Prospective assessment of dynamic changes in frailty and its impact on early clinical outcomes following physician-modified fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms.

INTRODUCTION: Frailty, a predictor of poor outcomes, has been widely studied as a screening tool in surgical decision-making. However, the impact of frailty on the outcomes after fenestrated-branched endovascular aortic repairs (FBEVARs) is less well established. In addition, the changes in frailty during recovery after FBEVAR are unknown. We aim to assess the impact of frailty on outcomes of high-risk patients undergoing physician-modified FBEVARs for complex abdominal and thoracoabdominal aortic aneurysms, as well as the changes in frailty during follow-up. METHODS: Consecutive patients enrolled in a single-center prospective Physician-Sponsored Investigational Device Exemption protocol (FDA# G200159) were evaluated. In addition to the baseline characteristics, frailty was assessed using the Hopkins Frailty Score (HFS) and frailty index (FI) measured by the Frailty Meter. Sarcopenia was measured by L3 total psoas muscle area (PMA). These measurements were repeated during follow-up. The follow-up HFS and FI were compared with baseline scores using the Wilcoxon signed-rank test, whereas follow-up PMA measurements were compared with the baseline using the paired t test. The association between baseline frailty and morbidity was evaluated by the Wilcoxon rank-sum test. RESULTS: Seventy patients were analyzed in a prospective Physician-Sponsored Investigational Device Exemption study from February 9, 2021, to June 2, 2023. At baseline, HFS identified 54% of patients as not frail, 43% as intermediately frail, and 3% as frail. Technical success of FBEVAR was 94% with one in-hospital mortality. Early major adverse events were seen in 10 (14.3%) patients. No difference in baseline FI was seen between patients with early morbidity and those without. Patients who were not frail per HFS were less likely to experience early morbidity (P = .033), and there was a significantly lower baseline PMA in patients who experienced early morbidity (P = .016). At 1 month, patients experienced a significant increase in HFS and HFS category (P = .001 and P = .01) and a significant decrease in sarcopenia (mean PMA: -96 mm2, P = .005). At 6 months, HFS and HFS category as well as PMA returned toward baseline (P = .42, P = .38, and mean PMA: +4 mm2, P = .6). CONCLUSIONS: Preoperative frailty and sarcopenia were associated with early morbidity after physician-modified FBEVAR. During follow-up, patients became more frail and sarcopenic by 1 month. Recovery from this initial decline was seen by 6 months, suggesting that frailty and sarcopenia are reversible processes rather than a unidirectional phenomenon of continued decline.

Disparities in Outcomes Between Sexes in Type B Aortic Dissection Patients Treated with TEVAR.

BACKGROUND: To evaluate differences in presentation and outcomes between sexes in patients who underwent thoracic endovascular aortic repair for type B aortic dissection (TBAD). METHODS: Between January 1, 2012 and January 1, 2017 186 patients underwent thoracic endovascular aortic repair for TBAD at a single institution. Men (n = 112) and women (n = 74) were compared based on presenting demographics, comorbidities, and postoperative complications. Primary outcomes were survival and need for reintervention. RESULTS: Women were older (P = 0.04) and had a lower body mass index (P = 0.03). More women (F) presented with continued pain or refractory hypertension (51.0% F, 30.0% M), while more men (M) presented with acute complicated dissections (19.0% F, 39.0% M) (P = 0.008). At presentation, women had statistically higher relative rates of chronic obstructive pulmonary disease (P = 0.05), hyperlipidemia (P = 0.03), and smoking (P = 0.03). Significantly more women were on Medicare without Medicaid (55.0% F, 34.0% M), while men had private insurance (35.0% F, 13.0% M) (P = 0.005). There was no significant difference in blood pressure control at presentation, discharge, or at 30 days. When normalized by body surface area, women had larger ascending aortic diameters (19.2(3.10)F, 17.5(2.40)M, P = 0.0002), as well as proportionally larger true lumens at the left subclavian artery (14.9(2.90)F, 13.4(2.50)M, P = 0.0002), carina (12.6(5.80)F, 9.90(4.80)M, P = 0.0009), and celiac (10.5(4.50)F, 8.50(4.10)M, P = 0.006) levels, and at the largest point of dissection (11.6(6.50)F, 9.60(4.80)M, P = 0.04), as well as proportionately smaller false lumens at the carina (5.90(5.60)F, 9.30(6.10)M, P = 0.003). Despite not being statistically significant, women had lower rates of stroke (6.80% F, 8.00% M, P = 0.7) and acute kidney injury (5.40% F, 11.6% M, P = 0.2), as well fewer days in the intensive care unit (ICU) (3.20(4.30)F, 4.60(6.60)M, P = 0.2) and an overall shorter length of stay (6.80(6.70)F, 8.00(8.20)M, P = 0.5). Kaplan-Meier estimates for survival for women versus men were 96.0% vs. 92.0%, 90.0% vs. 79.0%, and 70.0% vs. 69.0% at 30 days, 1 year, and 3 years, respectively (P = 0.042). Kaplan-Meier estimates for freedom from reintervention for women versus men were 89.0% vs. 90.0%, 58.0% vs. 72.0%, and 48.0% vs. 58.0% at 30 days, 1 year, and 3 years, respectively (P = 0.13). CONCLUSIONS: Women present with TBAD at an older age, have more comorbidities, lower socioeconomic status, and have larger ascending aortic diameters for their size. Despite having less severe dissections as evidenced by smaller false lumens and wider true lumens, it does not appear that this correlates with improved outcomes for women when compared to men. It appears that this is one of the few, if not only, aortic pathologies that result in comparable outcomes between sexes.

Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study.

OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

In-hospital cost-effectiveness analysis of open versus staged fenestrated/branched endovascular elective repair of thoracoabdominal aneurysms.

OBJECTIVE: To compare costs and effectiveness of elective open (OR) vs fenestrated/branched endovascular (ER) repair of thoracoabdominal aneurysms (TAAAs) in a high-volume center. METHODS: This single-center retrospective observational study (PRO-ENDO TAAA Study, NCT05266781) was designed as part of a larger health technology assessment analysis. All electively treated TAAAs between 2013 and 2021 were analyzed and propensity-matched. End points were clinical success, major adverse events (MAEs), hospital direct costs, and freedom from all causes and aneurysm-related mortality and reinterventions. Risk factors and outcomes were homogeneously classified according to the Society of Vascular Surgery reporting standards. Cost-effectiveness value and incremental cost-effectiveness ratio were calculated, considering the absence of MAEs as a measure of effectiveness. RESULTS: Propensity matching identified 102 pairs of patients out of 789 TAAAs. Mortality, MAE, permanent spinal cord ischemia rates, respiratory complications, cardiac complications, and renal injury were higher for OR (13% vs 5%, P = .048; 60% vs 17%, P < .001; 10% vs 3%, P = .045; 91% vs 18%, P < .001; 16% vs 6%, P = .024; 27% vs 6%, P < .001, respectively). Access complication rate (6% vs 27%; P < .001) was higher in the ER group. Intensive care unit stay was longer (P < .001) for OR, and ER patients were discharged home more frequently (3% vs 94%; P < .001). No differences in midterm end points were observed at 2 years. Despite ER reducing all the hospital cost items (-42% to -88%, P < .001), the higher expenses (P < .001) of the endovascular devices increased the overall cost of ER by 80%. Cost-effectiveness value for ER was favorable to OR (56,365 vs 64,903 €/patient) with an incremental cost-effectiveness ratio of 48,409 € per MAE saved. CONCLUSIONS: ER of TAAA reduces perioperative mortality and morbidity compared with OR, with no differences in reinterventions and survival rates at midterm follow-up. Despite the expenses for endovascular grafts, ER was found to be more cost-effective in preventing MAEs.

Outcomes of Complex Endovascular Treatment of Post-Dissection Aneurysms.

OBJECTIVE: Reports of endovascular treatment of chronic post-dissection aneurysms are limited to high volumes centres, posing questions about generalisability. METHODS: All endovascular repairs of intact pararenal and thoraco-abdominal aneurysms in the Vascular Quality Initiative from 2014 to 2021 were studied, and peri-operative and long term outcomes were compared between repairs of degenerative and post-dissection aneurysms. Peri-operative outcomes were compared using mixed effects logistic regression, and long term outcomes using Medicare linkage. RESULTS: There were 123 patients who completed treatment for post-dissection aneurysms and 3 635 for degenerative aneurysms, with 36% of post-dissection repairs and 6.7% of degenerative repairs performed in a staged fashion (p < .001). The majority (84%) of post-dissection aneurysms were extensive thoraco-abdominal aneurysms (TAAAs: Crawford Type 1, 2, 3, 5), compared with 22% of degenerative aneurysms (p < .001). Physician modified endografts were the primary repair type for post-dissection (73%), while commercially available fenestrated grafts were the dominant repair for degenerative (48%). The first stage of staged procedures was associated with a 2.8% peri-operative mortality rate, 5.1% spinal cord ischaemia, and 8.9% thoraco-abdominal life altering events (the composite of peri-operative death, stroke, permanent spinal cord ischaemia, and dialysis). Th final stage procedure and fluoroscopy times were similar, but technical success was lower in post-dissection repairs (75% vs. 83%, p = .018), both due to issues with the main endograft or bridging vessels (11% vs. 6.6%, p = .055), and types 1and 3 endoleak at completion (17% vs. 10%, p = .035). In addition, high volume surgeons had two fold higher odds of technical success than their low volume counterparts. Adjusted peri-operative outcomes were similar between pathology types, including when comparisons were restricted to extensive TAAAs. Crude and adjusted three year survival were similar, but three year re-interventions were significantly higher following post-dissection repairs (p < .001). CONCLUSION: Complex endovascular repair of chronic post-dissection aneurysms is feasible but is associated with high rates of re-interventions and non-trivial rates of lack of technical success. More data are needed to evaluate the long term durability of these procedures, and the utility of centralising these complex procedures.

Cost Analysis of Thoracic Endovascular Aortic Repair in Type B Aortic Dissection: How Much Does Quality Cost?

BACKGROUND: Aortic dissection (AD) is a life-threatening medical emergency that affects an estimated 3-4 people per 100,000 annually, with 40% of cases classified as type B AD (TBAD). TBAD can be further classified as being complicated (co-TBAD) or uncomplicated (un-TBAD) based on the presence or absence of certain features such as malperfusion and rupture. TBAD can be managed conservatively with optimal medical therapy (OMT), or invasively with open surgical repair (OSR) or thoracic endovascular aortic repair (TEVAR), depending on several factors such as type of TBAD and its clinical acuity. The cost-effectiveness, or cost-benefit profile, of these strategies must be given equal consideration. However, TBAD studies featuring cost analyses are limited within the literature. This narrative review aims to address the gap in the literature on cost-effectiveness of TBAD treatments by providing an overview of cost analyses comparing OMT with TEVAR in un-TBAD and TEVAR with OSR in co-TBAD. Another aim is to provide a market analysis of the commercially available TEVAR devices. METHODS: A comprehensive literature search was performed using several search engines including PubMed, Ovid, Google Scholar, Scopus, and Embase to identify and extract relevant studies. RESULTS: Several TEVAR devices are available commercially on the global market costing $12,000-19,495. Nevertheless, the Terumo Aortic RELAY® stent graft seems to be the most cost-effective, yielding highly favourable clinical outcomes. Despite the higher initial cost of TEVAR, evidence in the literature strongly suggest that it is superior to OMT for un-TBAD on the long-term. In addition, TEVAR is well established in the literature as being gold-standard repair technique for co-TBAD, replacing OSR by offering a more optimal cost-benefit profile through lower costs and improved results. CONCLUSIONS: The introduction of TEVAR has revolutionized the field of aortovascular surgery by offering a highly efficacious and long-term cost-effective treatment for TBAD.

False Lumen Flow Assessment by Magnetic Resonance Imaging and Long-Term Outcomes in Uncomplicated Aortic Dissection.

BACKGROUND: Despite the absence of clinical complications after an acute aortic dissection (AD) with persistent patent false lumen (FL), a high risk for clinical events may persist. OBJECTIVES: The aim of this study was to assess the natural evolution of noncomplicated AD and ascertain whether different FL flow patterns by magnetic resonance imaging (MRI) have independent prognostic value for AD-related events beyond established morphologic parameters. METHODS: One hundred thirty-one consecutive patients, 78 with surgically treated type A dissections and 53 with medically treated type B dissections, were followed up prospectively after acute AD with persistent patent FL in the descending aorta. Maximum aortic diameter, true lumen compression, entry tear, and partial FL thrombosis by computed tomography were assessed. Systolic antegrade true lumen and FL flow volumes and diastolic antegrade and retrograde flows were analyzed by MRI during the first year after AD. RESULTS: After a median follow-up period of 8.0 years (IQR: 4.6-10.9 years), 43 patients presented aorta-related events (25 died and 18 required endovascular treatment). FL systolic antegrade flow ≥30% with respect to total systolic antegrade flow and retrograde diastolic flow ≥80% with respect to total diastolic FL flow were predictors of aortic events. In multivariate analysis, aortic diameter >45 mm (HR: 2.91), type B dissection (HR: 2.44), and MRI flow pattern (HR: 16.87) were independent predictors of AD-related events. CONCLUSIONS: High systolic antegrade flow volume in the FL with significant diastolic retrograde flow assessed by MRI and aortic diameter >45 mm identify patients with higher risk for complications in whom more aggressive management would be indicated.

An assessment of the current medical management of thoracic aortic disease: A patient-centered scoping literature review.

Thoracic aortic aneurysm and dissection are complex diagnoses that require management by multidisciplinary providers using a variety of medical therapies, surgical interventions, and lifestyle modifications. Pharmacological agents, such as ß-blockers (atenolol) and angiotensin II type 1 receptor blockers (losartan), have been mainstay treatments for several years, and research from the past decade has continued to evaluate these and other medication classes to further improve patient morbidity and mortality. Combination ß- and renin-aldosterone-angiotensin blockade, statins, metformin, antioxidants, and vitamins have been evaluated as therapeutics in both thoracic and abdominal aortic aneurysms, as well as the effects of various antibiotics (ie, fluoroquinolones and tetracyclines) and benefits of lifestyle modifications (eg, diet and exercise) and enhanced patient-centered care and treatment adherence. In addition, as our understanding of the genetic, biochemical, and pathophysiological mechanisms behind these diseases expands, so do potential targets for future therapeutic research (eg, interleukins, matrix metalloproteases, and mast cells). This review incorporates the major meta-analyses, systematic and generalized reviews, and clinical trials published from 2010 through 2021 that focus on these topics in thoracic aortic aneurysms (and abdominal aneurysms when thoracic literature is scarce). Several key ongoing clinical trials, case studies, and in vivo/in vitro studies are also mentioned. Furthermore, we discuss current gaps in the literature and the abundance of clinical evidence for some interventions in abdominal aneurysms with few thoracic correlates, thus indicating a need for investigation of these subjects in the latter.

Procedure-Associated Costs and Mid-Term Outcomes of Endovascular Zone 0 and Zone 1 Aortic Arch Repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) of proximal aortic arch pathology provides a less-invasive treatment option for high-risk patients ineligible for open arch reconstruction. However, the fiscal impact of these techniques remains unclear. Therefore, our objective was to characterize the mid-term outcomes after Zone 0 and Zone 1 TEVAR and describe the associated technical costs, revenues, and net margins at a single tertiary medical center. METHODS: We examined all patients who underwent TEVAR between April 2011 and August 2019 via retrospective chart review. Patients were categorized by proximal endograft extent to identify Zone 0 or Zone 1 repairs. Procedural characteristics and outcomes were described. Technical costs, revenues, and margins were obtained from the hospital finance department. RESULTS: We identified 10 patients (6 Zone 0, 4 Zone 1) who were denied open arch reconstruction. Patients were predominantly female (n = 8; 80%) and the mean age was 72.8 ± 5.5 years. TEVAR was performed in 5 asymptomatic patients, urgently in 3 symptomatic patients, and emergently in 2 ruptured patients. TEVAR plus extra-anatomic bypass was performed in 4 patients. Another 4 patients also received parallel stent-grafting while 1 patient received a branched thoracic endograft and yet another an in-situ laser fenestration followed by branch stent grafting. Within the 30-day postoperative period, 1 patient experienced stroke and 1 patient died. Bypass and branch vessel patency were 100% through the duration of follow-up (mean 19.3 months). Mean total technical cost associated with all procedures or repair stages was $105,164 ± $59,338 while mean net technical margin was -$25,055 ± $18,746. The net technical margin was negative for 9 patients. CONCLUSIONS: Endovascular repair of the proximal aortic arch is associated with good mid-term outcomes in patients considered too high-risk for open repair. However, reimbursement does not adequately cover treatment cost, with net technical margins being negative in nearly all cases. To remain financially sustainable, efforts should be made to both optimize aortic arch TEVAR delivery as well as advocate for reimbursement commensurate with associated costs.

How Does Female Sex Affect Complex Endovascular Aortic Repair? A Single Centre Cohort Study.

OBJECTIVE: There is growing evidence of a female patient disadvantage in complex endovascular aortic repair using fenestrated and branched endografts (FB-EVAR) primarily related to peri-procedural events including ischaemic and access vessel complications. This study aimed to determine the impact of sex differences on treatment patterns, and in hospital outcomes in a single centre cohort. METHODS: This was a retrospective cross sectional single centre cohort study of all consecutive FB-EVAR procedures provided to patients with asymptomatic pararenal and thoraco-abdominal aortic aneurysm (TAAA) between 1 January 2010 and 28 February 2021. Adjusted multivariable logistic regression models were developed using backward (Wald) elimination of variables to determine the independent impact of female sex on short term outcomes. RESULTS: In total, 445 patients (24.3% females, median age 73.0 years, IQR 66, 78) were included. Female patients had a smaller aneurysm diameter, less frequent coronary artery disease (29.6% vs. 44.8%, p = .007) and history of myocardial infarction (2.8% vs. 15.4%, p < .001) when compared with males. Females were more frequently treated for TAAA than males (49.1% vs. 25.2%, p < .001). The median length of post-procedural hospital stay was 10 days in females and 9 in males. In adjusted analyses, female sex was independently associated with higher mortality (odds ratio [OR] 10.135, 95% CI 2.264 - 45.369), post-procedural complications (OR 2.500, 95% CI 1.329 - 4.702), spinal cord ischaemia (OR 4.488, 95% CI 1.610 - 12.509), sepsis (OR 4.940, 95% CI 1.379 - 17.702), and acute respiratory insufficiency (OR 3.283, 95% CI 1.015 - 10.622) after pararenal aortic aneurysm repair during the hospital stay. CONCLUSION: In this analysis of consecutively treated patients, female sex was associated with increased in hospital mortality, peri-procedural complications, and spinal cord ischaemia after elective complex endovascular repair of pararenal aortic aneurysm, while no differences were revealed in the TAAA subgroup. These results suggest that sex related patient selection and peri-procedural management should be studied in future research.

Hospitalization Cost and In-hospital Outcomes Following Type B Thoracic Aortic Dissection Repair.

BACKGROUND: Several studies have reported lower mortality and morbidity after thoracic endovascular aortic repair (TEVAR) when compared to open surgical repair (OSR) in the treatment of type B aortic dissection (TbAD). However, there are few studies in the literature on the cost of both treatment options. Thus, the aim of this study is to focus on in-hospital outcomes and cost associated with TbAD repair procedures in a national database in the United States. METHODS: A retrospective review of the Premier Healthcare Database (PHD) between June 2009 and March 2015 was performed. ICD-9-CM codes were used to identify patients who underwent OSR or TEVAR for TbAD. Endpoints included in-hospital adverse events, in-hospital mortality and hospitalization cost. Logistic regression models and generalized linear models were used to assess the impact of treatment type on the main outcomes. RESULTS: Out of 1752 patients with TbAD, 54.3% underwent OSR and 45.7% underwent TEVAR. Patients in the TEVAR group were older [median age, 64 (IQR 54-73) vs. 59 (IQR 49-70), P < 1] and more likely to have preexisting comorbidities. IAE rates were 78.6% for the OSR group compared to 43.1% for the TEVAR group, P < 0.001. Patients in the OSR group showed significantly higher in-hospital mortality (15.3% vs. 5.9%, P < 0.001). After adjusting for potential confounders, OSR was associated with a 5-fold increase in IAE [aOR(95%CI): 4.8 (3.8-6.1), P < 0.001] and a 3-fold increase in in-hospital mortality [aOR(95%CI): 3.3 (2.1-5.1), P < 0.001]. In regards to charges related to the hospital stay, total cost was significantly higher among patients undergoing OSR $53,371 ($39,029-$80,471) vs. TEVAR $45,311 ($31,479-$67,960), P < 0.001. CONCLUSION: The present study shows that TEVAR presents an advantage in terms of morbidity, mortality and cost when compared to OSR in the treatment of TbAD. However, long-term cost-effectiveness of both procedures remains unknown. Further research is warranted to see whether the superiority of TEVAR is maintained over time.

Sex-related outcomes after fenestrated-branched endovascular aneurysm repair for thoracoabdominal aortic aneurysms in the U.S. Fenestrated and Branched Aortic Research Consortium.

OBJECTIVE: Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. METHODS: The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). RESULTS: Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P = .043) but a lower prevalence of coronary artery disease (33% vs 52%; P < .0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P < .001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P < .001), experienced lower technical success (93% vs 98%; P = .002), and were less likely to be discharged to home (72% vs 83%; P = .009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P = .64), freedom from reintervention (81.7% vs 85.3%; P = .10), target vessel instability (87.5% vs 89.2%; P = .31), and survival (89.6% vs 91.7%; P = .26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P = .006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P = .46). CONCLUSIONS: Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated.

Epidemiology of thoracoabdominal aortic aneurysms.

Thoracoabdominal aortic aneurysms, although rare, continue to be associated with high morbidity and mortality in the modern era of vascular surgery, and knowledge of this disease is essential for those in clinical practice. Given the clinically silent nature of the disease, it is difficult to determine disease incidence, with most epidemiologic recommendations not made based on evidence regarding those diagnosed with the disease, but extrapolated from data on surgical outcomes. It appears that although men are more likely to develop thoracoabdominal aortic aneurysms, the distribution is not as skewed as in abdominal aortic aneurysms. Current evidence suggests that Black and Hispanic patients continue to have disproportionately poor disease outcomes, mostly attributed to later presentation and undergoing interventions at lower-volume centers. Although select patients meet criteria for disease screening based on personal or family history of aneurysmal disease, general population screening has not been recommended by any professional organization to date. Vascular surgeons need to continue to be at the forefront of thoracoabdominal aortic aneurysm management, especially as care becomes centered around comprehensive "aortic care centers" and as more endovascular therapies become available.

Measurement accuracy of prototype non-contrast, compressed sensing-based, respiratory motion-resolved whole heart cardiovascular magnetic resonance angiography for the assessment of thoracic aortic dilatation: comparison with computed tomography angiography.

BACKGROUND: Patients with thoracic aortic dilatation who undergo annual computed tomography angiography (CTA) are subject to repeated radiation and contrast exposure. The purpose of this study was to evaluate the feasibility of a non-contrast, respiratory motion-resolved whole-heart cardiovascular magnetic resonance angiography (CMRA) technique against reference standard CTA, for the quantitative assessment of cardiovascular anatomy and monitoring of disease progression in patients with thoracic aortic dilatation.  METHODS: Twenty-four patients (68.6 ± 9.8 years) with thoracic aortic dilatation prospectively underwent clinical CTA and research 1.5T CMRA between July 2017 and November 2018. Scans were repeated in 15 patients 1 year later. A prototype free-breathing 3D radial balanced steady-state free-precession whole-heart CMRA sequence was used in combination with compressed sensing-based reconstruction. Area, circumference, and diameter measurements were obtained at seven aortic levels by two experienced and two inexperienced readers. In addition, area and diameter measurements of the cardiac chambers, pulmonary arteries and pulmonary veins were also obtained. Agreement between the two modalities was assessed with intraclass correlation coefficient (ICC) analysis, Bland-Altman plots and scatter plots. RESULTS: Area, circumference and diameter measurements on a per-level analysis showed good or excellent agreement between CTA and CMRA (ICCs > 0.84). Means of differences on Bland-Altman plots were: area 0.0 cm2 [- 1.7; 1.6]; circumference 1.0 mm [- 10.0; 12.0], and diameter 0.6 mm [- 2.6; 3.6]. Area and diameter measurements of the left cardiac chambers showed good agreement (ICCs > 0.80), while moderate to good agreement was observed for the right chambers (all ICCs > 0.56). Similar good to excellent inter-modality agreement was shown for the pulmonary arteries and veins (ICC range 0.79-0.93), with the exception of the left lower pulmonary vein (ICC < 0.51). Inter-reader assessment demonstrated mostly good or excellent agreement for both CTA and CMRA measurements on a per-level analysis (ICCs > 0.64). Difference in maximum aortic diameter measurements at baseline vs follow up showed excellent agreement between CMRA and CTA (ICC = 0.91). CONCLUSIONS: The radial whole-heart CMRA technique combined with respiratory motion-resolved reconstruction provides comparable anatomical measurements of the thoracic aorta and cardiac structures as the reference standard CTA. It could potentially be used to diagnose and monitor patients with thoracic aortic dilatation without exposing them to radiation or contrast media.

Influence of Sex on Outcomes After Thoracic Endovascular Repair for Type B Aortic Dissection.

We aimed to investigate whether sex differences influence the clinical outcomes of patients who undergo thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). We retrospectively analyzed a prospectively maintained single-center cohort of patients with TBAD who underwent TEVAR between January 2010 and June 2017. We evaluated the in-hospital and long-term mortality and composite end point. Of the 913 patients, 793 (86.8%) were male and 120 (13.1%) were female. Compared to male patients, the female patients were older, more likely to have diabetes mellitus, but less likely to smoke or have hypertension. The proximal landing zone in 0 and 1 was higher in male patients (P = .023), who were more likely to require an aortic arch bypass. Endoleak, delirium, and ICU stay after stent-graft implantation were also more frequent in men. Sex factor was not associated with in-hospital or long-term mortality or the composite end point in the multivariable regression analyses and Cox regression model. The mean estimated survival time was similar between males and females (2462.9 ± 141.2 vs 2804.1 ± 117.4 days, P = .167) in the propensity score-matched cohort. Despite distinct characteristics between sex, there was no sex-related difference in long-term clinical outcomes after TEVAR for TBAD.

Thoracic aortic size in Brazilian smokers: measures using low-dose chest computed tomography anatomical and epidemiological assessment.

OBJECTIVES: Thoracic aortic aneurysms (TAAs) represent one-third of the hospitalizations for aortic diseases. The prevalence rate depends on the definition of the normal size of the aorta, which is quite variable, depending on the population studied. The aim of this study was to evaluate the characteristics of the thoracic aorta of Brazilian smokers, identifying the normal size of the aorta, presence of anatomical variations, and prevalence of TAA. MATERIALS AND METHODS: A total of 711 patients underwent radiological evaluation with low-dose computed tomography (CT) from January 2013 to July 2014 with the initial objective of lung nodule tracking. Two examiners evaluated these images, and measurements of maximum and serial diameters were performed manually in true orthogonal planes. Serial diameter measurements were taken every 2 cm in the ascending aorta and 5 cm in the descending segment. We searched for anatomical variations, aortic arch type, and correlations between anatomical characteristics, sex, body mass index, and body surface area (BSA). RESULTS: The maximum diameters were 33.61 (standard deviation [SD] 3.88), 28.66 (SD 2.89), and 28.36 mm (SD 3.09) for the ascending segment, aortic arch, and descending segment, respectively. A positive correlation was found between male sex, age, and BSA and aorta diameter. The bovine arch was the most common variation of the aortic arch type, and we found one (0.14%) case of TAA. CONCLUSIONS: This study with low-dose CT allowed the determination of the mean diameters of the ascending aorta, aortic arch, and descending aorta in Brazilian smokers and TAA prevalence.

Sex-related outcomes after open type IV thoracoabdominal aortic aneurysm repair.

OBJECTIVE: Although outcomes after infrarenal abdominal aortic aneurysm surgery are worse in women, sex-specific differences in outcomes after open type IV thoracoabdominal aortic aneurysm (TAAA) surgery are undefined. The goal of this study was to define sex-based disparities in short- and long-term outcomes after open type IV TAAA surgery. METHODS: All open type IV TAAA repairs performed during 27 years were evaluated using a single institutional database. Charts were retrospectively evaluated for major adverse events (in-hospital death, other major in-hospital complication) and long-term complications (graft- and aortic-related events and death). Univariate analyses were performed using the Fisher's exact test for categorical variables and Wilcoxon rank-sum testing for continuous variables. Logistic multivariable regression was used for the in-hospital end points death and major complication, and survival analyses were performed with Cox proportional hazards modeling and Kaplan-Meier techniques. RESULTS: During the 27-year study period, 234 patients had an open type IV TAAA repair; 85 were female and 149 were male. There were 26 (17.5%) men and 16 (18.8%) women who suffered a major in-hospital complication/death. There were eight (3.4%) in-hospital deaths, all occurring in men. Unadjusted survival at 5 years was 67.9% for women and 58.4% for men. Multivariable analyses revealed no sex-based difference in combined major in-hospital events and death (female: odds ratio [OR], 1.8; confidence interval [CI], 0.83-4.0; P = .13) or any complication (OR, 1.0; CI, 0.55-1.8; P = .99). However, women were less likely than men to be discharged to home (OR, 0.28; CI, 0.13-0.60; P = .001) and had decreased survival compared with men after discharge (hazard ratio, 2.1; CI, 1.2-3.5; P = .008). CONCLUSIONS: No sex-based differences were found for the in-hospital outcomes of death or major complication after open type IV TAAA repair. However, women are less likely than men to be discharged home. Among those who survive the index operation, female sex portends decreased survival following discharge after repair.

Health care costs of endovascular compared with open thoracoabdominal aortic aneurysm repair.

OBJECTIVE: To compare 1-year health care costs between endovascular and open thoracoabdominal aortic aneurysm (TAAA). METHODS: Population-based administrative health databases were used to capture TAAA repairs performed in Ontario, Canada, between January 2006 and February 2017. All health care costs incurred by the Ministry of Health from a single-payer universal health care system were included. Costs of the aortic endografts and ancillary devices for the index procedure were estimated as C$44,000 per endovascular case vs C$1000 for open cases, based on previous reports. Costs (2017 Canadian dollars) were calculated in phases (1, 1-3, 3-6, and 6-12 months from surgery) with censoring for death. For each phase, propensity score matching of endovascular and open cases based on preoperative patient and hospital characteristics was used. The association between preoperative characteristics (including repair approach) and the first month postprocedure cost was characterized through multivariable analysis. RESULTS: Overall 664 TAAA repairs were identified (open, n = 361 [54.5%] and endovascular, n = 303 [45.6%]). At 1 month, the median cost was higher for endovascular TAAA repair in the prematching cohort (C$64,892 vs C$36,647; P < .01). Similarly, in 241 well-balanced endovascular/open patient pairs after propensity score matching, the median health care costs were higher in endovascular TAAA cases during the first month (C$62,802 vs C$33,605; P < .01). The 1- to 3-month median cost was not statistically different between endovascular and open TAAA cases either before matching (C$2781 vs C$2618; P = .71) or after matching (C$2762 vs C$2092; P = .58). Likewise, in the 3- to 6-month and 6- to 12-month postprocedure intervals, there were no significant differences in the median health care costs between groups. On multivariable analysis, older age (5-year increments) (relative change [RC] in mean cost, 1.05; 95% confidence interval [CI], 1.04-1.06; P = .01), urgent procedures (RC, 1.29; 95% CI, 1.10-1.52; P < .01), and history of stroke (RC, 1.34; 95% CI, 1.00-1.78; P = .05) were associated with higher costs in the first postoperative month, whereas open relative to endovascular TAAA repair was associated with a decreased 1-month cost (RC, 0.65; 95% CI, 0.56-0.74; P < .01). CONCLUSIONS: TAAA repair is expensive regardless of technique. Compared with open TAAA repair, endovascular repair was associated with a higher early cost, owing to the upfront cost of the endograft and aortic ancillary devices. There was no difference in cost from 1 to 12 months after repair. A decrease in the cost of endovascular devices might allow equivalent costs between endovascular and open TAAA repair.

Ten-Year Clinical Characteristics and Early Outcomes of Type B Aortic Dissection Patients With Thoracic Endovascular Aortic Repair.

OBJECTIVE/BACKGROUND: This study examined the 10-year hospitalization characteristics, economic patterns and early clinical outcomes of type B aortic dissection (TBAD) patients that underwent thoracic endovascular aortic repair (TEVAR) in one high-volume hospital in China. METHODS: We performed a population-based retrospective analysis based on electronic medical record system data provided by Zhongshan Hospital Fudan University from 2009 to 2018. RESULTS: We identified 1,367 cases of TBAD patients with TEVAR over the past decade. The total incidence of in-hospital complications was 7.6% (104 of 1,367), among which acute kidney injury (AKI) had the highest incidence (3.1%, 42 of 1,367). Aortic-related reintervention was performed in 7 patients (0.5%). The overall aortic-related in-hospital mortality rate was 2.7% (37 of 1,367) and had no significant time-varying trend (P = 0.2). Among these, 27% of in-hospital deaths were caused by retrograde type A dissection (RTAD). Chronic TBAD had a higher risk of in-hospital death versus acute TBAD, with a risk ratio of 2.69 (95% confidence interval [CI]: 1.19-6.09). Patients with hypertension (risk ratio 4.63, 95% CI: 1.38, 15.54) also had a higher in-hospital death risk. These 2 factors were also the predictive factors for the composite endpoint of in-hospital adverse events (risk ratio 2.17, 95% CI: 1.43, 3.29 and risk ratio 4.83, 95% CI: 1.90, 12.28, respectively), in addition to Marfan syndrome (risk ratio 4.05, 95% CI: 1.61, 10.19). The average length of hospitalization significantly declined during the past decade (annual percentage change -6.3%, 95% CI -8.2 to -4.3), and the stent-grafts (SGs) cost was the main expenditure of the total hospitalization costs. CONCLUSION: Our study showed a favorable early outcome of TEVAR over the past decade. Greater attention should be paid to certain risk factors in order to reduce the in-hospital adverse events. SG expenditure is still the primary economic burden on Chinese TBAD patients.