Ambulatory Cardiology or General Internal Medicine Assessment Prior to Scheduled Major Vascular Surgery is Associated with Improved Outcomes.

OBJECTIVE: To characterize the association between ambulatory cardiology or general internal medicine (GIM) assessment prior to surgery and outcomes following scheduled major vascular surgery. BACKGROUND: Cardiovascular risk assessment and management prior to high-risk surgery remains an evolving area of care. METHODS: This is population-based retrospective cohort study of all adults who underwent scheduled major vascular surgery in Ontario, Canada, April 1, 2004-March 31, 2019. Patients who had an ambulatory cardiology and/or GIM assessment within 6 months prior to surgery were compared to those who did not. The primary outcome was 30-day mortality. Secondary outcomes included: composite of 30-day mortality, myocardial infarction or stroke; 30-day cardiovascular death; 1-year mortality; composite of 1-year mortality, myocardial infarction or stroke; and 1-year cardiovascular death. Cox proportional hazard regression using inverse probability of treatment weighting (IPTW) was used to mitigate confounding by indication. RESULTS: Among 50,228 patients, 20,484 (40.8%) underwent an ambulatory assessment prior to surgery: 11,074 (54.1%) with cardiology, 8,071 (39.4%) with GIM and 1,339 (6.5%) with both. Compared to patients who did not, those who underwent an assessment had a higher Revised Cardiac Risk Index (N with Index over 2= 4,989[24.4%] vs. 4,587[15.4%], P<0.001) and more frequent pre-operative cardiac testing (N=7,772[37.9%] vs. 6,113[20.6%], P<0.001) but, lower 30-day mortality (N=551[2.7%] vs. 970[3.3%], P<0.001). After application of IPTW, cardiology or GIM assessment prior to surgery remained associated with a lower 30-day mortality (weighted Hazard Ratio [95%CI] = 0.73 [0.65-0.82]) and a lower rate of all secondary outcomes. CONCLUSIONS: Major vascular surgery patients assessed by a cardiology or GIM physician prior to surgery have better outcomes than those who are not. Further research is needed to better understand potential mechanisms of benefit.

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

Vascular Closure Devices For Axillary Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery. MATERIALS AND METHODS: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data. RESULTS: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I2=60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I2=0%), dissection 3.1% (95% CI: 1.3%-7.3%, I2=0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I2=0%), infection <1% (95% CI: 0%-5.7%, I2=20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I2=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013). CONCLUSIONS: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications. CLINICAL IMPACT: Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.

The Use of Vascular Closure Devices for Brachial Artery Access: A Systematic Review and Meta-Analysis.

PURPOSE: To estimate the rates of technical success and adverse events of vascular closure devices (VCDs) in the brachial artery and compare the rates of adverse events with manual compression. MATERIALS AND METHODS: MEDLINE and Embase were searched for observational studies examining VCDs in the brachial artery. Meta-analyses were performed using random effects for the following outcomes: (a) technical success, (b) hematoma at the access site, (c) pseudoaneurysm, (d) local neurological adverse events, and (e) total number of adverse events. A pairwise meta-analysis compared VCD with manual compression for the outcomes of hematoma and the total number of adverse events. RESULTS: Of 1,761 eligible records, 16 studies including 510 access sites were included. Primary procedures performed were peripheral arterial disease interventions, percutaneous coronary intervention, and endovascular thrombectomy for ischemic stroke. The technical success rate was 93% (95% CI, 87%-96%; I2 = 47%). Data on the following adverse events were obtained via meta-analysis: (a) hematoma, 9% (5%-15%; I2 = 54%); (b) stenosis or occlusion at access site, 3% (1%-14%; I2 = 51%); (c) infection, 0% (0%-5%; I2 = 0%); (d) pseudoaneurysm, 4% (1%-13%; I2 = 61%); (e) local neurological adverse events, 5% (2%-13%; I2 = 54%); and (f) total number of adverse events, 15% (10%-22%; I2 = 51%). Angio-Seal success rate was 96% (93%-98%; I2 = 0%), whereas the ExoSeal success rate was 93% (69%-99%; I2 = 61%). When comparing VCD and manual compression, there was no difference in hematoma formation (relative risk, 0.75; 95% CI, 0.35-1.63; I2 = 0%; P = .47) or the total number of adverse events (relative risk, 0.75; 95% CI, 0.35-1.58; I2 = 76%; P = .45). CONCLUSIONS: Despite being off-label, studies suggest that VCDs in the brachial artery have a high technical success rate. There was no significant difference in adverse events between VCDs and manual compression in the brachial artery.

Typology, Severity, and Outcomes of Adverse Events Related to Angiographic Equipment-A Ten-Year Analysis of the FDA MAUDE Database.

Purpose: Angiographic equipment is a key component of healthcare infrastructure, used for endovascular procedures throughout the body. The literature on adverse events related to this technology is limited. The purpose of this study was to analyze adverse events related to angiographic devices from the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Methods: MAUDE data on angiographic imaging equipment from July 2011 to July 2021 were extracted. Qualitative content analysis was performed, a typology of adverse events was derived, and this was used to classify the data. Outcomes were assessed using the Healthcare Performance Improvement (HPI) and Society of Interventional Radiology (SIR) adverse event classifications. Results: There were 651 adverse events reported. Most were near misses (67%), followed by precursor safety events (20.5%), serious safety events (11.2%), and unclassifiable (1.2%). Events impacted patients (42.1%), staff (3.2%), both (1.2%), or neither (53.5%). The most common events associated with patient harm were intra-procedure system shut down, foot pedal malfunction, table movement malfunction, image quality deterioration, patient falls, and fluid damage to system. Overall, 34 (5.2%) events were associated with patient death; 18 during the procedure and 5 during patient transport to another angiographic suite/hospital due to critical failure of equipment. Conclusion: Adverse events related to angiographic equipment are rare; however, serious adverse events and deaths have been reported. This study has defined a typology of the most common adverse events associated with patient and staff harm. Increased understanding of these failures may lead to improved product design, user training, and departmental contingency planning.

Percutaneous Transluminal Angioplasty for Below-the-Elbow Critical Hand Ischemia: A Systematic Review.

PURPOSE: To perform a systematic review assessing the safety and efficacy of percutaneous transluminal angioplasty (PTA) for treatment of critical hand ischemia (CHI) due to below-the-elbow (BTE) obstructive arterial disease. MATERIALS AND METHODS: MEDLINE and EMBASE systematic searches were performed from inception to December 2020 to identify studies assessing PTA for management of BTE obstructive arterial disease. Three independent reviewers performed abstract selection, data extraction, and quality assessment. The Newcastle-Ottawa Scale was used to assess individual study bias for non-randomized controlled trials. RESULTS: Eight studies comprising 176 patients with obstructive BTE vessel disease were included. All studies had a score >5 on the Newcastle-Ottawa Scale, indicative of high quality. All studies used low-profile balloons (1.5-4 mm) for PTA of stenotic lesions or chronic total occlusions (CTOs). The weighted average technical success and clinical success rates were 89.3% (range = 82%-100%) and 69.9% (range = 19%-100%), respectively, at a mean follow-up of 29.7 ± 17.1 months. The short-term (<30 days) complication rate was low at 4.7% and most commonly included access site hematomas, pseudoaneurysms, and radial artery perforation or re-thrombosis. Nearly 20% of patients required an amputation, and most (96%) were minor (either distal phalanges or digits). Only 2 patients required above-wrist amputations. The primary and secondary patency rate at 5 years were 38% and 54%, respectively. The cumulative 5-year mortality rate was 33.1%. CONCLUSIONS: PTA for CHI due to BTE obstructive arterial disease is feasible with a high technical success rate and a low short-term complication rate. Additional long-term comparative studies are required to unequivocally establish the clinical benefit of endovascular treatment compared with conservative management or surgical bypass.

Overall Impact of the COVID-19 Pandemic on Interventional Radiology Services: A Canadian Perspective.

PURPOSE: The aim of this national survey was to assess the overall impact of the coronavirus disease 2019 (COVID-19) pandemic on the provision of interventional radiology (IR) services in Canada. METHODS: An anonymous electronic survey was distributed via national and regional radiology societies, exploring (1) center information and staffing, (2) acute and on-call IR services, (3) elective IR services, (4) IR clinics, (5) multidisciplinary rounds, (6) IR training, (7) personal protection equipment (PPE), and departmental logistics. RESULTS: Individual responses were received from 142 interventional radiologists across Canada (estimated 70% response rate). Nearly half of the participants (49.3%) reported an overall decrease in demand for acute IR services; on-call services were maintained at centers that routinely provide these services (99%). The majority of respondents (73.2%) were performing inpatient IR procedures at the bedside where possible. Most participants (88%) reported an overall decrease in elective IR services. Interventional radiology clinics and multidisciplinary rounds were predominately transitioned to virtual platforms. The vast majority of participants (93.7%) reported their center had disseminated an IR specific PPE policy; 73% reported a decrease in case volume for trainees by at least 25% and a proportion of trainees will either have a delay in starting their careers as IR attendings (24%) or fellowship training (35%). CONCLUSION: The COVID-19 pandemic has had a profound impact on IR services in Canada, particularly for elective cases. Many centers have utilized virtual platforms to provide multidisciplinary meetings, IR clinics, and training. Guidelines should be followed to ensure patient and staff safety while resuming IR services.

Leveraging vascular quality initiative data to improve hospital length of stay for patients undergoing endovascular aneurysm repair

Background: The Society for Vascular Surgery Vascular Quality Initiative (SVS-SVQI) is a database that provides insight into standards of care and highlights opportunities for quality improvement by benchmarking institutional data against local, regional and national trends. Endovascular aneurysm repair (EVAR) is a frequently performed vascular operation. Postoperative length of stay in hospital (LOS) varies among institutions. We reviewed the morbidity and mortality of patients who underwent EVAR at our institution and the financial impact of increased LOS for these patients. In addition, we sought to identify modifiable factors associated with prolonged LOS. Methods: We identified all patients who underwent elective EVAR between Jan. 1, 2011, and Dec. 31, 2014. Preoperative patient characteristics, intraoperative details, postoperative factors, long-term (1 yr) outcomes and cost data were reviewed. Univariate analysis was used to determine statistical differences between patients with LOS less than or equal to 2 days and greater than 2 days. Interventions were implemented to modify factors identified as having a negative impact on EVAR LOS. Results: Identified factors that negatively affected EVAR LOS included social, neurologic, cardiovascular, urologic and renal issues. Following targeted interventions, LOS after EVAR decreased from an average of 3.8 to 3.0 days (p < 0.05). Logistic regression (n = 124) identified cardiovascular issues as the most significant predictor of LOS greater than 2 days (p = 0.001, odds ratio 14.24, 95% confidence interval 2.8­71.4). Reduction in LOS was associated with the additional benefit of 6.6% adjusted cost savings. Conclusion: By leveraging SVS-VQI data, we were able to reduce EVAR LOS by identifying modifiable factors and instituting focused interventions. The reduction in LOS was associated with cost savings to the hospital.

Contexte: L'Initiative pour la qualité de la chirurgie vasculaire de la Société canadienne de chirurgie vasculaire (IQCV-SCCV) est une base de données qui donne un aperçu des normes thérapeutiques et souligne les possibilités d'améliorations de la qualité en faisant la comparaison entre les tendances institutionnelles et les tendances locales, régionales et nationales. La réparation endovasculaire d'anévrisme (REVA) est une intervention fréquente. La durée du séjour hospitalier postopératoire varie d'un établissement à l'autre. Nous avons examiné la morbidité et la mortalité chez les patients ayant subi une REVA dans notre établissement et mesuré l'impact économique d'un séjour hospitalier prolongé chez ces patients. De plus, nous avons tenté de dégager les facteurs modifiables associés à un séjour prolongé. Méthodes: Nous avons recensé tous les patients ayant subi une REVA entre le 1er janvier 2011 et le 31 décembre 2014. Nous avons pris en compte les caractéristiques préopératoires des patients, les détails peropératoires, les facteurs postopératoires, les résultats à long terme (1 an) et les coûts. Une analyse univariée a servi à déterminer les différences statistiques entre les patients ayant séjourné à l'hôpital 2 jours ou moins et plus de 2 jours. Des interventions ont été appliquées pour modifier les facteurs reconnus pour leur impact négatif sur le séjour hospitalier après une REVA. Résultats: Les facteurs identifiés pour leur effet négatif sur le séjour hospitalier après une REVA étaient entre autres problèmes sociaux, neurologiques, cardiovasculaires, urologiques et rénaux. Après l'application d'interventions ciblées, la durée du séjour hospitalier post-REVA a diminué d'une moyenne de 3,8 à 3,0 jours (p < 0,05). La régression logistique (n = 124) a permis d'identifier les problèmes cardiovasculaires comme principaux prédicteurs d'un séjour hospitalier de plus de 2 jours (p = 0,001, rapport des cotes 14,24, intervalle de confiance de 95 % 2,8­71,4). L'abrègement du séjour hospitalier a été associé à un avantage additionnel de 6,6 % en économies de coûts ajustées. Conclusion: Après analyse des données de l'IQCV-SCCV, nous avons réussi à abréger la durée des séjours hospitaliers pour REVA en identifiant les facteurs modifiables et en appliquant des interventions ciblées. L'abrègement des séjours hospitaliers a été associé à des économies pour l'hôpital.

Avoiding and Managing Error in Interventional Radiology Practice: Tips and Tools.

While there are limited data on error in interventional radiology (IR), the literature so far indicates that many errors in IR are potentially preventable. Yet, understanding the sources for error and implementing effective countermeasures can be challenging. Traditional methods for reducing error such as increased vigilance and new policies may be effective but can also contribute to an "error cycle." A hierarchy of effectiveness for patient safety interventions is outlined, and the characteristics of "high-reliability" organizations in other "high-risk" industries are examined for clues that could be implemented in IR. The evidence behind team error reduction strategies such as checklists is considered along with individual approaches such as "slowing down when you should." However, error in medicine is inevitable, and this article also seeks to outline an evidence-based approach to managing the psychological impact of being involved in medical error as a physician.

Sources of Error in Interventional Radiology: How, Why, and When

This article aims to provide an overview of the sources for error in interventional radiology (IR). Being both a procedure and an imaging-based specialty, IR has unique considerations as to how error can occur. However, compared to the surgical and medical literature, data on error in IR are lacking. The available IR literature is reviewed but supplemented with lessons from other specialties and the World Health Organization. Individual risks such as cognitive bias as well as system-level factors are also considered in order to generate a taxonomy for error in IR that includes the operator, patient, team, and environment.

Outcomes at a single center after subintimal arterial flossing with antegrade-retrograde intervention for critical limb ischemia.

OBJECTIVE: The subintimal arterial flossing with antegrade-retrograde intervention technique has been used to overcome antegrade recanalization failures for peripheral lower limb arterial occlusive disease. There are few outcomes published for this technique and we sought to evaluate outcomes at our institution over a 7-year period. METHODS: A retrospective review was performed of all subintimal arterial flossing with antegrade-retrograde intervention procedures of infrainguinal occlusive disease from 2009 to 2016. Retrograde and antegrade accesses were combined when occlusions could not be crossed from the antegrade direction. Baseline patient characteristics, procedures, procedure time, fluoroscopy time, contrast used, and radiation dose were collected. Posterior tibial waveforms, ankle-brachial index, limb salvage, vessel patency, and the presence of symptoms were assessed at follow-up. RESULTS: Treatment was performed in 52 limbs in 52 patients (35 men and 17 women; mean age, 77.62 ± 11.61 years) with critical limb ischemia and no appropriate venous conduit for surgical bypass. Among the cohort, 63.5% were diabetics, 98% had hypertension, 53.8% had a prior myocardial infarction, and 36.5% end-stage renal disease. The average Rutherford Category before the intervention was 5.08 ± 1.01. Retrograde pedal access was most commonly obtained in the anterior tibial artery/dorsalis pedis (55.7%), followed by the posterior tibial artery (40.3%). The technical success rate was 63.5% (33/52); adjunctive stenting was needed in 19 (36.5%) to optimize results. Preprocedural ankle-brachial index score was 0.54 ± 0.25, which improved after the procedure to an ankle-brachial index score of 0.77 ± 0.25. The primary patency rates at 3 and 6 months were 65% and 60%, respectively. The limb salvage rate at a mean follow-up of 5.4 months was 78.8%. There were 5 complications; 4 were hematomas managed conservatively and 1 was a major retroperitoneal bleed resulting in patient death. CONCLUSIONS: Retrograde pedal access is a viable revascularization technique for achieving limb salvage in patients with critical limb ischemia with acceptable patency for limb-threatening ischemia. This technique expands revascularization options after failed conventional endovascular antegrade approaches.

Transabdominal Direct Sac Puncture Embolization of Type II Endoleaks after Endovascular Abdominal Aortic Aneurysm Repair.

PURPOSE: To determine the efficacy and safety of transabdominal direct sac puncture embolization of type II endoleaks after endovascular abdominal aortic aneurysm repair (EVAR). MATERIALS AND METHODS: This retrospective review included 30 patients (4 women, 26 men; mean age = 79.1 years) who underwent 33 transabdominal direct sac puncture embolization procedures for type II endoleaks after EVAR. Embolization agents included cyanoacrylate glue only (45.5%), glue/coils (36.4%), and Onyx with or without glue/coils (18.1%). Technical success was defined as complete endoleak embolization on intraprocedural fluoroscopy. The primary outcome was freedom of aneurysm growth, which was defined as ≤ 5% aneurysm sac volume change on follow-up computed tomography (CT) imaging or ≤ 5 mm aneurysm sac diameter change on ultrasound without definite endoflow. Aneurysm sac volumes before and after embolization were manually segmented from CT images. The procedural complication rate was calculated. RESULTS: Technical success was achieved in 97% of patients (29/30). Follow-up imaging was available in 27 patients (25 CT; 2 ultrasound), and mean imaging follow-up duration was 15.5 months. Freedom of aneurysm growth was achieved in 85.2% of patients (23/27) after 1 or more embolization procedures. Median fluoroscopic and procedure times were 11.3 minutes and 90 minutes, respectively. The complication rate was 9.1% (3/33) and included 1 case of nontarget embolization with transient neuropraxia and 2 self-limiting rectus sheath hematomas relating to the percutaneous puncture site. No aneurysm-related mortality occurred during the follow-up period. CONCLUSIONS: Percutaneous transabdominal embolization is a safe and efficacious treatment for type II endoleak, with a short procedure time.

Combined Coil Embolization and Foam Sclerotherapy for the Management of Varicose Veins.

BACKGROUND: We propose a novel technique for endovenous treatment of varicose veins (VVs) using combined coil embolization and foam sclerotherapy of the great saphenous vein (GSV). METHODS: A retrospective case-series analysis on patients undergoing fluoroscopically guided coil embolization of the GSV and foam sclerotherapy of the GSV and below-knee varices at a single Canadian center. RESULTS: Twenty-two patients underwent the procedure on 23 legs. Most patients (78.3%) presented for follow-up 57.2 ± 21.9 days postoperatively. Doppler studies demonstrated complete GSV occlusion in all patients. While 3 patients (13.6%) noted skin discoloration overlying the treated VVs, none complained of pain on follow-up or developed leg numbness, deep vein thrombosis, or pulmonary emboli. CONCLUSIONS: Coil embolization and foam sclerotherapy are a novel and effective treatment for VVs that uses existing and readily available angiographic equipment.

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs.

BACKGROUND: Atherosclerotic peripheral arterial disease (PAD) can lead to disabling ischemia and limb loss. Treatment modalities have included risk factor optimization through life-style modifications and medications, or operative approaches using both open and minimally invasive techniques, such as balloon angioplasty. Drug-eluting balloon (DEB) angioplasty has emerged as a promising alternative to uncoated balloon angioplasty for the treatment of this difficult disease process. By ballooning and coating the inside of atherosclerotic vessels with cytotoxic agents, such as paclitaxel, cellular mechanisms responsible for atherosclerosis and neointimal hyperplasia are inhibited and its devastating complications are prevented or postponed. DEBs are considerably more expensive than uncoated balloons, and their efficacy in improving patient outcomes is unclear. OBJECTIVES: To assess the efficacy of drug-eluting balloons (DEBs) compared with uncoated, nonstenting balloon angioplasty in people with symptomatic lower-limb peripheral arterial disease (PAD). SEARCH METHODS: The Cochrane Vascular Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched December 2015) and Cochrane Register of Studies (CRS) (2015, Issue 11). The TSC searched trial databases for details of ongoing and unpublished studies. SELECTION CRITERIA: We included all randomized controlled trials that compared DEBs with uncoated, nonstenting balloon angioplasty for intermittent claudication (IC) or critical limb ischemia (CLI). DATA COLLECTION AND ANALYSIS: Two review authors (AK, TA) independently selected the appropriate trials and performed data extraction, assessment of trial quality, and data analysis. The senior review author (DKR) adjudicated any disagreements. MAIN RESULTS: Eleven trials that randomized 1838 participants met the study inclusion criteria. Seven of the trials included femoropopliteal arterial lesions, three included tibial arterial lesions, and one included both. The trials were carried out in Europe and in the USA and all used the taxane drug paclitaxel in the DEB arm. Nine of the 11 trials were industry-sponsored. Four companies manufactured the DEB devices (Bard, Bavaria Medizin, Biotronik, and Medtronic). The trials examined both anatomic and clinical endpoints. There was heterogeneity in the frequency of stent deployment and the type and duration of antiplatelet therapy between trials. Using GRADE assessment criteria, the quality of the evidence presented was moderate for the outcomes of target lesion revascularization and change in Rutherford category, and high for amputation, primary vessel patency, binary restenosis, death, and change in ankle-brachial index (ABI). Most participants were followed up for 12 months, but one trial reported outcomes at five years.There were better outcomes for DEBs for up to two years in primary vessel patency (odds ratio (OR) 1.47, 95% confidence interval (CI) 0.22 to 9.57 at six months; OR 1.92, 95% CI 1.45 to 2.56 at 12 months; OR 3.51, 95% CI 2.26 to 5.46 at two years) and at six months and two years for late lumen loss (mean difference (MD) -0.64 mm, 95% CI -1.00 to -0.28 at six months; MD -0.80 mm, 95% CI -1.44 to -0.16 at two years). DEB were also superior to uncoated balloon angioplasty for up to five years in target lesion revascularization (OR 0.28, 95% CI 0.17 to 0.47 at six months; OR 0.40, 95% CI 0.31 to 0.51 at 12 months; OR 0.28, 95% CI 0.18 to 0.44 at two years; OR 0.21, 95% CI 0.09 to 0.51 at five years) and binary restenosis rate (OR 0.44, 95% CI 0.29 to 0.67 at six months; OR 0.38, 95% CI 0.15 to 0.98 at 12 months; OR 0.26, 95% CI 0.10 to 0.66 at two years; OR 0.12, 95% CI 0.05 to 0.30 at five years). There was no significant difference between DEB and uncoated angioplasty in amputation, death, change in ABI, change in Rutherford category and quality of life (QoL) scores, or functional walking ability, although none of the trials were powered to detect a significant difference in these clinical endpoints. We carried out two subgroup analyses to examine outcomes in femoropopliteal and tibial interventions as well as in people with CLI (4 or greater Rutherford class), and showed no advantage for DEBs in tibial vessels at six and 12 months compared with uncoated balloon angioplasty. There was also no advantage for DEBs in CLI compared with uncoated balloon angioplasty at 12 months. AUTHORS' CONCLUSIONS: Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.

The in-hospital costs of treating high-risk patients with fenestrated and branched endografts.

OBJECTIVE: This study determined the 30-day morbidity and mortality and in-hospital costs of elective fenestrated (fEVAR) and branched (bEVAR) endovascular aneurysm repairs at a single academic institution and determined factors that influence them. METHODS: All elective fEVAR or bEVAR patients treated between November 2007 and March 2014 in a Canadian academic hospital were included. Procedural details, 30-day morbidity and mortality rates, and cost of hospitalization were analyzed. Nonparametric bootstrap analysis was used to compare means between groups and calculate confidence intervals (CIs). RESULTS: There were 84 consecutive fEVAR (n = 61) and bEVAR (n = 23) procedures. The 30-day mortality was 3.3% for fEVAR and 4.3% for bEVAR. Mean hospital stay was 7.2 ± 0.8 days for fEVAR and 12.6 ± 2.2 days for bEVAR. The mean cost of the index hospitalization was $57,000 for fEVAR and $91,000 for bEVAR. Device-related costs accounted for 55% of the total costs. The occurrence of intraoperative or postoperative events were used to further divide each of the fEVAR and bEVAR groups into "complicated hospitalization" (fEVAR, n = 10; bEVAR, n = 13) and "uncomplicated hospitalization" (fEVAR, n = 51; bEVAR, n = 10) groups. Device-related costs were not significantly different between the complicated and uncomplicated hospitalization groups (mean difference [95% CI] fEVAR: $3383 [-$3405 to $9809], P = .3; and bEVAR: $1930 [-$7892 to $11,288], P = .68). However, there were significant differences between the complicated and uncomplicated hospitalization groups in hospital length of stay (mean difference [95% CI] fEVAR: 8.1 [3.0-13.2] days, P = .001; and bEVAR: 10.8 [5.9-19.9] days, P = .002) and nondevice-related costs (mean difference [95% CI,] fEVAR: $25,843 [$11,689-$43,247], P = .001; and bEVAR; $20,326 [$9362-$36,615], P = .002). CONCLUSIONS: bEVAR and fEVAR are expensive interventions. Intraoperative adverse events and postoperative systemic complications dramatically increase costs and length of stay. Measures to minimize complications will reduce hospitalization costs and improve patient outcomes.

Radiofrequency in situ fenestration for aortic arch vessels during thoracic endovascular repair.

PURPOSE: To report the first clinical application of a novel technique using radiofrequency puncture to create retrograde in situ fenestrations during thoracic endovascular aortic repair (TEVAR). METHODS: Between June 2011 and December 2013, 40 TEVAR procedures were performed in our facility, including 10 cases in which in situ fenestration was planned. Two thoracic stent-graft models were deployed: the Valiant (n=5) and the Zenith TX2 (n=5). A 0.035-inch PowerWire radiofrequency guidewire delivered from a brachial approach was used to fenestrate the grafts covering a left subclavian artery (LSA) in 9 cases and a left common carotid artery in one. The fenestrations were serially dilated to 6 mm, and self-expanding Advanta V12 covered stents were positioned in the target arteries. RESULTS: Technical success was achieved in 6 of the 10 planned cases. Of the remaining 4 cases, stent-grafts were deployed in zone 3 in 2 cases (one received a chimney to the LSA). Another stent-graft was deployed in zone 2 without endoleak after fenestration was abandoned (the LSA had good filling via the vertebral artery). In the last case, the fenestration was unsuccessful in double-layered (proximal extension overlap) stent-grafts; a carotid-axillary bypass was required. There were no fenestration-related complications, but overall surgical complications included a case of paraparesis that resolved following spinal drainage and a death from a preexisting aortoesophageal fistula. There were no postoperative strokes. All fenestrations remained patent, and there were no endoleaks at a mean 12-month follow-up (range 1-33). CONCLUSION: Radiofrequency puncture is a viable alternative to needle or laser punctures for in situ fenestration during TEVAR. Early clinical results suggest technical feasibility and acceptable early outcomes.

Acute thrombosis of an abdominal aortic aneurysm presenting as cauda equina syndrome.

Acute aortic occlusion is an uncommon vascular emergency that can present with predominantly neurologic symptoms owing to spinal cord ischemia. We describe a 62-year-old woman who experienced acute thrombosis of an abdominal aortic aneurysm that initially presented as cauda equina syndrome. She was treated operatively with an axillary bifemoral bypass. Our case report is followed by a discussion of acute aortic occlusion.

Chronic thromboembolic pulmonary hypertension secondary to a vascular malformation: case report diagnosis by lung subtraction iodine mapping.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a challenging diagnosis that can occur even in the absence of a prior thrombotic event. The main screening test is ventilation-perfusion (VQ) scintigraphy. The gold standard treatment for CTEPH is pulmonary endarterectomy (PEA), however, balloon pulmonary angioplasty (BPA) is an emerging treatment, especially for CTEPH at the segmental level. We report on a case of a patient with segmental CTEPH diagnosed by lung subtraction iodine mapping (LSIM) in the context of a chest wall vascular malformation. CTEPH was treated with BPA and by embolization and ligation of their vascular malformation.