A 10-Year Single-Center Experience With the GORE TAG Conformable Thoracic Stent Graft in the Treatment of Thoracic Aortic Disease.

OBJECTIVE: The aim of this study was to report 10-year real-world single-center experience with the GORE TAG conformable thoracic aortic graft (CTAG), focusing on rupture-free survival, aortic-related reintervention, and device-related complications during midterm and long-term follow-up (FU). METHODS: This retrospective study analyzes results of thoracic endovascular aortic repair (TEVAR) performed between January 2009 and December 2018. Out of 419 TEVAR procedures within this period, 194 patients (male 57.2%, 111/194), with a mean age of 65 ± 13 years, were treated with the CTAG device. Indication for TEVAR was a thoracic aortic aneurysm in 24.7% (48/194), type B aortic dissection in 32.5% (63/194), penetrating aortic ulcer 15.5% (30/194), and miscellaneous 27.3% (53/194). Emergently were operated 43.8% (85/194) patients. Median follow-up (FU) including computed tomography imaging was 43.5 months (Q1-Q3: 8.6-67.0) and was completed in 91.2% (177/194) of patients. RESULTS: Overall survival rates were 75.8% (95% confidence interval [CI] = [0.76-0.70]) and 56.6% (95% CI = [0.57-0.50]) at 12 and 60 months, respectively. Cumulative incidence for aortic rupture was 11.9% (95% CI = [0.07-0.17]) at 60 and 90 months, respectively. Cumulative incidence for aortic-related reintervention was 27.5% (95% CI = [0.21-0.34]) at 60 and 90 months. Cumulative incidence for migration was 2.8% (95% CI = [0.004-0.05]) and 3.9% (95% CI = [0.007-0.07]) at 60 and 90 months, respectively. New endograft infections or material fatigue were not observed. CONCLUSIONS: The herein reported 10-year real-world single-center experience with the CTAG observed favorable long-term outcome. Thus, the device demonstrates appropriate persistent safety, efficacy, and clinical durability up to long-term FU in the treatment of diverse thoracic aortic pathologies.

Late Endograft Migration After Thoracic Endovascular Aortic Repair: A Systematic Review and Meta-analysis.

PURPOSE: The objective of this systematic review was to report the cumulative incidence of endograft migration (EM), as well as the morbidity, reintervention rates, and mortality related to EM. This study aimed to provide evidence-based data on patient-relevant sequelae of EM after thoracic endovascular aortic repair (TEVAR) performed using contemporary aortic endografts. MATERIALS AND METHODS: A systematic electronic search of literature in MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials was performed. The pooled synthesis of outcomes was performed using the inverse variance method. RESULTS: Seven prospective non-randomized and 4 retrospective studies, including a total of 1783 patients presenting 70 EMs, were considered for the quantitative analysis. The pooled rate of EM was 4% (95% CI, 2%-7%; range, 0.2%-11%; I2=82%); pooled morbidity rate was 31% (95% CI, 12%-59%; range, 0%-100%; I2=64%) and pooled reintervention rate was 32% (95% CI, 15%-56%; range, 0%-100%; I2=55%). The pooled mortality rate due to EM was 5% (95% CI, 1%-21%; range, 0%-40%; I2=24%). CONCLUSION: For the first time, this meta-analysis provides pooled reference estimates of EM after TEVAR. Thus, the results hold the potential to further characterize EM after TEVAR. The clinical relevance of EM is underlined by its association with high rates of endoleak-related morbidity, reintervention, and mortality. Close standardized surveillance after TEVAR for early detection of EM and prophylaxis of its sequelae is essential.

Early-Term Complications after Carotid Endarterectomy and Their Risk Factors: Eight-Year Employment of Local Treatment Protocol of a Russian High-Volume Center.

BACKGROUND: More than 20,000 carotid endarterectomies are performed annually in the Russian Federation. Until now, no studies based on the national carotid data set have been published. The objectives of this study were to evaluate early outcomes after carotid endarterectomy and to identify potential risk factors for major adverse cardiovascular events. MATERIALS AND METHODS: The retrospective analysis was based on data recorded in a single-center registry, including all carotid endarterectomies performed between 2010 and 2017. A univariate analysis was used to identify the risk factors for perioperative mortality, and predictors of stroke were determined using a multivariate logistic regression model. RESULTS: Data from 1,832 patients with a mean age of 64.1 ± 7.6 years were analyzed. The combined in-hospital mortality was 0.65% (12/1,832). The rate of stroke was 0.7% (13/1,832), and the rate of myocardial infarction was 1.1% (20/1,832). The 30-day stroke-free survival was 99%. A history of stroke (p = 0.02) and chronic obstructive pulmonary disease (COPD; p = 0.0001) were found to be predictive of a lethal stroke. Previous myocardial infarction (p = 0.0001), an advanced stage of congestive heart failure (p = 0.0001), and angina pectoris (p = 0.01) were associated with cardiac-related mortality. Moreover, diabetes mellitus (p = 0.03), COPD (p = 0.0001), and carotid calcinosis (p = 0.006) increased the risk of poor survival due to myocardial infarction. The mean duration of clamping was found to be an independent predictor of any perioperative stroke (OR = 1.109; 95% CI 1.052-1.129; p < 0.0001). CONCLUSIONS: The present retrospective analysis of the local carotid surgery register showed appropriate outcomes after CEA regarding the cumulative incidence of MACE, which is comparable to previously published international register data. A previous history of stroke, myocardial infarction, COPD, a prolonged clamping time during CEA, and diabetes mellitus were found to be factors of high-risk for cardiovascular mortality. A prolonged clamping was identified as an independent predictor of any stroke.

Endograft migration after thoracic endovascular aortic repair.

OBJECTIVE: The objective of this study was to evaluate the incidence, timing, and potential risk factors of late endograft migration after thoracic endovascular aortic repair (TEVAR). METHODS: A retrospective analysis was conducted of 123 patients receiving TEVAR for thoracic aortic aneurysms (TAAs), dissections, penetrating aortic ulcer, intramural hematoma, or traumatic transection between January 2005 and December 2015 with a minimum imaging-based follow-up of 6 months. Imaging analysis was performed by three independent readers. Migration was defined according to the reporting standards as a stent graft shift of >10 mm relative to a primary anatomic landmark or any displacement that led to symptoms or required therapy. A standardized measurement protocol in accordance with the reporting guidelines was used. Median follow-up was 3 years (range, 0.5-10 years). RESULTS: Migration occurred in nine (7.3%) patients and took place at the proximal landing zone (n = 1), overlapping zone (n = 4), or distal landing zone (n = 5), resulting in type I or type III endoleaks in 44% (n = 4/9) of the cases. All cases of migration with endoleaks underwent reintervention; 75% (n = 3/4) of the migration associated with endoleaks could have been identified on previous imaging before an endoleak occurred. Freedom from migration was 99.1% after 1 year, 94.0% after 3 years, and 86.1% after 5 years. Aortic elongation and TAA were identified as predisposing factors for migration (P = .003 and P = .01, respectively). No influence of the proximal landing zone (zone 0-4), type of aortic arch (I-III), or type of endograft on the incidence of migration was found. CONCLUSIONS: Graft migration after TEVAR occurs in a relevant proportion of patients, predominantly in patients with TAA and aortic elongation. Follow-up imaging of these patients should be specifically evaluated regarding the occurrence of migration.

Prevalence of the Computed Tomographic Morphological DISSECT Predictors in Uncomplicated Stanford Type B Aortic Dissection.

OBJECTIVE/BACKGROUND: The aim was to analyse the prevalence of computed tomographic (CT) morphological predictors and their influence on early chronic phase aortic diameter expansion in patients with uncomplicated acute Stanford type B aortic dissection (ATBAD). METHODS: This retrospective analysis reviewed the CT imaging of 140 patients admitted with uncomplicated ATBAD to two tertiary centres between March 2003 and April 2016. The prevalence of the following CT-morphological predictors was determined at baseline: primary entry tear (PET) diameter ≥ 10 mm, its location at the concavity of the aortic arch; maximum descending aortic diameter ≥ 40 mm; false lumen (FL) diameter ≥ 22 mm; partial FL thrombosis and a fusiform index (FI) of ≥0.64. Thoracic aortic diameter expansion (ADE) was evaluated in 65 patients treated by best medical therapy (BMT) (median CT follow up 11.6 months). Study end points were predictor prevalence and ADE. RESULTS: A mean ± SD of 2.45 ± 1.35 predictors were registered among all 140 patients; 75.0% of patients showed at least two predictors. In 7.9% of patients, no predictor was found. The prevalence of PET at the arch concavity was 18.6%, PET diameter ≥10 mm in 60.0%, maximal descending aortic diameter ≥40 mm in 51.4%, FL diameter ≥22 mm in 47.9%, partial FL thrombosis in 47.9%, and FI ≥ 0.64 in 20.7%. An ADE ≥5 mm was observed in 38 of 65 patients. Median observed ADE was 5.1 mm (median follow up (FU) 11.6 months, range -3.2-27.4 mm). Regression analysis for multiple predictors showed a basic ADE of 2.5 mm plus 1.9 mm per predictor at the median FU of 11.6 months (2.5 mm ± 1.9; 95% confidence interval CI -0.2-5.2 mm ± 0.7-3.0 mm; p = .003). CONCLUSION: In the majority of patients, at least one of the investigated morphological predictors of disease progression in uncomplicated ATBAD was detected. An ADE ≥5 mm affected 38 of 65 BMT patients. CT based predictors help to define TBAD patients at risk of progression.

Modern medical treatment with or without carotid endarterectomy for severe asymptomatic carotid atherosclerosis.

OBJECTIVE: This study assessed the value of modern medical treatment (MMT) with and without carotid endarterectomy (CEA) in patients with asymptomatic severe carotid artery stenosis. METHODS: We conducted a randomized trial involving 55 patients with 70% to 79% carotid stenosis at three Russian centers. Between 2009 and 2013, 31 patients were randomized to undergo CEA with MMT (CEA group) and 24 to receive MMT alone. The primary end point was nonfatal ipsilateral stroke or death from any cause during a follow-up period of 5.0 years. The secondary end point was any nonfatal stroke, carotid revascularization, or death from any cause during follow-up. RESULTS: The trial was stopped after a median follow-up of 3.3 years (maximum, 5.0 years). There were two primary events in the CEA group and nine events in the MMT group. The 3.3-year cumulative primary event rates were 6.5% in the CEA group and 37.5% in the MMT group (hazard ratio for the MMT group, 5.06; 95% confidence interval, 1.53-16.79; P = .008). The 3.3-year cumulative secondary end point was 12.9% in the CEA group and 50.0% in the MMT group (hazard ratio for the MMT group, 4.23; 95% confidence interval, 1.55-11.53; P = .0048). CONCLUSIONS: CEA as an initial management strategy could reduce the risk of death and major cerebrovascular events when added to MMT.

Standing the test of time: total aortic remodeling 13 years after TEVAR for acute type B aortic dissection.

Long-term outcome after thoracic endovascular aortic repair (TEVAR) of acute type B aortic dissection (aTBAD) is still underreported in current literature. This case report shows persistence of aortic remodeling without secondary complication or need of reintervention 13 years after TEVAR. A 45-year-old woman was referred to the emergency room with aTBAD. Due to early diameter progression in combination with therapy-refractory pain and uncontrolled hypertension, TEVAR was performed. Hereafter, the patient showed complete remodeling of the descending thoracic aorta without persistent false lumen perfusion in this segment and with stable true and false lumen diameter in the untreated abdominal segment for a 13-year period. No aortic-related reintervention was needed. With contemporary devices and adapted therapy, TEVAR seems able to treat complex thoracic disease. Long-term follow-up (FU) is mandatory to monitor the efficacy and durability of endovascular treatment in aortic disease.

[Cost-revenue aspects of endovascular treatment of distal aortic arch pathologies with respect to the introduction of a new thoracic side-branch prosthesis]. / Kosten-Erlös-Aspekte der endovaskulären Versorgung distaler Aortenbogenpathologien im Hinblick auf die Einführung einer neuen thorakalen Seitenarmprothese.

BACKGROUND: The standard vascular surgical procedure (SV) for the treatment of distal aortic arch pathologies involves a hybrid approach using a left carotid-subclavian bypass and thoracic endovascular aortic repair. Considering the introduction of a thoracic side branch prosthesis (TBE), the aim of this study was to analyze the cost-revenue aspects of both procedures. MATERIAL AND METHODS: A retrospective analysis was conducted on cases treated by SV from 2017 to 2022. To draw conclusions regarding the use of TBE, the main diagnoses and procedures of SV were recoded based on current classifications (ICD/OPS 2023) for revenue calculations and regrouped according to aG-DRG 2023. An OPS modification and regrouping were performed for modeling TBE revenues. RESULTS: A total of 13 cases were identified (mean age 62.5 ± 13.8 years; 10 males). After regrouping, the following DRGs were obtained: F42Z in N = 5, F51A in N = 4, F08B in N = 2, and F07A and F36B each in N = 1. The total revenue after regrouping was €â€¯666,514.13, including an additional payment (ZE) of €â€¯132,729.14. With the modeled application of TBE, a total revenue of €â€¯659,212.19 was achieved. Compared to SV, this represents a revenue decrease of €â€¯16,886.71 (changed DRG), but with an increase in ZE revenue by €â€¯65,559.78 (different ZE). The use of TBE resulted in a saving of 74 occupancy days, including 13.5 days in intensive care. CONCLUSION: A cost coverage seems probable with a change in the procedure, despite the yet to be determined pricing of TBE. This is highly dependent on the coding quality and the future development of ZE, given the annually changing DRG relative weights. Precise and transparent performance and cost documentation are essential for determining the pricing.

Thoracic Endovascular Aortic Repair (TEVAR) First in Patients with Lower Limb Ischemia in Complicated Type B Aortic Dissection: Clinical Outcome and Morphology.

Acute Type B aortic dissection (TBAD) can cause organ malperfusion, e.g., lower limb ischemia (LLI). Thoracic endovascular aortic repair (TEVAR) represents the standard treatment for complicated TBAD; however, with respect to LLI, data is scant. The aim of this study was to investigate clinical and morphological outcomes in patients with complicated TBAD and LLI managed with a "TEVAR-first" policy. Between March 1997 and December 2021, 731 TEVAR-procedures were performed, including 106 TBAD-cases. Cases with TBAD + LLI were included in this retrospective analysis. Study endpoints were morphological/clinical success of TEVAR, regarding aortic and extremity-related outcome, including extremity-related adjunct procedures (erAP) during a median FU of 28.68 months. A total of 20/106 TBAD-cases (18.8%, 32-82 years, 7 women) presented with acute LLI (12/20 Rutherford class IIb/III). In 15/20 cases, true lumen-collapse (TLC) was present below the aortic bifurcation. In 16/20 cases, TEVAR alone resolved LLI. In the remaining four cases, erAP was necessary. A morphological analysis showed a relation between lower starting point and lesser extent of TLC and TEVAR success. No extremity-related reinterventions and only one major amputation was needed. The data strongly suggest that aTEVAR-first-strategy for treating TBAD with LLI is reasonable. Morphological parameters might be of importance to anticipate the failure of TEVAR alone.

The outcome of acute occlusion of the abdominal aorta with bilateral limb ischaemia.

Background: The purpose of this study was to investigate if the duration of bilateral acute limb ischaemia (BALI) caused by acute aortic occlusion (AAO) affected amputation-free survival. Materials and methods: A retrospective analysis of patients treated between 1 January 2010 and 1 January 2019 for primary occlusion of the infrarenal aorta and BALI was performed. Univariate analysis was used to determine the risk factors for adverse outcomes and compare the duration of BALI between the amputation-free survival and non-amputation-free survival groups. Results: The data from 16 patients with a mean age of 70 ± 11 years were analysed. Predominantly females (56.3%, 9/16) were included in the study. Out of 16 patients, nine had Rutherford grade IIb, and seven had Rutherford grade III at admission. Seven patients underwent revascularisation attempts, two underwent primary major amputation, and seven underwent primary palliation. The mean ischaemia time was significantly shorter in the amputation-free survival group than in the non-amputation-free survival group (7.4 ± 3.5 h vs 22.4 ± 16.3 h, p = .01). The time frame for successful bilateral lower limb revascularisation was <11 h (p = .03). Conclusions: The duration of BALI due to AAO of <11 h was shown to be associated with improved amputation-free survival.

Dynamic Morphology of the Ascending Aorta and Its Implications for Proximal Landing in Thoracic Endovascular Aortic Repair.

In this study, we assessed the dynamic segmental anatomy of the entire ascending aorta (AA), enabling the determination of a favorable proximal landing zone and appropriate aortic sizing for the most proximal thoracic endovascular aortic repair (TEVAR). Methods: Patients with a non-operated AA (diameter < 40 mm) underwent electrocardiogram-gated computed tomography angiography (ECG-CTA) of the entire AA in the systolic and diastolic phases. For each plane of each segment, the maximum and minimum diameters in the systole and diastole phases were recorded. The Wilcoxon signed-rank test was used to compare aortic size values. Results: A total of 100 patients were enrolled (53% male; median age 82.1 years; age range 76.8−85.1). Analysis of the dynamic plane dimensions of the AA during the cardiac cycle showed significantly higher systolic values than diastolic values (p < 0.001). Analysis of the proximal AA segment showed greater distal plane values than proximal plane values (p < 0.001), showing a reversed funnel form. At the mid-ascending segment, the dynamic values did not notably differ between the distal plane and the proximal segmental plane, demonstrating a cylindrical form. At the distal segment of the AA, the proximal plane values were larger than the distal segmental plane values (p < 0.001), thus generating a funnel form. Conclusions: The entire AA showed greater systolic than diastolic aortic dimensions throughout the cardiac cycle. The mid-ascending and distal-ascending segments showed favorable forms for TEVAR using a regular cylindrical endograft design. The most proximal segment of the AA showed a pronounced conical form; therefore, a specific endograft design should be considered.

Outcome analysis of the Gore Conformable Thoracic Stent Graft with active control system for the treatment of arch and descending thoracic aortic disease.

OBJECTIVES: The aim of this study was to evaluate technical/clinical outcomes of the Gore TAG Conformable Thoracic Stent Graft with Active Control System (CTAG with ACS) in thoracic aortic disease since its introduction in Europe in 2017. METHODS: Patients undergoing thoracic endovascular aortic repair (TEVAR) with the device between 2017 and 2020 were identified from a prospectively maintained single-centre database and retrospectively analysed. Predominant indications were aortic dissection (n = 46), thoracic/thoraco-abdominal aneurysm (n = 20/n = 7), penetrating ulcer (n = 14) and intramural haematoma (n = 12). Emergency procedures were performed in 47% (54/115). The primary outcome was technical success. Secondary outcomes were clinical success, serious adverse events and procedure-related reintervention. ACS was assessed regarding angulation, accuracy and apposition. The median follow-up was 8.46 months (interquartile range: 3.18-16.89 months). RESULTS: A total of 115 consecutive patients (82 males, median age 63; interquartile range: 53-74 years) have been included. Technical success was achieved in 95.7% (110/115). Clinical success rate was 80.9% (93/115); mostly due to procedure-related death (n = 14). Overall mortality was 19.1% (22/115), with significant differences between elective/emergency procedures (log-rank: P < 0.001). Procedure-related serious adverse event rate was 44.3% (51/115). Procedure-related reintervention was performed in 20.9% (24/115). The cumulative incidence for reintervention differed significantly between elective/emergency cases (Gray's test: P = 0.0033). Angulation was used in 40.9% of patients (47/115), mostly in type II arches (52.7%). Deployment accuracy was 87.8% (101/115). Sufficient apposition was present in 93.0% (107/115). CONCLUSIONS: This single-centre study shows encouraging performance of the CTAG with ACS in an array of aortic pathologies. Although longer-term data must be awaited, ACS leads to overall favourable device placement. Despite ongoing advances in device technology, TEVAR remains challenging and is associated with significant burden inherent to the underlying disease.

Transcarotid balloon occlusion of the brachiocephalic artery to control bleeding due to sharp injuries of the right subclavian artery.

We present a new manoeuvre of transcarotid balloon occlusion of the brachiocephalic artery to control bleeding due to sharp injuries of the right subclavian artery. To control the bleeding, we employed a temporary balloon occlusion of the brachiocephalic artery with a 6.0 Fogarty balloon catheter, which was introduced through ECA retrogradely into the aorta, inflated and pulled back. Described manoeuvre is simple, rapid performed, relatively safe and it is capable of decreasing the morbidity and mortality rates of patients with sharp injuries to the right subclavian artery.