Early survival benefit of a low-profile endograft in blunt traumatic aortic injury.

OBJECTIVE: The aim of this study was to demonstrate the safety and effectiveness of a low-profile thoracic endograft (19-23 French) in subjects with blunt traumatic aortic injury. METHODS: A prospective, multicenter study assessed the RelayPro thoracic endograft for the treatment of traumatic aortic injury. Fifty patients were enrolled at 16 centers in the United States between 2017 and 2021. The primary endpoint was 30-day all-cause mortality. RESULTS: The cohort was mostly male (74%), with a mean age of 42.4 ± 17.2 years, and treated for traumatic injuries (4% Grade 1, 8% Grade 2, 76% Grade 3, and 12% Grade 4) due to motor vehicle collision (80%). The proximal landing zone was proximal to the left subclavian artery in 42%, and access was primarily percutaneous (80%). Most (71%) were treated with a non-bare stent endograft. Technical success was 98% (one early type Ia endoleak). All-cause 30-day mortality was 2% (compared with an expected rate of 8%), with an exact two-sided 95% confidence interval [CI] of 0.1%, 10.6% below the performance goal upper limit of 25%. Kaplan-Meier analysis estimated freedom from all-cause mortality to be 98% at 30 days through 4 years (95% CI, 86.6%-99.7%). Kaplan-Meier estimated freedom from major adverse events, all-cause mortality, paralysis, and stroke, was 98.0% at 30 days and 95.8% from 6 months to 4 years (95% CI, 84.3%-98.9%). There were no strokes and one case of paraplegia (2%) during follow-up. CONCLUSIONS: RelayPro was safe and effective and may provide an early survival benefit in the treatment of blunt traumatic aortic injury.

Spinal cord ischemia and reinterventions following thoracic endovascular repair for acute type B aortic dissections.

OBJECTIVE: The technical aspects of thoracic endovascular aortic repair (TEVAR) for acute type B aortic dissection (TBAD), specifically the location of proximal seal zone (PSZ) (need to cover the left subclavian artery [LSA]), distal seal zone (DSZ) (length of aortic coverage), benefit of LSA revascularization, and prophylactic lumbar drainage are still debated. Each of these issues has potential benefits but also has known risks. This study aims to identify factors associated with reintervention and spinal cord ischemia (SCI) following TEVAR for acute TBAD with a zone 3 entry tear. METHODS: The Vascular Quality Initiative was queried for TEVARs performed for acute TBAD with zone 3 entry tear, zone 3 proximal zone of disease, treated with TEVAR extending between zone 2 and zone 5. The primary outcomes were SCI and related reintervention. Secondary outcomes were stroke, arm ischemia, and retrograde type A dissection (RTAD). The exposure variables were PSZ 2 vs 3, DSZ 4 vs 5, prophylactic lumbar drain, and LSA revascularization. Univariate analyses were conducted with χ2 analysis, and multivariable logistic regression was used to evaluate association with outcomes. RESULTS: Of 583 patients who met inclusion criteria, 266 had PSZ 2 and 317 had PSZ 3. On univariate analysis, PSZ 2 was associated with a higher rate of reintervention, but PSZ2 was not significant on multivariable analysis after accounting for age, sex, race, smoking, PSZ, DSZ, prophylactic lumbar drain, and LSA patency. PSZ 2 was not associated with SCI, arm ischemia, or RTAD. PSZ 2 was associated with a trend towards a higher rate of stroke. DSZ 4 and DSZ 5 were performed in 161 and 422 TEVARs, respectively, and DSZ 5 was associated with a higher rate of SCI on univariate (3 [1.9%] vs 39 [9.2%]; P = .01) and multivariable (odds ratio, 7.384; 95% confidence interval, 2.193-24.867; P = .001) analyses. Prophylactic lumbar drain placement was not statistically significantly associated with SCI, but lack of postoperative LSA patency was associated with SCI (odds ratio, 2.966; 95% confidence interval, 1.016-8.656; P = .05). CONCLUSIONS: This study found that PSZ 2 was not associated with lower reinterventions or higher rates of SCI but trended towards a higher rate of stroke than PSZ 3. Additionally, DSZ 5 was strongly associated with SCI when compared with DSZ 4, highlighting the importance of limiting aortic coverage to coverage of the proximal entry tear when possible.

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.

Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment.

OBJECTIVE: The Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). METHODS: From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. RESULTS: We identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. CONCLUSIONS: Results at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch.

OBJECTIVE: We compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). METHODS: We conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. RESULTS: The median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). CONCLUSIONS: We found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Comparison of open and endovascular left subclavian artery revascularization for zone 2 thoracic endovascular aortic repair.

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013 and 2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia (SCI), and perioperative mortality (Pearson's χ2 test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox regression). Sensitivity analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; P < .001), and less preoperative spinal drain use (40% vs 49%; P < .001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs 19%) or emergently (7.4% vs 3.4%) (P < .001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs 4.8%; P = .026; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar SCI, perioperative mortality, and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

Efficacy of intentional undersized thoracic endovascular repair for Stanford type B aortic dissection.

OBJECTIVE: Thoracic endovascular aneurysm repair (TEVAR) is widely used for the treatment of aortic dissection. Endograft oversizing is a risk factor for stent graft-induced new entry tears and retrograde type A aortic dissection. However, there is no clear consensus on the optimal graft size selection for Stanford type B acute or subacute aortic dissection (TBAD). Herein, we examined the safety and efficacy of TEVAR using an intentionally undersized endograft to treat TBAD. METHODS: This retrospective chart review study included 82 patients who underwent TEVAR for acute or subacute Stanford TBAD between 2015 and 2022. We measured the true lumen diameter just distal to the subclavian artery and opted for a stent graft of the same diameter. In instances where deformation resulting from false lumen pressure displacement was pronounced, we measured the diameter at the site just proximal to the subclavian artery. Patients' characteristics, procedural, in-hospital, and follow-up data, and aortic remodeling were analyzed. The aortic diameter was analyzed using one-way analysis of variance followed by Dunnett's test. Survival and freedom from reintervention were estimated using Kaplan-Meier curves. RESULTS: The follow-up rate was 98.4%. The mean age was 58.3 ± 12.3 years, and 76 were men (92.7%). The mean diameters of the stent graft and native proximal landing zone were 30.9 ± 3.2 mm and 30.8 ± 3.0 mm, respectively. The oversize rate of the stent graft in relation to the native proximal aortic diameter was 0.3% ± 4.7%. In-hospital mortality was observed in one patient, retrograde type A aortic dissection in one patient, distal stent graft-induced new entry tear in zero patients, and type 1a endoleak in 22 patients (26.8%). Type 1a endoleaks, characterized by antegrade false lumen blood flow originating from the primary entry, in 12 patients spontaneously disappeared within 1 year of follow-up. According to aortic remodeling, 59 patients (86.8%) achieved complete aortic remodeling at the aortic arch level and 51 (75.0%) at the eighth thoracic vertebral level. The diameters of the aortic arch and descending aorta were significantly reduced compared with the postoperative measurements (P <.001). Survival rates were 97.5% and 93.6% at 1 and 3 years, respectively. Freedom from reintervention was 84.7% and 84.7% at 1 and 3 years, respectively. CONCLUSIONS: Intentionally undersized TEVAR was safe and achieved acceptable aortic remodeling despite a high rate of type 1a endoleaks. A type 1a endoleak was acceptable as it primarily diminished during the mid-term follow-up.

Urgent Candy-Plug Technique for Distal False Lumen Occlusion in Chronic Aortic Dissection.

INTRODUCTION: This study aimed to assess the impact of urgency on early and midterm outcomes of the Candy-Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair (TEVAR) for aortic dissection (AD). METHODS: The CP registry was reviewed, and patients were categorized into elective and urgent/emergent groups for analysis. Endpoints included technical success, clinical success, early (30-day) computed tomography angiography (CTA) findings, early (30-day) mortality, adverse events, aortic remodeling in patients with available CTA follow-up and re-intervention. RESULTS: A total of 155 patients received a custom-made Candy-Plug with 32 patients (44% males, mean age 61±9 years) were treated urgently vs. 123 patients (63% males, mean age 62±11 years) electively. The primary CP rate was higher in the urgent group; (28/32, (88%) in the urgent group vs. 96/123 (78%) in the elective group, p=051). The mean contrast volume was higher in the urgent group; (157±56ml in the urgent group vs. 130±71ml in the elective group, p=.017). Technical success was achieved in all patients in both groups. Clinical success was achieved in 25/32 (78%) patients in the urgent group vs. 113/123 (92%) in the elective group, p=.159. The early mortality rate was 4/32, (13%) patients in the urgent group vs. 1/123 (1%) in the elective group, p=.120). There was no statistically significant difference regarding the early adverse events between the urgent and elective CP groups. Early aortic-related re-interventions were required in 6/32 (19%) patients in the urgent group vs. 6/123 (5%) in the elective group, p=.094. Thoracic aortic aneurysm sac regression was lower in the urgent group (5/28, (18%) in the urgent group vs. 63/114 (55%) in the elective group, p=001). Stable thoracic aortic aneurysm sac was higher in the urgent group (22/28, (79%) in the urgent group vs. 47/114 (41%) in the elective group, p=000). An increase in thoracic aortic aneurysm sac occurred in 1/28 (4%) patient in the urgent group vs. 4/114 (4%) patients in the elective group, p=.096. CONCLUSION: The urgent use of the CP technique for distal FL occlusion in AD was feasible and effective. The decrease in aortic FL sac diameter may be affected by the urgent use of CP due to limited sizing availability. However, it achieved high rate of aortic remodeling.

Clinical impact of proximal fixation augmentation using the Najuta thoracic fenestrated stent graft during endovascular treatment for distal aortic arch aneurysm.

OBJECTIVE: Prevention of late type Ia endoleaks is the main concern in thoracic endovascular aortic aneurysm repair (TEVAR) for thoracic aortic aneurysm. Since 2017, we have performed zone 0 TEVAR with proximal fixation augmentation using a Najuta thoracic fenestrated stent graft in addition to zone 2 TEVAR for distal arch aneurysms. We report the early and midterm outcomes of TEVAR performed using this strategy. METHODS: This single-center retrospective study enrolled 386 cases of TEVAR for thoracic aortic disease between January 2013 and December 2020. Patients with thoracic aortic aneurysm treated by TEVAR landing at zone 2 was referred to as the standard group, whereas those treated by TEVAR landing at zone 0 using a Najuta fenestrated stent graft in addition to zone 2 TEVAR was referred to as the augmentation group. We retrospectively compared the clinical outcomes between the two groups. The primary end point was secondary intervention for postoperative type Ia endoleaks. Secondary end points were technical success, aneurysm-related death, and major adverse events (MAEs), including stroke, paraplegia, endoleaks, and secondary interventions. RESULTS: We performed TEVAR in 41 and 30 cases in the standard and augmentation groups, respectively. The mean aneurysm sizes in the standard and augmentation groups were 54.5 and 57.3 mm (P = .23), and the proximal neck lengths were 16.8 and 17.4 mm (P = .65), respectively. The anatomical characteristics seemed to be similar in both groups. The technical success rate in both groups was 100%. Three cases in the standard group had MAEs, including two stroke and one brachial artery pseudoaneurysm; whereas two cases had MAEs in the augmentation group, including one stroke and one paraplegia. There was no 30-day mortality or retrograde type A dissection in both groups. The mean observation periods in the standard and augmentation groups were 46 months (range, 1-123 months) and 35 months (range, 1-73 months), respectively. At 36 and 60 months after the procedure, the freedom from aneurysm-related death was 97.6% and 97.6% in the standard group, 100.0% and 100.0% in the augmentation group (P = .39); and the freedom from reintervention for type Ia endoleaks was 79.2% and 65.2% in the standard group, 100.0% and 100.0% in the augmentation group (P = .0087). A statistically significant decrease in reinterventions for type Ia endoleaks was observed in the augmentation group. CONCLUSIONS: Proximal fixation augmentation using the Najuta fenestrated stent graft during TEVAR for distal arch aneurysm is effective in preventing the postoperative late type Ia endoleaks.

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.

The impact of urgency of repair on outcomes following thoracic endovascular aortic repair for blunt thoracic aortic injury.

OBJECTIVE: Current societal recommendations regarding the timing of thoracic endovascular aortic repair (TEVAR) for blunt thoracic aortic injury (BTAI) vary. Prior studies have shown that elective repair was associated with lower mortality after TEVAR for BTAI. However, these studies lacked data such as Society for Vascular Surgery (SVS) aortic injury grades and TEVAR-related postoperative outcomes. Therefore, we used the Vascular Quality Initiative registry, which includes relevant anatomic and outcome data, to examine the outcomes following urgent/emergent (≤ 24 hours) vs elective TEVAR for BTAI. METHODS: Patients undergoing TEVAR for BTAI between 2013 and 2022 were included, excluding those with SVS grade 4 aortic injuries. We included covariates such as age, sex, race, transfer status, body mass index, preoperative hemoglobin, comorbidities, medication use, SVS aortic injury grade, coexisting injuries, Glasgow Coma Scale, and prior aortic surgery in a regression model to compute propensity scores for assignment to urgent/emergent or elective TEVAR. Perioperative outcomes and 5-year mortality were evaluated using inverse probability-weighted logistic regression and Cox regression, also adjusting for left subclavian artery revascularization/occlusion and annual center and physician volumes. RESULTS: Of 1016 patients, 102 (10%) underwent elective TEVAR. Patients who underwent elective repair were more likely to undergo revascularization of the left subclavian artery (31% vs 7.5%; P < .001) and receive intraoperative heparin (94% vs 82%; P = .002). After inverse probability weighting, there was no association between TEVAR timing and perioperative mortality (elective vs urgent/emergent: 3.9% vs 6.6%; odds ratio [OR], 1.1; 95% confidence interval [CI], 0.27-4.7; P = .90) and 5-year mortality (5.8% vs 12%; hazard ratio [HR], 0.95; 95% CI, 0.21-4.3; P > .9).Compared with urgent/emergent TEVAR, elective repair was associated with lower postoperative stroke (1.0% vs 2.1%; adjusted OR [aOR], 0.12; 95% CI, 0.02-0.94; P = .044), even after adjusting for intraoperative heparin use (aOR, 0.12; 95% CI, 0.02-0.92; P = .042). Elective TEVAR was also associated with lower odds of failure of extubation immediately after surgery (39% vs 65%; aOR, 0.18; 95% CI, 0.09-0.35; P < .001) and postoperative pneumonia (4.9% vs 11%; aOR, 0.34; 95% CI, 0.13-0.91; P = .031), but comparable odds of any postoperative complication as a composite outcome and reintervention during index admission. CONCLUSIONS: Patients with BTAI who underwent elective TEVAR were more likely to receive intraoperative heparin. Perioperative mortality and 5-year mortality rates were similar between the elective and emergent/urgent TEVAR groups. Postoperatively, elective TEVAR was associated with lower ischemic stroke, pulmonary complications, and prolonged hospitalization. Future modifications in society guidelines should incorporate the current evidence supporting the use of elective TEVAR for BTAI. The optimal timing of TEVAR in patients with BTAI and the factors determining it should be the subject of future study to facilitate personalized decision-making.

Proximal sealing in the aortic arch for inner curve disease using the Custom Relay® Scalloped and Fenestrated stent graft.

OBJECTIVE: This study aims to analyze early and midterm results of custom-made proximal scallop and fenestrated stent-grafts for thoracic endovascular aortic repair (TEVAR) with proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc., Sunrise, USA) in ten Italian centers between January 2014 and December 2022 were included. The primary endpoints were technical success, incidence of intraoperative major adverse events (MAEs), deployment accuracy, and rate of early neurological complications, endoleaks (Els) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The PLZ was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) due to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III Els were detected. There were no cases of in-hospital mortality, MAEs and retrograde dissection. Three (6.1%) minor strokes (National Institutes of Health Stroke Scale score≤4) were observed. At a mean follow-up time of 36.3 + 21.3 months the rate of type I-III Els and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) for non-aortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

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.

STABILISE (Stent-Assisted Balloon-Induced Intimal Disruption and Relamination in Aortic Dissection Repair) Is Associated With Good Anatomical Results on the Distal Thoracoabdominal Aorta at 2 Years.

PURPOSE: The aim of this comparative study was to evaluate the increased aortic diameter of the distal aorta after implementing the STABILISE technique in complicated type B aortic dissection (AD). DESIGN: This is a comparative monocentric retrospective study. MATERIALS AND METHODS: All patients who underwent an STABILISE procedure for complicated AD between 2018 and 2020 were included and compared with a historic cohort treated with thoracic endovascular aortic repair (TEVAR) alone. Aortic diameters were measured at 6 different levels on the thoracic and abdominal aorta. The primary end point was an increased aortic diameter at 1 and 2 years. The exclusion criterion was the absence of a computed tomography (CT) scan at 1 or 2 years. RESULTS: A total of 55 patients were included: 24 in the TEVAR group and 31 in the STABILISE group. At the level of the stent graft, there was a decrease in aortic diameters in both groups without significant differences. At the level of the distal aorta, there was an increase in aortic diameters in both groups without significant differences. There were significantly more patients in the TEVAR group with an unfavorable increase in aortic diameter >5 mm of the distal aorta at 2 years than in the STABILISE group: 8 (33%) vs 1 (3%) (p=0.01). For chronic ADs, a significantly greater increase in aortic diameters of the distal aorta was observed in the STABILISE group. CONCLUSIONS: The STABILISE technique is technically feasible and potentially leads to decreased longer re-intervention rates; indeed, more patients had an unfavorable increase in aortic diameter in the TEVAR group than in the STABILISE group at 2 years. The high rate of long-term distal aortic aneurysm progression and reintervention after TEVAR alone suggests that this option is not sufficient to definitively treat these complex patients. CLINICAL IMPACT: This article reported the results of stent assisted balloon induced intimal disruption and relamination (STABILISE) with a follow-up at 2 years. This is the first comparative study between STABILISE, which has emerged as a new technique inducing aortic remodeling and therefore better long-term outcome, and the standard technique TEVAR alone. STABILISE technique is associated with good results on the distal aorta at 2 years with a rate of patient with unfavorable aortic diameter evolution greater in TEVAR group compared to STABILISE group and could improve the long-term results on the distal aorta by inducing extensive aortic remodeling.

A Systematic Review on Thoracic Endovascular Repair Outcomes in Blunt Thoracic Aortic Injuries.

PURPOSE: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. MATERIALS AND METHODS: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. RESULTS: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16-89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3-119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). CONCLUSION: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.

Thoracoabdominal Aortic Aneurysm Repair Using Fenestrated and Branched Endovascular Grafts for High-Risk Patients: Evolving yet Safe.

PURPOSE: The purpose was to investigate outcomes of high-risk patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated or branched endovascular aneurysm repair (F/BEVAR) devices at a single center in Canada. MATERIALS AND METHODS: A retrospective review of all patients undergoing endovascular TAAA repair with F/BEVAR from June 2007 to July 2020. Imaging and clinical endpoints of interest including death, reintervention, and target vessel patency were reported. RESULTS: Ninety-five consecutive patients underwent endovascular TAAA repair using F/BEVAR stent grafts (63 males, median age 74 [interquartile range 70, 78] years). Repairs included 81 elective and 14 urgent/emergent cases (6 ruptures and 8 symptomatic). Graft deployment was 100% successful. Intraoperative target vessel revascularization was successful in 336/355 (94.6%) vessels with the celiac having the lowest success rate 72/82 (87.8%). In-hospital mortality was 9.5% (7.4% elective and 21.4% urgent/emergent, p=0.125) and permanent paraplegia was 4.2% (3.7% elective and 7.1% urgent/emergent, p=0.458). In-hospital complications included stroke in 5.3%, acute myocardial infarction in 8.4%, and bowel ischemia in 5.3%. No patients required permanent dialysis or tracheostomy during their hospital stay. However, 22 (23.2%) patients required additional unplanned procedures for various indications (branch occlusion, endoleaks, realignment) during their hospital stay. Patients were followed up for a mean of 3.6 ± 3.0 years. Clinical follow-up was 100%, with 80/86 (93%) having surveillance imaging. On follow-up imaging, 43 (50%) patients had at least 1 endoleak identified and 337/341 (98.8%) of the target vessels were found to be patent. At 5 years, cumulative probability of reintervention was 46.3% (95% confidence interval [CI], 36.1-56.4). Survival at 5 and 8 years was 50.1% (95% CI, 38.4-65.4) and 34.4% (95% CI, 22.5-52.8), respectively. Progression of aneurysmal disease leading to rupture on follow-up was confirmed in 1 patient at 10 years. CONCLUSION: Endovascular TAAA repair provides a safe treatment option with a high technical success rate and low pulmonary and renal complications. Long-term survival is similar to previous literature; however, high rates of secondary reintervention reaffirm the need for ongoing patient follow-up and further technical improvements. CLINICAL IMPACT: This study demonstrates that endovascular repair of TAAAs can be performed in a high-risk elderly population with acceptable rates of mortality, TALE and SCI, using evolving technology. The incidences of post-operative respiratory failure and renal dysfunction were lower in patients who underwent endovascular repair compared with open repair. Future technical and procedural refinements in addition to increasing surgical experience are expected to lead to further improvements in short- and long-term outcomes exceeding those of open repair.

Outcomes of Fenestrated and Branched Endografts for Partial and Total Endovascular Repair of the Aortic Arch - A Systematic Review and Meta-Analysis.

OBJECTIVE: Fenestrated and branched thoracic endovascular aortic repair (F/B-TEVAR) of the aortic arch is a viable approach in patients unsuitable for open repair. The aim was to summarise the published results of manufactured F/B-TEVAR devices for partial and total repair of the aortic arch, and to compare fenestrated with branched configurations. DATA SOURCES: PubMed, Scopus and The Cochrane Library were searched for articles (2018 - 2021) about patients with elective, urgent, or emergency aortic requiring a proximal landing zone in the aortic arch (zone 0 - 1 - 2) and treated by F/B-TEVAR. REVIEW METHODS: The systematic review and meta-analysis were performed according to the PRISMA guidelines. Open repair, supra-aortic trunk (SAT) debranching + standard TEVAR, and in situ physician modified and parallel grafts were excluded. Primary outcomes were technical success and 30 day mortality rate. Secondary outcomes were 30 day major adverse events, and overall survival and procedure related endpoints during follow up. RESULTS: Of 458 articles screened, 18 articles involving 571 patients were selected. Indications for intervention were chronic dissections (50.1%), degenerative aneurysms (39.6%), penetrating aortic ulcers (7.4%), and pseudoaneurysms (2%). F-TEVAR, B-TEVAR, and F+B-TEVAR were used in 38.4%, 54.1%, and 7.5% of patients, respectively. Overall, technical success was 95.9% (95% confidence interval [CI] 0.93 - 0.97; I2 = 0%; p for heterogeneity (Het) = .77) and the 30 day mortality rate was 6.7% (95% CI 0.05 - 0.09; I2 = 0%; p Het = .66). No statistical differences were found comparing fenestrated with branched endografts, except for a higher rate of type I - III endoleaks in F-TEVAR (9.8% vs. 2.6%; p = .034). The overall survival rate and freedom from aortic related death at the one year follow up ranged between 82 - 96.4% and 94 - 94.7%, respectively. Thirteen and five studies were considered at moderate and high risk of bias, respectively. CONCLUSION: F/B-TEVAR for the treatment of the aortic arch, according to experience in dedicated centres, now enjoys a satisfactory level of technical success together with a progressively reduced early mortality rate. There are several limitations, and further studies are needed to reach clearer conclusions.

National Diagnostic Reference Levels for Standard Descending Thoracic Endovascular Aortic Repair and Optimisation Strategies.

OBJECTIVE: The International Commission on Radiological Protection has highlighted the large number of medical specialties that use fluoroscopy outside diagnostic imaging departments without radiation protection programmes for patients and staff. Vascular surgery is one of these specialties. Thoracic endovascular aortic repair (TEVAR) is a complicated procedure requiring radiation protection guidance and optimisation. The recent EU Basic Safety Standards Directive requires the use and periodic updating of diagnostic reference levels (DRLs) for interventional procedures. The aim of this study was to determine doses for patients undergoing TEVAR with mobile Xray systems and hybrid rooms (fixed Xray systems) to obtain national DRLs and to suggest optimisation actions. METHODS: This was a retrospective cross sectional study. The Spanish Chapter of Endovascular Surgery conducted a national survey in 11 autonomous communities representing around 77.6% of the Spanish population (47.33 million inhabitants). A total of 266 TEVAR procedures from 17 Spanish centres were analysed, of which 53.0% were performed in hybrid operating rooms. National DRLs were obtained and defined as the third quartile of the median values from the different participating centres. RESULTS: The proposed national DRLs are: for kerma area product (KAP), 113.81 Gy·cm2 for mobile Xray systems and 282.59 Gy·cm2 for hybrid rooms; and for cumulative air kerma (CAK) at the patient entry reference point, 228.38 mGy for mobile systems and 910.64 mGy for hybrid rooms. CONCLUSION: Based on the requirement to know radiation doses for standard endovascular procedures, this study of TEVARs demonstrated that there is an increased factor of 2.48 in DRLs for KAP when the procedure is performed in a hybrid room compared with mobile C-arm systems, and an increased factor of 3.98 in DRLs for CAK when the procedure is performed with hybrid equipment. These results will help to optimise strategies to reduce radiation doses during TEVAR procedures.

Early and mid-term outcomes of open thoracoabdominal aortic aneurysm repair after thoracic endovascular aortic repair.

OBJECTIVE: To evaluate the early and mid-term outcomes of open repair in patients with thoracoabdominal aortic aneurysm (TAAA) after thoracic endovascular aortic repair (TEVAR). METHODS: This was a retrospective single center study. Data were retrospectively collected and analyzed for consecutive patients undergoing open TAAA repair (TAAAR) after TEVAR from November 2016 to June 2021. Indications for TAAAR included aneurysm progression due to endoleak, persisted false lumen perfusion, proximal/distal disease progression, and aorta rupture. The risk factor of operative mortality was analyzed by multivariable logistic regression model and the survival was evaluated by Kaplan-Meier. RESULTS: Sixty-three patients who met the inclusion criteria for the study were identified. The mean age at TAAAR was 41 ± 12 years and 43 (68.3%) were male. Marfan syndrome (MFS) was presented in 39 patients (61.9%). 60 (95.2%) patients presented with post-dissection aneurysm and 3 (4.8%) patients with degenerative aneurysm. The extent of TAAA was Crawford I in 9 (14.3%), II in 22 (34.9%), III in 23 (36.5%), and IV in 9 (14.3%). Emergent TAAAR was done in 10 (15.9%) patients, and deep hypothermic circulatory arrest was used in 22 (34.6%). Endograft was explanted in 31 (49.2%). Operative mortality was 11 (17.5%). Stroke, paraplegia, and acute kidney failure occurred in 5 (7.9%), 7 (11.1%), and 6 (9.5%) patients, respectively. Pulmonary complications occurred in 19 (30.2%) patients. The estimated survival was 74.8 ± 4.9% at 5 years. Late reoperations were performed in 2 patients at 2.5 years and 1.3 years, respectively. CONCLUSIONS: In this series of TAAA after TEVAR, TAAAR was related with a high risk of operative mortality and morbidity and the midterm outcomes represented a durable treatment and were respectable.

Clinical comparative analysis of 3D printing-assisted extracorporeal pre-fenestration and Castor integrated branch stent techniques in treating type B aortic dissections with inadequate proximal landing zones.

BACKGROUND: This study aims to compare the clinical effects of two distinct surgical approaches, namely 3D printing-assisted extracorporeal pre-fenestration and Castor integrated branch stent techniques, in treating patients with Stanford type B aortic dissections (TBAD) characterized by inadequate proximal landing zones. METHODS: A retrospective analysis was conducted on 84 patients with type B aortic dissection (TBAD) who underwent thoracic endovascular aortic repair (TEVAR) with left subclavian artery (LSA) reconstruction at our center from January 2022 to July 2023. Based on the different surgical approaches, the patients were divided into two groups: the group assisted by 3D printing for extracorporeal pre-fenestration (n = 44) and the group using the castor integrated branch stent (n = 40). Clinical indicators: including general patient information, operative time, surgical success rate, intraoperative and postoperative complication rates, re-intervention rate, and mortality, as well as postoperative aortic remodeling, were compared between the two groups. The endpoint of this study is the post-TEVAR mortality rate in patients. RESULTS: The surgical success rate and device deployment success rate were 100% in both groups, with no statistically significant difference (P > 0.05). However, the group assisted by 3D printing for extracorporeal pre-fenestration had a significantly longer operative time (184.20 ± 54.857 min) compared to the group using the castor integrated branch stent (152.75 ± 33.068 min), with a statistically significant difference (t = 3.215, p = 0.002, P < 0.05). Moreover, the incidence of postoperative cerebral infarction and beak sign was significantly lower in the group assisted by 3D printing for extracorporeal pre-fenestration compared to the castor-integrated branch stent group, demonstrating statistical significance. There were no significant differences between the two groups in terms of other postoperative complication rates and aortic remodeling (P > 0.05). Notably, computed tomography angiography images revealed the expansion of the vascular true lumen and the reduction of the false lumen at three specified levels of the thoracic aorta. The follow-up duration did not show any statistically significant difference between the two groups (10.59 ± 4.52 vs. 9.08 ± 4.35 months, t = 1.561, p = 0.122 > 0.05). Throughout the follow-up period, neither group experienced new endoleaks, spinal cord injuries, nor limb ischemia. In the castor-integrated branch stent group, one patient developed a new distal dissection, prompting further follow-up. Additionally, there was one case of mortality due to COVID-19 in each group. There were no statistically significant differences between the two groups in terms of re-intervention rate and survival rate (P > 0.05). CONCLUSION: Both 3D printing-assisted extracorporeal pre-fenestration TEVAR and castor-integrated branch stent techniques demonstrate good safety and efficacy in treating Stanford type B aortic dissection with inadequate proximal anchoring. The 3D printing-assisted extracorporeal pre-fenestration TEVAR technique has a lower incidence of postoperative cerebral infarction and beak sign, while the castor-integrated branch stent technique has advantages in operative time.