Is TCC-EZ a Suitable Alternative to Gold Standard Total-Contact Casting?

BACKGROUND: The total-contact cast (TCC) is the gold standard for off-loading diabetic foot ulcers (DFUs) given its nonremovable nature. However, this modality remains underused in clinical settings due to the time and experience required for appropriate application. The TCC-EZ is an alternative off-loading modality marketed as being nonremovable and having faster and easier application. This study aims to investigate the potential of the TCC-EZ to reduce foot plantar pressures. METHODS: Twelve healthy participants (six males, six females) were fitted with a removable cast walker, TCC, TCC-EZ, and TCC-EZ with accompanying brace removed. These off-loading modalities were tested against a control. Pedar-X technology measured peak plantar pressures in each condition. Statistical analysis of four regions of the foot (rearfoot, midfoot, forefoot, and hallux) was conducted with Friedman and Wilcoxon signed rank tests. Significance was set at P < .05. RESULTS: All of the off-loading conditions significantly reduced pressure compared with the control, except the TCC-EZ without the brace in the hallux region. There was no statistically significant difference between TCC-EZ and TCC peak pressure in any foot region. The TCC-EZ without the brace obtained significantly higher peak pressures than with the brace. The removable cast walker produced similar peak pressure reduction in the midfoot and forefoot but significantly higher peak pressures in the rearfoot and hallux. CONCLUSIONS: The TCC-EZ is a viable alternative to the TCC. However, removal of the TCC-EZ brace results in minimal plantar pressure reduction, which might limit clinical applications of the TCC-EZ.

Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.

OBJECTIVES: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation. METHODS: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention. RESULTS: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class. CONCLUSION: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities. CLINICAL TRIAL REGISTRATION: NCT02276313.

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.

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry.

PURPOSE: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups. RESULTS: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07). CONCLUSION: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.

Multicentre Covariate Adjustment Analysis of Short-Term and 5-Year Outcomes after Endovascular Repair according to Sex.

BACKGROUND: Several studies have reported worse outcomes in women compared to men after endovascular aneurysm repair (EVAR). This study aimed to evaluate sex-specific short-term and 5-year outcomes after EVAR. METHODS: A total of 409 consecutive patients underwent elective EVAR from 2004 to 2017 at two tertiary hospitals in Western Australia. Baseline, intraoperative, and postoperative variables were examined retrospectively according to sex. The primary outcome was 30-day mortality (death within 30 days after EVAR). Secondary outcomes were 30-day composite endpoint, length of stay after EVAR, 5-year survival, freedom from reintervention, residual aneurysm size after EVAR, and major adverse event rate at 5-year follow-up. RESULTS: A cohort of 409 patients, comprising 57 women (14%) and 352 men (86%), was analysed. Female patients were older (median age, 76.8 versus 73.5 years, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%, p=0.017). Male patients were more likely to be past smokers (40.9% versus 22.8%. CONCLUSION: This study found no significant differences in 30-day and 5-year outcomes between female and male patients treated with EVAR, implying that EVAR remains a safe treatment choice for female patients.

Multivariable Analysis of Patients With Severe Persistent Postprocedural Hypotension After Carotid Artery Stenting.

Purpose: To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). Materials and Methods: A total of 146 patients (mean age 72.8 years; 104 men) who underwent 160 CAS procedures using a standardized protocol at 3 vascular centers were retrospectively analyzed. The primary endpoint was postprocedural hypotension, defined as a reduction in systolic blood pressure (SBP) >40 mm Hg from baseline or an SBP of <90 mm Hg sustained for >1 hour after CAS. Potential prognostic factors for postprocedural hypotension were identified and subjected to logistic regression analyses; outcomes are presented as the odds ratios (ORs) with 95% confidence intervals (CIs). Results: PPH developed in 36 (24.7%) patients after 37 (23.1%) CAS procedures. These patients had significantly longer intensive care unit and hospital stays than those who did not develop hypotension (p<0.001). PPH was associated with severe lesion calcification (OR 6.28, 95% CI 1.81 to 21.98, p=0.004) and contrast volume (OR 1.02, 95% CI 1.01 to 1.02, p<0.001). A 4-fold increase in the risk of PPH (OR 4.22, 95% CI 1.38 to 13.33, p=0.012) was found between the embolic protection device most associated with PPH (Angioguard) and the device least associated with PPH (Emboshield NAV6). A similar trend was also observed for the Precise vs Xact stents (OR 6, 95% CI 2.08 to 17.6, p=0.001). Bootstrapped multivariable modeling identified the Precise stent and contrast volume as significant predictors of persistent postprocedural hypotension. Further investigation of the contrast volume revealed associations with sex, severe calcification, arch type, previous coronary artery bypass surgery, and primary stenting, suggesting that the contrast volume reflects the complexity of the procedure. Conclusion: The complexity of the procedure and type of stent may play a role in the development of postprocedural hypotension after CAS.

Perigraft hygroma - a rare cause of post-EVAR aneurysm growth.

Development of perigraft hygromas following repair of abdominal aortic aneurysms is extremely rare. A case is presented of a patient who was found to have a large hygroma despite two re-interventions on a previous EVAR.

Changes in Aortic Volumes Following Endovascular Sealing of Abdominal Aortic Aneurysms With the Nellix Endoprosthesis.

PURPOSE: To investigate the effects on aortic volumes of endovascular aneurysm sealing (EVAS) with the Nellix device. METHODS: Twenty-five consecutive patients (mean age 78±7 years; 17 men) with abdominal aortic aneurysms containing thrombus were treated with EVAS. Their pre- and post-EVAS computed tomography (CT) scans were reviewed to document volume changes in the entire aneurysmal aorta, the lumen, and the intraluminal thrombus. The changes are reported as the mean and 95% confidence interval (CI). RESULTS: Total aortic volume was greater on postoperative scans by a mean 17 mL (95% CI 10.0 to 23.5, p<0.001). The volume occupied by the endobags was greater than the preoperative lumen volume by a mean 28 mL (95% CI 24.7 to 31.7, p=0.002). Postoperatively, the aortic volume occupied by thrombus had decreased by a mean 11 mL (95% CI 4.7 to 18.2, p<0.001). There were good correlations between changes in aneurysm and thrombus volumes (r=0.864, p<0.001), between the planning CT/EVAS time interval and the change in aneurysm volume (r=0.640, p=0.001), and between the planning CT/EVAS time interval and the change in thrombus volume (r=0.567, p=0.003). CONCLUSION: There are significant changes in aortic volumes post EVAS. These changes may be a direct consequence of the technique and have implications for the planning and performance of EVAS.

Cryopreserved superficial femoral artery homografts for aortoiliac segment replacement in infection.

Treatment of aortic field infections is challenging and usually involves removal of the infected segment with re-vascularization of the distal arterial tree with infection-resistant graft material or via an extra-anatomical route. We present three cases of arterial infection treated successfully using cryopreserved superficial femoral artery homografts as aortoiliac substitutes. This new approach is a potential alternative to other in situ re-vascularization techniques.

Deficiencies persist in the experience of UK vascular trainees: a survey of Rouleaux Club members.

AIMS: To evaluate the training experience of the current United Kingdom (UK) vascular trainees. METHODS: A Web-based questionnaire was administered to 217 members of the Rouleaux Club, which represents UK vascular and endovascular trainees, between May and June 2011. RESULTS: A total of 153 trainees (71% response rate) completed the survey; 52% were in posts that do not offer endovascular training, 88% performed <10 peripheral angiograms, and 67% performed part or all of <10 endovascular aneurysm repairs in the last year. Half had no access to formal ultrasound training; 85% believe that vascular access will play a role in their future practice, but 49% performed no vascular access procedures in the past year. No experience of endovenous laser, radiofrequency ablation, or foam sclerotherapy was reported by 33%, 49%, and 46%, respectively. CONCLUSIONS: Trainee experience is insufficient for a modern specialist practice. Separate specialty training in the United Kingdom must address these deficiencies.

Magnitude of the forces acting on target vessel stents as a result of a mismatch between native aortic anatomy and fenestrated stent-grafts.

PURPOSE: To quantify the compression force acting on target vessel stents as a consequence of the misalignment between the native aortic anatomy and the fenestrated stent-graft owing to measuring errors during the design of the device. METHODS: The material properties of a fenestrated Zenith stent-graft were determined using a standardized tensile testing protocol. Aortic anatomy was modeled using fresh porcine aortas that were subjected to tensile testing. The net force acting on a target vessel stent due to incremental discrepancy between the target vessel ostia and the stent-graft fenestrations was calculated as the difference in wall tension between the aorta and the stent-graft in diastole and systole. The change in diameter between diastole and systole was set to 8%. RESULTS: Using the diastole model, underestimation of circumferential target vessel position by 15°, 22.5°, and 30° resulted in net forces on the target vessel stent of 0.6, 0.8, and 1.1 N, respectively. Overestimation of target vessel position by the same increments resulted in net forces of 0.3, 0.6, and 0.9 N, respectively. With the systolic model, underestimating target vessel position by 30° resulted in a 2.1-N maximum force on the stent, which potentially threatened the seal. In the longitudinal direction, underestimating target vessel separation by up to 10 mm resulted in a maximal force on the stent of 6.1 N, while overestimating target vessel separation did not result in any additional force on the stent due to fabric infolding. CONCLUSION: The magnitude of the forces generated solely due to mismatch between stent-graft design and native anatomy is modest and is unlikely to cause significant deformation of target vessel stents. Mismatch, however, may cause loss of seal.

Intra- and interobserver variability of target vessel measurement for fenestrated endovascular aneurysm repair.

PURPOSE: To evaluate intra- and interobserver agreement of target vessel measured from computed tomography (CT) scans with 2 measuring techniques used in planning fenestrated endovascular aneurysm repairs (FEVAR): multiplanar reconstruction (MPR) and semi-automated central lumen line (CLL). METHODS: CT datasets from 25 FEVAR patients were independently analyzed by 2 experienced observers according to a standardized protocol using the MPR (Leonardo workstation) and CLL (Aquarius workstation) techniques for each patient. Longitudinal vessel separation and clock-face position of the visceral aortic branches were measured twice. The repeatability coefficient (RC) was calculated using the Bland and Altman method to measure intra- and interobserver variability. Differences between groups were examined by paired t test (continuous data) or chi-squared analysis (categorical). Clock-face discrepancy >30 minutes was considered significant. RESULTS: Intraobserver mean difference was insignificant regardless of the measurement technique: the observer and workstation-specific RCs varied between 3.9 and 4.9 mm. Paired measurements differed by >3 mm in 8%. Interobserver variability was greater: observer and workstation-specific RC varied between 5.6 and 7.4 mm, with a tendency toward consistency using MPR, although the mean difference was insignificant. Paired measurements differed by >3 mm in 18%. There was no significant intraobserver variation in clock-face measurement, while interobserver variation was significant in 12% of measurements using the Aquarius workstation and 6% using the Leonardo workstation (p = 0.19). CONCLUSION: Subjective interpretation of anatomical landmarks is more important than measurement techniques or workstations used in the generation of measurement inconsistencies. Introduction of consensus regarding interpretation of anatomical detail and development of fenestrated stent-grafts tolerant of measurement errors might ameliorate some of the problems encountered in FEVAR.

Adjunctive iliac stents reduce the risk of stent-graft limb occlusion following endovascular aneurysm repair with the Zenith stent-graft.

PURPOSE: To determine whether the introduction of a policy of adjunctive stent insertion based on preoperative CT assessment or completion angiography reduced the incidence of limb occlusion after stent-graft implantation for endovascular aneurysm repair (EVAR). METHODS: A tertiary referral unit's endovascular database was retrospectively interrogated to compare the incidence of endograft limb occlusion in Zenith grafts following the introduction of a policy of selective adjunctive stent insertion. Group A included 288 limbs at risk in 146 patients (134 men; mean age 74+/-8 years) treated prior to August 2005 in whom adjunctive stents were inserted on an ad hoc basis only. Group B included 293 limbs at risk in 149 patients (127 men; mean age 76+/-7 years) treated after this date in whom a more aggressive adjunctive stenting strategy was adopted. Kaplan-Meier analysis was employed to compare outcomes. RESULTS: In total, 295 patients underwent EVAR involving 581 iliac vessels, of which 11 (1.8%) occluded at a median of 24 months (0-27). Of 65 limbs extended into the external iliac segment, 5 (7.6%) subsequently occluded; in the remaining 516 limbs, there were 6 (1.1%) occlusions (p = 0.004). Across the study group, 38 (6.5%) adjunctive stents were deployed in limbs deemed at risk; 1 (2.6%) of these occluded. In the remaining 543 unstented limbs, 10 (1.8%) occlusions occurred (p = 0.15). There were 11 occlusions in group A, in which 5 (1.7%) adjunctive stents had been deployed, but none in group B, which had received 33 (11.2%) stents (p<0.0001). Kaplan-Meier survival curves identified primary patency rates at 36 months of 96% and 100%, respectively (p = 0.001). CONCLUSION: Adjunctive stenting significantly reduces the risk of postoperative stent-graft limb occlusion without obvious compromise to the aneurysm repair.

Optimal technique for imaging iliac segments during endovascular repair of abdominal aortic aneurysms.

PURPOSE: To determine if oblique angulation of the image intensifier is adequate to image the entire length of the common iliac artery during endovascular aneurysm repair or if additional caudal tilt is necessary. METHODS: Using a 3D workstation, the apparent level of the iliac bifurcation (distal limit of the stent-graft) was determined on computed tomographic angiography by profiling the common iliac segment in oblique angulation only and repeated with a combination of oblique angulation and caudal tilt. Two independent observers measured twice the apparent length of the iliac segment in both profiles for 50 patients according to a set protocol. Intra- and interobserver variability was calculated using the Bland and Altman method; the differences between the two different profiles were tested using paired t tests. RESULTS: Of the 50 CTA datasets reviewed, 2 datasets were excluded owing to extensive calcification of the iliac system that prevented accurate interpretation of the image. Of the 96 segments studied, the iliac segments appeared longer (better profiled) with a combination of caudal tilt and oblique angulation in 80%, with an average discrepancy of 9 mm for observer 1 (range -1 to +28) and 7 mm for observer 2 (0 to +26). The effect of caudal tilt was statistically significant for individual observers (p = 0.001 and 0.024, respectively). Forty-six percent of iliac segments measured by observer 1 and 35% by observer 2 showed that the addition of caudal tilt resulted in improved profiling by at least 10 mm. Although inter- and intraobserver variation was significant, the gain in apparent iliac length with the addition of caudal tilt was preserved. CONCLUSION: When profiled with oblique angulation alone, the location of the iliac bifurcation may appear higher than its true location, resulting in underutilization of the iliac segment by >10 mm in over a third of the patients. The problem is corrected by employing additional caudal tilt.