The association of ruptured abdominal aortic aneurysm diameter with mortality in the International Consortium of Vascular Registries.

BACKGROUND: The mortality after ruptured abdominal aortic aneurysm (rAAA) repair is high, despite improvements in perioperative care, centralization of emergency vascular surgical services, and the introduction of endovascular aneurysm repair (EVAR). The diameter of intact AAA has been shown to be a predictor of short- and long-term survival. The aim of this study was to analyze the impact of AAA diameter on mortality for rAAA repair using contemporary data collected from the International Consortium of Vascular Registries and compare outcomes by sex and the type of repair patients received. METHODS: Prospective registry data on repair of rAAA from seven countries were collected from 2010 to 2016. The primary outcome was perioperative mortality after EVAR and open surgical repair (OSR). Data were stratified by type of repair and sex. Logistic regression models were used to estimate odds ratio (OR) for the association between AAA diameter and perioperative mortality and the association between type of repair and mortality. Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: The study population consisted of 6428 patients with a mean age ranging from 70.2 to 75.4 years; the mean AAA diameter was 7.7 ± 1.8 cm. Females had a significantly smaller AAA diameter at presentation compared with males (6.9 ± 1.6 cm vs 7.9 ± 1.8 cm; P < .001). who underwent OSR had larger AAA diameters compared with those who underwent EVAR (P < .001). Females who underwent repair were significantly older (P < .001). Males were more likely to have cardiac disease, diabetes mellitus, and renal impairment. Overall, AAA diameter was a predictor of mortality in univariate and multivariate analysis. When analyzing EVAR and OSR separately, the impact of AAA diameter per cm increase on mortality was apparent in both males and females undergoing EVAR, but not OSR (EVAR: male OR, 1.09 [95% confidence interval, 1.03-1.16] and EVAR: female OR, 1.17 [95% confidence interval, 1.02-1.35]). The early mortality rate for males and females who underwent EVAR was 18.9% and 25.9% (P < .001), respectively. The corresponding mortality for males and females who underwent OSR was 30.2% and 38.6% (P < .001), respectively. CONCLUSIONS: In these real-world international data, there is a significant association between rAAA diameters and early mortality in males and females. This association was more evident in patients undergoing EVAR, but not shown in OSR. Despite improvements in overall AAA repair outcomes, the risk of mortality after rAAA repair is consistently higher for females.

Outcomes Following Intact and Ruptured Aneurysm Repair across Nations: Analysis of International Registry Data from the VASCUNET Collaboration 2014 - 2019.

OBJECTIVE: To determine the peri-operative mortality rate for intact and ruptured abdominal aortic aneurysm (AAA) repair in 10 countries and to compare practice and outcomes over a six year period by age, sex, and geographic location. METHODS: This VASCUNET study used prospectively collected data from vascular registries in 10 countries on primary repair of intact and ruptured AAAs undertaken between January 2014 and December 2019. The primary outcome was peri-operative death (30 day or in hospital). Logistic regression models were used to estimate the association between peri-operative death, patient characteristics, and type of procedure. Factors associated with the use of endovascular aortic aneurysm repair (EVAR) were also evaluated. RESULTS: The analysis included 50 642 intact and 9 453 ruptured AAA repairs. The proportion of EVARs for intact repairs increased from 63.4% in 2014 to 67.3% in 2016 before falling to 62.3% in 2019 (p < .001), but practice varied between countries. EVAR procedures were more common among older patients (p < .001) and men (p < .001). Overall peri-operative mortality after intact AAA repair was 1.4% (95% confidence interval [CI] 1.3 - 1.5%) and did not change over time. Mortality rates were stable within countries. Among ruptured AAA repairs, the proportion of EVARs increased from 23.7% in 2014 to 35.2% in 2019 (p < .001). The average aortic diameter was 7.8 cm for men and 7.0 cm for women (p < .001). The overall peri-operative mortality rate was 31.3% (95% CI 30.4 - 32.2%); the rates were 36.0% (95% CI 34.9 - 37.2%) for open repair and 19.7% (95% CI 18.2 - 21.3%) for EVAR. This difference and shift to EVAR reduced peri-operative mortality from 32.6% (in 2014) to 28.7% (in 2019). CONCLUSION: The international practice of intact AAA repair was associated with low mortality rates in registry reported data. There remains variation in the use of EVAR for intact AAAs across countries. Overall peri-operative mortality remains high after ruptured AAA, but an increased use of EVAR has reduced rates over time.

Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.

AIMS: Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. METHODS AND RESULTS: Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints. CONCLUSION: Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.

Factors associated with successful median arcuate ligament release in an international, multi-institutional cohort.

OBJECTIVE: Prior research on median arcuate ligament syndrome has been limited to institutional case series, making the optimal approach to median arcuate ligament release (MALR) and resulting outcomes unclear. In the present study, we compared the outcomes of different approaches to MALR and determined the predictors of long-term treatment failure. METHODS: The Vascular Low Frequency Disease Consortium is an international, multi-institutional research consortium. Data on open, laparoscopic, and robotic MALR performed from 2000 to 2020 were gathered. The primary outcome was treatment failure, defined as no improvement in median arcuate ligament syndrome symptoms after MALR or symptom recurrence between MALR and the last clinical follow-up. RESULTS: For 516 patients treated at 24 institutions, open, laparoscopic, and robotic MALR had been performed in 227 (44.0%), 235 (45.5%), and 54 (10.5%) patients, respectively. Perioperative complications (ileus, cardiac, and wound complications; readmissions; unplanned procedures) occurred in 19.2% (open, 30.0%; laparoscopic, 8.9%; robotic, 18.5%; P < .001). The median follow-up was 1.59 years (interquartile range, 0.38-4.35 years). For the 488 patients with follow-up data available, 287 (58.8%) had had full relief, 119 (24.4%) had had partial relief, and 82 (16.8%) had derived no benefit from MALR. The 1- and 3-year freedom from treatment failure for the overall cohort was 63.8% (95% confidence interval [CI], 59.0%-68.3%) and 51.9% (95% CI, 46.1%-57.3%), respectively. The factors associated with an increased hazard of treatment failure on multivariable analysis included robotic MALR (hazard ratio [HR], 1.73; 95% CI, 1.16-2.59; P = .007), a history of gastroparesis (HR, 1.83; 95% CI, 1.09-3.09; P = .023), abdominal cancer (HR, 10.3; 95% CI, 3.06-34.6; P < .001), dysphagia and/or odynophagia (HR, 2.44; 95% CI, 1.27-4.69; P = .008), no relief from a celiac plexus block (HR, 2.18; 95% CI, 1.00-4.72; P = .049), and an increasing number of preoperative pain locations (HR, 1.12 per location; 95% CI, 1.00-1.25; P = .042). The factors associated with a lower hazard included increasing age (HR, 0.99 per increasing year; 95% CI, 0.98-1.0; P = .012) and an increasing number of preoperative diagnostic gastrointestinal studies (HR, 0.84 per study; 95% CI, 0.74-0.96; P = .012) Open and laparoscopic MALR resulted in similar long-term freedom from treatment failure. No radiographic parameters were associated with differences in treatment failure. CONCLUSIONS: No difference was found in long-term failure after open vs laparoscopic MALR; however, open release was associated with higher perioperative morbidity. These results support the use of a preoperative celiac plexus block to aid in patient selection. Operative candidates for MALR should be counseled regarding the factors associated with treatment failure and the relatively high overall rate of treatment failure.

Contemporary outcomes after treatment of aberrant subclavian artery and Kommerell's diverticulum.

OBJECTIVE: Aberrant subclavian artery (ASA) and Kommerell's diverticulum (KD) are rare vascular anomalies that may be associated with lifestyle-limiting and life-threatening complications. The aim of this study is to report contemporary outcomes after invasive treatment of ASA/KD using a large international dataset. METHODS: Patients who underwent treatment for ASA/KD (2000-2020) were identified through the Vascular Low Frequency Disease Consortium, a multi-institutional collaboration to investigate uncommon vascular disorders. We report the early and mid-term clinical outcomes including stroke and mortality, technical success, and other operative outcomes including reintervention rates, patency, and endoleak. RESULTS: Overall, 285 patients were identified during the study period. The mean patient age was 57 years; 47% were female and 68% presented with symptoms. A right-sided arch was present in 23%. The mean KD diameter was 47.4 mm (range, 13.0-108.0 mm). The most common indication for treatment was symptoms (59%), followed by aneurysm size (38%). The most common symptom reported was dysphagia (44%). A ruptured KD was treated in 4.2% of cases, with a mean diameter of 43.9 mm (range, 18.0-100.0 mm). An open procedure was performed in 101 cases (36%); the most common approach was ASA ligation with subclavian transposition. An endovascular or hybrid approach was performed in 184 patients (64%); the most common approach was thoracic endograft and carotid-subclavian bypass. A staged operative strategy was employed more often than single setting repair (55% vs 45%). Compared with endovascular or hybrid approach, those in the open procedure group were more likely to be younger (49 years vs 61 years; P < .0001), female (64% vs 36%; P < .0001), and symptomatic (85% vs 59%; P < .0001). Complete or partial symptomatic relief at 1 year after intervention was 82.6%. There was no association between modality of treatment and symptom relief (open 87.2% vs endovascular or hybrid approach 78.9%; P = .13). After the intervention, 11 subclavian occlusions (4.5%) occurred; 3 were successfully thrombectomized resulting in a primary and secondary patency of 95% and 96%, respectively, at a median follow-up of 39 months. Among the 33 reinterventions (12%), the majority were performed for endoleak (36%), and more reinterventions occurred in the endovascular or hybrid approach than open procedure group (15% vs 6%; P = .02). The overall survival rate was 87.3% at a median follow-up of 41 months. The 30-day stroke and death rates were 4.2% and 4.9%, respectively. Urgent or emergent presentation was independently associated with increased risk of 30-day mortality (odds ratio [OR], 19.8; 95% confidence interval [CI], 3.3-116.6), overall mortality (OR, 3.6; 95% CI, 1.2-11.2) and intraoperative complications (OR, 8.3; 95% CI, 2.8-25.1). Females had a higher risk of reintervention (OR, 2.6; 95% CI, 1.0-6.5). At an aneurysm size of 44.4 mm, receiver operator characteristic curve analysis suggested that 60% of patients would have symptoms. CONCLUSIONS: Treatment of ASA/KD can be performed safely with low rates of mortality, stroke and reintervention and high rates of symptomatic relief, regardless of the repair strategy. Symptomatic and urgent operations were associated with worse outcomes in general, and female gender was associated with a higher likelihood of reintervention. Given the worse overall outcomes when symptomatic and the inherent risk of rupture, consideration of repair at 40 mm is reasonable in most patients. ASA/KD can be repaired in asymptomatic patients with excellent outcomes and young healthy patients may be considered better candidates for open approaches versus endovascular or hybrid modalities, given the lower likelihood of reintervention and lower early mortality rate.

Editor's Choice - Infective Native Aortic Aneurysms: A Delphi Consensus Document on Terminology, Definition, Classification, Diagnosis, and Reporting Standards.

OBJECTIVE: There is no consensus regarding the terminology, definition, classification, diagnostic criteria, and algorithm, or reporting standards for the disease of infective native aortic aneurysm (INAA), previously known as mycotic aneurysm. The aim of this study was to establish this by performing a consensus study. METHODS: The Delphi methodology was used. Thirty-seven international experts were invited via mail to participate. Four two week Delphi rounds were performed, using an online questionnaire, initially with 22 statements and nine reporting items. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements revised, and results presented in iterative rounds. Consensus was defined as ≥ 75% of the panel selecting "strongly agree" or "agree" on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha coefficient > .80. RESULTS: All 38 panellists completed all four rounds, resulting in 100% participation and agreement that this study was necessary, and the term INAA was agreed to be optimal. Three more statements were added based on the results and comments of the panel, resulting in a final 25 statements and nine reporting items. All 25 statements reached an agreement of ≥ 87%, and all nine reporting items reached an agreement of 100%. The Cronbach's alpha increased for each consecutive round (round 1 = .84, round 2 = .87, round 3 = .90, and round 4 = .92). Thus, consensus was reached for all statements and reporting items. CONCLUSION: This Delphi study established the first consensus document on INAA regarding terminology, definition, classification, diagnostic criteria, and algorithm, as well as reporting standards. The results of this study create essential conditions for scientific research on this disease. The presented consensus will need future amendments in accordance with newly acquired knowledge.

International Multi-Institutional Experience with Presentation and Management of Aortic Arch Laterality in Aberrant Subclavian Artery and Kommerell's Diverticulum.

BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch. METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions. RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change. CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.

Thoracic Endovascular Aortic Repair Practice in 13 Countries: A Report From VASCUNET and the International Consortium of Vascular Registries.

OBJECTIVE: To assess practice patterns and short-term outcome after thoracic endovascular aortic repair (TEVAR), based on an international vascular registry collaboration. SUMMARY BACKGROUND DATA: TEVAR has become the primary surgical treatment modality for descending aortic pathologies, and has expanded to new patient cohorts, including the elderly. METHODS: Data on thoracic aortic aneurysms (TAA), type B aortic dissections (TBAD), and traumatic aortic injuries (TAI) treated with TEVAR from 2012 to 2016 were retrieved from registries and centers in 13 countries. RESULTS: Nine-thousand five-hundred eighteen TEVAR for TAA ( n = 4436), TBAD ( n = 3976) and TAI ( n = 1106) were included. The distribution of TEVAR procedures per pathology varied, with TAA repair constituting from 40% of TEVARs in the US to 72% in the UK ( P < 0.001).Mean intact TAA (iTAA) diameter varied from 59 (US) to 69 mm (Nancy, France) ( P < 0.001), 25.3% of patients having a diameter of <60 mm. Perioperative mortality after iTAA repair was 4.9%; combined mortality, stroke, paraplegia, and renal replacement therapy outcome was 12.8%. 18.6% of iTAA patients were ≥80 years old. Mortality was higher in this group (7.2%) than in patients <80 (3.8%) ( P < 0.001). After rTAA repair, perioperative mortality was 26.8%.Mortality was 9.7% after acute (within 14 days from onset of dissection) and 3.0% after chronic TBAD repair ( P < 0.001). Mortality after TAI was 7.8%, and depended on injury severity (grade IV (free rupture) 20.9%). CONCLUSIONS: This registry collaboration provides a unique platform to evaluate cross-border patterns of use and outcomes of TEVAR. A common core dataset is proposed, to achieve harmonization of registry-based quality outcome measures for TEVAR.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

High Level of Unwarranted Clinical Variation in the Use of Lower Extremity Revascularisation Procedures in Hungary (2013-2017).

OBJECTIVE: Assessment of variations in the use of lower extremity open vascular surgical procedures (LEOPEN) and lower extremity endovascular procedures (LEENDO) across small geographic areas in Hungary from 2013 to 2017. Introduction of a new metric giving a rough estimate of unwarranted clinical variation in revascularisation practice. METHODS: Spatial variation (at local administrative unit level) of referral for LEOPEN and LEENDO was evaluated through a retrospective analysis using healthcare administrative data of all beneficiaries in Hungary. The same assessment was performed for percutaneous coronary intervention in acute myocardial infarction (PCIAMI). The latter was considered a reasonable comparator (similar at risk population, well organised, guideline driven patient pathways, small room for referral discretion). Consequently, the ratio of spatial variations of LEOPEN and LEENDO to PCIAMI (as a reference) are thought to reflect unwarranted clinical variation. RESULTS: A total of 109 882 procedures were identified in the database (LEOPEN, LEENDO, PCIAMI) affecting 85 083 patients. While estimates of spatial variations for LEOPEN and LEENDO turned out to be high (systematic component of variation [SCV] 0.09 and 0.21, respectively), PCIAMI showed a low SCV value of 0.02. Consequently, the ratios of SCVs were SCV/SCVref = 4.67 (LEOPEN) and SCV/SCVref = 10.3 (LEENDO), indicating high levels of unwarranted clinical variation. CONCLUSION: The analysis showed that patients living in different locations of Hungary face very different odds of having lower extremity revascularisation procedures (open or endovascular). This spatial variation is thought to be related mainly to the failure in vascular service organisation. The newly introduced numerical estimate of unwarranted clinical variation may support within, and also between, system comparisons.

Association Between Hospital Volume and Failure to Rescue After Open or Endovascular Repair of Intact Abdominal Aortic Aneurysms in the VASCUNET and International Consortium of Vascular Registries.

OBJECTIVE: To investigate the association between hospital volume and failure to rescue (FtR), after open repair (OAR), and endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) among centers participating in the VASCUNET and International Consortium of Vascular Registries. SUMMARY OF BACKGROUND DATA: FtR (ie, in-hospital death following major complications) is a composite end-point representing the inability to treat complications effectively and prevent death. METHODS: Using data from 8 vascular registries, complication and mortality rates after intact AAA repair were examined (n = 60,273; EVAR-43,668; OAR-16,605). A restricted analysis using pooled data from 4 countries (Australia, Hungary, New Zealand, and USA) reporting data on all postoperative complications (bleeding, stroke, cardiac, respiratory, renal, colonic ischemia) was performed to identify risk-adjusted association between hospital volume and FtR. RESULTS: The most frequently reported complications were cardiac (EVAR-3.0%, OAR-8.9%) and respiratory (EVAR-1.0%, OAR-5.7%). In adjusted analysis, 4.3% of EVARs and 18.5% of OARs had at least 1 complication. The overall FtR rate was 10.3% after EVAR and 15.7% after OAR. Subjects treated in the highest volume centers (Q4) had 46% and 80% lower odds of FtR after EVAR (OR = 0.54; 95% CI = 0.34-0.87; P = 0.04) and OAR (OR = 0.22; 95% CI = 0.11-0.44; P < 0.001) when compared to lowest volume centers (Q1), respectively. Colonic ischemia had the highest risk of FtR for both procedures (adjusted predicted risks, EVAR: 27%, 95% CI 14%-45%; OAR: 30%, 95% CI 17%-46%). CONCLUSIONS: In this multi-national dataset, FtR rate after intact AAA repair with EVAR and OAR is significantly associated with hospital volume. Hospitals in the top volume quartiles achieve the lowest mortality after a complication has occurred.

In situ bypass and extra-anatomic bypass procedures result in similar survival in patients with secondary aortoenteric fistulas.

OBJECTIVE: The optimal revascularization modality in secondary aortoenteric fistula (SAEF) remains unclear in the literature. The purpose of this investigation was to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients with SAEF. METHODS: A retrospective, multi-institutional study of SAEF from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and operative and postoperative variables were recorded. The primary outcome was long-term mortality. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariate analyses were performed. RESULTS: During the study period, 182 patients at 34 institutions from 11 countries presented with SAEF (median age, 72 years; 79% male). The initial aortic procedures that resulted in SAEF were 138 surgical grafts (76%) and 42 endografts (23%), with 2 unknown; 102 of the SAEFs (56%) underwent complete excision of infected aortic graft material, followed by in situ (in-line) bypass (ISB), including antibiotic-soaked prosthetic graft (53), autogenous femoral vein (neoaortoiliac surgery; 17), cryopreserved allograft (28), and untreated prosthetic grafts (4). There were 80 patients (44%) who underwent extra-anatomic bypass (EAB) with infected graft excision. Overall median Kaplan-Meier estimated survival was 319 days (interquartile range, 20-2410 days). Stratified by EAB vs ISB, there was no significant difference in Kaplan-Meier estimated survival (P = .82). In comparing EAB vs ISB, EAB patients were older (74 vs 70 years; P = .01), had less operative hemorrhage (1200 mL vs 2000 mL; P = .04), were more likely to initiate dialysis within 30 days postoperatively (15% vs 5%; P = .02), and were less likely to experience aorta-related hemorrhage within 30 days postoperatively (3% aortic stump dehiscence vs 11% anastomotic rupture; P = .03). There were otherwise no significant differences in presentation, comorbidities, and intraoperative or postoperative variables. Multivariable Cox regression showed that the duration of antibiotic use (hazard ratio, 0.92; 95% confidence interval, 0.86-0.98; P = .01) and rifampin use at time of discharge (hazard ratio, 0.20; 95% confidence interval, 0.05-0.86; P = .03) independently decreased mortality. CONCLUSIONS: These data suggest that ISB does not offer a survival advantage compared with EAB and does not decrease the risk of postoperative aorta-related hemorrhage. After repair, <50% of SAEF patients survive 10 months. Each week of antibiotic use decreases mortality by 8%. Further study with risk modeling is imperative for this population.

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.

Editor's Choice - Optimal Threshold for the Volume-Outcome Relationship After Open AAA Repair in the Endovascular Era: Analysis of the International Consortium of Vascular Registries.

OBJECTIVE: As open abdominal aortic aneurysm (AAA) repair (OAR) rates decline in the endovascular era, the endorsement of minimum volume thresholds for OAR is increasingly controversial, as this may affect credentialing and training. The purpose of this analysis was to identify an optimal centre volume threshold that is associated with the most significant mortality reduction after OAR, and to determine how this reflects contemporary practice. METHODS: This was an observational study of OARs performed in 11 countries (2010 - 2016) within the International Consortium of Vascular Registry database (n = 178 302). The primary endpoint was post-operative in hospital mortality. Two different methodologies (area under the receiving operating curve optimisation and Markov chain Monte Carlo procedure) were used to determine the optimal centre volume threshold associated with the most significant mortality improvement. RESULTS: In total, 154 912 (86.9%) intact and 23 390 (13.1%) ruptured AAAs were analysed. The majority (63.1%; n = 112 557) underwent endovascular repair (EVAR) (OAR 36.9%; n = 65 745). A significant inverse relationship between increasing centre volume and lower peri-operative mortality after intact and ruptured OAR was evident (p < .001) but not with EVAR. An annual centre volume of between 13 and 16 procedures per year was associated with the most significant mortality reduction after intact OAR (adjusted predicted mortality < 13 procedures/year 4.6% [95% confidence interval 4.0% - 5.2%] vs. ≥ 13 procedures/year 3.1% [95% CI 2.8% - 3.5%]). With the increasing adoption of EVAR, the mean number of OARs per centre (intact + ruptured) decreased significantly (2010 - 2013 = 35.7; 2014 - 2016 = 29.8; p < .001). Only 23% of centres (n = 240/1 065) met the ≥ 13 procedures/year volume threshold, with significant variation between nations (Germany 11%; Denmark 100%). CONCLUSION: An annual centre volume of 13 - 16 OARs per year is the optimal threshold associated with the greatest mortality risk reduction after treatment of intact AAA. However, in the current endovascular era, achieving this threshold requires significant re-organisation of OAR practice delivery in many countries, and would affect provision of non-elective aortic services. Low volume centres continuing to offer OAR should aim to achieve mortality results equivalent to the high volume institution benchmark, using validated data from quality registries to track outcomes.

Contemporary Outcomes After Partial Resection of Infected Aortic Grafts.

INTRODUCTION: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. METHODS: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. RESULTS: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) CONCLUSION: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material.

A comparison of clinical outcomes of abdominal aortic aneurysm patients with favorable and hostile neck angulation treated by endovascular repair with the Treovance stent graft.

OBJECTIVE: The objective of this study was to compare outcomes of patients with favorable neck angulation (FNA) and hostile neck angulation (HNA) treated with the Treovance stent graft (Terumo Aortic [formerly Bolton Medical], Sunrise, Fla). METHODS: Patients with abdominal aortic aneurysms suitable for endovascular repair with Treovance were included in the RATIONALE postmarket surveillance registry. A post hoc subgroup analysis compared patients with infrarenal neck angles <60 degrees (FNA) and ≥60 degrees (HNA). RESULTS: After 1 year, 179 FNA (89.5%) and 21 HNA (10.5%) patients were analyzed. Both groups were similar in terms of sex (male, 92.7% FNA and 95.2% HNA) and age (73.0 years vs 72.6 years), but the HNA group had more Asian or other race representation (7.3% vs 19.0%) and more patients assigned to American Society of Anesthesiologists class 3 and class 4 (57.6% vs 66.7%). Mean suprarenal angles (standard deviation) were 13.1 (±13.5) degrees vs 29.0 (±16.4) degrees; mean infrarenal angles were 23.2 (±16.4) degrees vs 65.4 (±4.6) degrees, respectively. Aneurysm sac size maximum diameter was 58.1 (±9.8) mm vs 62.0 (±14.1) mm. There was a significant difference in unplanned adjunctive procedures (2.2% vs 19.0%; P = .01). Mean procedural duration was also significantly different for HNA patients, who underwent protracted operations (111.3 [±47.3] minutes vs 153.5 [±44.5] minutes; P < .0001). However, there were no significant differences in rates of clinical success (96.1% vs 95.2%). The rate of reintervention was low overall but 0% in the HNA group. Changes in sac size at 1 year were significant in both groups but not as pronounced in HNA patients (relative change of -11.8% [±13.3] vs -6.6% [±11.4]). CONCLUSIONS: Patients with high neck angulation treated with Treovance underwent more complex procedures but showed equally good technical success and 1-year clinical success parameters.

Lower Limb Amputations and Revascularisation Procedures in the Hungarian Population: A 14 Year Retrospective Cohort Study.

OBJECTIVE: The aim of this study was to assess the long term trends of lower limb amputation and revascularisation in Hungary over 14 years. METHODS: This was a retrospective cohort study that included all patients who underwent lower limb amputation or revascularisation over a 14 year period (2004-2017) in Hungary. Inpatient administrative data claims covering the entire beneficiary population were incorporated. Lower limb amputations (both minor and major) and revascularisation procedures (both open and endovascular) were identified in the claims files. Incidence rates were calculated and time trends were assessed via a generalised additive model. RESULTS: From 2004 to 2017, a total of 121 351 lower limb amputations (61 154 minor; 60 197 major) and 149 355 revascularisation procedures (89 243 open; 60 112 endovascular) were detected in 140 581 patients. The number of minor amputations decreased moderately in the last few years of the study period, while major amputations showed a slight decline (15%) beginning after 2013, which was more marked (22%) following adjustment for age. While the crude incidence of open vascular surgery procedures decreased by 31% (from 74.5/105 to 51.4/105), endovascular procedures showed growth by 79% (from 33.7/105 to 60.4/105) over the whole observation period. CONCLUSION: Observed amputation and revascularisation trends in Hungary are similar to the international experience. The major difference is a more than one decade lag in the starting point of the decline of amputations and in the move towards endovascular procedures. The number of amputations is more than twofold higher and the number of revascularisations is close to half that reported internationally. This comprehensive report of two vascular care performance indicators reveals an east/west vascular health divide in Europe and indicates the need to improve amputation prevention.

Editor's Choice - Assessment of Correlation Between Mean Size of Infrarenal Abdominal Aortic Aneurysm at Time of Intact Repair Against Repair and Rupture Rate in Nine Countries.

OBJECTIVE: This study aimed to analyse the mean abdominal aortic aneurysm (AAA) diameter for repair in nine countries, and to determine variation in mean AAA diameter for elective AAA repair and its relationship to rupture AAA repair rates and aneurysm related mortality in corresponding populations. METHODS: Data on intact (iAAA) and ruptured infrarenal AAA (rAAA) repair for the years 2010-2012 were collected from Denmark, England, Finland, Germany, Hungary, New Zealand, Norway, Sweden, and the USA. The rate of iAAA repair and rAAA per 100 000 inhabitants above 59 years old, mean AAA diameter for iAAA repair and rAAA repair, and the national rates of rAAA were assessed. National cause of death statistics were used to estimate aneurysm related mortality. Direct standardisation methods were applied to the national mortality data. Logistic regression and analysis of variance model adjustments were made for age groups, sex, and year. RESULTS: There was a variation in the mean diameter of iAAA repair (n = 34 566; range Germany = 57 mm, Denmark = 68 mm). The standardised iAAA repair rate per 100000 inhabitants varied from 10.4 (Hungary) to 66.5 (Norway), p<.01, and the standardised rAAA repair rate per 100 000 from 5.8 (USA) to 16.9 (England), p<.01. Overall, there was no significant correlation between mean diameter of iAAA repair and standardised iAAA rate (r2 = 0.04, p = .3). There was no significant correlation between rAAA repair rate (n = 12 628) with mean diameter of iAAA repair (r2 = 0.2, p = .1). CONCLUSION: Despite recommendations from learned society guidelines, data indicate variations in mean diameter for AAA repair. There was no significant correlation between mean diameter of AAA repair and rates of iAAA repair and rAAA repair. These analyses are subject to differences in disease prevalence, uncertainties in rupture rates, validations of vascular registries, causes of death and registrations.

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

PURPOSE:: To evaluate the safety and performance of the Treovance stent-graft. METHODS:: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. RESULTS:: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. CONCLUSION:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.