Cholangioscopy with Spyglass DS using percutaneous transhepatic cholangiography access: a retrospective cohort study.

Background: Conventional peroral methods to visualize biliary strictures are not feasible in some patients with altered anatomy or biliary obstruction, and percutaneous transhepatic cholangioscopy can be used as an alternative procedure. This study aimed to retrospectively review the use of percutaneous transhepatic cholangiography using the SpyGlass DS technology (S-PTCS) during a 5-year period at a Danish tertiary referral centre. Materials and methods: All patients who underwent S-PTCS at a single Danish tertiary referral centre between 2016 and 2021 were retrospectively analyzed. The visual, technical, and overall success rates of S-PTCS were analyzed, as well as the complication rate. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of S-PTCS were calculated. Results: Twenty-two patients were included in the study. Visual, technical, and overall success of S-PTCS was achieved in 17/22, 22/22, and 21/22 patients, respectively. S-PTCS yielded a sensitivity of 83.3%, a specificity of 100%, a PPV of 100%, a NPV of 94.1%, and an accuracy of 95.4%. Complications occurred in 1/22 patients. Conclusion: S-PTCS is a safe modality, with high success rates, high predictive values, and a low rate of complications. This study suggests that S-PTCS is an alternative to conventional methods in patients with indeterminate biliary strictures where conventional methods were unfeasible.

Efficacy of High-Dose Dexamethasone in Reducing the Symptoms of Postembolization Syndrome Following Prostatic Artery Embolization: Results of a Double-Blind Randomized Controlled Trial.

PURPOSE: To evaluate the efficacy of a single perioperative dose of dexamethasone in reducing postembolization syndrome following prostatic artery embolization. MATERIALS AND METHODS: We conducted a single-center double-blind randomized controlled trial from March 2021 to May 2022 (NCT04588857). Participants were randomized to receive either i.v. 24 mg dexamethasone or saline. The primary outcome measures were temperature, pain, and quality of life in the first 5 days following prostatic artery embolization. Sample size of 60 patients was needed for the assessment of primary outcomes. Participants were followed for 6 months and assessed for a variety of secondary outcome measures including inflammatory markers and lower urinary tract symptoms severity. RESULTS: Due to lack of clinical effect and mild symptoms in the control group, the trial was terminated early. 31 participants (16 dexamethasone vs. 15 control) were enrolled and analyzed. A difference in mean temperature was observed on day 1 (37.23 ± 0.64 °C control vs 36.74 ± 0.41 °C dexamethasone, p = 0.02, 95% CI 0.09-0.89). Difference in pain (score out of 10) was seen only on day 5 (1.48 ± 1.2 control vs. 2.9 ± 2.24 dexamethasone, p = 0.04, 95% CI - 2.78-- 0.04). A difference in C-reactive protein values was observed on day 2 (108 [54-161] mg/l control vs 10 [5-33] mg/l dexamethasone, p < 0.01). No significant differences in other outcomes were observed. No side effects were recorded. CONCLUSIONS: Twenty-four milligrams of dexamethasone bolus is safe but does not reduce postembolization syndrome following prostatic artery embolization.

Learning insertion of a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) catheter: Is clinical experience necessary? A prospective trial.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging and potentially life-saving procedure, necessitating qualified operators in an increasing number of centres. The procedure shares technical elements with other vascular access procedures using the Seldinger technique, which is mastered by doctors not only in endovascular specialties but also in trauma surgery, emergency medicine, and anaesthesiology. We hypothesised that doctors mastering the Seldinger technique (experienced anaesthesiologist) would learn the technical aspects of REBOA with limited training and remain technically superior to doctors unfamiliar with the Seldinger technique (novice residents) given similar training. METHODS: This was a prospective trial of an educational intervention. Three groups of doctors were enroled: novice residents, experienced anaesthesiologists, and endovascular experts. The novices and the anaesthesiologists completed 2.5 h of simulation-based REBOA training. Their skills were tested before and 8-12 weeks after training using a standardised simulated scenario. The endovascular experts, constituting a reference group, were equivalently tested. All performances were video recorded and rated by three blinded experts using a validated assessment tool for REBOA (REBOA-RATE). Performances were compared between groups and with a previously published pass/fail cutoff. RESULTS: Sixteen novices, 13 board-certified specialists in anaesthesiology, and 13 endovascular experts participated. Before training, the anaesthesiologists outperformed the novices by 30 percentage points of the maximum REBOA-RATE score (56% (SD 14.0) vs 26% (SD 17%), p<0.01). After training, there was no difference in skills between the two groups (78% (SD 11%) vs 78 (SD 14%), p = 0.93). Neither group reached the endovascular experts' skill level (89% (SD 7%), p<0.05). CONCLUSION: For doctors mastering the Seldinger technique, there was an initial inter-procedural transfer of skills advantage when performing REBOA. However, after identical simulation-based training, novices performed equally well to anaesthesiologists, indicating that vascular access experience is not a prerequisite to learning the technical aspects of REBOA. Both groups would need more training to reach technical proficiency.

Limb graft occlusion after endovascular aneurysm repair with the Cook Zenith Alpha abdominal graft.

OBJECTIVE: Prior reports of the low profile Zenith Alpha abdominal graft (Cook Medical Inc, Bloomington, IN) have shown impaired limb graft patency to be the primary causes of reintervention. Special notices from the manufacturer have indicated certain instructions for use (IFU) violations as the main reasons for these complications. In the present study, we assessed the incidence of limb graft occlusion (LGO) and analyzed the effects of the detailed anatomic risk factors for LGO highlighted in the IFU and previously reported studies. METHODS: A retrospective study was performed of 241 patients treated with the low profile Zenith Alpha at a single institution from October 1, 2015 to September 30, 2018. All computed tomography angiograms were analyzed using three-dimensional software. Data were extracted from the electronic medical records until the end of the study period (December 31, 2020). The cumulative incidence of LGO and LGO-related reinterventions were assessed. A regression analysis was performed to evaluate the possible risk factors associated with the development of LGO at specified time points. These included aortic and iliac diameters, graft component oversizing, iliac tortuosity and calcification, overlap of graft components, proximal alignment of ipsilateral and contralateral legs, and sealing zone in the external iliac artery. Reader agreement of iliac calcification and tortuosity was assessed in patients with LGO. RESULTS: A total of 33 limbs (7%) in 27 patients (11%) had become occluded. The cumulative incidence of LGO was 7% (95% confidence interval [CI], 5%-9%) per limb up to 3 years postoperatively. The previously described risk factors for LGO were studied using regression analysis; however, no positive association with LGO was identified. Heavily calcified common iliac arteries (CIAs) and external iliac arteries were protective against LGO compared with noncalcified vessels up to 3 years postoperatively (decreased risk, 17% [95% CI, -27% to -7%]; P = .001; and 15% [95% CI, -26 to -5]; P = .005, respectively). The reader agreement of iliac calcification and tortuosity showed substantial agreement (CIA intrareader kappa = 0.75; CIA interreader kappa = 0.62) and almost perfect agreement (intrareader kappa = 0.85; interreader kappa = 0.84), respectively. CONCLUSIONS: The cumulative incidence of LGO after endovascular aneurysm repair with the Zenith Alpha graft was 7% per limb up to 3 years postoperatively. None of the analyzed risk factors suggested by the IFUs or current literature were positively associated with LGO.

Center experience and other determinants of patient radiation exposure during prostatic artery embolization: a retrospective study in three Scandinavian centers.

OBJECTIVES: To evaluate the effects of center experience and a variety of patient- and procedure-related factors on patient radiation exposure during prostatic artery embolization (PAE) in three Scandinavian centers with different PAE protocols and levels of experience. Understanding factors that influence radiation exposure is crucial in effective patient selection and procedural planning. METHODS: Data were collected retrospectively for 352 consecutive PAE procedures from January 2015 to June 2020 at the three centers. Dose area product (DAP (Gy·cm2)) was selected as the primary outcome measure of radiation exposure. Multiple patient- and procedure-related explanatory variables were collected and correlated with the outcome variable. A multiple linear regression model was built to determine significant predictors of increased or decreased radiation exposure as reflected by DAP. RESULTS: There was considerable variation in DAP between the centers. Intended unilateral PAE (p = 0.03) and each 10 additional patients treated (p = 0.02) were significant predictors of decreased DAP. Conversely, increased patient body mass index (BMI, p < 0.001), fluoroscopy time (p < 0.001), and number of digital subtraction angiography (DSA) acquisitions (p < 0.001) were significant predictors of increased DAP. CONCLUSIONS: To minimize patient radiation exposure during PAE radiologists may, in collaboration with clinicians, consider unilateral embolization, pre-interventional CTA for procedure planning, using predominantly anteroposterior (AP) projections, and limiting the use of cone-beam CT (CBCT) and fluoroscopy. KEY POINTS: • Growing center experience and intended unilateral embolization decrease patient radiation exposure during prostatic artery embolization. • Patient BMI, fluoroscopy time, and number of DSA acquisitions are associated with increased DAP during procedures. • Large variation in radiation exposure between the centers may reflect the use of CTA before and CBCT during the procedure.

Efficacy of dexamethasone in reducing the postembolisation syndrome in men undergoing prostatic artery embolisation for benign prostatic hyperplasia: protocol for a single-centre, randomised, double-blind, placebo-controlled trial-the 'DEXAPAE' study.

INTRODUCTION: Postembolisation syndrome (PES) is the most common side effect of vascular embolisation of solid organs. Although prophylactic corticosteroids are known to reduce the incidence and severity of PES, no trials investigating their efficacy have been conducted in men undergoing prostatic artery embolisation (PAE). We postulate that steroids can have a similar effect in reducing PES after PAE. This paper describes the rationale and detailed protocol for a randomised controlled trial evaluating the efficacy of dexamethasone (DEXA) in reducing PES after PAE. METHODS AND ANALYSIS: In this single-centre, randomised, double-blind, placebo-controlled trial, we will enrol 60 individuals undergoing PAE for benign prostatic hyperplasia. Participants will be randomised to receive IV DEXA (24 mg) or placebo (saline). The primary outcomes will be postprocedural fever, pain and quality of life. The secondary outcomes will include postprocedural nausea, postprocedural medicine usage, laboratory parameters (C reactive protein, prostate-specific antigen) and early PAE results. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Danish Committee on Health Research Ethics in the Capital Region (H-20025910). The results from this trial will be disseminated through publication in peer-reviewed journals and national and international presentations. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT04588857; EudraCT number: 2020-000915-53.

Reliable and valid assessment of procedural skills in resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.

Developing a tool to assess competence in resuscitative endovascular balloon occlusion of the aorta: An international Delphi consensus study.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emergency procedure that is potentially lifesaving in major noncompressible torso hemorrhage. It may also improve outcome in nontraumatic cardiac arrest. However, the procedure can be technically challenging and requires the immediate presence of a qualified operator. Thus, evidence-based training and assessment of operator skills are essential for successful implementation and patient safety. A prerequisite for this is a valid and reliable assessment tool specific for the procedure. The aim of this study was to develop a tool for assessing procedural competence in REBOA based on best-available knowledge from international experts in the field. METHODS: We invited international REBOA experts from multiple specialties to participate in an anonymous three-round iterative Delphi study to reach consensus on the design and content of an assessment tool. In round 1, participants suggested items to be included. In rounds 2 and 3, the relevance of each suggested item was evaluated by all participants to reach consensus. Interround data processing was done systematically by a steering group. RESULTS: Forty panelists representing both clinical and educational expertise in REBOA from 16 countries (in Europe, Asia, and North and South America) and seven different specialties participated in the study. After 3 Delphi rounds and 532 initial item suggestions, the panelists reached consensus on a 10-item assessment tool with behaviorally anchored rating scales. It includes assessment of teamwork, procedure time, selection and preparation of equipment, puncture technique, guidewire handling, sheath handling, placement of REBOA catheter, occlusion, and evaluation. CONCLUSION: We present the REBOA-RATE assessment tool developed systematically by international experts in the field to optimize content validity. Following further studies of its validity and reliability, this tool represents an important next step in evidence-based training programs in REBOA, for example, using mastery learning. LEVEL OF EVIDENCE: Therapeutic, level V.

Three-dimensional ultrasound is a reliable alternative in endovascular aortic repair surveillance.

OBJECTIVE: Three-dimensional ultrasound (3D-US) has already demonstrated improved reproducibility with a high degree of agreement (intermodality variability), reproducibility (interoperator variability), and repeatability (intraoperator variability) compared with conventional two-dimensional ultrasound (2D-US) when estimating the maximum diameter of native abdominal aortic aneurysms (AAAs). The aim of the present study was, in a clinical, multicenter setting, to evaluate the accuracy of 3D-US with aneurysm model quantification software (3D-US abdominal aortic aneurysm [AAA] model) for endovascular aortic aneurysm repair (EVAR) sac diameter assessment vs that of computed tomography angiography (CTA) and 2D-US. METHODS: A total of 182 patients who had undergone EVAR from April 2016 to December 2017 and were compliant with a standardized EVAR surveillance program were enrolled from five different vascular centers (Rigshospitalet, Copenhagen, Denmark; Catharina Ziekenhuis, Eindhoven, Netherlands; L'hospital de la Timone, Paris, France; Cleveland Clinic, Cleveland, Ohio; and The Christ Hospital, Cincinnati, Ohio) in four countries. All image acquisitions were performed at the local sites (ie, 2D-US, 3D-US, CTA). Only the 2D-US and CTA readings were performed both locally and centrally. All images were read centrally by the US and CTA core laboratory. Anonymized image data were read in a randomized and blinded manner. RESULTS: The sample used to estimate the accuracy of the 3D-US AAA model and 2D-US included 164 patients and 177 patients, respectively. The Bland-Altman analysis revealed that the mean difference between CTA and 3D-US was -2.43 mm (95% confidence interval [CI], -5.20 to 0.14; P = .07) with a lower and upper limit of agreement of -8.9 mm (95% CI, -9.3 to -8.4) and 2.7 mm (95% CI, 2.3-3.2), respectively. For 2D-US and CTA, the mean difference was -3.62 mm (95% CI, -6.14 to -1.10; P = .002), with a lower and upper limit of agreement of -10.3 mm (95% CI, -10.8 to -9.8) and 2.5 mm (95% CI, 2-2.9), respectively. CONCLUSIONS: The 3D-US AAA model showed no significant difference compared with CTA for measuring the anteroposterior diameter, indicating less bias for 3D-US compared with 2D-US. Thus, 3D-US with AAA model software is a viable modality for anteroposterior diameter assessment for surveillance after EVAR.

Three- and Two-Dimensional Ultrasound is as Accurate as Computed Tomography in Aortic Sac Assessment after Endovascular Aortic Repair.

BACKGROUND: To compare aortic sac changes after endovascular aneurysm repair (EVAR) assessed by three-dimensional ultrasound (3D-US), two-dimensional ultrasound (2D-US), and traditional computed tomographic angiography (CTA). METHODS: Using volume assessment with three-dimensional CTA (3D-CTA-volume) as the gold standard, this study investigated aortic sac changes at three and 12 months after EVAR with three different ultrasound methods (2D-US anterior-posterior (AP) diameter, 3D-US AP centerline diameter, and 3D-US partial volume), and traditional CT multiplanar outer-to-outer diameter (CT-MPR OTO diameter). From august 1st, 2011 to January 2014, consecutive EVAR patients (n = 113) were available for analysis in two time intervals; 1) between preoperative and three-month follow-up and 2) between three and 12 month follow-up. RESULTS: The risk of missing true aortic sac growth (false negative finding) at three-month postoperative visit using 3D-US partial volume, 3D-US AP centerline diameter, 2D-US AP diameter, and CT-MPR OTO diameter was 19%, 21%, 22%, and 18%, respectively. Corresponding low sensitivities (0% to 21%) and kappa-values (<0.50) in detecting aortic sac changes were found. The risk of missing true growth between three and 12 months were lower (6%, 5%, 6%, and 6%, respectively), and matching sensitivities 33%, 33%, 17%, and 17%, respectively. CONCLUSIONS: All tested methods for aortic sac changes were as good as traditional CT-MPR OTO diameter and corresponded poorly with 3D-CTA-volume at three months postoperative visit but substantially better after 12 months where the residual sac change was more profound.

Gastrointestinal Applications of Iodine Quantification Using Dual-Energy CT: A Systematic Review.

Dual-energy computed tomography (DECT) can estimate tissue vascularity and perfusion via iodine quantification. The aim of this systematic review was to outline current and emerging clinical applications of iodine quantification within the gastrointestinal tract using DECT. The search was conducted with three databases: EMBASE, Pubmed and The Cochrane Library. This identified 449 studies after duplicate removal. From a total of 570 selected studies, 30 studies were enrolled for the systematic review. The studies were categorized into four main topics: gastric tumors (12 studies), colorectal tumors (8 studies), Crohn's disease (4 studies) and miscellaneous applications (6 studies). Findings included a significant difference in iodine concentration (IC) measurements in perigastric fat between T1-3 vs. T4 stage gastric cancer, poorly and well differentiated gastric and colorectal cancer, responders vs. non-responders following chemo- or chemoradiotherapy treatment among cancer patients, and a positive correlation between IC and Crohn's disease activity. In conclusion, iodine quantification with DECT may be used preoperatively in cancer imaging as well as for monitoring treatment response. Future studies are warranted to evaluate the capabilities and limitations of DECT in splanchnic flow.

Ex vivo-expanded autologous adipose tissue-derived stromal cells ensure enhanced fat graft retention in breast augmentation: A randomized controlled clinical trial.

Autologous fat grafting and implant surgery are used for volume restoration in plastic surgery. With the aim of producing a treatment superior to current solutions, we report a randomized, controlled, data assessor-blinded clinical trial comparing fat grafts enriched with ex vivo-expanded autologous adipose-derived stromal cells (ASCs) to nonenriched fat grafts in breast augmentation. The intervention group received ASC-enriched fat grafts (≥20 × 106 viable ex vivo-expanded ASCs per milliliter fat), and the control group received conventional nonenriched fat grafts. Volume retention was measured by magnetic resonance imaging, and clinical photographs were taken simultaneously for outcome evaluation. ASC-enriched fat grafts had significantly higher retention rates (mean = 80.2%) compared with conventional fat grafts (mean = 45.1%). Clinical photos showed statistically significant superior results in the intervention group, assessed by independent clinical experts. These results improve the prospects for using culture-expanded ASCs in both reconstructive and cosmetic volume restoration and make the procedure an attractive alternative to conventional fat grafting and implants. This study is registered at www.ClinicalTrials.gov, number H-16046960.

[Keraunoparalysis after lightning injury with transient ischaemia and paralysis of an extremity].

Keraunoparalysis is a transient paralysis of the extremities, which results from close contact with lightning. In this case report, a 58-year-old man came in close contact with a bolt of lightning. His left foot was pulseless, pale, cold and with absence of capillary refill. His symptoms were initially interpreted as arterial occlusion, and therefore bypass surgery and even amputation were considered. However, his symptoms resolved within hours. Therefore, clinicians must consider keranoparalysis as a differential diagnosis in patients struck by lightning.

Training and assessment of competence in resuscitative endovascular balloon occlusion of the aorta (REBOA) - a systematic review.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a potentially life-saving but high-risk emergency procedure in patients with haemorrhagic shock. Lack of physicians with competence in the procedure is a barrier to implementation of REBOA. It is currently unclear how training and assessment of competence should be done. OBJECTIVES: To report and evaluate research in training and assessment of competence in REBOA and femoral arterial access with the aim to investigate the effect of simulation-based training in the procedure and to provide suggestions for the future design of training programs and assessment tools. METHODS: Following PRISMA guidelines, PubMed, Embase, and Cochrane Library databases were searched for studies on training or assessment of competence in REBOA and femoral arterial access. Bias assessment was done using the Medical Education Research Study Quality Instrument. Evidence level was assessed using GRADE. RESULTS: Sixteen studies were included, six of them published as abstracts. Full-text studies included 189 trainees ranging in experience level from military medics to surgical specialists. Outcome measures were heterogenous; the most used were rater checklists, knowledge testing, and procedure time. All studies confirmed an effect of training of REBOA on procedural competence in a simulation setting but had a high degree of bias. No study developed or used an assessment tool supported by validity evidence and no study investigated mid and long-term outcomes. CONCLUSION: Simulation-based training of REBOA improves skills, however, the evidence level is very low and data cannot answer important questions on effect size, skill transfer and retention, and optimal course design. To advance research and training programmes, an assessment tool supported by validity evidence with broad applicability is needed.

Contrast Enhanced Three Dimensional Ultrasound for Intraluminal Thrombus Assessment in Abdominal Aortic Aneurysms.

OBJECTIVES: The impact of intraluminal thrombus (ILT) on abdominal aortic aneurysm (AAA) progression can be investigated non-invasively by three dimensional contrast enhanced ultrasound (3D-CEUS). The aim was to validate 3D-CEUS ILT volume and thickness measurements against computed tomography angiography (CTA), and to determine inter- and intra-operator reproducibility. METHODS: The design was for a planned comparison of 3D-CEUS and CTA and of repeated 3D-CEUS measurements in a blinded set up. Consecutive patients with asymptomatic AAA (n = 137, maximum diameter 30-55 mm) from a single centre were consecutively assessed by CTA and 3D-CEUS in a blinded setup. After exclusion of failed CTA (n = 2) and inconclusive 3D-CEUS (n = 8), 127 3D-CEUS/CTA pairs were analysed by Bland-Altman plots. 3D-CEUS inter- and intra-operator reproducibility were determined in a subgroup (n = 30) measured twice by two blinded investigators. RESULTS: In 24 of 127 (19%) patients, no ILT was found on 3D-CEUS. Intraluminal thrombus absence was confirmed by 3D-CTA analysis in all but two cases. Mean ILT volume difference between 3D-CEUS and CTA was 2.2 mL (5% of mean volume) and range of variability (ROV) amounted to ± 10.2 mL. Mean ILT thickness difference was 0.6 mm with a ROV of ± 4.6 mm 3D-CEUS inter-operator variations of ILT volume and thickness measurements were low (ROV ± 8.8 mL and ±2.9 mm, respectively). The corresponding intra-operator ROVs were ±7.5 mL and ±3.3 mm, respectively. CONCLUSIONS: 3D-CEUS demonstrated good reproducibility and a good agreement with CTA when estimating ILT volume and maximum thickness in AAA patients. It is a promising research tool to investigate potential interactions between ILT, AAA growth, and rupture.

Frequency and Effect of Access-Related Vascular Injury and Subsequent Vascular Intervention After Transcatheter Aortic Valve Replacement.

Vascular access and closure remain a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors, and clinical outcomes of access-related vascular injury and subsequent vascular intervention. During a 30-month period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by the use of a covered self-expanding stent (n = 49), balloon angioplasty (n = 33), or by surgical intervention (n = 1). In 16 patients (5%), the vascular injury was classified as a major vascular complication. Absence of a preprocedural computed tomography angiography (CTA) of the iliofemoral arteries (OR 2.04, p = 0.007) and female gender (OR 2.18, p = 0.004) were independent predictors of the need for access-related vascular intervention. In addition, a high sheath/common femoral artery ratio as measured on preoperative CTA was associated with a higher rate of post-TAVR vascular intervention. The radiation dose, iodine contrast volume, transfusion need, length of hospitalization, and 30-day mortality were not significantly different between patients with versus without access-related vascular intervention. In conclusion, access-related vascular intervention in patients who underwent transfemoral-TAVR is not uncommon. Female gender and a high sheath/common femoral artery ratio are risk factors for access-related vascular injury, whereas preprocedural planning with CTA of the access vessels may reduce the risk of vascular injury. Importantly, most access-related vascular injuries may be treated by percutaneous techniques with similar clinical outcomes to patients without vascular injuries.