Journal of Endovascular Therapy

Purpose: To compare outcomes of outpatient tibial artery procedures between an office endovascular center and a hospital angiography suite. Methods: A retrospective review was conducted of 204 outpatient tibial interventions performed on 161 patients (mean age 72±11.5 years; 81 men) in either an office (n=100) or hospital (n=104) angiography suite from April 2011 through September 2013. Patients who had an existing ipsilateral bypass that was completely proximal to the tibial trifurcation were eligible, as were patients with prior proximal endovascular interventions. Exclusion criteria included previous ipsilateral bypass involving the infrapopliteal vessels, in-patient status at the time of the procedure, planned admission after the procedure, and infrapopliteal stenting. Treatment included percutaneous transluminal angioplasty (PTA) or PTA with atherectomy. Primary outcomes were unplanned admission, emergency room visits, acute complications, and patency. Results: There were no significant differences in demographics or baseline Rutherford category between patients treated in an office endovascular suite vs a hospital angiography suite. Factors more prevalent in the hospital group included chronic obstructive pulmonary disease (16% vs 8%, p=0.045), renal insufficiency (37% vs 25%, p=0.017), and previous proximal bypass (12% vs 4%, p=0.045). Of the 100 office procedures, 25 involved PTA and 75 were PTA with atherectomy, while in the 104 hospital procedures, PTA was applied in 68 patients and PTA with atherectomy in 36. Thirty-day local complication rates (7% vs 11%, p=0.368), systemic complication rates (4% vs 8%, p=0.263), and mortality (1% vs 2%, p=0.596) in the office vs hospital setting were not statistically different. Unplanned postprocedure hospital admission rates for medical reasons were lower in the office group (2% vs 11%, p=0.01). Kaplan-Meier estimates of the 1-year follow-up data were better in the office group for primary patency (69% vs 53%, p=0.050), assisted primary patency (90% vs 89%, p=0.646), and amputation-free survival (89% vs 83%, p=0.476), but the differences were not statistically significant. Conclusion: Efficacy and safety of outpatient endovascular tibial artery interventions between office and hospital settings were similar, with lower unplanned admission rates and better patency. With appropriate patient selection, the office endovascular suite can be a safe alternative to the hospital angiography suite.

Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.

Purpose: To investigate if balloon angioplasty with a prolonged inflation time (>3 minutes) can prevent postdilation dissection in femoropopliteal lesions. Methods: A retrospective single-center analysis examined 294 consecutive patients (mean age 74.1±8.7 years; 215 men) with de novo femoropopliteal lesions treated with balloon angioplasty between 2013 and 2018. The patients were classified into 2 groups to compare angiographic dissection patterns: 175 patients treated with balloon angioplasty for 3 minutes (3-minute group) and 119 treated for >3 minutes (>3-minute group). Results: Mean balloon inflation time was 7.8±2.7 minutes in the >3-minute group. Severe dissections (type C or higher) were observed less frequently after balloon dilation in the >3-minute group (22.7% vs 50.9%, p<0.001); therefore, significantly more patients in the >3-minute group had successful endovascular treatment after initial balloon angioplasty (57.1% vs 38.3%, p=0.001). Additional balloon dilation was attempted more frequently in the 3-minute group (30.9% vs 14.3%, p=0.001); as a result, there were more patients in whom additional balloon dilation repaired severe dissection that occurred after the initial dilation (25.1% vs 10.9%, p=0.001). Multivariate analysis revealed that chronic total occlusion (p<0.001) and longer lesion (p<0.001) were independent predictors of severe dissection, and prolonged dilation time was independently related to preventing severe dissection (p<0.001). Among 171 patients undergoing successful balloon angioplasty without stent implantation, the Kaplan-Meier estimates of primary patency within 1 year did not differ significantly according to inflation time. Conclusion: Balloon dilation with prolonged inflation time (>3 minutes) may be effective as an initial strategy to prevent severe dissection in femoropopliteal lesions compared to inflation for 3 minutes.

Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%–75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

Purpose: To evaluate the incidence of elastic recoil in patients presenting with erectile dysfunction (ED) undergoing endovascular revascularization of the pudendal or penile arteries. Methods: A consecutive series of 21 ED patients (mean age 58.3±9.3 years) undergoing minimally invasive revascularization of 31 arteries was analyzed. ED lesions included the pudendal arteries (n=27) and the penile artery (n=4). Mean lesion length was 20.6±13.9 mm. Minimal lumen diameter (MLD) measurements were assessed at baseline, immediately after balloon angioplasty, and 10 minutes thereafter. Early recoil was defined as an MLD reduction >10%. Elastic recoil with >10% lumen compromise was treated with drug-coated balloons, while severe elastic recoil (>30%) required drug-eluting stents (DES). The International Index of Erectile Function (IIEF-15) score was obtained prior to and 3 months after the procedure to obtain information on functional outcomes subsequent to angioplasty. Results: Mean MLD at baseline was 0.9±0.6 mm, which improved to 2.0±0.9 mm immediately after balloon dilation. At 10 minutes after dilation, the MLD was 1.7±1.0 mm. Elastic recoil was observed in all 31 lesions and resulted in a mean lumen compromise of 21.2%. Severe (>30%) recoil was observed in 14 arteries, which underwent DES therapy. The IIEF-15 score improved from 31.3±11.2 at baseline to 49.8±16.8 (p<0.001) at the 3-month follow-up. Conclusion: Endovascular revascularization constitutes a safe and feasible treatment modality to restore erectile function in patients with arteriogenic ED and ineffective conservative management. Early elastic recoil is very frequent subsequent to balloon dilation of small-caliber erection-related arteries. Thus, mechanical scaffolding with DES is required in a high subset of ED patients to provide favorable early angiographic and clinical results.

Purpose: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). Methods: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). Results: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). Conclusion: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

Purpose: To analyze the results of isolated left subclavian artery (LSA) revascularization during thoracic endovascular aortic repair (TEVAR) using carotid-subclavian bypass (CSbp) or chimney grafts (CGs). Methods: A retrospective multicenter, observational study identified 73 patients (mean age 68±13 years, range 22–87; 56 men) with acute or chronic thoracic aortic lesions who underwent TEVAR with isolated LSA revascularization using either CSbp (n=42) or CGs (n=31) from January 2010 and February 2017. Primary endpoints were TEVAR-related mortality, postoperative stroke, freedom from type Ia endoleak, and LSA patency. Results: Primary technical success was achieved in all cases. Early TEVAR-related mortality was 4.2% (CSbp 2% vs CG 6%, p=0.571). Two (3%) patients had major ischemic strokes (one in each group). Mean follow-up was 24±21 months (range 1–72; median 15). Estimated freedom from TEVAR-related mortality was 93%±3% (95% CI 84.3% to 97.0%) at 12 and 36 months, with no significant difference between CSbp and CG (p=0.258). Aortic reintervention did not differ between the groups (CSbp 5% vs CG 6%, p=0.356); nor did freedom from type Ia endoleak (CSbp 98% vs CG 87%, p=0.134). Gutter-related endoleaks occurred in 4 (13%) CG patients, but none of the patients experienced sac enlargement or the need for reintervention and none died. Primary patency of the LSA was 100% for the entire group during the observation period. Conclusion: In our experience, LSA revascularization proved most satisfactory and equally effective with both the CSbp and CG techniques, without discernible differences at midterm follow-up.

Purpose: To investigate how 2-dimensional geometric parameters differ between ruptured and asymptomatic abdominal aortic aneurysms (AAAs) and provide a biomechanical explanation for the findings. Methods: The computed tomography angiography (CTA) scans of 30 patients (mean age 77±10 years; 23 men) with ruptured AAAs and 60 patients (mean age 76±8 years; 46 men) with asymptomatic AAAs were used to measure maximum sac diameter along the center lumen line, the cross-sectional lumen area, the total vessel area, the intraluminal thrombus (ILT) area, and corresponding volumes. The CTA data were segmented to create 3-dimensional patient-specific models for finite element analysis to compute peak wall stress (PWS) and the peak wall rupture index (PWRI). To reduce confounding from the maximum diameter, 2 diameter-matched groups were selected from the initial patient cohorts: 28 ruptured AAAs and another with 15 intact AAAs (diameters 74±12 vs 73±11, p=0.67). A multivariate model including the maximum diameter, the lumen area, and the ILT area of the 60 intact aneurysms was employed to predict biomechanical rupture risk parameters. Results: In the diameter-matched subgroup comparison, ruptured AAAs had a significantly larger cross-sectional lumen area (1954±1254 vs 1120±623 mm², p=0.023) and lower ILT area ratio (55±24 vs 68±24, p=0.037). The ILT area (2836±1462 vs 2385±1364 mm², p=0.282) and the total vessel area (3956±1170 vs 4338±1388 mm², p=0.384) did not differ statistically between ruptured and intact aneurysms. The PWRI was increased in ruptured AAAs (0.80 vs 0.48, p<0.001), but the PWS was similar (249 vs 284 kPa, p=0.194). In multivariate regression analysis, lumen area was significantly positively associated with both PWS (p<0.001) and PWRI (p<0.01). The ILT area was also significantly positively associated with PWS (p<0.001) but only weakly with PWRI (p<0.01). The lumen area conferred a higher risk increase in both PWS and PWRI when compared with the ILT area. Conclusion: The lumen area is increased in ruptured AAAs compared to diameter-matched asymptomatic AAAs. Furthermore, this finding may in part be explained by a relationship with biomechanical rupture risk parameters, in which lumen area, irrespective of maximum diameter, increases PWS and PWRI. These observations thus suggest a possible method to improve prediction of rupture risk in AAAs by measuring the lumen area without the use of computational modeling.

Purpose: To report an experimental study and clinical case using a coil packing technique that hastens occlusion of an Amplatzer Vascular Plug 1 (AVP1) in short-segment embolization of high-flow target vessels. Technique: An experimental vascular stenosis model was made of 12-mm soft polyvinyl chloride tubing. Under continuous pulsatile flow, a 12-mm AVP1 was deployed in the 4-mm-diameter stenosis. Before detachment of the AVP1, a 2.2-F microcatheter was inserted into the AVP1 through its mesh via a 6-F delivery guiding sheath in parallel with the delivery wire. Hydrogel microcoils were deployed tightly in the AVP1 and the plug was detached. After the procedure, the pulsatile saline flow was nearly obliterated. In the first clinical case, a 64-year-old man with a thoracic aortic stent-graft and single vessel debranching for type B aortic dissection developed a residual type II endoleak via the left subclavian artery. This coil packing technique in an AVP1 was employed to successfully embolize the leak. Conclusion: Based on the experimental study and the first experience in vivo, tight coil packing of an AVP1 might be a robust technique for ultrashort-segment embolization.

Purpose: To report Multilayer Flow Modulator (MFM) implantation from the sinotubular junction to the distal infrarenal aorta in the treatment of type B aortic dissection (TBAD) and demonstrate aortic remodeling using computational fluid dynamics (CFD) analysis over the course of 3-year follow-up. Case Report: A hypertensive patient with complicated TBAD required thoracic endovascular aortic repair due to severe thoracic pain associated with rapid progression of the false lumen aneurysm toward the distal aortic arch. Under general anesthesia, 2 aortic multilayer stents were placed over a 0.035-inch stiff guidewire in the compressed true lumen. The aorta was covered with 2 MFM stents between the sinotubular junction and the distal infrarenal aorta. Serial computed tomography scans showed progressive remodeling of the entire dissected aortic wall, with an excellent result at 24 months. Morphological and CFD vascular analysis confirmed the aortic remodeling, with a false lumen index drop from a preoperative 4.04 to 0.01 at 36 months. Conclusion: Endovascular aortic repair with multilayer stents is a promising treatment for complicated TBAD due to the unique ability of these devices to stabilize the entire aortic wall without compromising the flow in the major aortic side branches.

Purpose: To investigate the short-term outcomes and complications of straight vs tapered carotid stent placement for patients with symptomatic carotid stenosis. Methods: A prospective study was conducted to examine if tapered carotid stents (TCS) performed better than straight carotid stents (SCS) in terms of complications and outcomes in patients with a unilateral, symptomatic, internal carotid artery stenosis ⩾70%. Between January 2014 and January 2016, 236 patients were screened; 88 were excluded, leaving 148 patients for 1:1 randomization to carotid artery stenting with either SCS or TCS. The data were analyzed for differences between the groups in terms of complications (hemodynamic depression, cerebral hyperperfusion syndrome, puncture site sequelae) and endpoint events (stroke, myocardial infarction, and death) at 30 days and 6 months. Results: Two patients in the TCS group underwent endarterectomy after allocation, leaving 72 patients (mean age 65.1±8.8 years; 59 men) in the TCS group for analysis vs 74 (mean age 65.0±7.9 years; 58 men) in the SCS group. The technical success was 100% in both groups. The incidence of hemodynamic depression (hypotension and bradycardia) after the procedures were higher in the SCS group (p=0.04), and the patients who underwent SCS procedures had longer hospital stays (p=0.01). There was no difference in the incidences of complications, myocardial infarction, mortality, or stroke at 30 days or 6 months between the SCS and TCS groups. The rates of restenosis (4% SCS vs 1% TCS) were similar (p=0.63); all restenoses were moderate (50%–70%). Conclusion: When compared to straight stents, tapered carotid stents significantly decreased hemodynamic complications and hospital stay.

Purpose: To evaluate any intraoperative electroencephalographic (EEG) changes accompanying reversed flow with the ENROUTE Transcarotid Neuroprotection System during transcarotid artery revascularization (TCAR). Methods: A post hoc analysis was performed of the first 81 consecutive lead-in patients (mean age 72.8±8 years; 61 men) enrolled in the ROADSTER 1 trial at 5 participating institutions. All patients had high-grade carotid artery stenosis [53 (59.3%) left sided; 12 (14.8%) contralateral occlusions] and high-risk criteria for carotid endarterectomy. A third had symptoms of either stroke (13, 16.0%) or transient ischemic attack (14, 17.3%). This subset of early patients underwent EEG monitoring to detect any cerebral changes during reversed flow as an added safety measure mandated by the ROADSTER 1 trial protocol. Results: Mean flow reversal time was 12.9±8.2 minutes. The goal mean arterial pressure during reversed flow was 100 mm Hg, but 7 (8.6%) patients suffered hypotension. One (1.2%) patient had slight EEG changes secondary to blood pressure fluctuation; these resolved with blood pressure elevation. No other EEG changes were noted. One (1.2%) patient had a postoperative stroke and another (1.2%) had postoperative myocardial infarction (MI), leading to 2.5% 30-day stroke/death/MI rate. Conclusion: Temporary reversal of blood flow during TCAR is a safe maneuver and does not cause cerebral ischemia in the vast majority of patients, including those with contralateral carotid occlusion. Carotid stenting performed with reversed blood flow mitigates cerebral embolization and periprocedural stroke without concern for brain ischemia.