Endovascular Aortic Treatment Research Articles

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

ObjectivesThe early postoperative benefits of EVAR have been well established but questions remain regarding its durability at mid and long-term timepoints. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study utilized the GREAT Registry to explore the 5-year outcomes with the GORE® EXCLUDER® device in real-world clinical circumstances. MethodsAll patients within the GREAT registry that underwent an infrarenal AAA repair with the GORE® EXCLUDER® device were included in this study. Baseline characteristics and demographic information of the cohort were collected. Endpoints included mortality (all-cause and aneurysm related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events (MACE). ResultsA total of 3216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson comorbidity index score of ≥ 5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Post-operative MACE occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. ConclusionsThis study supports the durability of the GORE® EXCLUDER® device though 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter though 5 years.

Individualizing Surveillance after Endovascular Aortic Repair Using a Modular Imaging Algorithm.

Surveillance after endovascular aortic repair (EVAR) and fenestrated EVAR (FEVAR) is mainly directed by one-size-fits-all approaches instead of personalized decision making, even though treatment strategies and often endografts themselves are tailor-made to adjust for individual patients. We propose a modular imaging algorithm that escalates surveillance imaging based on invasiveness and need. In this retrospective observational study of single-center data, results of a modular imaging algorithm were analyzed. The algorithm is characterized by initiating the examination with standard B-mode then transitioning to Duplex ultrasound, B-Flow, and CEUS. Additional CT(A) studies are conducted where required. The study population included both patients receiving EVAR or FEVAR. A comparative analysis was conducted regarding endoleak detection. The study population included 28 patients receiving EVAR and 40 patients receiving FEVAR. They accounted for 101 follow-up visits, which led to 431 distinct imaging studies. CEUS has the highest endoleak detection rate, followed by CTA and B-Flow. Duplex ultrasound and B-Flow resulted in 0 and 1 false positive cases, respectively, considering CEUS the reference standard. In a select group of six patients, CEUS was omitted after endoleaks were displayed by Duplex ultrasound or B-Flow, leading to a successful type II coiling and no aneurysm-related adverse events. The proposed modular algorithm showed great potential to incorporate principles of personalized medicine in surveillance after endovascular aortic treatment. Since Duplex ultrasound and B-Flow rarely cause false positive endoleaks, more resource-intensive and invasive imaging studies such as CEUS and CTA can be omitted after positive identification.

Report of a semi-branched stent-graft to treat a type 1a endoleak after failed EVAR

BackgroundEndovascular techniques are advancing with the change of treatment paradigm for abdominal aortic aneurysms. Fenestrated EVAR (fEVAR) and branched EVAR (bEVAR) are used for complex aortic aneurysm repair. Both fEVAR and bEVAR have their own advantages and disadvantages. Semi-branches are a new feature that attempt to combine the advantages of both fEVAR and bEVAR.TechniqueWe describe the use of a 4-vessel semi-branched EVAR in a failed EVAR case with a type 1a endoleak.ConclusionThe novel feature of semi-branches in custom-made EVAR devices in endovascular aortic treatment following failed EVAR appear to be a feasible option.

Outcomes Following Extended Thoracic Endovascular Aortic Repair for Type B Aortic Dissection in the Global Registry for Endovascular Aortic Treatment

Outcomes Following Extended Thoracic Endovascular Aortic Repair for Type B Aortic Dissection in the Global Registry for Endovascular Aortic Treatment

Five-year outcomes for bell bottom, iliac branch endoprosthesis, and coil and cover approaches from the GREAT registry

ObjectiveThere are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia. MethodsSubjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ2 test and the Kruskal-Wallis rank-sum test. ResultsWe found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006). ConclusionsOverall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings.

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

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

Impact of Race on Outcomes of Thoracic Endovascular Aortic Repair in the Global Registry for Endovascular Aortic Treatment (GREAT)

Impact of Race on Outcomes of Thoracic Endovascular Aortic Repair in the Global Registry for Endovascular Aortic Treatment (GREAT)

Race-based outcomes of thoracic aortic aneurysms and dissections in the Global Registry for Endovascular Aortic Treatment

ObjectiveThis study characterizes racial differences in presentation, as well as short- and long-term outcomes after endovascular treatment of thoracic aortic aneurysm (TAA) and type B aortic dissection (TBAD). MethodsWe queried the Gore Global Registry for Endovascular Aortic Treatment for thoracic endovascular aortic repairs (TEVARs) performed between 2010 and 2016 and followed through 2022. Pathologies represented were descending TAA, complicated TBAD, and uncomplicated TBAD. Using standard statistical tests, we compared overall and pathology-specific demographics, procedural factors, and outcomes among Black and White patients undergoing TEVAR. ResultsWe identified 438 TEVAR cases, including 236 descending TAA, 121 complicated TBAD, and 74 uncomplicated TBAD. Overall, Black patients were younger and had a higher incidence of renal insufficiency (P = .001), whereas White patients had more chronic obstructive pulmonary disease (P = .003) and cardiac arrhythmias (P = .037). In patients treated for descending TAA, Black patients had increased device- and procedure-related complications (34.3% vs 17.4%; P = .014), conversion to open repair (2.9% vs 0%; P = .011) and type II endoleak (5.7% vs 1.0%; P = .040), but no differences in mortality, length of hospital stay, or major adverse cardiovascular events. Whereas outcomes of TEVAR for uncomplicated TBAD were comparable, Black patients more frequently presented with complicated TBAD than White patients (Black, 40.5% vs White, 24.8%; P = .008) and had subsequently greater reintervention rates (28.1% vs 12.4%; P = .012), all-cause mortality (hazard ratio, 4.28; 95% confidence interval, 1.74-10.5; P = .002) and aortic-related mortality (hazard ratio, 16.7; 95% confidence interval, 1.49-186; P = .022). ConclusionsDespite increased device- and procedure-related complications, similar short- and long-term outcomes are achieved in Black and White patients undergoing TEVAR for descending TAA and uncomplicated TBAD. However, Black patients are more likely to present with, require reintervention for, and suffer mortality from complicated TBAD.

Raised BMI is associated with fewer Type I endoleaks in patients treated with the Gore Excluder device: data from the Global Registry for Endovascular Aortic Treatment (GREAT).

Obesity is increasing in prevalence globally and within the cohort of vascular surgical patients, leading to poorer outcomes. There are few data on endoleak as a complication of AAA surgery in obese patients. The aim of this study was to use large scale registry data from the Global Registry for Endovascular Aortic Treatment (GREAT) to interrogate any relationship between obesity and endoleak following endovascular aneurysm repair (EVAR) using a Gore Excluder device (W. L. Gore & Associates, Newark, DE, USA), in order to guide treatment recommendations in the future. A retrospective review of the GREAT Registry was carried out and patients who were recorded as having a postoperative endoleak requiring intervention were included. Patient demographics including Body Mass Index (BMI), aneurysm parameters and on- or off-instructions for use (IFU) were recorded. Ruptured AAA were excluded. Data were obtained for 3326 patients with an operation date between August 25, 2010 and September 22, 2019. Obese patients were significantly less likely to have a Type 1 endoleak (Fisher's Exact P value=0.006), and the association was maintained in a multiple logistic regression model which controlled for age, gender, neck angulation and off IFU device use (OR=0.33, P=0.01). Among AAA patients treated with a Gore Excluder device (W. L. Gore & Associates), a higher BMI category was associated with a lower risk of Type 1 endoleak requiring reintervention. Further work needs to be carried out to assess our findings in other patient cohorts.

Outcome of Revascularizing the Left Subclavian Artery via Carotid-Subclavian Bypass.

Endovascular thoracic aortic treatment frequently requires extending the proximal landing zone up into the aortic arch with consecutive covering of the left subclavian artery orifice. Our aim was to report on our outcome of left subclavian artery revascularization using carotid-subclavian bypass via lateral access to the subclavian artery. Patients' charts in our aortic center were screened for all those who had undergone carotid-subclavian bypass during endovascular thoracic aortic repair procedures. We analyzed perioperative complications such as cervical plexus nerve or phrenic nerve injury, bleeding, and primary and follow-up graft patency. Between 2001 and 2020, 118 patients underwent carotid-subclavian bypass implantation. Postoperative complications included left-sided stroke in 3% and axillary, phrenic, and recurrent laryngeal nerve palsy in 3, 2, and 3%, respectively. Carotid-subclavian bypass-related death rate was 0%. Bypass patency was 92 ± 7% at 5 years. We documented nine (8%) bypass late occlusions with one left upper extremity ischemia and one late stroke due to an embolized thrombus formed at the bypass anastomosis. All others were asymptomatic. Carotid-subclavian bypass surgery is associated with very low risk of death, stroke, or any nerve palsy. Lateral access to the left subclavian artery reduces the risk of phrenic nerve injury.

Aortic Stiffness and Cardiac Modification After Open or Endovascular Aortic Treatment: Preliminary Results of a Single-Center Prospective Cohort Study

Increased aortic stiffness (AoS), is considered an independent marker of cardiovascular mortality and morbidity. Aortic endovascular treatment correlates to a worsening of AoS, indirectly evaluated with pulse wave velocity (PWV). This could lead to changes in cardiac geometry and efficiency over time. The aim of this study is to evaluate possible changes in AoS with consequent alterations in cardiac function after endovascular (ER) or open (OR) repair, also analyzing different endograft fabric. Patients who were candidate for elective ER or OR for different abdominal aortic disease were enrolled. PWV was measured during the preoperative period and after 1 year. Doppler echocardiography was performed before surgery and after 1 year evaluating arterial (Ea) and ventricular (Ees) elastance and their coupling (Ea/Ees), left ventricular left atrial volume index and left atrial volume index, ejection fraction, and ratio of early ventricular filling to atrial systole (E/A). Furthermore, systolic and diastolic blood pressure and exercise tolerance by the Specific Activity Scale score were assessed preoperatively and after one-year. All data were compared between ER and OR groups and between endo-PTFE and endo-Polyester group. Sixty patients have been enrolled in the 2-year period from 2019 to 2021 (19 OR and 41 ER). Both groups were homogeneous considering cardiovascular risk factors, except for age, which was lower for the OS group (67.2 ± 7.2 vs 75.4 ± 6.4 years; P < .001). Fifty-one patients completed the follow-up (13 OR, 38 ER). PWV increased in both groups, significantly in ER (+2.9 m/second; P = .016). Systolic blood pressure grew in both ER (+20.2 mm Hg; P < .001) and OR groups (+18.4 mm Hg; P = .005). Diastolic blood pressure grew in ER group (+5.2 mm Hg; P = .009) Ea increased +0.3 mm Hg/mL/m2 in both ER and OR groups (P = .026; P = .020), without significant changes in Ea/Ees coupling. E/A ratio decreased (−0.1; P < .001) in the ER group. No significant changes in left ventricular left atrial volume index, left atrial volume index and ejection fraction were recorded (Table I). In ER group, the Specific Activity Scale score got worse (+0.3; P = .004) and three cardiac events were recorded. Considering the subanalysis endo-PTFE vs endo-Polyester, PWV (+3.8 m/second; P = .023) and Ea (+0.4 mm Hg/mL/m2; P = .008) increased significantly in endo-Polyester group only (Table II). AoS increases after ER, mostly in patients with a polyester-covered device. Furthermore, the reversal of E/A ratio means an initial alteration in ventricular diastole, not related to significant mid-term changes in cardiac geometry. These changes could lead to diastolic disfunction with an increased risk of cardiovascular events over time. Further investigation is needed to validate our results.Table IPulse wave velocity (PWV), pressures and echocardiographic data after 1 year of follow-up in the open repair (OR) and endovascular repair (ER) groupsCharacteristicsOR (n = 13)P < .05ER (n = 38)P < .05Preoperative1 YearPreoperative1 YearPWV (m/second)11.6 ± 5.215.5 ± 8.1.05712.7 ± 3.615.6 ± 6.3.016SBP (mm Hg)132.9 ± 22.8151.3 ± 15.9.005134.7 ± 15.6154.9 ± 16.9<.001DBP (mm Hg)78.2 ± 8.481.9 ± 8.5.41573.9 ± 9.979.1 ± 8.4.009LVVi (mL/m2)50.3 ± 1257 ± 15.2.35948.1 ± 17.350.9 ± 16.2.093LAVi (mL/m2)31.5 ± 8.334.5 ± 13.6.89831.9 ± 6.634.9 ± 11.6.378EF (%)60 ± 5.758 ± 6.8.21559.4 ± 6.358.8 ± 6.1.604E/A ratio0.8 ± 0.31 ± 0.5.2500.8 ± 0.20.7 ± 0.2<.001Ea (mm Hg/mL/m2)1.4 ± 0.31.7 ± 0.4.0201.5 ± 0.51.8 ± 0.5.026Ees (mm Hg/mL/m2)1.6 ± 0.81.9 ± 0.5.1481.6 ± 0.61.7 ± 0.6.188Ea/Ees1 ± 0.30.9 ± 0.2.5781 ± 0.31.1 ± 0.3.740DBP, Diastolic blood pressure; Ea, arterial elastance; E/A, early ventricular filling to atrial systole ratio; Ees, ventricular end-systolic elastance; EF, ejection fraction; LAVi, left atrial volume index; LVVi, left ventricular volume index; SBP, systolic blood pressure.All data are reported as mean ± standard deviation. Open table in a new tab Table IIPulse wave velocity (PWV), pressures and echocardiographic data after 1 year of follow-up in endo-PTFE and endo-Polyester group.CharacteristicsEndo-PTFE (n = 15)P < .05Endo-Polyester (n = 23)P < .05Preoperative1 YearPreoperative1 YearPWV (m/second)11.7 ± 3.114 ± 4.6.09112.9 ± 3.116.7 ± 7.1.023SBP (mm Hg)128.7 ± 16.7157.3 ± 19.5<.001138.7 ± 13.9153.3 ± 15.1<.001DBP (mm Hg)68.7 ± 8.179 ± 7.1.00277.3 ± 9.479.1 ± 9.3.356LVVi (mL/m2)44.9 ± 9.647.7 ± 9.2.18450.2 ± 20.753 ± 19.4.330LAVi (mL/m2)32.8 ± 6.736.5 ± 13.2.31331.3 ± 6.833.9 ± 10.7.685EF (%)59.2 ± 4.158.9 ± 3.7159.5 ± 7.558.8 ± 7.2.557E/A ratio0.9 ± 0.30.7 ± 0.2.0160.8 ± 0.20.7 ± 0.2.001Ea (mm Hg/mL/m2)1.7 ± 0.71.7 ± 0.5.6071.4 ± 0.31.8 ± 0.5.008Ees (mm Hg/mL/m2)1.6 ± 0.71.8 ± 0.7.1761.6 ± 0.71.7 ± 0.6.637Ea/Ees1.1 ± 0.31 ± 0.3.5701 ± 0.31.1 ± 0.3.391DBP, Diastolic blood pressure; Ea, arterial elastance; E/A, early ventricular filling to atrial systole ratio; Ees, ventricular end-systolic elastance; EF, ejection fraction; LAVi, left atrial volume index; LVVi, left ventricular volume index; SBP, systolic blood pressure.All data are reported as mean ± standard deviation. 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Five-year sex-related outcomes of thoracic endovascular aortic repair in the Global Registry for Endovascular Aortic Treatment

ObjectiveThe impact of sex on outcomes of thoracic endovascular aortic repair (TEVAR) represents an area of increased interest over the last decade, and long-term data are lacking. The aim of the present study was to investigate sex-related differences in long-term outcomes after TEVAR using real-world data from the Global Registry for Endovascular Aortic Treatment. MethodsData were obtained retrospectively after querying the multicenter, sponsored Global Registry for Endovascular Aortic Treatment. Patients treated with TEVAR between December 2010 and January 2021 were selected regardless of the type of thoracic aortic disease. The primary outcome was sex-specific all-cause mortality at 5 years and maximum follow-up. Secondary outcomes were sex-specific all-cause mortality at 30 days and 1 year, and aorta-related mortality, major adverse cardiac events, neurological complications, and device-related complications or reinterventions at 30 days, 1 year, 5 years, and maximum follow-up. ResultsA total of 805 patients were analyzed; 535 (66.5%) were males. Females were older (median, 66 years [interquartile range (IQR), 57-75 years] vs 69 years [IQR, 59-78 years], P < .001). Males had more frequently a history of coronary artery bypass grafting and renal insufficiency (8.7% vs 3.7% [P = .010] and 22.4% vs 11.6% [P < .001]). The median follow-up was 3.46 years (IQR, 1.49-4.99 years) for males and 3.18 years (IQR, 1.29-4.86 years) for females. Indications for TEVAR were mostly descending thoracic aortic aneurysms (n = 307 [38.1%]) type B aortic dissections (n = 250 [31.1%]) or others (n = 248 [30.8%]). Freedom from 5-year all-cause mortality was similar for males and females (67% [95% CI, 62.1-72.2] vs 65.9% [95% CI, 58.5-74.2]; P = .847), and there were no differences in secondary outcomes. Multivariable Cox regression showed females to have lower all-cause mortality rates; however, this difference did not reach statistical significance (hazard ratio, 0.97; 95% CI, 0.72-1.30; P = .834). Additional subgroup analyses based on the indication for TEVAR did not identify differences between both sexes for the primary and secondary outcomes except more endoleak type II in females with complicated type B aortic dissection (1.8% vs 12.1%; P = .023). ConclusionsThe present analysis suggests that long-term outcomes of TEVAR performed irrespective of the type of aortic disease are similar for males and females. Further studies are needed to clarify existing controversies regarding the impact of sex on outcomes of TEVAR.

Aortic Stiffness and Cardiac Modification After Open Or Endovascular Aortic Treatment: Preliminary Results of a Single Centre Prospective Cohort Study

Objective: Increased arterial stiffness, particularly aortic stiffness (AoS), is considered an independent marker of cardiovascular mortality and morbidity. According to the literature, aortic endovascular treatment correlates to a worsening of AoS in the medium term, indirectly evaluated as an increase in pulse wave velocity (PWV). This appears to lead to changes in cardiac geometry and efficiency. The arterial elastance (Ea) represents the total workload opposite to the left ventricle; it is a poorly researched parameter in this field but it could estimate the total arterial compliance. The aim of this study is to evaluate possible changes in AoS with consequent alterations in cardiac function after endovascular repair (ER) or open surgery (OS), also by comparing these two different techniques.

Incidence, predictors, and prognostic impact of in-hospital serious adverse events in patients ≥75 years of age undergoing elective endovascular aneurysm repair.

This study sought to identify the factors associated with the occurrence of in-hospital serious adverse events after elective endovascular aortic repair (EVAR) in older patients within the Global Registry for Endovascular Aortic Treatment. Consecutive patients ages ≥75 years who received GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, AZ) for elective EVAR. Based on the age at index elective EVAR, patients were categorized into 3 groups for subsequent analyses: those ages 75 to 79, 80 to 84, and ≥85 years. The primary end points for this study were the incidence of serious adverse events and all-cause mortality. In-hospital complications were defined according to the International Organization for Standardization 14155 standard (https://www.iso.org/standard/71690.html) and considered serious adverse events if they led to any of the following: (1) a life-threatening illness or injury, (2) a permanent impairment of a body structure or a body function, (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. Overall, 1,333 older patients (ages 75-79: n= 601; 80-84: n= 474; and ≥85: n= 258) underwent elective EVAR in the Global Registry for Endovascular Aortic Treatment data set and were included in the present analysis. In total, 12 patients (0.9%) died perioperatively, and 103 patients (7.7%) experienced ≥1 in-hospital serious adverse event, with 18 patients (1.3%) experiencing >1 in-hospital complications. No significant differences were seen between the age groups in the rates of in-hospital serious adverse events (7.3% vs 8.2% vs 7.8%; P= .86). In logistic regression analysis, a history of chronic obstructive pulmonary disease (odds ratio= 2.014; 95% confidence interval, 1.215-3.340; P= .006) and prior requirement for dialysis (odds ratio= 4.655; 95% confidence interval, 1.087-19.928; P= .038) resulted as predictors for occurrence of in-hospital serious adverse events. In the whole cohort, the 5-year survival was 63% for patients who did not experience any in-hospital serious adverse events compared with 51% for those who experienced any complications (P= .003). Using multivariable Cox proportional hazards models, it was found that the occurrence of in-hospital serious adverse events (hazard ratio= 6.2; 95% confidence interval, 1.8-21.317; P= .003) and being underweight (hazard ratio= 7.0; 95% confidence interval, 1.371-35.783; P= .019) were the only independent predictors of death in ≤30 days from the initial intervention. Although age did not independently affect the risk for all-cause mortality in ≤180 days after the initial intervention, increasing age was associated with a higher risk for long-term death (ie, ≥181 days from index elective EVAR) in the multivariable analysis (ages 75-79: hazard ratio= 0.379; 95% confidence interval, 0.281-0.512; P < .001; and 80-84: hazard ratio= 0.562; 95% confidence interval, 0.419-0.754; P < .001). After elective EVAR in older patients (ie, ≥75 years), the occurrence of in-hospital serious adverse events appears to increase the risk of death, particularly in ≤180 days after the initial elective EVAR intervention, and might be related to patient baseline characteristics, including history of pulmonary and renal disease.

Gender Specific Outcomes of Thoracic Endovascular Aortic Repair: An Analysis from the Global Registry for Endovascular Aortic Treatment

Gender Specific Outcomes of Thoracic Endovascular Aortic Repair: An Analysis from the Global Registry for Endovascular Aortic Treatment

The development and potential implications of the US Fenestrated and Branched Aortic Research Consortium

The endovascular repair of thoracoabdominal aortic aneurysms has evolved during the last 2 decades, making fenestrated and branched endovascular aortic repair the preferred method to repair thoracoabdominal aortic aneurysms in high-risk patients. Single-center publications have given vascular specialists a significant amount of data, but patient numbers and clinical event rates remain limited. Statistical power to answer important clinical questions is often limited in the single-center studies published to date. In 2018, the principal investigators at the 10 physician-sponsored Investigational Device Exemption centers in the United States decided to coordinate and collect their data in a similar fashion. This effort would allow for the development of the largest cohort of patients in the world treated with complex endovascular devices. By combining efforts and resources, a much larger dataset was compiled to help resolve some of the unanswered questions about patients with complex aortic pathology. To date, the US Aortic Research Consortium has collected data from 2,281 patients and 9,124 target vessel treatment with complex aortic aneurysms treated with custom-manufactured fenestrated and branched endovascular aortic repair devices. These data have resulted in the publication of seven peer-reviewed articles describing various aspects and outcomes of complex endovascular aortic treatment.

Differences in Mid-Term Outcomes Between Patients Undergoing Thoracic Endovascular Aortic Repair for Aneurysm or Acute Aortic Syndromes: Report From the Global Registry for Endovascular Aortic Treatment

A retrospective review of the Global Registry for Endovascular Aortic Treatment between August 2010 and October 2016. Of 575 patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) (305) or acute aortic syndrome (AAS) (270), patients with DTAAs were older and had significantly higher comorbidities than patients with AAS. Between 1 month and 1 year after TEVAR, patients with AAS experienced higher all-cause mortality (7.5% vs 5.0%), aorta-related deaths (2.3% vs 0%), and reintervention rates (4.9% vs 3.0%) than those with DTAA. However, between 1 year and 3 years, all-cause mortality was higher for DTAA (11.8%) than for AAS (7.3%). Patients who underwent TEVAR for DTAA or AAS experienced different mortality and reintervention rates during early and mid-term follow-up.

GORE® TAG® conformable thoracic stent graft for the treatment of descending aortic pathologies.

Endovascular repair of the descending thoracic aorta has gained widespread acceptance as a primary treatment modality for thoracic aortic disease due to its minimally invasive approach and improved survival rates. GORE® TAG® Conformable Thoracic Stent Graft was designed for descending thoracic aortic aneurysms, penetrating ulcers, aortic transections and type B aortic dissections, which are accepted indications for endovascular therapy. The aim of this review is to summarize the clinical literature, focusing mainly on the publications that came from manufacturer's pre-market and post-market studies. Including the Global Registry for Endovascular Aortic Treatment (GREAT), sponsored by WL Gore & Associates (Flagstaff, AZ, USA), which is a large database of endovascular repair of various thoracic, abdominal and thoraco-abdominal aortic pathologies to identify and evaluate only those with isolated thoracic aortic pathology (arch and descending thoracic).

Differences in Mid-Term Outcomes Between Patients Undergoing Thoracic Endovascular Aortic Repair for Aneurysm or Acute Aortic Syndromes: Report From the Global Registry for Endovascular Aortic Treatment

Purpose: To analyze differences in baseline characteristics, overall mortality, device-related mortality, and re-intervention rates in patients who underwent thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysm (DTAA) with atherosclerotic/degenerative cause or acute aortic syndrome (AAS), using the Global Registry For Endovascular Aortic Treatment (GREAT). Materials and Methods: Patients submitted to TEVAR for AAS or DTAA, included in GREAT, were eligible for this analysis. Primary outcome was 30-day all-cause mortality rate. Secondary outcomes were 30-day aorta-related mortality and re-intervention rate, 1-year and 3-year all-cause mortality, aorta-related mortality and re-intervention rate. Results: Five-hundred and seventy-five patients were analyzed (305 DTAA and 270 AAS). Thirty-day mortality rate was 1.3% and 1.8% for DTAA and AAS, respectively (p=0.741). One-year and 3-year mortality rates were 6.2% versus 9.3 and 17.3% versus 15.9% for DTAA and AAS, respectively (p=0.209 and p=0.655, respectively). Aorta-related mortality rates at 30 days, 1 year and 3 years were 1.3%, 1.3%, and 2.6% for DTAA, 1.8%, 4.2%, and 4.2% for AAS (p=ns). Re-intervention rates at 30 days, 1 year, and 3 years were 1.3%, 4.3%, and 7.5% for DTAA, 3.3%, 8.1%, and 10.7% for AAS (p=ns). Furthermore, a specific analysis with similar outcomes was performed dividing follow-up in 3 periods (1-30 days, 31-365 days, 366-1096 days) and describing mutual differences between 2 groups and temporal trends in each group. Conclusion Patients who underwent TEVAR for DTAA or AAS experienced different mortality and re-intervention rates among years during mid-term follow-up. Although all-cause related deaths within 30 days were TEVAR-related, aorta-related deaths were more common for AAS patients within 1 year. A greater re-intervention rate was described for AAS patients, although only 1 year after TEVAR.

The Impact of Degenerative Connective Tissue Disorders on Outcomes Following Endovascular Aortic Intervention in the Global Registry for Endovascular Aortic Treatment

Endovascular therapy for the management of aortic pathology in patients with degenerative connective tissue disorder (DCTD) is controversial. Current guidelines are based on a paucity of literature and registry data are lacking. This study reports on medium term outcomes of patients with diagnosed DCTD compared to those without DCTD who were included in the W.L. Gore Global Registry for Endovascular Aortic Treatment (GREAT). Patients included in the GREAT registry who underwent treatment for any thoracic or abdominal aortic pathology were included and grouped according to the presence or absence of a DCTD. Baseline demographic and procedural data were collected as well as data relating to key outcomes within 5 years follow-up, including all-cause mortality, aortic-related mortality, reinterventions and serious adverse events (SAE). Multivariable Cox proportional hazards models were built to determine if any association existed between the presence of DCTD and any key outcomes. The analysis included 92 (1.9%) with DCTD and 4741 (98.1%) without DCTD. Patients with DCTD were more likely to be female (34.8% vs. 18.5%, P < .0001) and younger (66.8 [15.1] vs. 71.7 [10.3] years, P=.013) than those without DCTD. They were also more likely to have had prior aortic intervention (22.8% vs. 13.9%, P=.015) and an associated branch vessel procedure with the index operation (30.3% vs. 18.6%, P=.005). The majority of reinterventions in both groups occurred within the first 2 years and multivariable models demonstrated that the presence of DCTD was not predictive of all-cause mortality, aortic-related mortality, reinterventions or SAE within 5 years. Within the limitations of registry data, this work demonstrates the medium term safety and durability of endovascular stent-grafts across a spectrum of aortic pathology in some patients with DCTD. More work is required to determine the applicability of these findings to specific sub-types of DCTD and aortic pathology.