Registro de actividades de la Sociedad Española de Angiología y Cirugía Vascular, año 2019 / Registry of activities of the Spanish Society of Angiology and Vascular Surgery, year 2019

Objetivo: describir la actividad asistencial del año 2019 de los servicios/unidades de angiología y cirugía vascular en España. Pacientes y métodos: estudio transversal con encuesta a 107 centros sobre procedimientos quirúrgicos y exploraciones vasculares realizados en 2019. Análisis descriptivo de resultados y comparación de la ratio de actividad /100 000 habitantes con 2018. Resultados: respondieron 44 servicios (41,1 %), 4 de ámbito privado. De los 42 servicios docentes, respondieron 29 (65,9 %), un 65,9 %. En los servicios que respondieron se produjeron 26 960 ingresos, el 46,4 % urgentes y el 53,5 % programados (estancia media: 6,8 días). En la mayoría de sectores no hubo cambios significativos en la ratio/100 000 habitantes, salvo un aumento moderado (10,7 frente a 9,4) en el sector distal, tanto en procedimientos quirúrgicos (3,3 frente a 2,8) como en endovasculares (7,3 frente a 6,6). Descenso moderado de procedimientos endovasculares en los troncos supraaórticos (1,4 frente a 1,6). Hubo una disminución moderada de procedimientos quirúrgicos en aorta torácica (0,17 frente a 0,20) y abdominal (2,38 frente a 2,78), que contrastó con un aumento moderado en procedimientos endovasculares abdominotorácicos (0,40 frente a 0,35). En las arterias viscerales se encontró una disminución relevante de procedimientos endovasculares (0,89 frente a 1,16) y un aumento moderado de los quirúrgicos (0,99 frente a 0,89). En el sector aortoilíaco hubo un aumento moderado de procedimientos endovasculares (6,8 frente a 5,8). En 2019 también se encontró una disminución relevante en el número de procedimientos endovasculares relacionados con los accesos de hemodiálisis (1,2 frente a 1,5), un descenso moderado en el número de amputaciones mayores (6,9 frente a 7,8) y un descenso relevante de actividad sobre las malformaciones (0,32 frente a 0,59). Se encontró un aumento moderado en la actividad global sobre el sector venoso con respecto a la de 2018 (93,3 vs. 80,3)...(AU)

Introduction and objective: to describe the healthcare activity of the Angiology and Vascular Surgery services/units in Spain in 2019.Patients and methods: cross-sectional study with a survey of 107 centers on surgical procedures and vascularexplorations performed in 2019. Descriptive analysis of results and comparison of the activity ratio / 100,000inhabitants with 2018.Results: 44 services responded (41.1 %), with only 4 being private. Of the 42 teaching services, 29 (65.9 %) respon-ded, representing 65.9 % of the total. In the services that responded, there were 26,960 admissions, 46.4 % urgentand 53.5% scheduled, with an average stay of 6.8 days. Global surgical activity in arterial surgery in 2019 was similarto that of 2018. In most sectors there were no significant changes in the ratio / 100,000 inhabitants, except for amoderate increase (10.7 vs. 9.4) in the distal sector , finding the increase in both surgical procedures (3.3 vs. 2.8) andendovascular procedures (7.3 vs. 6.6). Furthermore, a moderate decrease in endovascular procedures was foundin the supra-aortic trunks (1.4 vs. 1.6). There was a moderate decrease in surgical procedures in the thoracic aorta(0.17 vs. 0.20) and abdominal (2.38 vs. 2.78), which contrasted with a moderate increase in thoraco-abdominalendovascular procedures (0.40 vs. to 0.35). In visceral arteries, a relevant decrease in endovascular procedures wasfound (0.89 vs. 1.16) and a moderate increase in surgical procedures (0.99 vs. 0.89). In the aorto-iliac sector therewas a moderate increase in endovascular procedures (6.8 vs. 5.8). In 2019, a relevant decrease was also found inthe number of endovascular procedures related to hemodialysis accesses (1.2 vs. 1.5), and a moderate decreasein the number of major amputations (6.9 vs. 7.8)...(AU)

Rural-Urban Disparities in Outcomes of Myocardial Infarction, Heart Failure, and Stroke in the United States.

BACKGROUND: U.S. policy efforts have focused on reducing rural-urban health inequities. However, it is unclear whether gaps in care and outcomes remain among older adults with acute cardiovascular conditions. OBJECTIVES: This study aims to evaluate rural-urban differences in procedural care and mortality for acute myocardial infarction (AMI), heart failure (HF), and ischemic stroke. METHODS: This is a retrospective cross-sectional study of Medicare fee-for-service beneficiaries aged ≥65 years with acute cardiovascular conditions from 2016 to 2018. Cox proportional hazards models with random hospital intercepts were fit to examine the association of presenting to a rural (vs urban) hospital and 30- and 90-day patient-level mortality. RESULTS: There were 2,182,903 Medicare patients hospitalized with AMI, HF, or ischemic stroke from 2016 to 2018. Patients with AMI were less likely to undergo cardiac catherization (49.7% vs 63.6%, P < 0.001), percutaneous coronary intervention (42.1% vs 45.7%, P < 0.001) or coronary artery bypass graft (9.0% vs 10.2%, P < 0.001) within 30 days at rural versus urban hospitals. Thrombolysis rates (3.1% vs 10.1%, P < 0.001) and endovascular therapy (1.8% vs 3.6%, P < 0.001) for ischemic stroke were lower at rural hospitals. After adjustment for demographics and clinical comorbidities, the 30-day mortality HR was significantly higher among patients presenting to rural hospitals for AMI (HR: 1.10, 95% CI: 1.08 to 1.12), HF (HR: 1.15; 95% CI: 1.13 to 1.16), and ischemic stroke (HR: 1.20; 95% CI: 1.18 to 1.22), with similar patterns at 90 days. These differences were most pronounced for the subset of critical access hospitals that serve remote, rural areas. CONCLUSIONS: Clinical, public health, and policy efforts are needed to improve rural-urban gaps in care and outcomes for acute cardiovascular conditions.

Epidemiology and Prognostic Factors in Acute Lower Limb Ischaemia: A Population Based Study.

OBJECTIVE: The aim of this study was to evaluate the contemporary population based incidence of acute lower limb ischaemia (ALI) and factors associated with major amputation/death at one year. METHODS: In this retrospective observational study, in hospital, operation, radiological, and autopsy registries were scrutinised to capture 161 citizens of Malmö, Sweden, with ALI between 2015 and 2018. Age and sex specific incidence rates were calculated in the population of Malmö between 2015 and 2018, expressed as number of patients per 100 000 person years (PY). Independent risk factors for major amputation/death at one year were identified by multivariable logistic regression analysis and expressed as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: One hundred and sixty-one patients with ALI gave an overall incidence of 12.2/100 000 PY (95% CI 10.3 - 14.1), with no sex related differences. Embolism (42.2%) was the most common cause of ALI. Among 52 patients with atrial fibrillation, 38.5% were on anticoagulant medication. Endovascular or open vascular revascularisation was performed in 54.7% of patients. The total cause specific mortality ratio was 2.63 (95% CI 1.66 - 3.61)/1 000 deaths, without no sex related differences. The combined major amputation/mortality rate at one year for the whole cohort was 46.6%. Rutherford ≥ IIb ALI (OR 4.19, 95% CI 1.94 - 9.02; p < .001), age (OR 1.03/year, 95% CI 1.00 - 1.06; p = .036), female sex (OR 2.37, 95% 1.07 - 5.26; p = .034), and anaemia (OR 2.46, 95% CI 1.08 - 5.62; p = .033) were associated with an increased risk of major amputation/death at one year. The major amputation/mortality rate at one year was 100% (n = 14/14) for patients living in a nursing home on admission. CONCLUSION: The incidence of ALI appears to be unchanged, and major amputation and mortality at one year remain high. It is necessary to include the substantial proportion of patients with ALI that do not undergo revascularisation in epidemiological studies. There is room for improvement in anticoagulation therapy in patients with atrial fibrillation to prevent ALI due to embolism. Research on gender inequalities in patients with ALI is warranted.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

Meta-analysis finds recurrent infection is more common after endovascular than after open repair of infected abdominal aortic aneurysm.

OBJECTIVE: Controversy has continued regarding the use of endovascular aneurysm repair (EVAR) vs open aneurysm repair (OAR) for infected abdominal aortic aneurysms (AAAs). In the present study, we investigated the comparative outcomes of EVAR and OAR for the treatment of infected AAAs. METHODS: We conducted a systematic review and meta-analysis using the MEDLINE and EMBASE databases through May 2021. We included studies that had described both EVAR and OAR for the treatment of infected AAAs. The primary endpoints were the rates of recurrent infection and related rupture and/or death. Perioperative and 1-year mortality and readmissions and reinterventions were also analyzed. RESULTS: Fourteen observational studies describing a total of 1203 patients (EVAR, 359 [29.8%]; OAR, 844 [70.2%]) were eligible for qualitative analysis. The baseline characteristics included diabetes mellitus (33.2%), fever at presentation (71.6%), rupture at diagnosis (26.1%), and positive blood cultures (52.5%). The mean follow-up period ranged from 12 to 40 months. The use of EVAR became more prevalent in recent years (2016-2020, 32.4%) compared with the former period (2010-2015, 13.8%; P < .0001). Fenestrated, branched, or concomitant visceral debranching EVAR was performed in 6.1% of cases. In OAR, surgical debridement was consistently performed, and in situ reconstruction was applied in 82.2% and an omental flap in 51.5%. In nine studies considered for quantitative analysis, the patients' background (EVAR, n = 264; OAR, n = 274) were statistically balanced. The crude rates of recurrent infection and related rupture or death were 13.6% (95% confidence interval [CI], 8.8%-18.5%) and 4.9% (95% CI 1.8%-8.0%), respectively. The pooled analyses depicted significantly higher rates of recurrent infection after EVAR than after OAR (relative risk [RR], 2.42; 95% CI, 1.80-3.27; P < .0001; I2 = 0%). Recurrent infection-related rupture or death (RR, 1.51; 95% CI, 0.70-3.23; P = .29; I2 = 0%), perioperative death (RR, 0.80; 95% CI, 0.39-1.65; P = .55; I2 = 35%), 1-year mortality (hazard ratio, 1.12; 95% CI, 0.97-1.28; P =.13; I2 = 0%), and readmission or reintervention (RR, 1.16; 95% CI, 0.74-1.82; P =.52; I2 = 0%) were not significantly different statistically between the two groups. Funnel plots showed no evidence of publication bias. Sensitivity analyses of leave-one-out meta-analysis confirmed higher rates of recurrent infection after EVAR. CONCLUSIONS: EVAR has become more prevalent as the initial treatment of infected AAAs. Although operative and 1-year survival were similar between OAR and EVAR groups, recurrent infection was more frequent after EVAR. This limitation should be weighed in selecting patients for EVAR in infected AAAs. Postoperative graft and infection surveillance are critical, especially after EVAR.

Sex-specific criteria for repair should be utilized in patients undergoing aortic aneurysm repair.

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.

A core outcome set for resuscitative endovascular balloon occlusion of the aorta: A consensus based approach using a modified Delphi method.

BACKGROUND: The utilization of resuscitative endovascular balloon occlusion of the aorta (REBOA) in trauma has grown exponentially in recent years. However, inconsistency in reporting of outcome metrics related to this intervention has inhibited the development of evidence-based guidelines for REBOA application. This study sought to attain consensus on a core outcome set (COS) for REBOA. METHODS: A review of "landmark" REBOA articles was performed, and panelists (first and senior authors) were contacted for participation in a modified Delphi study. In round 1, panelists provided a list of potential core outcomes. In round 2, using a Likert scale (1 [not important] to 9 [very important]), panelists scored the importance of each potential outcome. Consensus for core outcomes was defined a priori as greater than 70% of scores receiving 7 to 9 and less than 15% of scores receiving 1 to 3. Feedback was provided after round 2, and a third round was performed to reevaluate variables not achieving consensus and allow a final "write-in" round by the experts. RESULTS: From 17 identified panelists, 12 participated. All panelists (12 of 12, 100%) participated in each subsequent round. Panelists initially identified 34 unique outcomes, with two outcomes later added upon write-in request after round 2. From 36 total potential outcomes, 20 achieved consensus as core outcomes, and this was endorsed by 100% of the participants. CONCLUSION: Panelists successfully achieved consensus on a COS for REBOA-related research. This REBOA-COS is recommended for all clinical trials related to REBOA and should help enable higher-quality study designs, valid aggregation of published data, and development of evidence-based practice management guidelines. LEVEL OF EVIDENCE: Diagnostic test or criteria, level V. TRIAL REGISTRATION: Core Outcomes in Trauma Surgery: Development of a Core Outcome Set for Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) http://www.comet-initiative.org/Studies/Details/1709.

Endovascular aneurysm repair conversion is an increasingly common indication for open abdominal aortic aneurysm repair.

OBJECTIVE: Although endovascular aneurysm repair (EVAR) reintervention is common, conversion to open repair (EVAR-c) occurs less frequently but can be associated with significant technical complexity and perioperative risk. There is a paucity of data highlighting the evolution of periprocedural results surrounding EVAR-c and change in practice patterns, especially for referral centers that increasingly manage EVAR failures. The purpose of this analysis was to perform a temporal analysis of our EVAR-c experience and describe changes in patient selection, operative details, and outcomes. METHODS: A retrospective single-center review of all open abdominal aortic aneurysm repairs was performed (2002-2019), and EVAR-c procedures were subsequently analyzed. EVAR-c patients (n = 184) were categorized into two different eras (2002-2009, n = 21; 2010-2019, n = 163) for comparison. Logistic regression and Cox proportional hazards modeling were used for risk-adjusted comparisons. RESULTS: A significant increase in EVAR-c as an indication for any type of open aneurysm repair was detected (9% to 27%; P < .001). Among EVAR-c patients, no change in age or individual comorbidities was evident (mean age, 71 ± 9 years); however, the proportion of female patients (P = .01) and American Society of Anesthesiologists classification >3 declined (P = .05). There was no difference in prevalence (50% vs 43%; P = .6) or number (median, 1.5 [interquartile range (IQR), 0-5]) of preadmission EVAR reinterventions; however, time to reintervention decreased (median, 23 [IQR, 6-34] months vs 0 [IQR, 0-22] months; P = .005). In contrast, time to EVAR-c significantly increased (median, 16 [IQR, 9-39] months vs 48 [IQR, 20-83] months; P = .008). No difference in frequency of nonelective presentation (mean, 52%; P = .9] or indication was identified, but a trend toward increasing mycotic EVAR-c was observed (5% vs 15%; P = .09). Use of retroperitoneal exposure (14% vs 77%; P < .0001), suprarenal cross-clamp application (6286%; P = .04), and visceral-ischemia time (median, 0 [IQR, 0-11] minutes vs 5 [IQR, 0-20] minutes; P = .05) all increased. In contrast, estimated blood loss (P trend = .03) and procedure time (P = .008) decreased. The unadjusted elective 30-day mortality rate improved but did not reach statistical significance (elective, 10% vs 5%; P = .5) with no change for non-elective operations (18% vs 16%; P = .9). However, a significantly decreased risk of complications was evident (odds ratio, 0.88; 95% confidence interval, .8-.9; P = .01). One- and 3-year survival was similar over time. CONCLUSIONS: EVAR-c is now a common indication for open abdominal aortic aneurysm repair. Patients frequently present nonelectively and at increasingly later intervals after their index EVAR. Despite increasing technical complexity, decreased complication risk and comparable survival can be anticipated when patients are managed at a high-volume aortic referral center.

Results from a nationwide prospective registry on open surgical or endovascular repair of juxtarenal abdominal aortic aneurysms.

BACKGROUND: Juxtarenal abdominal aortic aneurysms (JRAAAs) can be treated either with open surgical repair (OSR) including suprarenal clamping or by complex endovascular aneurysm repair (cEVAR). In this study, we present the comparison between the short-term mortality and complications of the elective JRAAA treatment modalities from a national database reflecting daily practice in The Netherlands. METHODS: All patients undergoing elective JRAAA open repair or cEVAR (fenestrated EVAR or chimney EVAR) between January 2016 and December 2018 registered in the Dutch Surgical Aneurysm Audit (DSAA) were eligible for inclusion. Descriptive perioperative variables and outcomes were compared between patients treated with open surgery or endovascularly. Adjusted odds ratios for short-term outcomes were calculated by logistic regression analysis. RESULTS: In all, 455 primary treated patients with JRAAAs could be included (258 OSR, 197 cEVAR). Younger patients and female patients were treated more often with OSR vs cEVAR (72 ± 6.1 vs 76 ± 6.0; P < .001 and 22% vs 15%; P = .047, respectively). Patients treated with OSR had significantly more major and minor complications as well as a higher chance of early mortality (OSR vs cEVAR, 45% vs 21%; P < .001; 34% vs 23%; P = .011; and 6.6% vs 2.5%; P = .046, respectively). After logistic regression with adjustment for confounders, patients who were treated with OSR showed an odds ratio of 3.64 (95% confidence interval [CI], 2.25-5.89; P < .001) for major complications compared with patients treated with cEVAR, and for minor complications, the odds ratios were 2.17 (95% CI, 1.34-3.53; P = .002) higher. For early mortality, the odds ratios were 3.79 (95% CI, 1.26-11.34; P = .017) higher after OSR compared with cEVAR. CONCLUSIONS: In this study, after primary elective OSR for JRAAA, the odds for major complications, minor complications, and short-term mortality were significantly higher compared with cEVAR.

Early and midterm outcomes following open surgical conversion after failed endovascular aneurysm repair from the "Italian North-easT RegIstry of surgical Conversion AfTer Evar" (INTRICATE).

OBJECTIVE: To report the early and mid-term outcomes following open surgical conversion (OSC) after failed endovascular aortic repair (EVAR) using data from a multicentric registry. METHODS: A retrospective study was carried out on consecutive patients undergoing OSC after failed EVAR at eight tertiary vascular units from the same geographic area in the North-East of Italy, from April 2005 to November 2019. Study endpoints included early and follow-up outcomes. RESULTS: A total of 144 consecutive patients were included in the study. Endoleaks were the most common indication for OSC (50.7%), with endograft infection (24.6%) and occlusion (21.9%) being the second most prevalent causes. The overall rate of 30-day all-cause mortality was 13.9% (n = 20); 32 patients (22.2%) experienced at least one major complication. Mean length of stay was 13 ± 12.7 days. On multivariate logistic regression, age (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.01-1-19; P = .02), renal clamping time (OR, 1.07; 95% CI, 1.02-1.13; P = .01), and suprarenal/celiac clamping (OR, 6.66; 95% CI, 1.81-27.1; P = .005) were identified as independent predictors of perioperative major complications. Age was the only factor associated with perioperative mortality at 30 days. Renal clamping time >25 minutes had sensitivity of 65% and specificity of 70% in predicting the occurring of major adverse events (area under the curve, 0.72; 95% CI, 0.61-0.82). At 5 years, estimated survival was significantly lower for patients treated due to aortic rupture/dissection (28%; 95% CI, 13%-61%), compared with patients in whom the indication for treatment was endoleak (54%; 95% CI, 40%-73%), infection (53%; 95% CI, 30%-94%), or thrombosis (82%; 95% CI, 62%-100%; P = .0019). Five-year survival rates were significantly lower in patients who received emergent treatment (28%; 95% CI, 14%-55%) as compared with those who were treated in an urgent (67%; 95% CI, 48%-93%) or elective setting (57%; 95% CI, 43%-76%; P = .00026). Subjects who received suprarenal/celiac (54%; 95% CI, 36%-82%) or suprarenal (46%; 95% CI, 34%-62%) aortic cross-clamping had lower survival rates at 5 years than those whose aortic-cross clamp site was infrarenal (76%; 95% CI, 59%-97%; P = .041). Using multivariate Cox proportional hazard, older age and emergency setting were independently associated with higher risk for overall 5-year mortality. CONCLUSIONS: OSC after failed EVAR was associated with relatively high rates of early morbidity and mortality, particularly for emergency setting surgery. Endoleaks with secondary sac expansion were the main indication for OSC, and suprarenal aortic cross-clamping was frequently required. Endograft infection and emergent treatment remained associated with poorer short- and long-term survival.

Thrombectomy for anterior circulation stroke beyond 6 h from time last known well (AURORA): a systematic review and individual patient data meta-analysis.

BACKGROUND: Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis. METHODS: We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days. FINDINGS: Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years [SD 13·7], 259 [51·3%] women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76-3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83-3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0-2) than best medical therapy alone (122 [45·9%] of 266 vs 46 [19·3%] of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 [16·5%] of 266 vs 46 [19·3%] of 238) or symptomatic intracerebral haemorrhage (14 [5·3%] of 266 vs eight [3·3%] of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12-24 h (common OR 5·86 [95% CI 3·14-10·94]) than those randomly assigned within 6-12 h (1·76 [1·18-2·62]; pinteraction=0·0087). INTERPRETATION: These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6-24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6-24 h time window. FUNDING: Stryker Neurovascular.

Use of a disposable vascular pressure device to guide balloon inflation of resuscitative endovascular balloon occlusion of the aorta: a bench study.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) for rapid hemorrhage control is increasingly being used in trauma management. Its beneficial hemodynamic effects on unstable patients beyond temporal hemostasis has led to growing interest in its use in other patient populations, such as during cardiac arrest from nontraumatic causes. The ability to insert the catheters without fluoroscopic guidance makes the technique available in the prehospital setting. However, in addition to correct positioning, challenges include reliably achieving aortic occlusion while minimizing the risk of balloon rupture. Without fluoroscopic control, inflation of the balloon relies on estimated aortic diameters and on the disappearing pulse in the contralateral femoral artery. In the case of cardiac arrest or absent palpable pulses, balloon inflation is associated with excess risk of overinflation and adverse events (vessel damage, balloon rupture). In this bench study, we examined how the pressure in the balloon is related to the surrounding blood pressure and the balloon's contact with the vessel wall in two sets of experiments, including a pulsatile circulation model. With this data, we developed a rule of thumb to guide balloon inflation of the ER-REBOA catheter with a simple disposable pressure-reading device (COMPASS). We recommend slowly filling the balloon with saline until the measured balloon pressure is 160 mmHg, or 16 mL of saline have been used. If after 16 mL the balloon pressure is still below 160 mmHg, saline should be added in 1-mL increments, which increases the pressure target about 10 mmHg at each step, until the maximum balloon pressure is reached at 240 mmHg (= 24 mL inflation volume). A balloon pressure greater than 250 mmHg indicates overinflation. With this rule and a disposable pressure-reading device (COMPASS), ER-REBOA balloons can be safely filled in austere environments where fluoroscopy is unavailable. Pressure monitoring of the balloon allows for recognition of unintended deflation or rupture of the balloon.

Assessment of Discrepancies Between Follow-up Infarct Volume and 90-Day Outcomes Among Patients With Ischemic Stroke Who Received Endovascular Therapy.

Importance: Some patients have poor outcomes despite small infarcts after endovascular therapy (EVT), while others with large infarcts do well. Understanding why these discrepancies occur may help to optimize EVT outcomes. Objective: To validate exploratory findings from the Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion with Emphasis on Minimizing CT to Recanalization Times (ESCAPE) trial regarding pretreatment, treatment-related, and posttreatment factors associated with discrepancies between follow-up infarct volume (FIV) and 90-day functional outcome. Design, Setting, and Participants: This cohort study is a post hoc analysis of the Safety and Efficacy of Nerinetide in Subjects Undergoing Endovascular Thrombectomy for Stroke (ESCAPE-NA1) trial, a double-blind, randomized, placebo-controlled, international, multicenter trial conducted from March 2017 to August 2019. Patients who participated in ESCAPE-NA1 and had available 90-day modified Rankin Scale (mRS) scores and 24-hour to 48-hour posttreatment follow-up parenchymal imaging were included. Exposures: Small FIV (volume ≤25th percentile) and large FIV (volume ≥75th percentile) on 24-hour computed tomography/magnetic resonance imaging. Baseline factors, outcomes, treatments, and poststroke serious adverse events (SAEs) were compared between discrepant cases (ie, patients with 90-day mRS score ≥3 despite small FIV or those with mRS scores ≤2 despite large FIV) and nondiscrepant cases. Main Outcomes and Measures: Area under the curve (AUC) and goodness of fit of prespecified logistic models, including pretreatment (eg, age, cancer, vascular risk factors) and treatment-related and posttreatment (eg, SAEs) factors, were compared with stepwise regression-derived models for ability to identify small FIV with higher mRS score and large FIV with lower mRS score. Results: Among 1091 patients (median [IQR] age, 70.8 [60.8-79.8] years; 549 [49.7%] women; median [IQR] FIV, 24.9 mL [6.6-92.2 mL]), 42 of 287 patients (14.6%) with FIV of 7 mL or less (ie, ≤25th percentile) had an mRS score of at least 3; 65 of 275 patients (23.6%) with FIV of 92 mL or greater (ie, ≥75th percentile) had an mRS score of 2 or less. Prespecified models of pretreatment factors (ie, age, cancer, vascular risk factors) associated with low FIV and higher mRS score performed similarly to models selected by stepwise regression (AUC, 0.92 [95% CI, 0.89-0.95] vs 0.93 [95% CI, 0.90-0.95]; P = .42). SAEs, specifically infarct in new territory, recurrent stroke, pneumonia, and congestive heart failure, were associated with low FIV and higher mRS scores; stepwise models also identified 24-hour hemoglobin as treatment-related/posttreatment factor (AUC, 0.92 [95% CI, 0.90-0.95] vs 0.94 [95% CI, 0.91-0.96]; P = .14). Younger age was associated with high FIV and lower mRS score; stepwise models identified absence of diabetes and higher baseline hemoglobin as additional pretreatment factors (AUC, 0.76 [95% CI, 0.70-0.82] vs 0.77 [95% CI, 0.71-0.83]; P = .82). Absence of SAEs, especially stroke progression, symptomatic intracerebral hemorrhage, and pneumonia, was associated with high FIV and lower mRS score2; stepwise models also identified 24-hour hemoglobin level, glucose, and diastolic blood pressure as posttreatment factors associated with discrepant cases (AUC, 0.80 [95% CI, 0.74-0.87] vs 0.79 [95% CI, 0.72-0.86]; P = .92). Conclusions and Relevance: In this study, discrepancies between functional outcome and post-EVT infarct volume were associated with differences in pretreatment factors, such as age and comorbidities, and posttreatment complications related to index stroke evolution, secondary prevention, and quality of stroke unit care. Besides preventing such complications, optimization of blood pressure, glucose levels, and hemoglobin levels are potentially modifiable factors meriting further study.

Clinical Implications of the Coexistence of Anemia and Diabetes Mellitus in the Elderly Population.

Diabetes mellitus (DM) and also anemia are common in the elderly and have a negative impact on the clinical outcomes of patients. The coexistence of anemia and DM seems to be insufficiently recognized; therefore, the aim of our study is to analyze the incidence and clinical consequences of this coexistence, including mortality, in the population of people aged ≥60. A retrospective study was conducted on 981 primary care clinic patients aged ≥60 during 2013-2014. The prevalence of coexistence of DM and anemia (defined in accordance with WHO) and data on the incidence of comorbidities, hospitalization, medical procedures, and all-cause mortality were analyzed. In the study population, 25% had DM, while 5.4% had both DM and anemia. Peripheral artery disease (PAD) was found in 48 patients (4.89%) of the entire study population, more often in men (p < 0.001). Diabetic patients with anemia compared to nonanemic diabetics had more comorbidities (median 4 (4, 5) vs. 3 (2-4); p < 0.001)-PAD more often (p = 0.004), more hospitalization (median 2 (0-11) vs. 0 (0-11); p < 0.001), and more frequent medical procedures (e.g., percutaneous coronary intervention (p < 0.001), coronary artery bypass surgery (p = 0.027), arteriography (p < 0.001), and bypass surgery or endovascular treatments of lower limb ischemia (p < 0.001)). The cumulative survival of patients with both DM and anemia vs. nonanemic diabetics at 36 months was 86.4% vs. 99.3% (p < 0.001). A multivariate logistic regression model showed anemia to be a significant risk factor for death in diabetic patients (p = 0.013). Patients with both DM and anemia have more comorbidities than nonanemic diabetic patients; they are more often hospitalized, require medical procedures more frequently, and are at a higher risk of death. Effective treatment of anemia in patients with DM is advisable and may well improve the prognosis of patients.

Participation in a Chronic Limb Threatening Ischemia Randomized Trial Is Inversely Correlated With Regional Amputation Rate in Limb Threatening Ischemia Patients.

OBJECTIVE: The National Health Service demonstrated that regions of the United Kingdom with the highest number of patients enrolled in research studies had the lowest risk-adjusted mortality when patients were admitted to the hospital. Our goal was to investigate if this correlation was evident for patients with chronic limb threatening ischemia (CLI) treated in the United States (US). Accordingly, we examined correlations among sites participating in the Best Endovascular versus best Surgical Therapy in patients with Critical (BEST-CLI) trial, a multicenter, National Institute of Health-sponsored, international randomized controlled trial (RCT) comparing revascularization strategies in patients with CLI, and regional rates of major amputation from CLI. METHODS: We measured regional participation in the BEST-CLI trial by evaluating trial participation and enrollment rosters. To determine regional rates of lower limb amputation, we queried the Medicare database (2007-2016) for patients with concurrent peripheral arterial disease (PAD) and diabetes, then assessed how many had lower extremity amputations. Correlation of regional amputation rates with distribution of BEST-CLI sites in four US geographical regions was calculated using Pearson's correlation coefficients. Simple regression equations were used to calculate the significance of these correlation coefficients. RESULTS: Of 9,231,909 CLI patients, 342,406 underwent amputation in the Medicare dataset. Amputation rates per 1000 CLI patients differed by region (South 40.42, Midwest 40.12, West 34.81, Northeast 31.14). There were 116 US vascular centers, selected by volume and expertise that participated in BEST-CLI with the following distribution: South (n = 30, 26%), Midwest (n = 26, 22%), West (n = 29, 25%), and Northeast (n = 31, 27%). There was a negative correlation between the number of amputations per 1000 for Medicare CLI patients with diabetes and PAD and the number of BEST-CLI sites in the region which trended toward significance (Pearson R= -0.61, P = 0.39). CONCLUSIONS: Amputation rate among Medicare CLI patients is inversely correlated with US BEST-CLI site distribution. Higher participation in clinical research, especially within large RCTs, may be a marker of optimal PAD management.

Successful endovascular therapy for an adolescent patient with cerebral venous sinus thrombosis: A case report.

RATIONALE: Cerebral venous sinus thrombosis associated with protein S deficiency is rare in adolescent patients and has high disability and fatality.Patient concerns: A 15-year-old male student presented in the hospital with sudden headache, nausea, and vomiting and was diagnosed with protein S deficiency by gene testing. DIAGNOSES: Cerebral venous sinus thrombosis due to protein S deficiency was diagnosed in this adolescent patient, who underwent successful endovascular therapy (EVT). INTERVENTIONS: The patient was treated with standard anti-coagulation therapy including low-molecular-weight heparin (90 IU/kg/Q12 h) and dehydrant (mannitol 125 mL Q8 h); however, the symptoms were not alleviated. Successful EVT was implemented. OUTCOMES: Both the superior sagittal sinus and bilateral transverse sinus were recanalized after thrombus clearance. The patient achieved a complete recovery without any other stroke recurrence during follow-up. LESSONS: EVT can be performed with favorable and effective clinical outcomes in adolescent cerebral venous sinus thrombosis patients with protein S deficiency. EVT associated with standard anti-coagulation therapy may improve the prognosis and reduce mortality among such patients.

Management of endovascular therapy for acute ischemic stroke amid the COVID-2019 pandemic: a multicenter survey in China.

Objectives: The impact of COVID-19 pandemic on endovascular therapy (EVT) for acute ischemic stroke in China is unknown. This study was aimed to verify the volume change of EVT for acute ischemic stroke affected by COVID-19 and its potential factors.Methods: This cross-sectional study was conducted via an online questionnaire survey in China. The questionnaire was mainly composed of descriptive information, volume change of EVT for acute ischemic stroke, and the protection status of medical staff.Results: A total of 103 stroke physicians in 28 provinces across China completed the survey questionnaire. A volume decline in EVT for acute stroke occurred in 93 (90.3%) hospitals after lockdown (23 January 2020). Nearly half of the hospitals (51/103, 49.5%) experienced a volume decline of EVT case more than 50% and 14 (13.6%) hospitals completely ceased offering EVT. Hospitals with decline >50% of EVT case had higher proportion of hospitals with a designated area for COVID-19 screening in the emergency room (44/51, 86.3% vs 34/52, 65.4%, p= 0.01) and medical staff in quarantine (19/51, 37.3% vs 7/52, 13.5%, p< 0.01), with lower proportion of hospitals with personal protective equipment protocol (41/51, 80.4% vs 49/52, 94.2%, p= 0.03) than hospitals with decline ≤50%.Conclusions: The volume of EVT for acute ischemic stroke severely declined after lockdown in China. Designating a specific area for COVID-19 screening, insufficient personal protection and understaffing may exacerbate the volume decline of EVT.

Outcomes after clipping and endovascular coiling for aneurysmal subarachnoid hemorrhage among dual-eligible beneficiaries.

Dual-eligible beneficiaries, individuals with both Medicare and Medicaid coverage, represent a high-cost and vulnerable population; however, literature regarding outcomes is sparse. We characterized outcomes in dual-eligible beneficiaries treated for aneurysmal subarachnoid hemorrhage (aSAH) compared to Medicare only, Medicaid only, private insurance, and self-pay. A 10-year cross-sectional study of the National Inpatient Sample was conducted. Adult aSAH emergency admissions treated by neurosurgical clipping or endovascular coiling were included. Multivariable regression was used to adjust for confounders. A total of 57,666 patients met inclusion criteria. Dual-eligibles comprised 2.8% of admissions and were on average younger (62.4 years) than Medicare (70.0 years), older than all other groups, and had higher mean National Inpatient Sample-Subarachnoid Hemorrhage Severity Scores than all other groups (p ≤ 0.001). Among patients treated by clipping, dual-eligibles were less often discharged to home compared to Medicare (adjusted odds ratio (aOR) = 0.51, 95% CI = 0.30-0.87, p < 0.05) and all other insurance groups, p < 0.01. Likewise, those who received coiling were less often discharged to home compared to Medicaid (aOR = 0.41, 95% CI = 0.23-0.73), private (aOR = 0.42, 95% CI = 0.23-0.76) and self-pay patients (aOR = 0.24, 95% CI = 0.12-0.46). They also had increased odds of poor National Inpatient Sample-Subarachnoid Hemorrhage Outcome Measures compared to Medicaid, private, and self-pay patients, all p < 0.05. There were no differences in inpatient mortality or total complications. In conclusion, dual-eligible patients had higher aSAH severity scores, less often discharged home, and among patients who received coiling, dual-eligibles had increased odds of poor outcome. Dual-eligible patients with aSAH represent a vulnerable population that may benefit from targeted clinical and public policy initiatives.

Clinical Outcomes of Clipping and Coiling in Elderly Patients with Unruptured Cerebral Aneurysms: a National Cohort Study in Korea.

BACKGROUND: We aimed to analyze outcomes of clipping and coiling in treating unruptured intracranial aneurysms (UIAs) in elderly patients and to identify the age at which perioperative risk increases based on national cohort data in South Korea. METHODS: The incidence of perioperative intracranial hemorrhage (ICRH), perioperative cerebral infarction (CI), mortality, and moderate to severe disability data of the patients who underwent coiling or clipping for UIAs were retrieved. Estimated breakpoint (EBP) was calculated to identify the age at which the risk of treatment increases. RESULTS: A total of 38,207 patients were treated for UIAs. Among these, 22,093 (57.8%) patients underwent coiling and 16,114 (42.2%) patients underwent clipping. The incidence of ICRH, requiring a secondary operation, within 3 months in patients ≥ 65 years that underwent coiling and clipping was 1.13% and 4.81%, respectively, and that of both groups assessed were significantly higher in patients ≥ 75 years (coiling, P = 0.013, relative risk (RR) 1.81; clipping, P = 0.015) than younger patients. The incidence of CI within 3 months in patients aged ≥ 65 was 13.90% and 9.19% in the coiling and clipping groups, respectively. The incidence of CI after coiling in patients aged ≥ 75 years (P < 0.001, RR 1.96) and after clipping in patients aged ≥ 70 years (P < 0.001, RR 1.76) was significantly higher than that in younger patients. The mortality rates within 1 year in patients with perioperative ICRH or CI were 2.41% and 3.39% for coiling and clipping groups, respectively, in patients ≥ 65. These rates increased significantly at age 70 in the coiling group and at age 75 for the clipping group (P = 0.012 and P < 0.001, respectively). CONCLUSION: The risk of treatment increases with age, and this risk increases dramatically in patients aged ≥ 70 years. Therefore, the treatment decisions in patients aged ≥ 70 years should be made with utmost care.