Geometric Analysis of the Gore Excluder Conformable Endoprosthesis in the Infrarenal Aortic Neck: One Year Results of the EXCeL Registry.

OBJECTIVE: The Gore Excluder Conformable Endoprosthesis (CEXC) is designed to treat challenging infrarenal anatomy because of its active angulation control, repositionability, and enhanced conformability. This study evaluated 30 day and one year position and apposition of the CEXC in the infrarenal neck. METHODS: Patients treated with the CEXC between 2018 and 2022 with an available 30 day computed tomography angiogram (CTA) were selected from four hospitals in a prospective registry. Endograft apposition (shortest apposition length [SAL]) and position (shortest fabric distance [SFD]) were assessed on the 30 day and one year CTAs. Maximum infrarenal aortic curvature was compared between the pre- and post-operative CTAs to evaluate conformability of the CEXC. RESULTS: There were 87 patients with a 30 day CTA, and for 56 of these patients the one year CTA was available. Median (interquartile range [IQR]) pre-operative neck length was 22 mm (IQR 15, 32) and infrarenal angulation was 52° (IQR 31, 72). Median SAL was 21.2 mm (IQR 14.0, 29.3) at 30 days for all included patients. The SAL in 13 patients (15%) was < 10 mm at 30 days, and one patient had a SAL of 0 mm and a type Ia endoleak. There was no significant difference in SAL between patients within and outside instructions for use. The SAL significantly increased by 1.1 mm (IQR -2.3, 4.7; p = .042) at one year. The SAL decreased in seven patients (13%), increased in 13 patients (23%), and remained stable in 36 patients (64%). Median SFD was 2.0 mm (IQR 0.5, 3.6) at 30 days, which slightly increased by 0.3 mm (IQR -0.5, 1.8; p = .019) at one year. One patient showed migration (SFD increase ≥ 5 mm). Median endograft tilt was 15.8° (IQR 9.7, 21.4). Pre-operative maximum infrarenal curvature was 36 m-1 (IQR 26, 56) and did not significantly change thereafter. CONCLUSION: In most patients, the CEXC was implanted close to the renal arteries, and sufficient (≥ 10 mm) post-operative apposition was achieved at 30 days, which slightly increased at one year. Post-operative endograft tilt was relatively low, and aortic geometry remained unchanged after implantation of the CEXC, probably due to its high conformability.

On the feasibility of ultrasound Doppler-based personalized hemodynamic modeling of the abdominal aorta.

BACKGROUND: Personalized modeling is a promising tool to improve abdominal aortic aneurysm (AAA) rupture risk assessment. Computed tomography (CT) and quantitative flow (Q-flow) magnetic resonance imaging (MRI) are widely regarded as the gold standard for acquiring patient-specific geometry and velocity profiles, respectively. However, their frequent utilization is hindered by various drawbacks. Ultrasound is used extensively in current clinical practice and offers a safe, rapid and cost-effective method to acquire patient-specific geometries and velocity profiles. This study aims to extract and validate patient-specific velocity profiles from Doppler ultrasound and to examine the impact of the velocity profiles on computed hemodynamics. METHODS: Pulsed-wave Doppler (PWD) and color Doppler (CD) data were successfully obtained for six volunteers and seven patients and employed to extract the flow pulse and velocity profile over the cross-section, respectively. The US flow pulses and velocity profiles as well as generic Womersley profiles were compared to the MRI velocities and flows. Additionally, CFD simulations were performed to examine the combined impact of the velocity profile and flow pulse. RESULTS: Large discrepancies were found between the US and MRI velocity profiles over the cross-sections, with differences for US in the same range as for the Womersley profile. Differences in flow pulses revealed that US generally performs best in terms of maximum flow, forward flow and ratios between forward and backward flow, whereas it often overestimates the backward flow. Both spatial patterns and magnitude of the computed hemodynamics were considerably affected by the prescribed velocity boundary conditions. Larger errors and smaller differences between the US and generic CFD cases were observed for patients compared to volunteers. CONCLUSION: These results show that it is feasible to acquire the patient-specific flow pulse from PWD data, provided that the PWD acquisition could be performed proximal to the aneurysm region, and resulted in a triphasic flow pattern. However, obtaining the patient-specific velocity profile over the cross-section using CD data is not reliable. For the volunteers, utilizing the US flow profile instead of the generic flow profile generally resulted in improved performance, whereas this was the case in more than half of the cases for the patients.

In vivo Multi-perspective 3D + t Ultrasound Imaging and Motion Estimation of Abdominal Aortic Aneurysms.

Time-resolved three-dimensional ultrasound (3D + t US) is a promising imaging modality for monitoring abdominal aortic aneurysms (AAAs), providing their 3D geometry and motion. The lateral contrast of US is poor, a well-documented drawback which multi-perspective (MP) imaging could resolve. This study aims to show the feasibility of in vivo multi-perspective 3D + t ultrasound imaging of AAAs for improving the image contrast and displacement accuracy. To achieve this, single-perspective (SP) aortic ultrasound images from three different angles were spatiotemporally registered and fused, and the displacements were compounded. The fused MP had a significantly higher wall-lumen contrast than the SP images, for both patients and volunteers (P < .001). MP radial displacements patterns are smoother than SP patterns in 67% of volunteers and 92% of patients. The MP images from three angles have a decreased tracking error (P < .001 for all participants), and an improved SNRe compared to two out of three SP images (P < .05). This study has shown the added value of MP 3D + t US, improving both image contrast and displacement accuracy in AAA imaging. This is a step toward using multiple or large transducers in the clinic to capture the 3D geometry and strain more accurately, for patient-specific characterization of AAAs.

A Statistical Shape Model of Infrarenal Aortic Necks in Patients With and Without Late Type Ia Endoleak After Endovascular Aneurysm Repair.

PURPOSE: Hostile aortic neck characteristics, including short length, severe suprarenal and infrarenal angulation, conicity, and large diameter, have been associated with increased risk for type Ia endoleak (T1aEL) after endovascular aneurysm repair (EVAR). This study investigates the mid-term discriminative ability of a statistical shape model (SSM) of the infrarenal aortic neck morphology compared with or in combination with conventional measurements in patients who developed T1aEL post-EVAR. MATERIALS AND METHODS: The dataset composed of EVAR patients who developed a T1aEL during follow-up and a control group without T1aEL. Principal component (PC) analysis was performed using a parametrization to create an SSM. Three logistic regression models were created. To discriminate between patients with and without T1aEL, sensitivity, specificity, and the area under the receiver operating characteristic (ROC) curve (AUC) were calculated. RESULTS: In total, 126 patients (84% male) were included. Median follow-up time in T1aEl group and control group was 52 (31, 78.5) and 51 (40, 62.5) months, respectively. Median follow-up time was not statistically different between the groups (p=0.72). A statistically significant difference between the median PC scores of the T1aEL and control groups was found for the first, eighth, and ninth PC. Sensitivity, specificity, and AUC values for the SSM-based versus the conventional measurements-based logistic regression models were 79%, 70%, and 0.82 versus 74%, 73%, and 0.85, respectively. The model of the SSM and conventional measurements combined resulted in sensitivity, specificity, and AUC of 81%, 81%, and 0.92. CONCLUSION: An SSM of the infrarenal aortic neck determines its 3-dimensional geometry. The SSM is a potential valuable tool for risk stratification and T1aEL prediction in EVAR. The SSM complements the conventional measurements of the individual preoperative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleak after standard EVAR. CLINICAL IMPACT: A statistical shape model (SSM) determines the 3-dimensional geometry of the infrarenal aortic neck. The SSM complements the conventional measurements of the individual pre-operative infrarenal aortic neck geometry by increasing the predictive value for late type Ia endoleaks post-EVAR. The SSM is a potential valuable tool for risk stratification and late T1aEL prediction in EVAR and it is a first step toward implementation of a treatment planning support tool in daily clinical practice.

Performance of the BioIntegral Bovine Pericardial Graft in Vascular Infections: VASCular No-REact Graft Against INfection Study.

BACKGROUND: Vascular graft and endograft infections (VGEI) and native vessel infections (NVI) remain considerable challenges in vascular surgery, leading to high mortality and morbidity rates. Although in situ reconstruction is the preferred treatment, the material of choice is still a source of debate. Autologous veins are considered the first choice; however, xenografts may be an acceptable alternative. The performance of a biomodified bovine pericardial graft is assessed when implemented in an infected vascular area. METHODS: This is a prospective multicenter cohort study. Patients who underwent reconstruction for VGEI or NVI with a biomodified bovine pericardial bifurcated or straight tube graft were included from December 2017 until June 2021. The primary outcome measure was reinfection at mid-term follow-up. Secondary outcome measures included mortality, patency, and amputation rate. RESULTS: Thirty-four patients with vascular infections were included, of which 23 (68%) had an infected Dacron prosthesis after primary open repair and 8 (24%) had an infected endovascular graft. The remaining 3 (9%) had infected native vessels. At secondary repair, 3 (7%) patients had an in situ aortic tube reconstruction, 29 (66%) had an aortic bifurcated reconstruction, and 2 (5%) had an iliac-femoral reconstruction. At 1-year follow-up after the BioIntegral bovine pericardial graft reconstruction, the reinfection rate was 9%. The 1-year infection-related and procedure-related mortality rate was 16%. The occlusion rate was 6% and in total 3 patients underwent a lower limb amputation during the 1-year follow-up period. CONCLUSIONS: In situ reconstruction as treatment of (endo)graft and native vessel infections remains a challenge and reinfection looms as a potential consequence. In cases where time is of essence or when autologous venous repair is not feasible, a swift available solution is needed. The BioIntegral biomodified bovine pericardial graft may be an option as it shows reasonable results in terms of reinfection, in aortic tube and bifurcated grafts.

Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Thoracic outlet decompression surgery for Gilliatt-Sumner hand as a presentation of neurogenic thoracic outlet syndrome.

BACKGROUND: Chronic compression of the inferior trunk of the brachial plexus can result in severe pain and progressive atrophy and weakness of the musculature of the forearm and hand, known as Gilliatt-Sumner hand (GSH). The objective of treatment for these patients is to stop further atrophy and pain. Restoration of motor function has been thought to be seldom achieved. The aim of the present contemporary case series was to describe the diagnosis, treatment, and outcomes of surgery for GSH. METHODS: All patients referred between January 2017 and May 2021 with visible signs of a GSH were included. Visible GSH signs were defined as muscle atrophy of the abductor digiti minimi, abductor pollicis brevis, and/or interosseous musculature. All the patients had undergone additional electrodiagnostic (ED) assessments and high-resolution ultrasound (HRUS) studies. All the patients with a diagnosis of GSH had undergone thoracic outlet decompression (TOD) surgery using a transaxillary or supraclavicular approach. The outcomes were measured using the thoracic outlet syndrome disability scale, cervical brachial symptom questionnaire, and disability of the arm, shoulder, and hand scale scores and patient-reported outcomes of motor function, measured using a numerical rating scale (NRS). The standardized elevated arm stress test (sEAST) was used to assess the patients' motor function before and after TOD surgery. RESULTS: A total of 20 patients had been referred to our center with visible signs of a GSH. The clinical examination showed atrophy of the abductor digiti minimi, abductor pollicis brevis, and interosseous musculature in all 20 patients. The ED assessments showed plexopathy of the lower brachial plexus in all the patients. HRUS showed an indented inferior trunk of the brachial plexus (so-called wedge-sickle sign) in 18 patients (90%). Of the 20 patients, 17 had undergone TOD surgery (15 transaxillary TOD and 2 supraclavicular TOD). Three patients had refrained from surgery. The median follow-up interval was 15.0 months (interquartile range, 14.0 months). The thoracic outlet syndrome disability scale score had improved significantly (preoperatively: mean, 6.31; 95% confidence interval [CI], 5.49-7.13; postoperatively: mean, 4.25; 95% CI, 2.80-5.70; P = .026). The same improvement was seen for the cervical brachial symptom questionnaire scores (preoperatively: mean, 77.75; 95% CI, 66.63-88.87; postoperatively: mean, 42.65; 95% CI, 24.77-60.77; P = .001) and disability of the arm, shoulder, and hand scale scores (preoperatively: mean, 59.13; 95% CI, 51.49-66.77; postoperatively: mean, 40.96; 95% CI, 24.41-57.51; P = .032). The NRS score for muscle weakness and sEAST score showed no statistically significant differences before and after TOD for the whole group (mean preoperative NRS score for muscle weakness, 6.22; 95% CI, 4.31-8.14; mean postoperative NRS score for muscle weakness, 5.11; 95% CI, 3.25-6.97; P = .269). However, four patients (23.52%) had reported a ≥50% decrease in the NRS score for muscle weakness and a minimum increase of 20% in the total and average force using the sEAST. The NRS for numbness showed a statistically significant decrease for the whole group (preoperatively: mean, 5.67; 95% CI, 4.18-7.16; postoperatively: mean, 3.33; 95% CI, 1.37-5.29; P = .029). CONCLUSIONS: A combination of physical examination, ED assessments, and HRUS studies can differentiate GSH in the differential diagnosis. HRUS appears to have an advantage over ED studies in confirming GSH by visualization of compression of the brachial plexus. TOD surgery will stop the progressive muscle atrophy and significantly reduce neurogenic thoracic outlet syndrome complaints, and, in some patients, motor function will recover.

Reliability and validity of the standardized elevated arm stress test in the diagnosis of neurogenic thoracic outlet syndrome.

OBJECTIVE: We developed a standardized elevated arm stress test (sEAST) meter to standardize patients' posture and measure additional grip and fatigue parameters. In the present prospective cohort study, we aimed to determine the reliability and validity of the sEAST in the diagnosis of neurogenic thoracic outlet syndrome (NTOS). METHODS: Patients evaluated for NTOS between October 2018 and February 2020 were included and performed the sEAST. The patients were classified into a proven NTOS group or a symptomatic control group using the reporting standards for NTOS and the outcome of thoracic outlet decompression surgery. Healthy persons were recruited as an asymptomatic control group. The test-retest reliability, area under the receiver operating characteristic curve, and positive and negative predictive values were calculated for each sEAST parameter. RESULTS: A total of 426 patients with suspected NTOS and 147 healthy controls had performed the sEAST. The validity analysis was performed with data from 111 patients with proven NTOS, 94 symptomatic controls, and 147 asymptomatic controls. The reporting standards were inconclusive for 116 patients; 77 patients had been excluded because thoracic outlet decompression surgery had not been performed or was unsuccessful, and 28 because they had arterial or venous thoracic outlet syndrome. The area under the receiver operating characteristic curve for the proven NTOS group compared with the asymptomatic control and symptomatic control groups ranged from 0.59 to 0.77 and 0.54 to 0.63, respectively. The positive predictive value ranged from 46% to 65% and the negative predictive value from 51% to 66%. The test-retest reliability analysis for 80 patients with multiple sEAST measurements showed moderate to good (0.52-0.87) intraclass correlation coefficient values for the duration and grip strength parameters. However, the grip fatigue parameters demonstrated poor (0.46-0.16) intraclass correlation coefficient values. CONCLUSIONS: The sEAST showed good test-retest reliability for the duration and grip strength parameters. However, the discriminative value of all sEAST parameters was low for NTOS diagnostics. The good test-retest reliability of the sEAST parameters indicates that they could be valuable outcome measures for comparison in a diagnostic care pathway.

Reliability and validity of the elevated arm stress test in the diagnosis of neurogenic thoracic outlet syndrome.

OBJECTIVES: The objective of this retrospective analysis of prospectively collected data was to assess the test-retest reliability and validity of the elevated arm stress test (EAST) as measured by the duration in a cohort of patients with suspected neurogenic thoracic outlet syndrome (NTOS). METHODS: Patients evaluated for NTOS between January 2017 and September 2018 were identified. Test-retest reliability by the intraclass correlation coefficient was determined for duration of the EAST. For the validity analysis, patients were classified in a proven NTOS group or a symptomatic control group without NTOS using the Society for Vascular Surgery reporting standards and the outcome of thoracic outlet decompression surgery. A receiver operating characteristic curve was made for the duration of EAST. The area under the curve, and positive and negative predictive values were calculated for the EAST. RESULTS: In total, 428 patients with suspected NTOS were retrospectively analyzed. Of these patients, 61 were excluded because no EAST data was available. Another 101 patients were excluded because of inconclusive reporting standards, arterial or venous TOS, or because thoracic outlet decompression surgery was not performed or had a negative result. The validity analysis in the remaining 266 patients showed an area under the curve for the duration of the EAST of 0.62 (95% confidence interval, 0.55-0.69). The positive predictive value of the duration ranged between 65% and 66%, and the negative predictive value between 53% and 58%. For the test-retest reliability analysis, 118 patients were excluded because they performed only one measurement in a 100-day time period. Analysis in the remaining 148 patients showed an intraclass correlation coefficient value of 0.65 (95% confidence interval, 0.55-0.74) for duration. CONCLUSIONS: The EAST measured by the duration showed a moderate test-retest reliability, but the discriminative value was low in the diagnosis of NTOS. The outcome of the EAST measured by the duration should be used with caution.

Redo surgery for neurogenic thoracic outlet syndrome is useful.

OBJECTIVES: Surgery for neurogenic thoracic outlet syndrome (NTOS) has shown good outcome in numerous case series. However, 5% to 30% of patients will have persistent or recurrent symptoms, caused by incomplete first rib resection, reattachment of residual scalene muscle, fibrous scarring around the brachial plexus, or a wrong NTOS diagnosis. In patients with a sound diagnosis of recurrent or persisting NTOS, not responding to conservative measures, a secondary procedure can be considered. We report the results of redo thoracic outlet decompression surgery through the supraclavicular approach (SC-REDO-TOD) for persistent or recurrent NTOS. METHODS: A retrospective review of a prospective database was performed. Every patient referred from September 2016 until January 2020 was eligible for inclusion. In an SC-REDO-TOD, we perform complete (cartilage-cartilage) resection of the first rib, any bony and fibrous anomalies, complete anterior and middle scalenectomy, and complete neurolysis of the brachial plexus (complete anatomical decompression of the brachial plexus). Clinical outcomes were assessed by questionnaires including the Disability of Arm, Shoulder and Hand (DASH), Cervico-Brachial Symptoms Questionnaire (CBSQ), and TOS (thoracic outlet syndrome) Disability scale. RESULTS: In total, 45 patients had a SC-REDO-TOD. The median duration of hospital admission after SC-REDO-TOD was 1.41 days (interquartile range, 1.00 day). In total, 30 (66.66%) of 45 patients had recurrent NTOS, and 15 (33.33%) of 45 patients had persisting NTOS. Postoperative complications were seen in eight patients (18.18%). One patient had postoperative complications with permanent impairment (Horner syndrome). Seven patients had postoperative complications with full recovery (three patients had a chylous leakage that was treated with a median-chain triglycerides diet for 6 weeks, three patients had transient phrenic nerve palsy with full recovery <6 weeks, and one patient had a discrete Horner syndrome that resolved in 6 weeks). The median time of follow-up was 19.50 months (interquartile range, 14.00 months) and the response rate to the questionnaires was 91.11% at 6 months and 64.44% at 12 months. We found a positive and statistically significant difference for DASH score, CBSQ score, and TOS Disability Scale score comparing scores for all patients. (DASH score: P < .001; CBSQ score: P < .001; TOS Disability Scale: P < .001). Patients with first rib remnants showed a significant better response (lower DASH, CBSQ and TOS Disability Scale scores) compared with patients without first rib remnants (DASH score: P = .004; CBSQ score: P ≤ .014; TOS Disability Scale: P = .009). CONCLUSIONS: SC-REDO-TOD after a previous NTOS surgery shows good results with a low risk of permanent impairment. Patients with NTOS with first rib remnants after primary surgery seem to benefit the most from SC-REDO-TOD surgery.

Surgery Versus Continued Conservative Treatment for Neurogenic Thoracic Outlet Syndrome: the First Randomised Clinical Trial (STOPNTOS Trial).

OBJECTIVE: Neurogenic thoracic outlet syndrome (NTOS) is one of the most controversial clinical entities in medicine. Several major case series have shown promising results of surgery; however, solid scientific evidence is lacking. The aim of this trial was to objectify the effect of thoracic outlet decompression (TOD). METHODS: A single centre (high volume, tertiary TOS centre), non-blinded, randomised controlled trial was conducted with parallel group design. Patients with a diagnosis of NTOS refractory to conservative therapy were randomised to one of two intervention arms, receiving either a transaxillary thoracic outlet decompression (TA-TOD) or continued conservative treatment. After three months, the conservative treated group was also offered a TA-TOD. The primary outcome was change in Disability of the Arm, Shoulder and Hand (DASH) questionnaire score. Secondary outcomes were changes in Cervical Brachial Symptoms Questionnaire (CBSQ), TOS disability scale, and quality of life scores. Outcomes were assessed at baseline, three, six, and 12 months after inclusion. RESULTS: Fifty patients were enrolled in this trial: 25 in the TA-TOD group and 25 in the continued conservative treatment group. Follow up was completed in 24 and 22 patients, respectively. At three months, there was a statistically significant difference in DASH scores (TA-TOD: mean 45.15, 95% confidence interval [CI] 38.08 - 52.21; conservative treatment: mean 64.92, 95% CI 57.54 - 72.30; p < .001). All patients in the conservative treatment group applied for surgery three months after randomisation. After surgery of the conservative treatment group, there was no statistically significant difference between the groups for all primary and secondary outcome measures. CONCLUSIONS: TA-TOD for NTOS is effective in patients who do not respond to conservative treatment. Trial register number: NL63986.100.17.

Editor's Choice - Endurant Stent Graft in Patients with Challenging Neck Anatomy "One Step Outside Instructions for Use": Early and Midterm Results from the EAGLE Registry.

OBJECTIVE: The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits. METHODS: This was a prospective, international, multicentre, observational study. From 1 February 2012 to 1 September 2017, patients with an abdominal aortic aneurysm with a challenging infrarenal neck that were deemed suitable for endovascular aneurysm repair were included prospectively at 23 European centres. Patients were distributed by anatomy into three groups: short neck (SN; infrarenal neck 5 - 10 mm in combination with suprarenal angulation [α] ≤ 45° and infrarenal angulation [ß] ≤ 60°); medium neck (MN; infrarenal neck 10 - 15 mm with α ≤ 60° and ß 60° - 75° or α 45°- 60° and ß ≤ 75°; and long angulated neck (LN; infrarenal neck ≥ 15 mm with α ≤ 75° and ß 75°- 90° or α 60°- 75° and ß ≤ 90°. All computed tomography scans were reviewed by an independent core laboratory. Primary outcomes were technical and clinical success. Secondary endpoints were peri-operative major adverse events, all cause mortality, aneurysm related mortality, endoleaks, migration, and secondary intervention. RESULTS: One hundred and fifty patients (81.3% male) were included (SN = 55, MN = 16, LN = 79). The median follow up was 36 ± 12.6 months. In the overall cohort, the technical success rate was 93.3%. Estimated freedom from aneurysm related death was 97.3% at three years. Freedom from secondary interventions was 84.7% at three years. Estimated clinical success was 96.0%, 90.8%, and 83.2% at 30 days, one year, and three years, respectively. Estimated freedom from all cause mortality, late type IA endoleak, and migration at three years was 75.1%, 93.7%, and 99.3%, respectively. CONCLUSION: The early and midterm results of the EAGLE registry show that endovascular repair with the Endurant stentgraft in selected patients with challenging infrarenal neck anatomy yields results in line with large "real world" registries. Long term results are awaited for more definitive conclusions.

Duplex Ultrasound Studies Are Neither Necessary or Sufficient for the Diagnosis of Neurogenic Thoracic Outlet Syndrome.

BACKGROUND: Duplex ultrasound (DU) is used in the diagnosis of neurogenic thoracic outlet syndrome (NTOS) to measure compression of the subclavian artery (SCA) which is thought to strengthen the NTOS diagnosis. However, the value of DU in NTOS remains unclear. METHODS: A retrospective review of a prospectively acquired database from the TOS center of the Catharina Hospital Eindhoven was performed of patients referred between January 2017 and December 2019. Only "proven NTOS" patients, defined as a successful response to thoracic outlet decompression (TOD) surgery based on patient-reported outcomes (NRS pain scale, CBSQ and DASH score) were included to exclude wrongfully diagnosed NTOS patient. The presence of vascular symptoms (defined as discoloration, edema or temperature changes of the hand or fingers), results of provocative maneuvers, and outcome of DU was used for analysis. To assess the link between vascular symptoms and compression on DU, a chi-squared test was performed. Further, we looked for a correlation between vascular symptoms, compression on DU and clinical outcome using a repeated measures analysis of variance (ANOVA). RESULTS: Vascular symptoms were seen in 49 of 133 patients (36.8%). In total, 51 of 133 patients (38.3%) had at least 50% variation in SCA peak systolic velocity (PSV) during DU at the level of SCA stenosis. SCA occlusion was seen in 11 patients (8.3%) during provocative maneuvers. The presence of clinical "arterial symptoms" was not significantly correlated with vascular laboratory findings, neither for alterations in PSV during DU (P = 0.245) nor for positional SCA occlusion (P = 0.540). No statistically significant correlations between the degree of SCA stenosis and postoperative outcomes, as measured with the DASH, CBSQ, or NRS scale for pain were found (P = 0.787). CONCLUSIONS: The role of DU in the work-up of NTOS in patients with vascular complaints is questionable. Changes in flow velocities are seen in NTOS patients and do not correlate with "vascular symptoms" or clinical outcome.

Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy.

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.

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.

Feasibility and Outcomes of a Multidisciplinary Care Pathway for Neurogenic Thoracic Outlet Syndrome: A Prospective Observational Cohort Study.

OBJECTIVE: The North American Society for Vascular Surgery (SVS) reporting standards for neurogenic thoracic outlet syndrome (NTOS) were published in 2016 to produce consistency in the diagnosis and treatment of NTOS, but outcomes resulting from following these standards are not yet available. The results of a standardised multidisciplinary care pathway for NTOS based on the North American SVS reporting standards for NTOS are reported. METHODS: Patients referred between August 2016 and December 2019 with suspected NTOS were evaluated in this single center prospective cohort study. Diagnosis and treatment were performed according to a care pathway based on the North American SVS reporting standards. The outcome of surgically treated patients was determined by the Derkash score, thoracic outlet syndrome disability scale (TDS), Cervical Brachial Score Questionnaire (CBSQ), Disability of the Arm Shoulder and Hands Dutch language version (DASH-DLV) and Short Form-12 (SF-12) at three, six, 12, and 24 months. RESULTS: Of 856 referred patients, 476 (55.6%) patients were diagnosed with NTOS. Dedicated physiotherapy was successful in 186 patients (39.1%). Surgical treatment was performed in 290 (60.9%) patients of whom 274 were included in the follow up. At a mean follow up of 16.9 ± 9.2 months, significant improvement (p < .001) in TDS, CBSQ, DASH-DLV, and SF-12 scores was seen in the surgical group between baseline and all follow up intervals. Derkash outcome after surgical intervention was excellent in 83 (30.3%), good in 114 (41.6%), fair in 43 (15.7%), and poor in 34 (12.4%) of the patients. Complications occurred in 16 (5.8%) patients, and 32 (10.4%) patients experienced recurrent or persistent NTOS complaints. CONCLUSION: A multidisciplinary care pathway based on the North American SVS reporting standards for NTOS helped to confirm the diagnosis in 56% of patients referred, and guided the selection of patients who might benefit from thoracic outlet decompression surgery after unsuccessful dedicated physiotherapy. Intermediate follow up showed good outcomes in the majority of surgically treated patients.

Same Admission Hybrid Treatment of Primary Upper Extremity Deep Venous Thrombosis with Thrombolysis, Transaxillary Thoracic Outlet Decompression, and Immediate Endovascular Evaluation.

BACKGROUND: Multiple algorithms exist for treating acute primary upper extremity deep venous thrombosis (pUEDVT) caused by venous thoracic outlet syndrome (VTOS). In this case series, we present the results of our dedicated same admission treatment algorithm. METHODS: All patients between January 2015 and December 2019 with an established acute upper extremity deep venous thrombosis (symptoms <14 days) caused by VTOS were treated according to an algorithm consisting of same admission thrombolysis, transaxillary thoracic outlet decompression (TA-TOD) with extensive venolysis, and venography. If a residual stenosis of the subclavian vein was identified on venography, including by means of low-pressure diagnostic balloon inflation, correction by percutaneous transluminal angioplasty (PTA) was performed. The thoracic outlet syndrome disability scale, the Dutch language version of the disabilities of the arm, shoulder, and hand, and the VEINES-quality of life (VEINES-QOL/VEINES-symptoms) questionnaires were collected during follow-up. RESULTS: In total, 10 patients were treated for acute pUEDVT. After successful thrombolysis (100%) and TA-TOD, immediate venography showed residual stenosis of the subclavian vein in 8 of 10 patients (80%). Low-pressure dilatation of a balloon suited to the geometry of the axillosubclavian vein showed significant tapering in all cases (10/10) after which a formal venous PTA was performed. No stents were used. Mean time to discharge was 6.4 days. All patients were free of symptoms at a mean follow-up period of 34.4 months. Eight of the 10 patients completed follow-up questionnaires and reported a mean thoracic outlet syndrome disability scale of 0.6, mean disabilities of the arm, shoulder, and hand score of 4.2, and a median VEINES-Symptoms of 55.23 (IQR, 12.13), and VEINES-QOL of 55.29 (IQR, 15.42). CONCLUSIONS: A same admission treatment algorithm for acute pUEDVT in patients with VTOS including thrombolysis, TA-TOD with extensive venolysis, and immediate venography with PTA is effective with promising intermediate results.

Familial predisposition of thoracic outlet syndrome: does a familial syndrome exist? Report of cases and review of literature.

INTRODUCTION: Neurogenic thoracic outlet syndrome (NTOS) is caused by compression of the brachial plexus. The clinical presentation of NTOS is characterized by symptoms of pain, paresthesia, numbness or muscle weakness in the neck, arm or hand. METHODS: In this case report, five patients were diagnosed with NTOS. They all had a first degree relative with NTOS as well. CONLUSIONS: These cases show familial predisposition in thoracic outlet syndrome. Could a form of familial TOS exist?

Evaluation and treatment of thoracic outlet syndrome during the global pandemic due to SARS-CoV-2 and COVID-19.

The global SARS-CoV-2/COVID-19 pandemic has required a reduction in nonemergency treatment for a variety of disorders. This report summarizes conclusions of an international multidisciplinary consensus group assembled to address evaluation and treatment of patients with thoracic outlet syndrome (TOS), a group of conditions characterized by extrinsic compression of the neurovascular structures serving the upper extremity. The following recommendations were developed in relation to the three defined types of TOS (neurogenic, venous, and arterial) and three phases of pandemic response (preparatory, urgent with limited resources, and emergency with complete diversion of resources). • In-person evaluation and treatment for neurogenic TOS (interventional or surgical) are generally postponed during all pandemic phases, with telephone/telemedicine visits and at-home physical therapy exercises recommended when feasible. • Venous TOS presenting with acute upper extremity deep venous thrombosis (Paget-Schroetter syndrome) is managed primarily with anticoagulation, with percutaneous interventions for venous TOS (thrombolysis) considered in early phases (I and II) and surgical treatment delayed until pandemic conditions resolve. Catheter-based interventions may also be considered for selected patients with central subclavian vein obstruction and threatened hemodialysis access in all pandemic phases, with definitive surgical treatment postponed. • Evaluation and surgical treatment for arterial TOS should be reserved for limb-threatening situations, such as acute upper extremity ischemia or acute digital embolization, in all phases of pandemic response. In late pandemic phases, surgery should be restricted to thrombolysis or brachial artery thromboembolectomy, with more definitive treatment delayed until pandemic conditions resolve.

Ultrasound Based Wall Stress Analysis of Abdominal Aortic Aneurysms using Multiperspective Imaging.

BACKGROUND: Current clinical guidelines for surgical repair of abdominal aortic aneurysms (AAAs) are primarily based on maximum diameter assessment. From a biomechanical point of view, not only the diameter but also peak wall stresses will play an important role in rupture risk assessment. These methods require patient specific geometry which typically uses computed tomography (CT) or magnetic resonance imaging. Recently, wall stress analysis based on 3D ultrasound (US) has been proposed, and shows promising results. However, the major limitations in these studies were the use of manual segmentation and the limiting field of view of US. Therefore in this study, the AAA is imaged with multiperspective 3D ultrasound, merged to obtain a large field of view, and afterwards automatically segmented. Geometry and wall stress results were validated using CT imaging. METHODS: Three dimensional US and CT data were available for 40 AAA patients (maximum diameter 34-61 mm). The full US based AAA geometry was determined using automatic segmentation, and when the aneurysm exceeded a single 3D volume, automatic fusion of multiple 3D US volumes was used. Wall stress analysis was performed for all AAA patients and percentile wall stresses were derived. The accuracy of the US based geometry and wall stress prediction was measured by comparison with CT data. RESULTS: Estimated geometries derived from 3D US and CT data showed good similarity, with an overall median similarity index (SI) of 0.89 and interquartile range of 0.87-0.92, whereas the median Hausdorff distances (HD), a measure for the maximum local mismatch, was 4.6 (4.0-5.9) mm for all AAA geometries. Thereby, the wall stress results based on merged multiperspective 3D US data revealed a greater similarity to CT than single 3D US data. CONCLUSION: This study showed that large volume geometry assessment of AAAs using multiperspective 3D ultrasound, segmentation and fusion, and wall stress analysis is feasible in a robust and labour efficient manner.