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.

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.

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.

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.

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.

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.

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.

Pre-operative Aneurysm Thrombus Volume, But Not Density, Predicts Type 2 Endoleak Rate Following Endovascular Aneurysm Repair.

BACKGROUND: The impact of aneurysm thrombus characteristics on type 2 endoleak rate following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is unclear. The purpose of this study is to determine the impact of pre-operative aneurysm thrombus volume and density on the incidence of type 2 endoleak following EVAR for infrarenal AAA. METHODS: A retrospective analysis was completed on all patients who underwent standard EVAR at an academic medical institution between May 1, 2010 and June 1, 2016 with a minimum follow-up period of 12 months. The final analysis included 170 patients. Thrombus volume and density were determined by analyzing pre-operative computed tomography angiography (CTA) scans using the TeraRecon plaque analysis module. The number and diameter of patent infrarenal aortic branch vessels were also identified. Type 2 endoleak was diagnosed by post-operative CTA, duplex ultrasound, or angiography. RESULTS: Over a median follow-up period of 29 months, 88 (51.8%) of 170 patients had a type 2 endoleak. The thrombus volume as a proportion of the infrarenal aorta volume was significantly lower in patients with type 2 endoleak (odds ratio [OR] 0.034, 95% confidence interval [CI] 0.005-0.291, P = 0.002). The number of patent lumbar arteries was significantly greater in patients with type 2 endoleak (OR 1.45, 95% CI 1.16-1.56, P < 0.0005). Both variables independently predicted the incidence of type 2 endoleak in a multivariate analysis. Thrombus density was not related to the incidence of type 2 endoleak. CONCLUSIONS: A lower ratio of thrombus volume/infrarenal aorta volume and a higher number of patent lumbar arteries were associated with an increased incidence of type 2 endoleak. A multivariate logistic regression model was generated to pre-operatively predict the risk of type 2 endoleak. This model can guide the stratification of patients for intensity of endoleak surveillance following EVAR and consideration of pre-operative treatment.

Conservative management of type 1A endoleaks at completion angiogram in endovascular repair of infra-renal abdominal aortic aneurysms with current generation stent grafts.

PURPOSE: Proximal type 1A endoleaks on completion intra-operative angiography are not infrequently seen following endovascular abdominal aneurysm repair (EVAR). The natural course of these leaks is not well established. We sought to determine the rate of spontaneous resolution and a conservative treatment approach to these endoleaks. METHODS: All cases involving endovascular repairs of infra-renal abdominal aortic aneurysms resulting in proximal type 1A endoleak on final intra-operative completion angiography were retrospectively reviewed from 1 April 2010 and 30 March 2015. Demographic, pre and post-procedural imaging, and clinical outcomes were reviewed. Summarizing descriptive statistics are reported. RESULTS: Of the 337 patients who underwent an EVAR, 24 patients (7.1%) had a proximal type 1A endoleak on final intra-operative angiography. Twenty-two of 24 patients (92%) with proximal type 1A endoleaks had spontaneous resolution on follow-up imaging without any intervention, while two (8%) patients had a persistent endoleak. One of these patients required intervention. The median follow-up for patients with resolved endoleaks was 2.5 years vs. 4 and 6 years, respectively, for patients that did not resolve spontaneously. CONCLUSION: A conservative approach may be used in the management of patients with proximal type 1A endoleaks on completion angiography once maximum proximal seal was achieved intra-operatively as the vast majority of these leaks spontaneously seal.

Utility of the Vascular Quality Initiative in improving quality of care in Canadian patients undergoing vascular surgery

The Vascular Quality Initiative (VQI) is a national cooperative quality-improvement initiative designed to evaluate processes of care and outcomes in vascular surgery. The purpose of this report is to show the utility of such a database to provide insight into the standard of care provided, to highlight areas of local quality improvement, to benchmark our data against local, regional and national trends, and to ultimately improve safety in Canadian patients undergoing vascular surgery. We present the history of the database, its spread in the Canadian health care system and examples of quality improvements achieved from analyses of data recorded and retrieved from the VQI. Using the VQI, our institution was able to decrease the length of stay after endovascular aneurysm repair, decrease the contrast volume in endovascular aneurysm repair, save on costs, and provide medium-term outcome data on peripheral vascular interventions and smoking cessation strategies. The VQI is a powerful tool to improve patient safety and quality in vascular surgery. Its ability to create local regional improvement groups fosters a quality-focused culture and is important for Canadian patients.

La Vascular Quality Initiative (VQI) est une initiative de collaboration nationale axée sur l'amélioration de la qualité, conçue pour évaluer les processus de soins et les résultats en chirurgie vasculaire. Le but du présent rapport est de montrer l'utilité d'une telle base de données pour situer les normes de soins actuelles, mettre en lumière les secteurs d'amélioration de la qualité locale, évaluer nos données à la lumière des tendances locales, régionales et nationales et ultimement, améliorer la sécurité des patients canadiens de chirurgie vasculaire. Nous retraçons l'historique de cette base de données, son adoption par le système de santé canadien et donnons des exemples d'améliorations de la qualité obtenues grâce à l'analyse des données enregistrées et récupérées à partir de la base VQI. Cette base de données nous a permis d'abréger les séjours hospitaliers après la réparation endovasculaire des anévrismes, d'épargner sur les coûts et de compiler les résultats à moyen terme des interventions vasculaires périphériques et des stratégies d'abandon du tabagisme. La VQI est un outil puissant pour améliorer la sécurité des patients et la qualité de la chirurgie vasculaire. Sa capacité de créer des groupes loco-régionaux d'amélioration de la qualité favorise une culture axée sur la qualité et est importante pour les patients canadiens.

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.

Elastic Recoil after Balloon Angioplasty in Hemodialysis Accesses: Does It Actually Occur and Is It Clinically Relevant?

Purpose To qualify and quantify elastic recoil and determine its effect on access patency. Materials and Methods Research ethics board approval was obtained and all patients signed an informed consent form. This was a prospective, nonrandomized study of mature accesses that underwent balloon percutaneous transluminal angioplasty (PTA) between January 2009 and December 2012. After PTA, completion fistulography was performed at 0-, 5-, 10-, and 15-minute intervals. From Digital Imaging and Communications in Medicine images, percentage of lesion stenosis before and after PTA was measured at each time point. A total of 76 patients (44 men, 32 women; mean age, 59.6 years) were enrolled and underwent 154 PTAs in 56 grafts and 98 fistulas. Venous elastic recoil was defined as recurrent luminal narrowing greater than 50% within 15 minutes after full effacement of the stenosis by the angioplasty balloon. Data collected included sex, age, access type and location, lesion location, length, and time to next intervention. Access patency was estimated by using Kaplan-Meier survival method, association of variables with the risk of loss of patency was assessed by using a Cox proportional hazards model, and a multiple variable model was examined by considering all variables. Results Technical success of PTA with less than 30% residual stenosis was 78%. By 15 minutes, 15.6% (24 of 154) of treated lesions recurrently narrowed by more than 50%, with a majority observed at 5 minutes (15 of 24). Technical failure of PTA was predictive of elastic recoil (P < .001), as was cephalic arch stenosis in fistulas (P = .047) and autogenous fistulas (P = .04). Elastic recoil, when it did occur, did not influence patency. Six-month primary patency was 34.8% in grafts and 47.1% in fistulas. Conclusion Venous elastic recoil after PTA of stenoses in hemodialysis access circuits is common, but its occurrence does not influence access primary patency after PTA. (©) RSNA, 2015.

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.

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.

Randomized Trial Comparing Radiologic Pigtail Gastrostomy and Peroral Image-Guided Gastrostomy: Intra- and Postprocedural Pain, Radiation Exposure, Complications, and Quality of Life.

PURPOSE: To prospectively compare radiologically created pigtail gastrostomy (PG), in which the tube is inserted directly through the abdominal wall, versus peroral image-guided gastrostomy (POG), in which the tube is inserted through the mouth. Pain profiles (primary outcome measure), fluoroscopy times, total room times, technical success, complications, and quality of life (QOL) were measured. MATERIALS AND METHODS: Sixty patients were prospectively randomized to receive 14-F PG or 20-F POG tubes. All patients received prophylactically created gastrostomies before radiation therapy for head and neck squamous-cell carcinoma. Patients receiving palliative treatment were excluded, as were those with established pharyngeal obstruction. Pain was measured by numeric rating scale (NRS) scores for 6 weeks after the procedure and by intraprocedural fentanyl and midazolam doses and postprocedural 24-h morphine doses. Fluoroscopy times, total room times, technical success, complications up to 6 months, and gastrostomy-related QOL (using the Functional Assessment of Cancer Therapy-Enteral Feeding questionnaire) were determined. RESULTS: Fifty-six patients underwent the randomized procedure. The POG group required significantly higher intraprocedural midazolam and fentanyl doses (mean, 1.2 mg and 67 µg, respectively, for PG vs 1.9 mg and 105 µg for POG; P < .001) and had significantly longer fluoroscopy times (mean, 1.3 min for PG vs 4.8 min for POG; P < .0001). NRS scores, morphine doses, total room times, technical success, complication rates, and QOL did not differ significantly between groups. The one major complication, a misplaced PG in the peritoneal cavity, followed a technical failure of POG creation. CONCLUSIONS: Despite the differences in insertion technique and tube caliber, the measured outcomes of POG and PG are comparable.

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.

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.

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.

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.