Endovascular treatment for thoracic aortic disease from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: Global Registry for Endovascular Aortic Treatment (GREAT) is an international prospective multicenter registry collecting real-world data on performance of W. L. Gore thoracic and abdominal aortic endografts. This analysis evaluated the long-term differences in patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for any thoracic aortic pathology. METHODS: From August 2010 to October 2016, 5014 patients were enrolled in GREAT. The population of interest was comprised of only patients treated for thoracic aortic pathologies. Through 5 years, primary outcomes were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, paraplegia, and any reintervention through 5 years, grouped by pathology. Secondary outcomes were reintervention rate and freedom from serious device- and aortic-related events. RESULTS: The 578 patients with thoracic aortic pathologies enrolled in GREAT and identified for this analysis were categorized by common pathologies: thoracic aneurysm (n = 239), thoracic dissection (n = 203), arch (n = 26), and other (n = 110). The mean age of this population was 66.1 ± 12.8 years, and 64.7% were male. Procedure survival was 99.7%. In the overall group, at index procedure to 30 days and 31 days to 5 years, Kaplan-Meier estimates of freedom from all-cause mortality were 99.6% and 66.4%, respectively, and for aortic-related mortality were 97.7% and 94.6%, respectively. Aortic rupture rate was 0.5% (n = 3) at 30 days and 1.4% (n = 8) through 5 years. Stroke and spinal cord ischemic events were 1.9% (n = 11) and 1.6% (n = 9) at 30 days and at 5 years were 3.6% (n = 20), 0.5% (n = 3), respectively. Reinterventions were required in 7.3% (n = 42) at 30 days and 12.4% (n = 69) through 5 years. The number of patients with endoleaks at 30 days was 2.1% (n = 12): n = 3 (1.1%) for each of types IA, 1B, and II; n = 2 (0.3%) for type III; and n = 4 (0.7%) for unspecified. Through 5 years, the percentage of patients was 8.3% (n = 40): n = 15 (3.1%) for type IA; n = 10 (2.1%) for type IB; n = 11 (2.3%) for type II; and n = 9 (1.9%) for unspecified. One patient (0.2%) had stent migration at 30 days (aneurysm group); none were reported through 5 years. There were no incidents of stent compression or fracture from index procedure through 5 years. CONCLUSIONS: Data herein demonstrates durability and support for treatment of thoracic aortic disease with the GORE TAG conformable thoracic stent graft, including no incidents of stent compression/fracture and high freedom from aortic-related mortality. The planned analysis of follow-up to 10 years in GREAT will be beneficial.

Outcomes of endovascular therapy for Stanford type B aortic dissection in patients with sleep apnea syndrome.

OBJECTIVE: This study aimed to determine the influences of varying severity of sleep apnea syndrome (SAS) on the outcomes after thoracic endovascular aorta repair (TEVAR) in patients with Stanford type B aortic dissection (TBAD). METHODS: This observational study focused on individuals with TBAD plus SAS who received TEVAR between January 2018 and December 2022. Patients were divided into groups according to the results of the portable sleep-breathing monitoring systems: mild SAS (MSAS) and moderate-to-severe SAS (MSSAS). Clinical profiles were collected and analyzed. RESULTS: A total of 121 cases with TBAD plus SAS who underwent TEVAR were enrolled in this study. Two groups were formed by stratifying these cases: MSAS (74 cases) and MSSAS (47 cases). The MSSAS cases were found to be older relative to MSAS cases (51.7 ± 8.3 years vs 57.1 ± 12.8 years; P = .012) and had a higher body mass index (BMI; 25.7 ± 2.3 kg/m2vs 27.0 ± 2.3 kg/m2; P = .038). The investigation did not find any appreciable differences between the MSAS and MSSAS groups in terms of complications (endoleak, P = .403; stent-induced new entry, P >.999; and stent displacement: P >.999). However, the MSSAS group exhibited a significantly higher overall mortality rate compared with the MSAS group (log-rank P = .027). The tendency continued when examining cases with Marfan syndrome combined with MSSAS, where the overall mortality rate was significantly greater compared with Marfan syndrome cases with MSAS (log-rank P = .037). The absence of a significant difference was noteworthy in the freedom from reintervention between the MSAS and MSSAS groups (log-rank P = .278). The overall mortality rate was significantly higher in MSSAS group even after adjusting for varying potential confounders in the multivariate cox regression analysis (hazard ratio [HR], 1.875; 95% confidence interval [CI], 1.238-2.586; P = .012). A markedly higher rate of distal stent dilation in the MSSAS group was also observed compared with the MSAS group (HR, 2.5 mm/year [95% CI, 2-3 mm/year] vs HR, 4 mm/year [95% CI, 2.0-5.5 mm/year]; P = .029). CONCLUSIONS: MSSAS is associated with a significantly higher risk of overall mortality and dilation rate of the distal stent after TEVAR for TBAD patients. Hence, aggressive efforts to reverse the severity of SAS in time in these individuals seem to be necessary.

Extended thoracic endovascular aortic repair is optimal therapy in acute complicated type B dissection.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) represents optimal therapy for complicated acute type B aortic dissection (aTBAD). Persistent knowledge gaps remain, including the optimal length of aortic coverage, impact on distal aortic remodeling, and fate of the dissected abdominal aorta. METHODS: Review of the Emory Aortic Database identified 92 patients who underwent TEVAR for complicated aTBAD from 2012 to 2018. Standard TEVAR covered aortic zones 3 and 4 (from the left subclavian to the mid-descending thoracic aorta). Extended TEVAR fully covered aortic zones 3 though 5 (from the left subclavian to the celiac artery). Long-term imaging, clinical follow-up, and overall and aortic-specific mortality were reviewed. RESULTS: Extended TEVAR (n = 52) required a greater length of coverage vs standard TEVAR (n = 40) (240 ± 32 mm vs 183 ± 23 mm; P < .01). In-hospital mortality occurred in 5.4% of patients (7.7% vs 2.5%; P = .27) owing to mesenteric malperfusion (n = 3) or rupture (n = 2). The overall incidences of postoperative stroke, transient paraparesis, paraplegia, and dialysis were 5.4% (3.9% vs 7.5%; P = .38), 3.2% (5.8% vs 0%; P = .18), 0%, and 0% respectively, equivalent between groups. Follow-up was 96.6% complete to a mean of 6.1 years (interquartile range, 3.5-8.6 years). There were significantly higher rates of complete thrombosis or obliteration of the entire thoracic false lumen after Extended TEVAR (82.2% vs 51.5%; P = .04). Distal aortic reinterventions were less frequent after extended TEVAR (5.8% vs 20%; P = .04). Late aorta-specific survival was 98.1% after extended TEVAR vs 92.3% for standard TEVAR (P = .32). CONCLUSIONS: Extended TEVAR for complicated aTBAD is safe, results in a high rate of total thoracic false lumen thrombosis/obliteration, and reduces distal reinterventions. Longer-term follow-up will be needed to demonstrate a survival benefit compared to limited aortic coverage.

Access site complications in thoracic endovascular aortic repair.

BACKGROUND: Percutaneous access and use of vascular closure devices facilitate thoracic endovascular aortic repair (TEVAR) procedures during local anesthesia and allow immediate detection of signs of spinal ischemia. However, the very large bore access (usually ≥22F sheath) associated with TEVAR increases the risk of vascular complications. In this study, we sought to define the safety and feasibility of two percutaneous femoral artery closure devices during TEVAR, in terms of access site vascular complications and major, life-threatening, or fatal bleeding (≥major) within 48 hours. Access site vascular complications were defined as technical failure of vascular closure or later formation of pseudoaneurysm. METHODS: From March 2010 to December 2022, 199 transfemoral TEVAR were performed at Helsinki University Central Hospital, Finland. We retrospectively categorized these into three groups, based on surgeon preference for the access technique and femoral artery closure method: (1) surgical cut-down and vessel closure, n = 85 (42.7%), (2) percutaneous access and vascular closure with suture-based ProGlide, n = 56 (28.1%), or (3) percutaneous access and vascular closure with ultrasound-guided plug-based MANTA, n = 58 (29.1%). The primary outcome measure was technical success of vascular closure and access site vascular complications during index hospitalization. Secondary outcome measures were ≥major bleeding, early mortality, and hospital stay. RESULTS: The technical success rate was 97.6% vs 91.1% vs 93.1% for surgical cut-down, ProGlide, and MANTA, respectively (P = .213). The rate of access site vascular complication was 3.5% vs 8.9% vs 10.3%, respectively (P = .290), with two pseudoaneurysms detected postoperatively and conservatively managed in the MANTA group. The vascular closure method was not associated with increased risk of ≥major bleeding, early mortality, or hospital stay on univariate analysis. Predictors for ≥major bleeding after TEVAR in multivariable analysis were urgent procedure (odds ratio: 2.8, 95% confidence interval: 1.4-5.5; P = .003) and simultaneous aortic branch revascularization (odds ratio: 2.7, 95% confidence interval: 1.3-5.4; P = .008). CONCLUSIONS: In this study, the technical success rates of the percutaneous techniques demonstrated their feasibility during TEVAR. However, the number of access site complications for percutaneous techniques was higher compared with open approach, although the difference was not statistically significant. In the lack of evidence, the safety of the new MANTA plug-based vascular closure for TEVAR warrants further investigation.

Clinical outcomes of celiac artery coverage vs preservation during thoracic endovascular aortic repair.

OBJECTIVE: Adequate proximal and distal seal zones are necessary for successful thoracic endovascular aortic repair (TEVAR). Often, the achievement of an adequate distal seal zone requires celiac artery (CA) coverage by endograft with or without preservation of CA blood flow. The outcomes of CA coverage without its flow preservation were studied only in small case series. This study aims to determine the difference in outcomes between CA coverage with vs without preservation of CA blood flow during TEVAR using a multi-institutional national database. METHODS: The Vascular Quality Initiative database was reviewed for all TEVAR patients distally landing in zone 6. The cohort was divided into TEVAR with vs without CA flow preservation. Demographic, clinical, and perioperative characteristics, as well as postoperative mortality, morbidities, and complications, were compared between the groups. Univariate and multivariate regression analyses were performed. RESULTS: Of 25,549 reviewed patients, 772 had a distal landing in Zone 6, 212 of which (27.5%) had TEVAR without CA flow preservation, whereas 560 (72.5%) underwent TEVAR with CA flow preservation. Indications for TEVAR were aneurysm in 431 (55.8%), dissection in 247 (32.0%), or other in 94 (12.2%) cases. Patients who underwent TEVAR without CA flow preservation had statistically significantly higher rates of 30-day mortality (11.3% vs 5.9%; P = .010), 30-day disease/treatment-related mortality (8.0% vs 4.3%; P = .039), as well as a tendency of increased intestinal ischemia requiring intervention (1.9% vs 0.5%; P = .077). After adjusting for potential confounders, CA coverage without flow preservation was associated with more than a two-fold increase in the overall 30-day mortality (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.35-5.92; P = .006) and 30-day disease/treatment-related mortality (OR, 2.72; 95% CI, 1.11-6.72; P = .029). In a sub-group analysis based on disease pathology, these results persisted only in the aneurysm group (30-day mortality [OR, 2.36; 95% CI, 1.01-5.48; P = .047]; 30-day disease/treatment-related mortality [OR, 2.88; 95% CI, 1.08-7.67; P = .034]), whereas there was no significant association between CA flow preservation status and the endpoints in the dissection subgroup (30-day mortality [OR, 1.16; 95% CI, 0.22-6.05; P = .856], 30-day disease/treatment-related mortality [OR, 0.90; 95% CI, 0.16-5.19; P = .911]). CONCLUSIONS: CA coverage during TEVAR without preservation of its blood flow is associated with significantly higher mortality in patients with aortic aneurysm, but not dissection. In patients with aortic aneurysm, CA flow should be preserved during TEVAR whenever feasible, whereas in patients with dissection, it may be safe to cover CA without preservation of its flow. Prospective studies should be done to confirm these findings and compare the open vs endovascular revascularization techniques on outcomes.

Predicting the need for subclavian artery revascularization in thoracic endovascular aortic repair: A systematic review and meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aims to investigate the effectiveness of left subclavian artery revascularization compared with non-revascularization in thoracic endovascular aortic repair, and to summarize the current evidence on its indications. METHODS: A computerized search was conducted across multiple databases, including MEDLINE, SCOPUS, Cochrane Library, and Web of Science, for studies published up to November 2023. Study selection, data abstraction, and quality assessment (using the Newcastle-Ottawa Scale) were independently conducted by two reviewers, with a third author resolving discrepancies. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using random-effects models and publication bias was assessed using funnel plots. RESULTS: In the 76 included studies, left subclavian artery revascularization was associated with reduced risks of stroke (OR, 0.67; 95% CI, 0.45-0.98; n = 15,331), spinal cord ischemia (OR, 0.75; 95% CI, 0.56-0.99; n = 11,995), and arm ischemia (OR, 0.09; 95% CI, 0.01-0.59; n = 8438). No significant reduction in paraplegia (OR, 0.56; 95% CI, 0.21-1.47; n = 1802) or mortality (OR, 0.77; 95% CI, 0.53-1.12; n = 11,831) was observed. Moreover, the risk of endoleak was comparable in both groups (OR, 1.25; 95% CI, 0.55-2.84; P = .60; n = 793), whereas the risk of reintervention was significantly higher in the revascularization group (OR, 1.98; 95% CI, 1.03-3.83; P = .04; n = 272). Both groups had similar risks of major (OR, 0.45; 95% CI, 0.19-1.09; P = .08; n = 1113), minor (OR, 0.21; 95% CI, 0.01-3.45; P = .27; n = 183), renal (OR, 0.61; 95% CI, 0.12-3.06; P = .55; n = 310), and pulmonary (OR, 0.59; 95% CI, 0.16-2.15; P = .42; n = 8083) complications. The most frequent indications for left subclavian artery revascularization were primary prevention of spinal cord ischemia, augmentation of the landing zone, and primary stroke prevention. CONCLUSIONS: Left subclavian artery revascularization in thoracic endovascular aortic repair was associated with reduced neurological complications but was not found to impact mortality. The study highlights important indications for revascularization as well as significant predictors of complications, providing a basis for clinical decision-making and future research.

Surgeon volume and outcomes following thoracic endovascular aortic repair for blunt thoracic aortic injury.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) at high-volume hospitals has previously been associated with lower perioperative mortality, but the impact of annual surgeon volume on outcomes following TEVAR for BTAI remains unknown. METHODS: We analyzed Vascular Quality Initiative (VQI) data from patients with BTAI that underwent TEVAR between 2013 and 2023. Annual surgeon volumes were computed as the number of TEVARs (for any pathology) performed over a 1-year period preceding each procedure and were further categorized into quintiles. Surgeons in the first volume quintile were categorized as low volume (LV), the highest quintile as high volume (HV), and the middle three quintiles as medium volume (MV). TEVAR procedures performed by surgeons with less than 1-year enrollment in the VQI were excluded. Using multilevel logistic regression models, we evaluated associations between surgeon volume and perioperative outcomes, accounting for annual center volumes and adjusting for potential confounders, including aortic injury grade and severity of coexisting injuries. Multilevel models accounted for the nested clustering of patients and surgeons within the same center. Sensitivity analysis excluding patients with grade IV BTAI was performed. RESULTS: We studied 1321 patients who underwent TEVAR for BTAI (28% by LV surgeons [0-1 procedures per year], 52% by MV surgeons [2-8 procedures per year], 20% by HV surgeons [≥9 procedures per year]). With higher surgeon volume, TEVAR was delayed more (in <4 hours: LV: 68%, MV: 54%, HV: 46%; P < .001; elective (>24 hours): LV: 5.1%; MV: 8.9%: HV: 14%), heparin administered more (LV: 80%, MV: 81%, HV: 87%; P = .007), perioperative mortality appears lower (LV: 11%, MV: 7.3%, HV: 6.5%; P = .095), and ischemic/hemorrhagic stroke was lower (LV: 6.5%, MV: 3.6%, HV: 1.5%; P = .006). After adjustment, compared with LV surgeons, higher volume surgeons had lower odds of perioperative mortality (MV: 0.49; 95% confidence interval [CI], 0.25-0.97; P = .039; HV: 0.45; 95% CI, 0.16-1.22; P = .12; MV/HV: 0.50; 95% CI, 0.26-0.96; P = .038) and ischemic/hemorrhagic stroke (MV: 0.38; 95% CI, 0.18-0.81; P = .011; HV: 0.16; 95% CI, 0.04-0.61; P = .008). Sensitivity analysis found lower adjusted odds for perioperative mortality (although not significant) and ischemic/hemorrhagic stroke for higher volume surgeons. CONCLUSIONS: In patients undergoing TEVAR for BTAI, higher surgeon volume is independently associated with lower perioperative mortality and postoperative stroke, regardless of hospital volume. Future studies could elucidate if TEVAR for non-ruptured BTAI might be delayed and allow stabilization, heparinization, and involvement of a higher TEVAR volume surgeon.

Sex-based outcomes after thoracic endovascular aortic repair: A systematic review and meta-analysis.

OBJECTIVE: As it remains unclear whether there are sex-based differences in clinical outcomes after thoracic endovascular aortic repair (TEVAR), this meta-analysis aimed to evaluate differences in early outcomes and overall survival between female and male patients who underwent TEVAR. METHODS: The PubMed, Embase, Web of Science, and Cochrane Central databases were searched for eligible studies published through June 10, 2023, that reported sex-based differences in clinical outcomes after TEVAR. The primary outcome was operative mortality; second outcomes included stroke, spinal cord ischemia, acute kidney injury, hospital length of stay, and overall survival. Patient characteristics, operative data, and early outcomes were aggregated using the random-effects model, presenting pooled risk ratio (RR) or standardized mean difference along with their corresponding 95% confidence intervals (CIs). Overall survival was assessed by reconstructing individual patient data to generate sex-specific pooled Kaplan-Meier curves. This study was registered in PROSPERO (CRD42023426069). RESULTS: Of the 1785 studies retrieved, 14 studies met all eligibility criteria, encompassing a total of 17,374 patients, comprising 5026 female and 12,348 male patients. Female patients were older, had a smaller maximum aortic diameter, had lower rates of smoking and coronary artery disease, and had higher rates of anemia. Intraoperatively, female patients were more likely to use iliac conduits and require blood transfusions. There were no sex-based differences in operative mortality (RR: 1.12, 95% CI: 0.90-1.40; P = .309), stroke (RR: 1.14, 95% CI: 0.95-1.38; P = .165), spinal cord ischemia (RR: 1.33, 95% CI: 0.83-2.14; P = .234), acute kidney injury (RR: 0.78, 95% CI: 0.52-1.17; P = .228), and hospital length of stay (standardized mean difference: 0.09, 95% CI: -0.03 to 0.20; P = .141). Pooled Kaplan-Meier estimates showed a worse overall survival in female patients compared with male patients (87.2% vs 89.8% at 2 years, log-rank P = .001). CONCLUSIONS: Among patients treated by TEVAR, female sex was not associated with increased risk of operative mortality or major morbidity. However, female patients exhibited a lower overall survival after TEVAR compared with male patients.

Outcomes of thoracic endovascular aortic repair with physician-manufactured partial micropore stent grafts for aortic arch pathologies.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has been used extensively in the management of thoracic aortic diseases. Numerous efforts have been made to enhance clinical outcomes through the use of stent grafts. This study aimed to investigate the effectiveness and safety of physician-manufactured partial micropore stent grafts (PSMGs) in TEVAR. METHODS: Between December 2017 and June 2022, data were collected from 56 patients who underwent TEVAR using physician-manufactured PSMGs. The evaluation encompassed technical success, perioperative and follow-up morbidity and mortality, stroke incidence, and branch artery patency. RESULTS: In this investigation, 56 patients received treatment with physician-manufactured PSMGs. Of these patients, 46 were male, with a mean age of 62.1 ± 11.2 years. Aortic pathologies comprised aortic dissection (n = 31 [55.4%]), aortic aneurysms (n = 10 [17.9%]), penetrating aortic ulcer (n = 8 [14.3%]), and intramural hematoma (n = 7 [12.5%]). During a median follow-up of 18 months (interquartile range, 13-25 months), the stroke rate, supra-aortic branch patency rate, and endoleak rate were 0%, 100%, and 7.1%, respectively. There were no occurrences of all-cause mortality, stroke, or the necessity for open conversion. CONCLUSIONS: TEVAR with physician-manufactured PSMGs is a viable alternative for addressing aortic arch pathologies in proficient medical centers. The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality.

Outcomes of post-implantation syndrome after endovascular repair for Stanford type B aortic dissection.

OBJECTIVE: The aim of this study was to investigate the correlation between post-implantation syndrome (PIS) and long-term prognosis in patients with Stanford type B aortic dissection (TBAD) undergoing thoracic endovascular aortic repair (TEVAR). METHODS: This retrospective study included 547 consecutive patients diagnosed with TBAD who underwent TEVAR at our institution between January 2014 and December 2019. Patients were categorized into two groups: the PIS group (patients with post-TEVAR PIS) and the non-PIS group (patients without post-TEVAR PIS). In-hospital and follow-up data were analyzed. RESULTS: The incidence of PIS was 28.9% (158/547 patients). No baseline differences were observed between the PIS (n = 158) and the non-PIS (n = 389) groups. The proportion of emergency surgery in the PIS group was higher than that in the non-PIS group (44.9% vs 26.0%; P < .001), the operation time was longer (median, 65.0; interquartile range [IQR], 56.0-75.0 minutes vs 56.0; IQR, 45.0-66.0 minutes; P < .001), the volume of contrast medium used (median, 65.0; IQR, 56.0-75.0 mL vs 56.0; IQR, 45.0-66.0 mL; P < .001), and the average number of trunk stents (1.85 ± 0.4 vs 1.34 ± 0.5 pieces; P < .001) and branch stents (0.7 ± 0.7 vs 0.2 ± 0.5 pieces; P < .001) used were more in the PIS group than in the non-PIS group. The incidence of supra-aortic branch procedures was higher in the PIS group than in the non-PIS group. There was no significant difference in device-related complications (DRCs) or 30-day mortality between the two groups (2.5% vs 4.4%; P = .442 and 1.3% vs 1.3%; P = .688, respectively). Univariate and multivariable logistic regression analysis showed that emergency surgery, number of trunk stents >1, operation time >58.5 minutes, and contrast medium volume >75 mL were risk factors for PIS, and the odds ratios of emergency operation, number of trunk stents >1 piece, operation time >58.5 minutes, and contrast medium volume >75 mL were 2.526 (95% confidence interval [CI], 1.530-4.173), 4.651 (95% CI, 2.838-7.624), 3.577 (95% CI, 2.201-5.815), and 7.356 (95% CI, 4.111-13.160), respectively. Follow-up was completed in 98.5% (532/540) of the patients, with a median follow-up of 67 months (IQR, 50-86 months). There was no significant difference in survival between the PIS and non-PIS groups (12.4% vs 10.3%; P = .476) during follow-up. The incidences of DRCs (7.8% vs 11.6%; P = .200) and aortic false lumen thrombosis (75.8% vs 79.2%; P = .399) were comparable between the PIS and non-PIS groups. Univariate logistic regression analysis showed that PIS had no effect on long-term follow-up mortality, DRCs, entry flow, or aortic false lumen thrombosis rate. CONCLUSIONS: PIS is relatively common after TEVAR and emergency surgery; number of trunk stents >1, operation time >58.5 minutes, and contrast medium volume >75 mL are of high predictive value for the assessment of PIS after TEVAR. However, PIS had little effect on early and late postoperative mortality or DRCs.

Early three-dimensional growth in uncomplicated type B aortic dissection is associated with long-term outcomes.

OBJECTIVE: Late adverse events (LAEs) are common among initially uncomplicated type B aortic dissection (uTBAD); however, identifying those patients at highest risk of LAEs remains a significant challenge. Early false lumen (FL) growth has been suggested to increase risk, but confident determination of growth is often hampered by error in two-dimensional clinical measurements. Semi-automated three-dimensional (3D) mapping of aortic growth, such as by vascular deformation mapping (VDM), can potentially overcome this limitation using computed tomography angiograms (CTA). We hypothesized that FL growth in the early pre-dissection phase by VDM can accurately predict LAEs. METHODS: We performed a two-center retrospective study of patients with uTBAD, with paired CTAs in the acute (1-14 days) and subacute/early chronic (1-6 months) periods. VDM analysis was used to map 3D growth. Standard clinical CT measures (ie, aortic diameters, tear characteristics) were also collected. Multivariate analysis was conducted using a decision tree and Cox proportional hazards model. LAEs were defined as aneurysmal FL (>55 mm); rapid growth (>5 mm within 6 months); aorta-specific mortality, rupture, or re-dissection. RESULTS: A total of 107 (69% male) patients with uTBAD initially met inclusion criteria with a median follow-up of 7.3 years (interquartile range [IQR], 4.7-9.9 years). LAEs occurred in 72 patients (67%) at 2.5 years (IQR, 0.7-4.8 years) after the initial event. A multivariate decision tree model identified VDM growth (>2.1 mm) and baseline diameter (>42.7 mm) as optimal predictors of LAEs (area under the receiver operating characteristic curve = 0.94), achieving an 87% accuracy (sensitivity of 93%, specificity of 76%) after leave-one-out validation. Guideline reported high-risk features were not significantly different between groups. CONCLUSIONS: Early growth of the FL in uTBAD was the best tested indicator for LAEs and improves upon the current gold-standard of baseline diameter in selecting patients for early prophylactic thoracic endovascular aortic repair.

Comparative study of left vertebral artery revascularization in patients with and without aberrant left vertebral anatomy.

OBJECTIVE: Left vertebral artery revascularization is indicated in surgery involving zone 2 of the aortic arch and is typically accomplished indirectly via subclavian artery revascularization. For aberrant left vertebral anatomy, direct revascularization is indicated. Our objective was to compare the outcomes of direct vertebral artery revascularization with indirect subclavian artery revascularization for treating aortic arch pathology and to identify predictors of mortality. METHODS: A retrospective cohort study was conducted at a single tertiary hospital, including patients who underwent open or endovascular vertebral artery revascularization from 2005 to 2022. Those who underwent direct vertebral revascularization were compared with those who were indirectly revascularized via subclavian artery revascularization. The outcomes of interest were a composite outcome (any of death, stroke, nerve injury, and thrombosis) and mortality. Univariate logistic regression models were fitted to quantify the strength of differences between the direct and indirect revascularization cohorts. Cox regression was used to identify mortality predictors. RESULTS: Of 143 patients who underwent vertebral artery revascularization, 21 (14.7%) had a vertebral artery originating from the aortic arch. The median length of stay was 10 days (interquartile range, 6-20 days), and demographics were similar between cohorts. The incidence of composite outcome, bypass thrombosis, and hoarseness was significantly higher in the direct group (42.9% vs 18.0%, P = .019; 33.3% vs 0.8%, P < .0001; 57.1% vs 18.0%, P < .001, respectively). The direct group was approximately three times more likely to experience the composite outcome (odds ratio, 3.41; 95% confidence interval, 1.28, 9.08); similarly, this group was approximately six times more likely to have hoarseness (odds ratio, 5.88; 95% confidence interval, 2.21, 15.62). There was no significant difference in mortality rates at 30 days, 1, 3, 5, and 10 years of follow-up. Age, length of hospital stay, and congestive heart failure were identified as predictors of higher mortality. After adjusting for these covariates, the group itself was not an independent predictor of mortality. CONCLUSIONS: Direct vertebral revascularization was associated with higher rates of composite outcome (death, stroke, nerve injury, and thrombosis), bypass thrombosis and hoarseness. Patients with aberrant vertebral anatomy are at higher risks of these complications compared with patients with standard arch anatomy. However, after adjusting for other factors, mortality rates were not significantly different between the groups.

Comparison of total percutaneous in situ microneedle puncture and chimney technique for left subclavian artery fenestration in thoracic endovascular aortic repair for type B aortic dissection.

OBJECTIVE: To compare the outcomes of totally percutaneous in situ microneedle puncture for left subclavian artery (LSA) fenestration (ISMF) and chimney technique in type B aortic dissection (TBAD) during thoracic endovascular aortic repair (TEVAR). MATERIALS AND METHODS: Data on patients who underwent either chimney-TEVAR (n = 89) or ISMF-TEVAR (n = 113) from October 2018 to April 2022 were analyzed retrospectively. The primary outcomes were mortality and major complications at 30 days and during follow-up. RESULTS: The technical success rate was 84.3% in the chimney group and 93.8% in the ISMF group (p = 0.027). The incidence of immediate endoleakage was significantly higher in the chimney than ISMF group (15.7% vs 6.2%, respectively; p = 0.027). The 1- and 3-year survival rates in the chimney and ISMF groups were 98.9% ± 1.1% vs 98.1% ± 0.9% and 86.5% ± 6.3% vs 92.6% ± 4.1%, respectively (log-rank p = 0.715). The 3-year rate of cumulative freedom from branch occlusion in the chimney and ISMF group was 95.4% ± 2.3% vs 100%, respectively (log-rank p = 0.023). CONCLUSION: Both ISMF-TEVAR and chimney-TEVAR achieved satisfactory short- and mid-term outcomes for the preservation of the LSA in patients with TBAD. ISMF-TEVAR appears to offer better clinical outcomes with higher patency and lower reintervention rates. However, ISMF-TEVAR had longer operation times with higher procedure expenses. CLINICAL RELEVANCE STATEMENT: When LSA revascularization is required during TEVAR, in situ, fenestration, and chimney techniques are all safe and effective methods; in situ, fenestration-TEVAR appears to offer better clinical outcomes, but takes longer and is more complicated. KEY POINTS: LSA revascularization during TEVAR reduces post-operative complication rates. Both in situ ISMF-TEVAR and chimney-TEVAR are safe and effective techniques for the preservation of the LSA during TEVAR. The chimney technique is associated with a higher incidence of endoleakage and branch occlusion, but ISMF-TEVAR is a more complicated and expensive technique.

Incidence, Predictors, and Implications of Secondary Aortic Intervention Following Thoracic Endovascular Aortic Repair for Type B Dissection.

BACKGROUND: Secondary aortic intervention (SAI) following thoracic endovascular aortic repair (TEVAR) is not uncommon. However, a satisfactory management system has not been established for these patients. We aimed to report our single-center experience with SAI after prior TEVAR for type B aortic dissection (TBAD). METHODS: From January 2010 to May 2017, 860 eligible patients with TBAD underwent TEVAR. One hundred seven (12.4%) patients required SAI, either endovascularly (n=76) or surgically (n=31). The main indications for SAI were entry flow (n=58 [54.2%]), aneurysm expansion of the proximal or remote aorta (n=26 [24.3%]), retrograde type A aortic dissection (n=11 [10.3%]), distal stent-graft-induced new entry tear (n=6 [5.6%]), and stent migration (n=4 [3.7%]). The Kaplan-Meier curves were generated to determine the degree of freedom from SAI and the prognosis. Cox proportional hazards were used to screen for risk factors for SAI and poor prognosis. RESULTS: The overall 30-day mortality rate after SAI was 4.7% (n=5): endovascular (n=2 [2.6%]) vs open surgery (n=3 [9.7%]; p=0.145). The cumulative survival rates with or without SAI were 86.3%±3.6% vs 95.7%±0.8% at 3 years and 82.0%±4.2% vs 92.2%±1.1% at 5 years, respectively (log-rank p<0.001). Although no significant difference in survival was observed, the incidence of SAI was significantly greater in patients who underwent TEVAR during the chronic phase (acute [11.6%] vs subacute [9.6%] vs chronic [27.8]; p<0.001). Multivariate regression analysis revealed that prior TEVAR in the chronic phase (hazard ratio [HR]=1.73, 95% confidence interval [CI]=1.03-2.90; p=0.039), maximum aortic diameter (HR=1.05, 95% CI=1.04-1.07; p<0.001), and arch involvement (HR=1.48, 95% CI=1.01-2.18; p=0.048) were predictors of the incidence of SAI. In addition, the maximum aortic diameter was demonstrated to be the only risk factor for prognosis after adjusting for confounding factors. CONCLUSIONS: Thoracic endovascular aortic repair for chronic TBAD patients should be reconsidered. Open surgery is preferable for those with proximal progression, whereas endovascular treatment is more suitable for distal lesions. Close surveillance and timely reintervention after TEVAR, whether via endovascular techniques or open surgery, are necessary to prevent devastating complications. CLINICAL IMPACT: The management of patients with type B aortic dissection (TBAD) after thoracic endovascular aortic repair (TEVAR) is challenging. We summarized our single-center experience regarding secondary aortic intervention after TEVAR for TBAD. We found that TEVAR for chronic TBAD patients should be carefully evaulated, and open surgery is recommended for those with proximal progession, while endovascular treatment is more preferable for distal lesions.

Utilizing Single-Branched Stent in Combination With Fenestration or Chimney for Endovascular Repair of Aortic Arch Lesions With Aberrant Subclavian Artery.

OBJECTIVE: The study was to figure out the feasibility, efficacy, and safety of a single-branched stent graft, namely Castor, in combination with fenestration or chimney in the context of aortic arch lesions presenting with aberrant subclavian artery (ASA) and/or Kommerell's diverticulum (KD). METHODS: All consecutive patients with aortic arch lesions and ASA and/or KD receiving Castor from June 2018 to June 2023 were investigated. RESULTS: Incorporating 18 patients, the study encompassed 11 cases with KD, 3 cases with dysphagia; 2 cases of right-sided aortic arch with left-sided aberrant left subclavian artery (ALSA), and 16 cases of left-sided aortic arch with right-sided aberrant right subclavian artery (ARSA). The mean operation time was 132±23 minutes. The mean measured proximal aortic diameter was 30.9±1.6 mm, and proximal diameter of Castor stent was 34 (32, 34.5) mm, with oversize of 9.1±1.6%; the mean measured branch diameter was 8.8±0.97 mm, and branch diameter of Castor stent was 10 (8, 10) mm, with oversize of 0.86±0.57 mm. Technical success rate was 100%, and no in-hospital mortality, no stroke, and no endoleak were identified. One (5.6%) case with spinal cord ischemia and one (5.6%) case with poor healing of operative site were identified. During the follow-up period, no aortic-related death or secondary intervention was recorded. The maximal aortic diameter was significantly reduced at the sixth postoperative month (padj=0.031); KD diameter was significantly reduced at the third (padj=0.001) and sixth (padj<0.001) postoperative month. CONCLUSION: Totally endovascular repair of aortic arch lesions with ASA and KD via Castor stent in combination with fenestration or chimney is feasible, effective, and safe, which can achieve an encouraging medium-term outcome and provide excellent remodeling at the lesions. CLINICAL IMPACT: Single branched stent in combination with fenestration or chimney achieved a sufficient proximal landing zone and provided an encouraging medium-term outcome in this retrospective review of 18 patients receiving endovascular treatment of pathological aortic arch with aberrant subclavian artery and/or Kommerell's diverticulum. The authors suggest this time-saving and efficient technique to establish systematic experience for the treatment in this kind of patients.

Endovascular Repair Blunt Thoracic Aortic Injury in Adolescent: A Case Series.

BACKGROUND: Blunt traumatic aortic injury (BTAI) is a rare occurrence in adolescents, yet it is associated with a high mortality rate necessitating immediate treatment. Although endovascular repair has become the preferred treatment for such injuries in adults, its effectiveness in adolescents remains uncertain. CASE SUMMARY: Blunt traumatic aortic injury typically presents with concomitant injuries to other organs and carries a high perioperative mortality rate with operative repair (OR). In this report, we describe the treatment of 3 clinical cases of BTAI in adolescents using thoracic endovascular aortic repair (TEVAR). These cases contribute pertinent evidence supporting the efficacy of intravascular repair for BTAI. CONCLUSION: Operative repair (OR) remains the gold standard for treating BTAI in adolescents. Nevertheless, TEVAR therapy presents a viable alternative for patients with multiple injuries in whom anticoagulation is contraindicated. Further long-term observation is necessary to assess the lasting effects of TEVAR therapy. CLINICAL IMPACT: This study has provided insights into endovascular repair for adolescent BTAT, offering clinicians significant reference material for choosing treatment strategies for adolescent BTAT. The study aims to demonstrate the safety and effectiveness of endovascular repair treatments in a series of clinical cases involving adolescent BTAI.

Early Experience With Fenestration Modification of Castor Branched Stent-Graft for Aortic Arch Diseases.

PURPOSE: This study aimed to assess the safety and viability of combining branched stent graft with fenestrated thoracic endovascular aortic repair (TEVAR) in treating aortic arch lesions. MATERIALS AND METHODS: The cohort included patients presenting with aortic arch lesions who underwent treatment with a combination of branched stent graft and fenestrated TEVAR between July 2020 and November 2022. Technical success was defined as the precise deployment of the stent graft, maintenance of branch vessel patency, and the absence of type I endoleak. The secondary outcomes examined were complications and all-cause mortality. RESULTS: The study cohort comprised 21 patients (average age: 61.0±14.8 years) with aortic arch lesions from 3 tertiary care hospitals. The aortic arch lesions encompassed aortic dissection (N=8), aortic aneurysm (N=8), pseudoaneurysm (N=1), intramural hematoma (N=1), and penetrating aortic ulcer (N=3). The technical success rate achieved was 95.2% (20/21). Failure in one case was due to an intraoperative type I endoleak, which was rectified with an additional stent graft placement. The 30-day mortality rate was 4.8% (1/21). One patient suffered a stroke but responded well to medical intervention. The median hospital stay was 10.9±5.4 days. During the follow-up period, one death (4.8%) was associated with aortic complications. A type II endoleak was observed and managed with close monitoring. Two patients underwent re-interventions for retrograde type A dissection and stent migration, respectively. No occlusions were observed in the target branch arteries. CONCLUSIONS: The combination of branched stent graft with fenestrated TEVAR emerges as a viable strategy for addressing specific lesions in the aortic arch. CLINICAL IMPACT: This study demonstrates the feasibility of using branched stent grafts with fenestrated TEVAR for treating aortic arch lesions, achieving a technical success rate of 95.2%. Compared to traditional open surgery, this innovative, minimally invasive approach reduces perioperative mortality and complications, such as stroke and spinal cord ischemia. For clinicians, it offers a viable alternative for patients unfit for open repair, particularly in complex aortic arch cases. While the initial outcomes are promising, further research is needed to assess long-term durability and risks, including stent graft migration and late endoleak, ensuring the technique's safety and efficacy over time.

Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

Efficacy of Endovascular Repair Using Single Left Common Carotid Artery Stent Combined with Castor Single-Branched Stent-Graft in the Treatment of Regional Diseases of Zone 2 of the Aorta.

PURPOSE: To observe the short-term efficacy of thoracic endovascular aortic repair (TEVAR) using a single left common carotid artery chimney stent combined with a Castor single-branched stent-graft (SC-TEVAR) in the treatment of zone 2 (Z2) aortic diseases. MATERIALS AND METHODS: To conduct a retrospective analysis of 20 patients with Z2 aortic diseases who were treated in our department from June 2021 to April 2022. The lesions included true aortic degenerative aneurysms with diameter ≥5.0 cm and penetrating aortic ulcers with depth >1.0 cm or basal width >2.0 cm. All 20 patients accepted the SC-TEVAR treatment, which was a new hybrid method to assure the flow of the left common carotid artery (LCCA) and left subclavian artery (LSA). This method was defined as a concomitant chimney stent for LCCA and a Castor single-branched stent graft for the aorta and LSA. The baseline data and intraoperative data were collected to evaluate the safety and efficacy of this method. The patency of the target blood vessel and any associated complications were evaluated at 1 and 6 months postoperatively, to analyze the safety and efficacy of this new method. RESULTS: After discharge from the hospital, all patients were followed up by a specific follow-up team. At 6 monthly follow-up period, there were no cardiac events, stroke, hemiplegia, type I endoleak, type II endoleak, proximal stent graft-induced new entries, distal stent graft-induced new entries, wound infection, or bleeding. Only 1 patient developed an inguinal wound hematoma and got conservative treatment. Importantly, no patients developed stenosis or occlusion of the LCCA or LSA. The patency of branched arteries was 100%. The technical success rate was 90%. CONCLUSION: SC-TEVAR appears to be a new and relatively simple, safe, and effective treatment for Z2 aortic diseases. CLINICAL IMPACT: This was a single-center retrospective cohort study. A total of 20 patients with zone 2 aortic diseases accepted a new hybrid surgical method named SC-TEVAR. This method was not complicated and could be finished with only 3 peripheral artery exposure. The result showed no mortality, 100% patency of the branch artery, and 90% of technical success in 6 months of follow-up time. SC-TEVAR showed a satisfactory result in this retrospective study and could be promoted as an easy method to treat zone 2 aortic diseases.

Preclinical Evaluation of a Modular Inner-Branched Stent Graft to Reconstruct the Left Subclavian Artery in Thoracic Endovascular Aortic Repair: Experimental Study in Pigs.

PURPOSE: In approximate 40% of thoracic endovascular aortic repair (TEVAR) procedures, the left subclavian artery (LSA) needs to be covered to obtain sufficient proximal sealing zone. To preserve the LSA during the TEVAR for type B aortic dissection (TBAD) adjacent to LSA, our team designed a modular single inner-branched stent graft. This study was performed to evaluate the safety and feasibility of deploying a modular single inner-branched stent graft in a porcine model. MATERIALS AND METHODS: Modular inner-branched stent grafts were implanted in 14 pigs via right femoral and right carotid arterial access. Computed tomography angiography (CTA) and angiography were performed in all pigs to appraise the morphological characteristics of the stent grafts at the end of follow-up. The pigs were then euthanized, and tissues were collected for gross and histological examination. RESULTS: The technical success rate was 100% (14/14). One pig suddenly died 5 hours after operation, and 1 pig died after completing the follow-up CTA. During the follow-up period, all surviving pigs showed good mental state, normal diets and activities. Computed tomography angiography examinations showed that all stent grafts were intact without fracture. All bridging covered stents were patent. Angiography showed that the position, shape, and adhesion of the stent grafts were good, and no obvious endoleaks were found. Histological examination showed that the biocompatibility of the stent grafts was good. CONCLUSIONS: This study's outcomes demonstrate that it is safe and feasible to deploy a modular single inner-branched stent graft in a porcine model. CLINICAL IMPACT: This device is the first modular device designed to treat TBAD adjacent to LSA in China. This device is a modular two-component system consisting of a thoracic aortic stent graft with a retrograde inner branch and a bridging covered stent. The modular design and the retrograde inner branch are the two important innovations of this device. Theoretically, the device could make it easier and safer for clinicians to treat TBAD adjacent to the LSA.