Modelling years of life lost due to acute type A aortic dissection in the German healthcare setting: a predictive study.

OBJECTIVES: This study aimed to develop a patient-centred approach to the burden of acute type A aortic dissection (ATAAD) through modelling. The main objective was to identify potential improvements in managing this life-threatening cardiovascular condition and to provide evidence-based recommendations to optimise outcomes. DESIGN: We developed a predictive model along patient pathways to estimate the burden of ATAAD through the years of life lost (YLLs) metric. The model was created based on a systematic review of the literature and was parameterised using demographic data from the German healthcare environment. The model was designed to allow interactive simulation of different scenarios resulting from changes in key impact factors. SETTING: The study was conducted using data from the German healthcare environment and results from the literature review. PARTICIPANTS: The study included a comprehensive modelling of ATAAD cases in Germany but did not directly involve participants. INTERVENTIONS: There were no specific interventions applied in this study based on the modelling design. PRIMARY AND SECONDARY OUTCOME MEASURES: The single outcome measure was the estimation of YLL due to ATAAD in Germany. RESULTS: Our model estimated 102 791 YLL per year for ATAAD in Germany, with 62 432 and 40 359 YLL for men and women, respectively. Modelling an improved care setting yielded 93 191 YLL or 9.3% less YLL compared with the current standard while a worst-case scenario resulted in 113 023 or 10.0% more YLL. The model is accessible at https://acuteaorticdissection.com/ to estimate custom scenarios. CONCLUSIONS: Our study provides an evidence-based approach to estimating the burden of ATAAD and identifying potential improvements in the management of pathways. This approach can be used by healthcare decision-makers to inform policy changes aimed at optimising patient outcomes. By considering patient-centred approaches in any healthcare environment, the model has the potential to improve efficient care for patients suffering from ATAAD.

Comparison of Various Functional Assessment Tools to Identify Older Patients Undergoing Aortic Aneurysm Repair at Risk for Postoperative Complications.

BACKGROUND: To estimate whether the benefits of aortic aneurysm repair will outweigh the risks, determining individual risks is essential. This single-center prospective cohort study aimed to compare the association of functional tools with postoperative complications in older patients undergoing aortic aneurysm repair. METHODS: Ninety-eight patients (≥65 years) who underwent aortic aneurysm repair were included. Four functional tools were administered: the Montreal Cognitive Assessment (MoCA); the 4-Meter Walk Test (4-MWT); handgrip strength; and the Groningen Frailty Indicator (GFI). Primary outcome was the association between all tests and 30-day postoperative complications. RESULTS: After adjusting for confounders, the odds ratio for MoCA was 1.39 (95% confidence interval [CI] 0.450; 3.157; P = 0.723), for 4-MWT 0.63 (95% CI 0.242; 1.650; P = 0.348), for GFI 1.82 (95% CI 0.783; 4.323, P = 0.162), and for weak handgrip strength 4.78 (95% CI 1.338; 17.096, P = 0.016). CONCLUSIONS: Weak handgrip strength is significantly associated with the development of postoperative complications after aortic aneurysm repair. This study strengthens the idea that implementing a quick screening tool for risk assessment at the outpatient clinic, such as handgrip strength, identifies patients who may benefit from preoperative enhancement with help from, for example, Comprehensive Geriatric Assessment, eventually leading to better outcomes for this patient group.

A Monte Carlo Sensitivity Analysis for a Dimensionally Reduced-Order Model of the Aortic Dissection.

PURPOSE: Aortic dissection is associated with a high mortality rate. Although computational approaches have shed light on many aspects of the disease, a sensitivity analysis is required to determine the significance of different factors. Because of its complex geometry and high computational expense, the three-dimensional (3D) fluid-structure interaction (FSI) simulation is not a suitable approach for sensitivity analysis. METHODS: We performed a Monte Carlo simulation (MCS) to investigate the sensitivity of hemodynamic quantities to the lumped parameters of our zero-dimensional (0D) model with numerically calculated lumped parameters. We performed local and global analyses on the effect of the model parameters on important hemodynamic quantities. RESULTS: The MCS showed that a larger lumped resistance value for the false lumen and the tears result in a higher retrograde flow rate in the false lumen (the coefficient of variation, c v , i = 0.0183 , the sensitivity S X i σ = 0.54 , Spearman's coefficient, ρ s = 0.464 ). For the intraluminal pressure, our results show a significant role in the resistance and inertance of the true lumen (the coefficient of variation, c v , i = 0.0640 , the sensitivity S X i σ = 0.85 , and Spearman's coefficient, ρ s = 0.855 for the inertance of the true lumen). CONCLUSION: This study highlights the necessity of comparing the results of the local and global sensitivity analyses to understand the significance of multiple lumped parameters. Because of the efficiency of the method, our approach is potentially useful to investigate and analyze medical planning.

Changes in global mortality from aortic aneurysm.

OBJECTIVE: Globally, there has been a marked increase in aortic aneurysm-related deaths between 1990 and 2019. We sought to understand the underlying etiologies for this mortality trend by examining secular changes in both demographics and the prevalence of risk factors, and how these changes may vary across sociodemographic index (SDI) regions. METHODS: We queried the Global Burden of Disease Study (GBD) for aortic aneurysm deaths from 1990 to 2019 overall and by age group. We identified the percentage of aortic aneurysm deaths attributable to each risk factor identified by GBD modeling (smoking, hypertension, lead exposure, and high sodium diet) and their respective changes over time. We then analyzed aneurysm mortality by SDI region. RESULTS: The number of aortic aneurysm-related deaths have increased from 94,968 in 1990 to 172,427 in 2019, signifying an 81.6% increase, which greatly exceeds the 18.2% increase in all-cause mortality observed over the same time interval. Examination of age-specific mortality demonstrated that the number of aortic aneurysm deaths markedly correlated with advancing age. However, when considering rate of death rather than mortality count, overall age-standardized death rates decreased 18% from 2.72 per 100,000 in 1990 to 2.21 per 100,000 in 2019. Analysis of the specific risk factors associated with aneurysm death revealed that the percentage of deaths attributable to smoking decreased from 45.6% in 1990 to 34.6% in 2019, and deaths attributable to hypertension decreased from 38.7% to 34.7%. Globally, hypertension surpassed smoking as the leading risk factor. The reported rate of death was consistently greater as SDI increased, and this effect was most pronounced among low-middle and middle SDI regions (173.2% and 170.4%, respectively). CONCLUSIONS: Despite an overall increase in the number of aneurysm deaths, there was a decrease in the age-standardized death rate, demonstrating that the observed increased number of aortic aneurysm deaths between 1990 and 2019 was primarily driven by an overall increase in the age of the global population. Fortunately, it appears that the increase in overall aneurysm-related deaths has been modulated by improved risk factor modification, in particular smoking. Given the rise in aneurysm-related deaths, global expansion of vascular specialty capabilities is warranted and will serve to amplify improvements in population-based aneurysm health achieved with risk factor control.

Spatiotemporal trends in the burden of aortic aneurysms caused by high sodium intake from 1990 to 2019: A global, regional, and national analysis.

BACKGROUND AND AIMS: This study, drawing on Global Burden of Disease (GBD) data, examines spatiotemporal trends in mortality and disability-adjusted life years (DALYs) linked to aortic aneurysm (AA) from high sodium intake. The aim is a comprehensive analysis globally, regionally, and nationally spanning 1990 to 2019. METHODS AND RESULTS: Quantifying AA deaths and DALYs due to high sodium intake, incorporating age-standardized mortality rate (ASMR) and age-standardized DALYs rate (ASDR), revealed a global surge. Deaths rose by 86.09 %, DALYs by 74.02 % from 1990 to 2019. EAPC for ASMR and ASDR displayed negative trends (-0.72 and -0.77). High/middle-high Socio-demographic Index (SDI) regions bore higher burdens than lower SDI regions. Males consistently had higher burdens across SDI regions, with both genders showing a slight downward trend. Age-wise, AA deaths and DALYs rose with age, followed by decline. A positive correlation existed between SDI and global burden, inversely related to EAPC for ASMR and ASDR. CONCLUSION: AA burden from high sodium intake is pronounced in high SDI regions, necessitating targeted interventions. The global data highlights a significant increase in AA deaths and DALYs due to high sodium intake, urging prompt and effective control measures.

Outcomes for High-Risk Surgical Procedures Across High- and Low-Competition Hospital Markets.

Importance: Maintaining competition among hospitals is increasingly seen as important to achieving high-quality outcomes. Whether or not there is an association between hospital market competition and outcomes after high-risk surgery is unknown. Objective: To evaluate whether there is an association between hospital market competition and outcomes after high-risk surgery. Design, Setting, and Participants: We performed a retrospective study of Medicare beneficiaries who received care in US hospitals. Participants were 65 years and older who electively underwent 1 of 10 high-risk surgical procedures from 2015 to 2018: carotid endarterectomy, mitral valve repair, open aortic aneurysm repair, lung resection, esophagectomy, pancreatectomy, rectal resection, hip replacement, knee replacement, and bariatric surgery. Hospitals were categorized into high-competition and low-competition markets based on the hospital market Herfindahl-Hirschman index. Comparisons of 30-day mortality and 30-day readmissions were risk-adjusted using a multivariate logistic regression model adjusting for patient factors (age, sex, comorbidities, and dual eligibility), year of procedure, and hospital characteristics (nurse ratio and teaching status). Data were analyzed from May 2022 to March 2023. Main Outcomes and Measures: Thirty-day postoperative mortality and readmissions. Results: A total of 2 242 438 Medicare beneficiaries were included in the study. The mean (SD) age of the cohort was 74.1 (6.4) years, 1 328 946 were women (59.3%), and 913 492 were men (40.7%). When examined by procedure, compared with low-competition hospitals, high-competition market hospitals demonstrated higher 30-day mortality for 2 of 10 procedures (mitral valve repair: odds ratio [OR], 1.11; 95% CI, 1.07-1.14; and carotid endarterectomy: OR, 1.06; 95% CI, 1.03-1.09) and no difference for 5 of 10 procedures (open aortic aneurysm repair, bariatric surgery, esophagectomy, knee replacement, and hip replacement; ranging from OR, 0.97; 95% CI, 0.94-1.00, for hip replacement to OR, 1.09; 95% CI, 0.94-1.26, for bariatric surgery). High-competition hospitals also demonstrated 30-day readmissions that were higher for 5 of 10 procedures (open aortic aneurysm repair, knee replacement, mitral valve repair, rectal resection, and carotid endarterectomy; ranging from OR, 1.01; 95% CI, 1.00-1.02, for knee replacement to OR, 1.05; 95% CI, 1.02-1.08, for rectal resection) and no difference for 3 procedures (bariatric surgery: OR, 1.03; 95% CI, 0.99-1.07; esophagectomy: OR, 1.02; 95% CI, 0.99-1.06; and pancreatectomy: OR, 1.00; 95% CI, 0.99-1.01). Hospitals in high-competition compared with low-competition markets cared for patients who were older (mean [SD] age of 74.4 [6.6] years vs 74.0 [6.2] years, respectively; P < .001), were more likely to be racial and ethnic minority individuals (77 322/450 404 [17.3%] vs 23 328/444 900 [5.6%], respectively; P < .001), and had more comorbidities (≥2 Elixhauser comorbidities, 302 415/450 404 [67.1%] vs 284 355/444 900 [63.9%], respectively; P < .001). Conclusions and Relevance: This study found that hospital market competition was not consistently associated with improved outcomes after high-risk surgery. Efforts to maintain hospital market competition may not achieve better postoperative outcomes.

Oral fluoroquinolones and risk of aortic aneurysm or dissection: A nationwide population-based propensity score-matched cohort study.

STUDY OBJECTIVE: To investigate risk of aortic aneurysm or dissection in patients using oral fluoroquinolones compared to those using macrolides in real-world clinical practice among a large US general population. DESIGN: Retrospective cohort study design. DATA SOURCE: MarketScan commercial and Medicare supplemental databases. PATIENTS: Adults patients with at least one prescription fill for fluoroquinolone or macrolide antibiotics. INTERVENTION: Fluoroquinolone or macrolide antibiotics. MEASUREMENTS AND MAIN RESULTS: The primary outcome was estimated incidence of aortic aneurysm or dissection associated with the use of fluoroquinolones compared with macrolides during a 60-day follow-up period in a 1:1 propensity score-matched cohort. We identified 3,174,620 patients (1,587,310 in each group) after 1:1 propensity score matching. Crude incidence of aortic aneurysm or dissection was 1.9 cases per 1000 person-years among fluoroquinolone users and 1.2 cases per 1000 person-years among macrolide users. In multivariable Cox regression, compared with macrolides, the use of fluoroquinolones was associated with an increased risk of aortic aneurysm or dissection (aHR: 1.34; 95% CI: 1.17-1.54). The association was primarily driven by a high incidence of aortic aneurysm cases (95.8%). Results of sensitivity (e.g., fluoroquinolone exposure ranging from 7 to 14 days (aHR: 1.47; 95% CI: 1.26-1.71)) and subgroup analyses (e.g., ciprofloxacin (aHR: 1.26; 95% CI: 1.07-1.49) and levofloxacin (aHR: 1.44; 95% CI: 1.19-1.52)) remained consistent with main findings. CONCLUSIONS: Fluoroquinolone use was associated with a 34% increased risk of aortic aneurysm or dissection compared with macrolide use among a general US population.

HETEROTAXY SYNDROME IN COVID-19 PATIENT WITH PULMONARY EMBOLISM AND AORTIC ANEURYSM: A RARE ACCIDENTAL COMBINATION (RADIOLOGICAL ASSESSMENT). / GETEROTAKSIIa, TROMBOEMBOLIIa LEGENEVOÏ ARTERIÏ TA ANEVRYZMA AORTY: RIDKISNE VYPADKOVE POIeDNANNIa (RADIOLOGIChNA OTsINKA).

With limited time for analysing computed tomography (CT) data in medical emergencies, radiologists and clinicians are not always aware of congenital pathologies, especially in asymptomatic cases. We present a case report of heterotaxy syndrome detected incidentally in a 62-year-old female with massive pulmonary embolism, local saccular aneurysm of the aortic arch and COVID-19. The presented case describes an unusual combination of life-threatening conditions and congenital anomalies. Using the CT angiography, we reported the preserved topography and morphology of the heart chambers. The superior and inferior venae cavae were located on the left, draining into a significantly dilated coronary sinus. Disordered abdominal organ arrangement included midline liver, right-sided stomach, the central location of the short pancreas, malrotation of the intestine, polysplenia, and atypical rise of visceral branches of the abdominal aorta. A comprehensive assessment of CT images promoted verification of undiagnosed congenital anomalies. Prompt recognition of heterotaxy syndrome in life-threatening conditions significantly impacts treatment tactics and should be the course of diagnostic and cautious interventions to reduce further complications.

The burden of aortic aneurysm in China from 1990 to 2019: findings from the Global Burden of Disease Study 2019.

BACKGROUND: Aortic aneurysm (AA) is a global public health concern. However, little is known about the disease burden of AA in China. METHODS: Following the general analytic strategy used in the Global Burden of Disease Study (GBD) 2019, we analyzed the mortality and years of life lost (YLLs) due to AA, stratified by sex, age, and province-level region in China from 1990 to 2019. The temporal trend of AA burden in China was analyzed and the main attributable risk factors for AA in China were also explored. RESULTS: In China, the total AA deaths were 17,038 (95% UI: 14,392-19,980) in 2019, an increase of 136.1% compared with that in 1990, with an age-standardized death rate (ASDR) of 0.93 (95% UI: 0.79-1.08) per 100,000 person-years in 2019, a decrease of 6.8%. Meanwhile AA caused 378,578 (95% UI: 315,980-450,479) YLLs in 2019, an increase of 102.6% compared with that in 1990, with a crude YLL rate of 26.6 (95% UI: 22.2-31.7) per 100,000 person-years, an increase of 68.6%. The AA mortality and YLLs were higher in males than in females. AA caused most YLLs in the 65- to 75-year-old age group. The AA mortality and YLLs varied significantly among provinces in China, and the change in ASDR showed a negative correlation with the sociodemographic index of different provinces, namely, more decline of ASDR in developed provinces. High systolic blood pressure was shown to be the most significant attributable risk factor for AA burden in both males and females, and smoking was another major attributable risk factor, especially in males. CONCLUSIONS: The disease burden of AA increased significantly from 1990 to 2019 in China, with higher mortality and YLLs in males, senior populations, and among residents of most western provinces in China. High systolic blood pressure and smoking were two major attributable risk factors for AA mortality in China.

An observational assessment of aortic deformation during infrarenal and complex endovascular aortic aneurysm repair.

OBJECTIVE: Real-time aortic deformation during endovascular aortic aneurysm repair (EVAR) has not been reported. Successful EVAR relies on predicting intraoperative aortic-endograft deformation from preoperative imaging. Correct prediction is essential, because malalignment of endografts decreases patient survival. We describe intraoperative aortic deformation during infrarenal EVAR and complex fenestrated/branched EVAR (F/BEVAR), relating deformation to preoperative anatomy and follow-up outcomes. METHODS: A multicenter, retrospective cohort of aortic aneurysm patients undergoing operation between January 2019 and February 2021, substratified by repair, infrarenal EVAR (n = 50), F/BEVAR (n = 80), and iliac branch graft with F/B/EVAR (IBG + F/B/EVAR; n = 27), were compared using software-based nonrigid two- and three-dimensional aortic deformational intraoperative assessment (CYDAR). Preoperative computed tomography reconstructions of aortic and iliac tortuosities were assessed against intraoperative deformation, the primary outcome, and related to perioperative and follow-up adverse outcomes. RESULTS: All treatment groups had low preoperative visceral aortic tortuosity; the EVAR group had higher iliac tortuosity (1.43 ± 0.05; P = .018). Intraoperative aortic visceral deformation was consistently cranial and anterior; IBG + F/B/EVAR patients had the largest magnitude deformation (superior mesenteric artery, EVAR 5.1 ± 0.9 mm; F/BEVAR 4.4 ± 0.4 mm; IBG 8.3 ± 1.2 mm; P = .004). Celiac artery, superior mesenteric artery, and bilateral renal artery deformations were correlated (R = 0.923-0.983). Iliac deformation was variable in magnitude and direction. Preoperative tortuosity was not correlated with the magnitude of intraoperative deformation nor was deformation magnitude related to endograft instability during follow-up, including endoleak development, reinterventions, or visceral vessel complications. CONCLUSIONS: The aorta deforms consistently during EVAR at the visceral aortic segment but unpredictably at the iliac bifurcation. Aortoiliac deformation is unrelated to adverse perioperative outcomes, branch instability, or reinterventions during short-term follow-up.

Projection of global burden and risk factors for aortic aneurysm - timely warning for greater emphasis on managing blood pressure.

RATIONALE: Aortic aneurysm (AA) is a serious condition that largely increases the risk of aortic dissection and sudden death. Exploring the global burden of disease and changes in risk factors for AA is essential for public health policy development. OBJECTIVE: To project the death burden from AA and its attributable risk factors in the following decade based on the epidemiological data over the past 30 years. METHODS AND RESULTS: We analysed the death burden of AA and trends of four risk factors from 1990-2019 using the updated 2019 Global Burden of Disease study database by Joinpoint regression analysis. Furthermore, we project the AA-related death burden for the next decade using the Bayesian age-period-cohort model. This study discovered that the global burden of death attributable to AA began to increase after decreasing for two decades. This upward trend will continue in the subsequent decade (average annual percent change: 0.318%, 95% CI: 0.288 to 0.348). Meanwhile, the disease burdens in all economic regions except high-middle socio-demographic index (SDI) regions will continuously increase in the next decade, with the fastest acceleration in the low-middle SDI region (average annual percent change: 1.183%, 95% CI: 1.166 to 1.200). Notably, high systolic blood pressure will surpass the contribution of smoking to become the most important risk factor for mortality due to AA. CONCLUSION: This study discovered a rebounding trend in the aortic aneurysm-related death burden globally. High systolic blood pressure will be the top risk factor attributed to death from AA. Therefore, it should be considered as the first-degree risk factor in the guidance of AA management and criteria for population-based screening programs.Key messagesThe death burden of aortic aneurysms is beginning to rebound globally, and the trend will continue for the next decade.High systolic blood pressure will replace smoking as the most important risk factor associated with aortic aneurysm death.

The impact of hospital size on national trends and outcomes in isolated open proximal aortic surgery.

OBJECTIVE: To determine the impact of hospital size on national trend estimates of isolated open proximal aortic surgery for benchmarking hospital performance. METHODS: Patients age >18 years who underwent isolated open proximal aortic surgery for aneurysm and dissection from 2002 to 2014 were identified using the National Inpatient Sample. Concomitant valvular, vessel revascularization, re-do procedures, endovascular, and surgery for descending and thoracoabdominal aorta were excluded. Discharges were stratified by hospital size and analyzed using trend, multivariable regression, propensity-score matching analysis. RESULTS: Over a 13-year period, 53,657 isolated open proximal aortic operations were performed nationally. Although the total number of operations/year increased (∼2.9%/year increase) and overall in-hospital mortality decreased (∼4%/year; both P < .001 for trend), these did not differ by hospital size (P > .05). Large hospitals treated more sicker and older patients but had shorter length of stay and lower hospital costs (both P < .001). Even after propensity-score matching, large hospital continued to demonstrate superior in-hospital outcomes, although only statistically for major in-hospital cardiac complications compared with non-large hospitals. In our subgroup analysis of dissection versus non-dissection cohort, in-hospital mortality trends decreased only in the non-dissection cohort (P < .01) versus dissection cohort (P = .39), driven primarily by the impact of large hospitals (P < .01). CONCLUSIONS: This study demonstrates increasing volume and improving outcomes of isolated open proximal aortic surgeries nationally over the last decade regardless of hospital bed size. Moreover, the resource allocation of sicker patients to larger hospital resulted shorter length of stay and hospital costs, while maintaining similar operative mortality to small- and medium-sized hospitals.

Comparison of Patient Outcomes Among Integrated Residency Versus Fellowship-trained Vascular Surgeons.

OBJECTIVE: This study aims to evaluate whether graduates of integrated vascular surgery residency (IVSR) programs achieve similar surgical outcomes in clinical practice as compared to graduates of vascular surgery fellowships (VSF). SUMMARY OF BACKGROUND DATA: Early sub-specialization through IVSR programs decreases the total years of surgical training. However, it is unclear whether IVSR graduates achieve comparable outcomes to fellowship-trained surgeons once in clinical practice. METHODS: We identified all vascular surgeons who finished IVSR and VSF programs between 2013-2017 using American Board of Surgery data, which was linked to the Vascular Quality Initiative registry (2013-2019) to evaluate provider-specific clinical outcomes following carotid, lower extremity, and aortic aneurysm repair procedures. The association between training models and the composite outcome of 1-year mortality, major adverse cardiac events and/or other major complications were analyzed using mixed-effects logistic regression models. RESULTS: A total of 338 surgeons (31% IVSR, 69% VSF) submitted cases into the Vascular Quality Initiative registry, including 8155 carotid, 21,428 lower extremity, and 5800 aortic aneurysm repair procedures. Composite 1-year outcome rates were comparable between IVSR and VSF-trained surgeons following carotid endarterectomy (8%-IVSR vs 7%-VSF), lower extremity revascularization (19%-IVSR vs 16%-VSF), and aortic aneurysm repair (13%-IVSR vs 13%-VSF) procedures. These findings among IVSR-trained surgeons persisted following risk adjustment for severity of patient disease and indications for undertaking carotid [aOR: 1.04 (0.84-1.28)], lower extremity [aOR: 1.03 (0.84-1.26)], and aortic [aOR: 0.96 (0.76-1.21)] procedures when compared to VSF-trained surgeons. CONCLUSIONS: Despite fewer total years of training, graduates of IVSR programs achieve equivalent surgical outcomes as fellowship-trained vascular surgeons once in practice. These results suggest that concerns about differential competence among integrated residency graduates are not warranted.

Global, regional, and national burden of aortic aneurysm, 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017.

AIMS: This study aimed at evaluating the age, sex, and country-income patterns in aortic aneurysm disease burden, analysing trends in mortality and years of life lost (YLLs), as well as their causal drivers and risk factors, using the 2017 Global Burden of Diseases, Injuries, and Risk Factors Study (GBD 2017). METHODS AND RESULTS: We described the temporal, global, and regional (195 countries) patterns of aortic aneurysm (thoracic and abdominal) mortality, YLLs, their drivers [sociodemographic index (SDI), healthcare access and quality index (HAQ index)] and risk factors using the GBD 1990-2017. Correlation and mixed multilevel modelling between aortic aneurysm mortality, YLLs, HAQ index and other variables were applied. From 1990 to 2017, a global declining trend in age-standardized aortic aneurysm mortality was found [2.88 deaths/100 000 (95% uncertainty intervals, UI 2.79 to 3.03) in 1990 and 2.19 deaths/100 000 (95% UI 2.09 to 2.28) in 2017]. Among high-income countries (HICs) a consistent declining Spearman's correlation between age-standardised aortic aneurysm mortality, SDI (HICs; 1990 rho: 0.57, P ≤ 0.001; 2017 rho: 0.41, P = 0.001) and HAQ index was observed (HICs; 1990 rho: 0.50, P <0.001; 2016 rho: 0.35, P = 0.006); in comparison with low- and middle-income countries where correlation trends were weak and mixed. At a global level, higher HAQ index was related with lower aortic aneurysm mortality and YLLs [mortality, coef: -0.05, 95% confidence interval (CI): -0.06, -0.04; YLLs, coef: -0.94, 95% CI: -1.17, -0.71]. CONCLUSIONS: Age-standardized aortic aneurysm mortality declined globally between 1990 and 2017. Globally, age-standardized aortic aneurysm mortality and YLLs were related to changes in SDI and HAQ index levels, while country-level income-related variations were also observed.

Utilización profiláctica o terapéutica de sistemas de anclaje en la reparación endovascular de aneurismas aórticos (EVAR/TEVAR) / Prophylactic or therapeutic use of endoanchoring systems in endovascular aortic aneurysm repair (EVAR/TEVAR)

INTRODUCCIÓN Un aneurisma arterial es una dilatación patológica de una arteria. Se produ cen por degeneración de la pared arterial, que conlleva su adelgazamiento y posterior debilitamiento, con una pérdida de su resistencia a la tracción, aumentando por tanto su vulnerabilidad a los aumentos de presión intravas cular. Pueden ser congénitos o adquiridos, generalmente por aterosclerosis, infecciones, vasculitis o traumatismos. Fuera del cerebro, las localizaciones más frecuentes son la aorta abdominal y la torácica, y en miembros inferio res la arteria poplítea y la femoral común. El aneurisma aórtico es una importante causa de muerte en España. Los aneurismas aórticos se presentan con más frecuencia en varones y en la porción abdominal de la aorta. En los últimos años las técnicas endovasculares para el tratamiento de aneurismas aórticos (EVAR/TEVAR) suponen una alternativa a la cirugía abierta tradicional, con menor morbimortalidad temprana e infe rior estancia hospitalaria. Su indicación depende de la anatomía arterial del pa

INTRODUCTION An arterial aneurysm is a pathological dilatation of an artery. They are caused by degeneration of the arterial wall, which leads to thinning and sub sequent weakening, with a loss of its resistance to traction, thus increasing its vulnerability to increases in intravascular pressure. They may be congenital or acquired, usually due to atherosclerosis, infection, vasculitis or trauma. Outside the brain, the most frequent locations are the abdominal and tho racic aorta, and in the lower limbs the popliteal and common femoral arter ies. Aortic aneurysm is a major cause of death in Spain. Aortic aneurysms occur more frequently in men and in the abdominal portion of the aorta. In recent years, endovascular techniques for the treatment of aortic aneurysms (EVAR/TEVAR) represent an alternative to traditional open surgery, with lower early morbidity and mortality and shorter hospital stay. Their indication depends on the patient's arterial anatomy. There is a high er risk of migration/endoleak when the patient has an abdominal aortic aneurysm with a hostile neck (marked angulation, short length, complex shape, wide diameter or presence of calcification or thrombus). In thoracic aortic aneurysms, an anatomical feature to consider is the proximal neck diameter. Anchoring systems to increase adhesion and fixation of the endograft to the aortic wall used in endovascular procedures for aortic aneurysm re pair are an alternative therapeutic approach to open surgery. OBJECTIVES The aim of this document is to provide the Spanish National Health System (SNHS) with sound information on the effectiveness and safety of the pro phylactic or therapeutic use of an anchoring system in endovascular aortic aneurysm repair (EVAR/TEVAR) procedures. METHODS Adaptation to the Spanish context of the evaluation report on endoanchoring systems in endovascular repair of aortic aneurysms "Agencia de Evaluación de Tecnologías Sanitarias-AETS-ISCIII, Republika Slovenija Ministrstvo za Zdravjel. Prophylactic or therapeutic use of endoanchoring systems in endo vascular aortic aneurysm repair (EVAR/TEVAR). Collaborative Assessment: EUnetHTA; 2019. Report No.: OTCA20." [1], developed by a European team led by the Agency for Health Technology Assessment of the Institute of Health Carlos III (AETS-ISCIII). The structure of this document is based on the "Guide for the prepara tion and adaptation of rapid health technology assessment reports" [2] of the Spanish Network of Health Technology Assessment Agencies. Evidence was retrieved from a systematic literature search initial ly up to April 2019, updated for this document to September 2020 with no new studies identified, following a predefined strategy in PubMed, MEDLINE, EMBASE, Cochrane Central Register of Controlled Tri als and the Cochrane Database for Systematic Reviews, as well as after hand searching references of selected studies and queries to manufac turers. Literature selection and data extraction were peer-reviewed. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology [3] was used for evidence assessment. The risk of bias assessment tool used was the IHE-20 checklist for case series (single-arm studies) [4]. RESULTS The literature search yielded 441 references. The final selection provided 11 studies with a total of 684 patients. 10 studies were prospective case series (one of them with propensity-matched retrospective controls and one study was a retrospective case series). All studies were included in the effective ness analysis and 8 studies were included in the safety analysis. The quality of evidence was rated very low in all selected studies [1]. The variability of the follow-up (from less than a year to 48 months) for most of the outcomes, and not always well specified time points of the events, limited the analysis. Also, not all had computed tomography imaging results in their follow-up records. Sample sizes were small for those patients with secondary interventions and with TEVAR. Patients who underwent a primary intervention due to prophylaxis (prophylactic group) were the most studied group, although this sample, when pooled, numbered less than 400 patients and not all had at least one year of follow-up. This may cause that late outcomes were not yet occurring, e.g., reinterventions due to complica tions. The risk of endograft complications at the proximal neck increased over time, with endoleaks and migration more commonly arising as a longer term problem. In regards to the safety of the intervention, most of the adverse events were presented and analysed as a pooled total (not per subgroup) due to the difficulty of extracting and/or calculating by subgroups in most of the studies included in the safety domain. The only registered trial (ANCHOR) ongoing in 2018 reported the following comparative 1-, 2- and 3-year results for the occurrence of type 1a endoleaks: 0.6%, 1.1% and 1.7%, respectively, for the primary arm, and 7.9%, 5.9% and 2.4%, respectively, for the revision arm. No cases of endograft migration were reported in the primary interven tion or in the revision arm (secondary intervention) in AAA patients. The only control data involved a cohort of 99 patients obtained by propensity matching that reported the rate of complications (migration or endoleaks), although there were no significant differences with the intervention-free control group. Procedure-related mortality in EVAR patients was one of the most evaluated safety outcomes in the 8 included studies, with a rate close to 0% at 30-day follow-up. This rate was 3.7% in the only TEVAR study in cluded. The rate of stroke (considered as procedure-related morbidity), low in this case series, was more frequently associated with TEVAR procedures and EVAR procedures than with open surgery at short or mid-term follow up periods [1]. For patients in the prophylaxis group with abdominal aneurysms, the aneurysm-related mortality rate at 30 days was 0.25%. The aneurysm-relat ed mortality rate at one year was 0.26%. For patients with thoracic aneu rysms, the aneurysm-related mortality rate at 30 days was 3.7% and 9.3% at one year. No deaths related to aneurysm were reported in cases requiring a secondary intervention [1]. Regarding ruptured aneurysms, in patients with abdominal aneurysms and primary intervention, no cases were reported during 48-month follow up period. In patients who underwent a secondary intervention, no aneu rysms ruptures were reported. For thoracic aneurysms the rupture rate was 1.9%. Regarding the reintervention rate, a 9.7% was estimated in patients with primary intervention and abdominal aneurysms. For thoracic aneu rysms, a 16.7% has been informed. The rate of recurrence of complications estimated in patients with prophylactic intervention and abdominal aneu rysm was 2.5%. In patients with secondary intervention and abdominal an eurysm a rate of recurrence of complications of 13.63%was estimated. In patients with thoracic aneurysm a rate of recurrence of complications of 7.4% was estimated. Overall mortality appeared to be inferior in the primary prophylactic intervention group compared to the secondary intervention group, probably because the intervention was not determined by the presence of previous complications. It was also low in the secondary intervention groups, how ever, this may be a reflection of the small sample size and brief follow-up period. Nevertheless, in the latter case, those patients whose interventions were due to type I endoleaks had the highest rate of mortality at one year within the secondary setting (7%). The highest mortality rates at one year were recorded by the thoracic study and the retrospective series on primary patients (all kinds) (11% and 13%, respectively) [1]. CONCLUSIONS In terms of effectiveness, again the evidence precludes any firm conclusions as to whether the use of endoanchors in EVAR/TEVAR procedures results in better outcomes. Globally, the information compiled on critical outcomes (rate of type I endoleaks or migration, rate of reintervention, rate of aneu rysm rupture or rate of aneurysm-related mortality), although of very low quality, would suggest effectiveness of the device. Nonetheless, evidence from high-quality comparative studies remains lacking. Results should be compared with treatment regimens without the Heli-FX™ EndoAnchor™ system in randomised controlled trials for most of the critical and important outcomes. With regard to safety, based on the results from observational studies, and within the limitations of the low-quality evidence available, the data suggest that the use of Heli-FX™ EndoAnchor™ in EVAR patients (pro phylactically or as part of endograft migration or type I endoleak treatment) would be safe in the midterm follow-up for those presenting unfavourable neck anatomy and probably safe over long-term follow-up for those with friendly neck anatomies. However, comparative data on standard endovas cular therapy are not currently available. We cannot form any conclusions regarding the safety of Heli-FX™ EndoAnchor™ in TEVAR patients.