Orthogonal SARS-CoV-2 Serological Assays Enable Surveillance of Low-Prevalence Communities and Reveal Durable Humoral Immunity.

We conducted a serological study to define correlates of immunity against SARS-CoV-2. Compared to those with mild coronavirus disease 2019 (COVID-19) cases, individuals with severe disease exhibited elevated virus-neutralizing titers and antibodies against the nucleocapsid (N) and the receptor binding domain (RBD) of the spike protein. Age and sex played lesser roles. All cases, including asymptomatic individuals, seroconverted by 2 weeks after PCR confirmation. Spike RBD and S2 and neutralizing antibodies remained detectable through 5-7 months after onset, whereas α-N titers diminished. Testing 5,882 members of the local community revealed only 1 sample with seroreactivity to both RBD and S2 that lacked neutralizing antibodies. This fidelity could not be achieved with either RBD or S2 alone. Thus, inclusion of multiple independent assays improved the accuracy of antibody tests in low-seroprevalence communities and revealed differences in antibody kinetics depending on the antigen. We conclude that neutralizing antibodies are stably produced for at least 5-7 months after SARS-CoV-2 infection.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

BACKGROUND: In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). METHODS: Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. RESULTS: A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. CONCLUSIONS: Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Initial Outcomes of the Gore TAG Thoracic Branch Endoprosthesis for Endovascular Repair of Blunt Thoracic Aortic Injury.

BACKGROUND: Endovascular repair of blunt thoracic aortic injury (BTAI) has dramatically reduced the morbidity and mortality of intervention. Injuries requiring zone 2 coverage of the aorta traditionally require left subclavian artery (LSA) sacrifice or open revascularization. Furthermore, these injuries are associated with an increased risk of in-hospital mortality and long-term morbidity. Here we report 1-year outcomes of total endovascular repair of BTAI with the GORE® TAG® Thoracic Branch Endoprosthesis for LSA preservation. METHODS: Across 34 investigative sites, 9 patients with BTAI requiring LSA coverage were enrolled in a nonrandomized, prospective study of a single-branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for LSA perfusion. RESULTS: This initial cohort included 8 male and 1 female patient with a median age of 43 (22, 76) and 12 months of follow-up. Five total years of follow-up are planned. All participants had grade 3 BTAI. All procedures took place between 2018 and 2019. The median injury severity score was 2 (0, 66). The median procedure time was 109 min (78, 162). All aortic injuries were repaired under general anesthesia and with heparinization. A spinal drain was used in one patient. Post-deployment balloon angioplasty was conducted in one case at the distal landing zone. There was one asymptomatic LSA branch occlusion 6 months after repair. It was attributed to the purposeful proximal deployment of the branch stent to accommodate an early vertebral takeoff. The occlusion did not require revascularization. There were no strokes, mortalities, or aortic adverse events (migration, endoleak, native aortic expansion, dissection, or thrombosis) through 12 months of follow-up. CONCLUSIONS: Initial cohort outcomes suggest that endovascular repair of zone 2 BTAI is feasible and has favorable outcomes using the thoracic branch device with LSA preservation. Additional cases and longer-term follow-up are required for a definitive assessment of the device's safety and durability in traumatic aortic injuries.

Outcomes of embolization procedures for type II endoleaks following endovascular abdominal aortic repair.

OBJECTIVE: The objective of this study was to investigate the mid-term outcomes of embolization procedures for type II endoleak after endovascular abdominal aortic repair, and clarify the risk factors for aneurysm enlargement after embolization procedures. METHODS: This was a retrospective multicenter registry study enrolling patients who underwent embolization procedures for type II endoleaks after EVAR from January 2012 to December 2018 at 19 Japanese centers. The primary end point was the rate of freedom from aneurysm enlargement, more than 5 mm in the aortic maximum diameter, after an embolization procedure. Demographic, procedural, follow-up, and laboratory data were collected. Continuous variables were summarized descriptively, and Kaplan-Meier analyses and a Cox regression model were used for statistical analyses. RESULTS: A total of 315 patients (248 men and 67 women) were enrolled. The average duration from the initial embolization procedure to the last follow-up was 31.6 ± 24.6 months. The rates of freedom from aneurysm enlargement at 3 and 5 years were 55.4 ± 3.8% and 37.0 ± 5.2%, respectively. A multivariate analysis revealed that a larger aortic diameter at the initial embolization procedure and the presence of a Moyamoya endoleak, defined as heterogeneous contrast opacity with an indistinct faint border, were associated with aneurysm enlargement after embolization management. CONCLUSIONS: The embolization procedures were generally ineffective in preventing further expansion of abdominal aortic aneurysms in patients with type II endoleaks after EVAR, especially in patients with a large abdominal aortic aneurysm and/or a presence of a Moyamoya endoleak.

Cardiac Pulsatile Helical Deformation of the Thoracic Aorta Before and After Thoracic Endovascular Aortic Repair of Type B Dissections.

PURPOSE: Type B aortic dissections propagate with either achiral (nonspiraling) or right-handed chiral (spiraling) morphology, have mobile dissection flaps, and are often treated with thoracic endovascular aortic repair (TEVAR). We aim to quantify cardiac-induced helical deformation of the true lumen of type B aortic dissections before and after TEVAR. MATERIAL AND METHODS: Retrospective cardiac-gated computed tomography (CT) images before and after TEVAR of type B aortic dissections were used to construct systolic and diastolic 3-dimensional (3D) surface models, including true lumen, whole lumen (true+false lumens), and branch vessels. This was followed by extraction of true lumen helicity (helical angle, twist, and radius) and cross-sectional (area, circumference, and minor/major diameter ratio) metrics. Deformations between systole and diastole were quantified, and deformations between pre- and post-TEVAR were compared. RESULTS: Eleven TEVAR patients (59.9±4.6 years) were included in this study. Pre-TEVAR, there were no significant cardiac-induced deformations of helical metrics; however, post-TEVAR, significant deformation was observed for the true lumen proximal angular position. Pre-TEVAR, cardiac-induced deformations of all cross-sectional metrics were significant; however, only area and circumference deformations remained significant post-TEVAR. There were no significant differences of pulsatile deformation from pre- to post-TEVAR. Variance of proximal angular position and cross-sectional circumference deformation decreased after TEVAR. CONCLUSION: Pre-TEVAR, type B aortic dissections did not exhibit significant helical cardiac-induced deformation, indicating that the true and false lumens move in unison (do not move with respect to each other). Post-TEVAR, true lumens exhibited significant cardiac-induced deformation of proximal angular position, suggesting that exclusion of the false lumen leads to greater rotational deformations of the true lumen and lack of true lumen major/minor deformation post-TEVAR means that the endograft promotes static circularity. Population variance of deformations is muted after TEVAR, and dissection acuity influences pulsatile deformation while pre-TEVAR chirality does not. CLINICAL IMPACT: Description of thoracic aortic dissection helical morphology and dynamics, and understanding the impact of thoracic endovascular aortic repair (TEVAR) on dissection helicity, are important for improving endovascular treatment. These findings provide nuance to the complex shape and motion of the true and false lumens, enabling clinicians to better stratify dissection disease. The impact of TEVAR on dissection helicity provides a description of how treatment alters morphology and motion, and may provide clues for treatment durability. Finally, the helical component to endograft deformation is important to form comprehensive boundary conditions for testing and developing new endovascular devices.

Implications of IR Being a Primary Specialty on the Professional Organizational Relationship between Interventional and Diagnostic Radiology.

The recent awarding of primary specialty status to interventional radiology (IR) invites a re-examination of the long-standing relationship between IR and diagnostic radiology (DR). In this new era, it is important to evaluate how the organizations that represent these 2 specialties can best contribute to strengthening a growth in collaborations and partnerships that will benefit their members and patients. Areas of organizational focus with the potential to enhance the future for both groups include combining efforts directed toward advocacy and government relations, developing practice models to create successful IR and DR working relationships, and providing more data to demonstrate the value of IR above and beyond the work relative value units and professional revenues that IR generates.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

OBJECTIVE: Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. METHODS: Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. RESULTS: More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. CONCLUSIONS: Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Five-year results of the STABLE II study for the endovascular treatment of complicated, acute type B aortic dissection with a composite device design.

OBJECTIVE: To provide the 5-year outcomes of the use of a composite device (proximal covered stent graft + distal bare stent) for endovascular repair of patients with acute, type B aortic dissection complicated by aortic rupture and/or malperfusion. METHODS: Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE) II was a prospective, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe). Patients were enrolled between August 2012 and January 2015 at sites in the United States and Japan. Five-year follow-up was completed by January 2020. RESULTS: In total, 73 patients (mean age: 60.7 ± 10.9 years; 65.8% male) with acute type B dissection complicated by malperfusion (72.6%), rupture (21.9%), or both (5.5%) were enrolled. Patients were treated with either a composite device (79.5%) or the proximal stent graft alone (no distal bare stent, 20.5%). Dissections were more extensive in patients who received the composite device (408.9 ± 121.3 mm) than in patients who did not receive a bare stent (315.9 ± 100.1 mm). The mean follow-up was 1209.4 ± 754.6 days. Freedom from all-cause mortality was 80.3% ± 4.7% at 1 year and 68.9% ± 7.3% at 5 years. Freedom from dissection-related mortality remained at 97.1% ± 2.1% from 1-year through 5-year follow-up. Within the stent-graft region, the rate of either complete thrombosis or elimination of the false lumen increased over time (82.1% of all patients at 5 years vs 55.7% at first postprocedure computed tomography), with a higher rate at 5 years in patients who received the composite device (90.5%) compared with patients without the bare stent (57.1%). Throughout the follow-up, overall true lumen diameter increased within the stent-graft region, and overall false lumen diameter decreased. At 5 years, 20.7% of patients experienced a decrease in maximum transaortic diameter within the stent-graft region, 17.2% experienced an increase, and 62.1% experienced no change. Distal to the treated segment (but within the dissected aorta), 23.1% of patients experience no change in transaortic diameter at 5 years; a bare stent was deployed in all these patients at the procedure. Five-year freedom from all secondary intervention was 70.7% ± 7.2%. CONCLUSIONS: These 5-year outcomes indicate a low rate of dissection-related mortality for the Zenith Dissection Endovascular System in the treatment of patients with acute, complicated type B aortic dissection. Further, these data suggest a positive influence of composite device use on false lumen thrombosis. Continuous monitoring for distal aortic growth is necessary in all patients.

Midterm Outcomes of Endovascular Repair of Aortic Arch Aneurysms with the Gore Thoracic Branch Endoprosthesis.

OBJECTIVE: Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported. METHODS: This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported. RESULTS: The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm. CONCLUSION: Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

Quantification of true lumen helical morphology and chirality in type B aortic dissections.

Chirality is a fundamental property in many biological systems. Motivated by previous observations of helical aortic blood flow, aortic tissue fibers, and propagation of aortic dissections, we introduce methods to characterize helical morphology of aortic dissections. After validation on computer-generated phantoms, the methods were applied to patients with type B dissection. For this cohort, there was a distinct bimodal distribution of helical propagation of the dissection with either achiral or exclusively right-handed chirality, with no intermediate cases or left-handed cases. This clear grouping indicates that dissection propagation favors these two modes, which is potentially due to the right-handedness of helical aortic blood flow and cell orientation. The characterization of dissection chirality and quantification of helical morphology advances our understanding of dissection pathology and lays a foundation for applications in clinical research and treatment practice. For example, the chirality and magnitude of helical metrics of dissections may indicate risk of dissection progression, help define treatment and surveillance strategies, and enable development of novel devices that account for various helical morphologies.NEW & NOTEWORTHY A novel definition of helical propagation of type B aortic dissections reveals a distinct bimodality, with the true lumen being either achiral (nonhelical) or exclusively right-handed. This right-handed chirality is consistent with anatomic and physiological phenomena such as right-handed twist during left ventricle contraction, helical blood flow, and tissue fiber direction. The helical character of aortic dissections may be useful for pathology research, diagnostics, treatment selection, therapeutic durability prediction, and aortic device design.

Influence of thoracic endovascular aortic repair on true lumen helical morphology for Stanford type B dissections.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) can change the morphology of the flow lumen in aortic dissections, which may affect aortic hemodynamics and function. This study characterizes how the helical morphology of the true lumen in type B aortic dissections is altered by TEVAR. METHODS: Patients with type B aortic dissection who underwent computed tomography angiography before and after TEVAR were retrospectively reviewed. Images were used to construct three-dimensional stereolithographic surface models of the true lumen and whole aorta using custom software. Stereolithographic models were segmented and co-registered to determine helical morphology of the true lumen with respect to the whole aorta. The true lumen region covered by the endograft was defined based on fiducial markers before and after TEVAR. The helical angle, average helical twist, peak helical twist, and cross-sectional eccentricity, area, and circumference were quantified in this region for pre- and post-TEVAR geometries. RESULTS: Sixteen patients (61.3 ± 8.0 years; 12.5% female) were treated successfully for type B dissection (5 acute and 11 chronic) with TEVAR and scans before and after TEVAR were retrospectively obtained (follow-up interval 52 ± 91 days). From before to after TEVAR, the true lumen helical angle (-70.0 ± 71.1 to -64.9 ± 75.4°; P = .782), average helical twist (-4.1 ± 4.0 to -3.7 ± 3.8°/cm; P = .674), and peak helical twist (-13.2 ± 15.2 to -15.4 ± 14.2°/cm; P = .629) did not change. However, the true lumen helical radius (1.4 ± 0.5 to 1.0 ± 0.6 cm; P < .05) and eccentricity (0.9 ± 0.1 to 0.7 ± 0.1; P < .05) decreased, and the cross-sectional area (3.0 ± 1.1 to 5.0 ± 2.0 cm2; P < .05) and circumference (7.1 ± 1.0 to 8.0 ± 1.4 cm; P < .05) increased significantly from before to after TEVAR. The distinct bimodal distribution of chiral and achiral native dissections disappeared after TEVAR, and subgroup analyses showed that the true lumen circumference of acute dissections increased with TEVAR, although it did not for chronic dissections. CONCLUSIONS: The unchanged helical angle and average and peak helical twists as a result of TEVAR suggest that the angular positions of the true lumen are constrained and that the endografts were helically conformable in the angular direction. The decrease of helical radius indicated a straightening of the corkscrew shape of the true lumen, and in combination with more circular and expanded lumen cross-sections, TEVAR produced luminal morphology that theoretically allows for lower flow resistance through the endografted portion. The impact of TEVAR on dissection flow lumen morphology and the interaction between endografts and aortic tissue can provide insight for improving device design, implantation technique, and long-term clinical outcomes.

Evaluation of the Gore TAG thoracic branch endoprosthesis in the treatment of proximal descending thoracic aortic aneurysms.

BACKGROUND: Thoracic endovascular aortic repair has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts have provided a new option to maintain branch patency. METHODS: Six investigative sites enrolled 31 patients in a nonrandomized, prospective investigational device exemption feasibility trial of a single branched aortic endograft for the management of aneurysms that include the distal aortic arch. The Gore TAG thoracic branch endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz), an investigational device, allows for graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion. RESULTS: All 31 patients (100%) had undergone successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Their average age was 74.1 ± 10.4 years. The aneurysm morphology was fusiform in 12 and saccular in 19 patients, with a mean maximum aortic diameter of 54.8 ± 10.9 mm. The mean follow-up period for the cohort was 25.2 ± 11.1 months. We have reported the patient outcomes at 1 month and 1 year. At 1 month, the side branch patency was 100% and the freedom from core laboratory-reported device-related endoleak (types I and III) was 96.7%, without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through 1 year, five patients had died; none of the deaths were related to the device or procedure (clinical endpoint committee adjudicated). One thoracic reintervention was required. No conversions were required, and no aneurysm growth (core laboratory) was reported. One case of the loss of side branch patency was diagnosed in the left subclavian artery in an asymptomatic individual from computed tomography at 6 months, with no reported subsequent adverse events due to loss of patency. Endoleaks were reported by the core laboratory in five patients at 12 months (two, type II; and three, indeterminate). CONCLUSIONS: The present investigational device exemption feasibility study has reported the preliminary results of the use of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.

Impact of Thoracic Endografting on the Hemodynamics of the Native Aorta: Pre- and Postoperative Assessments of Wall Shear Stress and Vorticity Using Computational Fluid Dynamics.

PURPOSE: To quantify the hemodynamic consequences of thoracic endovascular aortic repair (TEVAR) by comparing the preoperative and postoperative wall shear stress (WSS) and vorticity profiles on computational fluid dynamics (CFD) simulations. MATERIALS AND METHODS: The pre- and postoperative computed tomography (CT) scans from 20 consecutive patients (median age 69 years, range 20-87) treated for different thoracic aortic pathologies (11 aneurysms, 5 false aneurysms, 3 penetrating ulcers, and 1 traumatic aortic rupture) were segmented to construct patient-specific CFD models using a meshless code. The simulations were run over the cardiac cycle, and the WSS and vorticity values measured at the proximal and distal landing zones were compared. RESULTS: The CFD runs provided 4-dimensional simulations of blood flow in all patients. WSS and vorticity profiles at the proximal landing zone (located in zones 0-3 in 15 patients) varied in 18 and 20 of the cases, respectively; WSS was increased in 11 cases and the vorticity in 9. Pre- and postoperative WSS median values were 4.19 and 4.90 Pa, respectively. Vorticity median values were 40.38 and 39.17 Hz, respectively. CONCLUSION: TEVAR induces functional alterations in the native thoracic aorta, though the prognostic significance of these changes is still unknown. CFD appears to be a valuable tool to explore aortic hemodynamics, and its application in a larger series would help define a predictive role for these hemodynamic assessments.

Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study.

PURPOSE: To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR). MATERIALS AND METHODS: This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study (ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms. RESULTS: No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years. CONCLUSION: The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup.

Branch Vessel Patency after Thoracic Endovascular Aortic Repair for Type B Aortic Dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) for type B aortic dissections is used to promote false lumen (FL) thrombosis and favorable aortic remodeling, but its impact on occlusion of FL origin branch vessels has not been widely described. We compare FL versus true lumen (TL) branch vessel patency after TEVAR. METHODS: Patients treated by TEVAR for type B aortic dissection in zones 2-5 in the Vascular Quality Initiative from 2009 to 2018 were evaluated. The primary outcome was postoperative branch patency. Secondary outcomes were need for branch vessel intervention, preoperative origin, and postoperative patency of individual branch vessels (celiac, superior mesenteric artery, renal arteries, and iliac arteries). A subset analysis was performed comparing acute and chronic dissections. RESULTS: Of 11,774 patients, 1,484 met criteria for analysis. The left renal was the most common to have FL origin (21.6%), whereas right and left common iliac arteries were the most likely to originate off both lumens (BLs; 22% and 24%). Branch vessels that originated from the TL, FL, BLs, or were obstructed had postoperative patency rates of 99%, 99%, 99%, and 87% (P < 0.0001). Branch vessel treatment was performed in 5% of patients. The right (2.5%) and left (2.8%) renal arteries were the most frequently obstructed branches postoperatively. On multivariate analysis, preoperatively obstructed branches (odds ratio 0.03, P < 0.0001) were negatively associated with postoperative branch patency and branch vessel treatment (odds ratio 3.8, P = 0.004) was positively associated with postoperative patency. FL or BL origin, number of zones covered by TEVAR, urgency, dissection chronicity (acute versus chronic), and demographics were not independently associated with patency. These findings remained unchanged in the subset analysis of only acute dissections. CONCLUSIONS: Branch vessel patency rates after TEVAR for a type B aortic dissection are high and are not significantly different for FL or BL origin vessels compared with TL vessels. Branches that are patent before TEVAR almost always remain patent after TEVAR, but branch vessel stenting may be required in less than 5%.

Management of Renal Arteries in Conjunction with Thoracic Endovascular Aortic Repair for Complicated Stanford Type B Aortic Dissection: The Japanese Multicenter Study (J-Predictive Study).

Background Management of abdominal branches associated with Stanford type B aortic dissection is controversial without definite criteria for therapy after thoracic endovascular aortic repair (TEVAR). This is in part due to lack of data on natural history related to branch vessels and their relationship with the dissection flap, true lumen, and false lumen. Purpose To investigate the natural history of abdominal branches after TEVAR for type B aortic dissection and the relationship between renal artery anatomy and renal volume as a surrogate measure of perfusion. Materials and Methods This study included patients who underwent TEVAR for complicated type B dissection from January 2012 to March 2017 at 20 centers. Abdominal aortic branches were classified with following features: patency, branch vessel origin, and presence of extension of the aortic dissection into a branch (pattern 1, supplied by the true lumen without branch dissection; pattern 2, supplied by the true lumen with branch dissection, etc). The branch artery patterns before TEVAR were compared with those of the last follow-up CT (mean interval, 19.7 months) for spontaneous healing. Patients with one kidney supplied by pattern 1 and the other kidney by a different pattern were identified, and kidney volumes over the course were compared by using a simple linear regression model. Results Two hundred nine patients (mean age ± standard deviation, 66 years ± 13; 165 men and 44 women; median follow-up, 18 months) were included. Four hundred fifty-nine abdominal branches at the last follow-up were evaluable. Spontaneous healing of the dissected branch occurred in 63% (64 of 102) of pattern 2 branches. Regarding the other patterns, 6.5% (six of 93) of branches achieved spontaneous healing. In 79 patients, renal volumes decreased in kidneys with pattern 2 branches with more than 50% stenosis and branches supplied by the aortic false lumen (patterns 3 and 4) compared with contralateral kidneys supplied by pattern 1 (pattern 2 vs pattern 1: -16% ± 16 vs 0.10% ± 11, P = .002; patterns 3 and 4 vs pattern 1: -13% ± 14 vs 8.5% ± 14, P = .004). Conclusion Spontaneous healing occurs more frequently in dissected branches arising from the true lumen than in other branch patterns. Renal artery branches supplied by the aortic false lumen or a persistently dissected artery with greater than 50% stenosis are associated with significantly greater kidney volume loss. © RSNA, 2019 Online supplemental material is available for this article.

Thoracic aortic geometry correlates with endograft bird-beaking severity.

OBJECTIVE: Aortic geometry has been shown to influence the development of endograft malapposition (bird-beaking) in thoracic endovascular aortic repair (TEVAR), but the extent of this relationship lacks clarity. The aim of this study was to develop a reproducible method of measuring bird-beak severity and to investigate preoperative geometry associated with bird-beaking. METHODS: The study retrospectively analyzed 20 patients with thoracic aortic aneurysms or type B dissections treated with TEVAR. Computed tomography scans were used to construct three-dimensional geometric models of the preoperative and postoperative aorta and endograft. Postoperative bird-beaking was quantified with length, height, and angle; categorized into a bird-beak group (BBG; n = 10) and no bird-beak group (NBBG; n = 10) using bird-beak height ≥5 mm as a threshold; and correlated to preoperative metrics including aortic cross-sectional area, inner curvature, diameter, and inner curvature × diameter as well as graft diameter and oversizing at the proximal landing zone. RESULTS: Aortic area (1002 ± 118 mm2 vs 834 ± 248 mm2), inner curvature (0.040 ± 0.014 mm-1 vs 0.031 ± 0.012 mm-1), and diameter (35.7 ± 2.1 mm vs 32.2 ± 4.9 mm) were not significantly different between BBG and NBBG; however, inner curvature × diameter was significantly higher in BBG (1.4 ± 0.5 vs 1.0 ± 0.3; P = .030). Inner curvature and curvature × diameter were significantly correlated with bird-beak height (R = 0.462, P = .041; R = 0.592, P = .006) and bird-beak angle (R = 0.680, P < .001; R = 0.712, P < .001). CONCLUSIONS: TEVAR bird-beak severity can be quantified and predicted with geometric modeling techniques, and the combination of high preoperative aortic inner curvature and diameter increases the risk for development of TEVAR bird-beaking.

STABLE II clinical trial on endovascular treatment of acute, complicated type B aortic dissection with a composite device design.

OBJECTIVE: To evaluate the safety and effectiveness of a composite device design (covered stent graft and bare metal stent) for the treatment of patients with acute, complicated type B aortic dissection (TBAD) presenting with aortic rupture and/or branch vessel malperfusion. METHODS: In this prospective, nonrandomized, multicenter study, 73 patients (65.8% male; mean age, 60.7 years) with acute, complicated TBAD were enrolled between August 2012 and January 2015 to receive treatment with the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark) at institutions in the United States and Japan. The primary safety end point was the rate of freedom from major adverse events at 30 days, and the primary effectiveness end point was the rate of survival at 30 days. This article reports primary outcomes at 30 days and follow-up results through 1 year, reflecting study data as of March 2018. RESULTS: Of 73 patients, 20 presented with aortic rupture (27%) and 57 presented with branch vessel obstruction/compromise (78%), including 4 patients presenting with both conditions. The covered stent graft was used in all patients (median, 1; range, 1-3; 1 stent graft used in 64.4%; 47/73), and the bare metal dissection stent was used in 58 of 73 patients (79.5%). Thirty-day mortality occurred in five patients (6.8%): one procedure related, three unrelated to dissection repair, and one indeterminate. Thirty-day major adverse events included myocardial infarction (1.4%), bowel ischemia (1.4%), renal insufficiency/renal failure requiring dialysis (6.8%), stroke (6.8%), paraplegia or paraparesis (5.5%), and prolonged ventilatory support (13.7%). Nine deaths occurred from 31 to 365 days (only one death related to dissection repair); the Kaplan-Meier estimate of freedom from all-cause mortality was 80.3% ± 4.7% at 1 year. Within 365 days, 9 of 73 patients (12.3%) underwent 10 secondary interventions; no patients required conversion to open surgery. At the 12-month follow-up, complete or partial thrombosis of the false lumen was seen in 100% of patients (46/46) within the stent graft region and in 97.4% of patients (38/39) within the dissection stent region. Growth (>5 mm) of the maximum transaortic diameter was observed in 14.9% of patients (7/47) in the stent graft region and in 38.5% of patients (15/39) within the dissection stent region at 12 months. CONCLUSIONS: Thirty-day and 1-year results from the STABLE II study demonstrated favorable clinical and anatomical outcomes for the treatment of rupture and malperfusion in the setting of acute, complicated TBAD. Five-year follow-up is ongoing.

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Vascular Closure Device During Percutaneous EVAR and TEVAR Procedures.

Purpose: To evaluate the safety and effectiveness of the MANTA percutaneous vascular closure device in patients undergoing percutaneous endovascular aneurysm repair (PEVAR) or thoracic endovascular aortic repair (TEVAR). Materials and Methods: The SAFE MANTA Study (ClinicalTrials.gov identifier NCT02908880) was a prospective, single-arm, multicenter trial in patients undergoing endovascular interventions using large-bore sheaths (transcatheter aortic valve replacement, PEVAR, or TEVAR) at 20 sites in North America. Patient selection intended to test the MANTA device in populations without morbid obesity, severe calcification, or a severely scarred femoral access area. Of the 263 patients enrolled in the primary analysis cohort, 53 (20.2%) patients (mean age 74.9±8.9 years; 41 men) underwent PEVAR (n=51) or TEVAR (n=2) procedures and form the cohort for this subgroup analysis. Per protocol a single MANTA device was deployed in all PEVAR/TEVAR cases. Results: The mean time to hemostasis in the PEVAR/TEVAR cohort was 35±91 seconds, with a median time of 19 seconds vs 24 seconds in the overall SAFE MANTA population. The MANTA device met the definition for technical success in 52 (98%) of 53 PEVAR/TEVAR cases compared with 97.7% in the overall SAFE MANTA population. One (1.9%) major complication (access-site stenosis) occurred in this subgroup compared to 14 (5.3%) events in the SAFE population. In the PEVAR/TEVAR group, 1 pseudoaneurysm was noted prior to discharge, another at 30-day follow-up, and one at 60 days. One (1.9%) of the 3 minor pseudoaneurysms was treated with ultrasound-guided compression and the other 2 required no treatment. Conclusion: The MANTA device demonstrated a short time to hemostasis and low complication rates compared with published literature results of other percutaneous closure devices. Time to hemostasis and complication rates were comparable between the PEVAR/TEVAR patients and the full SAFE MANTA study cohort. The MANTA device provides reliable closure with a single percutaneous device for PEVAR/TEVAR procedures.