An Analysis of Cost-Effectiveness and Clinical Outcomes of a Comprehensive Aortic Service in a Tertiary Center over One Year.

BACKGROUND: Endovascular aortic repair (EVAR) is an established and attractive alternative to open surgical repair (OSR) of abdominal aortic aneurysms (AAA) due to its superior short-term safety profile. However, opinions are divided regarding its long-term cost-effectiveness. We compared the total yearly cost of running endovascular and OSR services in a single tertiary center to determine whether fenestrated EVAR (FEVAR) represents a clinically efficacious, affordable treatment option. METHODS: A single-center retrospective review was performed on 109 patients undergoing a procedure related to index or previous abdominal aortic repair, with 1 year follow-up. Data was collected from the National Vascular Registry and hospital records. The primary outcome was cost per quality-adjusted life year. Secondary outcomes included 30-day mortality and morbidity, reintervention rates, length of hospital stay, aneurysm, and all-cause mortality at 1 year for elective index procedures. RESULTS: The average cost per patient of all FEVAR was £16,041.53 (±8,857.54), £13,893.51 (±£21,425.25) for standard EVAR, and £15,357.22 (±£15,904.49) for OSR (FEVAR versus EVAR P = 0.55, FEVAR versus OSR P = 0.83, OSR versus EVAR P = 0.76). Of the secondary outcomes, significant findings included increased length of stay and respiratory morbidity for patients undergoing open versus endovascular repair. There was no significant difference in 30-day or 1-year mortality between groups. CONCLUSIONS: FEVAR, EVAR, and OSR all represent cost-effective options for aortic repair with similar outcomes. Our data highlights the potential for FEVAR to present a viable alternative to open repair, particularly in higher-risk groups, when performed in specialist centers.

Implantable Pressure-Sensing Devices for Monitoring Abdominal Aortic Aneurysms in Post-Endovascular Aneurysm Repair.

Over the past two decades, there has been extensive research into surveillance methods for the post-endovascular repair of abdominal aortic aneurysms, highlighting the importance of these technologies in supplementing or even replacing conventional image-screening modalities. This review aims to provide an overview of the current status of alternative surveillance solutions for endovascular aneurysm repair, while also identifying potential aneurysm features that could be used to develop novel monitoring technologies. It offers a comprehensive review of these recent clinical advances, comparing new and standard clinical practices. After introducing the clinical understanding of abdominal aortic aneurysms and exploring current treatment procedures, the paper discusses the current surveillance methods for endovascular repair, contrasting them with recent pressure-sensing technologies. The literature on three commercial pressure-sensing devices for post-endovascular repair surveillance is analyzed. Various pre-clinical and clinical studies assessing the safety and efficacy of these devices are reviewed, providing a comparative summary of their outcomes. The review of the results from pre-clinical and clinical studies suggests a consistent trend of decreased blood pressure in the excluded aneurysm sac post-repair. However, despite successful pressure readings from the aneurysm sac, no strong link has been established to translate these measurements into the presence or absence of endoleaks. Furthermore, the results do not allow for a conclusive determination of ongoing aneurysm sac growth. Consequently, a strong clinical need persists for monitoring endoleaks and aneurysm growth following endovascular repair.

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.

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.

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.

Kinetic Elephant Trunk Technique: Early Results in Chronic Symptomatic Aortic Dissection Management.

BACKGROUND: The aim was to expand our understanding of the dynamic evolution of the aorta throughout the dissection time course. We investigated how the disease process can be modulated to equalize lumen pressure, enhance perfusion, and stabilize the aorta along its entire length using the kinetic elephant trunk (kET) technique. METHODS: We performed the kET on 9 patients with chronic symptomatic aortic dissection (CSAD) as a primary or secondary intervention, regardless of the chronicity of the dissection. Endovascular scissoring of the intraluminal septum is performed in the infradiaphragmatic dissected aorta to equalize pressure between true and false lumens and allow all branched vessels to be supplied from one lumen. The Streamliner Multilayer Flow Modulator (SMFM), an uncovered cobalt-alloy aortic device, is deployed from the aortic sinus, covering the supra-aortic branches, distally into the distal aorta (primary intervention). In the case of a previous ascending aorta Dacron graft, the SMFM is deployed (secondary intervention) at the level of the Dacron graft so that it is overlapped with the graft and landed in the distal aorta. RESULTS: In the initial study period, all-cause and aortic-related survival were 100%, respectively; all great vessels and visceral branches were patent; and freedom of stroke, end-organ ischemia, paraplegia, and renal failure were 100%. CONCLUSIONS: The kET is a treatment process for managing CSAD. Its simplicity, consistency, and reproducibility in high-risk patients with low morbidity and mortality add to the armamentarium of the cardiovascular specialist. Further assessment of the medium- and long-term outcomes is needed to fully establish the benefits of kET.

Minimising failure in critical lower limb ischaemia intervention: Adjuvant capillary bed recruitment is the missed opportunity.

Critical limb ischaemia is the end stage of peripheral arterial disease before limb loss. Contemporary interventions to restore blood flow have high morbidity and mortality and fail to provide sustained restoration of peripheral circulation. Cell-based therapies designed to promote neovascularisation or angiogenesis have been shown in trials to be safe but clinically ineffective. Notwithstanding endless research in the area, no headway has been made in identifying a successful therapy designed specifically to target muscle disease in critical lower limb ischaemia. Thus, the quest to find an effective, lasting solution for critical lower limb ischaemia continues and requires more innovative therapeutic tactics. Our aim is to highlight the crucially interlinked role of the capillary bed, skeletal muscle mass and mitochondria in critical lower limb ischaemia patients and to identify novel therapeutic mechanisms that the vascular interventionalist can add to their armamentarium.

Stem Cell Smart Technology, where are we now and how far we have to go?

Approximately eight million people in the United States have peripheral arterial disease, which increases exponentially with age. There have been a plethora of available treatments including surgery, angioplasty, atherectomy, laser technology, and cell-based therapies. Cell-based therapies were developed in the hope of translating laboratory-based technology into clinical successes. However, clinical results have been disappointing. Infusion or injection for stem cell therapy is still considered experimental and investigational, and major questions on safety and durability have arisen. In no option patients, how can they be treated safely and successfully? In this article, we review contemporary practice for cell therapy, its pitfalls and breakthroughs, and look at the future ahead. We introduce a novel smart system for minimally invasive delivery of cell therapies, which exemplifies the next generation of endovascular solutions to stem cell technology and promises safety, efficacy, and reliability.

Quality of time spent without symptoms of disease or toxicity of treatment for transmetatarsal amputation versus digital amputation in diabetic patients with digital gangrene.

Aim We aim to compare the outcome of diabetic patients with gangrenous toes who were managed initially either by digital amputation or by transmetatarsal amputation. The null hypothesis is that transmetatarsal amputation had less theatre trips and better healing. Materials and Methods A parallel observational comparative study of all diabetic patients who underwent either digital or transmetatarsal amputation in a tertiary referral center from 2002 through 2015. Comorbid conditions, subsequent amputations, hospital stay, and readmission were noted. Results A total of 223 patients underwent minor amputation during the study period, of which 147 patients were diabetic and 76 patients were non-diabetic. Seventy-seven patients had digital amputation and 70 transmetatarsal amputation in diabetic patients. Demographics were similar in both groups. The median time to major amputation was (400 ± IQR 1205 days) in the digital amputation group, compared to 690 ± IQR 891 days in the transmetatarsal amputation group ( P = 0.974). 29.9% of digital amputations and 15.7% of transmetatarsal amputations in diabetic patients, required minor amputations or revision procedures ( P = 0.04). Median length of hospital stay was (20 days, IQR 27) in the digital group and (17 days, IQR17) in the transmetatarsal amputation group ( P = 0.17). Need for re-admission was 48.1% in digital patients compared to 50% in transmetatarsal amputation patients ( P = 0.81). Quality of time spent without symptoms of disease or toxicity of treatment (Q-TWiST) was (315 days, IQR 45) in digital group and (346 days, IQR 48) in the transmetatarsal amputation patients ( P = 0.099). Conclusion Despite the lack of statistical significance, transmetatarsal amputation offered better outcome in the diabetic patients, with less re-intervention rate, shorter hospital stays, less theatre trips, and longer time without toxicity (TWiST).

Common femoral artery endarterectomy in the age of endovascular therapy.

OBJECTIVES: Common femoral artery endarterectomy (CFE) is the standard treatment for common femoral artery occlusive disease. We aim to assess the medium term outcomes of CFE with or without further concomitant procedures. DESIGN: A retrospective observational study. METHODS: All patients who underwent either isolated CFE (ICFE), CFE with angioplasty for occlusive arterial disease (CFEA) or concomitant CFE with endovascular aortic aneurysm repair (CFEE) were included. Patient demographics follow up, clinical improvement, types of CFE closure, patency rates, and survival-free amputation were noted. RESULTS: From 2002 to 2015, 1512 patients were referred with a diagnosis of critical limb ischemia. Of those, 1134 required revascularization. Sixty-one patients underwent 66 CFE. Ten limbs underwent an ICFE, 35 had CFEA, and 21 underwent CFEE. Demographics were comparable in all groups. Twenty-seven were closed primarily, while 39 required patch closure (12 venous, 8 Dacron, 19 biological). Technical success was 100% in ICFEs, 94% in CFEA, and 100% for CFEE ( p = 0.274). Immediate clinical success was 100% in both CFE and CFEE, but was 85.7% in CFEA ( p = 0.035). Immediate hemodynamic success was similar in all three groups ( p = 0.73). Sustained hemodynamic success was 30% in ICFE, 54.3% in CFEA, and 23.8% in CFEE ( p = 0.056). At two years, the primary patency was 90% in ICFE, 74.3% in CFEA, and 100% in CFEE ( p = 0.049). Primary-assisted patency was 90% in ICFE, 82.9% in CFEA, and 100% in CFEE ( p = 0.17). Secondary patency was 90% in ICFE, 94.3% in CFEA, and 100% in CFEE ( p = 0.409). Re-intervention was required in 26.9% of primary closures, versus 12.8% with patch closures ( p = 0.279). Amputation-free survival was 100% in ICFE, 80% in CFEA, and 100% in CFEE ( p = 0.056). CONCLUSION: CFE is a reliable and dependable procedure, even in the absence of good distal runoff.