A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial.

BACKGROUND: Chronic limb-threatening ischaemia is the severest manifestation of peripheral arterial disease and presents with ischaemic pain at rest or tissue loss (ulceration, gangrene, or both), or both. We compared the effectiveness of a vein bypass first with a best endovascular treatment first revascularisation strategy in terms of preventing major amputation and death in patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. METHODS: Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-2 was an open-label, pragmatic, multicentre, phase 3, randomised trial done at 41 vascular surgery units in the UK (n=39), Sweden (n=1), and Denmark (n=1). Eligible patients were those who presented to hospital-based vascular surgery units with chronic limb-threatening ischaemia due to atherosclerotic disease and who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion. Participants were randomly assigned (1:1) to receive either vein bypass (vein bypass group) or best endovascular treatment (best endovascular treatment group) as their first revascularisation procedure through a secure online randomisation system. Participants were excluded if they had ischaemic pain or tissue loss considered not to be primarily due to atherosclerotic peripheral artery disease. Most vein bypasses used the great saphenous vein and originated from the common or superficial femoral arteries. Most endovascular interventions comprised plain balloon angioplasty with selective use of plain or drug eluting stents. Participants were followed up for a minimum of 2 years. Data were collected locally at participating centres. In England, Wales, and Sweden, centralised databases were used to collect information on amputations and deaths. Data were analysed centrally at the Birmingham Clinical Trials Unit. The primary outcome was amputation-free survival defined as time to first major (above the ankle) amputation or death from any cause measured in the intention-to-treat population. Safety was assessed by monitoring serious adverse events up to 30-days after first revascularisation. The trial is registered with the ISRCTN registry, ISRCTN27728689. FINDINGS: Between July 22, 2014, and Nov 30, 2020, 345 participants (65 [19%] women and 280 [81%] men; median age 72·5 years [62·7-79·3]) with chronic limb-threatening ischaemia were enrolled in the trial and randomly assigned: 172 (50%) to the vein bypass group and 173 (50%) to the best endovascular treatment group. Major amputation or death occurred in 108 (63%) of 172 patients in the vein bypass group and 92 (53%) of 173 patients in the best endovascular treatment group (adjusted hazard ratio [HR] 1·35 [95% CI 1·02-1·80]; p=0·037). 91 (53%) of 172 patients in the vein bypass group and 77 (45%) of 173 patients in the best endovascular treatment group died (adjusted HR 1·37 [95% CI 1·00-1·87]). In both groups the most common causes of morbidity and death, including that occurring within 30 days of their first revascularisation, were cardiovascular (61 deaths in the vein bypass group and 49 in the best endovascular treatment group) and respiratory events (25 deaths in the vein bypass group and 23 in the best endovascular treatment group; number of cardiovascular and respiratory deaths were not mutually exclusive). INTERPRETATION: In the BASIL-2 trial, a best endovascular treatment first revascularisation strategy was associated with a better amputation-free survival, which was largely driven by fewer deaths in the best endovascular treatment group. These data suggest that more patients with chronic limb-threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infra-inguinal, revascularisation procedure to restore limb perfusion should be considered for a best endovascular treatment first revascularisation strategy. FUNDING: UK National Institute of Health Research Health Technology Programme.

"Awake" Spinal Cord Monitoring Under Local Anesthesia and Conscious Sedation in Fenestrated and Branched Endovascular Aortic Repair.

INTRODUCTION: Endovascular repair of thoracoabdominal aortic aneurysms carries a risk of spinal cord ischemia, the causes of which remain uncertain. We hypothesized that local anesthesia (LA) with conscious sedation could abrogate the potential suppressive cardiovascular effects of general anesthesia (GA) and facilitate intraoperative monitoring of neurological function. Here, we examine the feasibility of this technique during fenestrated (FEVAR) or branched endovascular aortic repair (BEVAR). MATERIALS AND METHODS: Consecutive patients undergoing FEVAR or BEVAR under LA and conscious sedation by a team at a single center were analyzed. Patients received conscious sedation using intravenous remifentanil and propofol infusions in conjunction with a local anesthetic agent. No patient had a prophylactic spinal drain inserted. Outcome measures included conversion to GA, need for vasopressors and/or spinal drainage, length of stay, complications, and patient survival. RESULTS: A total of 44 patients underwent FEVAR or BEVAR under LA and conscious sedation. The cohort included thoracoabdominal aortic aneurysms (n=41) and pararenal aneurysms treated with endografts covering the supraceliac segment (n=3). Four patients (9%) required conversion to GA at a median operative duration of 198 minutes (range 97-495 minutes). Vasopressors were required intraoperatively in 3 of the cases that were converted to GA. No patient developed spinal cord ischemia and none had insertion of a spinal drain. The median hospital length of stay was 4 days (range 2-41 days). Postoperative delirium and hospital-acquired pneumonia was seen in 7% of patients. All patients survived to 30 days, with 95% alive at a median follow-up of 15 months (range 3-26 months). CONCLUSION: LA and conscious sedation is a feasible anesthetic technique for the endovascular repair of thoracoabdominal aortic aneurysms.

Cerebral monitoring in patients undergoing carotid endarterectomy using a triple assessment technique.

OBJECTIVES: Selective shunting during carotid endarterectomy (CEA) is advocated to reduce shunt related stroke. Cerebral monitoring is essential for temporary carotid shunting. Many techniques are available for cerebral monitoring, however, none is superior to monitoring the patient's neurological status (awake testing) while performing the procedure under local anaesthesia (LA). Cerebral oximetry (CO) and trans-cranial Doppler (TCD) has previously been used to show the adequacy of cerebral circulation in patients undergoing CEA. The aim of this study is to assess the reliability of CO and TCD in predicting the need for shunting compared to the awake testing. METHODS: Patients scheduled for CEA under LA were included. Patients converted to general anaesthesia (GA) and patients with no TCD window were excluded from the study. The Somanetics INVOS(®) CO was used for ipsilateral cerebral monitoring in all patients, in addition to TCD and awake testing. The percentage fall in CO regional oxygen saturation (rSO(2)), and decline in the mean flow velocity (FVm) in TCD following carotid artery clamping recorded. A drop in rSO(2) of ≥20% or FVm of ≥50% was considered an indicator of cerebral ischaemia that may predict the need for carotid shunting. Patients only shunted based on awake testing. RESULTS: Forty-nine patients underwent triple assessment. The median clamp time was 24 min. 8/49 patients (16.3%) needed carotid shunting based on awake testing. In this group, six patients had ≥20% drop in rSO(2), and ≥50% drop in FVm. However, two patients had a non-significant drop in both rSO(2) and FVm (false negative). In the non-shunted group (41/49), one patient had a significant drop in rSO(2) (false positive) while 10/41 patients had a >50% drop in FVm. This represents sensitivity of 75%, and specificity of 97.5% for CO compared to sensitivity of 75% and specificity of 75% for TCD in prediction of shunting. The positive predictive value and negative predictive value were 85.7 and 95.2%, respectively for CO, compared to 37.5 and 93.9% for TCD. CONCLUSIONS: TCD is less accurate than CO in predicting the need for carotid shunting during CEA. A combination of both methods does not add to the accuracy of detecting the need for carotid shunting.