Editor's Choice - Two Year Results of the Randomised DISCOVER Trial Comparing Covered Versus Bare Metal Stents in the Common Iliac Artery.

OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery. METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381). RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study. CONCLUSION: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.

The Effect of Arterial Disease Level on Outcomes of Supervised Exercise Therapy for Intermittent Claudication: A Prospective Cohort Study.

OBJECTIVE: To assess whether level of arterial obstruction determines the effectiveness of SET in patients with IC. BACKGROUND DATA: Guidelines advocate SET before invasive treatment for IC, but early revascularization remains widespread, especially in patients with aortoiliac disease. METHODS: Patients were recruited from 10 Dutch centers between October 2017 and October 2018. Participants received SET first, followed by endovascular or open revascularization in case of insufficient effect. They were grouped according to level of stenosis (aortoiliac, femoropopliteal, multilevel, or rest group with no significant stenosis). Changes from baseline walking performance (maximal and functional walking distance on a treadmill test, 6-minute walk test) and vascular quality of life questionnaire-6 at 3 and 6 months were compared, after multivariate adjustment for possible confounders. Freedom from revascularization was estimated with Kaplan-Meier analysis. RESULTS: Some 267 patients were eligible for analysis (aortoiliac n = 70, 26%; femoropopliteal n = 115, 43%; multilevel n = 69, 26%; rest n = 13, 5%). No between group differences in walking performance or vascular quality of life questionnaire-6 were found. Mean improvement in maximal walking distance after 6 months was 439 m [99% confidence interval (CI) 297-581], 466 m (99% CI 359-574), 353 m (99% CI 210-496), and 403 m (99% CI 58-749), respectively (P = 0.40). Freedom from intervention was 73.9% for aortoiliac disease and 88.6% for femoropopliteal disease (hazard ratio 2.46, 99% CI 0.96 - 6.30, P = 0.013). CONCLUSIONS: Short-term effectiveness of SET for IC is not determined by the location of stenosis. Although aortoiliac disease patients improved walking performance and health-related quality of life similarly compared to other arterial disease level groups, they underwent revascularization more often.

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.

Personalised Outcomes Forecasts of Supervised Exercise Therapy in Intermittent Claudication: An Application of Neighbours Based Prediction Methods with Routinely Collected Clinical Data.

OBJECTIVE: Insights regarding individual patient prognosis may improve exercise therapy by informing patient expectations, promoting exercise adherence, and facilitating tailored care. Therefore, the aim was to develop and evaluate personalised outcomes forecasts for functional claudication distance over six months of supervised exercise therapy for patients with intermittent claudication. METHODS: Data of 5 940 patients were eligible for analysis. Neighbours based predictions were generated via an adaptation of predictive mean matching. Data from the nearest 223 matches (a.k.a. neighbours) for an index patient were modelled via Generalised Additive Model for Location Scale and Shape (GAMLSS). The realised outcome measures were then evaluated against the GAMLSS model, and the average bias, coverage, and precision were calculated. Model calibration was analysed via within sample and of sample analyses. RESULTS: Neighbours based predictions demonstrated small average bias (- 0.04 standard deviations; ideal = 0) and accurate average coverage (48.7% of realised data within 50% prediction interval; ideal = 50%). Moreover, neighbours based predictions improved prediction precision by 24%, compared with estimates derived from the whole sample. Both within sample and of sample testing showed predictions to be well calibrated. CONCLUSION: Neighbours based prediction is a method for generating accurate personalised outcomes forecasts for patients with intermittent claudication undertaking supervised exercise therapy. Future work should examine the influence of personalised outcomes forecasts on clinical decisions and patient outcomes.

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.

Supervised Exercise Therapy is Effective for Patients With Intermittent Claudication Regardless of Psychological Constructs.

OBJECTIVE: According to current guidelines, supervised exercise therapy (SET) is the treatment of choice for intermittent claudication (IC). Little is known about the potential consequences of psychological factors on the effectiveness of treatment. The aim of this study was to determine possible associations between a set of psychological constructs and treatment outcomes, and to investigate whether self efficacy increased after SET. METHODS: This was a substudy of the ELECT Registry, a multicentre Dutch prospective cohort study in patients with IC receiving primary SET. A complete set of validated questionnaires scoring extraversion, neuroticism, conscientiousness, anxiety, depression, self control, optimism, and self efficacy was obtained in 237 patients (median age 69 years, 40% female). Anxiety and depression were dichotomised using established cutoff scores, whereas other scores were analysed as continuous measures. Multiple linear regression analyses determined possible associations between these independent variables and maximum and functional walking distances (MWD and FWD, respectively), Six Minute Walk Test (6MWT), and VascuQol-6 (dependent variables). Self efficacy during 12 months of SET was analysed using a linear mixed model. RESULTS: Neuroticism and anxiety were associated with lower overall VascuQol-6 scores (estimate -1.35 points [standard error (SE) 0.57; p = .018] and -1.98 points [SE 0.87, p = .023], respectively). Optimism and self efficacy demonstrated higher overall 6MWT (5.92 m [SE 2.34; p = .012] and 1.35 m [SE 0.42; p = .001], respectively). Self control was associated with lower overall log MWD (-0.02 [SE 0.01; p = .038] and log FWD (-0.02 [SE 0.01; p = .080), whereas self efficacy had a higher overall log MWD (0.01 [SE 0.003; p = .009]) and log FWD (0.01 [SE 0.003; p = .011]). Depressive patients with IC demonstrated a greater improvement in 6MWT during follow up (17.56 m [SE 8.67; p = .044]), but this small effect was not confirmed in sensitivity analysis. Self efficacy did not increase during follow up (0.12% [SE 0.49; p = .080]). CONCLUSIONS: The beneficial effects of SET occur regardless of the psychological constructs, supporting current guidelines recommending a SET first strategy in each patient with IC.

Vascular Quality of Life Questionnaire-6 Before and After Supervised Exercise Therapy in Patients with Intermittent Claudication.

OBJECTIVE: The Vascular Quality of Life Questionnaire-6 (VascuQoL-6) is a short, disease specific instrument used to determine health related quality of life (HRQoL) in patients with peripheral arterial disease. This study aimed to assess the minimally important difference (MID) and substantial clinical benefit (SCB) of the VascuQoL-6 in Dutch patients with intermittent claudication (IC) receiving supervised exercise therapy (SET). METHODS: Consecutive patients with IC who were recruited from a single centre between January 2016 and December 2016 completed the VascuQoL-6 before initiation and after three months of SET. They subsequently answered an anchor question rating their current health status as much improved, improved, unchanged, deteriorated, or much deteriorated, compared with baseline. The MID for improvement and deterioration and SCB were calculated using anchor based and distribution based methods. RESULTS: A total of 124 patients with IC (58% male, mean age 68 years) completed the study protocol. Baseline VascuQoL-6 scores increased from 16.3 ± 4.4 to 18.7 ± 3.8 after three months of SET (p < .001). MID values ranged from +2.0 to +3.8 points regarding HRQoL improvement and from +0.2 to -2.2 points regarding HRQoL deterioration. The SCB ranged from +3.7 to +5.0 points. Depending on the MID approach, 32% - 41% of patients achieved a clinically meaningful improvement in HRQoL. CONCLUSION: Approximately one in three patients with IC reported a clinically meaningful improvement in HRQoL after three months of SET. The range of MID and SCB values provides caregivers with an idea of how much change in VascuQoL-6 scores is considered relevant or substantial by their patients. Applying cutoff points for MID and SCB may optimise the interpretation of trial results and may help to set a benchmark for success of SET.

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.

Abnormal preoperative digital brachial index is associated with lower 2-year arteriovenous fistula access patency.

OBJECTIVE: The aim of the present study was to assess whether a single measurement of the digital brachial index (DBI; systolic finger pressure/systemic pressure ratio), reflecting the arm's circulation, was associated with access patency in patients with severe chronic kidney disease scheduled for arteriovenous fistula (AVF) creation. METHODS: A bilateral DBI was obtained using digital plethysmography just before construction of the patient's first AVF from January 2009 to December 2017 at one center. A DBI of 80% to 99% was considered normal, and a DBI of <80% (low) or DBI of ≥100% (high) were considered abnormal. DBI values ipsilateral to the AVF were used for analysis. The primary and secondary access patency rates were calculated using reported standards and compared using standard statistical techniques. RESULTS: Data sets of 163 patients were obtained (69 women; age, 71 ± 12 years). The median follow-up was 40 weeks (range, 0-104 weeks; follow-up index, 99% ± 1%). Patients with abnormal preoperative DBI values had lower 2-year primary patency rates (low DBI, 25% ± 11%; high DBI, 28% ± 6%; normal DBI, 49% ± 8%; P = .018). After correction for age, sex, hypertension, diabetes mellitus, cardiovascular disease, smoking status, and a history of ipsilateral central venous catheter use, an adjusted model demonstrated that abnormal DBI values conferred an increased risk of primary patency failure (low DBI [<80%]: hazard ratio [HR], 2.25; 95% confidence interval [CI], 1.13-4.48; high DBI [≥100%]: HR, 1.74; 95% CI, 1.06-2.85; P < .030 for both). Patients with a low preoperative DBI had also had diminished secondary patency (HR, 2.86; 95% CI, 1.08-7.59; P = .035). In contrast, the diameters of the outflow veins did not determine access patency. CONCLUSIONS: Patients with abnormal DBI values before AVF construction for hemodialysis had lower 2-year access patency rates compared with patients with a normal DBI. Plethysmographic finger measurements might have a role in the preoperative counseling of patients with severe chronic kidney disease requiring an AVF.

Systolic finger pressures during an Allen test before hemodialysis access construction predict severe postoperative hand ischemia.

OBJECTIVE: The Allen test is a simple bedside method for determining hand perfusion. Earlier studies in patients on hemodialysis (HD) found that an Allen test before access construction did not predict hand ischemia later on. The study aimed to assess whether an Allen test combined with finger plethysmography before access surgery has a potential to predict the onset of severe HD access induced distal ischemia (HAIDI). METHODS: Before the first access construction in patients with chronic kidney disease, systolic finger pressures (Pdig, in millimeters of mercury) were obtained using plethysmography at rest and after serial compression of the radial and ulnar artery. A decrease in Pdig (∂Pdig) was calculated as the difference between Pdig-rest and Pdig-compression. The severity of postoperative HAIDI was graded as suggested by a 2016 consensus meeting. Patients with a severe type of HAIDI (grade 2b-4, intolerable pain, invasive treatment required) were compared with controls not having HAIDI. RESULTS: A total of 105 patients with chronic kidney disease (mean age 70 ± 13 years; 65% males) receiving their first access between January 2009 and December 2018 in one center fulfilled study criteria. Ten patients (10%) developed severe HAIDI at 14 ± 5 months after access construction. Before access creation, all patients with HAIDI demonstrated a radial or ulnar dominant hand perfusion pattern compared with just 57% in controls (P = .010). Compression resulted in an almost two-fold greater ∂Pdig in patients with severe HAIDI (51 ± 8 mm Hg vs 27 ± 3 mm Hg; P = .005). A 40-mm Hg ∂Pdig cut-off value demonstrated optimal tests characteristics (sensitivity of 80%, specificity of 77%, positive predictive value of 27%, negative predictive value of 97%) indicating a 10 times greater risk of developing severe HAIDI. CONCLUSIONS: Finger plethysmography quantifying ∂Pdig during an Allen test before access creation may identify patients who have a substantially increased risk of developing severe hand ischemia after HD access surgery.

Diagnostic accuracy of automated oscillometric determination of the ankle-brachial index in peripheral artery disease.

OBJECTIVE: Peripheral artery disease (PAD) is underdiagnosed in primary care settings, partly because of limited accuracy of the Doppler ankle-brachial index (ABI). This study aimed to assess the diagnostic accuracy of an automated oscillometric ABI device compared with reference standard vascular laboratory Doppler ABI equipment and to examine the influence of oscillometric errors on performance. METHODS: Consecutive patients who were referred to a large general hospital for an ABI measurement were invited to participate. In each patient, the oscillometric analysis was followed by the Doppler analysis. Legs with incompressible ankle arteries were excluded from analysis. ABI values were compared using the Bland-Altman method. Oscillometric errors were defined as the incapacity of the oscillometer to report a value of ABI. A receiver operating characteristic curve was constructed, and the area under the curve was computed. RESULTS: A total of 201 patients participated. The Bland-Altman plot showed a mean difference of 0.05 ± 0.12 (limits of agreement, -0.20 to 0.29), representing a small ABI overestimation after oscillometry. Oscillometric errors occurred more commonly in limbs with PAD than in limbs without PAD (28% and 7%, respectively; P < .001). Considering a 0.9 threshold and after oscillometric error exclusion, the oscillometric ABI showed a 74% sensitivity and a 97% specificity for a diagnosis of PAD. When oscillometric errors were considered as abnormal ABIs, sensitivity increased to 86% and specificity was maintained at 95%. The receiver operating characteristic curve showed an area under the curve of 0.96. The best oscillometric ABI cutoff point was 1.00. Using this threshold and when considering oscillometric errors as abnormal ABIs, sensitivity improved to 94% while maintaining specificity at 92%. CONCLUSIONS: Oscillometric ABI showed good diagnostic accuracy compared with the reference standard. However, the high incidence of oscillometric errors and the challenges to correctly interpret readings may limit the use of the oscillometric method in PAD diagnosis.

Chronic exertional compartment syndrome in the differential diagnosis of peripheral artery disease in older patients with exercise-induced lower limb pain.

OBJECTIVE: Peripheral artery disease (PAD) and chronic exertional compartment syndrome (CECS) both cause exercise-induced lower limb pain. CECS is mostly described in young individuals and may therefore not be considered in older patients with intermittent claudication. The aim of our study was to identify differences in characteristics and symptomatology between patients with CECS and PAD that may help in recognizing CECS in patients ≥50 years with exercise-induced lower limb pain. METHODS: In this case-control study, patients with CECS ≥50 years were selected from a prospectively followed cohort and compared with a sample of newly diagnosed patients with PAD ≥50 years. A questionnaire assessed frequency and severity of lower limb pain, tightness, cramps, muscle weakness, and altered skin sensation at rest and during exercise. RESULTS: At rest, patients with CECS (n = 43, 42% female, 57 years; range, 50-76 years) reported significantly more pain, tightness, muscle weakness and altered skin sensation (all P < .01) than patients with PAD (n = 41, 39% female, 72 years; range, 51-93 years). Having CECS was associated with a significantly higher combined symptom score at rest (P = .02). During exercise, patients with CECS experienced more tightness, muscle weakness and altered sensation (P < .01), but not pain and cramps (P = .36; P = .70). Exercise-induced complaints occurred much later in patients with CECS than in patients with PAD (15 minutes vs 4 minutes; P < .01). Persistence of pain over 4.5 minutes proved most discriminative for the presence of CECS (sensitivity, 95%; specificity, 54%; positive predictive value, 65%). Exercise cessation completely alleviated complaints in all patients with PAD (n = 41) but not in 73% (n = 29) of the patients with CECS. Ongoing discomfort strongly predicted the presence of CECS (sensitivity, 73%; specificity, 100%; positive predictive value, 100%). CONCLUSIONS: Patients with CECS ≥50 years report a symptom pattern that is different from patients with PAD. These differences may aid vascular surgeons in identifying older patients with CECS.

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.

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data.

OBJECTIVE: The purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date. METHODS: Patients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak. RESULTS: Through 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up. CONCLUSIONS: In the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.