An international, multispecialty, expert-based Delphi Consensus document on controversial issues in the management of patients with asymptomatic and symptomatic carotid stenosis.

OBJECTIVE: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear. METHODS: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response. RESULTS: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence. CONCLUSIONS: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research.

Mobile health technologies to improve walking distance in people with intermittent claudication.

BACKGROUND: Peripheral arterial disease (PAD) is the obstruction or narrowing of the large arteries of the lower limbs, which can result in impaired oxygen supply to the muscle and other tissues during exercise, or even at rest in more severe cases. PAD is classified into five categories (Fontaine classification). It may be asymptomatic or various levels of claudication pain may be present; at a later stage, there may be ulceration or gangrene of the limb, with amputation occasionally being required. About 20% of people with PAD suffer from intermittent claudication (IC), which is muscular discomfort in the lower extremities induced by exertion and relieved by rest within 10 minutes; IC causes restriction of movement in daily life. Treatment for people with IC involves addressing lifestyle risk factors. Exercise is an important part of treatment, but supervised exercise programmes for individuals with IC have low engagement levels and high attrition rates. The use of mobile technologies has been suggested as a new way to engage people with IC in walking exercise interventions. The novelty of the intervention, low cost for the user, automation, and ease of access are some of the advantages mobile health (mhealth) technologies provide that give them the potential to be effective in boosting physical activity in adults. OBJECTIVES: To assess the benefits and harms of mobile health (mhealth) technologies to improve walking distance in people with intermittent claudication. SEARCH METHODS: The Cochrane Vascular Information Specialist conducted systematic searches of the Cochrane Vascular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and CINAHL, and also searched the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov. The most recent searches were carried out on 19 December 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in people aged 18 years or over with symptomatic PAD and a clinical diagnosis of IC. We included RCTs comparing mhealth interventions to improve walking distance versus usual care (no intervention or non-exercise advice), exercise advice, or supervised exercise programmes. We excluded people with chronic limb-threatening ischaemia (Fontaine III and IV). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were change in absolute walking distance from baseline, change in claudication distance from baseline, amputation-free survival, revascularisation-free survival. Our secondary outcomes were major adverse cardiovascular events, major adverse limb events, above-ankle amputation, quality of life, and adverse events. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included four RCTs involving a total of 614 participants with a clinical diagnosis of IC. The duration of intervention of the four included RCTs ranged from 3 to 12 months. Participants were randomised to either mhealth or control (usual care or supervised exercise programme). All four studies had an unclear or high risk of bias in one or several domains. The most prevalent risk of bias was in the area of performance bias, which was rated high risk as it is not possible to blind participants and personnel in this type of trial. Based on GRADE criteria, we downgraded the certainty of the evidence to low, due to concerns about risk of bias, imprecision, and clinical inconsistency. Comparing mhealth with usual care, there was no clear evidence of an effect on absolute walking distance (mean difference 9.99 metres, 95% confidence interval (CI) -27.96 to 47.93; 2 studies, 503 participants; low-certainty evidence). None of the included studies reported on change in claudication walking distance, amputation-free survival, or revascularisation-free survival. Only one study reported on major adverse cardiovascular events (MACE) and found no clear difference between groups (risk ratio 1.37, 95% CI 0.07 to 28.17; 1 study, 305 participants; low-certainty evidence). None of the included studies reported on major adverse limb events (MALE) or above-ankle amputations. AUTHORS' CONCLUSIONS: Mobile health technologies can be used to provide lifestyle interventions for people with chronic conditions, such as IC. We identified a limited number of studies that met our inclusion criteria. We found no clear difference between mhealth and usual care in improving absolute walking distance in people with IC; however, we judged the evidence to be low certainty. Larger, well-designed RCTs are needed to provide adequate statistical power to reliably evaluate the effects of mhealth technologies on walking distance in people with IC.

Barriers and challenges faced by orthodontists in providing orthodontic care and implementing new innovative technologies in the field of orthodontics among children and adults: a qualitative study.

Orthodontic treatment requires the cooperation of patients as well as orthodontists. Therefore, the aim of the study was to investigate and address the challenges and barriers orthodontists have in achieving the desired orthodontic results, as well as make recommendations for ways to address the stated problems and introduce new innovative technologies to the area of orthodontics. This qualitative study wasbased on the grounded theory. Twelve orthodontists participated in face-to-face interviews, which were primarily comprised of open-ended questions. Data analysis was carried out manually using the "by hand" method. Orthodontists between the age group of 29-42 were interviewed. The answers varied depending on the years of experience of the interviewees. Teenagers and boys were found to be most non-compliant with the treatment. The average treatment span ranged between 6 months for mild cases up to 3 years for severe orthodontic cases occurring most commonly in government hospitals. Patient compliance plays a major role in orthodontics. Poor oral hygiene maintenance, brackets breakage by patients, and missed appointments were the major concerns mentioned by participants and hindered getting the desired results. Patients' main worries were related to the cost of therapy, premolar extractions, the length of treatment, and the possibility of relapse. Patient counseling and reinforcement at the start of the treatment can help to overcome the challenges and barriers in orthodontics since patient motivation is a very important factor in obtaining the desired results. It is recommended to conduct more training sessions for the orthodontists in order to introduce them to new technological paradigms.

A comprehensive review of vascular complications in COVID-19.

This study aims to review the available literature pertinent to vascular complications in COVID-19. A systematic search was performed using PubMed and Google Scholar to identify all relevant studies based on our study objective. Multiple studies have reported widespread systemic inflammation and procoagulant/hypercoagulable state in COVID-19, including thrombotic microangiopathy, endothelial dysfunction, bleeding disorder, and thrombosis. However, large specialised studies on vascular complications are lacking despite current evidence indicating dysfunctional coagulation pathways. Furthermore, there are no clear and definitive recommendations regarding thromboprophylaxis or full therapeutic anticoagulation in COVID-19. Several studies have reported hypercoagulability and vascular complications as important predictors of patient outcome in COVID-19. Therefore, it is important to understand the pathogenesis, epidemiology, management, and outcomes of patients who develop venous or arterial thrombosis and those with a pre-existing thrombotic disease who contract COVID-19 for risk stratification, thromboprophylaxis, optimal antithrombotic therapy during active infection and long-term anticoagulation following discharge or recovery.

Endovascular versus conventional open surgical repair for thoracoabdominal aortic aneurysms.

BACKGROUND: Thoracoabdominal aortic aneurysms (TAAAs) are a life-threatening condition which remain difficult to treat. Endovascular and open surgical repair (OSR) provide treatment options for patients, however, due to the lack of clinical trials comparing these, the optimum treatment option is unknown. OBJECTIVES: To assess the effectiveness and safety of endovascular repair versus conventional OSR for the treatment of TAAAs. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 26 April 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations. SELECTION CRITERIA: We considered all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing endovascular repair to OSR for TAAAs for inclusion in the review. The main outcomes of interest were prevention of aneurysm rupture (participants without aneurysm rupture up to 5 years from intervention), aneurysm-related mortality (30 days and 12 months), all-cause mortality, spinal cord ischaemia (paraplegia, paraparesis), visceral arterial branch compromise causing mesenteric ischaemia or renal failure, and rate of reintervention. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles and abstracts identified from the searches to identify those that met the inclusion criteria. We planned to undertake data collection, risk of bias assessment, and analysis in accordance with Cochrane recommendations. We planned to assess the certainty of the evidence using GRADE. MAIN RESULTS: No RCTs or CCTs met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: Due to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of endovascular compared to OSR in patients with TAAAs and are unable to provide any evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs addressing this objective are necessary, however conducting such studies will be logistically and ethically challenging for this life-threatening disease.

Hybrid Deep Venous ARterialisation (DVAR) for No-Option Chronic Limb Threatening Ischemia.

BACKGROUND: Hybrid Deep Venous ARterialisation (DVAR) is offered as a last-ditch attempt for limb salvage in patients with chronic limb threatening ischemia (CLTI). It provides non-selective arterialisation independent of the angiosome, which harnesses the complex venous capillary network bed developed in the leg and foot. METHODS: We present two elderly men who underwent DVAR to salvage limb with CLTI. DVAR was performed by creating an arteriovenous connection by anastomosis of the great saphenous vein (GSV) at the level of the distal popliteal and proximal tibio-peroneal trunk. Fasciotomy was performed over the length of the GSV. Subsequently, proximal in-situ catheter valvotomies of the GSV valves were undergone with the adjuvant on-table balloon maturation. The distal tarsal veins underwent balloon valvotomy under direct vision with subsequent proximal and distal tarsal veins valvuloplasties. Completion angiogram demonstrated restoration of the flow in the foot and both the patients were relieved of rest pain. CONCLUSION: We successfully performed DVAR in 2 elderly patients. Our experience shows that DVAR is a simple and safe option that is easily reproducible without the need for complex endovascular hardware, only if a suitable GSV to the foot is available with no history of deep vein thrombosis.

Optimal Management of Asymptomatic Carotid Stenosis in 2021: The Jury is Still Out. An International, Multispecialty, Expert Review and Position Statement.

OBJECTIVES: The recommendations of international guidelines for the management of asymptomatic carotid stenosis (ACS) often vary considerably and extend from a conservative approach with risk factor modification and best medical treatment (BMT) alone, to a more aggressive approach with a carotid intervention plus BMT. The aim of the current multispecialty position statement is to reconcile the conflicting views on the topic. MATERIALS AND METHODS: A literature review was performed with a focus on data from recent studies. RESULTS: Several clinical and imaging high-risk features have been identified that are associated with an increased long-term ipsilateral ischemic stroke risk in patients with ACS. Such high-risk clinical/imaging features include intraplaque hemorrhage, impaired cerebrovascular reserve, carotid plaque echolucency/ulceration/ neovascularization, a lipid-rich necrotic core, a thin or ruptured fibrous cap, silent brain infarction, a contralateral transient ischemic attack/stroke episode, male patients < 75 years and microembolic signals on transcranial Doppler. There is growing evidence that 80-99% ACS indicate a higher stroke risk than 50-79% stenoses. CONCLUSIONS: Although aggressive risk factor control and BMT should be implemented in all ACS patients, several high-risk features that may increase the risk of a future cerebrovascular event are now documented. Consequently, some guidelines recommend a prophylactic carotid intervention in high-risk patients to prevent future cerebrovascular events. Until the results of the much-anticipated randomized controlled trials emerge, the jury is still out regarding the optimal management of ACS patients.

Surgical and radiological interventions for treating symptomatic extracranial cervical artery dissection.

BACKGROUND: Cervical artery dissection (CeAD) is a pathological bleed or tear, or both, in the wall of the carotid or vertebral arteries as they course through the neck, and is a leading cause of stroke in young people. OBJECTIVES: To assess the effectiveness of surgical and radiological interventions versus best medical treatment alone for treating symptomatic cervical artery dissection. SEARCH METHODS: We performed comprehensive searches of the Cochrane Stroke Group Trials Register (last searched March 2020), the Cochrane Central Register of Controlled Trials (CENTRAL), 2020, Issue 4, in the Cochrane Library (searched March 2020), MEDLINE (1946 to March 2020) and Embase (1974 to March 2020). We searched relevant ongoing trials and research registers (searched March 2020), checked references in all relevant papers for additional eligible studies, and contacted authors and researchers in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of either surgical or endovascular intervention for the management of symptomatic CeAD were eligible for inclusion. Only studies with anticoagulants or antiplatelet treatment as the control group were included. Two review authors planned to independently extract data. DATA COLLECTION AND ANALYSIS: Primary outcomes were ipsilateral stroke and disability. Secondary outcomes were death, any stroke, or transient ischaemic attack, residual stenosis (> 50%), recurrence of cervical dissection, expanding pseudoaneurysm, or major bleeding. We analysed the studies according to the first choice of treatment. We planned to assess for risk of bias and apply GRADE criteria for any included studies. MAIN RESULTS: We did not find any completed RCTs or CCTs undertaken in this area of research. AUTHORS' CONCLUSIONS: No RCTs or CCTs compared either surgery or endovascular therapy with control. Thus, there is no available evidence to support their use for the treatment of extracranial cervical artery dissection in addition to antithrombotic therapy in people who continue to have neurological symptoms when treated with antithrombotic therapy alone.

Endovascular versus open surgical repair for complicated chronic Type B aortic dissection.

BACKGROUND: Type B aortic dissection can lead to serious and life-threatening complications such as aortic rupture, stroke, renal failure, and paraplegia, all of which require intervention. Traditionally, these complications have been treated with open surgery. Recently however, endovascular repair has been proposed as an alternative. OBJECTIVES: To assess the effectiveness and safety of thoracic aortic endovascular repair versus open surgical repair for treatment of complicated chronic Type B aortic dissection (CBAD). SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and AMED databases, as well as the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 2 August 2021. We searched references of relevant articles retrieved through the electronic search for additional citations. SELECTION CRITERIA: We considered all randomised controlled trials (RCTs) and controlled clinical trials (CCTs) assessing the effects of thoracic aortic endovascular repair (TEVAR) versus open surgical repair (OSR) for treatment of complicated chronic Type B aortic dissection (CBAD). Outcomes of interest were mortality (all-cause, dissection-related), neurological sequelae (stroke, spinal cord ischaemia/paresis-paralysis, vertebral insufficiency), morphological outcomes (false lumen thrombosis, progression of dissection, aortic diameters), acute renal failure, ischaemic symptoms (visceral ischaemia, limb ischaemia), re-intervention, and health-related quality of life. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles and abstracts identified by the searches to identify those that met the inclusion criteria. From title and abstract screening, we did not identify any trials (RCTs or CCTs) that required full-text assessment. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of evidence using GRADE. MAIN RESULTS: We did not identify any trials (RCTs or CCTs) that met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: Due to lack of RCTs or CCTs investigating the effectiveness and safety of TEVAR compared to OSR for patients with complicated CBAD, we are unable to provide any evidence to inform decision-making on the optimal intervention for these patients. High-quality RCTs or CCTs addressing this objective are necessary. However, conducting such studies will be challenging for this life-threatening disease.

Hybrid repair versus conventional open repair for aortic arch dissection.

BACKGROUND: A dissection of the aorta is a separation or tear of the intima from the media. This tear allows blood to flow not only through the original aortic flow channel (known as the true lumen), but also through a second channel between the intima and media (known as the false lumen). Aortic dissection is a life-threatening condition which can be rapidly fatal. There is debate on the optimal surgical approach for aortic arch dissection. People with ascending aortic dissection have poor rates of survival. Currently open surgical repair is regarded as the standard treatment for aortic arch dissection. We intend to review the role of hybrid and open repair in aortic arch dissection. OBJECTIVES: To assess the effectiveness and safety of a hybrid technique of treatment over conventional open repair in the management of aortic arch dissection. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 8 February 2021. We also undertook reference checking for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and clinical controlled trials (CCTs), which compared the effects of hybrid repair techniques versus open surgical repair of aortic arch dissection. Outcomes of interest were dissection-related mortality and all-cause mortality, neurological deficit, cardiac injury, respiratory compromise, renal ischaemia, false lumen thrombosis (defined by partial or complete thrombosis) and mesenteric ischaemia. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all records identified by the literature searches to identify those that met our inclusion criteria. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. We planned to assess the certainty of the evidence using GRADE. MAIN RESULTS: We identified one ongoing study and two unpublished studies that met the inclusion criteria for the review. Due to a lack of study data, we could not compare the outcomes of hybrid repair to conventional open repair for aortic arch dissection. AUTHORS' CONCLUSIONS: This review revealed one ongoing RCT and two unpublished RCTs evaluating hybrid versus conventional open repair for aortic arch surgery. Observational data suggest that hybrid repair for aortic arch dissection could potentially be favourable, but conclusions can not be drawn from these studies, which are highly selective, and are based on the clinical status of the patient, the presence of comorbidities and the skills of the operators. However, a conclusion about its definitive benefit over conventional open surgical repair cannot be made from this review without published RCTs or CCTs. Future RCTs or CCTs need to have adequate sample sizes and follow-up, and assess clinically-relevant outcomes, in order to determine the optimal treatment for people with aortic arch dissection. It must be noted that this may not be feasible, due to the reasons mentioned.

Hybrid repair versus conventional open repair for thoracic aortic arch aneurysms.

BACKGROUND: Thoracic aortic arch aneurysms (TAAs) can be a life-threatening condition due to the potential risk of rupture. Treatment is recommended when the risk of rupture is greater than the risk of surgical complications. Depending on the cause, size and growth rate of the TAA, treatment may vary from close observation to emergency surgery. Aneurysms of the thoracic aorta can be managed by a number of surgical techniques. Open surgical repair (OSR) of aneurysms involves either partial or total replacement of the aorta, which is dependent on the extent of the diseased segment of the aorta. During OSR, the aneurysm is replaced with a synthetic graft. Hybrid repair (HR) involves a combination of open surgery with endovascular aortic stent graft placement. Hybrid repair requires varying degrees of invasiveness, depending on the number of supra-aortic branches that require debranching. The hybrid technique that combines supra-aortic vascular debranching with stent grafting of the aortic arch has been introduced as a therapeutic alternative. However, the short- and long-term outcomes of HR remain unclear, due to technical difficulties and complications as a result of the angulation of the aortic arch as well as handling of the arch during surgery. OBJECTIVES: To assess the effectiveness and safety of HR versus conventional OSR for the treatment of TAAs. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 22 March 2021. We also searched references of relevant articles retrieved from the electronic search for additional citations. SELECTION CRITERIA: We considered for inclusion in the review all published and unpublished randomised controlled trials (RCTs) and controlled clinical trials (CCTs) comparing HR to OSR for TAAs. DATA COLLECTION AND ANALYSIS: Two review authors independently screened all titles and abstracts obtained from the literature search to identify those that met the inclusion criteria. We retrieved the full text of studies deemed as potentially relevant by at least one review author. The same review authors screened the full-text articles independently for inclusion or exclusion. MAIN RESULTS: No RCTs or CCTs met the inclusion criteria for this review. AUTHORS' CONCLUSIONS: Due to the lack of RCTs or CCTs, we were unable to determine the safety and effectiveness of HR compared to OSR in people with TAAs, and we are unable to provide high-certainty evidence on the optimal surgical intervention for this cohort of patients. High-quality RCTs or CCTs are necessary, addressing the objective of this review.

Management of Concealed Type IV Endoleak and Aortic Sac Hygroma by Prone ContrASt EnHancement Computed Tomography Angiography.

BACKGROUND: Aortic sac hygroma and concealed endoleaks (EL) after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm needs particular attention with aggressive management as they are associated with rapid sac expansion and rupture risk. However, they can be erroneously reported as type IV or V EL with supine computed tomography (CT) scans, leading to delay in management. Therefore, we describe a novel diagnostic technique, 'Prone contrASt enHanced computed tomography Angiography' (PASHA), to document concealed EL METHODS: We present eight case descriptions with continuous sac expansion after primary EVAR. Management began with diagnosis using the PASHA imaging technique. PASHA is a multiphase CTA positional technique for increasing the accuracy of detecting EL after EVAR. Furthermore, the PASHA imaging technique also guides whether the open or endovascular intervention could be used effectively to manage the sac expansion. In synchrony with the PASHA technique, "EVAR GORE SalvAge FAbric Technique" (ARAFAT) was to salvage previous EVAR. RESULTS: The PASHA technique diagnosed all cases of type IIIb EL, as it enhanced the degree of contrast infiltration into the aortic sac when microleaks were present. ARAFAT was effectively used in five elderly patients. Another three had an open conversion; two with double breasting of the aortic sac and one EVAR explantation. CONCLUSIONS: The PASHA protocol helped classify and localize the concealed EL (type IV, V), which were not appropriately diagnosed by supine CT protocols. PASHA and ARAFAT were used as a fully functioning protocol to overcome apparent challenges in accurate diagnosis and subsequent concealed EL management in high-risk patients.

Significance of Distal Runoff Score as a Key Influencer on Clinical Outcomes after Endovascular Interventions for Superficial Femoral Artery Disease.

BACKGROUND: Endovascular therapy (EVT) is being adopted by many surgeons as a suitable first choice in the treatment of most femoropopliteal disease when clinically indicated. However, there are multiple factors affecting the outcome of EVT including the anatomy of lesions and distal runoff status. The evidence of runoff effect on the outcome of superficial femoral artery (SFA) interventions is still scarce and not well studied in the current literature. The aim of this study was to investigate the effect of runoff score on the outcomes of SFA endovascular interventions. METHODS: Retrospective analysis was carried out on prospectively collected data on patients who underwent SFA endovascular intervention for critical limb ischemia (CLI) in a single tertiary center. Patients with Rutherford categories 4, 5, and 6 who did not have any previous vascular interventions were included in the study. The modified SVS runoff score was used after calculating scores from popliteal and all tibial vessels. Runoff was stratified into good (score <5), compromised (score 5-10), and poor (score >10). Amputation-free survival, patency rates, and overall survival were compared between all groups at 5 years. RESULTS: Between 2011 and 2018, 254 procedures were performed in 220 patients. Technical success was >92%; 66 patients required SFA stents, and 55 had concomitant tibial angioplasty. There was no significant difference between good, compromised, or poor runoff groups regarding complication rates, with 3.5% overall perioperative mortality (5 cases in the compromised group and 4 in the poor runoff group). A runoff score of <5 was associated with significantly marked clinical improvement (P < 0.001). Patency rates were significantly worse in the compromised and poor runoff groups, with 5-year cumulative primary patency rates of 80%, 50%, and 22% in the good, compromised, and poor runoff groups, respectively (P < 0.001). Amputation-free survival worsened as the runoff got poorer with 98%, 91%, and 78% in the good, compromised, and poor runoff groups, respectively, at 5 years (P < 0.001). SFA stenting and concomitant tibial angioplasty led to slight improvement in patency rates in the poor runoff group. CONCLUSIONS: Poor runoff with a score of >10 was associated with significantly reduced amputation-free survival and patency rates at 5 years in patients undergoing SFA endovascular intervention for CLI. Patients with a runoff score of <5 showed marked clinical improvement postoperatively when compared with patients with a runoff score of ≥5.

Antimalarial and cytotoxic drugs on COVID-19 and the cardiovascular burden: Literature review and lessons to be learned.

BACKGROUND: The world is witnessing an unprecedented crisis with Coronavirus disease 2019 (COVID-19). It is important to accurately analyze the available evidence to provide correct clinical guidance for optimal patient care. We aim to discuss current clinical evidence regarding chloroquine, hydroxychloroquine, azithromycin, remdesivir, and the cardiovascular burden of COVID-19. METHODS: A literature review was performed using PubMed and Google Scholar. Additional clinical trials were identified through the "TrialsTracker" project. RESULTS: We found conflicting evidence of chloroquine, hydroxychloroquine plus azithromycin, and remdesivir in COVID-19 despite promising early reports of in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2. Some of the current studies have demonstrated adverse drug reactions to chloroquine and hydroxychloroquine + azithromycin. Widespread systemic inflammation and procoagulant/hypercoagulable state, including thrombotic microangiopathy, endothelial dysfunction, bleeding disorder, and thrombosis are increasingly being witnessed in COVID-19. Evidence of cardiac injury and stroke is mostly reported in hospitalized patients; however, large specialized studies that focus on cardiac or neuropathology are lacking. DISCUSSION: There is no convincing clinical evidence of chloroquine, hydroxychloroquine with or without azithromycin, and remdesivir use in COVID-19. As evidence of systemic inflammation is rapidly unfolding, there is a dire need to maximize our resources to find the best possible solutions to the current crisis while conclusive evidence from clinical trials emerges.

Effect of virtual cement gap settings on the marginal fit of cemented resin-ceramic crowns on implant abutments.

STATEMENT OF PROBLEM: Agreement on the perfect virtual cement space value for computer-aided design and computer-aided manufacturing (CAD-CAM) implant-supported resin-ceramic crowns with the best marginal adaptation is lacking. The range of cement gap settings in some CAD design software programs is wide (0 to 200 µm), and manufacturer recommendations regarding the best cement gap setting for certain types of ceramics is not specific. PURPOSE: The purpose of this in vitro study was to evaluate the effect of virtual cement gap settings on the marginal fit of cemented resin-ceramic crowns on implant abutments. MATERIAL AND METHODS: Thirty implant analogs and matching stock abutments were coupled and implanted into autopolymerizing acrylic resin blocks. Three groups (n=10) of resin-ceramic molar crowns with 3 different virtual cement space settings (40, 60, and 100 µm) were designed by using a CAD design software program. The crowns were cemented over their corresponding abutments under a static load by using a specially designed cementing device. A scanning electron microscope was used to measure the mean vertical marginal gap (MG) for each group, where a total of 120 measurements for each of the 3 groups (12 sites per crown and 10 crowns per group) were evaluated. One-way analysis of variance and the post hoc Tukey pairwise comparison tests were used to analyze the data (α=.05). RESULTS: A significant difference (P<.001) was found between the MG values of the resin-ceramic implant-supported crowns fabricated by using the 3 cement space settings. The smallest MG was obtained with the 60-µm setting as compared with the 40-µm and 100-µm settings. CONCLUSIONS: A limited inverse relation was found between the MGs of CAD-CAM-fabricated resin-ceramic implant-supported crowns and the cement gap settings in the exocad software program. The smallest MGs were obtained when a 60-µm cement space value was used (P<.001).

Safety of Triple Neuroprotection with Targeted Hypothermia, Controlled Induced Hypertension, and Barbiturate Infusion during Emergency Carotid Endarterectomy for Acute Stroke after Missing the 24 Hours Window Opportunity.

BACKGROUND: The aim of this study is to establish the initial safety of triple neuroprotection (TNP) in an acute stroke setting in patients presenting outside the window for systemic tissue plasminogen activator (tPA). METHODS: Over 12,000 patients were referred to our vascular services with carotid artery disease, of whom 832 had carotid intervention with a stroke rate of 0.72%. Of these, 25 patients presented (3%), between March 2015 and 2019, with acute dense stroke. These patients had either failed tPA or passed the recommended timing for acute stroke intervention. Fifteen (60%) had hemi-neglect with evidence of acute infarct on magnetic resonance imaging of the brain and a Rankin score of 4 or 5. Ninety-six percent had an 80-99% stenosis on the symptomatic side. Mean ABCD3-I score was 11.35. All patients underwent emergency carotid endarterectomy (CEA) with therapeutically induced hypothermia (32-34°C), targeted hypertension (systolic blood pressure 180-200 mm Hg), and brain suppression with barbiturate. RESULTS: There were no cases of myocardial infarction, death, cranial nerve injury, wound hematoma, or procedural bleeding. Mean hospital stay was 8.4 (±9.5) days. All cases had resolution of neurological symptoms, except 3 who had failed previous thrombolysis. Eighty percent had a postoperative Rankin score of 0 on discharge and 88% of patients were discharged home with 3 requiring rehabilitation. CONCLUSIONS: Positive neurological outcomes and no serious adverse events were observed using TNP during emergency CEA in patients with acute brain injury. We recommend TNP for patients who are at an increased risk of stroke perioperatively, or who have already suffered from an acute stroke beyond the recommended window of 24 hr. Certainly, the positive outcomes are not likely reproducible outside of high-volume units and patients requiring this surgery should be transferred to experienced surgeons in appropriate tertiary referral centers.

Staged Hybrid Single Lumen Reconstruction (TIGER) in Management of Chronic Symptomatic Complex Type B Aortic Dissection, Techniques, and Literature Review.

BACKGROUND: Endovascular intervention for chronic symptomatic type B aortic dissection (CS-TBAD) induces aortic wall stress with negative hemodynamic cardiovascular consequences. CS-TBAD risks increased morbidity and mortality due to septum maturation with significant impact on false lumen modulation, and partial lumen thrombosis conveying the worst outcome. The aim of the TIGER technique is total aortic remodeling with true lumen expansion, false lumen regression and complete thrombosis, and stabilization of overall aortic diameter. METHODS: We report 5 cases of aortic dissection with a mean follow-up of 16 months (6-28 months). All had aneurysmal dilation, with 3 having acute pan aortic dissection and 2 having CS-TBAD. All were managed by sTaged HybrId sinGle lumEn Reconstruction (TIGER). Our first approach was to create one single lumen from the supraceliac, infradiaphragmatic aorta to both common iliac arteries with open surgical patching of the visceral arteries; then, we performed a TEVAR 3 months later. RESULTS: Three patients required a left subclavian artery chimney graft and one required bilateral subclavian to carotid artery transposition. No spinal drainage was required, and all patients had intraoperative transesophageal echo for wire guidance. We had no aortic rupture or retrograde type A dissection, and we experienced no renal, visceral, cardiac, pulmonary, or spinal complications. All patients, but one, went off their antihypertensive medication. All patients had normal estimated glomerular filtration rate postoperatively, and they all demonstrated accelerated aortic modulation. CONCLUSIONS: TIGER was not only effective at the semiacute stage to initiate remodeling and prevent malperfusion, it also facilitated a straightforward TEVAR at stage 2, which was made easier by avoiding visceral branch stenting. Moreover, it decreased the length of aortic segment, which was stented, thereby avoiding critical shattering, branch dislodgment, and visceral compromise; spinal ischemia; and negative cardiovascular consequences.

Cost-effectiveness analysis of endovascular versus open repair of abdominal aortic aneurysm in a high-volume center.

OBJECTIVE: Endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs) is the standard treatment for anatomically suitable patients. EVAR has been associated with a lower perioperative morbidity and mortality compared with open surgical repair (OSR) at the expense of increased reinterventions and costs. We aimed to compare the outcomes of EVAR and OSR for elective AAA repair. The primary end point was cost per QALY at 3 years. Secondary end points were perioperative morbidity and mortality; freedom from reintervention; length of hospital, high-dependency unit, and intensive care unit stay; and freedom from all-cause mortality. METHODS: The project was approved by the Galway Clinical Research Ethics Committee. This project followed the Declaration of Helsinki. This was an audit of interventions that had already taken place. No active clinical intervention was undertaken, and patients' anonymity was preserved; thus, individual patient consent was not obtained. Data on all elective AAA repairs at a tertiary referral vascular center were collected from 2002 to 2015. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured on the basis of a quality-adjusted time without symptoms or toxicity assessment. Data were analyzed using parametric and nonparametric tests. RESULTS: Between 2002 and 2015, a total of 494 patients required elective AAA surgery; 401 underwent EVAR and 93 underwent OSR. Demographics and vascular-related risk factors were similar in both groups. Median (interquartile range) cost per QALY at 3 years was €5776 (€5541-€6481) for EVAR vs €7101 (€5812-€8952) for OSR (P < .001). EVAR was associated with reduced perioperative morbidity (12.2% vs 50%; P < .001). There was no significant association between procedure and perioperative mortality (EVAR, 1.7%; OSR, 4.3%; P = .130). There was no significant association found between the procedure and reintervention (P = .502). Our subgroup analysis found no association between procedure and improvement in all-cause mortality, QALYs, costs, or cost per QALY. CONCLUSIONS: EVAR is cost-effective with improved cost per QALY compared with OSR.

Q-TWiST and Cost-Effectiveness Analysis of Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a High Deliberate Practice Volume Center.

BACKGROUND: The objective of the study was to compare the cost-effectiveness of endovascular aortic repair (rEVAR) versus open surgical repair (rOSR) for ruptured abdominal aortic aneurysm (rAAA), where rEVAR is regularly performed outside of instructions for use (IFUs) (shorter and more angulated necks). Primary end point is incremental cost-effectiveness ratio (ICER) of rEVAR versus rOSR and aneurysm-related mortality. Secondary end points are cost per quality-adjusted life years (QALYs), perioperative morbidity and mortality, reintervention, and all-cause mortality. METHODS: All rAAA repairs performed between 2002 and 2016 in a single center were scrutinized. Between 2002 and 2007, most rAAAs were repaired using rOSR. From 2007 to 2016, we implemented a rEVAR with an anatomically possible protocol. During this time, severe angulation was rarely seen as a contraindication to rEVAR, and rEVAR was performed on aneurysms with an infrarenal aortic neck cranial to the aneurysm with a diameter of 20-33 mm and a length of at least 5 mm. Demographics and outcomes were reported according to the Society for Vascular Surgery guidelines. QALY was measured based on quality of time spent without symptoms of disease or toxicity of treatment (Q-TWiST) assessment. RESULTS: Eight hundred aneurysm surgeries were performed; of these, 135 were emergency surgeries of which 88 were for rAAA; (42 rEVARs and 46 rOSRs). Primary technical success (rEVAR 89.1% vs. rOSR 87.8%; P = 0.1), perioperative morbidity (rEVAR 56.5% vs. rOSR 64.3%; P = 0.457), and mortality (rEVAR 26.1% vs. rOSR 28.6%; P = 0.794) were nonsignificantly favorable in rEVAR patients. Freedom from reintervention was significantly lower in rEVAR patients at 3 years (rEVAR 74% vs. rOSR 90%; P = 0.038). Three-year aneurysm-related survival (rEVAR 65% vs. rOSR 62%; P = 0.848) and all-cause survival (rEVAR 56% vs. rOSR 51%; P = 0.577) were higher in rEVAR patients. At 3 years, rEVAR patients had a higher QALY of 1.671 versus OSR of 1.549 (P = 0.502). Operating room (P = 0.001) and total accommodation costs (P = 0.139) were lower in rEVAR patients, while equipment (P < 0.001), surveillance, and reintervention (P < 0.001) costs were higher. Median cost of rEVAR at 3 years was €23,352 vs. €20,494 for OSR (P < 0.084) (power>80%). Median cost per QALY of rEVAR at 3 years was €13,974 vs. €13,230 for rOSR (P = 0.296). ICER for rEVAR versus rOSR was €23,426 (95% confidence interval [CI] < €0 to > €30,000). At 3 years, the area under the curve and 95% CI for Q-TWiST was higher in rEVAR compared with OSR (rEVAR 500.819 vs. rOSR 437.838). CONCLUSIONS: There is no significant difference in cost or QALYs between rEVAR and rOSR even when rEVAR is performed on complex cases outside of IFU (shorter and more angulated necks). There is a significantly higher freedom from secondary intervention in rOSR patients compared with rEVAR patients at 3 years.

Female Gender as a Risk Factor for Adverse Outcomes After Carotid Revascularization.

BACKGROUND: We aim to identify gender differences in complications after carotid surgery. Our primary endpoint is the incidence of perioperative stroke, myocardial infarction, and mortality. Secondary endpoints include restenosis and reintervention rates. METHODS: All patients undergoing carotid endarterectomy from July 2003 to May 2016 were reviewed. The Society for Vascular Surgery carotid reporting standards were used as a guideline for data collection. RESULTS: Over 13 years, 9,585 patients with carotid disease were referred to our institution. A total of 690 procedures were performed (633 carotid endarterectomies, 54 carotid angioplasties and stenting, and 3 bypasses). Of these 633 carotid endarterectomy procedures, 31.8% (201) were in women and 68.2% (432) were in men. In the perioperative period, female gender was found to be an independent predictor of stroke (odds ratio [OR]: 8.597, 95% confidence interval [CI]: 0.967-76.429, P = 0.041), restenosis (OR: 2.103, 95% CI: 1.445-3.060, P < 0.001), and reintervention (OR: 6.448, 95% CI: 1.313-31.667, P = 0.019). Mortality and cardiac morbidity did not significantly differ between genders. Ten-year stroke-free survival was 98.0% in women and 99.1% in men (logrank P = 0.259). Ten-year restenosis-free survival was 77.6% (45 of 201) in women and 89.4% (45 of 425) in men (logrank P < 0.001). Ten-year reintervention-free survival was 97.0% in women and 99.5% in men (logrank P = 0.008). Female gender was not an independent predictor of myocardial infarction (P = 0.713) and mortality (P = 0.856), respectively. The mean follow-up time was 47.06 ± 37.48 months with a median follow-up time of 43 months (interquartile range: 14.0-72.5). CONCLUSIONS: Female gender was an independent predictor of postoperative stroke, restenosis, and reintervention. Symptom status at the time of surgery and type of closure of the arteriotomy did not influence development of stroke in female patients.