Global Registry For Endovascular Aortic Treatment Research Articles

5-Year Outcomes of Endovascular Treatment for Aortic Dissection From the Global Registry for Endovascular Aortic Treatment

Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of W. L. Gore (Flagstaff, AZ) aortic endografts. The purpose is to analyze long term outcomes/patient survival and device performance in patients undergoing thoracic endovascular aortic repair (TEVAR) for acute/chronic and complicated/uncomplicated Type B aortic dissection (TBAD). From August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with TEVAR for TBAD through 5-year follow-up (day 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. 265 patients were identified. Mean age was 60.9 ± 11.9 years [range, 19-84 years; 211 (79.6%) males]. Devices used were GORE® TAG® and Conformable GORE® TAG® Thoracic Endoprosthesis (TAG/CTAG) (W.L. Gore, Flagstaff, AZ). 228 patients (86.0%) underwent primary endovascular treatment [144 (54.3%) off-label]. 22 (8.3%) underwent reintervention after prior endovascular procedure, 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 following outcomes, aortic rupture rate was 1.1% (n=3) and 1.9% (n=5). Stroke rate was 1.1% (n=3) and 4.2% (n=11). Spinal cord ischemic event rate was 1.5% (n=4) and 2.6% (n=7). Re-interventions were required in 6.4% (n=17) and 21.1% (n=56) of patients. 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%). 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, 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. Results at 5-year follow-up demonstrate that the use of TAG/CTAG can be supported in treatment of TBAD (acute, chronic, complicated and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

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)

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.

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.

Outcomes after endovascular reintervention for aortic interventions

ObjectiveEndovascular reinterventions are often performed after previous open or endovascular aortic procedures. We used the GREAT (Global Registry for Endovascular Aortic Treatment) database to compare the outcomes between these groups. We also compared reintervention of any type with a group of patients who had undergone primary endovascular abdominal aortic aneurysm repair (EVAR). MethodsAll patients enrolled in GREAT were grouped according to a previous EVAR or open abdominal aortic procedure (OAP). Univariate analysis was performed using the χ2, Wilcoxon rank sum, and Fisher exact tests. Cox proportional analysis was used to test the predictors for all-cause and aorta-related mortality. ResultsA total of 3974 subjects who had undergone EVAR with follow-up data available were included in the GREAT. Of the 3974 procedures, 196 (4.9%) were reinterventions (49 after OAP and 147 after previous EVAR). Reintervention after previous EVAR showed a trend toward a greater endoleak rate through 2 years (13.6% vs 4.1%; P = .07), although no difference was found in the occurrence of the intervention (12.2% vs 17.7%; P = .37). Reintervention after OAP resulted in higher all-cause mortality through 2 years of follow-up (32.7% vs 17.7%; P = .0.03). The predictors of mortality included prior OAP, renal insufficiency, and the use of cutdown for access. Compared with the patients who had undergone primary endovascular repair, patients in the reintervention cohort were older (75.3 years vs 73.3 years; P = .0005), had had only femoral artery access used (95.8% vs 90.3%; P < .0001), and were more likely to have undergone aortic branch vessel procedures (32.3% vs 13.3%; P < .0001). Both all-cause and aorta-related mortality through 2 years was higher in the reintervention group than in the primary EVAR group (21.4% vs 12.5% [P = .0003; and 4.6% vs 1% [P < .0001], respectively). On multivariate analysis, the predictors of aortic-related mortality included reintervention, renal insufficiency, chronic obstructive pulmonary disease, underweight body mass index, increasing aortic diameter, and the use of brachial artery or other arterial access sites. ConclusionsEndovascular reintervention for aortic pathology was associated with higher mortality than was primary EVAR. Reinterventions after prior OAPs were associated with higher mortality than were prior EVARs.

Early and Long-Term Outcomes of Endovascular Aortic Repair in Young and Low Surgical Risk Patients in the Global Registry for Endovascular Aortic Treatment

Purpose: To investigate early- and long-term outcomes of endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) in young and low surgical risk patients. Methods: The global registry for endovascular aortic treatment (GREAT) was queried for all patients with AAA undergoing standard EVAR; patients were excluded if had previous AAA repair or underwent concomitant procedures. Young patients were defined if age <60; surgical risk was assessed through the validated Medicare perioperative risk score (MPRS) based on age, sex, renal function, heart failure, and peripheral vascular disease. Patients were classified as low (MPRS<3), average (MPRS 3–11), or high (MPRS>11) risk. Young versus older patients and low-risk versus average/high-risk patients were compared. The primary endpoints were early (30 days) major adverse events (MAEs), 5-year freedom from overall mortality, aortic-related mortality, and freedom from device-related reinterventions. Time-to-event endpoints were calculated by Kaplan–Meier curves. Results: Of 3217 included patients, 182 (6%) were <60 years old, 956 (30%) had a low surgical risk, 1561 (49%) an average risk, 700 (22%) a high risk. Young patients had a less angulated proximal neck (27.2±18.4° vs 30.9±21.5°; p=0.05); in low-risk compared to average/high-risk patients, a longer neck length (3±1.8 vs 2.8±1.4 cm; p=0.01) and lower neck angulation (29.7±21.8° vs 33.2±22.2°; p=0.01) were present. Young age alone had no significant impact on early mortality (0% vs 0.6%; p=0.62.) and MAEs (3.9% vs 6.1%; p=0.20), while these were significantly lower in low-risk compared to average/high-risk patients (early mortality: 0.1% vs 0.7%, p=0.04; MAEs: 4.1% vs 6.7%, p=0.005). At 5 years, overall survival was significantly higher in young (88% vs 76%; p<0.001) and lower-risk (77% vs 54%; p<0.001) patients; low-risk patients also had significantly decreased aortic-related mortality (0% vs 2%; p=0.04) and reintervention rates (6% vs 11%; p=0.007). There were no statistically significant differences in mortality (0% vs 2%; p=0.42) and reintervention rate (10% vs 10%; p=1.00) between young and older patients. Conclusion: In this real-world registry, EVAR was more often offered in cases with suitable anatomy in young and low-risk patients. Low operative risk, rather than young age alone, predicted excellent early outcomes and low 5-year mortality, aortic-related mortality, and reintervention rates.

Incidence, Predictors, and Prognostic Impact of In-hospital Serious Adverse Events in Patients ≥75 Undergoing Endovascular Aneurysm Repair in the Global Registry of Endovascular Aortic Treatment

We sought to identify factors associated with the occurrence of in-hospital serious adverse events (SAEs) after elective endovascular aortic repair (EVAR) in elderly patients enrolled in the Global Registry for Endovascular Aortic Treatment (GREAT).

Endovascular repair of descending thoracic aortic aneurysms-a mid-term report from the Global Registry for Endovascular Aortic Treatment (GREAT).

The aim of this study was to evaluate the short- to mid-term outcomes of descending thoracic aortic aneurysm (DTAA) repair from the Gore Global Registry for Endovascular Aortic Treatment (GREAT). This is a multicentre sponsored prospective observational cohort registry. The study population comprised those treated for DTAA receiving GORE thoracic aortic devices for DTAA repair between August 2010 and October 2016. Major primary outcomes were early and late survival, freedom from aorta-related mortality and freedom from aorta-related reintervention. There were 180 (58.1%) males and 130 (41.9%) females: the mean age was 70 ± 11 years (range 18-92). The median maximum DTAA diameter was 60 mm (interquartile range 54-68.8). Technical success was achieved in all patients. Operative mortality, as well as immediate conversion to open repair, was never observed. At the 30-day window, mortality occurred in 4 (1.3%) patients, neurological events occurred in 4 (1.3%) patients (transient ischaemic attacks/stroke n = 3, paraplegia n = 1) and the reintervention rate was 4.5% (n = 14). Estimated survival was 95.6% [95% confidence interval (CI) 92.6-97.4] at 6 months, 92.7% (95% CI 89.1-95.2) at 1 year and 57.3% (95% CI 48.5-65.1) at 5 years. Freedom from aorta-related mortality was 98.3% (95% CI 96.1-99.3) at 6 months, 98.3% (95% CI 96.1-99.3) at 1 year and 92.2% (95% CI 83.4-96.4) at 5 years. Freedom from thoracic endovascular aortic repair (TEVAR)-related reintervention at 5 years was 87.2% (95% CI 81.2-91.4). TEVAR for DTAAs using GORE thoracic aortic devices is associated with a low rate of device-related reinterventions and is effective at preventing aorta-related mortality for up to 5 years of follow-up. NCT number: NCT01658787. 161, 164.

Excluder Stent Graft-Related Outcomes in Patients with Aortic Neck Anatomy Outside of Instructions For Use (IFU) within the Global Registry for Endovascular Aortic Treatment (GREAT): Mid-term Follow-Up Results

The utilisation rate of endovascular aortic aneurysm repair has increased continuously over the past 2 decades. Endovascular aortic aneurysm repair is still performed frequently in patients with an unfavourable proximal seal zone, despite the associated late complications. We aimed to evaluate the mid-term durability of the GORE® EXCLUDER® AAA Endoprosthesis, featuring the C3 delivery system, in patients with a proximal neck anatomy outside the instructions for use (IFU). A retrospective sub-analysis of the Global Registry for Endovascular Aortic Treatment including patients treated for abdominal aortic aneurysms with the GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, Arizona) was performed. A "challenging neck" was defined as those treated outside the IFU with an aortic neck length <15 mm and/or aortic neck angle >60°. Cox proportional analyses were used to test for time-to-event differences between those treated within and outside the IFU while accounting for covariates, specifically proximal neck length and neck angle. The main outcomes assessed were 5-year all-cause mortality, 5-year endoleak development (type I or III), and 5-year device-related reinterventions. Of the 3,324 patients included in the analysis, 411 (12.4%) had a challenging neck and 2,913 (87.6%) did not. The patients in the challenging neck group were significantly older (74.9 years vs. 73.2 years, p≤0.0001) and had a significantly larger aortic aneurysm diameter at the time of the intervention than those treated within the IFU (61.2 mm vs. 56.4 mm, P< 0.0001), shorter proximal neck length (18 mm vs. 30 mm, P< 0.0001) and larger infrarenal neck angle (60.8° vs. 25.8°, P< 0.0001). In the multivariate analysis, brachial access site and challenging neck were not independent risk factors; increased age was associated with a shorter time to mortality (hazard ratio 1.051, 95% confidence interval 1.039-1.062, P< 0.0001), as was the use of tobacco (hazard ratio 1.329, 95% confidence interval 1.124-1.571, P= 0.0009). The 5-year all-cause mortality (36.2% vs. 27.5%, P= 0.002) and aorta-related mortality (3.8% vs. 1.1%, P= 0.002) were significantly higher in the challenging neck group. The risk of death within 5 years also increased significantly at 1.1% per millimetre increase in the abdominal aortic aneurysm diameter (P= 0.0005). Furthermore, the rates of type Ia endoleak development (7% vs. 1.2%, P< 0.001) and requirement for reintervention (13.3% vs. 9.7%, P< 0.001) were higher in those treated outside the IFU (challenging neck group). Treatment with the Excluder AAA Endograft outside the IFU was associated with higher 5-year mortality values, increased type Ia endoleak development rates, and a greater need for reintervention compared with treatment within the IFU. This reiterates that fenestrated and open treatments should be strongly considered in cases with aortic neck anatomies outside the IFU. Infrarenal endovascular intervention outside the IFU should only be used when there is no alternative, with meticulous procedural planning and intervention to promote satisfactory outcomes.

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

BackgroundEndovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU.PurposeTo identify whether graft selection influences outcomes following EVAR outside of IFU.MethodologyA retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts.ResultsOf the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder.ConclusionTreatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

Aortic endograft sizing and endoleak, reintervention, and mortality following endovascular aneurysm repair

ObjectiveEndograft sizing for endovascular abdominal aortic aneurysm repair (EVAR) is not consistent despite published instructions for use (IFU). We sought to identify factors associated with over/undersizing, determine sex influence on sizing, and examine sizing effects on endoleak, reintervention, and mortality by analyzing data obtained from the W.L. Gore & Associates Global Registry for Endovascular Aortic Treatment (GREAT). MethodsAll patients enrolled in GREAT undergoing EVAR were included for analysis. Proximal/distal aortic landing zones were compared with device implanted to assess sizing as related to IFU. χ2/Fisher exact tests were used to evaluate associations between IFU sizing and demographics. Logistic regression modeling was used to identify predictors of outside IFU sizing. Cox proportional hazards regression analyzed the relationship between sizing and endoleak, device-related reinterventions, and all-cause/aortic mortality. ResultsThere were 3607 EVAR subjects enrolled in GREAT as of March 2020. Of them, 1896 (53%) were within IFU for sizing, 791 (22%) were oversized, 540 (15%) were undersized, and 380 (10%) had both over- and undersized components. Factors predictive of use outside of IFU included female sex (P = .001), non-white race (P = .0003), decreased proximal neck length (P < .061), or larger iliac diameters (P < .0001). Women were more likely than men to have proximal neck undersizing and iliac limb oversizing, and men were more likely to have iliac limb undersizing. On multivariate analysis, undersizing of the proximal graft was associated with endoleak (hazard ratio [HR], 1.8) and aortic (HR, 60.5) and all-cause (HR, 18.0) mortality. Undersizing of iliac limbs was associated with endoleak (HR, 1.5) and device-related reintervention (HR, 1.4). Iliac limb outside IFU sizing was associated with aortic (HR, 2.6) and all-cause (HR, 1.3) mortality. Proximal and distal oversizing was not associated with adverse outcomes. Female sex was associated with mortality on univariate but not multivariate analysis. ConclusionsWomen undergoing EVAR with GORE EXCLUDER abdominal aortic aneurysm Endoprosthesis (W.L. Gore & Associates Inc, Flagstaff, Ariz) are more likely to have proximal stent-graft undersizing and iliac limb oversizing, whereas men are more likely to have undersized iliac limbs. Proximal aortic graft undersizing is associated with endoleak and all-cause/aortic mortality, whereas undersizing of iliac limbs is associated with endoleak and device-related reintervention. Oversizing was not associated with adverse outcomes.

The Impact of Endograft Selection on Mid-Term Outcomes in Female Patients Following Endovascular Aortic Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA).

BackgroundAbdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort.PurposeTo identify whether graft selection influences outcomes following AAA endoluminal repair in female patients.MethodologyA retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts.ResultsOf the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT.ConclusionThe newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

OP410 Real-World Benefit Of Endovascular Repair Of Abdominal Aortic Aneurysms - Comparison Of GORE® Global Registry for Endovascular Aortic Treatment And National Institute for Clinical Excellence 2018 Guidance

IntroductionEndovascular aneurysm repair (EVAR) is routinely used for treatment of abdominal aortic aneurysm (AAA). In 2018, draft guidance from the National Institute for Clinical Excellence (NICE) suggested EVAR was not cost-effective compared to open surgical repair. The analysis was driven by clinical inputs from randomized control trials which may not reflect current clinical practice. Data from registries may inform more robust economic modelling. The Global Registry for Endovascular Aortic Treatment (GREAT) was initiated to collect contemporary real-world data on the performance of GORE® aortic endografts and includes long-term data on survival, re-interventions and resource use. This study compares the real-world values for mortality and resource use following elective EVAR as collected by GREAT with the 2018 NICE AAA draft guidance.MethodsA total of 1,348 patients (88.7% men; mean age 73.1 years) undergoing elective AAA repair with the GORE® EXCLUDER device. Mortality, re-intervention and resource use was compared with the economic inputs for 2018 NICE draft guidance cost-utility analysis.ResultsAll patients survived EVAR compared to the 0.4 percent mortality indicated in the NICE analysis. All-cause mortality was lower through 1, 3 and 5 years with values of 6.9, 14.8 and 16.2 percent respectively compared to the NICE base case. The average length of stay was 3.7 days in GREAT compared to 8.34 days in the NICE analysis. Short- and long-term re-interventions were also lower with real-world data (3.6% versus 7.3% and 5.5% versus 8.3%).ConclusionsGREAT provides conflicting data on survival and resource use associated with EVAR compared to inputs of the 2018 NICE draft guidance These differences are likely to significantly alter incremental cost-effectiveness ratios. Robust cost-effectiveness modelling in health technology assessments should consider contemporary data, as it is likely more reflective of current clinical practice and more informative for clinical and economic decision making for AAA.

Predictors of Aneurysm Sac Shrinkage Utilizing a Global Registry

Aneurysm sac remodeling is a complex multifactorial process with unknown factors influencing sac regression after endovascular aortic aneurysm repair (EVAR). We sought to identify factors associated with this process by analyzing data obtained from patients treated with the GORE EXCLUDER endovascular aneurysm repair (EVAR) endoprosthesis from December 2010 to October 2016 enrolled in the Global Registry for Endovascular Aortic Treatment (GREAT). All patients enrolled in GREAT with three years CT angiography (CTA) follow-up in each of the three successive years after EVAR were included. The percentage of sac size reduction toward device diameter was calculated and used as a surrogate for sac regression with the formula used being: sac size reduction = ((AAA baseline diameter - AAA diameter at follow-up)/(AAA baseline diameter - device diameter))∗100. The cohort was divided into two groups in accordance with the percentage of aneurysm sac reduction at three years; one with the top quartile of patients and the other with the lowest three quartiles. Demographic and procedural variables were analyzed using univariate and regression modeling to determine factors predictive of sac regression. There were 3265 subjects enrolled with follow-up as of May 2018 of which 526 (16.2%) had three years of CTA surveillance. Overall aneurysm sac size decreased from a mean of 58.0mm (Std Dev: 10.4, range: 34.2, 100.0) to a mean of 49.3mm (Std Dev: 14.1, range: 0, 140) for a percentage reduction toward device diameter of a mean 28.2% (Std Dev: 39.0, range: -103.7, 183.9). On multivariate logistic regression model; two factors proved to be statistically significant contributors to a larger percentage reduction in aneurysm sac: a conical neck (odds ratio [OR]=1.64, P-value=0.023) and a larger proximal device diameter (OR=1.09, P-value=0.023). On the other hand, two factors were negative predictors of sac shrinkage, namely: old age (OR=0.96, P-value=0.002) and larger baseline aneurysm sac diameter (OR=0.98, P-value=0.028). Aneurysms with conical necks and larger proximal device neck diameters have an increased percentage change in sac size over time after EVAR. Older age and larger initial diameters of aneurysms were negatively associated with percentage change in sac size as well as sac regression. Further study is needed to determine the clinical utility of these observations and applicability across multiple endoprosthesis platforms.

Aortic Endograft Sizing and Endoleak, Reintervention, and Mortality After Endovascular Aneurysm Repair

Aortic endograft sizing for endovascular aneurysm repair (EVAR) is not consistent despite published instructions for use (IFU). By analyzing data obtained from the Global Registry for Endovascular Aortic Treatment (GREAT), we sought to identify factors associated with oversizing and undersizing; to determine sex influence on sizing; and to examine sizing effects on endoleak, reintervention, and mortality. All patients enrolled in GREAT undergoing EVAR were included for analysis. Proximal and distal aortic landing zones were compared with device implanted to assess sizing as related to IFU. The χ2 and Fisher exact tests were used to evaluate associations between IFU sizing and demographics. Logistic regression modeling was used to identify predictors of outside IFU sizing. Cox proportional hazards regression analyzed the relationship between sizing and endoleak, device-related reinterventions, and all-cause/aortic mortality. There were 3607 participants enrolled in GREAT as of March 2020. Of these, 1896 (53%) were within IFU for sizing, 791 (22%) were oversized, 540 (15%) were undersized, and 380 (10%) had both oversized and undersized components. Factors predictive of use outside of IFU included female sex (P = .001), nonwhite race (P = .0003), decreased proximal neck length (P < .001), and smaller proximal aortic (P < .0001) or larger iliac diameters (P < .0001). Women were more likely than men to have proximal neck undersizing and iliac limb oversizing, and men were more likely to have iliac limb undersizing. On multivariate analysis, undersizing of the proximal graft was associated with endoleak (hazard ratio [HR], 1.8) and aortic (HR, 65.7) and all-cause (HR, 18.0) mortality. Undersizing of iliac limbs was associated with endoleak (HR, 1.5) and device-related reintervention (HR, 1.3). Proximal and distal oversizing was not associated with adverse outcomes. Female sex was associated with mortality on univariate but not on multivariate analysis. Women undergoing EVAR with Gore Excluder endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) are more likely to have proximal stent graft undersizing and iliac limb oversizing, whereas men are more likely to have undersized iliac limbs. Proximal aortic graft undersizing is associated with endoleak and all-cause/aortic mortality, whereas undersizing of iliac limbs is associated with endoleak and device-related reintervention.

Gender Related Access Complications After TEVAR: Analysis from the Retrospective Multicentre Cohort GORE® GREAT Registry Study

The Global Registry for Endovascular Aortic Treatment (GREAT), a retrospective sponsored registry, was queried to determine the incidence and identify potential predictors of access related complications after TEVAR. This is a multicentre, observational cohort study. For the current study, all patients were treated only with the Conformable GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Thoracic Endoprosthesis devices for any kind of thoracic aortic disease. All serious adverse events within 30 days of the procedure were documented by sites. The following were considered access related complications: surgical site infection, pseudoaneurysm, avulsion, dissection, arterial bleeding, access vessel thrombosis/occlusion, seroma, and lymphocoele. A total of 887 patients was analysed: most of the cases had an operative indication for TEVAR of degenerative atherosclerotic aneurysm (n = 414, 46.7%) and type B dissection (n = 270, 30.4% either complicated or uncomplicated). Two hundred and ninety-five patients (33.3%) were female. The overall access related complication rate was 2.8% (n = 25): 4.7% (n = 14) in women and 1.8% (n = 11) in men (p = .013). After adjustment for age, urgency, device diameter, introducer sheath (≥24Fr vs. ≤ 24Fr), access vessel diameters, and access method, female gender was significantly associated with the risk of access complications (OR 2.85; p = .038). Brachial artery for access was also found to be an independent predictor of access related complications (OR 8.32; p < .001). This analysis suggests that women may have a higher access related complication rate after TEVAR, irrespective of the clinical setting, type of aortic disease, and device sizing.

Outcomes After Endovascular Reintervention for Aortic Interventions

Endovascular reinterventions often follow previous open or endovascular aortic procedures. We used the Global Registry for Endovascular Aortic Treatment (GREAT) to compare outcomes between these groups and to compare reintervention of any type with primary endovascular aortic repair.

Early and Long-term Outcomes of Endovascular Aortic Repair in Young and Low-Surgical-Risk Patients in the Global Registry for Endovascular Aortic Treatment

The objective was to investigate early and long-term outcomes of endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysm in young and low-surgical-risk patients in the Global Registry for Endovascular Aortic Treatment (GREAT).

Sex-Related Outcomes After Endovascular Aneurysm Repair Within the Global Registry for Endovascular Aortic Treatment (GREAT)

Retrospective analysis from the Global Registry for Endovascular Aortic Treatment (GREAT) between August 2010 and October 2016 Of 3758 patients (3220 male, 538 female) who received Gore Excluder stent grafts (W. L. Gore & Associates, Flagstaff, Ariz) and underwent endovascular infrarenal abdominal aortic aneurysm repair (EVAR), women had shorter, more angulated necks and more reintervention for device-related issues than men did but not more endoleaks. Women had lower mortality rates but higher rates of reintervention and morbidity after EVAR.