Constantijn E.V.B. Hazenberg

Systematic Review of Off-the-Shelf or Physician-Modified Fenestrated and Branched Endografts

Purpose: To determine the safety and efficacy of off-the-shelf fenestrated/branched grafts (OSFGs) and physician-modified stent-grafts (PMSGs) for the treatment of complex abdominal aortic aneurysms. Methods: A systematic search of the MEDLINE database via PubMed from January 2001 through March 2015 retrieved 23 relevant articles evaluating the clinical outcomes following the management of patients with pararenal or thoracoabdominal aortic aneurysms. The 15 articles on PMSGs and 8 on OSFGs contained data on 308 patients (mean age 72.93±2.89 years; 213 men). The safety endpoint was major adverse events; the efficacy outcome measure was clinical treatment success (aneurysm exclusion without type I/III endoleak, permanent paralysis, long-term dialysis, or unresolved major complications). Extracted outcome data were pooled and compared between groups; data are given as the pooled proportions and 95% confidence interval (CI). Clinical data are presented as the weighted mean. Results: Of the 308 patients analyzed, almost one third were operated on an emergency basis. The mean aneurysm diameters were 75.9±17.3 mm (range 56–115) for the PMSGs and 68.1±13.7 mm (range 60–100) for the OSFGs. A total of 936 renal and visceral vessels were targeted. Major adverse events (safety) occurred in 24 (12.8%) PMSG patients (95% CI 8.6% to 18.7%) and in 9 (7.4%) OSFG patients (95% CI 3.7% to 14%). Clinical treatment success (efficacy) was observed in 171/187 (91.4%) PMSG patients (95% CI 86.2% to 94.9%) and in 115/121 (95%) OSFG patients (95% CI 89.1% to 98.0%). Corresponding cumulative 30-day target vessel and branch stent perfusion rates were 97.2% (95% CI 95.1% to 98.4%) and 97.6% (95% CI 95.5% to 98.8%) for the PMSG group and 99.6% (95% CI 98.3% to 99.9%) and 98.4% (95% CI 96.5% to 99.4%) for the OSFG group. Six (3.2%) deaths occurred in the PMSG group only; 2 (1.1%) were aneurysm related. Overall branch patency was recorded in 443/458 (96.7%) and in 468/478 (97.9%) of target vessels in the PMSG and OSFG groups, respectively. Conclusion: Off-the-shelf and physician-modified technology seems effective and safe, in both the elective and acute settings, for the treatment of complex aortic aneurysms. Future research within a randomized trial should investigate the true limitations of these devices.

Telemedical home-monitoring of diabetic foot disease using photographic foot imaging - a feasibility study

We assessed the feasibility of using a photographic foot imaging device (PFID) as a tele-monitoring tool in the home environment of patients with diabetes who were at high risk of ulceration. Images of the plantar foot were taken three times a week over a period of four months in the home of 22 high-risk patients. The images were remotely assessed by a diabetic foot specialist. At the end of the study, 12% of images were missing, mainly due to modem or server failures (66%), or non-adherence (11%). All three referrals for diagnosed ulcers and 31 of 32 referrals for abundant callus resulted in treatment. Health-related quality of life (EQ-5D visual analogue scale), increased from 7.5 at baseline to 7.9 at end of follow-up, but not significantly. Mean scores on a visual analogue scale for different usability domains (independence, ease of use, technical aspects and value) ranged from seven to nine. The study demonstrates the feasibility of using the PFID for the early diagnosis of foot disease, which may prevent complications in high-risk patients with diabetes.

The validity and reliability of diagnosing foot ulcers and pre-ulcerative lesions in diabetes using advanced digital photography.

BACKGROUND The goal of this study was to determine the validity and reliability of assessing the presence of plantar foot ulceration and pre-ulcerative lesions in diabetes patients from digital photographs that were produced using a new photographic foot imaging device. METHODS In 32 diabetes patients who had a foot ulcer or were at high risk of ulceration (a total of 60 feet), high-quality photographic images of the plantar foot surface were collected. Each foot was assessed live, from photographs 2 weeks later, and again 4 weeks later for the presence of an ulcer, abundant callus, or the absence of signs. Each foot was assessed by four independently operating foot care specialists. Agreement scores were calculated using κ values (range, 0-1). Sensitivity and specificity scores were also calculated. RESULTS Foot ulceration was cumulatively scored 59 times, callus 78 times, and absence of signs 149 times during live assessment. Agreement with photographic assessment was very good for ulcer (κ = 0.87) and absence of signs (κ = 0.83) and good for callus (κ = 0.61). Sensitivity and specificity were high for ulcer (88% and 98%, respectively), callus (69% and 89%, respectively), and absence of signs (both 90%). Intra-observer agreement between repeated photographic assessments was good to excellent for all outcomes and observers (κ between 0.70 and 1.00). Inter-observer agreement for photographic assessments was good for ulcer (κ = 0.72-0.88) and absence of signs (κ = 0.59-0.75) and moderate to good for callus (κ = 0.48-0.73). For live assessment, inter-observer agreement scores were only slightly higher. CONCLUSIONS The data illustrate that diabetic foot ulcers and pre-ulcerative lesions can be diagnosed in a valid and reliable manner by trained professionals from digital photographs produced with the foot imaging device. This supports the intended use of the device as a telemedical monitoring tool in the home environment for early detection of diabetic foot disease and prevention of severe complications in high-risk diabetes patients.

Plasma fibrinogen level as a potential predictor of hemorrhagic complications after catheter-directed thrombolysis for peripheral arterial occlusions

Background: The benefit of catheter‐directed thrombolysis for peripheral arterial occlusions is limited by hemorrhagic complications. Plasma fibrinogen level (PFL) has been suggested as a predictor of these hemorrhagic complications, but the accurateness of prediction is unknown. We summarized the available evidence on the predictive value of PFL for hemorrhagic complications after catheter‐directed thrombolysis for acute or subacute peripheral native artery or arterial bypass occlusions. Methods: We systematically searched PubMed and Embase until January 2016 for peer‐reviewed publications on adults undergoing thrombolysis for acute or subacute peripheral native artery or arterial bypass occlusions, assessing the predictive value of PFL for hemorrhagic complications. Two authors independently performed data extraction. Risk of bias was assessed with the Quality in Prognosis Studies (QUIPS) tool. Results: In total, six studies (two randomized clinical trials and four cohort studies) reported on 613 patients undergoing 623 thrombolytic interventions for peripheral native artery or arterial bypass occlusions. No risk estimates for PFL and hemorrhagic complications were reported, two risk estimates were calculated, and nine associations between PFL and hemorrhagic complications were reported. For PFL <100 mg/dL compared with ≥100 mg/dL, the calculated relative risk was 0.33 (95% confidence interval, 0.05‐2.25) for major bleeding and 1.39 (95% confidence interval, 1.06‐1.81) for any bleeding. There were considerable differences in the time point of PFL measurement, the thrombolytic agents, the doses of the agents, and the definition of outcomes. PFL seems inaccurate in predicting hemorrhagic complications. Overall, the included studies were at high risk of bias. Conclusions: Based on the current literature, the predictive value of PFL for predicting hemorrhagic complications after catheter‐directed thrombolysis for acute or subacute peripheral native artery and arterial bypass occlusions is unproven.

Midterm outcomes and evolution of gutter area after endovascular aneurysm repair with the chimney graft procedure

Objective The objective of this study was to describe our experience with endovascular aneurysm repair (EVAR) with the use of chimney grafts for branch vessel preservation. Methods Patients treated with a chimney graft procedure between October 2009 and May 2015 were included for analysis. Patients who were not considered eligible for open surgical repair or for conventional, branched, or fenestrated endovascular repair were selected. A standardized operating procedure with left brachial or axillary artery cutdown access for the chimney grafts and bilateral femoral artery cutdown access for the aortic main device was used. Outcomes were noted according to the Society for Vascular Surgery reporting standards. In addition, evolution of gutter area over time was determined. Estimated rates of survival, freedom from aneurysm growth, and clinical success at 24 months of follow‐up were calculated. Results Thirty‐three patients (mean age, 77.6 ± 6.8 years; 87.9% male) with a mean preoperative maximum aneurysm diameter of 71.7 ± 13.5 mm were included. A total of 54 of an intended 54 chimney grafts were deployed. Primary technical success and 30‐day secondary clinical success rates were 87.9% and 84.8%, respectively. The early mortality rate was 6.1% (n = 2). The early type IA endoleak rate was 6.1% (n = 2), and the chimney graft occlusion rate was 6.1% (n = 2). Median follow‐up duration was 26 months (interquartile range, 14.8‐37.3 months). The estimated 2‐year actuarial survival rate was 78.1% (standard error, ±7.4%). Late complications included type IA endoleak (n = 1), chimney graft occlusion (n = 2), type II endoleak with aneurysm growth (n = 4), and distal stent graft limb kinking and occlusion (n = 1). Late reinterventions included coil or glue embolization (n = 3), distal limb extension (n = 2), open endoleak ligation (n = 2), Palmaz stent placement (n = 1), repeated EVAR (n = 1), and femorofemoral bypass graft (n = 1). At 2 years, the estimated secondary clinical success and freedom from aneurysm growth rates were 80.5% (±7.2%) and 84.4% (±7.2%). Gutter size showed a small but significant decrease over time at the level of the proximal markers and at 10 mm distal from the markers. Conclusions Midterm results show that a standardized procedure for EVAR using chimney grafts for branch vessel preservation is an acceptable option for high‐risk patients with large, complex aneurysms who are unfit for open repair and who have been excluded from fenestrated EVAR. Gutter size decreases over time, but the rate of branch vessel loss and reinterventions demonstrate that this approach should remain reserved for those who are at truly prohibitive risk for open or fenestrated stent graft repair.

Below-the-Knee Retrograde Access for Peripheral Interventions: A Systematic Review

Purpose: To investigate the hypothesis that interventions involving retrograde below-the-knee (BTK) vessel punctures have an acceptably low complication rate and high procedural success. Methods: A systematic review was performed of the MEDLINE and Scopus databases for articles describing the results of BTK retrograde access for peripheral interventions. Outcome measures were access success, procedure success, and complications. A predefined subgroup analysis was performed of prospective studies to reduce the influence of possible reporting bias on outcomes. Results: Nineteen articles, including 3 prospective studies, were selected, including a total of 1905 interventions in 1395 patients (mean age 69.5 years; 918 men). The BTK vessels were punctured in 1168 (61.3%) of these interventions. Access was successful in 94.0% of BTK attempts, 86.0% of all lesions were successfully crossed using a retrograde access, and 84.0% of interventions achieved technical success. Forty-eight (4.1%) distal access site complications were reported. Vessel perforations were seen in 13 (1.1%) interventions, vasospasm in 5 (0.4%), and acute distal occlusions in 5 (0.4%). Predefined subgroup analysis of prospective studies showed similar results (p=0.24). Conclusion: A retrograde approach to facilitate peripheral endovascular interventions is a safe and successful technique and should be considered when an antegrade approach is not possible or fails to cross the lesion. Because of missing data on long-term outcomes and methodological shortcomings, real world data of retrograde access in nonexpert centers remains necessary before this technique can be advised to all interventionists dealing with peripheral artery disease.

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

Purpose: To determine which patient and C-arm characteristics are the strongest predictors of intraoperative patient radiation dose rates (DRs) during endovascular aneurysm repair (EVAR) procedures and create a patient risk chart. Methods: A retrospective analysis was performed of 74 EVAR procedures, including 16,889 X-ray runs using fixed C-arm imaging equipment. Four multivariate log-linear mixed models (with patient as a random effect) were constructed. Mean air kerma DR (DRAK, mGy/s) and the mean dose area product DR (DRDAP, mGycm2/s) were the outcome variables utilized for fluoroscopy as differentiated from digital subtraction angiography (DSA). These models were used to predict the maximum radiation duration allowed before a 2-Gy skin threshold (for DRAK) or a 500-Gycm2 threshold (for DRDAP) was reached. Results: The strongest predictor of DRAK and DRDAP for fluoroscopy imaging was the radiation protocol, with an increase of 200% when changing from “low” to “medium” and 410% from “low” to “normal.” The strongest predictors of DRAK and DRDAP for DSA were C-arm angulation, with an increase of 47% per 30° of angulation, and body mass index (BMI), with an increase of 58% for every 5-point increase in BMI. Based on these models, a patient with a BMI of 30 kg/m2, combined with 45° of rotation and a field size of 800 cm2 in the medium fluoroscopy protocol has a predicted DRAK of 0.39 mGy/s (or 85.5 minutes until the 2-Gy skin threshold is reached). While using comparable settings but switching the acquisition to a DSA with a “2 frames per second” protocol, the predicted DRAK will be 6.6 mGy/s (or 5.0 minutes until the 2-Gy threshold is reached). Conclusion: X-ray radiation DRs are constantly fluctuating during and between patients based on BMI, the protocols, C-arm position, and the image acquisitions that are used. An instant patient risk chart visualizes these radiation dose fluctuations and provides an overview of the expected duration of X-ray radiation, which can be used to predict when follow-up dose thresholds are reached during abdominal endovascular procedures.

Surgical Treatment of Acute Thoracic Stent-Graft Occlusion

A 24-year-old man presented with acute onset paraplegia related to complete occlusion of a thoracic stent graft placed 2 years prior for repair of traumatic type B aortic dissection. Following emergency surgery comprising reestablishment of aortic flow by stent removal and aortic reconstruction, the paraplegia started to resolve partly, despite an estimated 5-hour interval of preoperative myelum ischemia. Anatomical characteristics of the stent graft placement appear to have played a role in causing this rare complication. Six months later, the patient could walk again with a stick. This case shows that early intervention in cases of full paraplegia may be considered.

Procedure and step-based analysis of the occupational radiation dose during endovascular aneurysm repair in the hybrid operating room

Objective: This study measured the cumulative occupational X‐ray radiation dose received by support staff during endovascular aortic procedures and during additional intraoperative steps in the hybrid operating room. Methods: Radiation dose measurements were performed during interventions on 65 patients receiving 90 stent grafts during endovascular aneurysm repair (EVAR), bifurcated EVAR, thoracic EVAR, iliac branched device deployment, aortouni‐iliac stenting, and fenestrated/branched EVAR (F/BrEVAR). X‐ray imaging was acquired using the Philips Allura FD20 Clarity System (Philips Medical Systems, Best, The Netherlands). The occupational radiation dose (also referred to as the estimated effective dose, E, measured in millisieverts) was measured with the DoseAware Xtend system (Philips Medical Systems) personal dosimeters. E was reported per staff member (ESTAFF), where “staff” was a generic term for each staff member included in the study: the first operator (FO), the second operator (ESO), a virtual maximum operator (MO), and all additional supporting staff, including the sterile nurse, nonsterile nurse, anaesthesiologist, and radiation technician. The primary outcome was the median cumulative ESTAFF (or EFO, EMO, and so on), which was presented as the median cumulative dose per intervention and stratified for several within‐interventional EVAR and F/BrEVAR steps or stents. The second outcome was the percentage of the absorbed E by a supporting staff member in relation to the E measured by the reference badge attached on the C‐arm (ESTAFF% or EFO%, EMO%, and so on). All outcomes are presented as median with interquartile range, unless stated differently. Results: The occupational effective dose in millisieverts of the MO (EMO) was 0.055 (0.029–0.082) for aortouni‐iliac stenting (n = 6), 0.084 (0.054–0.141) during thoracic EVAR (n = 14), 0.036 (0.026–0.068) during bifurcated EVAR (n = 38), 0.054 (0.035–0.126) during iliac branched device deployment (n = 8), and 0.345 (0.235–0.757) during F/BrEVAR (n = 24). The median EMO in millisieverts was 0.025 (0.012–0.062) per renal target vessel (TV) and 0.146 (0.07–0.315) for a nonrenal visceral TV. During all noncomplex interventions, the EMO% was 4.4% (2.7%‐7.3%), with the lowest median rate at 3.5% (2.5%‐5%) for EVAR. The highest median rate EMO% was found for F/BrEVAR procedures: 8.2% (5.0%‐14.4%). Conclusions: With maximum operator shielding during femoral access, relative occupational radiation risk can be minimized. However, digital subtraction angiography image acquisition, recanalization of TVs, recanalization of superior mesenteric artery or celiac artery, and recanalization of branched TVs are predictors for increased occupational radiation dose risks caused by increased radiation doses to the patient and reduced options for shielding of the operator.