Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

INTRODUCTION: Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD). However, published data regarding the safety of these devices are limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present 3 years of MAUDE adverse events data for the Jetstream Atherectomy System (Boston Scientific) for the treatment of PAD. MATERIALS AND METHODS: We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction, or both. Adverse events were classified using the Cardiovascular and Interventional Radiological Society of Europe's (CIRSE) classification system for adverse events. RESULTS: The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). As per the CIRSE adverse events classification, most events had no post-procedural sequelae (475; 95%), followed by those requiring prolonged observation (14; 2.8%), and post-procedural therapy without long-term sequelae (10; 2.0%). One hundred six devices (21%) were returned for manufacturer analysis. CONCLUSION: We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream, and could help guide improvements in product design and manufacturer-user training. There is greater need for root-cause analysis that can aided by returning devices to the manufacturer. CLINICAL IMPACT: We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. The MAUDE database is useful for capturing and characterizing modes of device failure/malfunction not typically described in conventional clinical studies. This may provide valuable information to help guide improvements in product design and manufacturer-user training. This information could also potentially be useful in helping establish manufacturer and product liability in the setting of medicolegal claims. We hope that by contributing to the growing understanding of the safety profile of the Jetstream Atherectomy System, our study may help physicians and patients come to more informed decisions regarding treatment options for PAD.

Operator Intracranial Dose Protection During Fluoroscopic-Guided Interventions.

PURPOSE: We utilized an anthropomorphic model made with a human skull to determine how different personal protective equipment influence operator intracranial radiation absorbed dose. MATERIALS AND METHODS: A custom anthropomorphic phantom made with a human skull coated with polyurethane rubber, mimicking superficial tissues, and was mounted onto a plastic thorax. To simulate scatter, an acrylic plastic scatter phantom was placed onto the fluoroscopic table with a 1.5 mm lead apron on top. Two Radcal radiation detectors were utilized; one inside of the skull and a second outside. Fluoroscopic exposures were performed with and without radiation protective equipment in AP, 45-degree RAO, and 45-degree LAO projections. RESULTS: The skull and soft tissues reduce intracranial radiation by 76% when compared to radiation outside the skull. LAO (308.95 µSv/min) and RAO projections (96.47µSv/min) result in significantly higher radiation exposure to the primary operator when compared to an AP projection (54 µSv/min). All tested radiation protection equipment demonstrated various reduction in intracranial radiation when compared to no protection. The hood (68% reduction in AP, 91% LAO, and 43% in RAO), full cover (53% reduction in AP, 76% in LAO, and 54% in RAO), and open top with ear coverage (43% reduction in AP, 77% reduction in LAO, and 22% in RAO) demonstrated the most reduction in intracranial radiation when compared to the control. CONCLUSION: All tested equipment provided various degrees of additional intracranial protection. The skull and soft tissues attenuate a portion of intracranial radiation.

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.

Utility of 4D CT in endoleak characterization after advanced endovascular aortic repair.

OBJECTIVES: To assess the performance of dynamic or 4D CT in characterizing endoleaks in advanced endovascular aortic repair (branched and fenestrated) when other modalities fail to fully characterize the leak, most often conventional CTA. METHODS: Retrospective review of 13 patients from 2008 to 2021 who underwent 16 4D CTs to characterize endoleaks in branched and fenestrated endovascular aortic repair (FB-EVAR). The 4D CTs were performed covering up to 16 cm of the z-axis, with anywhere between 10 and 40 iterations performed every 2 s. These settings were adjusted depending on graft characteristics and type of endoleak suspected. The scans were assessed for their ability to detect the endoleak (sensitivity), and further to characterize the endoleak by type and subtype (specificity). RESULTS: Overall sensitivity in 16 scans for endoleak detection was 100%. There was a specificity of 87.5% for determining the type of endoleak (14/16). These results included two studies that were inconclusive and repeated due to technical difficulties. In patients where a specific subtype was not established, the leak was localized to the appropriate target vessel. Average dose for the 4D CT was 4724 mGy*cm (1108-11069), with the outlining higher dose scans secondary to higher iterations in those scans. CONCLUSIONS: 4D CT is a useful adjunctive tool in FB-EVAR surveillance with excellent sensitivity and specificity in characterizing endoleaks. This allows for accurate localization of leaks, which is critical for management planning.

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: A Systematic Review and Meta-analysis.

PURPOSE: To perform a systematic review and meta-analysis assessing the safety and efficacy of balloon pulmonary angioplasty (BPA) in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). MATERIALS AND METHODS: Systematic literature searches were performed from inception to June 2022 to identify studies assessing BPA for CTEPH. Outcomes of interest included the following functional and hemodynamic measures: (a) six-minute walk distance (6MWD), (b) New York Heart Association (NYHA) status, (c) World Health Organization (WHO)-Functional Class status, (d) cardiac index (CI), (e) mean pulmonary artery pressure (mPAP), (f) mean right atrial pressure (mRAP), and (g) pulmonary vascular resistance (PVR). Subgroup analysis was also performed for BPA in post-pulmonary endarterectomy (PEA) patients. All reported BPA-related complications were also recorded. Forty unique studies with a total of 1763 patients were identified for meta-analysis. RESULTS: All functional and hemodynamic parameters improved significantly following BPA; 6MWD increased 70 m (95% CI 58-82; P < 0.001), NYHA class improved by - 0.9 classes (95% CI - 1.0 to - 0.8; P < 0.001), WHO-FC class improved by - 1 classes ((95% CI - 1.2 to - 0.9; P < 0.001), CI increased 0.26 L/min/m2 (95% CI 0.17-0.35; P < 0.001), mPAP decreased - 13.2 mmHg (95% CI - 14.7 to - 11.8; P < 0.001), mRAP decreased - 2.2 mmHg (95% CI - 2.8 to - 1.6; P < 0.001), and PVR decreased - 311 dyne/cm/s-5 (95% CI - 350 to - 271; P < 0.001). Meta-analysis of patients who underwent BPA for persistent pulmonary hypertension post-PEA demonstrated significant improvements in 6MWD, WHO-FC, PVR and mPAP. Most common complications included lung injury (8.16%), hemoptysis (7.07%) and vessel injury (5.05%). CONCLUSION: BPA represents a safe and effective treatment option for select individuals with CTEPH with significant improvements in hemodynamic parameters, improved exercise tolerance and a relatively low risk of major complications.

Surgery for complications after thoracic endovascular aortic repair with arch vessel debranching: Role of imaging in preoperative planning.

We describe here a series of patients who presented with failed hybrid arch and descending thoracic aortic aneurysm repairs, while highlighting the instrumental role that advanced medical imaging played in formulating an operative plan. Each case involved persistent 1A endoleaks and aneurysm sac growth after hybrid arch repairs tackled by arch debranching followed by thoracic endovascular aortic repair. Two open cases were described as well as one endovascular case. Imaging played a key role in elucidating the site of endoleak and in operative planning. These cases highlight the importance of multidisciplinary input between cardiac surgery, vascular surgery and radiology in management of complex aortic patients.

Minimally Invasive Segmental Artery Coil Embolization (MISACE) Prior to Endovascular Thoracoabdominal Aortic Aneurysm Repair.

PURPOSE: Minimally Invasive Segmental Artery Coil Embolization (MISACE) is a novel approach to reduce paraplegia risk in Thoracoabdominal aortic aneurysm (TAAA) repair with limited data. We report our experience with MISACE as a method of spinal cord pre-conditioning to prevent spinal cord ischemia following endovascular repair of TAAA. MATERIAL AND METHODS: A retrospective analysis of 17 patients who had an attempted MISACE prior to endovascular TAAA repair with mean follow-up of 350 days (2017-2020). Baseline patient and aneurysm characteristics along with procedural technique and outcomes were analyzed. RESULTS: Mean age of 69 years and 76.5% were males. TAAA Crawford classification were II, n = 6 (35.3%), III, n = 4 (23.5%) and IV, n = 5 (29.4%). The mean aortic diameter was 70.6 ± 10.9 mm. Staged repair was performed on 9 patients. Technically successful embolization occurred in 14 patients (82.4%) and was unsuccessful in 3 patients. The median number of embolized arteries was 3 and 71% of the target arteries were between T9 and T12. Mean fluoroscopy time was 51.5 ± 22.5 min and mean contrast volume used was 132.8 ± 56.1 mL. Average number of catheters used was 4.6 and 3.5 wires. No complications related to the procedure. Mean interval between embolization to endovascular TAAA repair was 51.2 days (5-110 days). All patients received spinal drainage at the time of repair. Postoperatively, 2/14 of patients developed paraparesis in the MISACE successful group and 1/3 patients developed paraplegia in the unsuccessful group. CONCLUSIONS: MISACE is a promising strategy to prevent SCI. This data demonstrates the technique is feasible and safe but anatomic challenges remain.

Outcome after pulmonary endarterectomy for segmental chronic thromboembolic pulmonary hypertension.

OBJECTIVE: Determine the long-term outcome and need for additional therapy after pulmonary endarterectomy (PEA) for segmental chronic thromboembolic pulmonary hypertension. METHODS: Retrospective analysis of a prospective cohort of 401 consecutive Canadian patients undergoing PEA between August 2005 and March 2020 in Toronto. The outcome of segmental disease defined as Jamieson type 3 was compared with more proximal disease defined as Jamieson type 1 and 2. The cohort was divided into 3 intervals to analyze the trend over time: 2005-2010, 2011-2015, and 2016-2020. RESULTS: Type 3 disease accounted for 41% of patients undergoing PEA durig 2016-2020 compared with 7% in 2006-2010. Total pulmonary vascular resistance improved by 505 ± 485 dynes/s/cm-5 in type 3 disease and by 593 ± 452 dynes/s/cm-5 in type 1 or 2 disease (P = .07). Mortality after PEA was similar between type 3 and type 1 and 2 disease at 30-days (2.8% vs 2.3%; P = .8) and at 1 year (7.7% vs 5.5%; P = .4). At 5 years, the survival was lower in type 3 disease (80% vs 91% in type 1 or 2 disease; P = .002). Type 3 disease was an independent predictor for the initiation of pulmonary hypertension-targeted medical therapy after PEA with a cumulative incidence of 38% at 10 years compared with 20% in type 1 and 2 disease (P < .0001). Post-PEA balloon pulmonary angioplasty was predominantly performed in type 3 disease (8% vs 1% in more type 1 or 2 disease; P = .0002). CONCLUSIONS: PEA achieved excellent early and long-term results in segmental chronic thromboembolic pulmonary hypertension. However, patients with segmental disease are at increased risk of requiring additional therapy after PEA and should be carefully monitored.

SUPERA Stenting in the Common Femoral Artery: Early Experience and Practical Considerations.

PURPOSE: Endovascular therapy in the management of de novo common femoral disease remains controversial. Considerable interest has been generated in recent years due to recent technological advancement in the design of vascular stents. In particular, SUPERA (Abbot Vascular Inc, Santa Clara USA) stents are designed to offer increased flexibility and less adverse interactions with the arterial wall, thus making it potentially better suited for common femoral lesions. However, despite such theoretical advantages, there is lack of data in its use in clinical practice. This study provides illustrative examples of SUPERA stents in different clinical settings and contributes to important clinical data for the overall efficacy and safety profile of endovascular interventions in common femoral artery (CFA) disease. MATERIALS AND METHODS: Retrospective analysis of all endovascular CFA procedures between January 1, 2011, and December 31, 2019, was conducted. Data collected included demographics, clinical symptoms, medical comorbidities, procedural characteristics, and immediate and short-term complications. Detailed analysis was performed on the stenting cohort. RESULTS: During our study period, a total of 69 patients underwent endovascular interventions involving the CFA at our institution, of which 16 patients had stenting procedures for a total of 18 stent deployments. Technical success was achieved in all stenting procedures. A total of 15 SUPERA stents were placed in 13 patients. No stent fractures were observed. Overall primary patency rate of SUPERA stents at the time of 12-month follow-up was 100% in patients who had a follow-up assessment (n = 12 stents). CONCLUSION: Endovascular intervention of the CFA is an evolving topic in the interventional radiology and vascular surgery community. Recent development of newer generation of devices such as SUPERA peripheral stents offers significant potential benefits given their inherent design. Despite the theoretically promising design of the SUPERA, there is a lack of data to support its use. This study contributes important patient-level data for SUPERA stent deployments.

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.

Endovascular Management of Unused Fenestrations or Branches in Fenestrated/Branched Aortic Endograft.

Fenestrated and branched aortic endograft (F/B EVAR) has become a widely accepted technique in the management of aneurysmal aortic pathology. However, intra-procedurally in some situations, there are F/B that remain unused because of target vessel occlusion or failure to cannulate the target artery. Leaving the F/B open will result in an ongoing endoleak, unless treated at the time. Herein we described the necessary considerations and several endovascular techniques to occlude these fenestrations and branches in this situation.

Ascending Aortic Length and Its Association With Type A Aortic Dissection.

Background The aim of this study was to determine the role of ascending aortic length and diameter in type A aortic dissection. Methods and Results Computed tomography scans from patients with acute type A dissections (n=51), patients with proximal thoracic aortic aneurysms (n=121), and controls with normal aortas (n=200) were analyzed from aortic annulus to the innominate artery using multiplanar reconstruction. In the control group, ascending aortic length correlated with diameter (r2=0.35, P<0.001), age (r2=0.17, P<0.001), and sex (P<0.001). As a result of immediate changes in aortic morphology at the time of acute dissection, predissection lengths and diameters were estimated based on models from published literature. Ascending aortic length was longer in patients immediately following acute dissection (median, 109.7 mm; interquartile range [IQR], 101.0-115.1 mm), patients in the estimated predissection group (median, 104.2 mm; IQR, 96.0-109.3 mm), and patients in the aneurysm group (median, 107.0 mm; IQR, 99.6-118.7 mm) in comparison to controls (median, 83.2 mm; IQR, 74.5-90.7 mm) (P<0.001 all comparisons). The diameter of the ascending aorta was largest in the aneurysm group (median, 52.0 mm; IQR, 45.9-58.0 mm), followed by the dissection group (median, 50.3 mm; IQR, 46.6-57.5 mm), and not significantly different between controls and the estimated predissection group (median, 33.4 mm [IQR, 30.7-36.7 mm] versus 35.2 mm [IQR, 32.6-40.3 mm], P=0.09). After adjustment for diameter, age, and sex, the estimated predissection aortic lengths were 16 mm longer than those in the controls and 12 mm longer than in patients with nondissected thoracic aneurysms. Conclusions The length of the ascending aorta, after adjustment for age, sex, and aortic diameter, may be useful in discriminating patients with type A dissection from normal controls and patients with nondissected thoracic aneurysms.

Randomized Controlled Trial of Percutaneous Radiologic Gastrostomy Performed With and Without Gastropexy: Technical Success, Patient-Reported Outcomes and Safety.

PURPOSE: The aim of this study is to compare balloon-retention percutaneous radiologic gastrostomy (PRG) tube insertion performed with and without gastropexy, primarily focusing on pain and patient-reported outcomes. MATERIALS AND METHODS: Research ethics board approved a dual-arm, single-centre, randomized trial of 60 patients undergoing primary 14-French PRG tube insertion (NCT04107974). Patients were randomized to receive either PRG with gastropexy or without gastropexy. Data were collected for technical outcomes, patient-reported outcomes pre-procedure, post-procedure and at 1-month, as well as quality of life parameters at 1-month post-procedure (EQ5D-5L, Visual Analogue Scale and Functional Assessment of Cancer Therapy-Enteral Feeding questionnaires). Complications occurring up to 6-months post-procedure were recorded. RESULTS: Sixty patients were randomized to the gastropexy group (n = 30) or non-gastropexy (n = 30) group. One non-gastropexy patient was withdrawn from the study due to failed insertion. PRG procedural time was significantly longer when using gastropexy (mean 11.4 ± 7.19 min) compared with non-gastropexy (mean 6.79 ± 4.63 min; p < 0.05). Pain scores did not differ between the two groups pre-procedure, post-procedure and at 1-month follow-up, nor did 1-month quality of life parameters. Six (20%) minor complications occurred in the gastropexy group and nine (31%) minor complications in the non-gastropexy group (p = 0.330). Two (6.9%) major complications occurred in the non-gastropexy group (p = 0.458). CONCLUSION: There is comparable patient tolerability when balloon-retention PRG insertion is performed with or without gastropexy sutures. This study also demonstrated a trend towards fewer complications when gastropexy is utilized. However, further larger trials are required to compare complications of the two approaches for PRG insertion. LEVEL OF EVIDENCE: Level 2, randomized trial.

Complication rates associated with antegrade use of vascular closure devices: a systematic review and pooled analysis.

BACKGROUND: Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating at the common femoral artery (CFA). However, off-label use in antegrade and/or superficial femoral artery (SFA) access has become more common in the treatment of peripheral arterial disease. Despite this, there is a paucity of comparative literature assessing individual VCD safety profiles and relative complication risks of CFA vs SFA applications. METHODS: MEDLINE and EMBASE systematic searches were performed from inception to October 2019 to identify studies assessing VCD use in antegrade CFA and SFA interventions. Abstract selection and data extraction were performed by two independent reviewers. Primary outcomes included bleeding-related complications, vessel occlusion or stenosis, embolization, pseudoaneurysm formation, or arteriovenous fistula formation. RESULTS: Twenty-four unique studies with 4124 vascular closure events via six unique VCDs were included (Angioseal, Exoseal, Femoseal, Glubran 2, Mynx, Starclose; 3698 CFA, 426 SFA). Pooled occurrence of all complications across closure devices used in the CFA and SFA ranged from 0.9% (Mynx) to 7.4% (Starclose) and 0% (Perclose) to 10.1% (Starclose), respectively, depending on VCD type. Clinically meaningful differences were identified between devices with a trend toward significance (P = .08 CFA, P = .07 SFA). Individual devices demonstrated a range of bleeding complication rates from 0.4% (Mynx) to 7.2% (Femoseal) for the CFA site and from 0% (Perclose) to 6.4% (Starclose) for the SFA site (P = .01 and P = .03, respectively). Significant heterogeneity between studies precludes definitive characterization of the device as cause for variations in bleeding complication rates. Pooled complication rates did not differ between the CFA and SFA arms (4.6% vs 5.8%, P = .56). Bleeding complication rates also did not differ between the CFA and SFA arms (3.6% vs 3.6%, P = .98). CONCLUSIONS: Clinically meaningful differences in overall pooled complications were identified between VCDs with a trend toward significance. Significant differences between VCDs exist with respect to bleeding risk. However, this must be interpreted with caution as these differences could be secondary to interstudy heterogeneity. Finally, no difference was identified between antegrade SFA and CFA VCD use with respect to overall complication and bleeding risks.

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.

Type IA endoleak caused by interlocked suprarenal bare-metal stents after endovascular abdominal aortic aneurysm repair with successful endovascular rescue.

A physically active 90-year-old man underwent endovascular repair of an asymptomatic but enlarging abdominal aortic aneurysm. Postoperative computed tomography demonstrated entanglement of nonadjacent proximal bare-metal stents. This was associated with graft infolding and a type IA endoleak. The patient underwent percutaneous transluminal angioplasty and placement of a Palmaz stent. Subsequent surveillance imaging showed resolution of the type I endoleak >1 year later. This report demonstrates an uncommon cause of stent graft infolding, an already rare complication of endovascular aneurysm repair, and highlights the need to carefully assess the morphologic appearance of the proximal fixation stents after graft deployment.

Rare complication of esophageal necrosis and perforation after fenestrated endovascular aneurysm repair.

Fenestrated endovascular aneurysm repair (FEVAR) is a minimally invasive technique used to treat complex abdominal aortic aneurysms. We present the case of a 69-year-old man with a juxtarenal abdominal aortic aneurysm treated with FEVAR. The patient experienced postoperative dysphagia and sepsis. Investigations revealed a perforated esophagus due to esophageal ischemia and necrosis, leading to complete esophagectomy and subsequent esophageal reconstruction. This case highlights esophageal necrosis and perforation as a potential complication of FEVAR and serves as a reminder to have a low threshold for investigating and emergently managing this condition, which otherwise has a high mortality rate.

Mediastinal bronchial artery aneurysm with short inflow segment successfully treated with a patent ductus arteriosus occluder device.

Bronchial artery aneurysm (BAA) is a rare vascular abnormality that may result in life-threatening bleeding if it is left untreated. We present the case of a 35-year-old man with a mediastinal BAA characterized by a short inflow artery segment and tortuous single outflow vessel. The patient's BAA was treated with a novel approach involving placement of a patent ductus arteriosus closure device in the short inflow segment as well as coil embolization of the outflow vessel, successfully excluding the BAA. Two-week follow-up revealed no flow in the embolized artery on computed tomography angiography. This case demonstrates the first successful use of a patent ductus arteriosus occluder device in the treatment of a mediastinal BAA with short inflow segment.

Diagnosis and management of right external iliac vein "sandwich": A rare cause of iliofemoral deep venous thrombosis.

Several anatomic abnormalities predispose patients to iliofemoral deep venous thrombosis, the most common of which is compression of the left iliac vein between the right common iliac artery and lumbar vertebrae, or May-Thurner syndrome. Other areas of venous compression can occur but are rare. This case report describes the presentation, diagnosis, and management of a patient with compression of the right iliac vein "sandwiched" between the right internal and external iliac arteries. After treatment, the patient demonstrated significant improvement in symptoms.

Initial Experience With Viabahn VBX as the Bridging Stent Graft for Branched and Fenestrated Endovascular Aneurysm Repair.

PURPOSE: To evaluate the feasibility and safety of a novel balloon-expandable, heparin-bonded endoprosthesis (Viabahn VBX, W. L. Gore and Associates) when used as a bridging stent graft (BSG) with fenestrated and branched endovascular aneurysm repair (FB-EVAR). FB-EVAR and BSGs increase repair complexity with the potential for endoleak formation, stenosis, thrombosis, and graft migration. The mechanical construction of the Viabahn VBX and its antithrombogenic properties may provide an advantage for FB-EVAR over existing BSGs. The efficacy, safety, and clinical outcomes were assessed. MATERIALS AND METHODS: Research ethics board approved, prospective, single arm cohort, pilot study of patients undergoing FB-EVAR between February 2017 and January 2018. Fenestrated and branched endovascular aneurysm repair was performed per the standard institutional protocol by a team composed of vascular surgeons and interventional radiologists. Viabahn VBX endografts were used for all intended visceral branches as long as appropriately sized devices were available (Under Investigational Testing Authorization from Health Canada). Patient characteristics, procedural details, and technical and clinical outcomes were reviewed and summarized. RESULTS: FB-EVAR was performed in 13 patients (9 male and 4 female) mean age of 74 (range: 61-83) with a total of 41 Viabahn VBXs stents implanted. Mean maximum aneurysm size was 6.7 cm (range: 5.5-9.0 cm) and included 5 juxtarenal abdominal aortic aneurysms and 8 thoracoabdominal; 3 type V, 3 type IV, and 2 type III (Crawford Classification). The Viabahn VBX was successfully deployed in 40 (98%) of 41 of cases. At median follow-up of 223 days (range: 2-462), there was a (40/40) 100% Viabahn VBX patency rate. Seven endoleaks were identified intra- or post procedurally in 6 (46%) of 13 cases, including 1 type IB, 3 type II, 2 type III, and 1 unclassified. Nine complications occurred in 6 patients. CONCLUSION: The Viabahn VBX stent is a safe and effective BSG for FB-EVAR with no early stent thrombosis. Further evaluation is required to determine longer term stent efficacy.