Automating sedation state assessments using natural language processing.

INTRODUCTION: Common goals for procedural sedation are to control pain and ensure the patient is not moving to an extent that is impeding safe progress or completion of the procedure. Clinicians perform regular assessments of the adequacy of procedural sedation in accordance with these goals to inform their decision-making around sedation titration and also for documentation of the care provided. Natural language processing could be applied to real-time transcriptions of audio recordings made during procedures in order to classify sedation states that involve movement and pain, which could then be integrated into clinical documentation systems. The aim of this study was to determine whether natural language processing algorithms will work with sufficient accuracy to detect sedation states during procedural sedation. DESIGN: A prospective observational study was conducted. METHODS: Audio recordings from consenting participants undergoing elective procedures performed in the interventional radiology suite at a large academic hospital were transcribed using an automated speech recognition model. Sentences of transcribed text were used to train and evaluate several different NLP pipelines for a text classification task. The NLP pipelines we evaluated included a simple Bag-of-Words (BOW) model, an ensemble architecture combining a linear BOW model and a "token-to-vector" (Tok2Vec) component, and a transformer-based architecture using the RoBERTa pre-trained model. RESULTS: A total of 15,936 sentences from transcriptions of 82 procedures was included in the analysis. The RoBERTa model achieved the highest performance among the three models with an area under the ROC curve (AUC-ROC) of 0.97, an F1 score of 0.87, a precision of 0.86, and a recall of 0.89. The Ensemble model showed a similarly high AUC-ROC of 0.96, but lower F1 score of 0.79, precision of 0.83, and recall of 0.77. The BOW approach achieved an AUC-ROC of 0.97 and the F1 score was 0.7, precision was 0.83 and recall was 0.66. CONCLUSION: The transformer-based architecture using the RoBERTa pre-trained model achieved the best classification performance. Further research is required to confirm the that this natural language processing pipeline can accurately perform text classifications with real-time audio data to allow for automated sedation state assessments. CLINICAL RELEVANCE: Automating sedation state assessments using natural language processing pipelines would allow for more timely documentation of the care received by sedated patients, and, at the same time, decrease documentation burden for clinicians. Downstream applications can also be generated from the classifications, including for example real-time visualizations of sedation state, which may facilitate improved communication of the adequacy of the sedation between clinicians, who may be performing supervision remotely. Also, accumulation of sedation state assessments from multiple procedures may reveal insights into the efficacy of particular sedative medications or identify procedures where the current approach for sedation and analgesia is not optimal (i.e. a significant amount of time spent in "pain" or "movement" sedation states).

Integrated pulmonary index during procedural sedation and analgesia: A cluster-randomized trial.

AIM: To evaluate the effectiveness of utilizing the integrated pulmonary index for capnography implementation during sedation administered by nurses. DESIGN: Cluster-randomized trial. METHODS: Participants were enrolled from the interventional radiology department at an academic hospital in Canada. Nurses were randomized to either enable or disable the Integrated Pulmonary Index feature of the capnography monitor. Procedures were observed by a research assistant to collect information about alarm performance characteristics. The primary outcome was the number of seconds in an alert condition state without an intervention being applied. RESULTS: The number of seconds in an alarm state without intervention was higher in the group that enabled the integrated pulmonary index compared to the group that disabled this feature, but this difference did not reach statistical significance. Likewise, the difference between groups for the total alarm duration, total number of alarms and the total number of appropriate alarms was not statistically significant. The number of inappropriate alarms was higher in the group that enabled the Integrated Pulmonary Index, but this estimate was highly imprecise. There was no difference in the odds of an adverse event (measured by the Tracking and Reporting Outcomes of Procedural Sedation tool) occurring between groups. Desaturation events were uncommon and brief in both groups but the area under the SpO2 90% desaturation curve scores were lower for the group that enabled the integrated pulmonary index. CONCLUSION: Enabling the integrated pulmonary index during nurse-administered procedural sedation did not reduce nurses' response times to alarms. Therefore, integrating multiple physiological parameters related to respiratory assessment into a single index did not lower the threshold for intervention by nurses. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: The time it takes to respond to capnography monitor alarms will not be reduced if the integrated pulmonary Iindex feature of capnography monitors is enabled during nurse-administered procedural sedation. IMPACT: Results do not support the routine enabling of the integrated pulmonary index when nurses use capnography to monitor patients during procedural sedation as a strategy to reduce the time it takes to initiate responses to alarms. REPORTING METHOD: CONSORT. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution. TRIAL REGISTRATION: This study was prospectively registered at ClinicalTrials.gov (ID: NCT05068700).

An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 1 Foundational Knowledge.

Artificial intelligence (AI) is rapidly evolving and has transformative potential for interventional radiology (IR) clinical practice. However, formal training in AI may be limited for many clinicians and therefore presents a challenge for initial implementation and trust in AI. An understanding of the foundational concepts in AI may help familiarize the interventional radiologist with the field of AI, thus facilitating understanding and participation in the development and deployment of AI. A pragmatic classification system of AI based on the complexity of the model may guide clinicians in the assessment of AI. Finally, the current state of AI in IR and the patterns of implementation are explored (pre-procedural, intra-procedural, and post-procedural).

An Introductory Guide to Artificial Intelligence in Interventional Radiology: Part 2: Implementation Considerations and Harms.

The introduction of artificial intelligence (AI) in interventional radiology (IR) will bring about new challenges and opportunities for patients and clinicians. AI may comprise software as a medical device or AI-integrated hardware and will require a rigorous evaluation that should be guided based on the level of risk of the implementation. A hierarchy of risk of harm and possible harms are described herein. A checklist to guide deployment of an AI in a clinical IR environment is provided. As AI continues to evolve, regulation and evaluation of the AI medical devices will need to continue to evolve to keep pace and ensure patient safety.

Feasibility of Artificial Intelligence Powered Adverse Event Analysis: Using a Large Language Model to Analyze Microwave Ablation Malfunction Data.

Objectives: Determine if a large language model (LLM, GPT-4) can label and consolidate and analyze interventional radiology (IR) microwave ablation device safety event data into meaningful summaries similar to humans. Methods: Microwave ablation safety data from January 1, 2011 to October 31, 2023 were collected and type of failure was categorized by human readers. Using GPT-4 and iterative prompt development, the data were classified. Iterative summarization of the reports was performed using GPT-4 to generate a final summary of the large text corpus. Results: Training (n = 25), validation (n = 639), and test (n = 79) data were split to reflect real-world deployment of an LLM for this task. GPT-4 demonstrated high accuracy in the multiclass classification problem of microwave ablation device data (accuracy [95% CI]: training data 96.0% [79.7, 99.9], validation 86.4% [83.5, 89.0], test 87.3% [78.0, 93.8]). The text content was distilled through GPT-4 and iterative summarization prompts. A final summary was created which reflected the clinically relevant insights from the microwave ablation data relative to human interpretation but had inaccurate event class counts. Conclusion: The LLM emulated the human analysis, suggesting feasibility of using LLMs to process large volumes of IR safety data as a tool for clinicians. It accurately labelled microwave ablation device event data by type of malfunction through few-shot learning. Content distillation was used to analyze a large text corpus (>650 reports) and generate an insightful summary which was like the human interpretation.

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.

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.

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.

Assessment of open surgical and endovascular management of true hepatic artery aneurysms over 20 years highlights increased rupture risk in females.

BACKGROUND: True hepatic artery aneurysms (HAAs) are rare but have been associated with a significant risk of rupture and associated mortality. The 2020 release of HAA-specific clinical practice guidelines represented an important step toward management standardization. However, it remains essential to build on the body of evidence to further refine these recommendations. METHODS: The HAA management and outcomes from a single academic center during a 20-year period were retrospectively reviewed. We identified 72 patients from the institutional radiology database (November 24, 1999 to 2019). Pseudoaneurysms were excluded, and 48 patients were found to have had true HAAs. Forty-three HAA patients had sufficient medical records for inclusion in the analysis. RESULTS: Of the 43 patients with HAA included, 65% were male. The mean age was 63 years (range, 22-89 years). Of the HAAs, 72% presented asymptomatically, 16% had ruptured, and 12% were symptomatic at presentation. Most HAAs were of atherosclerotic origin (74%). In addition, 16% of the patients had other visceral aneurysms and 12% had nonvisceral aneurysms on presentation. The mean HAA size overall was 3.3 cm (range, 0.8-10.8 cm), with most being solitary (72%) and involving the common hepatic artery (65%). Rupture was more common in females (40%) and those with vasculitis (67%), with females representing 86% of all patients with rupture. The mean size at intervention was 4.8 cm (21 patients [49%]). Ten patients (23%) had undergone open surgical repair (seven elective and three emergent because of rupture). Eleven patients (26%) had undergone endovascular intervention (64% elective and 36% emergent). Nonoperative management was selected for 22 patients (51%). These patients had a mean HAA diameter of 2.1 cm, and 59% had a life-limiting illness. Of the 18 patients who had been initially monitored for a mean of 3.9 ± 4.1 years, 3 had undergone elective repair and 2 had minimal growth. None of these patients had a subsequently documented rupture. CONCLUSIONS: True HAAs are a rare but important clinical phenomenon, with 16% of patients presenting with rupture in this study. Endovascular intervention is a promising alternative to open surgical repair, with no 30-day mortality, and is suitable for ruptured HAAs. Importantly, for the first time, our findings have demonstrated an increased risk of rupture for females, highlighting the need for additional data and ultimately, sex-specific guidelines.

Effect of vertebral compression fractures on aortic neck angulation after endovascular aneurysm repair.

OBJECTIVE: Aortic neck angulation (ANA) prior to endovascular aneurysm repair (EVAR) and its changes after EVAR are considered important predictors of postoperative complications. We sought to assess the effects of vertebral body height loss on ANA in patients post-EVAR. METHODS: All patients who had undergone EVAR for infrarenal aortic aneurysms in our institution between August 2010 and December 2018 were assessed. Anterior and posterior vertebral body heights were measured in all patients on preoperative, early postoperative, and follow-up computed tomography scans (T12-L5 vertebral bodies). Patients who had significant height loss in their follow-up period were designated as the Study group. These were matched to a Control group of the same size using propensity-score matching based on age, gender, and duration between follow-up scans. Aortic neck morphology indices including ANA and its changes were measured, and information related to postoperative endoleaks and aneurysm sac size were extracted in the Study and Control groups. RESULTS: During the follow-up period, 10 of 185 patients had a radiologically significant vertebral body compression fracture. There was no significant difference between the Study (n = 10) and Control groups in age (77.6 ± 6.9 vs 77.2 ± 7.5 years; P = .64), gender (seven males and three females in each group; P = 1.0), duration between postoperative scans (1830 ± 665 vs 1800 ± 670 days; P = .25), preoperative ANA (36.0° ± 15.6° vs 42.4° ± 18.6°; P = .41), and early postoperative ANA (21.9° ± 11.7° vs 20.9° ± 16.3°; P = .72). Changes in ANA in the postoperative period (7.2° ± 11.1° vs -4.7° ± 6.7°; P = .009; power = .838) were significantly higher in the Study group. CONCLUSIONS: Post-EVAR vertebral body compression fractures exacerbate ANA. Awareness of this can guide both preoperative assessment and postoperative management and follow-up.

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.

Uterine Artery Embolization for Pedunculated Subserosal Fibroids: A Systematic Review and Meta-Analysis.

PURPOSE: To provide a comprehensive overview of the literature assessing the safety and efficacy of uterine artery embolization (UAE) for patients with pedunculated subserosal fibroids. MATERIALS AND METHODS: MEDLINE and Embase databases were searched without language or publication type restrictions for observational studies to estimate safety (adverse events) and efficacy (devascularization, fibroid volume reduction, and uterine volume reduction) outcomes. Case reports were included to qualitatively report adverse events. Meta-analysis was performed for single proportions and mean changes with random-effects modeling. RESULTS: Of 98 eligible articles, 11 studies were included in the final analysis. Of the adverse events detailed in these cases, 5 events were mild, 2 were moderate (torsion of pedunculated fibroid requiring laparoscopic myomectomy and persistent bleeding after embolization requiring hysterectomy), and 1 was severe (fibroid necrosis causing bowel obstruction requiring bowel resection and hysterectomy). There were no deaths reported in the literature. The pooled risk of adverse events was 1.7% (95% confidence interval [CI], 0.29%-9.2%; 4 of 181; I2 = 0%). The pooled devascularization rate was 75.9% (95% CI, 62.4%-85.6%; 140 of 189; I2 = 75%) at 3.91 months of follow-up. The percent volume reduction of the dominant pedunculated fibroid was 38.6% (95% CI, 33.0%-44.2%; I2 = 0%) at 4.3 months of follow-up. The percent uterine volume reduction was 36.7% (95% CI, 30.3%-43.0%; I2 = 47%) at 3.5 months of follow-up. CONCLUSIONS: UAE for pedunculated subserosal fibroids has a low risk of adverse events and effectively reduces fibroid and uterine size.

Endovascular coil embolization of inferior mesenteric artery to ileal-conduit fistula: a case report.

BACKGROUND: Uretero-arterial fistulas (UAFs) are uncommon and pose a diagnostic dilemma, making them life threatening if not recognized and treated expediently. UAFs to small arteries such as a branch of the inferior mesenteric artery (IMA) are very uncommon and present a further diagnostic and treatment challenge. There should be a high index of suspicion for UAFs when intervening on patients with history of treated pelvic cancers and long-standing ureteric stents experiencing hematuria not attributable to another cause. CASE PRESENTATION: We present a case of a fistula formed between a distal branch of the IMA-superior rectal artery-and an ileal-conduit in a patient with a long-standing reverse nephroureterostomy (Hobbs) catheter presenting with abdominal pain and hematuria through the conduit. During a tube exchange, contrast injection demonstrated a fistula with the superior rectal artery, multiple ileal intraluminal blood clots, and active extravasation. The patient became tachycardic and hypotensive, actively bleeding through the ileal-conduit, prompting a massive transfusion protocol. Successful endovascular coiling of the superior rectal artery was performed with resolution of active extravasation and stabilization of the patient. The patient recovered and was discharged in stable condition 10 days later. CONCLUSIONS: Although UAFs are uncommon, our case demonstrated key predisposing risk factors to fistula development; pelvic cancer surgery, pelvic radiation, and a prolonged ureteric stent through the ileal-conduit. Typically, UAFs arise from communication with the iliac arterial system, however in this instance we have demonstrated that fistulization to other arterial vessels is also possible. Endovascular management has become the preferred method of therapy, typically involving the placement of covered stents when involving the iliac arterial system. In this instance stent grafting was not possible due to the small caliber vessel and therefore had to be embolized.

Integrated Pulmonary Index during nurse-administered procedural sedation: Study protocol for a cluster-randomized trial.

AIM: To determine if smart alarm-guided treatment of respiratory depression using the Integrated Pulmonary Index is an effective way to implement capnography during nurse-administered sedation. DESIGN: Parallel cluster-randomized trial. METHODS: Nurses will be randomized to use capnography with or without the Integrated Pulmonary Index enabled. Capnography alarm performance will be compared between nurses using capnography alone or with the Integrated Pulmonary Index enabled. The target sample size is 400 adult patients scheduled for elective procedures with nurse-administered sedation. The primary outcome is the number of seconds in an alert condition state without an intervention being applied. Secondary outcomes are alarm burden, number of appropriate alarms, number of inappropriate alarms, total duration of alert conditions, choice of alarm settings and adverse sedation events. This study has been funded since April 2021. DISCUSSION: Implementing capnography into practice for respiratory monitoring during nurse-administered sedation is considered a high priority. The Integrated Pulmonary Index shows promise as a strategy to optimize the implementation of capnography for respiratory monitoring during nurse-administered sedation. If it is found in this study that using the Integrated Pulmonary Index improves the nursing management of physiologically abnormal states during nurse-administered sedation, it would provide the high-level evidence needed to support broader use of this 'smart alarm' strategy for respiratory monitoring in practice. IMPACT: With advances in medical technology continuing to expand the indications for minimally invasive surgical techniques, the use of nurse-administered sedation during medical procedures is likely to expand in the future. The findings may be applied to other populations receiving nurse-administered sedation during medical procedures. Results from this study will help translate the usage of smart alarm-guided treatment of respiratory depression during procedural sedation. TRIAL REGISTRATION: NCT05068700.

Arteries of the Lower Limb-Embryology, Variations, and Clinical Significance.

OBJECTIVES: The purpose of this article is to review the embryology of the lower limb arterial anatomy along with common variants and their clinical relevance. DESIGN: Embryologic variations of the lower limb arterial system may be explained by i.) persistence of primordial arterial segments, ii.) abnormal fusion, iii.) segmental hypoplasia/absence, or a combination of both. Persistent sciatic artery, corona mortis, and popliteal entrapment syndrome will also be discussed with associated symptoms, and potential complications. CONCLUSION: Knowledge of these variations is essential for surgical and endovascular management as failure to recognize them can result in complications.

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.