Impact of isolated type 2 endoleak on subsequent cardiovascular events and mortality.

OBJECTIVE: Assess subsequent cardiovascular events and all-cause mortality in patients with intact AAA treated by EVAR according to the existence of isolated EL2 at 1 year after EVAR implantation. METHODS: This retrospective, single-centre study included patients treated with EVAR between 2010 and 2017 in the vascular surgery department of the University Hospital of Lyon with a infrarenal AAA > 50 mm. The baseline clinical characteristics collected just before EVAR were retrieved from electronic patient records of our institution. AAA characteristics, procedure and the one-year post-operative CTA were reported. Study endpoints, major adverse cardiovascular events (MACE), major adverse lower extremity events (MALE) and all-cause mortality, were recorded during follow-up. Patients were divided into 2 groups according to the presence of isolated EL2 (EL2 +) or absence (EL2 -) of any endoleak on CTA at 1 year. MACE, MALE and all-cause mortality were compared between both groups. RESULTS: During the study period, 589 patients were treated by endovascular surgery and 207 were included. According to the CTA results at 1 year, 60 patients (29%) were included in the EL2 + group, and 147 patients (71%) in the EL2 - group. A total of 109 patients (53%) experienced a MACE or MALE; significantly fewer patients in the EL2 + than in the EL2 - group did so (p = .009). There were 47 patients (23%) who experienced at least one MALE, and the frequency was significantly lower in the EL2 + group (p = .017). CONCLUSION: Patients with AAA treated by EVAR who did not develop EL2 at one year, were at higher risk of MALE during follow-up. This might be explained by more frequent symptomatic LEPAD at baseline in this group. These patients therefore require a closer follow-up and strict control of cardiovascular risk factors to prevent cardiovascular morbi-mortality.

Dissection of the Celiac Trunk Is a Mild Disease.

BACKGROUND: The purpose of this study was to assess whether the presence of an aneurysmal or dissecting arterial disease was a risk factor of poor prognosis in patients presenting a dissection of the celiac trunk (CT). METHODS: All patients presenting a CT dissection between January 1, 2014, and June 30, 2022, were included. Patients with a CT dissection due to the extension of an aortic dissection were excluded. Les antécédents familiaux de dissection, de maladie anévrysmale, de maladie athéromateuse ou du tissu conjonctif, la pratique d'une activité physique ou sportive, un effort inhabituel les jours précédant la dissection ainsi qu'un traumatisme étaient recherchés. Family history of dissection, aneurysmal disease, atheromatous or connective tissue disease, physical activity or sport, an unusual effort in the days prior to the dissection and trauma were sought after. Ischemic or aneurysmal complications in the acute phase and the evolution of the dissection were evaluated and compared between patients with an isolated dissection and those presenting an aneurysmal or dissecting arterial disease. RESULTS: 45 patients were included in the study. Twenty-three (51.1%) patients presented with symptomatic CT dissection, and 22 (48.9%) with asymptomatic CT dissection. All the patients initially had medical management alone. The mean follow-up was 32 ± 25 months and all patients were asymptomatic at the time last news. 24 (53.3%) presented an isolated CT dissection, and 21 (46.7%) a CT dissection associated with aneurysmal or dissecting arterial disease. There was no significant difference between patients with an isolated CT dissection and those with an associated dissecting or aneurysmal pathology. CONCLUSIONS: CT dissection is a stable disease in the midterm, which makes it a mild arterial pathology, with or without aneurysmal or dissecting anomalies in another territory. The mechanical stress exerted on the CT by the arcuate ligament could be responsible for parietal trauma and favor the occurrence of a CT dissection.

The obstetrical consequences of ischemic stroke in women of childbearing age.

PURPOSE: Although recurrence risk is a major concern for women having had an ischemic stroke (IS) and who are planning a pregnancy, studies on recurrence risk and pregnancy outcomes are scarce and heterogeneous. METHODS: This retrospective study assessed women aged 15-44 years with a diagnosis of ischemic stroke admitted in the Lyon Stroke Centre, France, between January 2009 and December 2013. The primary outcome was stroke recurrence during pregnancy or the post-partum period. Secondary outcomes were pregnancy complications. RESULTS: Overall, 104 women with a prior ischemic stroke were included. Mean age at the time of the stroke was 36 ± 6.7 years old. Stroke etiology was large-artery atherosclerosis for 1 woman, cardioembolism for 23 women, and undetermined for 55 women. No antiphospholipid syndrome was found. Among them, 29 women had 58 subsequent pregnancies. Overall, there were three IS recurrence (2.9%), but none occurred during pregnancy. There were 27 miscarriages (47% of pregnancies), two pre-eclampsia (3%), and one stillbirth (1.7%). CONCLUSIONS: We observed no recurrence of IS during pregnancy. The study also highlighted that the risk of miscarriages was higher than general population and that of stillbirth should be further studied.

American Society of Anesthesiologists-Physical Status Classification As An Independent Risk Factor of Surgical Site Infection After Infra-Inguinal Arterial Bypass.

OBJECTIVES: The present study aimed to assess whether high-risk American Society of Anesthesiologists (ASA)-Physical Status was an independent risk factor for the development of surgical site infection (SSI) after infra-inguinal lower extremity bypass (LEB). SUMMARY OF BACKGROUND DATA: The ASA-Physical Status Classification System assesses the overall physical status preoperatively. ASA-Physical Status is associated with postoperative morbidity and mortality. However, limited data are available on how ASA-Physical Status Class affects the development of SSI after infra-inguinal LEB. METHODS: Patients who had undergone infra-inguinal LEB from January 1, 2015 to December 31, 2018, for obliterative arteriopathy or popliteal aneurysm at our university hospital were included. SSI risk factors were identified using multivariable logistic regression. The length of hospital stay, major limb events (MALE), major adverse cardiovascular events (MACE), and all-cause mortality were compared for patients with SSI versus those without SSI 3 months and 1- year of follow-up after the index surgery. RESULTS: Among the 267 patients included, 30 (11.2%) developed SSI during the 3-month period and 32 (12%) at 1 year. ASA-Physical Status ≥3 [odds ratio (OR): 3.7, 95% confidence interval CI) 1.5-11.1], emergency surgery (OR: 2.7, 95% CI 1.2-6.0), general anesthesia (OR: 2.8, 95% CI 1.3-6.1), and procedure performed by a junior surgeon (OR: 2.7, 95% CI 1.3-6.0) were independently associated with SSI. At 3 months and 1 year, SSI was significantly associated with MALE (including surgical wound debridement, subsequent thrombectomy, major amputation), length of hospital stay, and all-cause mortality. CONCLUSION: The ASA-Physical Status should be considered in medical management when an infra-inguinal LEB is considered in frail patients, to prevent surgical complications.

Carer preparedness improved by providing a supportive educational intervention for carers of patients with high-grade glioma: RCT results.

BACKGROUND: High-grade glioma (HGG) is a rapidly progressing and debilitating disease. Family carers take on multiple responsibilities and experience high levels of distress. We aimed to deliver a nurse-led intervention (Care-IS) to carers to improve their preparedness to care and reduce distress. METHODS: We conducted a randomised controlled trial (ACTRN:12612001147875). Carers of HGG patients were recruited during patients' combined chemoradiation treatment. The complex intervention comprised four components: (1) initial telephone assessment of carer unmet needs; (2) tailored hard-copy resource folder; (3) home visit; and, (4) monthly telephone support for up to 12 months. Primary outcomes included preparedness for caregiving and distress at 2, 4, 6 and 12 months. Intervention effects were estimated using linear mixed models which included a time by group interaction. Secondary outcomes included anxiety, depression, quality of life, carer competence and strain. RESULTS: We randomised 188 carers (n = 98 intervention, n = 90 control). The intervention group reported significantly higher preparedness for caregiving at 4 months (model ß = 2.85, 95% CI 0.76-4.93) and all follow-up timepoints including 12 months (model ß = 4.35, 95% CI 2.08-6.62), compared to the control group. However, there was no difference between groups in carer distress or any secondary outcomes. CONCLUSIONS: This intervention was effective in improving carer preparedness. However, carer distress was not reduced, potentially due to the debilitating/progressive nature of HGG and ongoing caring responsibilities. Future research must explore whether carer interventions can improve carer adjustment, self-efficacy and coping and how we support carers after bereavement. Additionally, research is needed to determine how to implement carer support into practice.

An angiosome-centred approach for TcpO2 electrode positioning.

Background: The latest guidelines propose a TcpO2 value of 30 mmHg to help to confirm the diagnosis of chronic limb threatening ischemia. However, placement of electrodes is not standardised. The relevance of an "angiosome-centred" approach for TcpO2 electrode positioning has never been evaluated. We therefore retrospectively analysed our TcpO2 results to study the impact of electrode placement on the different angiosomes of the foot. Patients and methods: Patients consulting the vascular medicine department laboratory for suspicion of CLTI using TcpO2 electrodes placement on the different angiosome arteries of the foot (first inter metatarsal space, lateral edge of the foot and plantar side of the foot) were included. As the mean intra-individual variation is reported to be 8 mmHg, a variation of mean TcpO2 for the 3 locations ≤8 mmHg was considered to be not clinically significant. Results: Thirty-four patients (34 ischemic legs) were analysed. The mean TcpO2 was higher at the lateral edge of the foot (55 mmHg) and plantar side of the foot (65 mmHg) than at the first intermetatarsal space (48 mmHg). There was no clinically significant variation of mean TcpO2 according to anterior/posterior tibial artery patency and fibular artery patency. This was present when stratifying on the number of patent arteries. Conclusions: The present study suggests that multi-electrode TcpO2 is not useful to assess tissue oxygenation in the different angiosomes of the foot to guide surgical decision; first intermetatarsal electrode alone would be preferred. TcpO2 seems rather to evaluate overall tissue oxygenation of the foot. Electrode location on the plantar side of the foot may overestimate results and lead to misinterpretation.

Acute aortoiliac occlusion in a patient with novel coronavirus disease-2019.

The severe acute respiratory syndrome novel coronavirus-2 pandemic is affecting almost every country in the world. Even if the major symptoms of coronavirus disease-2019 are respiratory, different symptoms at presentation are now recognized. Venous thromboembolism has been reported in infected patients and few but increasing cases of arterial thrombosis have been described. We report a case of acute aortoiliac and lower limb artery occlusions in a patient presenting with severe coronavirus disease-2019 infection. The mechanism of the occlusion seemed to be distal embolization from a floating thrombus in the aortic arch caused by a major inflammatory state and virus infection. The patient underwent aortoiliac and lower limb artery mechanical thrombectomy, but required unilateral major amputation.

Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Coeliac and Inferior Mesenteric Artery Status.

OBJECTIVE: The benefit of preventive treatment for superior mesenteric artery (SMA) stenosis remains uncertain. The latest European Society for Vascular Surgery (ESVS) guidelines remain unclear given the lack of data in the literature. The aim of this study was to evaluate asymptomatic SMA stenosis prognosis according to the presence of associated coeliac artery (CA) and/or inferior mesenteric artery (IMA) stenosis. METHODS: This was a single academic centre retrospective study. The entire computed tomography (CT) database of a single tertiary hospital was reviewed from 2009 to 2016. Two groups were defined: patients with isolated > 70% SMA stenosis (group A) and patients with both SMA and CA and/or IMA > 70% stenosis (group B). Patient medical histories were reviewed to determine the occurrence of mesenteric disease (MD) defined as development of acute mesenteric ischaemia (AMI) or chronic mesenteric ischaemia (CMI). RESULTS: Seventy-seven patients were included. Median follow up was 39 months. There were 24 patients in group A and 53 patients in group B. In group B, eight (10.4%) patients developed MD with a median onset of 50 months. AMI occurred in five patients with a median of 33 months and CMI in three patients with a median of 88 months. Patients of group B developed more MD (0% vs. 15.1%; p = .052). The five year survival rate was 45% without significant difference between groups. CONCLUSION: Patients with SMA stenosis associated with CA and/or IMA seem to have a higher risk of developing mesenteric ischaemia than patients with isolated SMA stenosis. Considering the low life expectancy of these patients, cardiovascular risk factor assessment and optimisation of medical treatment is essential. Preventive endovascular revascularisation could be discussed for patients with non-isolated > 70% SMA stenosis, taking into account life expectancy.

A Thrombosed Popliteal Aneurysm Ruptured in the Setting of Chronic Limb Ischemia: A Rare Complication that Can Occur at Long Term.

Rupture of a chronic thrombosed or excluded popliteal arterial aneurysm is rare, but has been previously reported in the literature. The management of a ruptured thrombosed popliteal aneurysm, in a context of chronic limb ischemia, raises the problem of latent ischemia and its outcome. In this case report, we present the first case of a ruptured thrombosed popliteal aneurysm in a patient presenting chronic ischemia.

Effects on Mortality and Cardiovascular Events of Adherence to Guideline-Recommended Therapy 4 Years after Lower Extremity Arterial Revascularization.

BACKGROUND: All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), and HMG-CoA-reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the current risk of cardiovascular (CV) events and mortality and also to evaluate the effect of pharmacologic treatment on patient's survival, CV events, and additional vascular surgery in vascularized LE-PAD patients. This observational, cohort study analyzed prospectively collected data of 140 consecutive patients after hospitalization for LE-PAD revascularization in the vascular surgery department of our university hospital, between January 1 and June 30, 2013. METHODS: Data from guideline-recommended classes of medications (ACE, ARB, statins, and antiplatelet agents or anticoagulation) were collected at the time of discharge to hospitalization and at the end of the follow-up. Information about mortality, CV events, and additional vascular surgery was collected during follow-up. RESULTS: The mean follow-up of patients was 41 months. Mortality and CV events concerned 24% and 12% of the patients, respectively, and additional vascular surgery was performed in 33% of the patients. There was no difference in mortality and CV event rates according to pharmacologic treatment. Additional vascular surgery rate of LE-PAD patients with best medical treatment tended to be lower than without (incidence rate ratio = 0.5777; 95% confidence interval, 0.3101-1.06; P = 0.08). Best medical treatment was prescribed in 54% of patients at discharge of hospitalization. This proportion (54%) was statistically unchanged at the end of follow-up. CONCLUSIONS: In this small cohort, we failed to show that best medical treatment decreased mortality or CV event rates, but it tended to be associated with decreased additional vascular surgery rate. Further studies taking into consideration the control of CV risk factors could be interesting to demonstrate better outcome from LE-PAD patients with best medical treatment compared with LE-PAD patients without. There is an urgent need for a more effective implementation of currently recommended medication and a continued search after more effective pharmacologic treatment options in LE-PAD.

Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study.

The aim of this pilot study was to test the feasibility and acceptability of a family carer intervention for carers of patients with high-grade glioma (HGG). The intervention consisted of: (1) an initial telephone assessment of carer needs; (2) a personalised tabbed resource file; (3) nurse-led home visit; and (4) ongoing telephone support. Two consumer representatives reviewed the intervention resources. The intervention was then piloted with participants who were the primary carer for patients undergoing treatment for HGG in Western Australia. Two consumers provided feedback on the resource, and 10 carers participated in the pilot. Positive feedback was received about the resource manual and intervention. Suggestions were also made for changes which were implemented into the trial. The surveys were shortened based on feedback. Participants identified a large range of issues during nursing assessments which would not otherwise be identified or addressed for carers receiving routine care. As a result of providing the intervention, the nurse was able to make referrals to address needs that were identified. This pilot study enabled us to refine and test the Care-IS intervention and test the feasibility and acceptability of proposed survey instruments. We were also able to estimate recruitment and retention and the overall study timeline required for the randomised controlled trial we are now conducting. It has also demonstrated the role of the nurse who delivered the intervention and allowed us to refine communication and referral pathways.

How Admission to a Vascular Surgery Department Improves Medical Treatment in Patients with Lower Extremity Peripheral Arterial Disease.

BACKGROUND: All patients with lower extremity peripheral arterial disease (LE-PAD) should benefit from recommended pharmacologic therapies including antiplatelet agents, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blockers (ARBs), and hydroxy-methyl-glutaryl-coenzyme A reductase inhibitors (statins). In the present study, this triple therapy was defined as the best medical treatment. This study was designed to determine the number of patients who received best medical treatment at admission and at discharge from a vascular surgery department. We also examined the number of patients who received adapted medical treatment and every pharmacologic class separately. Finally, we investigated whether there were differences in prescribing rates according to patient characteristics and cardiovascular history, clinical grade of LE-PAD, and the type of surgery practiced. MATERIALS AND METHODS: This study is a retrospective chart analysis of 140 consecutive patients admitted to the vascular surgery department of our university hospital, between January 1, 2013, and June 30, 2013. To be included, patients required a vascular surgery for peripheral arterial disease with atherosclerosis. Data from guideline-recommended classes of medications (antiplatelet agents, ACE, ARBs, and statins) at the time of admission and discharge were collected and compared. RESULTS: Best medical treatment was prescribed in 44% patients before hospital admission and in 50% at discharge (P = 0.10). Before hospital admission, 84% of patients had antiplatelet therapy compared with 96% at discharge (P = 0.0004); 73% had a statin, compared with 83% at discharge (P = 0.001); 64% had an ACE inhibitor or ARB, compared with 63% at the time of discharge (P = 1).The proportion of patients receiving best medical treatment at admission and discharge increased in case of coronary artery disease (P = 0.004). There was no difference in prescriptions of best medical treatment and best or adapted treatments at admission and discharge according to the severity of LE-PAD or type of revascularization. CONCLUSIONS: Admission to a vascular department significantly increased the rate of prescription of antiplatelet and statin therapy, but no significant improvement was achieved for the prescription of best medical treatment and best or adapted treatments.

BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301).

BACKGROUND: Despite adequate trans-urethral resection of the bladder tumour (TURBT), non-muscle-invasive bladder cancer (NMIBC) is associated with high rates of recurrence and progression. Instillation of Bacillus Calmette-Guérin (BCG) into the urinary bladder after TURBT (adjuvant intravesical administration) reduces the risk of both recurrence and progression, and this is therefore the standard of care for high-risk tumours. However, over 30 % of people still recur or progress despite optimal delivery of BCG. Our meta-analysis suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both mitomycin and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase III trial using standard techniques for intravesical administration. METHODS AND DESIGN: The BCG + MMC trial (ANZUP 1301) is an open-label, randomised, stratified, two-arm multi-centre phase III trial comparing the efficacy and safety of standard intravesical therapy (BCG alone) against experimental intravesical therapy (BCG and mitomycin) in the treatment of adults with resected, high-risk NMIBC. Participants in the control group receive standard treatment with induction (weekly BCG for six weeks) followed by maintenance (four-weekly BCG for ten months). Participants in the experimental group receive induction (BCG weeks 1, 2, 4, 5, 7, and 8; mitomycin weeks 3, 6, and 9) followed by four-weekly maintenance (mitomycin weeks 13, 17, 25, 29, 37, and 41; BCG weeks 21, 33, and 45). The trial aims to include 500 participants who will be centrally randomised to one of the two treatment groups in a 1:1 ratio stratified by T-stage, presence of CIS, and study site. The primary endpoint is disease-free survival; secondary endpoints are disease activity, time to recurrence, time to progression, safety, health-related quality of life, overall survival, feasibility, and resource use. TRIAL REGISTRATION: This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12613000513718 ).

The management of acute adverse effects of breast cancer treatment in general practice: a video-vignette study.

BACKGROUND: There has been a focus recently on the use of the Internet and email to deliver education interventions to general practitioners (GPs). The treatment of breast cancer may include surgery, radiotherapy, chemotherapy, and/or hormone treatment. These treatments may have acute adverse effects. GPs need more information on the diagnosis and management of specific adverse effects encountered immediately after cancer treatment. OBJECTIVE: The goal was to evaluate an Internet-based educational program developed for GPs to advise patients with acute adverse effects following breast cancer treatment. METHODS: During phase 1, participants viewed 6 video vignettes of actor-patients reporting 1 of 6 acute symptoms following surgery and chemotherapy and/or radiotherapy treatment. GPs indicated their diagnosis and proposed management through an online survey program. They received feedback about each scenario in the form of a specialist clinic letter, as if the patient had been seen at a specialist clinic after they had attended the GP. This letter incorporated extracts from local guidelines on the management of the symptoms presented. This feedback was sent to the GPs electronically on the same survey platform. In phase 2, all GPs were invited to manage similar cases as phase 1. Their proposed management was compared to the guidelines. McNemar test was used to compare data from phases 1 and 2, and logistic regression was used to explore the GP characteristics that were associated with inappropriate case management. RESULTS: A total of 50 GPs participated. Participants were younger and more likely to be female than other GPs in Australia. For 5 of 6 vignettes in phase 1, management was consistent with expert opinion in the minority of cases (6%-46%). Participant demographic characteristics had a variable effect on different management decisions in phase 1. The variables modeled explained 15%-28% of the differences observed. Diagnosis and management improved significantly in phase 2, especially for diarrhea, neutropenia, and seroma sample cases. The proportion of incorrect management responses was reduced to a minimum (25.3%-49.3%) in phase 2. CONCLUSIONS: There was evidence that providing feedback by experts on specific cases had an impact on GPs' knowledge about how to appropriately manage acute treatment adverse effects. This educational intervention could be targeted to support the implementation of shared care during cancer treatment.

Early observations with an ERAS pathway for thyroid and parathyroid surgery: Moving the goalposts forward.

BACKGROUND: Enhanced recovery after surgery pathways have become the standard of care in various surgical specialties. In this study, we discuss our initial experience with a staged enhanced recovery after surgery pathway in endocrine surgery and assess the impact of this pathway on select perioperative outcomes and unanticipated admissions. METHODS: We collected information regarding all thyroid/parathyroid surgeries performed by endocrine surgeons at our institution before and after the implementation of the multi-intervention enhanced recovery after surgery pathway. We compared relevant outcomes for all cases 1 year before (n = 479) and 1 year after (n = 166) implementation of the pathway. We also compared outcomes between enhanced recovery after surgery patient groups with varying levels of enhanced recovery after surgery compliance. RESULTS: Enhanced recovery after surgery was associated with a significant decrease in total length of stay (9.2 vs 7.5 hours, P < .0001). Whereas there was no significant decrease in all-cause unanticipated postoperative admissions, there was a decrease in patient-initiated admissions in the Enhanced recovery after surgery group. There was also a significant decrease in mean postoperative morphine milligram equivalents (14.4 vs 16.2 vs 24.8, P = .0015), average daily morphine milligram equivalents (25.6 vs 45.6 vs 53, P < .0001), and average daily pain scores (1.89 vs 2.38 vs 2.74, P = .0045) in the Enhanced recovery after surgery group (particularly with increasing Enhanced recovery after surgery compliance). There were no significant differences in the requirement for postoperative antiemetics or in the post-anesthesia care unit length of stay. CONCLUSION: This study demonstrates a significant benefit from Enhanced recovery after surgery pathways for thyroidectomies and parathyroidectomies, even with initial data and a staggered roll-out plan. Further directions include a follow-up study once we reach a higher level of institutional compliance with all components of the Enhanced Recovery After Surgery pathway and a prospective trial to identify the relative significance of different portions of the Enhanced Recovery after Surgery pathway, particularly the superficial cervical plexus block.

NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma.

Background: There is an immunologic rationale to evaluate immunotherapy in the older glioblastoma population, who have been underrepresented in prior trials. The NUTMEG study evaluated the combination of nivolumab and temozolomide in patients with glioblastoma aged 65 years and older. Methods: NUTMEG was a multicenter 2:1 randomized phase II trial for patients with newly diagnosed glioblastoma aged 65 years and older. The experimental arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant nivolumab and temozolomide. The standard arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant temozolomide. The primary objective was to improve overall survival (OS) in the experimental arm. Results: A total of 103 participants were randomized, with 69 in the experimental arm and 34 in the standard arm. The median (range) age was 73 (65-88) years. After 37 months of follow-up, the median OS was 11.6 months (95% CI, 9.7-13.4) in the experimental arm and 11.8 months (95% CI, 8.3-14.8) in the standard arm. For the experimental arm relative to the standard arm, the OS hazard ratio was 0.85 (95% CI, 0.54-1.33). In the experimental arm, there were three grade 3 immune-related adverse events which resolved, with no unexpected serious adverse events. Conclusions: Due to insufficient evidence of benefit with nivolumab, the decision was made not to transition to a phase III trial. No new safety signals were identified with nivolumab. This complements the existing series of immunotherapy trials. Research is needed to identify biomarkers and new strategies including combinations.

Reference Probe for TcpO2 at Rest: A Systematic Review.

(1) Background: Transcutaneous oxygen pressure (TcpO2) is used to determine the severity of lower extremity arterial disease (LEAD). Many authors used a ratio of limb to chest TcpO2, also called the regional perfusion index (RPI), which should be independent of variations in oxygen delivery and reflective of local limb oxygen supply. The relevance of a reference probe-positioned TcpO2 electrode is debated. We aimed to review the relevance of the reference probe in previous studies using rest TcpO2. (2) Methods: We searched Medline and the Cochrane Central Register of Controlled Trials on 22 September 2022 using keywords related to TcpO2, reference probe and LEAD. (3) Results/Discussion: Fifteen studies were included in the review. Nine studies investigated LEAD severity (n = 9), amputation healing predication (n = 4), surgical outcome prediction (n = 2), therapeutic effect (n = 3) and difference according to diabetic status (n = 1). Four studies investigated more than 1 indication. Among 12 (16.7%) studies using RPI, only two authors found a benefit of using RPI instead of absolute TcpO2. Using only univariate analysis, one author reported that RPI was significantly related to viability at 1 year, while distal TcpO2 was not, on 13 limbs. The following year, the same author published a new study including 118 limbs that reported that RPI and absolute TcPO2 were both prognostic factors for limb viability at 1 year using a multivariate model. (4) Conclusions: Only one study firmly supporting the use of RPI, calculated using a reference probe on the arm, to predict BKA healing. Prospective studies are needed to validate this result; for other indications there is insufficient data supporting the use of a TcpO2 reference probe at rest.