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INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) in chronic dissection is associated with a risk for distal stent-graft-induced new entry (dSINE) in up to a quarter of cases. We assess the mid-term outcome of a novel dissection-specific stent-graft (DSSG), which is a custom-made device based on the Cook Alpha platform, with a modified graft design and a distal endovascular elephant trunk without any supporting stent to reduce the radial force on the dissection membrane at the distal landing zone. METHODS: A retrospective single-center study of chronic dissection patients at high risk of dSINE who received an elective endovascular repair with DSSG from January 2017 to June 2023. The primary outcome is Kaplan-Meier (KM) estimated freedom from dSINE during follow-up. Secondary outcomes included technical success, aortic remodeling, and anatomical evaluation of the distal landing zone in cases with dSINE during follow-up versus those without. RESULTS: Thirty patients (24 males) with a median age of 66 years [range=31-78] underwent elective TEVAR with the DSSG. The majority, n=27 (90%), had previous aortic repair; 7 (23%) had established connective tissue disease, and 6 (20%) had established dSINE after previous stent-graft implantation as an indication for TEVAR. Technical success was achieved in n=29 (97%). Median follow-up was 38.5 months (4.3-76.4), and KM estimated freedom from dSINE at 1 and 3 years was 95.6% (SE 0.043) and 89% (SE 0.081), respectively Four cases developed dSINE during follow-up. The median distance from the distal stent-graft to the coeliac trunk was 74mm (range=18-123) in the dSINE group versus 26mm (range=0-74) in the non-dSINE group (p=0.049). Median proximal tangential aortic angulation in the distal landing zone was 38.5° (range=26°-50°) in the dSINE group compared to 21° (range=3-61°) in the non-dSINE group (p=0.052). CONCLUSIONS: The Use of a novel DSSG with low radial force for TEVAR in the setting of chronic dissection is safe and feasible, with remodeling outcomes comparable with standard TEVAR. The reduced distal radial force in the DSSG does not eliminate the risk for dSINE over time, with new entries occurring, particularly in cases where the distal landing zone is in a tortuous aortic segment and not close to the coeliac trunk. CLINICAL IMPACT: Using the novel dissection-specific stent-graft with reduced radial force is safe and feasible but does not completely eliminate the risk of dSINE occurring over time. The exact positioning of the distal stent-graft in a straight aortic segment, close to the coeliac trunk, may be of importance to further mitigate the risk.

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OBJECTIVES: Distal stent graft-induced new entry (dSINE) can occur after thoracic endovascular aortic repair (TEVAR) for type B aortic dissection (TBAD). In this study we aimed to compare the effectiveness of restrictive bare stent (RBS), tapered stent graft (TSG), and non-TSG in TEVAR in preventing dSINE after a midterm follow-up. METHODS: This retrospective cohort study included patients with TBAD who underwent TEVAR (June 2010 to December 2018). The occurrence of dSINE during follow-up was examined. Predictors of dSINE were determined using Fine-Gray regression with death as the competing event. Survival was evaluated using Cox proportional hazards regression. RESULTS: Finally, 364 patients were included: 111 with non-TSG TEVAR, 125 with TSG TEVAR, and 128 with TEVAR with RBS. After 54.5 months, incidences of dSINE in the 3 groups were 12.61%, 4.80%, and 1.56%, respectively (P = .002). On Fine-Gray regression adjusted for clinically relevant covariates, the expansion mismatch ratio (subdistribution hazard ratio, 1.09; 95% CI, 1.07-1.12; P < .001) and complete false lumen thrombosis (subdistribution hazard ratio, 0.35; 95% CI, 0.13-0.94; P = .037) were identified as predictors of dSINE. The Cox proportional hazards regression analysis revealed that dSINE was not only a risk factor for aortic-related mortality (hazard ratio, 17.90; 95% CI, 3.27-98.12; P = .001), but also a predominant risk factor for all-cause mortality (hazard ratio, 4.91; 95% CI, 1.66-14.52; P = .004). CONCLUSIONS: dSINE can happen in TBAD patients who undergo TEVAR. Thus, long-term surveillance is crucial. TSG and RBS had lower expansion mismatch ratios, which might help prevent dSINE.

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Distal stent graft-induced new entry tear (dSINE) is an important complication of thoracic endovascular aortic repair (TEVAR) for the treatment of type B aortic dissection (TBAD). This study aims to explore whether the aorta distal to the stent plays an important role in the occurrence of dSINE. Sixty-nine patient-specific geometrical models of twenty-three enrolled patients were reconstructed from preoperative, postoperative, and predSINE computed tomography scans. Computational fluid dynamics (CFD) simulations were performed to calculate the von Mises stress in the CFD group. Meanwhile, morphological measurements were performed in all patients, including measurements of the inverted pyramid index at different follow-up time points and the postoperative true lumen volume change rate. In the CFD study, the time-averaged von Mises stress of the true lumen distal to the stent in dSINE patients was significantly higher than that in the CFD controls (20.42 kPa vs. 15.47 kPa). In the morphological study, a special aortic plane (plane A) with an extremely small area distal to the stent was observed in dSINE patients, which resulted in an inverted pyramid structure in the true lumen distal to the stent. This structure in dSINE patients became increasingly obvious during the follow-up period and finally reached the maximum value before dSINE occurred (mean, 3.91 vs. 1.23). At the same time, enlargement of the true lumen distal to the stent occurs before dSINE, manifesting as a continuous increase in the true lumen volume (mean, 0.70 vs. 013). A new theory of what causes dSINE to occur has been proposed: the inverted pyramid structure of the true lumen distal to the stent caused an increase in the von Mises stress in this region and aortic enlargement, which ultimately led to the occurrence of dSINE.

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BACKGROUND: To evaluate the safety and efficacy of the conformable thoracic aortic endograft (Conformable TAG Thoracic Endoprosthesis [CTAG]; W. L. Gore & Associates, Flagstaff, Ariz) and Valiant Captivia thoracic stent graft (Medtronic Inc., Santa Rosa, CA) for acute type B aortic dissection (TBAD). METHODS: The early and mid-term outcomes were analyzed for 413 patients undergoing TEVAR using conformable TAG thoracic endoprosthesis and Valiant Captivia thoracic stent graft for acute TBAD. 100 propensity-matched pairs of patients were generated, including 100 patients in the CTAG group and 200 patients in the Valiant Captivia group. RESULTS: Operative mortality were 2.33% (3 of 129) in the CTAG group and 1.76% (5 of 284) in the Valiant Captivia group. The median follow-up was 41.67 (26.00-60.67) months. No significant difference in mortality (9 [7.00%] vs. 36 [12.68%], P = 0.95) or re-intervention rate (3 [2.33%] vs. 20 [7.04%], P = 0.29) was observed between two groups. CTAG group have a lower incidence rate of distal stent graft-induced new entry tear than Valiant Captivia group (2.33% vs. 9.86%, P = 0.045). Lower incidence of type Ia endoleak was identified in the CTAG group (2.22%) than the Valiant Captivia group (14.41%) in patients with type III arch (P = 0.039). CONCLUSIONS: Both Valiant Captivia thoracic stent graft and CTAG thoracic endoprosthesis can be safely performed for acute TBAD with low operative mortality, favorable mid-term survival and freedom from reintervention. CTAG thoracic endoprosthesis had fewer dSINE even with larger oversizing and potentially suitable for type III arch with fewer type Ia endoleaks.

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Background: Distal stent graft induced new entry (dSINE) is an emerging complication after frozen elephant trunk (FET) procedure. The aim of this computational fluid dynamics (CFD) study was to investigate the role of wall shear stress (WSS) after the development of dSINE based on hemodynamic changes. Methods: Aortic diameter and WSS of five patients who developed a dSINE after FET procedure were retrospectively analyzed before and after the occurrence of dSINE. Patient-specific 3-dimentional surface models of the aortic lumen were reconstructed from computed tomography angiographic datasets (pre dSINE: n=5, dSINE: n=5) to perform steady-state CFD simulations with laminar blood flow and zero pressure outlet conditions. WSS was calculated at the level of the stent graft (SG), the landing zone of the SG and at a location further distal to the SG, as well as on the outer and inner curvature of the aorta from SG center to its distal end. Results: Post dSINE occurrence, median WSS increased significantly from 0.87 [interquartile range (IQR): 0.83-1.03] to 1.55 (IQR: 1.09-2.70) Pa, (P=0.043) within the SG and from 1.22 (IQR: 0.81-1.44) to 1.76 (IQR: 1.55-3.60) Pa, (P=0.043) at the landing zone of the SG. A non-significant increase from 1.22 (IQR: 0.59-3.50) to 2.58 (IQR: 1.16-3.78) Pa, (P=0.686) further downstream was observed. WSS at the outer curvature of the SG was significantly higher compared to WSS at the inner curvature for dSINE. Conclusions: Adverse hemodynamic conditions in the form of elevated WSS consist inside and at the distal end of the SG as well as at the outer curvature of the aorta, which may contribute to weakening of the aortic wall. These new findings emphasize the relevance and potential of WSS in dSINE for additional adverse events, such as aortic rupture. Further prospective studies are warranted to explore if the combination of clinical parameters with WSS might be useful to decide which patients require an urgent reintervention in terms of a SG extension.

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BACKGROUND: Reintervention for residual dissection after repaired type A aortic dissection remains challenging. When a frozen elephant trunk (FET) is used, the incidence of distal stent graft-induced new entry (d-SINE) is reportedly high in chronic dissection. AIMS: We report a case of successful redo arch repair using fenestrated and covered FET techniques for chronic residual aortic dissection. METHODS: After the arch was transected proximal to the left subclavian artery (LSCA), and a modified FET prosthesis, in which the distal edge of the FET was covered, was deployed. A fenestration was created in the FET on the LSCA aspect. RESULTS: The postoperative course was uneventful. DISCUSSION: The distal edge of the FET was covered to prevent d-SINE. Creation of a fenestration on the FET eliminates the need to reconstruct the LSCA. CONCLUSION: The fenestrated FET technique simplifies redo arch repair and the covered FET technique can potentially prevent d-SINE.

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Objectives: To investigate the midterm results after zone 0 arch repair with frozen elephant trunks for acute type A aortic dissection. Methods: Between October 2014 and April 2021, 196 patients underwent zone 0 arch repair with frozen elephant trunks for acute type A aortic dissection. The true lumen area, aortic lumen area, and false lumen status were assessed at four aortic levels, the proximal and distal descending thoracic aorta (level A and level B, respectively), celiac artery branching (level C), and terminal aorta (level D). Aortic remodeling (postoperative area as a percentage of the preoperative area) was classified into 3 groups, positive (true lumen area ≥120% with aortic lumen <120% or true lumen area ≥80% with aortic lumen <80%), minimal (80% ≤ true lumen area and aortic lumen area <120%), and negative remodeling (all other changes). Results: In-hospital mortality was 13 (6.6%) patients. The overall survival rate was 85.1% at 5 years. The freedom from distal aortic reintervention was 89.9% at 5 years. The prevalence of completely thrombosed or obliterated false lumen at 2 years was 96.8% at level A, 88.4% at level B, 47.2% at level C, and 27.6% at level D. The prevalence of positive aortic remodeling at 2 years was 84.7% at level A, 75.0% at level B, 29.2% at level C, and 16.7% at level D. Conclusions: Zone 0 arch repair with frozen elephant trunks for acute type A aortic dissection can avoid invasive aortic arch resection and facilitate aortic remodeling of the descending thoracic aorta. The FET effect on aortic remodeling is limited at the aortic level below the FET stent end.

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OBJECTIVES: The incidence rate of distal stent graft-induced new entry (d-SINE) after frozen elephant trunk technique for aortic dissection remains controversial. The aim of this study was to investigate the incidence and seek the clinical and anatomical predictive factors. METHODS: This study is a retrospective multicentre evaluation of complications including d-SINE, aortic events and reintervention after the frozen elephant trunk procedure for aortic dissection. RESULTS: Our cohort included a total of 177 consecutive patients who underwent the frozen elephant trunk procedure for acute and chronic aortic dissection at 5 centres in Japan from May 2014 to March 2021. The incidence rate of d-SINE was 14.1% (25/177 patients). The cumulative incidence of d-SINE was 7.1%, 12.4% and 21.4% after 12, 36 and 60 months, respectively. d-SINE was not associated with mid-term survival rate. After competing risk regression analysis, onset time >48 h (subdistribution hazard ratio, 3.80; 95% confidence interval, 1.13-12.79; P = 0.031) was detected as an independent predictor. CONCLUSIONS: Awareness that there is a relatively higher incidence of d-SINE after frozen elephant trunk procedures is important. Non-hyper-acute phase was detected as an independent risk factor. Pre-emptive endovascular repair may be appropriate to protect new entry in high-risk patients.

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Distal stent graft-induced new entry is not rare after frozen elephant trunk implantation. We report a case of covered frozen elephant trunk placement for prevention of distal stent graft-induced new entry. Coverage of the rigid distal stent edge using a graft reduces mechanical stress on the intima and radial force of the distal stent; therefore, this technique can potentially prevent distal stent graft-induced new entry.

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OBJECTIVES: We present our first experience of using a new dissection-specific hybrid stent graft (SG) (the 'Soft Elephant Trunk') in the frozen elephant trunk technique, in patients with non-acute DeBakey type I aortic dissection. METHODS: Between September 2016 and February 2021, patients with non-acute DeBakey type I aortic dissection underwent the frozen elephant trunk procedure at our centre using 3 SG types: group Z used stiff, distal Z-shaped nitinol SGs (E-Vita, Medtronic); group R used a stiff, ring-shaped nitinol SG (Thoraflex); and group S used a soft, distal dissection-specific SG. Predictors of distal SG-induced new entry were analysed. End points were hospital- and midterm-follow-up results. RESULTS: The study comprised 109 patients with 46 (42.2%), 22 (20.2%) and 41 (37.6%) patients in groups Z, R and S, respectively. No significant differences were found in early outcomes. Freedom from distal SG-induced new entry was comparable in groups Z, R and S (68.9% vs 92.9% vs 100%, log-rank = 0.14). There was no significant difference in follow-up between the groups. Four-year survival rates were 80.44%, 71.59% and 95.06% in groups Z, R and S, respectively. On multivariable analysis, the presence of connective tissue disorders [hazard ratio (HR) = 5.62, P = 0.11] and SG diameter (HR = 1.37, P = 0.034) were strong predictors of distal SG-induced new entry. CONCLUSIONS: Dissection-specific hybrid SG with a soft distal end is effective in patients with non-acute DeBakey type I aortic dissection. Compared to non-soft distal SGs, this can reduce the incidence of distal complications. Long-term outcomes are necessary to determine the potential advantages and disadvantages of the new prosthesis.

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OBJECTIVES: Our goal was to evaluate the extent of stent-graft (SG) elastic recoil in the descending aorta after the frozen elephant trunk procedure in acute (AAD) and chronic (CAD) aortic dissection as well as the impact of SG movement on distal stent graft-induced new entry (d-SINE). METHODS: We retrospectively analysed 149 (105 AAD, 44 CAD) of 259 aortic dissection patients after the frozen elephant trunk procedure between January 2005 and April 2019. Inclusion criteria were at least 1-year computed tomography angiography (CTA) aortic examinations during a follow-up time of 3.8 ± 2.7 years and absence of open or endovascular reintervention. Multiplanar reconstruction of CTA scans was used to define the SG vector position and movement in a virtual Cartesian coordinate system. The angle φ of vector movement and changes of aortic areas at the distal landing zone were analysed. RESULTS: The distal SG position changed over time in the cranial (10.06 ± 11.12 mm), dorsal (8.45 ± 11.12 mm) and lateral (4.96 ± 9.89 mm) directions (P < 0.001). The total change of φ (4.08 ± 7.03°) was greater in AAD than in CAD (P = 0.026). d-SINE was more common in CAD (P < 0.001) and was associated with the size of the aortic area, aortic area enlargement and continuous SG unfolding (P < 0.001). CONCLUSIONS: With the frozen elephant trunk technique, movement and change of SG orientation in the descending aorta were observed over time. Elastic recoil was greater in AAD than in CAD. The incidence of d-SINE was particularly dependent on the size of the aortic lumen and SG radial expansion and less on elastic recoil.

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A computational approach is used to investigate potential risk factors for distal stent graft-induced new entry (dSINE) in aortic dissection (AD) patients. Patient-specific simulations were performed based on computed tomography images acquired from six AD patients (three dSINE and three non-dSINE) to analyze the correlation between anatomical characteristics and stress/strain distributions. Sensitivity analysis was carried out using idealized models to independently assess the effect of stent graft length, stent tortuosity and wedge apposition angle at the landing zone on key biomechanical variables. Mismatch of biomechanical properties between the stented and nonstented regions led to high stress at the distal stent graft-vessel interface in all patients, as well as shear strain in the neighboring region, which coincides with the location of tear formation. Stress was observed to increase with the increase of stent tortuosity (from 263 kPa at a tortuosity angle of 50 deg to 313 kPa at 30 deg). It was further amplified by stent graft landing at the inflection point of a curve. Malapposition of the stent graft led to an asymmetrical segment within the aorta, therefore changing the location and magnitude of the maximum von Mises stress substantially (up to +25.9% with a +25 deg change in the distal wedge apposition angle). In conclusion, stent tortuosity and wedge apposition angle serve as important risk predictors for dSINE formation in AD patients.

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Objectives: Distal stent graft-induced new entry (dSINE), defined as a new tear caused by a stent graft, has been increasingly observed following total arch replacement using frozen elephant trunk (FET) for aortic dissection. We aimed to investigate the incidence and treatment of dSINE after the use of FET. Methods: This retrospective study evaluated 70 patients who underwent total arch replacement using FET for aortic dissection between August 2014 and March 2020. They were followed up for at least 6 months postoperatively. Between-group comparisons were performed between those who did and did not develop dSINE. The risk factors for the development of dSINE and the treatment of dSINE were analyzed. Results: dSINE occurred postoperatively in nine patients (12.9%) with a median time frame of 17.7±11.7 months. The incidence of dSINE did not differ significantly according to classification, phase of dissection, or oversizing. All patients in the dSINE group developed enlargement of the false lumen. dSINE closure was successfully achieved without complications via thoracic endovascular aortic repair (TEVAR) in all patients. Conclusion: No independent factors predicting the development of dSINE were noted in this study. Additional TEVAR for dSINE provides good results and achieves false lumen thrombosis in the thoracic aorta, with no complications.

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Objective: We examined complications of the downstream aorta after the frozen elephant trunk (FET) procedure. Methods: Complications were diagnosed in eight patients: true aneurysm alone in five patients; type A aortic dissection in two patients; and both true aneurysm and type B aortic dissection in one patient. Results: Elective surgery was performed in seven patients. Five patients received a Matsui-Kitamura stent graft (MKS) and three patients received a J Graft Open Stent Graft (JGOSG). The FET procedure was successfully applied in all cases. Over the long term, dilatation of the descending thoracic aorta (dTA) alone was identified in two patients and dilatation of the dTA and migration was identified in three patients using the MKS. Complications of graft kinking and migration were seen in one patient and distal stent graft-induced new entry in two patients using the JGOSG. Thoracic aortic stent graft repair was successfully performed for complications in seven patients. Conclusion: For the improvement of clinical results, FET devices need to offer flexibility and appropriate radial force.

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OBJECTIVE: The frozen elephant trunk (FET) procedure has emerged as a potential single-step treatment for pathologies of the thoracic aorta, but the procedure's true potential to be a single-step treatment remains unclear. The aim of this study was to evaluate the need and outcomes of aortic reinterventions after previous FET implantation. METHODS: Patient characteristics and follow-up data of 107 patients following the FET procedure were evaluated and compared between patients with and without aortic reinterventions. A competing risk regression model was analyzed to identify independent predictors of aortic reintervention and to predict the risk for reintervention. RESULTS: Intended completion, anticipated reinterventions, and unexpected reinterventions were performed in 35 patients (33%). There was no difference in the underlying pathology between patients with or without aortic reintervention. An endovascular reintervention was performed in 24 patients (69%), open surgery in 7 patients (20%) and a hybrid approach in 4 patients (11%). No stroke or permanent spinal cord injuries were observed. In-hospital mortality after reintervention was 14% (5 patients), but there was no difference in survival during follow-up after FET implantation (log rank test, P = .58). No risk factors for aortic reinterventions were identified. The risk for aortic reintervention was 31% (95% confidence interval [CI], 21%-42%), 49% (95% CI, 35%-62%), and 64% (95% CI, 44%-79%) after 12, 24, and 36 months, respectively. CONCLUSIONS: Aortic reinterventions are common and likely after FET implantation, but this study did not identify independent predictors. Reinterventions are associated with acceptable morbidity and mortality. Close follow-up of all patients undergoing FET procedure is paramount.

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