Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

Importance: The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing surveillance to capture rare adverse events and long-term safety issues. Objective: To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs), which have been the subject of safety concerns, using clinical data from a large health care system. Design, Setting, and Participants: This retrospective cohort study included patients with electronic health record (EHR) data in the Veterans Affairs Corporate Data Warehouse. Exposure: Implantation of an AFX Endovascular AAA System (AFX) device (any of 3 iterations) or a non-AFX comparator EVAR device from January 1, 2011, to December 21, 2021. Main Outcomes and Measures: The primary outcomes were rates of type III endoleaks and all-cause mortality; and rates of these outcomes associated with AFX devices compared with non-AFX devices, assessed using Cox proportional hazards regression models and doubly robust causal modeling. Information on type III endoleaks was available only as free-text mentions in clinical notes, while all-cause mortality data could be extracted using structured data. Device-specific information required by the FDA is ascertained using unique device identifiers (UDIs), which include factors such as model numbers, catalog numbers, and manufacturer-specific product codes. The availability of UDIs in EHRs was assessed. Results: In total, 13 941 patients (mean [SD] age, 71.8 [7.4] years) received 1 of the devices of interest (AFX with Strata [AFX-S]: 718 patients [5.2%]; AFX with Duraply [AFX-D]: 404 patients [2.9%]; or AFX2: 682 patients [4.9%]), and 12 137 (87.1%) received non-AFX devices. The UDIs were not recorded in the EHR for any patient with an AFX device, and partial UDIs were available for 19 patients (0.1%) with a non-AFX device. This necessitated the development of advanced natural language processing tools to define the cohort of patients for analysis. The study identified a significantly higher risk of type III endoleaks at 5 years among patients receiving any of the AFX device iterations, including the most recent version, AFX2 (11.6%; 95% CI, 8.1%-15.1%) compared with that among patients with non-AFX devices (5.7%; 95% CI, 2.2%-9.2%; absolute risk difference, 5.9%; 95% CI, 2.3%-9.4%). However, there was no significantly higher all-cause mortality for any of the AFX device iterations, including for AFX2 (19.0%; 95% CI, 16.0%-22.0%) compared with non-AFX devices (18.0%; 95% CI, 15.0%-21.0%; absolute risk difference, 1.0%; 95% CI, -2.1% to 4.1%). Conclusions and Relevance: The findings of this cohort study suggest that clinical data can be used for the postmarketing device surveillance required by the FDA. The study also highlights ongoing challenges to performing larger-scale surveillance, including lack of consistent use of UDIs and insufficient relevant structured data to efficiently capture certain outcomes of interest.

Evaluation of the prognostic value of computed tomography-derived body composition in patients undergoing endovascular aneurysm repair.

BACKGROUND: Endovascular aneurysm repair (EVAR) is the most common mode of repair of abdominal aortic aneurysms (AAA) in the UK. EVAR ranges from standard infrarenal repair to complex fenestrated and branched EVAR (F/B-EVAR). Sarcopenia is defined by lower muscle mass and function, which is associated with inferior perioperative outcomes. Computed tomography-derived body composition analysis offers prognostic value in patients with cancer. Several authors have evaluated the role of body composition analysis in predicting outcomes in patients undergoing EVAR; however, the evidence base is limited by heterogeneous methodology. METHODS: Six hundred seventy-four consecutive patients (58 (8.6%) female, mean (SD) age 74.4 (6.8) years) undergoing EVAR and F/B-EVAR at three large tertiary centres were retrospectively recruited. Subcutaneous and visceral fat indices (SFI and VFI), psoas and skeletal muscle indices, and skeletal muscle density were measured at the L3 vertebral level from pre-operative computed tomographies. The maximally selected rank statistic technique was used to define optimal thresholds to predict mortality. RESULTS: There were 191 deaths during the median follow-up period of 60.0 months. Mean (95% CI) survival in the low SMI versus high SMI subgroups was 62.6 (58.5-66.7) versus 82.0 (78.7-85.3) months (P < 0.001). Mean (95% CI) survival in the low SFI versus high SFI subgroups was 56.4 (48.2-64.7) versus 77.1 (74.2-80.1) months (P < 0.001). One-year mortality in the low SMI versus high SMI subgroups was 10% versus 3% (P < 0.001). Low SMI was associated with increased odds of one-year mortality (OR 3.19, 95% CI 1.60-6.34, P < 0.001). Five-year mortality in the low SMI versus high SMI subgroups was 55% versus 28% (P < 0.001). Low SMI was associated with increased odds of five-year mortality (OR 1.54, 95% CI 1.11-2.14, P < 0.01). On multivariate analysis of all patients, low SFI (HR 1.90, 95% CI 1.30-2.76, P < 0.001) and low SMI (HR 1.88, 95% CI 1.34-2.63, P < 0.001) were associated with poorer survival. On multivariate analysis of asymptomatic AAA patients, low SFI (HR 1.54, 95% CI 1.01-2.35, P < 0.05) and low SMI (HR 1.71, 95% CI 1.20-2.42, P < 0.01) were associated with poorer survival. CONCLUSIONS: Low SMI and SFI are associated with poorer long-term survival following EVAR and F/B-EVAR. The relationship between body composition and prognosis requires further evaluation, and external validation of the thresholds proposed in patients with AAA is required.

Resultados de cirugía de aneurisma abdominotorácico abierto mediante circulación extracorpórea parcial izquierda en un centro de bajo volumen / Results of open thoracoabdominal aneurysm repair with left partial cardiopulmonary bypass in a low-volume center

Introducción: la reparación abierta del aneurisma de aorta abdominotorácica (AATA) es técnicamente un reto, tanto desde el punto de vista quirúrgico como circulatorio, y en consecuencia conlleva un riesgo significativo de morbilidad y mortalidad operatorias. El objetivo de este estudio es analizar los resultados y las complicaciones de este tipo de intervenciones en nuestro centro. Métodos: se recogieron los antecedentes, los datos intraoperatorios y las complicaciones posoperatorias de pacientes tratados de aneurisma abdominotorácico abierto en un periodo de 15 años. Resultados: entre enero de 2005 y diciembre de 2019 se intervinieron un total de 27 pacientes por aneurisma abdominotorácico. 25 pacientes presentaban aneurisma y 2, disección crónica. 5 pacientes ya tenían realizada una cirugía aórtica previa: 2 fueron tratados de AAA mediante bypass aortoaórtico y aortobiilíaco, 2 pacientes por disección aórtica de tipo I mediante sustitución del arco aórtico y 1 por aneurisma de aorta torácica en el que se realizó TEVAR y bypass carótido-carotídeo y carótido-subclavio. La edad media fue de 66,5 ± 7,77 años y el 21 % fueron mujeres. En cuanto a la clasificación de Crawford de los aneurismas abdominotorácicos, 1 era del tipo I, 7 del tipo II, 9 del tipo III, 9 del tipo IV y 1 del tipo V. 23 intervenciones fueron de manera programada y 4, urgentes. Los AATA de tipo I, II, III y V se trataron mediante circulación extracorpórea parcial izquierda. La mortalidad total fue del 14,81 % y la programada, del 8,69 %. La incidencia de paraparesia posquirúrgica fue del 7,4 %. No hubo casos de paraplejia ni de ictus. La incidencia de infarto agudo de miocardio fue del 7,4 % y la de complicaciones respiratorias, del 48 %. La incidencia de insuficiencia renal aguda fue del 29,6 %. 5 de estos 8 pacientes requirieron hemodiálisis temporal.(AU)

Introduction: open TAA repair is technically challenging, both from a surgical and circulatory point of view, and consequently carries a significant risk of operative morbidity and mortality. The aim of this study is to analyze results and complications of this type of intervention in our center. Methods: demographic characteristics, intraoperative data and postoperative complications of patients who underwent open thoracoabdominal aneurysm repair were collected between January 2005 and December 2019 in our center. Results: a total of 27 patients underwent thoracoabdominal aneurysm surgery. 25 patients had aortic aneurysm and 2 chronic dissection. 5 patients had already undergone previous aortic intervention. The mean age was 66.5 ± 7,77 and 21% were women. Regarding Crawford's classification of thoracoabdominal aneurysms, there were 1 Type I, 7 Type II, 9 Type III, 9 Type IV, and 1 Type V. 23 patients were treated electively and 4 urgently. Types I, II, III, and V TAAA were treated with left partial cardiopulmonary bypass. Total mortality was 14.81 % and elective mortality was 8.69 %. The incidence of postsurgical paraparesis was 7.4 %. There were no cases of paraplegia or stroke. The incidence of acute myocardial infarction was 7.4 % and of pulmonary complications 48 %. The incidence of acute renal failure was 29.6 %. 5 of these eight patients required temporary hemodialysis. 1 patient presented postoperative visceral ischemia requiring left hemicolectomy. The median intensive care unit length of stay was 4 days and median hospital length of stay was 16 days. Conclusions: despite the complexity of open thoracoabdominal aneurysm surgery and the significant risk of complications, surgical repair with left partial cardiopulmonary bypass can be performed with acceptable results in a low-volume center.(AU)

Induction of CD73 prevents death after emergency open aortic surgery for a ruptured abdominal aortic aneurysm: a randomized, double-blind, placebo-controlled study.

Mortality remains high after emergency open surgery for a ruptured abdominal aortic aneurysm (RAAA). The aim of the present study was to assess, if intravenous (IV) Interferon (IFN) beta-1a improve survival after surgery by up-regulating Cluster of differentiation (CD73). This is a multi-center phase II double-blind, 2:1 randomized, parallel group comparison of the efficacy and safety of IV IFN beta-1a vs. placebo for the prevention of death after open surgery for an infra-renal RAAA. All study patients presented a confirmed infra-renal RAAA, survived the primary emergency surgery and were treated with IFN beta-1a (10 µg) or matching placebo for 6 days after surgery. Major exclusion criteria included fatal hemorrhagic shock, chronic renal replacement therapy, diagnosed liver cirrhosis, severe congestive heart failure, advanced malignant disease, primary attempt of endovascular aortic repair (EVAR), and per-operative suprarenal clamping over 30 min. Main outcome measure was all-cause mortality at day 30 (D30) from initial emergency aortic reconstruction. The study was pre-maturely stopped due to a reported drug-drug interaction and was left under-powered. Out of 40 randomized patients 38 were included in the outcome analyses (27 IFN beta-1a and 11 placebo). There was no statistically significant difference between treatment groups at baseline except more open-abdomen and intestinal ischemia was present in the IFN beta-1a arm. D30 all-cause mortality was 22.2% (6/27) in the IFN beta-1a arm and 18.2% (2/11) in the placebo arm (OR 1.30; 95% CI 0.21-8.19). The most common adverse event relating to the IFN beta-1a was pyrexia (20.7% in the IFN beta-1a arm vs. 9.1% in the placebo arm). Patients with high level of serum CD73 associated with survival (P = 0.001) whereas the use of glucocorticoids and the presence of IFN beta-1a neutralizing antibodies associated with a poor CD73 response and survival. The initial aim of the trial, if postoperative INF beta-1a treatment results on better RAAA survival, could not be demonstrated. Nonetheless the anticipated target mechanism up-regulation of CD73 was associated with 100% survival. According to present results the INF beta-1a induced up-regulation of serum CD73 was blocked with both use of glucocorticoids and serum IFN beta-1a neutralizing antibodies. The study was pre-maturely stopped due to interim analysis after a study concerning the use if IV IFN beta-1a in ARDS suggested that the concomitant use of glucocorticoids and IFN beta-1a block the CD73 induction. Trial registration: ClinicalTrials.gov NCT03119701. Registered 19/04/2017 (retrospectively registered).

A meta-analysis of safety and efficacy of endovascular aneurysm repair in aneurysm patients with severe angulated infrarenal neck.

OBJECTIVES: A growing number of abdominal aortic aneurysms with severe angulated neck anatomy is treated by endovascular means. However, contradictory early and late outcomes have been reported. Our review and outcome analysis attempted to evaluate the available literature and provide clinicians with a base for clinical implementation and future research. MATERIALS AND METHODS: A systematic review of the literature was undertaken to identify the outcomes of endovascular aneurysm repair in patients with severe infrarenal neck angulation (SNA ≥ 60°) vs non-severe neck angulation (NSNA). Outcome measures included perioperative complications, type 1a endoleak, neck-related secondary procedures, stent graft migration, aneurysm rupture, increase (>5mm) in sac diameter, all-cause and aneurysm-related mortality (PROSPERO Nr.: CRD42021233253). RESULTS: Six observational studies reporting on 5981 patients (1457 with SNA and 4524 with NSNA) with a weighted mean follow-up period of 1.8 years were included. EVAR in SNA compared with NSNA was associated with a higher rate of type 1a endoleak at 30 days (4.0% vs 1.8%; p< 0.00001), at 1 year (2.8% vs 1.9%; p<0.03), at 2 years (4.9% vs 2.1%; p< 0.0002), at 3 years (5.6% vs 2.6%; p< 0.0001). The rate of neck-related secondary procedures was significantly higher at 1 year (6.6% vs 3.9%; p<0.05) and at 3 years (13.1% vs 9%; p<0.05). Graft migration, aneurysm sack increase, aneurysm rupture and all-cause mortality were not statistically different at mid-term. CONCLUSIONS: The use of EVAR in severely angulated infrarenal aortic necks is associated with a high rate of early and mid-term complications. However, aortic related and all-causes mortality are not higher compared to patients with NSNA. Therefore, EVAR should be cautiously used in patients with SNA.

A stable aneurysm sac after endovascular aneurysm repair as a predictor for mortality: An in-depth analysis.

OBJECTIVE: The aim of the present study was to compare the long-term survival of patients with a stable aneurysm sac vs those with aneurysm sac regression after endovascular aneurysm repair (EVAR) and to identify the independent risk factors for aneurysm sac regression and mortality after EVAR. METHODS: We reviewed all the patients who had undergone EVAR from 2005 to 2018 with computed tomography angiography available at 1 year of follow-up. Aneurysm sac regression was defined as a diameter decrease of >10%. We used multivariable regression to identify the independent risk factors for sac regression. Kaplan-Meier analysis and Cox regression were performed to test the differences in 5-year mortality between a stable sac diameter and sac regression. RESULTS: The inclusion criteria were met by 325 patients, with 185 in the sac regression group and 140 in the stable sac group. Multivariable logistic regression analysis showed that treatment of a ruptured aneurysm was an independent risk factor for aneurysm sac regression (hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.07-0.96). Age (HR, 1.05; 95% CI, 1.01-1.09), ischemic heart disease (HR, 1.94; 95% CI, 1.13-3.31), neck thrombus (HR, 2.72; 95% CI, 1.07-6.95), and a type II endoleak (HR, 19.21; 95% CI, 7.32-50.40) were independent risk factors for a stable aneurysm sac diameter. Multivariable Cox regression showed a significantly increased risk of mortality for patients with a stable aneurysm sac after EVAR (odds ratio, 2.25; 95% CI, 1.36-3.72). No significant differences were found in cause of death between the two groups. CONCLUSIONS: A stable aneurysm sac after EVAR was associated with increased mortality. Age, ischemic heart disease, neck thrombus, and a type II endoleak were independent risk factors for a stable aneurysm sac. However, a well-founded explanation for this finding is still lacking. Future research should focus on aggressive treatment of type II endoleaks and inflammatory processes as potential pathophysiologic mechanisms.

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.

Intraoperative cone beam computed tomography to improve outcomes after infrarenal endovascular aortic repair.

OBJECTIVE: We evaluated whether a combination of intraoperative contrast-enhanced cone beam computed tomography (ceCBCT) and postoperative contrast-enhanced ultrasound (CEUS) after infrarenal endovascular abdominal aortic aneurysm repair (EVAR) could reduce late stent graft-related complications and, consequently, reintervention. METHODS: All consecutive patients who had received infrarenal bifurcated stent grafts in our hybrid room (IGS 730; GE Healthcare, Île-de-France, France) during two discrete periods were included in the present study. From November 2012 to September 2013, two-dimensional completion angiography was performed after each EVAR, followed by computed tomography angiography (CTA) before discharge (group 1). From October 2013 to January 2015, intraoperative ceCBCT was performed, followed by CEUS within the first postoperative days (group 2). Comparative analyses of the outcomes were performed. The primary endpoint was late stent graft-related complications, a composite factor incorporating aneurysm-related death, type I or III endoleaks, kink or occlusion of the iliac limb, and aortic sac enlargement after the first 30 postoperative days. The secondary endpoint was all stent graft-related reinterventions. All-cause and aneurysm-related deaths were also recorded. RESULTS: Overall, 100 consecutive patients (50 each in groups 1 and 2) were enrolled, with a median follow-up of 60 months (interquartile range, 41-69 months). At 60 months after the index procedure, the freedom from late stent graft-related complications in each group was 61.6% (95% confidence interval [CI], 47.0%-80.6%) for group 1 and 81.7% (95% CI, 70.1%-95.2%) for group 2 (P = .033). The use of intraoperative ceCBCT was independently associated with a reduced rate of late stent graft-related complications on multivariate analysis (hazard ratio, 0.39; 95% CI, 0.16-0.95; P = .038) but did not appear to significantly protect against stent graft-related reinterventions (hazard ratio, 0.53; 95% CI, 0.20-1.39; P = .198) or all-cause death (P = .47). CONCLUSIONS: To the best of our knowledge, the present study is the first to report the influence of routine ceCBCT on late outcomes after EVAR. The use of ceCBCT shows the potential for reducing late stent graft-related complications associated.

Any Postoperative Surveillance Improves Survival after Endovascular Repair of Ruptured Abdominal Aortic Aneurysms.

BACKGROUND: Endovascular aortic repair (EVAR) has advanced the care of patients with ruptured abdominal aortic aneurysms (rAAA) with improved early postoperative morbidity and mortality. However, this comes at the cost of a rigorous postoperative surveillance schedule to monitor for further aneurysmal degeneration. Adherence to surveillance recommendations is known to be poor in the elective setting, but has yet to be studied in the ruptured population. The aim of this study is to investigate predictors of incomplete surveillance after EVAR for rAAA (rEVAR) and examine how adherence impacts outcomes. METHODS: This was a retrospective case control study of patients undergoing rEVAR at a multiple hospital single healthcare center (2003-2020). Patients were excluded if they underwent open conversion during their index hospitalization or died within 60 days of surgery. Follow-up was broadly categorized as complete surveillance (60-day postoperative visit and annually thereafter) or incomplete surveillance, comprising both patients with less than recommended surveillance (minimal surveillance) and completely lost to follow-up (LTF). Any follow-up was defined as patients with complete or minimal surveillance. We investigated predictors of complete versus incomplete surveillance by multivariate logistic regression. Secondary outcomes included overall survival and cumulative incidence of reintervention controlling for the competing risk of mortality, generating hazard ratios (HR) and subdistribution hazard ratios (SHR). RESULTS: One-hundred and sixty patients (mean age 74 ± 10.1 years, 81.2% male) out of 673 total rAAA met study inclusion criteria. Complete surveillance was seen in 41.3% of our cohort, with the remainder with minimal surveillance (29.4%) or LTF (29.4%). Incomplete surveillance was associated with male sex (odds ratio [OR] 2.56; 95% CI 1.02-6.43), lack of a primary care provider (PCP; OR 0.20; 95% CI 0.04-0.99), and longer driving distance from home to treating hospital (OR 2.37; 95% CI 1.08-5.20). Survival was not different between complete and incomplete surveillance groups, however any follow-up conferred improved survival over LTF (HR 0.57; 95% CI 0.331-0.997; P = 0.049). Reintervention was associated with incomplete surveillance (SHR 0.29; 95% CI 0.11-0.75), and discharge to a facility (SHR 0.25; 95% CI 0.067-0.94). CONCLUSIONS: Incomplete surveillance was observed in over 50% of patients who underwent rEVAR and was associated with male sex, lack of PCP, and longer driving distance. Any follow-up conferred a survival benefit, yet incomplete surveillance was associated with a lower risk of reintervention. Targeted strategies to prevent LTF, and less stringent, personalized follow-up plans that may confer similar survival benefit with better patient adherence should be investigated.

Compensated Patient Injuries in the Treatment of Abdominal Aortic and Iliac Artery Aneurysms in Finland: A Nationwide Patient Insurance Registry Study.

OBJECTIVES: Patient injury claims data and insurance records provide detailed information on patient injuries. This study aimed to identify the errors and adverse events that led to patient injuries in vascular surgery for the treatments of abdominal aortic aneurysms (AAA) and iliac artery aneurysms (IAA) in Finland. The study also assessed the severity and preventability of the injuries. MATERIALS AND METHODS: A retrospective analysis of Finnish Patient Insurance Centre's insurance charts of compensated patient injuries in the treatment of AAA and IAA. Records of all compensated patient injury claims involving AAA and IAA between 2004 and 2017 inclusive were reviewed. Contributing factors to injury were identified and classified. The injuries were assessed for their preventability by using the WHO Surgical Safety Checklist correctly. The degree of harm was graded by Clavien-Dindo classification. RESULTS: Twenty-six patient injury incidents were identified in the treatment of 23 patients. Typical injuries involved delays in diagnosis or treatment, errors in surgical technique or injuries to adjacent anatomic organs. Three (13.0%) patients died due to patient injury. Two deaths were caused by delays in diagnosis of ruptured abdominal aortic aneurysm (RAAA) and the third death was due to missed diagnosis of post-operative myocardial infarction. Retained foreign material caused injuries to two (8.7%) patients. One (4.3%) patient had a severe postoperative infection. Three (13.0%) patients experienced an injury to an adjacent organ. One patient had a bilateral and another a unilateral above-the-knee amputation due to patient injury. Three injuries were considered preventable. Most harms were grade IIIb Clavien-Dindo classification in which injured patients required a surgical intervention under general anesthesia. CONCLUSIONS: Compensated patient injuries involving the treatment of AAA and IAA are rare, but are often serious. Injuries were identified during all stages of care. Most injuries involved open surgical procedures.

Frailty as a Predictor of Mortality for Fenestrated EVAR and Open Surgical Repair of Aortic Aneurysms Involving Visceral Vessels.

OBJECTIVES: Frailty has been correlated with poor outcomes after major surgery across multiple specialties, but has not been studied in patients undergoing open or endovascular repair of suprarenal and thoracoabdominal aortic aneurysms. Fenestrated endovascular aneurysm repair (FEVAR) has emerged as a lower risk alternative to open surgical repair (OSR) for patients with complex aortic aneurysms involving the visceral artery branches. The objective of the current study was to examine the relationship between frailty and peri-operative outcomes for FEVAR and OSR in patients with suprarenal and thoracoabdominal aortic aneurysms. METHODS: The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) database was used to identify patients who underwent FEVAR or OSR for the years 2011 through 2017. Frailty was quantified using a modified 5-factor frailty index (mFI-5) that was previously validated for surgical patients. Frailty was correlated with the primary endpoint of 30-day mortality. Logistic regression was used to identify predictors of 30-day mortality. RESULTS: A total of 675 FEVAR and 1,779 OSR operations were included in the analysis. The 30-day mortality rate was 3.0% for FEVAR and 7.1% for OSR (P = 0.002). Increasing frailty was significantly associated with higher 30-day mortality for both FEVAR (P = 0.018) and OSR (P = 0.0003). Independent predictors of 30-day mortality were frailty score (Odds Ratio [OR] 1.22 [per 0.1-unit increase]; P = 0.0005), type of repair (OSR versus FEVAR, OR 2.46; P = 0.0001), age (OR 1.03; P = 0.0025), female sex (OR 1.61; P = 0.007), Hispanic ethnicity (OR 2.68; P = 0.021), American Society of Anesthesiology [ASA] class (OR 1.57; P = 0.035), preoperative dialysis (OR 3.45; P = 0.032), and history of bleeding disorder (OR 2.60; P < 0.0001). CONCLUSIONS: Frailty, as measured using a mFI-5 score, is an independent predictor of 30-day mortality, overall complications, and length of stay after FEVAR or OSR. Frailty should be used to identify patients at high risk of adverse postoperative outcomes to determine if this risk is modifiable or whether nonoperative is the most appropriate option. FEVAR may offer improved 30-day outcomes, compared to OSR, for the frailest patients.

A systematic review and meta-analysis on early mortality after abdominal aortic aneurysm repair in females in urgent and elective settings.

OBJECTIVE: Females represent a group of patients with higher mortality after abdominal aortic aneurysm (AAA), endovascular (EVAR), or open surgical (OSR), repair. This systematic review aimed to evaluate the 30-day mortality after AAA repair in females, comparing both EVAR and OSR, in elective and urgent settings. METHODS: The protocol of the review was registered to the PROSPERO database (CRD42021242686). A search of the English literature was conducted, using PubMed, EMBASE, and CENTRAL databases, from inception to March 5, 2021, using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines (PRISMA). Only studies reporting on 30-day mortality of AAA repair, in urgent and elective settings, comparing EVAR and OSR, in the female population were eligible. Patients were stratified according to the need for elective or urgent repair. Symptomatic and ruptured cases were included into the urgent group. Individual studies were assessed for risk of bias using the (Risk Of Bias In Non-randomised Studies - of Interventions) ROBINS-I tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to evaluate the quality of evidence. The primary outcome was 30-day mortality after AAA repair in the female population, comparing EVAR and OSR. The outcomes were summarized as odds ratio, along with their 95% confidence intervals (CIs), through a paired meta-analysis. RESULTS: Eight studies reported data on 30-day mortality following AAA repair. A total of 56,982 females (22,995 EVAR vs 33,987 OSR) were included. A significantly reduced total 30-day mortality rate was recorded among females that underwent EVAR compared with OSR (odds ratio [OR], 0.25; 95% CI, 0.23-0.27; P < .001; Ι2 = 86%). In addition, a reduced 30-day mortality was found in females that underwent elective EVAR compared with OSR (OR, 0.37; 95% CI, 0.33-0.41; P < .001; Ι2 = 48%). Despite the fact that OSR was more frequently offered in the urgent setting (OR, 0.21; 95% CI, 0.19-0.23; P < .001; Ι2 = 84%), EVAR was associated with a reduced 30-day mortality (OR, 0.48; 95% CI, 0.40-0.57; P < .001; Ι2 = 0%). CONCLUSIONS: In females, EVAR is associated with lower 30-day mortality in both elective and urgent AAA repair, although it appears as less likely to be offered in the setting of urgent AAA repair.

Incidence, predictive factors, and outcomes of intraprocedure adverse events during fenestrated-branched endovascular aortic repair of complex abdominal and thoracoabdominal aortic aneurysms.

OBJECTIVE: To evaluate the incidence of intraoperative adverse events (IAEs) and their impact on outcomes after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysm (TAAAs). METHODS: We reviewed the clinical and imaging data of 600 consecutive patients (445 males; mean age, 75 ± 8 years) who underwent FB-EVAR between 2007 and 2019 in a single institution. IAE was defined as any intraoperative complication or technical problem requiring additional and unplanned procedures, and was classified as access-related, target artery (TA)-related, or graft-related. End points included rates of IAEs, 30-day or in-hospital mortality, major adverse events, patient survival, freedom from secondary intervention, and TA instability. RESULTS: A total of 122 IAEs were identified in 105 patients (18%). IAEs were TA-related in 55 patients (9%), access-related in 46 patients (8%), and graft-related in seven patients (1%). Female sex was more frequent among patients with IAEs (44% vs 22%; P < .001). Patients with IAEs had smaller renal artery diameter (-0.4 mm, 5.4 ± 0.8 mm vs 5.8 ± 0.9 mm; P < .001), and were treated more often for TAAAs (72% vs 54%; P < .03). Technical success was achieved in 96.5% of patients and was lower for patients with IAEs (82% vs 99%; P < .001). Major adverse events were significantly more frequent among patients who had IAEs (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.21-3.25), most due to acute kidney injury (27% vs 11%; P < .001) including new-onset dialysis (5% vs 1%; P = .01). On multivariate logistic regression model, female sex (OR, 2.5; 95% CI, 1.5-4.0), TA stenosis >50% (OR, 2.0; 95% CI, 1.3-3.3), and Crawford Extent II TAAA (OR, 1.9; 95% CI, 1.1-3.3) were predictive of IAEs, whereas preloaded design (OR, 0.6; 95% CI, 0.4-0.9) and TA diameter (+1 mm; OR, 0.6; 95% CI, 0.4-0.9) were protective of IAEs. IAEs negatively affected secondary intervention (hazard ratio [HR], 1.6; 95% CI, 1.1-2.3) and TA instability (HR, 2.5; 95% CI, 1.2-5.4); however, IAEs did not affect patient survival (HR, 1.0; 95% CI, 0.7-1.4). CONCLUSIONS: IAEs are common, occurring in nearly one of five patients treated with FB-EVAR for complex aortic aneurysms, and have a negative impact on clinical outcomes. IAEs were associated with female sex, TA diameter, and more extensive aortic disease.

Surgeon volume and established hospital perioperative mortality rate together predict for superior outcomes after open abdominal aortic aneurysm repair.

BACKGROUND: In 2018, the Society for Vascular Surgery (SVS) published hospital volume guidelines for elective open abdominal aortic aneurysm (AAA) repair, recommending that elective open surgical repair of AAAs should be performed at centers with an annual volume of ≥10 open aortic operations of any type and a documented perioperative mortality of ≤5%. Recent work has suggested a yearly surgeon volume of at least seven open aortic cases for improved outcomes. The objective of the present study was to assess the importance of hospital volume and surgeon volume at these cut points for predicting 1-year mortality after open surgical repair of AAAs. METHODS: We evaluated patients who had undergone elective open AAA repair using the New York Statewide Planning and Research Cooperative System database from 2003 to 2014. The effect of the SVS guidelines on postoperative mortality and complications was evaluated. Confounding between the hospital and surgeon volumes was identified using mixed effects multivariate Cox proportional hazards analysis. The effect of the interactions between hospital volume, established hospital perioperative survival, and surgeon volume on postoperative outcomes was also investigated. RESULTS: The cohort consisted of 7594 elective open AAA repairs performed by 542 surgeons in 137 hospitals during the 12-year study period. Analysis of the 2018 guidelines using the Statewide Planning and Research Cooperative System database revealed 1-year and 30-day mortality rates of 9.2% (range, 8.3%-10.1%) and 3.5% (range, 2.9%-4.1%) for centers that were within the SVS guidelines and 13.6% (range, 12.5%-14.7%) and 6.9% (range, 6.1%-7.8%) for those that were outside the guidelines, respectively (P < .001 for both). Multivariate survival analysis revealed a hazard ratio for a surgeon volume of ≥7, hospital volume of ≥10, and hospital 3-year perioperative mortality of ≤5% of 0.80 (95% confidence interval [CI], 0.70-0.93; P = .003), 0.91 (95% CI, 0.77-1.08; P = .298), and 0.72 (95% CI, 0.62-0.82; P < .001), respectively. Additionally, procedures performed by surgeons with a yearly average volume of open aortic operations of at least seven and at hospitals with an established elective open AAA repair perioperative mortality rate of ≤5% showed improved 1-year (33.2% relative risk reduction; P < .001) and 30-day (P = .001) all-cause survival and improved postoperative complication rates. CONCLUSIONS: These data have demonstrated that centers that meet the SVS AAA volume guidelines are associated with improved 1-year and 30-day all-cause survival. However, the results were confounded by surgeon volume. A surgeon open aortic volume of at least seven procedures and an established hospital perioperative mortality of ≤5% each independently predicted for 1-year survival after open AAA repair, with the hospital volume less important. These results indicate that surgeons with an annual volume of at least seven open aortic operations of any type should perform elective open AAA repair at centers with a documented perioperative mortality of ≤5%.

Mid-Term Outcomes of Chimney Endovascular Aortic Aneurysm Repair: A Systematic Review and Meta-analysis.

BACKGROUND: To provide an overview of the literature on the mid-term outcomes of chimney EVAR (ChEVAR) for the treatment of juxtarenal abdominal aortic aneurysms (JAAA). METHODS: Different electronic databases were searched for published articles up to January 2020. The eligibility criteria were studies describing mid- or long-term outcomes of chimney EVAR (mean follow-up at least 1 year) for treatment of JAAA, including more than 10 cases, published in English, and with full text available. The outcomes measure were overall survival rate, target vessel patency, and freedom from reintervention at 3 years. Quality of the included studies was analyzed using the MINORS criteria. Pooled effect estimates were analyzed using random-effect models and heterogeneity was tested using I2 statistics. RESULTS: Thirteen articles met the inclusion criteria. The included studies described 1,019 patients. According to the quality assessment, methodological quality was moderate to poor. The pooled overall survival, freedom from reintervention, and target vessel patency at 3 year was 81.4 % (95%CI 73.8-87.9), 85.7% (95%CI 75.6-93.5), and 95.1% (95%CI 89.3-98.7) respectively. CONCLUSIONS: The results of this review show good to acceptable short and mid-term survival and good mid-term durability, which supports that ChEVAR as a suitable alternative in high-risk JAAA. However, proper patient selection for ChEVAR seems essential to attain good mid-term outcomes, and further large prospective and good quality studies are required to demonstrate its long-term results and enable conclusions on specific determinants for outcome.

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.

Outcomes and Predictors of Mortality in a Belgian Population of Patients Admitted with Ruptured Abdominal Aortic Aneurysm and Treated by Open Repair in the Contemporary Era.

BACKGROUND: Abdominal aortic aneurysm (AAA) rupture is a serious condition that results in extremely high mortality rates. Some improvements in outcome have been reported during the last 2 decades. The objective of the present study was to determine the overall and operative (by open repair) mortality related to ruptured AAA in the contemporary era and to identify preoperative, intraoperative, and early postoperative parameters associated with poor outcomes. METHODS: We performed a retrospective review of all consecutive patients admitted to our single institution with a diagnosis of ruptured AAA between 2004 and 2013. A total of 103 parameters, including demographic characteristics, medical history, clinical and biological parameters, cardiovascular risk factors, emergency level, diagnostic modalities, time from symptoms to diagnosis and treatment, type of operative procedure and postoperative complications, were analyzed. The primary endpoint considered in this study was the cumulative incidence rate of mortality. The secondary endpoint was the identification, by logistic regression methods, of risk factors for overall mortality as well as for operative, and postoperative mortality. RESULTS: Within our study period, 104 patients were admitted for a ruptured AAA. The majority of patients (84.6%) were male, and the AAA was known in 34.6% of the patients. Rupture occurred for a maximal diameter lower than 55 mm in 25% of the female population, compared to 5.7% of the male population (P = 0.030). The proportions of admitted patients who died before (preoperative mortality), during (intraoperative mortality) or after (postoperative hospital mortality) surgery was 17.3%, 16.3%, and 18.3%, respectively, yielding a cumulative in-hospital mortality of 51.9%. In the multivariate analysis, age ≥ 80 (P = 0.001), myocardial ischemia on the admission ECG (P = 0.046), and management by the physician response unit (P = 0.002) were the only preoperative parameters associated with a higher risk of hospital mortality. Four risk factors were found to be associated with a higher risk of postoperative mortality in the multivariate analysis, and all patients presenting with 3 or more of these risk factors (n = 5) died. CONCLUSIONS: The overall mortality of ruptured AAA in a contemporary cohort of patients who underwent open repair remains high and does not seem to have decreased during recent decades. Ruptures occur at smaller diameters in women than in men, supporting a lower threshold for intervention in women with known AAA. We developed risk scores to predict the mortality of patients with rAAA at different times of their hospital course. The validity of these scores should be assessed in prospective clinical studies.