Service delivery in acute ischemic stroke patients: Does sex matter?

BACKGROUND AND PURPOSE: Women with acute ischemic stroke (AIS) are older and have greater preexisting handicap than men. Given that these factors do not fully explain their poorer long-term outcomes, we sought to investigate potential sex differences in the delivery of acute stroke care in a large cohort of consecutive AIS patients. METHODS: We analyzed all patients from ASTRAL (Acute Stroke Registry and Analysis of Lausanne) from March 2003 to December 2019. Multivariable analyses were performed on acute time metrics, revascularization therapies, ancillary examinations for stroke workup, subacute symptomatic carotid artery revascularization, frequency of change in goals of care (palliative care), and length of hospital stay. RESULTS: Of the 5347 analyzed patients, 45% were biologically female and the median age was 74.6 years. After multiple adjustments, female sex was significantly associated with higher onset-to-door (adjusted hazard ratio [aHR] = 1.09, 95% confidence interval [CI] = 1.04-1.14) and door-to-endovascular-puncture intervals (aHR = 1.15, 95% CI = 1.05-1.25). Women underwent numerically fewer diagnostic examinations (adjusted odds ratio [aOR] = 0.94, 95% CI = 0.85-1.04) and fewer subacute carotid revascularizations (aOR = 0.69, 95% CI = 0.33-1.18), and had longer hospital stays (aHR = 1.03, 95% CI = 0.99-1.07), but these differences were not statistically significant. We found no differences in the rates of acute revascularization treatments, or in the frequency of change of goals of treatments. CONCLUSIONS: This retrospective analysis of a large, consecutive AIS cohort suggests that female sex is associated with unfavorable pre- and in-hospital time metrics, such as a longer onset-to-door and door-to-endovascular-puncture intervals. Such indicators of less effective stroke care delivery may contribute to the poorer long-term functional outcomes in female patients and require further attention.

Hospital Volume of Elective Abdominal Aortic Aneurysm Repair as a Predictor of Mortality After Ruptured Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Registry data suggest that centralising abdominal aortic aneurysm (AAA) surgery decreases the mortality rate after AAA repair. However, the impact of higher elective volumes on ruptured AAA (rAAA) repair associated mortality rates remains uncertain. This study aimed to examine associations between intact AAA (iAAA) repair volume and post-operative rAAA death. METHODS: Using data from official national registries between 2015 - 2019, all iAAA and rAAA repairs were separately analysed across 10 public hospitals. The following were assessed: 30 day and 12 month mortality rate following open surgical repair (OSR) and endovascular aneurysm repair (EVAR). Associations between the 5 year hospital iAAA repair volumes (organised into tertiles) and rAAA associated mortality rate were analysed, regardless of treatment modality. Receiver operating characteristic (ROC) curves were generated to identify iAAA volume thresholds for decreasing the rAAA mortality rate. Subanalysis by treatment type was conducted. Threshold analysis was repeated with the Markov chain Monte Carlo (MCMC) procedure to confirm the findings. RESULTS: A total of 1 599 iAAAs (80.2% EVAR, 19.8% OSR) and 196 rAAAs (66.3% EVAR, 33.7% OSR) repairs were analysed. The median and interquartile range of the volume/hospital/year for all iAAA repairs were 39.2 (31.2, 47.4). The top volume iAAA tertile exhibited lower rAAA associated 30 day (odds ratio [OR] 0.374; p = .007) and 12 month (OR 0.264; p < .001) mortality rates. The ROC analysis revealed a threshold of 40 iAAA repairs/hospital/year (EVAR + OSR) for a reduced rAAA mortality rate. Middle volume hospitals for open iAAA repair had reduced 30 day (OR 0.267; p = .033) and 12 month (OR 0.223; p = .020) mortality rates, with a threshold of five OSR procedures/year. The MCMC procedure found similar thresholds. No significant association was found between elective EVAR volumes and ruptured EVAR mortality. CONCLUSION: Higher iAAA repair volumes correlated with a lower rAAA mortality rate, particularly for OSR. The recommended iAAA repair threshold is 40 procedures/year and five procedures/year for OSR. These findings support high elective volumes for improving the rAAA mortality rate, especially for OSR.

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.

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.

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.

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.

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.

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.

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.

Maintaining high thrombectomy rates during pandemics.

PURPOSE OF REVIEW: The aim of this article is to review the current literature on endovascular treatment of acute ischemic stroke in the aftermath of the coronavirus disease 2019 (COVID-19) lockdown. RECENT FINDINGS: The outbreak of the COVID-19 has had effect of unprecedented magnitude on the social, economic and personal aspects around the globe. Healthcare providers were forced to expand capacity to provide care to the surging number of symptomatic COVID-19 patients, while maintaining a fully operating service for all non-COVID patients. The recent literature suggesting an overall decrease in acute ischemic stroke admissions as well as total number of endovascular treatments will be reviewed. Although the underlying reasons therefore remain the matter of debate, it seems that the imposed restrictions, requiring social distancing, and stopping all nonessential services, have led to a higher threshold for patients to seek medical attention, in particular in those with less severe symptoms. Thus, raising public awareness on the importance of strokes and transient ischemic attacks is even more important in the light of the current situation to avoid serious healthcare, economic consequences, and limit long term morbidity. SUMMARY: The priority remains maintaining a fast and efficient pre and in-hospital work-flow while mitigating nosocomial transmission and protecting the patient and the healthcare workers with appropriate personal protective equipment.

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.

Outcomes of Vascular and Endovascular Interventions Performed During the Coronavirus Disease 2019 (COVID-19) Pandemic.

OBJECTIVE: The aim of the COVER Study is to identify global outcomes and decision making for vascular procedures during the pandemic. BACKGROUND DATA: During its initial peak, there were many reports of delays to vital surgery and the release of several guidelines advising later thresholds for vascular surgical intervention for key conditions. METHODS: An international multi-center observational study of outcomes after open and endovascular interventions. RESULTS: In an analysis of 1103 vascular intervention (57 centers in 19 countries), 71.6% were elective or scheduled procedures. Mean age was 67 ±â€Š14 years (75.6% male). Suspected or confirmed COVID-19 infection was documented in 4.0%. Overall, in-hospital mortality was 11.0% [aortic interventions mortality 15.2% (23/151), amputations 12.1% (28/232), carotid interventions 10.7% (11/103), lower limb revascularisations 9.8% (51/521)]. Chronic obstructive pulmonary disease [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.30-3.15] and active lower respiratory tract infection due to any cause (OR 24.94, 95% CI 12.57-241.70) ware associated with mortality, whereas elective or scheduled cases were lower risk (OR 0.4, 95% CI 0.22-0.73 and 0.60, 95% CI 0.45-0.98, respectively. After adjustment, antiplatelet (OR 0.503, 95% CI: 0.273-0.928) and oral anticoagulation (OR 0.411, 95% CI: 0.205-0.824) were linked to reduced risk of in-hospital mortality. CONCLUSIONS: Mortality after vascular interventions during this period was unexpectedly high. Suspected or confirmed COVID-19 cases were uncommon. Therefore an alternative cause, for example, recommendations for delayed surgery, should be considered. The vascular community must anticipate longer term implications for survival.

The American Association for the Surgery of Trauma Renal Grading System-Should Segmental Kidney Infarction be Classified as a Grade IV Injury?

PURPOSE: In 2018 the American Association for the Surgery of Trauma revised renal injury grading. One change was inclusion of segmental kidney infarction under grade IV injuries. We aimed to assess how segmental kidney infarction will change the scope of grade IV injuries and compare bleeding control interventions in those with and without isolated segmental kidney infarction. METHODS: We used high grade renal trauma data from 7 level 1 trauma centers from 2013 to 2018 as part of the Multi-institutional Genito-Urinary Trauma Study. Initial computerized tomography scans were reviewed to regrade the injuries. Injuries were categorized as isolated segmental kidney infarction if segmental parenchymal infarction was the only reason for inclusion under grade IV injury. All other grade IV injuries (including combined injury patterns) were categorized as without isolated segmental kidney infarction. Bleeding interventions were compared between those with and without isolated segmental kidney infarction. RESULTS: From 550 patients with high grade renal trauma and available computerized tomography, 250 (45%) were grade IV according to the 2018 American Association for the Surgery of Trauma grading system. Of these, 121 (48%) had isolated segmental kidney infarction. The majority of patients with isolated segmental kidney infarction (88%) would have been assigned a lower grade using the original 1989 grading system. Rate of bleeding control interventions was lower in isolated segmental kidney infarction compared to other grade IV injuries (7% vs 21%, p=0.002). Downgrading all patients with isolated segmental kidney infarction to grade III did not change the grading system's associations with bleeding interventions. CONCLUSIONS: Approximately half of the 2018 American Association for the Surgery of Trauma grade IV injuries have isolated segmental kidney infarction. Including isolated segmental kidney infarction in grade IV injuries increases the heterogeneity of these injuries without increasing the grading system's ability to predict bleeding interventions. In future iterations of the American Association for the Surgery of Trauma renal trauma grading isolated segmental kidney infarction could be reclassified as grade III injury.

Volume-outcome relationships in open and endovascular repair of abdominal aortic aneurysm: administrative data 2006-2018.

BACKGROUND: The aim of this study was to use recent evidence to investigate and update volume-outcome relationships after open surgical repair (OSR) and endovascular repair (EVAR) of abdominal aortic aneurysm in England. METHODS: Hospital Episode Statistics (HES) data from April 2006 to March 2018 were obtained. The primary outcome was in-hospital death. Other outcomes included duration of hospital stay, readmissions within 30 days, and critical care requirements. Case-mix adjustment included age, sex, HES year, deprivation index, weekend admission, mode of admission, type of procedure and co-morbidities. RESULTS: Annual volume of all repairs combined appeared to be an appropriate measure of volume. After case-mix adjustment, a significant relationship between volume and in-hospital mortality was seen for OSR (P < 0·001) but not for EVAR (P = 0·169 for emergency and P = 0·363 for elective). The effect appeared to extend beyond 60 repairs per year to volumes above 100 repairs per year. There was no significant relationship between volume and duration of hospital stay or 30-day readmissions. In patients receiving emergency OSR, higher volume was associated with longer stay in critical care. CONCLUSION: Higher annual all-procedure volumes were associated with significantly lower in-hospital mortality for OSR, but such a relationship was not significant for EVAR. There was not enough evidence for a volume effect on other outcomes.

Predicting outcomes in older patients undergoing vascular surgery using the Hospital Frailty Risk Score.

BACKGROUND: Frailty may explain why some older patients having vascular surgery are at high risk of adverse outcomes. The Hospital Frailty Risk Score (HFRS) has been designed specifically for use with administrative data and has three categories of frailty risk (low, intermediate and high). The aim of this study was to evaluate the HFRS in predicting mortality, and hospital use in older patients undergoing vascular surgery. METHODS: Routinely collected hospital data linked to death records were analysed for all patients aged 75 years or older who had undergone either endovascular or open vascular surgery between 2010 and 2012 in New South Wales, Australia. Multilevel logistic regression models were used to compare outcomes adjusted for patient and procedural factors, with and without frailty. RESULTS: Some 9752 patients were identified, of whom 1719 (17·6 per cent) had a high-risk HFRS. Patients in the high-risk frailty category had an adjusted odds ratio for death by 30 days after surgery of 4·15 (95 per cent c.i. 2·99 to 5·76) compared with those in the low-risk frailty category, and a similarly increased odds of death by 2 years (odds ratio 4·27, 3·69 to 4·95). Adding the HFRS to a model adjusted for age, sex, co-morbidity score, socioeconomic status, previous hospitalization and vascular procedure type improved the prediction of 2-year mortality and prolonged hospital stay, but there was minimal improvement for 30-day mortality and readmission. CONCLUSION: Adjusting for the HFRS in addition to other patient and procedural risk factors provided greater discrimination of outcomes in this cohort of older patients undergoing vascular surgery.

Comparison of Pre-Amputation Evaluation in Patients with and without Chronic Kidney Disease.

INTRODUCTION: Patients with chronic kidney disease (CKD) and peripheral artery disease (PAD) are more likely to undergo lower extremity amputation than patients with preserved kidney function. We sought to determine whether patients with CKD were less likely to receive pre-amputation care in the 1-year prior to lower extremity amputation compared to patients without CKD. METHODS: We conducted a retrospective observational study of patients with PAD-related lower extremity amputation between January 2014 and December 2017 using a large commercial insurance database. The primary exposure was CKD identified using billing codes and laboratory values. The primary outcomes were receipt of pre-amputation care, defined as diagnostic evaluation (ankle-brachial index, duplex ultrasound, and computed tomographic angiography), specialty care (vascular surgery, cardiology, orthopedic surgery, and podiatry), and lower extremity revascularization in the 1-year prior to amputation. We conducted separate logistic regression models to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) among patients with and without CKD. We assessed for effect modification by age, sex, Black race, and diabetes status. RESULTS: We identified 8,554 patients with PAD-related amputation. In fully adjusted models, patients with CKD were more likely to receive diagnostic evaluation (aOR 1.30; 95% CI 1.17-1.44) and specialty care (aOR 1.45, 95% CI 1.27-1.64) in the 1-year prior to amputation. There was no difference in odds of revascularization by CKD status (aOR 1.03, 0.90-1.19). Age, sex, Black race, and diabetes status did not modify these associations. DISCUSSION/CONCLUSION: Patients with CKD had higher odds of receiving diagnostic testing and specialty care and similar odds of lower extremity revascularization in the 1-year prior to amputation than patients without CKD. Disparities in access to pre-amputation care do not appear to explain the higher amputation rates seen among patients with CKD.

Association of Medicaid Expansion with In-Hospital Outcomes After Abdominal Aortic Aneurysm Repair.

OBJECTIVES: Multiple studies have shown improved outcomes and higher utilization of care with the increase of insurance coverage. This study aims to assess whether Medicaid expansion (ME) has changed the utilization and outcomes of abdominal aortic aneurysm (AAA) repair in the United States. DESIGN: Retrospective observational study. MATERIALS: Data of patients undergoing AAA repair in the Vascular Quality Initiative (2010-2017). METHODS: Interrupted time-series (ITS) analysis was utilized to evaluate changes in annual trends of postoperative outcomes after elective AAA repair before and after 2014. We also assessed if these trend changes were significant by comparing the changes in states which adopted ME in 2014 versus nonexpansion states (NME), and conducting a difference-in-difference analysis. Primary outcomes included in-hospital mortality and adverse events (bowel and leg ischemia, cardiac, renal, respiratory, stroke and return to the OR). RESULTS: A total of 19,143 procedures were included (Endovascular: 85.8% and open: 14.2%), of which 40.9% were performed in ME States. Compared to preexpansion trends (P1), there was a 2% annual increase in elective AAA repair in ME states (P1: -1.8% versus P2: +0.2%, P< 0.01) with no significant change in NME (P1: +0.3% versus P2: +0.2%, P = 0.97). Among elective cases, annual trends in the use of EVAR increased by 2% in ME states (95% confidence interval (CI) = -0.1, 4.1, P = 0.06), compared to a 3% decrease in NME States [95%CI = -5.8, -0.6, P = 0.01) (PMEversusNME < 0.01]. There was no association between ME and in-hospital mortality. Nonetheless, it was associated with a decrease in the annual trends of in-hospital complications (ME: -1.4% (-2.1,-0.8) versus NME: +0.2% (-0.2, +0.8), P < 0.01). CONCLUSIONS: While no association between ME and increased survival was noted in states which adopted ME, there was a significant increase of elective AAA cases and EVAR utilization and a decrease in in-hospital complications in ME States.

The Administrative Risk Analysis Index (RAI-A) Does Not Predict Reintervention or Mortality Within 30 Days in Patients Who Undergo Elective Open or Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Frailty scores are increasingly utilized to predict postoperative complications. The purpose of this study is to determine whether the administrative risk analysis index (RAI-A) can be used to predict reintervention or mortality within 30 days in patients who undergo elective open or endovascular abdominal aortic aneurysm (AAA) repair. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was used to query data from elective open or endovascular aortic aneurysm repairs from 2011 to 2018. The administrative risk analysis index (RAI-A) score was calculated for each patient using two approaches (conservative versus liberal) due to discrepancies in NSQIP data categorization. Multivariable regression analysis was performed to determine whether there were statistical or clinical significance for incremental increases of RAI-A for both the open and endovascular repair group. Outcome measures were re-intervention or death within 30 days. RESULTS: Data from 4106 and 11,733 patients who underwent open and endovascular repair, respectively, were included in the analysis. The number of reinterventions within 30 days was 9.1% (375 out of 4106 patients) in the open repair group and 4.0% (463 out of 11,685 patients) in the endovascular group. Thirty-day mortality was 4.7% (192 out of 4106 patients) in the open repair group, and 0.9% (109 out of 11,685 patients) in the endovascular group. In the conservative calculation of RAI-A scores, the open and endovascular repair groups had median RAI-A scores of 7 (mean 8.31) and 9 (mean 9.51), respectively. There was no significant association between RAI-A scores and outcome measures in either group. For predicting 30 d reintervention, the C statistic was 0.535 (OR 1.02) for the open repair group and 0.532 (OR 1.02) for endovascular repair. For predicting 30-day mortality, the C statistic was 0.626 (OR 1.07) in the open repair group and 0.701 (OR 1.09) in the endovascular repair group. In the liberal calculation of RAI-A scores, the open and endovascular repair groups had median RAI-A scores of 6 (mean 6.19) and 7 (mean 7.65), respectively. There was no significant association between RAI-A scores and outcome measures in either group. For predicting 30 d reintervention, the C statistic was 0.527 (OR 1.02) for open repair and 0.529 (OR 1.02) for endovascular repair. For predicting 30-day mortality, the C statistic was 0.625 (OR 1.07) in the open repair group and 0.695 (OR 1.08) in the endovascular repair group. CONCLUSIONS: The RAI-A is not useful in predicting 30 d reintervention or mortality in patients who undergo elective open or endovascular AAA repair.

Editor's Choice - Variation in Intact Abdominal Aortic Aneurysm Repair Outcomes by Country: Analysis of International Consortium of Vascular Registries 2010 - 2016.

OBJECTIVE: Outcomes for intact abdominal aortic aneurysm (AAA) repair vary over time and by healthcare system, country, and surgeon. The aim of this study was to analyse peri-operative mortality for intact AAA repair in 11 countries over time and compare outcomes by gender, age, and geographical location. METHODS: Prospective data on primary repair of intact AAA were collected from 11 countries through the International Consortium of Vascular Registries (ICVR) and analysed for two time periods, 2010 - 2013 and 2014 - 2016. The primary outcome was peri-operative mortality after endovascular aneurysm repair (EVAR) and open surgical repair (OSR). Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: A total of 103 715 patients were included. The percentage of patients undergoing EVAR increased from 63.6% to 71.2% (p < .001) over the study period. This proportion varied by country from 35% in Hungary to 81% in the United States. Overall peri-operative mortality decreased from 2.1% to 1.6 % (p < .001). Mortality also declined significantly over time for both OSR 4.2% to 3.6 % (p = .002) and EVAR 1.0% to 0.7% (p = .002). Mortality was significantly higher for female than male patients (3.0% vs. 1.6% p < .001). The percentage of patients > 80 years old undergoing AAA repair remained constant at 23.6% (p = .91). Peri-operative mortality was higher for patients > 80 years than for those < 80 years old (2.7% vs. 1.6% p < .001). Forty-six per cent (n = 275) of all EVAR deaths occurred in the over 80s. CONCLUSION: The proportion of AAA repairs performed using EVAR has increased over time. Peri-operative mortality continues to decline for both OSR and EVAR. Outcomes however were significantly worse for both women and those aged over 80, so efforts should be focused on these patient groups to further reduce elective AAA mortality rates.