Sex Differences in Mortality Risk after the First Hospitalisation due to Lower Extremity Peripheral Arterial Disease.

OBJECTIVE: Lower extremity peripheral arterial disease (PAD) is a severe condition that increases the risk of major adverse cardiovascular events, major adverse limb events, and all cause mortality. This study aimed to investigate the mortality risk among females and males hospitalised for the first time due to lower extremity PAD. METHODS: Three cohorts of patients who were admitted for the first time due to lower extremity PAD in 2007 - 2010, 2011 - 2014, and 2015 - 2018 were constructed. For the 2007 - 2010 and 2011 - 2014 cohorts, the 28 day, one year, and five year mortality were calculated, assessing survival time from date of hospital admission until date of death, end of study period, or censoring. For the 2015 - 2018 cohort, only 28 day and one year mortality were investigated due to lack of follow up data. Mortality of these cohorts was compared with the general population using standardised mortality rates (SMRs), and the risk of mortality between sexes was evaluated using Cox proportional hazards models. Cox models were adjusted for age, cardiovascular disease, and diabetes mellitus to account for potential confounding factors. RESULTS: In total, 7 950, 9 670, and 13 522 patients were included in the 2007 - 2010, 2011 - 2014, and 2015 - 2018 cohorts, respectively. Over 60% of individuals in each cohort were male. Mortality rates at 28 day and one year remained stable across all cohorts, while the five year mortality rate increased both for males and females in the 2011 - 2014 cohort. The SMRs both of females and males with PAD were significantly higher than in the general population. Multivariable regression analyses found no significant differences in mortality risk between sexes at 28 days and one year. However, the five year mortality risk was lower in females, with a hazard ratio of 0.89 (95% confidence interval [CI] 0.83 - 0.97) in the 2007 - 2010 cohort and 0.88 (95% CI 0.82 - 0.94) in the 2011 - 2014 cohort. CONCLUSION: The five year mortality risk has increased, and females face a lower mortality risk than males. Lower extremity PAD still carries unfavourable long term consequences compared with the general population.

Long-term outcomes of chimney endovascular aneurysm repair procedure for complex abdominal aortic pathologies.

OBJECTIVE: The aim of this study was to update our earlier experience and to evaluate long-term outcomes of chimney endovascular aortic repair performed for selected cases with complex abdominal aortic aneurysm. METHODS: A single-center retrospective cohort study was conducted on 51 consecutive patients who underwent chimney endovascular aortic repair procedure, deemed unfit for open surgical repair and fenestrated endovascular aneurysm repair, from October 2009 to November 2019. Kaplan-Meier analyses were used to assess the estimated overall survival, freedom from aneurysm related mortality, freedom from reintervention, freedom from target vessel instability, and freedom from type Ia endoleaks. RESULTS: Fifty-one patients (mean age, 77.1 ± 7.5 years) with a mean preoperative maximum aneurysm diameter of 74.2 ± 20.1 mm were included. Mean follow-up duration was 48.6 months (range, 0-136 months). Estimated overall survival at 5 and 7 years was 36.3% ± 7.1% and 18.3% ± 6.0%, respectively. Freedom from aneurysm-related mortality was 88.6% ± 4.9% at 7 years. Estimated freedom from type Ia endoleaks at 7 years was 91.8% ± 3.9%. A total of 21 late reinterventions were performed in 17 patients (33%). Most of them were performed to treat type II endoleaks with sac growth (47.6%; n = 10) and type Ib endoleak (23.8%; n = 5). Estimated freedom from reintervention at 7 years was 56.3% ± 7.9%. Estimated freedom from target vessel instability at 7 years was 91.5% ± 4.1%. CONCLUSIONS: The 7-year results of chimney endovascular aortic repair procedures performed in our center confirm the long-term safety and effectiveness of this technique in a series of high-risk patients with large aneurysms. The present study has, to the best of our knowledge, the longest follow-up for patients treated with chimney endovascular aortic repair, and it provides data to the scarce literature on the long-term outcomes of this procedure, showing acceptable to good long-term results.

Editor's Choice - Radiation Dose Reduction During Contralateral Limb Cannulation Using Fiber Optic RealShape Technology in Endovascular Aneurysm Repair.

OBJECTIVE: The increasing number of endovascular procedures has resulted in an increasing radiation burden, particularly for the treatment team. Fiber Optic RealShape (FORS) technology uses laser light instead of fluoroscopy to visualise the endovascular guidewire and catheters. These devices can be used during the navigational part of procedures, such as cannulation of the contralateral limb (CL) in endovascular aneurysm repair (EVAR). The aim of this study was to describe the effect of using FORS on radiation dose during CL cannulation in standard EVAR. METHODS: This was a non-randomised, retrospective comparison study of prospectively collected, single centre data from FORS guided EVAR compared with a conventional fluoroscopy only guided EVAR cohort. A total of 27 FORS guided cases were matched 1:1 based on sex, age, and body mass index (BMI) with 27 regular (fluoroscopy only) EVARs. This study primarily focused on (1) technical success of FORS and (2) navigation time and radiation dose (cumulative air kerma [CAK], air kerma area product [KAP], and fluoroscopy time [FT]) during cannulation of the CL. In addition, overall procedure time and radiation dose of the complete EVAR procedure were studied. RESULTS: In 22 (81%) of the 27 FORS guided cases the CL was successfully cannulated using FORS. All radiation dose parameters were significantly lower in the FORS group (CAK, p < .001; KAP, p = .009; and FT, p < .001) for an equal navigation time (p = .95). No significant differences were found when comparing outcomes of the complete procedure. CONCLUSION: Use of FORS technology significantly reduces radiation doses during cannulation of the CL in standard EVAR.

Reduction of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease Combining Fiber Optic RealShape Technology and Intravascular Ultrasound.

Vascular surgeons and interventional radiologists face chronic exposure to low-dose radiation during endovascular procedures, which may impact their health in the long term due to their stochastic effects. The presented case shows the feasibility and efficacy of combining Fiber Optic RealShape (FORS) technology and intravascular ultrasound (IVUS) to reduce operator exposure during the endovascular treatment of obstructive peripheral arterial disease (PAD). FORS technology enables real-time, three-dimensional visualization of the full shape of guidewires and catheters, embedded with optical fibers that use laser light instead of fluoroscopy. Hereby, radiation exposure is reduced, and spatial perception is improved while navigating during endovascular procedures. IVUS has the capacity to optimally define vessel dimensions. Combining FORS and IVUS in a patient with iliac in-stent restenosis, as shown in this case report, enables passage of the stenosis and pre- and post-percutaneous transluminal angioplasty (PTA) plaque assessment (diameter improvement and morphology), with a minimum dose of radiation and zero contrast agent. The aim of this article is to describe the method of combining FORS and IVUS stepwise, to show the potential of merging both techniques in view of reducing radiation exposure and improving navigation tasks and treatment success during the endovascular procedure for the treatment of PAD.

Plasma Extracellular Vesicle Serpin G1 and CD14 Levels are Associated with Major Adverse Cardiovascular Events and Major Adverse Limb Events in Patients Undergoing Femoral Endarterectomy.

OBJECTIVE: Plasma extracellular vesicles (EV) are an emerging source of biomarkers for diagnosis and prognosis of cardiovascular disease (CVD). Risk stratification for common adverse events such as major adverse limb events (MALE) and major adverse cardiovascular events (MACE) by an EV blood sample could improve healthcare management by individualising drug therapy or improving informed decision making regarding revascularisations in patients with peripheral artery disease (PAD). As such, this study investigated the associations between plasma EV proteins and prospectively registered MALE and MACE in consecutive patients undergoing femoral endarterectomy. METHODS: Using the Athero-Express biobank study, four EV proteins (Cystatin C, CD14, Serpin C1, and Serpin G1) were measured in the high density lipoprotein subfraction isolated from plasma of 317 PAD patients undergoing arterial revascularisation. Multivariable Cox proportional hazard regression was used to investigate the association between plasma EV protein levels and MACE and MALE in the three year post-operative period. RESULTS: Most patients were treated for claudication (Fontaine II, 52.8%), although rest pain (Fontaine III, 30.1%) and ischaemic wounds (Fontaine IV, 17.1%) were common in this cohort. Within three years 51 patients died, amongst whom 25 deaths were due to CVD, 39 patients experienced a MACE, and 125 patients experienced a MALE. Multivariable regression models, based on statistically proven covariables and literature, showed a significant association of Serpin G1 (HR 1.49; 95% CI 1.08 - 2.06; p = .016) and CD14 (HR 1.40; 1.03 - 1.90; p = .029) with MACE, and of Serpin G1 (HR 1.29; 1.07 - 1.57; p = .009) with MALE. CONCLUSION: Serpin G1 and CD14 plasma EV protein levels are associated with future MACE and MALE in patients with severe PAD.

Peripheral Interventions in Patients with Pseudoxanthoma Elasticum (PXE).

OBJECTIVE: Pseudoxanthoma elasticum (PXE) is an autosomal recessive metabolic disorder that may be associated with a high prevalence of peripheral artery disease (PAD) and related symptoms. However, the evidence supporting this association is weak, as only small cohort studies are available. Furthermore, limited data are available on the outcome of lower limb peripheral arterial interventions (PAI) in patients with PXE. It was the aim of this study to clarify the prevalence of PAD, and the occurrence and outcome of PAI in patients with PXE. METHODS: This was a retrospective review of prospectively collected data from the Dutch Expertise Centre for PXE database. Clinical data of consecutive patients with a definitive diagnosis of PXE were examined. The primary endpoint was the prevalence of PAD (defined as an ankle brachial index of < 0.9). The secondary endpoint was to report an overview of PAI and target lesion revascularisations. RESULTS: In 285 PXE patients (median age 58 years), 50.9% of patients (n = 145) met the criteria for PAD. Seventeen patients underwent a PAI, mostly for intermittent claudication, at a median age of 51 years. The incidence of PAI was 2.25 per 1 000 patient years in patients with PAD and PXE. A total of 58 interventions was recorded, of which 35 were target lesion revascularisations in nine patients. Twenty one revascularisations were performed within a year following the primary intervention, in 16 cases due to an acute occlusion. CONCLUSION: Within a well phenotyped and large PXE cohort, the diagnosis of PAD was prevalent in one in two patients. The observed rate of peripheral interventions was low, while the re-intervention rate was unfavourable after endovascular or bypass surgical procedures, with over half of these re-interventions indicated within a year.

Carotid tortuosity is associated with extracranial carotid artery aneurysms.

Background: Tortuous arteries may be associated with carotid dissection. The intima disruption caused by a carotid dissection is a possible cause of extracranial carotid artery aneurysms (ECAAs). The aim was to investigate if carotid tortuosity is also associated with ECAA in patients without presence or history of a carotid artery dissection. Methods: A retrospective case-control study was performed including 35 unilateral ECAA patients (cases) and 105 age- and sex-matched controls. Tortuosity was expressed as tortuosity-index (TI), curvature, and torsion measured on computed tomography angiography (CTA) data in 3Mensio Vascular and MATLAB by two independent investigators. Primary comparison was tortuosity in ipsi- versus contralateral carotid artery within the cohort of ECAA patients. Secondary comparison was tortuosity with ipsilateral carotid arteries in control patients. All observations were assessed on inter- and intra-operator reproducibility. Results: Carotid tortuosity was comparable within the cohort of ECAA patients (Spearman correlation 0.76, P<0.001), yet distinctively higher in comparison with unilateral controls. After adjustment for patient characteristics, presence of ECAA was associated with TI (ß 0.146, 95% CI: 0.100-0.192). All tortuosity observations showed excellent inter- and intra-operator reproducibility. Conclusions: Carotid tortuosity seems to be a risk factor for development of ECAA. Surveillance of individuals with increased carotid tortuosity therefore potentially ensures prompt diagnosis and treatment of ECAA. However, future research should investigate if persons with an increased tortuosity do indeed develop ECAA.

Superficial Femoral Artery Recanalization Using Fiber Optic RealShape Technology.

PURPOSE: Report of a successful case of endovascular recanalization of an occluded superficial femoral artery (SFA) using Fiber Optic RealShape (FORS) technology. CASE REPORT: A 79-year-old male was referred for evaluation of multiple ischemic pretibial ulcers of the right lower extremity. Computed tomography-angiography (CTA) imaging confirmed significant stenosis of the right common femoral artery (CFA) and an occlusion of the SFA from its origin to the Hunter's canal. The patient was treated with a hybrid surgical procedure: an endarterectomy of the CFA and SFA origin was performed combined with an endovascular recanalization of the occluded SFA using FORS technology. During recanalization, the FORS guidewire slowly twisted subintimally around the occluded lumen of the SFA, maintaining the created corkscrew shape after pre-dilation with the percutaneous transluminal angioplasty (PTA) balloon and subsequent stenting. CONCLUSIONS: FORS technology can be successfully used during recanalization of an occluded SFA without the use of fluoroscopy. The corkscrew shape formed during recanalization in this case was retained during PTA balloon pre-dilation and stenting; this potentially improves hemodynamics and thereby reduces the risk of in-stent restenosis. However, expanding patient series and longer follow-up data are needed to increase the understanding of the feasibility and effectiveness of using FORS in the treatment of peripheral arterial occlusive disease.

New tools to reduce radiation exposure during aortic endovascular procedures.

INTRODUCTION: The evolution of endovascular surgery over the past 30 years has made it possible to treat increasingly complex vascular pathologies with an endovascular method. Although this generally speeds up the patient's recovery, the risks of health problems caused by long-term exposure to radioactive radiation increase. This warrants the demand for radiation-reducing tools to reduce radiation exposure during these procedures. AREAS COVERED: For this systematic review Pubmed, Embase and Cochrane library databases were searched on 28 December 2021 to provide an overview of tools that are currently used or have the potential to contribute to reducing radiation exposure during endovascular aortic procedures. In addition, an overview is presented of radiation characteristics of clinical studies comparing a (potential) radiation-reducing device with conventional fluoroscopy use. EXPERT OPINION: Radiation-reducing instruments such as fiber optic shape sensing or electromagnetic tracking devices offer the possibility to further reduce or even eliminate the use of radiation during endovascular procedures. In an era of increasing endovascular interventional complexity and awareness of the health risks of long-term radiation exposure, the use of these technologies could have a major impact on an ongoing challenge to move toward radiation-free endovascular surgery.

Safety and feasibility study of non-invasive robot-assisted high-intensity focused ultrasound therapy for the treatment of atherosclerotic plaques in the femoral artery: protocol for a pilot study.

INTRODUCTION: Peripheral arterial disease (PAD) is an atherosclerotic disease leading to stenosis and/or occlusion of the arterial circulation of the lower extremities. The currently available revascularisation methods have an acceptable initial success rate, but the long-term patency is limited, while surgical revascularisation is associated with a relatively high perioperative risk. This urges the need for development of less invasive and more effective treatment modalities. This protocol article describes a study investigating a new non-invasive technique that uses robot assisted high-intensity focused ultrasound (HIFU) to treat atherosclerosis in the femoral artery. METHODS AND ANALYSIS: A pilot study is currently performed in 15 symptomatic patients with PAD with a significant stenosis in the common femoral and/or proximal superficial femoral artery. All patients will be treated with the dual-mode ultrasound array system to deliver imaging-guided HIFU to the atherosclerotic plaque. Safety and feasibility are the primary objectives assessed by the technical feasibility of this therapy and the 30-day major complication rate as primary endpoints. Secondary endpoints are angiographic and clinical success and quality of life. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained in 2019 from the Medical Ethics Committee of the University Medical Center Utrecht, the Netherlands. Data will be presented at national and international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NL7564.

Reduction of Occupational Radiation Exposure During Endovascular Treatment of Peripheral Artery Disease Using Radiation Absorbing Drapes.

BACKGROUND: A chronic exposure to low dose radiation, as encountered in endovascular procedures, may impact the health of surgeons and radiologists over a timespan of several months to a lifetime. This study evaluates the feasibility and efficacy of a radiation absorbing sterile drape (RADPAD) to reduce operator exposure during the endovascular treatment of obstructive peripheral artery disease (PAD). METHODS: Between February 2016 and September 2017, patients with PAD who received percutaneous transluminal angioplasty, stent placement, remote endarterectomy, or a combination thereof were included in this nonrandomized study. Patients were equally divided over a study cohort (with RADPAD) and a control cohort (without RADPAD). The unshielded body dose (E) of the staff was measured via electronic dosimeters placed at a chest height of the first operator (FO), second operator (SO), and sterile nurse (SN). A virtual maximum operator (MO) dose was constructed, yielding the highest dose per fluoroscopy run for either of the operators. Simultaneously, the dose area product (DAP) and C-arm settings for each fluoroscopy run were extracted. Staff exposures of the study cohort and control cohort were compared in terms of relative exposure (E/DAP). A secondary analysis involved an analysis of the individual fluoroscopy runs using a multivariate generalized linear mixed effect model. RESULTS: In total, 49 patients were included in this study. The use of RADPAD was technically feasible. Significant reductions of relative exposure were observed when comparing the study cohort with the control cohort. The relative exposure of the FO was reduced with 66.5% (1.82 vs. 0.61 µSv/Gycm2, P < 0.001), the relative exposure of the SO with 68.3% (0.55 vs. 0.17 µSv/Gycm2, P = 0.02), and the relative exposure of the MO with 65.8% (2.06 vs. 0.71 µSv/Gycm2, P < 0.001). Dose levels of SN were too low to draw conclusions under the current sample size. The multivariate generalized linear mixed effect model showed a significant correlation between absolute exposure of the MO and the use of the RADPAD (odds: 0.51, P < 0.001). CONCLUSIONS: Usage of a radiation absorbing drape (RADPAD) during endovascular treatment of PAD results in statistically significant reduction in a relative operator dose while presenting no drawbacks. The use of these drapes is advised in future peripheral endovascular procedures.

Blunt thoracic aortic injury and TEVAR: long-term outcomes and health-related quality of life.

PURPOSE: Treatment of blunt thoracic aortic injuries (BTAIs) has shifted from the open surgical approach to the use of thoracic endovascular aortic repair (TEVAR), of which early outcomes appear promising but controversy regarding long-term outcomes remains. The goal of this study was to determine the long-term TEVAR outcomes for BTAI, particularly radiographic outcomes, complications and health-related quality of life (HRQoL). METHODS: Retrospectively, all patients with BTAIs presented at a single level 1 trauma center between January 2008 and December 2018 were included. Radiographic and clinical outcomes were determined (early and long term). In addition, HRQoL scores using EuroQOL-5-Dimensions-3-Level (EQ-5D-3L) and Visual Analog Scale (EQ-VAS) questionnaires were assessed, and compared to an age-adjusted reference and trauma population. RESULTS: Thirty-one BTAI patients met the inclusion criteria. Of these, 19/31 received TEVAR of which three died in hospital due to aorta-unrelated causes. In total, 10/31 patients died due to severe (associated) injuries before TEVAR could be attempted. The remaining 2/31 had BTAIs that did not require TEVAR. Stent graft implantation was successful in all 19 patients (100%). At a median radiographic follow-up of 3 years, no stent graft-related problems (endoleaks/fractures) were observed. However, one patient experienced acute stent graft occlusion approximately 2 years after TEVAR, successfully treated with open repair. Twelve patients required complete stent graft coverage of the left subclavian artery (LSCA) (63%), which did not result in ischemic complaints or re-interventions. Of fourteen surviving TEVAR patients, ten were available for questionnaire follow-up (follow-up rate 71%). At a median follow-up of 5.7 years, significant HRQoL impairment was found (p < 0.01). CONCLUSION: This study shows good long(er)-term radiographic outcomes of TEVAR for BTAIs. LSCA coverage did not result in complications. Patients experienced HRQoL impairment and were unable to return to an age-adjusted level of daily-life functioning, presumably due to concomitant orthopedic and neurological injuries.

Mid-Term Outcomes of Chimney Endovascular Aortic Aneurysm Repair: A Systematic Review and Meta-analysis.

BACKGROUND: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA). METHODS: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analyzed using the MINORS criteria. Pooled effect estimates were analyzed using random-effect models and heterogeneity was tested using I2 statistics. RESULTS: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8-87.9), 85.7% (95%CI 75.6-93.5), and 95.1% (95%CI 89.3-98.7) respectively. CONCLUSIONS: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome.

High lipoprotein(a) is associated with major adverse limb events after femoral artery endarterectomy.

BACKGROUNDS AND AIMS: Elevated lipoprotein(a) (Lp[a]) has been identified as a causal risk factor for cardiovascular disease including peripheral arterial disease (PAD). Although Lp(a) is associated with the diagnosis of PAD, it remains elusive whether there is an association of Lp(a) with cardiovascular and limb events in patients with severe PAD. METHODS: Preoperative plasma Lp(a) levels were measured in 384 consecutive patients that underwent iliofemoral endarterectomy and were included in the Athero-Express biobank. Our primary objective was to assess the association of Lp(a) levels with Major Adverse Limb Events (MALE). Our secondary objective was to relate Lp(a) levels to Major Adverse Cardiovascular Events (MACE) and femoral plaque composition that was acquired from baseline surgery. RESULTS: During a median follow-up time of 5.6 years, a total of 225 MALE were recorded in 132 patients. Multivariable analysis, including history of peripheral intervention, age, diabetes mellitus, end stage renal disease and PAD disease stages, showed that Lp(a) was independently associated with first (HR of 1.36 (95% CI 1.02-1.82) p = .036) and recurrent MALE (HR 1.36 (95% CI 1.10-1.67) p = .004). A total of 99 MACE were recorded but Lp(a) levels were not associated with MACE.sLp(a) levels were significantly associated with a higher presence of smooth muscle cells in the femoral plaque, although this was not associated with MALE or MACE. CONCLUSIONS: Plasma Lp(a) is independently associated with first and consecutive MALE after iliofemoral endarterectomy. Hence, in patients who undergo iliofemoral endarterectomy, Lp(a) could be considered as a biomarker to enhance risk stratification for future MALE.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

OBJECTIVE: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. SUMMARY OF BACKGROUND DATA: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). METHODS: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. RESULTS: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. CONCLUSIONS: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.

Target vessel displacement during fenestrated and branched endovascular aortic repair and its implications for the role of traditional computed tomography angiography roadmaps.

BACKGROUND: This retrospective study quantifies target vessel displacement during fenestrated and branched endovascular aneurysm repair due to the introduction of stiff guidewires and stent graft delivery systems. The effect that intraoperative vessel displacement has on the usability of computed tomography angiography (CTA) roadmaps is also addressed. METHODS: Patients that underwent fenestrated or branched EVAR were included in this retrospective study. Two imaging datasets were collected from each patient: (I) preoperative CTA and (II) intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) acquired after the insertion of the stiff guidewire and stent graft delivery system. After image registration, the 3D coordinates of the ostium of the celiac artery, superior mesenteric artery, right renal artery and left renal artery were recorded in both the CTA and the ceCBCT dataset by two observers. The three-dimensional displacement of the ostia of the target vessels was calculated by subtracting the coordinates of CTA and ceCBCT from one another. Additionally, the tortuosity index and the maximum angulation of the aorta were calculated. RESULTS: In total 20 patients and 77 target vessels were included in this study. The ostium of the celiac, superior mesenteric, right renal and left renal artery underwent non-uniform three-dimensional displacement with mean absolute displacement of 8.2, 7.7, 8.2 and 6.2 mm, respectively. The average displacement of all different target vessels together was 7.8 mm. A moderate correlation between vessel displacement and the maximum angulation of the aortoiliac segment was found (Spearman's ρ=0.45, P<0.05). CONCLUSIONS: The introduction of stiff endovascular devices during fenestrated or branched EVAR causes significant, non-uniform displacement of the ostium of the visceral and renal target vessels. Consequently, preoperative CTA roadmaps based on bone registration are suboptimal to guide target vessel catheterization during these procedures.

Radiation Awareness for Endovascular Abdominal Aortic Aneurysm Repair in the Hybrid Operating Room: An Instant Operator Risk Chart for Daily Practice.

INTRODUCTION: While the operator radiation dose rates are correlated to patient radiation dose rates, discrepancies may exist in the effect size of each individual radiation dose predictors. An operator dose rate prediction model was developed, compared with the patient dose rate prediction model, and converted to an instant operator risk chart. MATERIALS AND METHODS: The radiation dose rates (DRoperator for the operator and DRpatient for the patient) from 12,865 abdomen X-ray acquisitions were selected from 50 unique patients undergoing standard or complex endovascular aortic repair (EVAR) in the hybrid operating room with a fixed C-arm. The radiation dose rates were analyzed using a log-linear multivariable mixed model (with the patient as the random effect) and incorporated varying (patient and C-arm) radiation dose predictors combined with the vascular access site. The operator dose rate models were used to predict the expected radiation exposure duration until an operator may be at risk to reach the 20 mSv year dose limit. The dose rate prediction models were translated into an instant operator radiation risk chart. RESULTS: In the multivariate patient and operator fluoroscopy dose rate models, lower DRoperator than DRpatient effect size was found for radiation protocol (2.06 for patient vs 1.4 for operator changing from low to medium protocol) and C-arm angulation. Comparable effect sizes for both DRoperator and DRpatient were found for body mass index (1.25 for patient and 1.27 for the operator) and irradiated field. A higher effect size for the DRoperator than DRpatient was found for C-arm rotation (1.24 for the patient vs 1.69 for the operator) and exchanging from femoral access site to brachial access (1.05 for patient vs 2.5 for the operator). Operators may reach their yearly 20 mSv year dose limit after 941 minutes from the femoral access vs 358 minutes of digital subtraction angiography radiation from the brachial access. CONCLUSION: The operator dose rates were correlated to patient dose rate; however, C-arm angulation and changing from femoral to brachial vascular access site may disproportionally increase the operator radiation risk compared with the patient radiation risk. An instant risk chart may improve operator dose awareness during EVAR.

First in Human Clinical Feasibility Study of Endovascular Navigation with Fiber Optic RealShape (FORS) Technology.

OBJECTIVE: Endovascular procedures are conventionally conducted using two dimensional fluoroscopy. A new technology platform, Fiber Optic RealShape (FORS), has recently been introduced allowing real time, three dimensional visualisation of endovascular devices using fiberoptic technology. It functions as an add on to conventional fluoroscopy and may facilitate endovascular procedures. This first in human study assessed the feasibility of FORS in clinical practice. METHODS: A prospective cohort feasibility study was performed between July and December 2018. Patients undergoing (regular or complex) endovascular aortic repair (EVAR) or endovascular peripheral lesion repair (EVPLR) were recruited. FORS guidance was used exclusively during navigational tasks such as target vessel catheterisation or crossing of stenotic lesions. Three types of FORS enabled devices were available: a flexible guidewire, a Cobra-2 catheter, and a Berenstein catheter. Devices were chosen at the physician's discretion and could comprise any combination of FORS and non-FORS devices. The primary study endpoint was technical success of the navigational tasks using FORS enabled devices. Secondary study endpoints were user experience and fluoroscopy time. RESULTS: The study enrolled 22 patients: 14 EVAR and eight EVPLR patients. Owing to a technical issue during start up, the FORS system could not be used in one EVAR. The remaining 21 procedures proceeded without device or technology related complications and involved 66 navigational tasks. In 60 tasks (90.9%), technical success was achieved using at least one FORS enabled device. Users rated FORS based image guidance "better than standard guidance" in 16 of 21 and "equal to standard guidance" in five of 21 procedures. Fluoroscopy time ranged from 0.0 to 52.2 min. Several tasks were completed without or with only minimal X-ray use. CONCLUSION: Real time navigation using FORS technology is safe and feasible in abdominal and peripheral endovascular procedures. FORS has the potential to improve intra-operative image guidance. Comparative studies are needed to assess these benefits and potential radiation reduction.