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.

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.

No Evidence That Analgesic Use after COVID-19 Vaccination Negatively Impacts Antibody Responses.

Uptake of mRNA vaccines, especially booster immunizations, against COVID-19 has been lower than hoped, perhaps in part due to their reactogenicity. Analgesics might alleviate symptoms associated with vaccination, but they might also impact immune responses. We semiquantitatively measured Ab responses following COVID-19 vaccination in 2354 human participants surveyed about analgesic use after vaccination. Participants who used nonsteroidal anti-inflammatory drugs or acetaminophen after vaccination showed elevated Ab levels against the receptor-binding domain of Spike protein relative to those who did not use analgesics. This pattern was observed for both mRNA-1273 and BNT162b2 and across age groups. Participants who used analgesics more frequently reported fatigue, muscle aches, and headaches than did those who did not use painkillers. Among participants who reported these symptoms, we observed no statistically significant differences in Ab levels irrespective of analgesic use. These data suggest that elevated Ab levels are associated with symptoms and inflammatory processes rather than painkiller use per se. Taken together, we find no evidence that analgesic use reduces Ab responses after COVID-19 vaccination. Recommendation of their use to alleviate symptoms might improve uptake of booster immunizations.

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.

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.

Controlled balloon false lumen obliteration for the endovascular management of chronic dissection in the descending thoracic aorta.

Objective: Retrograde false lumen perfusion has limited the utility of aortic stent grafting for chronic aortic dissection. It is unknown whether balloon septal rupture can improve the outcomes for endovascular management of chronic aortic dissection. Methods: Included patients underwent false lumen obliteration and creation of a single-lumen aortic landing zone using balloon aortoplasty during thoracic endovascular aortic repair. The distal thoracic stent graft was sized to the total aortic lumen diameter, and septal rupture was performed within the stent graft with a compliant balloon in the region 5 cm proximal to the distal fabric edge. Clinical and radiographic outcomes are reported. Results: Forty patients, with an average age 56 years, underwent thoracic endovascular aortic repair with septal rupture. Seventeen patients (43%) had chronic type B dissections, 17 of 40 patients (43%) had residual type A dissections, and 6 of 40 patients (15%) had acute type B dissections. Nine cases were emergency, complicated by rupture or malperfusion. Perioperative complications included 1 death (2.5%) due to rupture of the descending thoracic aorta and 2 (5%) instances each of stroke (neither permanent) and spinal cord ischemia (1 permanent). Two (5%) stent graft-induced new injuries were seen. Average postoperative computed tomography follow-up was 1.4 years. Thirteen patients (33%) had a decrease in aortic size, 25 of 39 patients (64%) were stable, and 1 of 39 patients (2.6%) had an increased aortic size. Partial and complete false lumen thrombosis were achieved in 10 of 39 patients (26%) and 29 of 39 patients (74%), respectively. Midterm aortic-related survival was 97.5% at an average of 1.6 years. Conclusions: Controlled balloon septal rupture offers an effective endovascular method to treat aortic dissection in the distal thoracic aorta.

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.

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.).

First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study.

Purpose: The benefit of using the Zilver PTX drug-eluting stent (DES) in superficial femoral artery (SFA) lesions has been demonstrated in multiple clinical studies. This prospective, multicenter study evaluated the 1-year safety and effectiveness of the DES for the treatment of femoropopliteal lesions in a Chinese patient population. Methods: Patients with a single de novo or restenotic SFA lesion ≤140 mm and a Rutherford classification of 2 to 4 were treated with the DES. The primary endpoint was primary patency assessed by duplex ultrasound at 1-year. Secondary endpoints included adverse events, event-free survival (EFS), and freedom from target lesion revascularization (TLR). Clinical outcomes included Rutherford classification, ankle-brachial index (ABI), and the walking impairment questionnaire (WIQ). Results: In this study, 178 patients with symptomatic peripheral artery disease were enrolled at nine institutions in China. The average lesion length was 79.0 ± 48.6 mm (range 14.8-245.4 mm) and 50.0% of lesions were total occlusions. The 1-year primary patency rate was 81.9%. Covariate analysis revealed that lesion length (p < 0.01) was the only significant factor for patency. No paclitaxel-related adverse events or amputations were reported. The 1-year rate for EFS was 94.9% and freedom from TLR was 95.5%. Through 1-year, treatment with the DES resulted in statistically significant improvement in ABI and WIQ scores compared with pre-procedure (p < 0.001). Clinical improvement of at least 1 Rutherford class was achieved in 142 of 174 patients (81.6%). Conclusion: This study showed promising short-term results for the treatment of SFA lesions with Zilver PTX DES in Chinese patients. Unique identifier: ClinicalTrials.gov, identifier: NCT02171962.

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.

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.

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.

Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction.

PURPOSE: To assess safety and patency of the Venovo venous stent for the treatment of iliofemoral vein obstruction. MATERIALS AND METHODS: Twenty-two international centers enrolled 170 patients in the VERNACULAR study (93 post-thrombotic syndrome; 77 non-thrombotic iliac vein lesions). Primary outcome measures were major adverse events at 30 days and 12-month primary patency (freedom from target vessel revascularization, thrombotic occlusion, or stenosis > 50%). Secondary outcomes included the Venous Clinical Severity Score Pain Assessment and Chronic Venous Quality-of-Life Questionnaire assessments (hypothesis tested). Secondary observations included primary patency, target vessel and lesion revascularization (TVR/TLR), and assessment of stent integrity through 36 months. RESULTS: Freedom from major adverse events through 30 days was 93.5%, statistically higher than a pre-specified performance goal of 89% (p = 0.032) while primary patency at 12 months was 88.6%, also statistically higher than a performance goal of 74% (p < 0.0001). Mean quality-of-life measures were statistically improved compared to baseline values at 12 months (p < 0.0001). Primary patency at 36 months was 84% (Kaplan-Meier analysis) while freedom from TVR/TLR was 88.1%. There was no stent embolization/migration, and no core laboratory assessed stent fractures reported through 36 months. Six deaths were reported; none adjudicated as device or procedure related. CONCLUSION: The Venovo venous stent was successfully deployed in obstructive iliofemoral vein lesions and met the pre-specified primary outcome measures through 12 months. At 3 years, primary patency was 84%, reintervention rates were low, standardized quality-of-life and pain measures improved from baseline, and there was no stent migration or fractures. LEVEL OF EVIDENCE: Level 2-prospective, multicenter, controlled clinical study without a concurrent control or randomization. Pre-specified endpoints were hypothesis-tested to performance goals derived from peer-reviewed clinical literature. REGISTRATION CLINICALTRIALS.GOV: Unique Identifier NCT02655887.

Management of arch aneurysms with a single-branch thoracic endograft in zone 0.

BACKGROUND: We present preliminary data from a patient cohort undergoing thoracic endovascular aortic repair for Ishimaru zone 0 and 1 using a novel branched arch endograft. METHODS: This US multicenter early feasibility investigational device exemption clinical trial treated 9 patients with a mean age 72.8 ± 8.0 years (77.8% male). The endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the innominate or left carotid artery while maintaining branch vessel patency. Pathology treated included fusiform (n = 2) or saccular (n = 7) aneurysm, with a maximum aortic diameter of 6.3 ± 0.7 cm. Treatment was into zone 0 in 8 patients, and zone 1 in 1 patient. RESULTS: All patients underwent initial successful first-stage supra-aortic trunk revascularization using a variety of techniques, without the occurrence of stroke. For the second thoracic endovascular aortic repair stage, median total treatment length was 20 cm. The primary end point of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day mortality or spinal cord ischemia. Cerebrovascular events were observed in 2 patients through 30 days. No type I or III endoleaks were reported and all side branches were patent at 12-month imaging follow-up. CONCLUSIONS: Endovascular repair of Ishimaru zone 0 or 1 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the mid-term outcomes with this device in other pathologies and further define the occurrence of postoperative neurologic events.

SARS-CoV-2 Rapid Antigen Testing of Symptomatic and Asymptomatic Individuals on the University of Arizona Campus.

SARS-CoV-2, the cause of COVID19, has caused a pandemic that has infected more than 80 M and killed more than 1.6 M persons worldwide. In the US as of December 2020, it has infected more than 32 M people while causing more than 570,000 deaths. As the pandemic persists, there has been a public demand to reopen schools and university campuses. To consider these demands, it is necessary to rapidly identify those individuals infected with the virus and isolate them so that disease transmission can be stopped. In the present study, we examined the sensitivity of the Quidel Rapid Antigen test for use in screening both symptomatic and asymptomatic individuals at the University of Arizona from June to August 2020. A total of 885 symptomatic and 1551 asymptomatic subjects were assessed by antigen testing and real-time PCR testing. The sensitivity of the test for both symptomatic and asymptomatic persons was between 82 and 90%, with some caveats.

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.

Multiaxial pulsatile dynamics of the thoracic aorta and impact of thoracic endovascular repair.

PURPOSE: The thoracic aorta is a highly mobile organ whose dynamics are altered by thoracic endovascular aorta repair (TEVAR). The aim of this study was to quantify cardiac pulsatility-induced multi-axial deformation of the thoracic aorta before and after descending aortic TEVAR. METHODS: Eleven TEVAR patients (8 males and 3 females, age 57-89) underwent retrospective cardiac-gated CT angiography before and after TEVAR. 3D geometric models of the thoracic aorta were constructed, and lumen centerlines, inner and outer surface curves, and cross-sections were extracted to measure aortic arclength, centerline, inner surface, and outer surface longitudinal curvatures, as well as cross-sectional effective diameter and eccentricity for the ascending and stented aortic portions. RESULTS: From pre- to post-TEVAR, arclength deformation was increased at the ascending aorta from 5.9 ±â€¯3.1 % to 8.8 ±â€¯4.4 % (P < 0.05), and decreased at the stented aorta from 7.5 ±â€¯5.1 % to 2.7 ±â€¯2.5 % (P < 0.05). Longitudinal curvature and diametric deformations were reduced at the stented aorta. Centerline curvature, inner surface curvature, and cross-sectional eccentricity deformations were increased at the distal ascending aorta. CONCLUSIONS: Deformations were reduced in the stented thoracic aorta after TEVAR, but increased in the ascending aorta near the aortic arch, possibly as a compensatory mechanism to maintain overall thoracic compliance in the presence of reduced deformation in the stiffened stented aorta.

Improved midterm outcomes after endovascular repair of nontraumatic descending thoracic aortic rupture compared with open surgery.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has become first-line treatment for descending thoracic aortic rupture (DTAR), but its midterm and long-term outcomes remain undescribed. This study evaluated whether TEVAR would improve midterm outcomes of nontraumatic DTAR relative to open surgical repair (OSR). METHODS: Between December 1999 and October 2018, 118 patients with DTAR were treated with either OSR (n = 39) or TEVAR (n = 79) at a single center. Primary end points were 30-day and long-term all-cause mortalities. Secondary end points included stroke, permanent spinal cord ischemia (SCI), prolonged ventilation support or tracheostomy, permanent hemodialysis, and aortic reintervention. RESULTS: Thirty-day mortality was significantly lower with TEVAR (OSR, 38.5%; TEVAR, 16.5%; P = .01). Stroke (15.6% vs 3.8%; P = .03), permanent SCI (15.6% vs 2.5%; P = .02), prolonged ventilation (30.8% vs 8.9%; P = .002), and tracheostomy (12.8% vs 2.5%; P = .04) were significantly lower after TEVAR than OSR. Need for hemodialysis trended higher after OSR (12.8% vs 5.1%; P = .2). Mean follow ups were 1048 ± 1591 days for OSR group and 828 ± 1258 days for TEVAR. All-cause mortality at last follow-up was significantly lower after TEVAR than OSR (35.4% vs 66.7%; P = .001). Aortic reintervention was required more frequently within 30 days after TEVAR (15.2% vs 2.6%; P = .06). By multivariate analysis, TAAA was an independent predictor for mortality. CONCLUSIONS: TEVAR improves both early and midterm outcomes of DTAR relative to OSR. TAAA was a predictor of mortality. Endovascular approach to DTAR may provide the greatest chance at survival.