RAS is warranted., (Published by Elsevier Inc.)

The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System has been developed to stratify amputation risk on the basis of extent of the wound, level of ischemia, and severity of foot infection (WIfI). However, there are no currently validated metrics to assess, grade, and consider functional status, especially ambulatory status, as a major consideration during limb salvage efforts. Therefore, we propose an adjunct to the current WIfI system to include the patient's ambulatory functional status after initial assessment of limb threat. We propose a functional ambulatory score divided into grade 0, ambulation outside the home with or without an assistive device; grade 1, ambulation within the home with or without an assistive device; grade 2, minimal ambulation, limbs used for transfers; and grade 3, a person who is bed-bound. Adding ambulatory function as a supplementary assessment tool can guide clinical decision making to achieve optimal future functional ambulatory outcome, a patient-centered goal as critical as limb preservation. This adjunct may aid limb preservation teams in rapid, effective communication and clinical decision making after initial WIfI assessment. It may also improve efforts toward patient-centered care and functional ambulatory outcome as a primary objective. We suggest a score of functional ambulatory status should be included in future trials of patients with chronic limb-threatening ischemia., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF)., Objectives: The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group)., Methods: Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy. Effectiveness endpoints were the change from baseline to 6 months in 6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The safety endpoint included the major adverse neurological or cardiovascular system or procedure-related event rate (MANCE)., Results: Results from, timeline and rationale for, cohorts A, B, and C are presented in detail in the text. Cohort D, which represented the intended use population that reflected the U.S. Food and Drug Administration-approved instructions for use (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001)., Conclusions: BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196)., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)