Background Continuous telemonitoring of vital signs in a clinical or home setting may lead to improved knowledge of patients’ baseline vital signs and earlier detection of patient deterioration, and it may also facilitate the migration of care toward home. Little is known about the performance of available wearable sensors, especially during daily life activities, although accurate technology is critical for clinical decision-making. Objective The aim of this study is to assess the data availability, accuracy, and concurrent validity of vital sign data measured with wearable sensors in volunteers during various daily life activities in a simulated free-living environment. Methods Volunteers were equipped with 4 wearable sensors (Everion placed on the left and right arms, VitalPatch, and Fitbit Charge 3) and 2 reference devices (Oxycon Mobile and iButton) to obtain continuous measurements of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature. Participants performed standardized activities, including resting, walking, metronome breathing, chores, stationary cycling, and recovery afterward. Data availability was measured as the percentage of missing data. Accuracy was evaluated by the median absolute percentage error (MAPE) and concurrent validity using the Bland-Altman plot with mean difference and 95% limits of agreement (LoA). Results A total of 20 volunteers (median age 64 years, range 20-74 years) were included. Data availability was high for all vital signs measured by VitalPatch and for HR and temperature measured by Everion. Data availability for HR was the lowest for Fitbit (4807/13,680, 35.14% missing data points). For SpO2 measured by Everion, median percentages of missing data of up to 100% were noted. The overall accuracy of HR was high for all wearable sensors, except during walking. For RR, an overall MAPE of 8.6% was noted for VitalPatch and that of 18.9% for Everion, with a higher MAPE noted during physical activity (up to 27.1%) for both sensors. The accuracy of temperature was high for VitalPatch (MAPE up to 1.7%), and it decreased for Everion (MAPE from 6.3% to 9%). Bland-Altman analyses showed small mean differences of VitalPatch for HR (0.1 beats/min [bpm]), RR (−0.1 breaths/min), and temperature (0.5 °C). Everion and Fitbit underestimated HR up to 5.3 (LoA of −39.0 to 28.3) bpm and 11.4 (LoA of −53.8 to 30.9) bpm, respectively. Everion had a small mean difference with large LoA (−10.8 to 10.4 breaths/min) for RR, underestimated SpO2 (>1%), and overestimated temperature up to 2.9 °C. Conclusions Data availability, accuracy, and concurrent validity of the studied wearable sensors varied and differed according to activity. In this study, the accuracy of all sensors decreased with physical activity. Of the tested sensors, VitalPatch was found to be the most accurate and valid for vital signs monitoring.

BACKGROUND: Sufficient apposition and oversizing of the endograft in the aortic neck are both essential for durable endovascular aneurysm repair (EVAR). These measures are however not regularly stated on post-EVAR computed tomography angiography (CTA) scan reports. In this study endograft apposition and neck enlargement (NE) after EVAR with an Endurant II(s) endograft were analyzed and associated with supra-and infrarenal aortic neck morphology. METHODS:In 97 consecutive elective patients, the aortic neck morphology was measured on the pre-EVAR CTA scan on a 3mensio vascular workstation. The distance between the lowest renal artery and the proximal edge of the fabric (shortest fabric distance, SFD), and the shortest length of circumferential apposition between endograft and aortic wall (shortest apposition length, SAL) was determined on the early post-EVAR CTA scan. NE, defined as the aortic diameter change between pre-and post-EVAR CTA scan, was determined at eight levels: +40, +30, +20, +15, +10, 0, -5 and -10 mm relative to the lowest renal artery baseline.The aortic neck diameter and preoperative oversizing were correlated to NE with the Pearson correlation coefficient. The effective post-EVAR endograft oversizing is calculated from the nominal endograft diameter and the post-EVAR neck diameter where the endograft is circumferentially apposed. RESULTS:The median time (interquartile range, IQR) between the EVAR procedure and the pre-and post-EVAR CTA scan was 40 (25, 71) days and 36 (30, 46) days, respectively. The Endurant II(s) endograft was deployed with a median (IQR) SFD of 1.0 (0.0, 3.0) mm. The SAL was <10 mm in 9% of patients and significantly influenced by the pre-EVAR aortic neck length (p=0.001), hostile neck shape (p=0.017), and maximum curvature at the suprarenal aorta (p=0.039). The median (interquartile range) SAL was 21.0 (15.0, 27.0) mm with a median (IQR) pre-EVAR infrarenal neck length of 23.5 (13.0, 34.8) mm. The median (IQR) 3 difference between the SAL and neck length was -5.0 (-12.0, 2.8) mm. Significant (p<.001) NE of 1.7 (0.9, 2.5) mm was observed 5 mm below the renal artery baseline, which resulted in an effective post-EVAR endograft oversizing <10% in 43% of the patients. No correlation was found between NE and aortic neck diameter or preoperative oversizing. CONCLUSIONS:Circumferential apposition between an endograft and the infrarenal aortic neck, SAL, and NE can be derived from standard postoperative CT scans. These variables provide essential information about the post-procedural endograft and aortic neck morphology regardless of the preoperative measurements. Patients with SAL <10 mm or effective oversizing <10% due to NE may benefit from intensified follow-up, but clinical consequences of SAL and NE should be evaluated in future longitudinal studies with longer term follow-up.

Purpose: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established endovascular treatment option for pararenal abdominal aortic aneurysms in which balloon-expandable covered stents (BECS) are used to bridge the fenestration to the target vessels. This study presents midterm clinical outcomes and patency rates of the Advanta V12 BECS used as a bridging stent. Methods: All patients treated with FEVAR with at least 1 Advanta V12 BECS were included from 2 large-volume vascular centers between January 2012 and December 2015. Primary endpoints were freedom from all-cause reintervention, and freedom from BECS-associated complications and reintervention. BECS-associated complications included significant stenosis, occlusion, type 3 endoleak, or stent fracture. Secondary endpoints included all-cause mortality in-hospital and during follow-up. Results: This retrospective study included 194 FEVAR patients with a mean age of 72.2±8.0 years. A total of 457 visceral arteries were stented with an Advanta V12 BECS. Median (interquartile range) follow-up time was 24.6 (1.6, 49.9) months. The FEVAR procedure was technically successful in 93% of the patients. Five patients (3%) died in-hospital. Patient survival was 77% (95% CI 69% to 84%) at 3 years. Freedom from all-cause reintervention was 70% (95% CI 61% to 78%) at 3 years, and 33% of all-cause reinterventions were BECS associated. Complications were seen in 24 of 457 Advanta V12 BECSs: type 3 endoleak in 8 BECSs, significant stenosis in 4 BECSs, occlusion in 6 BECSs, and stent fractures in 3 BECSs. A combination of complications occurred in 3 BECSs: type 3 endoleak and stenosis, stent fracture and stenosis, and stent fracture and occlusion. The freedom from BECS-associated complications for Advanta V12 BECSs was 98% (95% CI 96% to 99%) at 1 year and 92% (95% CI 88% to 95%) at 3 years. The freedom from BECS-associated reinterventions was 98% (95% CI 95% to 100%) at 1 year and 94% (95% CI 91% to 97%) at 3 years. Conclusion: The Advanta V12 BECS used as bridging stent in FEVAR showed low complication and reintervention rates at 3 years. A substantial number of FEVAR patients required a reintervention, but most were not BECS related.

Purpose: Changes in the flared end of balloon-expandable covered stent (BECS) may precede BECS-associated complications but are not regularly assessed with computed tomographic angiography (CTA) after fenestrated endovascular aneurysm repair (FEVAR). Validation of the flare geometric analysis (FGA) and assessment of intraobserver and interobserver variability are investigated in this study. Methods: Two series of 3 BeGraft BECSs (Bentley InnoMed GmbH, Hechingen, Germany) and 1 series of 3 Advanta V12 BECSs (Getinge AB, Göteborg, Sweden) were deployed in 3 side branches (45°, 60°, and 90° aortic branch angles) of an aorta phantom model. A standard post-FEVAR CTA scan was acquired. Computed tomographic angiography–derived measurements consisted of centerline reconstructions and placement of 3-dimensional coordinate markers by 2 observers in a vascular workstation. Flare geometric analysis calculates 3 BECS parameters: the circumferential flare-to-fenestration distance (FFD), which is the distance from the proximal end of the flare to fenestration, and diameters at the proximal end of the flare (Dflare) and at the fenestration (Dfenestration). Computed tomographic angiography–derived measurements were validated against microscopy measurements. Bland-Altman plots were used to determine the intraobserver and interobserver variability of the BECS parameters and intraclass correlation coefficient (ICC). Results: For each BECS, the FFD at 4 equidistant quadrants of the circumference, Dflare, and Dfenestration were calculated. The mean difference and repeatability coefficient (RC) of the validation were 0.8 (2.1) mm for FFD, 0.4 (1.0) mm for Dflare, and −0.2 (1.2) mm for Dfenestration. The mean intraobserver and interobserver difference (RC) was 0.5 (1.6) mm and 0.7 (2.6) mm for FFD, 0.1 (0.6) mm and 0.1 (0.7) mm for Dflare, and −0.1 (0.8) mm and −0.8 (1.0) mm for Dfenestration. The mean ICC of intraobserver variability was 0.86 for FFD, 0.94 for Dflare, and 0.78 for Dfenestration. The mean ICC of interobserver variability was 0.77 for FFD, 0.92 for Dflare, and 0.48 for Dfenestration. Conclusion: This study showed that FGA of the flared ends of BECS can be performed with high accuracy in a phantom model, with good intraobserver and interobserver variability. Flare geometric analysis can be used to determine flare geometry of the BECS on standard post-FEVAR CTA scans.

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