Prevalence of type II endoleak after elective endovascular aneurysm repair with polytetrafluoroethylene- or polyester-based endografts.

OBJECTIVE: Type II endoleak is the most frequent complication after endovascular abdominal aneurysm repair. Polytetrafluoroethylene and polyester (PE) are the two most commonly used graft materials in endovascular aneurysm repair (EVAR) devices. Biological properties of the material might influence the appearance and persistence of type II endoleak (T2EL). Therefore, the aim of this study was to evaluate potential differences in the prevalence of T2EL after EVAR between polytetrafluoroethylene (PTFE) and PE endografts in patients electively treated for an infrarenal abdominal aortic aneurysm. METHODS: A single-center, retrospective, observational study was conducted between January 2011 and January 2022. Preoperative, procedural, and follow-up data were derived from electronic health records. Imaging included computed tomography scans, and/or duplex ultrasound examination. The primary end point was the prevalence of T2EL diagnosed within 1 year after EVAR. Secondary end points included the prevalence of T2EL throughout follow-up, early (≤30 days) and late (>30 days) T2EL, the rate of T2EL disappearance during the follow-up period, the prevalence of type I and III endoleak, and T2EL-related reinterventions. RESULTS: Follow-up was available for 394 patients, 245 in the PE and 149 in the PTFE group. The prevalence of T2EL diagnosed within 1 year after endovascular repair was 11.8% in the PE group and 21.5% in the PTFE group (P = .010). There was no significant difference in early (≤30 days) and late (>30 days) T2EL between groups (P = .270 and P = .311). There was no difference in the freedom from endoleak type II reinterventions between groups (P = .877). CONCLUSIONS: The prevalence of T2EL after elective EVAR is significantly higher with the use of PTFE-based endografts compared with PE-based endografts. This difference is mostly based on T2EL diagnosed after 30 days of follow-up.

Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass.

OBJECTIVE: To assess the impact of heparin-bonded endoprosthesis compared with femoropopliteal bypass on key hospital resources and revenues up to 1-year follow-up. DESIGN: A 2-arm scenario resource consumption data analysis was modeled based on a multicentre prospective randomized controlled trial. SETTING: Six centers in the Netherlands. PARTICIPANTS: A total of 100 patients were assigned to 2 arms (50 each arm). The first arm evaluated endovascular treatment using the heparin-bonded Viabahn endoprosthesis and the second the femoropopliteal bypass. Resource consumption rates were compared between arms. PRIMARY AND SECONDARY OUTCOMES MEASURES: Resource consumption rates, including hospital stay for bypass procedure, operating room time, type of anesthesia, number of used (endo)grafts, use of different types of bed locations (vascular ward, medium or intensive care), readmission for wound infections, and reinterventions over a period of 12 months. RESULTS: Endovascular repair used fewer hospital resources, with an overall difference of €149.983. Hospital stay was 118 days less (261 vs 379), including 21 fewer days in medium/intensive care (5 vs 26) and 50 fewer operating room hours (100 vs 150). Fewer patients required general anesthesia (31 vs 39), and there were less surgical site infections (3 vs 12). In the surgical bypass group, there were 18 fewer days of hospital stay related to reinterventions (80 vs 62), and the cost of the devices was €309.996, cheaper. The total monetary difference was € 160.013, in favor of the femoropopliteal bypass (€3.200, per patient). CONCLUSIONS: Endovascular repair of the superficial femoral artery reduces the use of valuable hospital resources. Its major limitation is the cost of the devices, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall. These benefits may outweigh the fewer reinterventions in the surgical bypass group. REGISTRATION: The SuperB Trial was registered in clinicaltrials.gov; NCT-ID: NCT01220245. CLINICAL IMPACT: Modeling is a useful technique to predict the impact of treatment modalities on hospital resources and revenue. This study uses real-world data from the SuperB Trial to compare two treatment strategies of superficial femoral artery disease, reflecting actual clinical practice and patient outcomes. The analysis focused on direct costs associated with hospital resources and device usage without considering indirect costs or long-term cost-effectiveness. The analysis showed that endovascular repair reduces the use of valuable hospital resources. Its major limitation is device costs, which should be balanced against the reduction in peri-procedural morbidity and faster recovery. In the context of shortage of hospital beds, it offers capacity benefits, allowing for the treatment of more patients overall.

Five-Year Outcomes of the SuperB Trial: A Multicenter Randomized Controlled Trial Comparing Heparin-Bonded Endograft to Surgical Femoropopliteal Bypass.

OBJECTIVE: This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status. BACKGROUND: The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking. METHODS: Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses. RESULTS: At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups. CONCLUSION: Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions. CLINICAL IMPACT: This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm.

A systematic review summarizing local vascular characteristics of aneurysm wall to predict for progression and rupture risk of abdominal aortic aneurysms.

OBJECTIVE: At present, the rupture risk prediction of abdominal aortic aneurysms (AAAs) and, hence, the clinical decision making regarding the need for surgery, is determined by the AAA diameter and growth rate. However, these measures provide limited predictive information. In the present study, we have summarized the measures of local vascular characteristics of the aneurysm wall that, independently of AAA size, could predict for AAA progression and rupture. METHODS: We systematically searched PubMed and Web of Science up to September 13, 2021 to identify relevant studies investigating the relationship between local vascular characteristics of the aneurysm wall and AAA growth or rupture in humans. A quality assessment was performed using the ROBINS-I (risk of bias in nonrandomized studies of interventions) tool. All included studies were divided by four types of measures of arterial wall characteristics: metabolism, calcification, intraluminal thrombus, and compliance. RESULTS: A total of 20 studies were included. Metabolism of the aneurysm wall, especially when measured by ultra-small superparamagnetic iron oxide uptake, and calcification were significantly related to AAA growth. A higher intraluminal thrombus volume and thickness had correlated positively with the AAA growth in one study but in another study had correlated negatively. AAA compliance demonstrated no correlation with AAA growth and rupture. The aneurysmal wall characteristics showed no association with AAA rupture. However, the metabolism, measured via ultra-small superparamagnetic iron oxide uptake, but none of the other measures, showed a trend toward a relationship with AAA rupture, although the difference was not statistically significant. CONCLUSIONS: The current measures of aortic wall characteristics have the potential to predict for AAA growth, especially the measures of metabolism and calcification. Evidence regarding AAA rupture is scarce, and, although more work is needed, aortic wall metabolism could potentially be related to AAA rupture. This highlights the role of aortic wall characteristics in the progression of AAA but also has the potential to improve the prediction of AAA growth and rupture.

Long-Term Outcomes of the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique in Patients With Aorto-Iliac Occlusive Disease.

BACKGROUND: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. METHODS: Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. RESULTS: One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. CONCLUSION: The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. CLINICAL IMPACT: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted.

Association between clinician reported outcome and patient reported outcome measures one year after stroke.

OBJECTIVES: Patient reported outcome measures (PROM) are increasingly important in the evaluation of care. In this study we evaluate patient PROM in stroke patients and the association with clinical reported outcomes. MATERIALS AND METHODS: Of 3706 first-ever stroke patients, 1861 were discharged home and invited to fill out PROM at discharge, 90 days and one-year after stroke. PROM include mental and physical health and patients' self-reported functionals status, all available via International Consortium for Health Outcomes Measurement. Clinician reported measures as NIHSS, Barthel index were collected during hospital admission and modified Rankin Scale (mRS) 90 days after stroke. PROM compliance was evaluated. Clinician reported measures were related to PROM. RESULTS: 844 (45%) of the invited stroke patients filled out PROM. In general, those patients were younger and less severely affected (higher Barthel index and lower mRS). Compliance after enrolment is about 75%. Barthel index and mRS correlated with all PROM at 90 days and one-year. In age and gender adjusted multiple regression analysis, mRS was a consistent predictor for all PROM subsets, and Barthel index holds predictive value for physical health and patients' self-reported functional status. CONCLUSIONS: Participation rate to fill out PROM is only 45% among stroke patients who were discharged home, and compliance rate is around 75% up one-year follow-up. PROM associated with the clinician reported functional outcome measures Barthel index, and mRS score. Low mRS score is a consistent predictor of better PROM at one year. We propose to use mRS in stroke care evaluation, until PROM participation improves.

Major adverse cardiac events after elective infrarenal endovascular aortic aneurysm repair.

OBJECTIVE: There is a significant cardiac morbidity and mortality after endovascular aneurysm repair (EVAR). However, information about long-term risk of cardiac events after EVAR and potential predictors is lacking. Therefore, the aim of this study was to determine incidence and predictors of major adverse cardiac events (MACE) at 1 and 5 years after elective EVAR for infrarenal abdominal aortic aneurysms. METHODS: Baseline, perioperative, and postoperative information of 320 patients was evaluated. The primary outcome was the incidence of MACE after EVAR, which was defined as acute coronary syndrome, unstable angina pectoris, de novo atrial fibrillation, hospitalization for heart failure, mitral valve insufficiency, revascularization (including percutaneous coronary intervention and coronary artery bypass grafting), as well as cardiovascular and noncardiovascular death. Kaplan-Meier analyses were performed to determine incidences of MACE, MACE excluding noncardiovascular death and cardiac events by excluding noncardiovascular and vascular death from MACE. Predictors of MACE were identified using univariate and multivariate binary regression analysis. RESULTS: Through 1 and 5 years of follow-up after EVAR, freedom from MACE was 89.4% (standard error [SE], 0.018) and 59.8% (SE, 0.033), freedom from MACE excluding noncardiovascular death was 94.7% (SE, 0.013) and 77.5% (SE, 0.030) and freedom from cardiac events was 96.0% (SE, 0.011) and 79.1% (SE, 0.030), respectively. Predictors for MACE within 1 year were American Society of Anesthesiologists (ASA) score of III or IV (odds ratio [OR], 3.17; 95% confidence interval [CI], 1.52-6.59) and larger abdominal aortic diameter (OR, 1.04; 95% CI, 1.01-1.08). A history of atrial fibrillation (OR, 0.14; 95% CI, 0.03-0.60) was a negative predictor factor. Predictors for MACE through 5 years were a history of heart failure (OR, 4.10; 95% CI 1.36-12.32) and valvular heart disease (OR, 2.31; 95% CI, 0.97-5.51), American Society of Anesthesiologists score of 3 or 4 (OR, 1.66; 95% CI, 0.96-2.88), and older age (OR, 1.04; 95% CI, 1.01-1.08). CONCLUSIONS: MACE is a common complication during the first 5 years after elective EVAR. Cardiac diseases at baseline are strong predictors for long-term MACE and potentially helpful in optimizing future postoperative long-term follow-up.

Individual patient data meta-analysis of patients treated with a heparin-bonded Viabahn in the femoropopliteal artery for chronic limb-threatening ischemia.

OBJECTIVES: The aim of the study was to analyze available data on patients treated for chronic limb-threatening ischemia (CLTI) with the heparin-bonded Viabahn endoprosthesis. BACKGROUND: The patency of self-expanding covered stents in patients with complex femoropopliteal lesions is encouraging. However, data were mostly derived in patients with intermittent claudication. Patients with CLTI often have more advanced disease and worse outcome. METHODS: After the abstract screening, full-text papers were checked. Authors were approached to consider joining the consortium. Data were sent anonymously, databases were merged and an individual patient data meta-analysis was performed. Kaplan-Meier curves were used to calculate the freedom from amputations, the amputation-free survival, and patency rates. RESULTS: Seven studies were enrolled, representing 161 limbs that were treated for CLTI. Median lesion length was 28.0 cm (interquartile range 25.0-33.0 cm) and 82.7% were chronic total occlusions. The technical success rate was 98.1% and the 30-day mortality 1.9%. Through 2-year follow-up, the freedom-from-major-amputations was 99.3%, with an amputation-free survival of 78.8%. The freedom-from-loss-of primary, primary-assisted, and secondary patency was 70.4%, 71.8%, and 88.2%, respectively, at 1-year and 59.5%, 62.7%, and 86.1% at 2-year follow-up, respectively. The reintervention-free survival was 62.2% at a 2-year follow-up. CONCLUSIONS: Treatment of femoropopliteal disease in CLTI patients with the use of the heparin-bonded Viabahn is safe and effective with favorable clinical outcomes and low amputation rates. Reinterventions are needed in a subset of the population to maintain endoprosthesis patency. Close follow-up using duplex is recommended to detect potential edge stenosis, allowing treatment before device occlusion.

The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Technique for Aorto-Iliac Occlusive Disease.

Endovascular treatment options of aorto-iliac occlusive disease have emerged, leading to better outcomes in more complex pathology, which typically involves a reconstruction of the aortic bifurcation. The Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) configuration was introduced in 2013, in an attempt to optimize outcomes, when compared to the kissing stent configuration, which was traditionally the preferred endovascular technique for this pathology. CERAB aims to optimize geometry, and with that the arterial flow patterns that are associated with loss of patency. In CERAB, the aortic bifurcation is reconstructed using three balloon-expandable covered stents in a tight connection with each other and with an appropriate wall apposition, thereby minimizing geometrical mismatch (Fig. 1a-c). The reconstruction can be extended on both sides and could be combined with chimney, or parallel, grafts in aortic side branches that need to be preserved. In the current paper, the details of the CERAB technique are described and supported by evidence derived from pre-clinical studies that confirm the more optimal geometry and flow patterns compared to kissing stents. Also, a summary is provided of published clinical evidence, including technical and clinical outcomes of the technique. These data show promising early results, with patency rates in line with those achieved with open surgery, also in patients with extensive disease. Finally, the potential modes of failures and future developments are discussed.

The relation between physical fitness, frailty and all-cause mortality after elective endovascular abdominal aortic aneurysm repair.

BACKGROUND: Accurate determination of probable surgical outcomes is fundamental in decision-making regarding appropriate abdominal aortic aneurysm treatment. These outcomes depend, among other factors, on patient-related factors such as physical fitness. The primary aim of this study was to evaluate the correlation between physical fitness, measured by the metabolic equivalent of task (MET) score and the five-factor Modified Frailty Index (MFI-5), and all-cause mortality. METHODS: Four hundred twenty-nine patients undergoing elective endovascular treatment of an infrarenal aortic aneurysm (EVAR) from January 2011 to September 2018 were identified in an existing local abdominal aortic aneurysm database. Physical fitness was measured by the MFI-5 and the METs as registered during preoperative screening. The primary end point was 1-year all-cause mortality and secondary end points included 5-year all-cause mortality, freedom from aneurysm-related mortality and aneurysm-related reinterventions. Correlations were analyzed using Spearman's rho and survival was analyzed using Kaplan-Meier analyses. The effect of physical fitness on mortality was assessed by binary logistics regression analyses. RESULTS: There was a positive correlation between the MFI-5 and 1-year all-cause mortality (Rho = 0.163; P = .001), but not between the METs and 1-year all-cause mortality (Rho = -0.083; P = .124). A significant correlation between both MFI-5 and METs and 5-year all-cause mortality was observed (Rho = 0.255; P < .001 and Rho = -0.154; P = .004). When stratified by the MFI-5, the 1- and 5-year follow-up survival rates were 95.1% and 85.9%, respectively, in the group with the lowest MFI-5 and 74.5% and 33.1% in the group with the highest MFI-5 score (P = .007 and P < .001). When stratified by METs categories for 1-year follow-up, no significant differences in survival between the groups were observed (P = .090). The 5-year follow-up survival rate was 39.4% in the lowest METs category and 76.3% in the highest METs category (P = .039). Logistic regression analysis, assessing the impact of age, sex, METs, and the MFI-5 on the risk of all-cause mortality, showed that only age and the MFI-5 made a significant contribution. CONCLUSIONS: There is a significant positive association between the MFI-5 and both the 1- and 5-year all-cause mortality rates after EVAR; METs only correlated with the 5-year all-cause mortality. Only age and the MFI-5 contributed to predicting overall survival after EVAR; therefore, it could be recommended to add the MFI-5 for guidance in preoperative counselling.

Changes in Noninvasive Arterial Stiffness and Central Blood Pressure After Endovascular Abdominal Aneurysm Repair.

PURPOSE: To evaluate the impact of elective endovascular aneurysm repair (EVAR) on the carotid-femoral pulse wave velocity (cfPWV) and central pressure waveform, through 1-year follow-up. MATERIALS AND METHODS: A tonometric device was used to measure cfPWV and estimate the central pressure waveform in 20 patients with an infrarenal abdominal aortic aneurysm scheduled for elective EVAR. The evaluated central hemodynamic parameters included the central pressures, the augmentation index (AIx), and the subendocardial viability ratio (SEVR). AIx quantifies the contribution of reflected wave to the central systolic pressure, whereas SEVR describes the myocardial perfusion relative to the cardiac workload. Measurements were performed before EVAR, at discharge, and 6 weeks and 1 year after EVAR. RESULTS: CfPWV was increased at discharge (12.4±0.4 vs 11.3±0.5 m/s at baseline; p=0.005) and remained elevated over the course of 1-year follow-up (6 weeks: cfPWV = 12.2±0.5 m/s; 1 year: cfPWV = 12.2±0.7 m/s, p<0.05). After an initial drop in systolic central pressure at discharge, all the central pressures increased thereafter up to 1 year, without significant differences compared with baseline. The same was observed for the AIx and SEVR. CONCLUSION: Endovascular aortic aneurysm repair caused an increase in pulse wave velocity compared with baseline, which remained elevated through 1 year follow-up, which may be related to an increased cardiovascular risk. However, no differences in central pressure, augmentation index, and subendocardial viability ration were observed during follow-up.

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

OBJECTIVE: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. METHODS: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. RESULTS: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. CONCLUSION: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

Drug-coated balloon angioplasty for the treatment of edge stenosis after self-expanding covered stent placement for superficial femoral artery occlusive disease.

BACKGROUND: Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. PURPOSE: The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. METHOD: We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). RESULTS: A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). CONCLUSION: The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

Endograft Conformability in Fenestrated Endovascular Aneurysm Repair for Complex Abdominal Aortic Aneurysms.

Purpose: To compare the impact of 2 commercially available custom-made fenestrated endografts on patient anatomy. Materials and Methods: The records of 234 patients who underwent fenestrated endovascular aneurysm repair for abdominal aortic aneurysm from March 2002 to July 2016 in 2 hospitals were screened to identify those who had pre- and postoperative computed tomography angiography assessments with a slice thickness of ≤2 mm. The search identified 145 patients for further analysis: 110 patients (mean age 72.4±7.1 years; 94 men) who had been treated with the Zenith Fenestrated (ZF) endograft and 35 patients (mean age 72.3±7.3 years; 30 men) treated with the Fenestrated Anaconda (FA) endograft. Measurements included aortic diameters at the level of the superior mesenteric artery (SMA) and renal arteries, target vessel angles, target vessel clock positions, and the target vessel tortuosity index. Variables were tested for inter- and intraobserver agreement. Results: There was a good agreement between observers in all tested variables. The native anatomy changed in both groups after endograft implantation. In the ZF group, changes were seen in the angles of the celiac artery (p=0.012), SMA (p=0.022), left renal artery (LRA) (p<0.001), and the right renal artery (RRA) (p<0.001); the aortic diameter at the SMA level (p<0.001); and the LRA (p<0.001) and RRA (p<0.001) clock positions. In the FA group, changes were seen in the angles of the LRA (p=0.001) and RRA (p<0.001) and in the SMA tortuosity index (p=0.044). Between group differences in changes were seen for the aortic diameters at the SMA and renal artery levels (p<0.001 for both) and the LRA clock position (p=0.019). Conclusion: Both custom-made fenestrated endografts altered vascular anatomy. The data suggest a higher conformability of the Fenestrated Anaconda endograft compared with the Zenith Fenestrated.

Pulmonary complications and survival after elective infrarenal endovascular abdominal aneurysm repair in patients with documented chronic obstructive pulmonary disease.

BACKGROUND: Elective abdominal aortic aneurysm (AAA) repair is advocated in patients where risk of rupture exceeds the risks of peri-procedural morbidity and mortality. Chronic obstructive pulmonary disease (COPD) is a known risk factor for AAA and increased operative morbidity in general. Since literature on the correlation between the clinical classification of COPD and morbidity following endovascular infrarenal AAA repair (EVAR) is scarce, assessment per individual remains a challenge. OBJECTIVE: To analyse the pulmonary and all-cause morbidity and mortality in patients with documented COPD and relate this to their GOLD classification. METHODS: Sixty-eight patients with COPD, documented by a lung function test, who underwent elective EVAR between July 2002 and July 2018 were retrospectively reviewed. The primary endpoint was the incidence of 30-day pulmonary adverse events. Procedural characteristics, length of hospital stay, pulmonary and all-cause morbidity including major adverse events (MAEs) during follow-up and five-year survival divided per GOLD classification were the secondary endpoints. RESULTS: There was no statistically significant difference in the incidence of pulmonary adverse events between GOLD I/II and GOLD III/IV patients. There was neither procedural nor 30-day mortality in either group. Through 30 days and 1 year, there was no difference in pulmonary and all-cause morbidity between groups. Three MAEs occurred in the GOLD I/II group versus 2 MAE in the GOLD III/IV group during the first postoperative year. The five-year survival was 66.0%, 60.9% and 61.9% for patients with GOLD I, GOLD II and GOLD III, respectively. Three of four GOLD IV died within the first year after EVAR. CONCLUSION: EVAR can be safely performed in patients with COPD, with low 30-day morbidity and mortality rates. Although severe co-morbidity should be taken into account, EVAR seems to be justified in patients with COPD with a GOLD classification I, II or III. Further research should focus on optimising the pulmonary condition in patients selected for EVAR.

Meta-analysis of Individual Patient Data After Kissing Stent Treatment for Aortoiliac Occlusive Disease.

PURPOSE: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. MATERIALS AND METHODS: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. RESULTS: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p<0.005). Any previous endovascular intervention (HR 2.52, p=0.02) was the main predictor for loss of secondary patency; history of cardiovascular disease (HR 0.27, p=0.04) was the main predictor of sustained secondary patency. CONCLUSION: The kissing stent technique has a good safety profile and acceptable patency rates up to 2 years, even in TASC C and D lesions, supporting an endovascular-first approach for AIOD.

Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study.

PURPOSE: To report a post hoc analysis performed to evaluate 1-year safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in subjects with critical limb ischemia (CLI) enrolled in the IN.PACT Global study ( ClinicalTrials.gov identifier NCT01609296). MATERIALS AND METHODS: Of 1535 subjects enrolled in the study, 156 participants (mean age 71.8±10.4; 87 men) with CLI (Rutherford categories 4,5) were treated with DCB angioplasty in 194 femoropopliteal lesions. This cohort was compared to the 1246 subjects (mean age 68.2±10.0 years; 864 men) with intermittent claudication (IC) treated for 1573 lesions. The CLI cohort had longer lesions (13.9±10.6 vs 11.9±9.4 cm, p=0.009) and a higher calcification rate (76.8% vs 67.7%, p=0.011). Major adverse events [MAE; composite of all-cause mortality, clinically-driven target lesion revascularization (CD-TLR), major (above-ankle) target limb amputation, and thrombosis at the target lesion site], lesion and vessel revascularization rates, and EuroQol-5D were assessed through 1 year. The Kaplan-Meier method was used to estimate survival, CD-TLR, and amputation events; estimates are presented with the 95% confidence intervals (CI). RESULTS: Estimates of 12-month freedom from major target limb amputation were 98.6% (95% CI 96.7% to 100.0%) in subjects with CLI and 99.9% (95% CI 99.8% to 100.0%) in subjects with IC (p=0.002). Freedom from CD-TLR through 12 months was 86.3% (95% CI 80.6% to 91.9%) in CLI subjects and 93.4% (95% CI 91.9% to 94.8%) in IC subjects (p<0.001). The MAE rate through 12 months was higher in CLI subjects (22.5% vs 10.7%, p<0.001), and CLI patients had poorer overall survival (93.0%, 95% CI 88.9% to 97.2%) than IC subjects (97.0%, 95% CI 96.0% to 97.9%, p=0.011). Health status significantly improved in all domains at 6 and 12 months in both groups. CONCLUSION: Treatment of femoropopliteal disease with DCB in CLI patients is safe through 12-month follow-up, with a low major amputation rate of 1.4%. The rates of MAE and CD-TLR were higher in CLI subjects and reinterventions were required sooner. Additional research is needed to evaluate long-term outcomes of DCB treatment for femoropopliteal lesions in CLI patients.

Three-year outcome of the covered endovascular reconstruction of the aortic bifurcation technique for aortoiliac occlusive disease.

OBJECTIVE: The objective of this study was to demonstrate the 3-year outcome of the covered endovascular reconstruction of the aortic bifurcation (CERAB) technique for the treatment of extensive aortoiliac occlusive disease (AIOD). METHODS: Between February 2009 and July 2016, all patients treated with the CERAB technique for AIOD were identified in the local databases of two centers and analyzed. Demographics and lesion characteristics were scored. Follow-up consisted of clinical assessment, duplex ultrasound, and ankle-brachial indices. Patency rates and clinically driven target lesion revascularization were calculated by Kaplan-Meier analysis. RESULTS: Of 130 patients (69 male and 61 female) treated, 68% were diagnosed with intermittent claudication and 32% suffered from critical limb ischemia. The majority (89%) were TransAtlantic Inter-Society Consensus II D lesions, and the remaining were B and C lesions (both 5%). Median follow-up was 24 months (range, 0-67 months). The technical success rate was 97%, and 67% of cases were performed completely percutaneously. The ankle-brachial index improved significantly from 0.65 ± 0.22 preoperatively to 0.88 ± 0.15 after the procedure. The 30-day minor and major complication rate was 33% and 7%. The median hospital stay was 2 days (range, 1-76 days). At 1 year and 3 years of follow-up, 94% and 96% of the patients clinically improved at least one Rutherford category (2% and 0% unchanged, 4% and 4% worsened). Limb salvage rate was 98% at 1 year and 97% at 3 years of follow-up. Primary, primary assisted, and secondary patency was 86%, 91%, and 97% at 1 year; 84%, 89%, and 97% at 2 years; and 82%, 87%, and 97% at 3 years. Freedom from clinically driven target lesion revascularization was 87% at 1-year follow-up and 86% at both 2-year and 3-year follow-up. CONCLUSIONS: The CERAB technique is a safe and feasible technique for the treatment of extensive AIOD with good 3-year results regarding patency and clinical improvement.