Journal of Endovascular Therapy

Purpose: To evaluate the safety and efficacy of the novel SELUTION sustained-limus-release (SLR) drug-eluting balloon (DEB) in the treatment of femoropopliteal lesions. Materials and Methods: Between October 2016 and May 2017, 50 subjects (mean age 69.6±10.4 years; 29 men) with symptomatic moderate to severe lower limb ischemia (Rutherford categories 2 or 3) were enrolled at 4 German centers for the SELUTION SLR first-in-human trial (ClinicalTrials.gov NCT02941224). The SELUTION SLR utilizes micro-reservoirs (biodegradable polymer spheres containing sirolimus) embedded within an amphipathic membrane coated onto an angioplasty balloon. The biodegradable reservoirs are transferred to the target vessel lumen during brief balloon inflation. The primary trial objective was comparison of angiographic late lumen loss at 6 months against an objective performance criterion (OPC) value of 1.04 mm for uncoated balloon angioplasty. Secondary endpoints included device, procedural, and clinical success; clinical and imaging assessments of primary patency and restenosis; functional assessments including Rutherford category and ankle-brachial index (ABI); and major adverse events [composite of cardiovascular mortality, index limb amputation, target limb thrombosis, and clinically-driven target lesion revascularization (CD-TLR)]. Results: At 6 months, median angiographic late lumen loss following SELUTION SLR treatment was 0.19 mm (range −1.16 to 3.07). Mean angiographic late lumen loss (n=34) was 0.29±0.84 mm (95% CI −0.01 to 0.58), significantly lower than the 1.04-mm OPC value (p<0.001). The rate of primary patency by duplex ultrasound was 88.4%, and freedom from angiographic binary restenosis was 91.2%. Through 6 months, there was significant improvement over baseline in Rutherford categories (p<0.001) and in ABI measurements (p<0.001). A single case (2%) of CD-TLR occurred at 5 months. There were no other major adverse events. Conclusion: Through 6 months, the SELUTION SLR DEB appears to inhibit restenosis effectively and safely, improving outcomes in subjects with symptomatic femoropopliteal disease.

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

Purpose: To evaluate the immediate postoperative and midterm outcomes of complex thoracoabdominal aortic aneurysm (TAAA) treatment with fenestrated/branched physician-modified endovascular grafts (PMEGs) or open debranching of the visceral aorta with bypass graft revascularization plus endovascular aneurysm exclusion (hybrid repair). Materials and Methods: A retrospective analysis was conducted of 88 patients (mean age 70.0±10.6 years; 73 men) with complex TAAAs who underwent treatment with PMEGs (60, 68%) or a hybrid technique (28, 32%) between 2016 and 2019. The mean aneurysm diameter was 64.5±11.7 mm, and 37 patients (42%) were symptomatic. The Zenith TX2 and Ankura were the main stent-grafts used in the PMEG group. The hybrid technique involved visceral debranching with extra-anatomical bypass graft revascularization and subsequent stent-graft deployment (1- or 2-stage procedure). Results: In the PMEG group, 35 patients received modified stent-grafts with 4 fenestrations, 8 patients had 4 branches per device, and 17 patients had combinations (50 fenestrations and 18 branches) that successfully revascularized 228 of the 240 targets (95%). In the 28 hybrid cases, all 110 target vessels were successfully revascularized with bypass grafts. The overall 30-day mortality was 3.4% (2 PMEG and 1 hybrid), and the early rate of target vessel stenosis/occlusion was 3.3% (5 in PMEG group and 6 in the hybrid repair group). The 30-day morbidity was mainly attributed to pulmonary complications (15%), lower limb ischemia (8%), or spinal cord ischemia with paraplegia (6%). Eleven patients (13%) had deteriorated renal function with a >30% decrease in the glomerular filtration rate. The mean follow-up was 22.3±4.9 months, and mortality was 4.5% (3.3% in the PMEG group vs 7.1% in the hybrid repair group). Conclusion: PMEGs and hybrid techniques seem to be feasible treatment options for aortic aneurysms necessitating visceral vessel revascularization. PMEGs may have a lower morbidity than the hybrid technique, which nonetheless remains an important option available for complex aortic aneurysms.

Purpose: To describe a new custom-made thoracic device able to seal against the aortic wall and occlude intercostal arteries for spinal cord preconditioning during the first thoracic stage of a thoracoabdominal endovascular repair. Technique: The custom-made device, based on the Zenith Alpha stent-graft, combines different features from 2 previously described devices: the outer part is designed with a bell-bottom configuration similar to the “Embo” stent-graft, while the inner part mimics the “2 in 1” design. The outer stent-graft is designed to span the entire length of the thoracic aorta and cover as many intercostal arteries as possible during the first stage to effectively precondition the spinal cord. The sutured inner component is customizable in diameter and 20 to 40 mm shorter than the outer stent-graft. The technique has been used in 5 patients. Conclusion: The use of this new custom-made thoracic stent-graft might represent an additional tool for effectively preconditioning the spinal cord during fenestrated and branched staged procedures whenever a proximal thoracic proximal component is needed.

Purpose: To evaluate the perioperative stroke incidence following thoracic endovascular aortic repair (TEVAR) with differing left subclavian artery (LSA) coverage and revascularization approaches in a real-world setting of a nationwide clinical registry. Materials and Methods: The National Surgical Quality Improvement Program registry was interrogated from 2005 to 2017 to identify all nonemergent TEVAR and/or open LSA revascularization procedures. In this time frame, 2346 TEVAR cases met the selection criteria for analysis. The 30-day stroke incidence was compared between patients undergoing TEVAR with (n=888) vs without (n=1458) LSA coverage, for those with (n=228) vs without (n=660) concomitant LSA revascularization among those with coverage, and following isolated LSA revascularization for occlusive disease (n=768). Multivariable logistic regression was employed for risk-adjusted analyses and to identify factors associated with stroke following TEVAR. Results of the regression analyses are presented as the adjusted odds ratio (OR) with 95% confidence interval (CI). Results: The stroke incidence was 2.3% following TEVAR without vs 5.2% with LSA coverage (p<0.001). In TEVARs with LSA coverage, the stroke incidence was 7.5% when the LSA was concomitantly revascularized and 4.4% without concomitant revascularization, while stroke occurred in 0.5% of isolated LSA revascularizations. Of 33 TEVAR patients experiencing a perioperative stroke, 8 (24%) died within 30 days. LSA coverage was associated with stroke both with concomitant revascularization (OR 4.0, 95% CI 2.2 to 7.5, p<0.001) and without concomitant revascularization (OR 2.2, 95% CI 1.3 to 3.8, p=0.002). Other preoperative factors associated with stroke were dyspnea (OR 1.8, 95% CI 1.1 to 3.0, p=0.014), renal dysfunction (OR 2.2, 95% CI 1.0 to 3.8, p=0.049), and international normalized ratio ≥2.0 (OR 3.6, 95% CI 1.0 to 13, p=0.045). Conclusion: Stroke following TEVAR with LSA coverage occurs frequently in the real-world setting, and concurrent LSA revascularization was not associated with a lower stroke incidence.

Purpose: To analyze the anatomical characteristics of arch aneurysms and evaluate the anatomical feasibility of 4 next-generation stent-grafts with either branched or fenestrated configurations. Materials and Methods: A retrospective analysis was conducted of 213 patients (mean age 75.0±7.1 years; 179 men) with arch aneurysms treated using total arch replacement or zone 0 or 1 thoracic endovascular aortic repair (TEVAR) from 2007 to 2017 at 2 Japanese hospitals. Anatomical analyses were performed using the centerline of flow technique on a 3-dimensional workstation. The anatomical feasibility of the Zenith A-branch, TAG Thoracic Branch Endoprosthesis (TBE), Terumo Aortic Relay Plus Double Branched (DB), and fenestrated Najuta stent-grafts were evaluated based on the instructions for use (IFU). Results: The mean lengths from the sinotubular junction (STJ) to the innominate artery (IA) and from the IA to the left common carotid artery were 114.9±15.9 and 12.8±5.6 mm, respectively. The mean aortic diameters at the STJ and IA were 31.3±3.4 and 34.1±5.3 mm, respectively. In terms of feasibility, 5.2% of patients were within the Zenith A-branch IFU, 40.8% for the TAG TBE, 24.9% for the Relay Plus DB, and 13.6% for the Najuta. Significant (>50% circumference) thrombus/calcification at the sealing zone affected nearly half of the patients, but there is currently no standardized definition or evaluation method for “significant” thrombus/calcification. Conclusion: Only 5% to 41% of arch aneurysm patients are anatomically suitable for TEVAR using any one of the next-generation branched or fenestrated stent-grafts. Furthermore, a definitive method of evaluating the thrombus/calcification burden needs to be established in future IFU.

Purpose: To analyze the structural variation of the aortic arch and the supra-aortic arteries and establish an average spatial configuration that would be a pattern for a “universal double fenestration” design for physician-modified endovascular grafts (PMEGs) used in total thoracic endovascular aortic repair (TEVAR). Materials and Methods: Aortic arch morphology was retrospectively analyzed by reviewing the preoperative thoracic computed tomography angiography scans in 33 consecutive patients (mean age 68 years; 27 men) treated between January 2017 and March 2019 using double-fenestrated PMEGs for zone 0 TEVAR. Image analysis was completed according to a standardized technique on a vascular workstation with center lumen line reconstruction for all measurements. Variations in branching pattern of the aortic arch were classified into 8 types. Results: The arch trunk configuration was type I in 26 patients (79%), type II in 5 (15%), type III in 1, and type IV in 1. Mean aortic diameters at the level of mid ascending aorta, innominate artery (IA), left common carotid artery (LCCA), and left subclavian artery (LSA) were 35.7±3.7, 34.2±4.5, 33.3±6.7, and 33.7±4.7 mm, respectively. Mean diameters of the trunk were 12.2±1.7, 7.5±1.4, and 8.0±0.8 mm, respectively. Mean longitudinal center to center lengths were 15.9±2.5 mm between the LSA and LCCA and 12.1±3.0 mm between the LCCA and IA. Mean clock positions using the LSA as reference were 12:50 for the IA and 12:05 for the LCCA. In 32 patients (97%) all the supra-aortic branch vessels fit perfectly inside two delimited areas defined by a proximal common square area of 30×30 mm for the IA and LCCA and a second distal 8-mm-diameter circle for the LSA. Conclusion: Variations of the aortic arch anatomy are numerous and common. A general morphological pattern is described that delimits the aortic area where these variations occur. This information can be utilized for the design of an off-the-shelf double-fenestrated stent-graft for zone 0 TEVAR.

The accrual of clinical studies poses important challenges to researchers and practitioners, especially in the field of endovascular therapy, where patient, lesion, technique, and device subtleties abound. Systematic reviews and meta-analyses may prove particularly fruitful in such settings by increasing statistical precision and bolstering external validity if the evidence base on a specific topic is consistent or by highlighting important discrepancies in the opposite scenario. However, mastering the correct approach to systematic review and meta-analysis is challenging for careful readers or for those interested in conducting such an evidence synthesis exercise. The present article highlights a stepwise approach to systematic reviews and meta-analyses, focusing on endovascular interventions, which will prove useful to anyone reading or wishing to synthesize the evidence base on endovascular topics to optimize decision making or shape future research efforts.

Purpose: To compare and contrast the midterm outcomes of the E-liac and Zenith (ZBIS) iliac branch devices (IBDs) for the preservation of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: Between January 2014 and December 2018, 84 consecutive patients (median age 74 years; 76 men) were electively treated with the E-liac (n=44) or ZBIS (n=40) IBDs and were retrospectively analyzed to evaluate the technical success, patency, need for reintervention, and mortality associated with these devices. Results: Technical success was achieved in 95 of 99 implantations (95.9%) without any statistically significant difference between the groups (93.7% vs 98.0%, p=0.114). During the first 30 days, 3 occlusions in the ZBIS group and 1 in the E-liac group were identified. There was 1 perioperative death in the ZBIS group. The median follow-up was 37 months for the ZBIS group and 28 months for the E-liac group (p=0.657). Six patients from the ZBIS group and 7 from the E-liac group were lost to follow-up. Among the remaining, there were 2 further deaths recorded, 1 in each group. Four further reinterventions in the E-liac group and 2 in the ZBIS group were performed during follow-up. The Kaplan-Meier estimates of freedom from reintervention were 87.2% (95% CI 82.6% to 90.2%) for the ZBIS group and at 86.0% (95% CI 83.7% to 89.1%) for the E-liac group (p=0.563); the freedom from occlusion estimates were 89.7% (95% CI 85.8% to 94.5%) and 95.3% (95% CI 92% to 98.7%; p=0.317), respectively. Conclusion: The E-liac and the ZBIS IBDs showed equally high technical success, midterm patency, and low reintervention rates.

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.

Purpose: To investigate whether patients who develop aneurysm sac shrinkage following endovascular aneurysm repair (EVAR) have better outcomes than patients with a stable or increased aneurysm sac. Materials and Methods: The Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence was used to interrogate MEDLINE and EMBASE. Thesaurus headings were adapted accordingly. Case-control studies were identified comparing outcomes in patients demonstrating aneurysm sac shrinkage after EVAR with those of patients with a stable or expanded aneurysm sac. Pooled estimates of dichotomous outcome data were calculated using the odds ratio (OR) and 95% confidence interval (CI). Meta-analysis of time-to-event data was conducted using the inverse-variance method; the results are reported as a summary hazard ratio (HR) and 95% CI. Summary outcome estimates were calculated using random-effects models. Results: Eight studies were included in quantitative synthesis reporting a total of 17,096 patients (8518 patients with sac shrinkage and 8578 patients without sac shrinkage). The pooled incidence of sac shrinkage at 12 months was 48% (95% CI 40% to 56%). Patients with aneurysm sac shrinkage had a significantly lower hazard of death (HR 0.73, 95% CI 0.60 to 0.87), secondary interventions (HR 0.42, 95% CI 0.29 to 0.62), and late complications (HR 0.37, 95% CI 0.24 to 0.56) than patients with a stable or increased aneurysm sac. Furthermore, their odds of rupture were significantly lower than those in patients without shrinkage (OR 0.09, 95% CI 0.02 to 0.36). Conclusion: Sac regression is correlated to improved survival and a reduced rate of secondary interventions and EVAR-related complications. The prognostic significance of sac regression should be considered in surveillance strategies. Intensified surveillance should be applied in patients who fail to achieve sac regression following EVAR.