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OBJECTIVE: Patients with chronic kidney disease (CKD) are considered a high-risk population, and the optimal approach to the treatment of carotid disease remains unclear. Thus, we compared outcomes following carotid revascularization for patients with CKD by operative approach of carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid arterial revascularization (TCAR). METHODS: The Vascular Quality Initiative was analyzed for patients undergoing carotid revascularizations (CEA, TFCAS, and TCAR) from 2016 to 2021. Patients with normal renal function (estimated glomular filtration rate >90 mL/min/1.72 m2) were excluded. Asymptomatic and symptomatic carotid stenosis were assessed separately. Preoperative demographics, operative details, and outcomes of 30-day mortality, stroke, myocardial infarction (MI), and composite variable of stroke/death were compared. Multivariable analysis adjusted for differences in groups, including CKD stage. RESULTS: A total of 90,343 patients with CKD underwent revascularization (CEA, n = 66,870; TCAR, n = 13,459; and TFCAS, n = 10,014; asymptomatic, 63%; symptomatic, 37%). Composite 30-day mortality/stroke rates were: asymptomatic: CEA, 1.4%; TCAR, 1.2%; TFCAS, 1.8%; and symptomatic: CEA, 2.7%; TCAR, 2.3%; TFCAS, 3.7%. In adjusted analysis, TCAR had lower 30-day mortality compared with CEA (asymptomatic: adjusted odds ratio [aOR], 0.4; 95% confidence interval [CI], 0.3-0.7; symptomatic: aOR, 0.5; 95% CI, 0.3-0.7), and no difference in stroke, MI, or the composite outcome of stroke/death in both symptom cohorts. TCAR had lower risk of other cardiac complications compared with CEA in asymptomatic patients (aOR, 0.7; 95% CI, 0.6-0.9) and had similar risk in symptomatic patients. Compared with TFCAS, TCAR patients had lower 30-day mortality (asymptomatic: aOR, 0.5; 95% CI, 0.2-0.95; symptomatic: aOR, 0.3; 95% CI, 0.2-0.4), stroke (symptomatic: aOR, 0.7; 95% CI, 0.5-0.97), and stroke/death (asymptomatic: aOR, 0.7; 95% CI, 0.5-0.97; symptomatic: aOR, 0.6; 95% CI, 0.4-0.7), but no differences in MI or other cardiac complications. Patients treated with TFCAS had higher 30-day mortality (aOR, 1.8; 95% CI, 1.2-2.5) and stroke risk (aOR, 1.3; 95% CI, 1.02-1.7) in symptomatic patients compared with CEA. There were no differences in MI or other cardiac complications. CONCLUSIONS: Among patients with CKD, TCAR and CEA showed rates of stroke/death less than 2% for asymptomatic patients and less than 3% for symptomatic patients. Given the increased risk of major morbidity and mortality, TFCAS should not be performed in patients with CKD who are otherwise anatomic candidates for TCAR or CEA.
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Estenosis Carotídea , Endarterectomía Carotidea , Insuficiencia Renal Crónica , Stents , Accidente Cerebrovascular , Humanos , Masculino , Femenino , Endarterectomía Carotidea/efectos adversos , Endarterectomía Carotidea/mortalidad , Anciano , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/mortalidad , Insuficiencia Renal Crónica/diagnóstico , Factores de Riesgo , Estenosis Carotídea/mortalidad , Estenosis Carotídea/cirugía , Estenosis Carotídea/complicaciones , Estenosis Carotídea/diagnóstico por imagen , Estudios Retrospectivos , Medición de Riesgo , Resultado del Tratamiento , Factores de Tiempo , Persona de Mediana Edad , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Anciano de 80 o más Años , Bases de Datos Factuales , Infarto del Miocardio/mortalidad , Infarto del Miocardio/etiología , Estados Unidos/epidemiología , Sistema de RegistrosRESUMEN
OBJECTIVE: Increased angulation of the proximal aortic neck has been associated with complications following endovascular repair of infrarenal aortic aneurysms, including increased incidence of endoleaks, stent migration, secondary interventions, and conversions. However, knowledge on the impact of aortoiliac tortuosity on outcomes following fenestrated repair remains limited. This study aims to quantify the effect of aortoiliac tortuosity on outcomes following fenestrated repair. METHODS: A single-center, retrospective review of all patients who underwent a physician-modified endovascular repair for the treatment of juxtarenal aortic aneurysms under a single physician-sponsored investigation device exemption study from 2011 to 2021 was performed. Center luminal lines and geometric distances were obtained using TeraRecon software (San Mateo, CA). A tortuosity index was calculated (tortuosity index = centerline distance/geometric line distance) for each iliac vessel as well as for the infrarenal aorta according to Society for Vascular Surgery reporting standards. Aortic and iliac tortuosity were assessed independently and stratified as low and high. Demographics, comorbidities, anatomic and operative details, and outcomes were compared using univariable and multivariable analysis. RESULTS: A total of 135 patients were identified. Thirty-eight patients (28%) had high aortic tortuosity, and 55 patients (42%) had high iliac tortuosity. Patients with high tortuosity were older (aortic: 78 vs 76 years; P = .04; iliac: 78 vs 75 years; P = .01) and differed by sex. Twenty-two percent of men and 50% of women had high aortic tortuosity (P = .01). Forty-seven percent of men and 20% of women had high iliac tortuosity (P = .01). There were no differences in comorbidities based on aortic tortuosity, but coronary artery disease (high: 58% vs low: 36%; P = .01) and hypertension (high: 69% vs low: 86%; P = .02) differed based on iliac tortuosity. Aneurysm diameter was larger for patients with high iliac tortuosity (72 mm vs 64 mm; P < .01), and fluoroscopy time was longer for patients with high aortic tortuosity (41 vs 31 minutes; P = .02). When outcomes were assessed, high iliac tortuosity was associated with increased rate of reinterventions (hazard ratio, 2.6; 95% confidence interval, 1.2-6.0) and type 1 or 3 endoleak (hazard ratio, 5.2; 95% confidence interval, 1.7-16); however, all other outcomes were similar. CONCLUSIONS: Among patients treated with physician-modified endovascular repair for juxtarenal aneurysms, iliac tortuosity but not aortic tortuosity, is associated with increased reinterventions and type 1 or type 3 endoleaks. Long-term follow-up is critical for patients with high iliac tortuosity to ensure that high-risk endoleaks are identified and treated early to avoid the risk of rupture.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Masculino , Humanos , Femenino , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Endofuga/complicaciones , Resultado del Tratamiento , Procedimientos Endovasculares/efectos adversos , Stents , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Estudios Retrospectivos , Diseño de PrótesisRESUMEN
OBJECTIVE: The modified Harborview Risk Score (HRS) is a simple measure initially derived from a single institutional dataset used to predict ruptured abdominal aortic aneurysm (rAAA) repair survival preoperatively using basic labs and vital signs collected upon presentation. However, validation of this widely applicable scoring system has not been performed. This study aims to validate this scoring system using a large multi-institutional database. METHODS: All patients who underwent repair of an rAAA from 2011 to 2018 in the National Surgical Quality Improvement Program (NSQIP) and at a single academic medical center were included. The modified HRS was calculated by assigning 1 point for each of the following: age >76 years, creatinine >2 mg/dL, international normalized ratio >1.8, and any systolic blood pressure less than 70 mmHg. Assessment of the prediction model was then completed. Using a primary outcome measure of 30-day mortality, the receiver operating characteristic area under the curve was calculated. The discrimination between datasets was compared using a Delong test. Mortality rates for each score were compared between datasets using the Pearson χ2 test. Comparative analysis for patients with a score of 4 was limited due to a small sample size. RESULTS: A total of 1536 patients were identified using NSQIP, and 163 patients were assessed in the institutional dataset. There were 518 patients with a score of 0 (455 NSQIP, 63 institutional), 676 patients with a score of 1 (617 NSQIP, 59 institutional), 391 patients with a score of 2 (364 NSQIP, 27 institutional), 106 with a score of 3 (93 NSQIP, 13 institutional), and 8 patients with a score of 4 (7 NSQIP, 1 institutional). No difference was found in the receiver operating characteristic area under the curves between datasets (P = .78). Thirty-day mortality was 10% NSQIP vs 22% institutional for a score of 0; 28% NSQIP vs 36% institutional for a score of 1; 41% NSQIP vs 44% institutional for a score of 2; 45% NSQIP vs 69% institutional for a score of 3; and 57% NSQIP vs 100% institutional for a score of 4. Score 0 was the only score with a significant mortality rate difference between datasets (P = .01). CONCLUSIONS: The modified HRS is confirmed to be broadly applicable as a clinical decision-making tool for patients presenting with rAAAs. Therefore, this easily applicable model should be applied for all patients presenting with rAAAs to assist with provider and patient decision-making prior to proceeding with repair.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Anciano , Técnicas de Apoyo para la Decisión , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Factores de Tiempo , Resultado del Tratamiento , Estudios Retrospectivos , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/cirugía , Complicaciones Posoperatorias/etiología , Medición de Riesgo , Implantación de Prótesis Vascular/efectos adversosRESUMEN
INTRODUCTION: Custom-branched/fenestrated grafts are widely available in other countries, but in the United States, they are limited to a handful of centers, with the exception of a 3-vessel juxtarenal device (ZFEN). Consequently, many surgeons have turned to alternative strategies such as physician-modified endografts (PMEGs). We therefore sought to determine how widespread the use of these grafts is. METHODS: We studied all complex endovascular repairs of complex and thoracoabdominal aortic aneurysms in the Vascular Quality Initiative from 2014 to 2022 to examine temporal trends. RESULTS: A total of 5826 repairs were performed during the study period: 1895 ZFEN, 3241 PMEG, 595 parallel grafting, and 95 where parallel grafting was used in addition to ZFEN, with a mean of 2.7 ± 0.98 vessels incorporated. Over time, the number of PMEGs steadily increased, both overall and for juxtarenal aneurysms, whereas the number of ZFENs essentially leveled off by 2017 and has remained steady ever since. In the most recent complete year (2021), PMEGs outnumbered ZFENs by over 2:1 overall (567 to 256) and nearly twofold for juxtarenal repairs. In three-vessel cases involving juxtarenal aneurysms, PMEGs were used as frequently as ZFENs (43% vs 43%), whereas the proportion of juxtarenal aneurysms repaired using a four-vessel graft configuration increased from 20% in 2014 to 29% in 2021 (P < .001). The differences in PMEG use were more pronounced as surgeon volume increased. Surgeons in the lowest quartile of volume performed <2 complex repairs annually, evenly split between PMEGs and ZFENs. However, surgeons in the highest quartile of volume performed a median of 18 (interquartile range: 10-21) PMEGs/y, but only 1.6 (interquartile range: 0.8-3.4) ZFENs/y. The number of physician-sponsored investigational device exemption trials of PMEGs has expanded from 1 in 2012 to 8 currently enrolling. As those data are not included in the Vascular Quality Initiative, the true number of PMEGs is likely substantially higher. CONCLUSIONS: PMEGs have become the dominant endovascular repair modality of complex abdominal and thoracoabdominal aortic aneurysms outside of investigational device exemptions. The field of endovascular aortic surgery and patients with complex aneurysms would benefit from broader publication of PMEG techniques, outcomes, and comparisons to custom-manufactured grafts.
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Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Diseño de Prótesis , Humanos , Aneurisma de la Aorta Torácica/cirugía , Prótesis Vascular/tendencias , Procedimientos Endovasculares/tendencias , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Implantación de Prótesis Vascular/tendencias , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/efectos adversos , Estados Unidos , Factores de Tiempo , Resultado del Tratamiento , Pautas de la Práctica en Medicina/tendencias , Masculino , Estudios Retrospectivos , Femenino , Anciano , Bases de Datos Factuales , Sistema de Registros , Aneurisma de la Aorta ToracoabdominalRESUMEN
OBJECTIVE: The only commercially available thoracic branched endoprosthesis (TBE) for treatment of the aortic arch was released in 2022. Limited data outside of clinical trial results have been reported. This study describes the demographics, anatomic details, and outcomes for patients treated for zone 0 to 2 using TBEs outside of a clinical trial. METHODS: All patients treated using TBEs for zone 0 to 2 were included. Patients treated as part of the clinical trial for zone 0 to 1 (n = 6) were excluded. Patient demographics, comorbidities, anatomic and operative details, and outcomes were reported. Outcomes and survival were then compared between groups. RESULTS: Of 40 patients, six patients underwent repair of zone 0, three of zone 1, and 31 of zone 2. There were no differences in demographics, comorbidities, or operative details by zone of treatment; however, the frequency of genetic aortopathy differed (zone 0: 0%; zone 1: 67%; and zone 2: 6.4%; P < .01). Seventy-three percent of patients were treated for dissection vs 27% with isolated aneurysms. Of the patients, 2.5% were treated for rupture, 22% were treated for symptomatic aneurysms, and 75% were treated electively. Forty-eight percent of repairs included a proximal cuff, and 83% received distal extension. Technical success was achieved in 100% of patients. Mean fluoroscopy time was 18 minutes, and median fluoroscopy dose was 416 mGy. Sixty percent of patients had prior aortic ascending/arch repair. TBE was planned as part of a complete thoracoabdominal repair in 45% of patients. Thirty-day mortality was 2.5% overall, with a single death in a zone 0 patient that occurred at day 1 due to a myocardial infarction. There were no reinterventions within 30 days. All other outcomes were similar. The 30-day stroke rate was 5.0%. The strokes occurred at day 6 (zone 1) and day 15 (zone 2); however, both were due to occlusion of a prior proximal surgical bypass and unrelated to the TBE side branch or embolization. Specifically, both patients had occlusion of a branch of their prior zone 1 or zone 2 arch replacement. An endoleak occurred in 7.5% of patients at 30-day follow-up (type II: 5.0%; unknown: 2.5%). At a mean follow-up of 6.6 months, 100% of side branches were patent. CONCLUSIONS: Repair of the aortic arch including TBE can be performed electively and urgently with acceptable stroke and death rates. TBE provides a valuable tool for patients requiring complete repair of a thoracoabdominal aneurysm. Continued investigation is underway to assess long-term safety and efficacy outside of the clinical trial.
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Aorta Torácica , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Prótesis Vascular , Procedimientos Endovasculares , Complicaciones Posoperatorias , Diseño de Prótesis , Humanos , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/mortalidad , Procedimientos Endovasculares/instrumentación , Masculino , Femenino , Resultado del Tratamiento , Anciano , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/instrumentación , Aorta Torácica/cirugía , Aorta Torácica/diagnóstico por imagen , Persona de Mediana Edad , Factores de Tiempo , Estudios Retrospectivos , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/mortalidad , Complicaciones Posoperatorias/etiología , Factores de Riesgo , Stents , Disección Aórtica/cirugía , Disección Aórtica/diagnóstico por imagen , Disección Aórtica/mortalidad , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: Owing to the significant morbidity and mortality of open thoracoabdominal aortic aneurysm surgery, complex endovascular repairs (eTAAA) have become increasingly common, but still carry substantial risk. These repairs require large bore access, with resultant pelvic and lower extremity ischemia. We therefore hypothesized that operative timing would be associated with outcomes, as efficient surgery would limit the ischemic time as well as anesthesia time. METHODS: We studied all eTAAA repairs (Crawford Types 1-3, 5) incorporating at least one branch vessel from 2014 to 2021 in the Vascular Quality Initiative, and categorized them into quartiles of total operating time. To account for variations in case complexity and intraoperative events, we performed a sub-analysis stratifying each surgeon by their median operating time. Multilevel logistic regression was employed to compare perioperative outcomes including mortality, thoracoabdominal life altering events (TALE:composite of perioperative death, stroke, permanent paralysis and/or dialysis), spinal cord ischemia (SCI), acute kidney injury (AKI), major adverse cardiac events (MACE), myocardial infarction, and dialysis. RESULTS: There were 2,925 eTAAA repairs during the study period. Procedure times ranged from <204 minutes in the first quartile to >365 minutes in the fourth. Longer cases more commonly involved older patients who were more often female, and higher rates of prior stroke, and preoperative anemia. They involved larger, more extensive aneurysms, with higher rates of prior aortic surgery, and more commonly employed PMEGs or parallel grafting to incorporate more branch vessels. In addition, they were less often staged procedures, and used more spinal drains, femoral cutdowns, and upper extremity access. Operating time decreased as experience increased. In adjusted analyses, the odds of mortality and every morbidity studied increased stepwise with operating time, with 4 to 13-fold higher odds in the highest quartiles. Spinal cord ischemia had the strongest association with procedure times, with seven-fold higher odds (OR 7.2 [2.9-17.9], P<.001) of any SCI in the highest quartile compared to the lowest, and 13-fold higher odds of permanent SCI (OR 13.1 [3.9-44.7], P<.001). These results were consistent when surgeons were grouped into quartiles by their median operating times. Medium-term mortality was also higher in the upper quartile of operating time (HR 2.7 [1.4-5.1], P=.002). CONCLUSION: Longer operating times for complex eTAAA repairs were associated with markedly higher rates of morbidity and mortality, especially spinal cord ischemia. These results emphasize the importance of expeditious repairs by experienced teams.
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BACKGROUND: Given changes in intervention guidelines and the growing popularity of endovascular treatment for aortic aneurysms, we examined the trends in admissions and repairs of abdominal aortic aneurysms (AAAs), thoracoabdominal aortic aneurysms (TAAAs), and thoracic aortic aneurysms (TAAs). METHODS: We identified all patients admitted with ruptured aortic aneurysms and intact aortic aneurysms repaired in the Nationwide Inpatient Sample between 2004 and 2019. We then examined the use of open, endovascular, and complex endovascular repair (OAR, EVAR, and cEVAR) for each aortic aneurysm location (AAA, TAAA, and TAA), alongside their resulting in-hospital mortality, over time. cEVAR included branched, fenestrated, and physician-modified endografts. RESULTS: 715,570 patients were identified with AAA (87% intact repairs and 13% rupture admissions). Both intact AAA repairs and ruptured AAA admissions decreased significantly between 2004 and 2019 (intact 41,060-34,215, P < .01; ruptured 7175-4625, P = .02). Of all AAA repairs performed in a given year, the use of EVAR increased (2004-2019: intact 45%-66%, P < .01; ruptured 10%-55%, P < .01) as well as cEVAR (2010-2019: intact 0%-23%, P < .01; ruptured 0%-14%, P < .01). Mortality after EVAR of intact AAAs decreased significantly by 29% (2004-2019, 0.73%-0.52%, P < .01), whereas mortality after OAR increased significantly by 16% (2004-2019, 4.4%-5.1%, P < .01). In the study, 27,443 patients were identified with TAAA (80% intact and 20% ruptured). In the same period, intact TAAA repairs trended upward (2004-2019, 1435-1640, P = .055), and cEVAR became the most common approach (2004-2019, 3.8%-72%, P = .055). A total of 141,651 patients were identified with ascending, arch, or descending TAAs (90% intact and 10% ruptured). Intact TAA repairs increased significantly (2004-2019, 4380-10,855, P < .01). From 2017 to 2019, the mortality after OAR of descending TAAs increased and mortality after thoracic endovascular aneurysm repair decreased (2017-2019, OAR 1.6%-3.1%; thoracic endovascular aneurysm repair 5.2%-3.8%). CONCLUSIONS: Both intact AAA repairs and ruptured AAA admissions significantly decreased between 2004 and 2019. The use of endovascular techniques for the repair of all aortic aneurysm locations, both intact and ruptured, increased over the past two decades. Most recently in 2019, 89% of intact AAA repairs, infrarenal through suprarenal, were endovascular (EVAR or cEVAR, respectively). cEVAR alone increased to 23% of intact AAA repairs in 2019, from 0% a decade earlier. In this period of innovation, with many new options to repair aortic aneurysms while maintaining arterial branches, endovascular repair is now used for the majority of all intact aortic aneurysm repairs. Long-term data are needed to evaluate the durability of these procedures.
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OBJECTIVE: Studies have suggested that aortic thrombus may be associated with adverse outcomes following endovascular repair of aortic aneurysms, while other reports have suggested higher rates of sac regression and reduced risk of endoleak. However, the effect of thrombus burden on outcomes following physician modified endografts (PMEGs) remains unknown. This study aimed to assess the volume and morphology of thrombus burden and the effect on outcomes following PMEG for juxtarenal abdominal aortic aneurysm. METHODS: This was a retrospective cohort study of patients who underwent PMEG from 2009 to 2021 in a single centre, investigational device exemption trial. Thrombus burden was measured as a percentage of luminal volume using pre-operative computed tomography scans from the lowest renal artery to the level of the aortic bifurcation using centreline reconstructive software. Morphology was documented by the presence of finger like projections. Univariate and multivariate analyses evaluated the impact on peri-operative and long term outcomes. RESULTS: Volumetrical and morphological measures of thrombus burden were assessed in 142 patients; 40.1% of the cohort were classified as having a high thrombus burden (≥ 50% luminal volume) on volumetrical assessment and 22.5% had finger like projections on morphological assessment. Type II endoleak was more frequently observed in those with low thrombus burden (60.0% vs. 33.3%; p = .008) and persisted after multivariate analysis (odds ratio 2.5, 95% confidence interval 1.1 - 5.8), but there were no other significant differences in peri-operative adverse events or late outcomes-including sac behaviour, freedom from re-intervention, and overall survival-when stratifying thrombus burden by quantitative or qualitative measures. There were no observed differences in operative characteristics or anatomical characteristics, including landing zone characteristics and rates of inferior mesenteric artery patency. CONCLUSION: While thrombus burden and morphology were not associated with adverse peri-operative events or survival, low thrombus burden was associated with an increase in type II endoleak. These findings suggest that thrombus burden should not deter treatment for patients requiring PMEG.
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OBJECTIVE: To assess whether outcomes of rupture repair differ by aortic repair history and determine the ideal approach for rupture repair in patients with previous aortic repair. METHODS: This retrospective review included all patients who underwent repair of a ruptured infrarenal abdominal aortic aneurysm from 2003 - 2021 recorded in the Vascular Quality Initiative (VQI) registry. Pre-operative characteristics and post-operative outcomes and long term survival were compared between patients with and without prior aortic repair. To assess the impact of open and endovascular approaches to rupture, a subgroup analysis was then performed among patients who ruptured after a prior infrarenal aortic repair. Univariable and adjusted analyses were performed to account for differences in patient characteristics and operative details. RESULTS: A total of 6 197 patients underwent rupture repair during the study period, including 337 (5.4%) with prior aortic repairs. Univariable analysis demonstrated an increased 30 day mortality rate in patients with prior repairs vs. without (42 vs. 36%; p = .034), and prior repair was associated with increased post-operative renal failure (35 vs. 21%; p < .001), respiratory complications (32 vs. 24%; p < .001), and wound complications (9 vs. 4%; p < .001). Following adjustment, all outcomes were similar with the exception of bowel ischaemia, which was decreased among patients with prior repair (OR 0.7, 95% CI 0.6 - 0.9). Subgroup analysis demonstrated that patients with a prior aortic repair history who underwent open rupture repair had increased odds for 30 day death (OR 1.3, 95% CI 1.2 - 1.7) and adverse secondary outcomes compared with those managed endovascularly. CONCLUSION: Prior infrarenal aortic repair was not independently associated with increased morbidity or mortality following rupture repair. Patients with a prior aortic repair history demonstrated statistically significantly higher mortality and morbidity when treated with an open repair compared with an endovascular approach. An endovascular first approach to rupture should be strongly encouraged whenever feasible in patients with prior aortic repair.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Procedimientos Endovasculares , Complicaciones Posoperatorias , Humanos , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/mortalidad , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/complicaciones , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/métodos , Procedimientos Endovasculares/mortalidad , Rotura de la Aorta/cirugía , Rotura de la Aorta/mortalidad , Estudios Retrospectivos , Masculino , Femenino , Anciano , Resultado del Tratamiento , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/mortalidad , Implantación de Prótesis Vascular/métodos , Anciano de 80 o más Años , Factores de Riesgo , Sistema de Registros , Persona de Mediana Edad , Medición de RiesgoRESUMEN
BACKGROUND: Endovascular treatment allows for the staging of thoracoabdominal aortic aneurysm repairs (eTAAAs) in an effort to decrease the risk of spinal cord ischemia (SCI), but data are limited. METHODS: We studied all eTAAAs in the Vascular Quality Initiative from 2014 to 2021. Inverse probability weighting was used to compare perioperative and long-term outcomes of staged and single-stage repairs. Thoracoabdominal life-altering events (TALEs) are the composite endpoint consisting of death/stroke/permanent SCI/permanent dialysis. RESULTS: There were 3,258 total operations during the study period. In total, 841 cases (26%) were staged repairs, and 2,417 (74%) were completed in a single stage, but in the cohort of patients with extensive aneurysms, 44% were staged. Staging methods included thoracic endograft (78%), branch (23%), and iliac (5%). Staged repairs were more often employed by high-volume surgeons at high-volume centers; for larger, more extensive aneurysms, with higher rates of prior aortic surgery. After adjustment, staged repair and single-stage treatment were associated with similar odds of all perioperative outcomes and including mortality, TALE, acute kidney injury, stroke, dialysis, and SCI, as well as long-term survival. This was consistent in the subgroups of patients with extensive aneurysms undergoing elective procedures. Of note, first-stage thoracic endografts were associated with 2.6% mortality, 7.3% TALE, 1.5% dialysis, and 4.1% SCI, and 25% of patients did not undergo a second stage. First-stage procedures accounted for one-third of perioperative complications including half of the deaths in the staged cohort. CONCLUSIONS: Staged eTAAA repairs were associated with similar perioperative and long-term complications to single-stage treatments. However, first stage procedures are associated with significant morbidity and mortality, and one-quarter of patients never complete their repairs. These data demonstrate the necessity of evaluating the outcomes of all patients planned for staged procedures, not only those who make it to the final stage. More data are needed as to the optimal method of spinal cord protection for these challenging aneurysms.
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Aneurisma de la Aorta Torácica , Aneurisma de la Aorta Toracoabdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia de la Médula Espinal , Accidente Cerebrovascular , Humanos , Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Factores de Riesgo , Resultado del Tratamiento , Estudios Retrospectivos , Procedimientos Endovasculares/efectos adversos , Complicaciones Posoperatorias , Factores de Tiempo , Isquemia de la Médula Espinal/etiología , Isquemia de la Médula Espinal/cirugía , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: Recent literature has suggested a decreasing experience with open aortic surgery among recent vascular surgery graduates. While trainees have a wide exposure to endovascular aortic repair, experience with both endovascular and open management of thoracoabdominal aneurysms, as well as the early career surgeon comfort with these procedures, remains unknown. Thus, we sought to evaluate early practice patterns in the surgical treatment of complex aortic surgery among recent US vascular surgery graduates. METHODS: An anonymous survey was distributed among all vascular surgeons who completed vascular surgery residency or fellowship in 2020. Self-reported data assessed the number and type of cases performed in training, surgeon experience in early practice, and surgeon desire for additional training in these areas. RESULTS: A total of 62 surgeons completed the survey with a response rate of 35%. Seventy-nine percent of respondents completed fellowship training (as compared to integrated residency), and 87% self-described as training in an academic environment. Sixty-six percent performed less than 5 open thoracoabdominal aortic surgeries and 58% performed less than 5 4-vessel branched/fenestrated aortic repairs (F/BEVARs), including 56% who completed less than 5 physician modified endovascular grafts repairs. Only 11% of respondents felt adequately prepared to perform open thoracoabdominal operations following training. For both open and F/BEVAR procedures, more than 80% respondents plan to perform such procedures with a partner in their current practice, and the majority desired additional open (61%) and endovascular (59%) training for the treatment of thoracoabdominal aneurysms. CONCLUSIONS: The reported infrequency in open thoracoabdominal and multivessel F/BEVAR training highlights a desire and utility for an advanced aortic training paradigm for surgeons wishing to focus on this area of vascular surgery. Further research is warranted to determine the optimal way to provide such training, whether through advanced fellowships, junior faculty apprenticeship models, or regionalization of this highly complex patient care. The creation of these programs may provide pivotal opportunity, as vascular surgery and the management of complex aortic pathology continues to evolve.
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Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Aneurisma de la Aorta Torácica/cirugía , Procedimientos Endovasculares/métodos , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/cirugía , Aorta/cirugíaRESUMEN
OBJECTIVE: Our aim was to describe the racial and ethnic differences in presentation, baseline and operative characteristics, and outcomes after aortoiliac aneurysm repair. SUMMARY OF BACKGROUND DATA: Previous studies have demonstrated racial and ethnic differences in prevalence of abdominal aortic aneurysms and showed more complex iliac anatomy in Asian patients. METHODS: We identified all White, Black, Asian, and Hispanic patients undergoing aortoiliac aneurysm repair in the VQI from 2003 to 2019. We compared baseline comorbidities, operative characteristics, and perioperative outcomes by race and ethnicity. RESULTS: In our 60,435 patient cohort, Black patients, followed by Asian patients, were most likely to undergo repair for aortoiliac (W:23%, B:38%, A:31%, H:22%, P < 0.001) and isolated iliac aneurysms (W:1.0%, B:3.1%, A:1.5%, H:1.6%, P < 0.001), and White and Hispanic patients were most likely to undergo isolated aortic aneurysm repair (W:76%, B:59%, A:68%, H:76%, P < 0.001). Black patients were more likely to undergo symptomatic repair and underwent rupture repair at a smaller aortic diameter. The iliac aneurysm diameter was largest in Black and Asian patients. Asian patients were most likely to have aortic neck angulation above 60 degree, graft oversizing above 20%, and completion endoleaks. Also, Asian patients were more likely to have a hypogastric artery aneurysm and to undergo hypogastric coiling. CONCLUSION: Asian and Black patients were more likely to undergo repair for aortoiliac and isolated iliac aneurysms compared to White and Hispanic patients who were more likely to undergo repair for isolated aortic aneurysms. Moreover, there were significant racial differences in the demographics and anatomic characteristics that could be used to inform operative approach and device development.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco , Humanos , Aneurisma Ilíaco/cirugía , Prótesis Vascular , Stents , Factores Raciales , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/cirugía , Aorta Abdominal/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVE: The Society for Vascular Surgery has recommended immediate transfer of patients with ruptured abdominal aortic aneurysms (rAAAs) to a regional center when feasible. However, Black patients might be less likely to be transferred and more likely to be turned down for repair. We, therefore, examined the transfer rates, turndown rates, and outcomes for Black vs White patients presenting with rAAAs in two large databases. METHODS: We examined all rAAA repairs in the Vascular Quality Initiative from 2003 to 2020 to evaluate the transfer rates and outcomes for Black vs White patients. We used the National Inpatient Sample from 2004 to 2015 to examine the turndown rates. Mixed effects logistic regression, Cox regression, and marginal effects modeling were used to study the interaction between race, insurance status, surgery type (open repair vs endovascular aortic aneurysm repair), and hospital volume. RESULTS: We identified 4935 patients with rAAAs in the Vascular Quality Initiative (6.2% Black) and 48,489 in the National Inpatient Sample (6.0% Black). The rates of transfer were high; however, Black patients were significantly less likely to undergo transfer before repair compared with White patients (49% Black vs 62% White; P = .002). The result was consistent in both crude and adjusted analyses when considering only stable patients and was not modified by insurance status, surgery type, or hospital volume. No significant differences were found in perioperative mortality (22% vs 26%; P = .098) or complications (52% vs 52%; P = .64). However, Black patients were significantly more likely to be turned down for repair (37% vs 28%; odds ratio, 1.5; 95% confidence interval, 1.2-1.9; P < .001). A significant interaction was found between race and insurance status with respect to turndown. Patients with private insurance had undergone surgery at a similar rate, regardless of race. However, among patients with Medicare or Medicaid/self-pay, Black patients were less likely than were White patients to undergo repair (Medicare, 64% vs 72%; P = .001; Medicaid/self-pay, 43% vs 61%; P = .031). Patients with Medicaid/self-pay were also less likely to undergo repair than were patients of the same race with either Medicare or private insurance (P < .05). CONCLUSIONS: We found that Black patients with rAAAs are poorly served by the current systems of interhospital transfer in the United States, because they less often undergo transfer before repair. Although the postoperative outcomes appeared similar, this finding could be falsely optimistic, because Black patients, especially the underinsured, were turned down for repair more often even after adjustment. Significant work is needed to better understand the reasons underlying these disparities and identify the targets to improve the care of Black patients with rAAAs.
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Aneurisma de la Aorta Abdominal , Rotura de la Aorta , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Anciano , Humanos , Estados Unidos/epidemiología , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/etiología , Implantación de Prótesis Vascular/efectos adversos , Medicare , Rotura de la Aorta/diagnóstico por imagen , Rotura de la Aorta/cirugía , Rotura de la Aorta/etiología , Complicaciones Posoperatorias/etiologíaRESUMEN
OBJECTIVE: Endoleaks may be seen at case completion of endovascular abdominal aortic aneurysm repair (EVAR), and the presence of an endoleak may impact outcomes. However, the clinical implications of various endoleaks seen during follow-up is not well-described. Therefore, we studied the impact of endoleaks at completion and at follow-up on mid-term outcomes. METHODS: We reviewed patients who underwent EVAR from 2003 to 2016 within the Vascular Quality Initiative-Medicare database and identified patients with endoleak at procedure completion and during follow-up, excluding those presenting with rupture. We stratified cohorts by presence of completion and follow-up endoleak subtypes. The primary outcome was 5-year survival, and secondary outcomes included 5-year freedom from reintervention and freedom from rupture. We used Kaplan-Meier estimates and log-rank tests to analyze differences in time-to-event endpoints. RESULTS: Of 21,745 patients with completion endoleak data, 5085 (23%) had an endoleak. Compared with those without endoleak, those with type I endoleaks had lower 5-year survival (69% vs 75%; P < .001), type II endoleaks had higher survival (79%; P < .001), and types III, IV, and indeterminate were not statistically different (73%, 73%, and 75%, respectively). Freedom from reintervention for types I and III endoleaks were significantly lower than no endoleak cohort (I: 76%; P < .001; III: 72%; P < .001 vs 83%), but freedom from rupture was higher for those with type II and III endoleak (95% and 97% vs 94%; P < .001). Of 14,479 patients with detailed follow-up endoleak data, 2290 (16%) had an endoleak. Compared with those without endoleak, types I and III had significantly lower 5-year survival (I: 80%; P = .002; III: 66%; P < .001 vs 84%), but there were no differences for types II (82%) and indeterminate (77%). Those with any type of follow-up endoleak had lower 5-year freedom from reintervention (I: 70%; P < .001; II: 76%; P = .006; III: 36%; P < .001; indeterminate: 60%; P = .007 vs 84%), and lower freedom from rupture (I: 92%; P < .001; II: 91%; P = .16; III: 88%; P = .01; indeterminate: 90%; P = .11 vs 94%). CONCLUSIONS: Compared with patients with no endoleak, those with type I completion endoleaks have lower 5-year survival and freedom from reintervention. Patients with types I and III follow-up endoleaks also have lower survival, and any endoleak at follow-up is associated with lower freedom from reintervention and freedom from rupture. These data highlight the importance of careful patient selection and close postoperative follow-up after EVAR, as the presence of endoleaks, specifically type I and III, over time portends worse outcomes.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Anciano , Estados Unidos , Resultado del Tratamiento , Estudios de Seguimiento , Factores de Riesgo , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/etiología , Medicare , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/cirugía , Estudios RetrospectivosRESUMEN
OBJECTIVE: Transcarotid artery revascularization (TCAR) has emerged as an effective method for carotid artery stenting. However, anatomic eligibility for TCAR is most often limited by an inadequate clavicle-to-carotid bifurcation length of <5 cm. Preoperative clavicle-to-carotid bifurcation distances may be underestimated when using conventional straight-line measurements on computed tomographic angiography (CTA) imaging. We therefore compared clavicle-to-carotid bifurcation lengths as measured by straight-line CTA, center-line CTA, and intraoperative duplex ultrasound (US), to assess potential differences. METHODS: We conducted a single-center, retrospective review of consecutive TCAR procedures performed between 2016 and 2019 for atherosclerotic carotid disease. For each patient, we compared clavicle-to-carotid bifurcation lengths measured by straight-line CTA, center-line CTA using TeraRecon image reconstruction, and intraoperative duplex US with neck extension and rotation. We further assessed patient and imaging characteristics in individuals with a ≥0.5 cm difference among the measurement methods. In particular, common carotid artery (CCA) tortuosity, defined as the inability to visualize the entire CCA from clavicle to carotid bifurcation on both a single coronal and sagittal imaging cut, was examined as a contributing factor for these discrepancies. RESULTS: Of the 70 TCAR procedures identified, 46 had all three imaging modalities available for review. The median clavicle-to-carotid bifurcation length was found to be 6.4 cm (interquartile range [IQR], 5.4-6.7 cm) on straight-line CTA, 7.0 cm (IQR, 6.0-7.5 cm) on intraoperative duplex US, and 7.2 cm (IQR, 6.5-7.5 cm) on center-line CTA (P < .001). Patients with a ≥0.5 cm difference between their straight-line CTA and either their intraoperative duplex US or center-line CTA measurements were more likely to have tortuous CCAs (60.0% vs 19.1%; P = .01; 51.4% vs 0.0%; P = .01). There were no notable differences in age, gender, prior neck/cervical spine surgery, or neck immobility among these individuals. In patients with tortuous CCAs, duplex US and center-line CTA measurements added 1.0 cm (IQR, 0.6-1.5 cm) and 1.1 cm (IQR, 0.9-1.6 cm) more in length than straight-line CTA measurements, respectively. There was a strong linear correlation between the additional lengths provided by duplex US measurements and those provided by center-line CTA measurements for each individual within the tortuous CCA group (r = 0.83). CONCLUSIONS: The use of straight-line CTA during preoperative planning can underestimate the clavicle-to-carotid bifurcation lengths in patients undergoing carotid revascularization, particularly in those with tortuous CCAs. Both duplex US performed with extended-neck surgical positioning and center-line CTA provide similar and longer carotid length measurements, and should be utilized in patients with tortuous carotid vessels to better determine TCAR anatomic eligibility.
Asunto(s)
Estenosis Carotídea , Humanos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/cirugía , Clavícula , Stents , Procedimientos Quirúrgicos Vasculares , Arteria Carótida ComúnRESUMEN
OBJECTIVE: Reports of endovascular treatment of chronic post-dissection aneurysms are limited to high volumes centres, posing questions about generalisability. METHODS: All endovascular repairs of intact pararenal and thoraco-abdominal aneurysms in the Vascular Quality Initiative from 2014 to 2021 were studied, and peri-operative and long term outcomes were compared between repairs of degenerative and post-dissection aneurysms. Peri-operative outcomes were compared using mixed effects logistic regression, and long term outcomes using Medicare linkage. RESULTS: There were 123 patients who completed treatment for post-dissection aneurysms and 3 635 for degenerative aneurysms, with 36% of post-dissection repairs and 6.7% of degenerative repairs performed in a staged fashion (p < .001). The majority (84%) of post-dissection aneurysms were extensive thoraco-abdominal aneurysms (TAAAs: Crawford Type 1, 2, 3, 5), compared with 22% of degenerative aneurysms (p < .001). Physician modified endografts were the primary repair type for post-dissection (73%), while commercially available fenestrated grafts were the dominant repair for degenerative (48%). The first stage of staged procedures was associated with a 2.8% peri-operative mortality rate, 5.1% spinal cord ischaemia, and 8.9% thoraco-abdominal life altering events (the composite of peri-operative death, stroke, permanent spinal cord ischaemia, and dialysis). Th final stage procedure and fluoroscopy times were similar, but technical success was lower in post-dissection repairs (75% vs. 83%, p = .018), both due to issues with the main endograft or bridging vessels (11% vs. 6.6%, p = .055), and types 1and 3 endoleak at completion (17% vs. 10%, p = .035). In addition, high volume surgeons had two fold higher odds of technical success than their low volume counterparts. Adjusted peri-operative outcomes were similar between pathology types, including when comparisons were restricted to extensive TAAAs. Crude and adjusted three year survival were similar, but three year re-interventions were significantly higher following post-dissection repairs (p < .001). CONCLUSION: Complex endovascular repair of chronic post-dissection aneurysms is feasible but is associated with high rates of re-interventions and non-trivial rates of lack of technical success. More data are needed to evaluate the long term durability of these procedures, and the utility of centralising these complex procedures.
Asunto(s)
Aneurisma de la Aorta Abdominal , Aneurisma de la Aorta Torácica , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Isquemia de la Médula Espinal , Humanos , Anciano , Estados Unidos , Prótesis Vascular , Aneurisma de la Aorta Torácica/diagnóstico por imagen , Aneurisma de la Aorta Torácica/cirugía , Aneurisma de la Aorta Torácica/etiología , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Medicare , Aneurisma de la Aorta Abdominal/cirugía , Isquemia de la Médula Espinal/etiologíaRESUMEN
BACKGROUND AND PURPOSE: The net benefit of carotid endarterectomy (CEA) is determined partly by the risk of procedural stroke or death. Current guidelines recommend CEA if 30-day risks are <6% for symptomatic stenosis and <3% for asymptomatic stenosis. We aimed to identify prediction models for procedural stroke or death after CEA and to externally validate these models in a large registry of patients from the United States. METHODS: We conducted a systematic search in MEDLINE and EMBASE for prediction models of procedural outcomes after CEA. We validated these models with data from patients who underwent CEA in the American College of Surgeons National Surgical Quality Improvement Program (2011-2017). We assessed discrimination using C statistics and calibration graphically. We determined the number of patients with predicted risks that exceeded recommended thresholds of procedural risks to perform CEA. RESULTS: After screening 788 reports, 15 studies describing 17 prediction models were included. Nine were developed in populations including both asymptomatic and symptomatic patients, 2 in symptomatic and 5 in asymptomatic populations. In the external validation cohort of 26 293 patients who underwent CEA, 702 (2.7%) developed a stroke or died within 30-days. C statistics varied between 0.52 and 0.64 using all patients, between 0.51 and 0.59 using symptomatic patients, and between 0.49 to 0.58 using asymptomatic patients. The Ontario Carotid Endarterectomy Registry model that included symptomatic status, diabetes, heart failure, and contralateral occlusion as predictors, had C statistic of 0.64 and the best concordance between predicted and observed risks. This model identified 4.5% of symptomatic and 2.1% of asymptomatic patients with procedural risks that exceeded recommended thresholds. CONCLUSIONS: Of the 17 externally validated prediction models, the Ontario Carotid Endarterectomy Registry risk model had most reliable predictions of procedural stroke or death after CEA and can inform patients about procedural hazards and help focus CEA toward patients who would benefit most from it.
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Estenosis Carotídea/cirugía , Ensayos Clínicos como Asunto/normas , Endarterectomía Carotidea/normas , Modelos Teóricos , Selección de Paciente , Sistema de Registros/normas , Estenosis Carotídea/diagnóstico , Endarterectomía Carotidea/métodos , Humanos , Valor Predictivo de las Pruebas , Medición de Riesgo/métodos , Medición de Riesgo/normasRESUMEN
OBJECTIVE: Vulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States. METHODS: We queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups. RESULTS: The FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P < .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P = .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P = .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P = .75). CONCLUSIONS: Racial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Femenino , Estados Unidos , Implantación de Prótesis Vascular/efectos adversos , Prótesis Vascular , Etnicidad , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Estudios Retrospectivos , Factores de Riesgo , Grupos Minoritarios , Stents , Aneurisma de la Aorta Abdominal/cirugíaRESUMEN
OBJECTIVE: Female patients are more likely to undergo repair of intact and ruptured abdominal aortic aneurysm (AAA) at smaller aortic diameter compared with male patients. By adjusting for inherent anatomic differences between sexes, aortic size index (ASI) and aortic height index (AHI) may provide an additional method for guiding treatment. We therefore analyzed sex-specific criteria for AAA repair using aortic diameter, ASI, and AHI. METHODS: We identified all patients who underwent AAA repair between 2003 and 2019 in the Vascular Quality Initiative database. The Dubois and Dubois formula was used to calculate body surface area; aortic diameter was divided by body surface area to calculate ASI. Aortic diameter was divided by height to calculate AHI. Cumulative distribution curves were used to plot the proportion of patients who underwent repair of ruptured aneurysm according to aortic diameter, ASI, and AHI. Multivariable logistic regression modeling was used to identify the association of female sex with perioperative mortality and any major postoperative complication. RESULTS: We identified 55,647 patients, of whom 12,664 were female (20%). For both intact and rupture repair, female patients were older, less likely to undergo endovascular aneurysm repair, and more likely to have comorbid conditions. Female patients underwent repair at smaller median aortic diameter compared with male patients for intact (5.4 vs 5.5 cm; P < .001) and rupture repair (6.7 vs 7.7 cm; P < .001). However, ASI was higher in female patients for both intact (3.1 vs 2.7 cm/m2; P < .001) and rupture repair (3.8 vs 3.7 cm/m2; P < .001), whereas AHI was higher in female patients for intact repair (3.3 vs 3.1 cm/m; P < .001) but lower for rupture repair (4.1 vs 4.3 cm/m; P < .001). When analyzing the cumulative distribution of rupture repair in male patients, 12% of rupture repairs were performed at an aortic diameter below 5.5 cm. To achieve the same proportion of rupture repair in female patients, the repair diameter was only 4.9 cm. However, when ASI and AHI were used, female and male patients both reached 12% of rupture repair at an ASI of 2.7 cm/m2 and an AHI of 3.0 cm/m. CONCLUSIONS: Our study provides data to strongly support the sex-specific 5.0-cm aortic diameter threshold suggested for repair in female patients by the Society for Vascular Surgery. The high percentage of patients undergoing rupture repair below 5.5 cm in male patients and 5.0 cm in female patients highlights the need to better identify patients at risk of rupture at smaller aortic diameters.
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Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/estadística & datos numéricos , Procedimientos Endovasculares/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Medición de Riesgo/métodos , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Factores de Riesgo , Distribución por Sexo , Factores Sexuales , Factores de Tiempo , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: Compliance with Society for Vascular Surgery (SVS) abdominal aortic aneurysm (AAA) clinical practice guideline (CPG)-diameter thresholds is variable for endovascular aneurysm repair (EVAR). To evaluate the implications and appropriateness of repairs that are noncompliant with current guidelines, we investigated the long-term outcomes, adherence to imaging follow-up, and associated health care costs in patients undergoing EVAR for AAA who do or do not meet recommended diameter thresholds. METHODS: All patients receiving elective EVAR from 2003 to 2016 in the SVS Vascular Quality Initiative with linked Medicare claims were reviewed. Weekend procedures and isolated iliac aneurysms, as well as symptomatic and ruptured presentations, were excluded. Diameter thresholds for noncompliant repairs were defined as: men <55 mm; women <50 mm who did not have an iliac diameter ≥30 mm. We evaluated adherence to postoperative imaging surveillance, reimbursement amounts, reintervention, rupture, and all-cause mortality. We defined an EVAR quality metric as performance of the index procedure with freedom from conversion to open repair, 5-year rupture-free survival, and adherence to minimum imaging surveillance (at least one computed tomography scan documented between 6 and 24 months postoperatively). RESULTS: Among 19,018 elective EVARs, 35% did not meet CPG diameter thresholds (26% within 5 mm of threshold). The rate of noncompliant repairs increased over time (24% in 2003 vs 36% in 2016; P < .001). Patients undergoing noncompliant repairs were younger, less likely to have multiple comorbidities, and more likely to receive EVAR with adherence to instructions for use criteria (89% vs 79%; P < .001). Patients undergoing noncompliant repairs had greater 5-year freedom from reintervention (86% vs 81%; P < .001), rupture-free survival (94% vs 92%; P = .01), and overall survival rates (71% vs 61%; P < .001) compared with repairs that complied with CPG diameter thresholds. Although noncompliant repairs had higher rates of 1-year imaging surveillance, overall differences were modest (68% vs 65%; P = .003). Importantly, for the entire cohort, follow-up imaging surveillance decreased over time (93% in 2003 vs 63% in 2014; P < .001). Notably, although noncompliant repairs had higher rates of achieving the composite quality metric compared with compliant repairs (43% vs 38%; P < .001), failure occurred with a significant majority of all repairs. CONCLUSIONS: Compliance with SVS-endorsed CPG diameter thresholds for elective EVAR is poor, and rates of noncompliance are increasing. Noncompliant repairs appear to be offered more commonly to patients with fewer comorbidities and favorable anatomy, and these repairs are associated with improved rates of reintervention, rupture, and survival compared with procedures meeting CPG diameter thresholds. Importantly, noncompliant repairs fail to meet minimum quality standards in a majority of cases, which underscores the need for further policies to improve the overall quality and appropriateness of AAA care delivery nationally.