International Collaborative Study Comparing Outcomes of Fenestrated Endovascular Aortic Repair in OCtogenarian vs Non-Octogenarian Patients: The FEVOC study.

OBJECTIVE: With an increasing life expectancy, more octogenarian patients are referred with complex aortic aneurysms (cAAA). The aim of this study was to evaluate short and mid-term outcomes following fenestrated aortic repair (FEVAR) in octogenarians. SUMMARY BACKGROUND DATA: Few studies looking at octogenarian-specific outcomes with diverging results. METHODS: Retrospective, multicentre cohort study including consecutive patients undergoing elective FEVAR for cAAAs or type IV thoracoabdominal aortic aneurysms between 2007-2022 in eight high-volume centres. Octogenarians vs. non-octogenarians were compared. The primary outcome was 30-day mortality. Secondary outcomes included 1, 2 and 5-year survival and reintervention rates. RESULTS: A total of 729 patients (median age of 74.8 years [IQR 69.2 - 79.14]) were included, 169 (23%) of which were octogenarians, with 316 (43.3%) patients undergoing juxta/pararenal aneurysm repair. Although octogenarians presented less complex but larger (61 mm vs. 58 mm) aneurysms, the number of fenestrations was similar across groups. No differences in in-hospital mortality (4.1 vs. 3.0%), MAE (16.6% vs 12.2%) or reintervention rates (11.2 vs. 10%) were found. Multivariable logistic regression of in-hospital mortality identified BMI (OR 0.66, 95% CI 0.51-0.95, P=0.003), chronic heart failure (OR 7.70, 95% CI 1.36-36.15, P=0.003) and GFR<45 ml/min/1.73 m2 (OR 5.25, 95% CI 1.20-22.86, P=0.027) as independent predictors. Median follow-up was 41 months. The 1, 2 and 5-year survival rates were 91.3%, 81.8% and 49.5% in octogenarians vs 90.6%, 86.5% and 68.8% in non-octogenarian patients (Log-rank: =0.001). Freedom from aortic-related death and freedom from reintervention at five-years were similar across groups (log-rank=0.94 and .76, respectively). Age>80 was not an independent predictor of 30-day or long-term mortality on multivariable and Cox regression analysis. CONCLUSIONS: Elective FEVAR in octogenarians appears to be safe, with similar outcomes as in younger patients. Future studies looking at improved patient selection methods to ensure long-term survival benefits in both octogenarians and younger patients are warranted.

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.

One-year follow-up after active aortic aneurysm sac treatment with shape memory polymer devices during endovascular aneurysm repair.

OBJECTIVE: To determine the safety and efficacy of treating abdominal aortic aneurysm (AAA) sacs with polyurethane shape memory polymer (SMP) devices during endovascular aneurysm repair (EVAR), using a technique to fully treat the target lumen after endograft placement (aortic flow volume minus the endograft volume). SMP devices self-expand in the sac to form a porous scaffold that supports thrombosis throughout its structure. METHODS: Two identical prospective, multicenter, single-arm studies were conducted in New Zealand and the Netherlands. The study population was adult candidates for elective EVAR of an infrarenal AAA (diameter of ≥55 mm in men and ≥50 mm in women). Key exclusion criteria were an inability to adequately seal a common iliac artery aneurysm, patent sac feeding vessels of >4 mm, and a target lumen volume of <20 mL or >135 mL. Target lumen volumes were estimated by subtracting endograft volumes from preprocedural imaging-based flow lumen volumes. SMP devices were delivered immediately after endograft deployment via a 6F sheath jailed in a bowed position in the sac. The primary efficacy end point was technical success, defined as filling the actual target lumen volume with fully expanded SMP at the completion of the procedure. Secondary efficacy outcome measures during follow-up were the change in sac volume and diameter, rate of type II endoleak and type I or III endoleaks, and the rate of open repair and related reinterventions, with data collection at 30 days, 6 months, and 1 year (to date). Baseline sac volumes and diameters for change in sac size analyses were determined from 30-day imaging studies. Baseline and follow-up volumes were normalized by subtraction of the endograft volume. RESULTS: Of 34 patients treated with SMP devices and followed per protocol, 33 patients were evaluable at 1 year. Preprocedural aneurysm volume was 181.4 mL (95% confidence interval [CI], 150.7-212.1 mL) and preprocedural aneurysm diameter was 60.8 mm (95% CI, 57.8-63.9 mm). The target lumen volume was 56.3 mL (95% CI, 46.9-65.8 mL). Technical success was 100% and the ratio of SMP fully expanded volume to estimated target lumen volume was 1.4 ± 0.3. Baseline normalized sac volume and diameter were 140.7 mL (95% CI, 126.6-154.9 mL) and 61.0 mm (95% CI, 59.7-62.3 mm). The adjusted mean percentage change in normalized volume at 1 year was -28.8% (95% CI, -35.3 to -22.3%; P < .001). The adjusted mean change in sac diameter at 1 year was -5.9 mm (95% CI, -7.5 to -4.4 mm; P < .001). At 1 year, 81.8% of patients (95% CI, 64.5%-93.0%) achieved a ≥10% decrease in normalized volume and 57.6% of patients (95% CI, 39.2%-74.5%) achieved a ≥5 mm decrease in diameter. No device- or study procedure-related major adverse events occurred through 1 year after the procedure. CONCLUSIONS: Treatment of AAA sacs with SMP devices during EVAR resulted in significant sac volume and diameter regression at 1 year with an acceptable safety profile in this prospective study.

Editor's Choice - Association of Pedal Acceleration Time With Healing and Amputation Free Survival in Patients With Ulceration and Gangrene.

OBJECTIVE: Pedal acceleration time (PAT) is a novel non-invasive perfusion measurement that may be useful in the management of patients with ulceration and gangrene. The objective of this study was to report the association between PAT and wound healing, amputation free survival (AFS), and mortality at one year. METHODS: This prospective observational study reviewed all patients who underwent PAT after presentation with ulceration or gangrene from 1 January 2020 to 30 June 2022. PAT was defined as the time (in milliseconds) from the onset of systole to the peak of systole in the mid artery. The final PAT of a limb was used to assess outcomes (presenting PAT if no revascularisation, or post-revascularisation PAT). Wound healing, major limb amputation, and death at one year were collected. Healing was assessed with Fine-Gray competing risks model, AFS via logistic regression, and survival using Cox proportional hazards model. RESULTS: Overall, 265 patients (307 limbs) were included. The median patient age was 71 years and 74.0% (196/265) had diabetes mellitus. Patient demographics were similar among the final PAT category cohorts. Compared with a final PAT category 1, analysis of one year outcomes showed that the final PAT categories 2 - 4 had lower wound healing (category 2, hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.43 - 0.9, p = .012; category 3, HR 0.21, 95% CI 0.08 - 0.58, p = .002; category 4, HR 0.12, 95% CI 0.04 - 0.34, p < .001), lower AFS (category 2, odds ratio [OR] 2.86, 95% CI 1.64 - 5.0, p < .001; category 3, OR 5.1, 95% CI 1.71 - 15.22, p = .003; category 4, OR 12.59, 95% CI 4.34 - 36.56, p < .001), and lower survival (category 2, HR 1.89, 95% CI 1.17 - 3.03, p =.009; category 3, HR 2.37, 95% CI 1.05 - 5.36, p = .039; category 4, HR 4.52, 95% CI 2.48 - 8.21, p < .001). CONCLUSION: The final PAT measurement is associated with wound healing, AFS, and death at one year. PAT may be a valuable tool to assess perfusion of the foot.

Branch Thrombus after Endovascular Treatment with Arch Branched Devices for Aortic Arch Pathologies.

OBJECTIVE: The aim of this study was to describe the occurrence of branch thrombosis following endovascular treatment of aortic arch pathology using an arch branched device (ABD) and to determine whether this is influenced by clinical and geometric parameters. METHODS: In this retrospective observational study of patients treated with an ABD in three centres, the primary endpoint was thrombus formation within a branch during follow up. Secondary endpoints were technical success, serious adverse events (SAEs), early and late death, stroke, and re-interventions. Geometric measurements (tortuosity index and curvature) were determined on pre- and post-operative computed tomography angiograms. RESULTS: Thirty nine patients were treated and 68 antegrade branches were analysed (innominate artery, n = 27; common carotid artery [CCA], n = 40; left subclavian artery [LSA], n = 1). Thrombus was identified within seven branches (10%) on surveillance imaging (innominate artery, n = 6; CCA, n = 1; LSA, n = 0; p = .021) and was associated with a wider distal bridging stent diameter (median 14.0 mm [13.3, 15.3] vs. 8.7 mm [IQR 5.9]; p = .026), a higher degree of reversed tapering (4.3 mm [3.8, 5.2] vs. 1.2 mm [0.3, 3.1]; p = .023), use of polyethylene terephthalate (Dacron) covered (vs. expanded polytetrafluoroethylene) bridging stents (23% vs. 2%; p = .011), and higher body mass index (BMI) (32.1 kg/m2 [28.7, 36.2] vs. 25.7 kg/m2 [23.8, 29.2]; p = .029), but not with pre-operative or post-operative tortuosity index or curvature or alterations. Regarding secondary outcomes, the technical success rate was 97%, SAEs occurred in 15 patients (38%), early and late death rates were 8% and 23%, respectively, and early and late stroke rates were 5% and 23%, respectively. CONCLUSION: The risk of developing branch thrombosis after endovascular intervention with an ABD is considerable, especially of innominate artery branches, characterised by Dacron covered large diameter bridging stents, and in patients with a high BMI. Large prospective studies are required to analyse factors associated with branch thrombosis.

Editor's Choice - 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.

Outcomes of Elective and Non-elective Fenestrated-branched Endovascular Aortic Repair for Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.

Comparison of single- and multistage strategies during fenestrated-branched endovascular aortic repair of thoracoabdominal aortic aneurysms.

OBJECTIVE: The aim of this study was to compare outcomes of single or multistage approach during fenestrated-branched endovascular aortic repair (FB-EVAR) of extensive thoracoabdominal aortic aneurysms (TAAAs). METHODS: We reviewed the clinical data of consecutive patients treated by FB-EVAR for extent I to III TAAAs in 24 centers (2006-2021). All patients received a single brand manufactured patient-specific or off-the-shelf fenestrated-branched stent grafts. Staging strategies included proximal thoracic aortic repair, minimally invasive segmental artery coil embolization, temporary aneurysm sac perfusion and combinations of these techniques. Endpoints were analyzed for elective repair in patients who had a single- or multistage approach before and after propensity score adjustment for baseline differences, including the composite 30-day/in-hospital mortality and/or permanent paraplegia, major adverse event, patient survival, and freedom from aortic-related mortality. RESULTS: A total of 1947 patients (65% male; mean age, 71 ± 8 years) underwent FB-EVAR of 155 extent I (10%), 729 extent II (46%), and 713 extent III TAAAs (44%). A single-stage approach was used in 939 patients (48%) and a multistage approach in 1008 patients (52%). A multistage approach was more frequently used in patients undergoing elective compared with non-elective repair (55% vs 35%; P < .001). Staging strategies were proximal thoracic aortic repair in 743 patients (74%), temporary aneurysm sac perfusion in 128 (13%), minimally invasive segmental artery coil embolization in 10 (1%), and combinations in 127 (12%). Among patients undergoing elective repair (n = 1597), the composite endpoint of 30-day/in-hospital mortality and/or permanent paraplegia rate occurred in 14% of single-stage and 6% of multistage approach patients (P < .001). After adjustment with a propensity score, multistage approach was associated with lower rates of 30-day/in-hospital mortality and/or permanent paraplegia (odds ratio, 0.466; 95% confidence interval, 0.271-0.801; P = .006) and higher patient survival at 1 year (86.9±1.3% vs 79.6±1.7%) and 3 years (72.7±2.1% vs 64.2±2.3%; adjusted hazard ratio, 0.714; 95% confidence interval, 0.528-0.966; P = .029), compared with a single stage approach. CONCLUSIONS: Staging elective FB-EVAR of extent I to III TAAAs was associated with decreased risk of mortality and/or permanent paraplegia at 30 days or within hospital stay, and with higher patient survival at 1 and 3 years.

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.

Acute aortic syndrome: nationwide study of epidemiology, management, and outcomes.

BACKGROUND: Epidemiological studies on acute aortic syndrome (AAS) have relied largely on unverified administrative coding, leading to wide-ranging estimates of incidence. This study aimed to evaluate the incidence, management, and outcomes of AAS in Aotearoa New Zealand. METHODS: This was a national population-based retrospective study of patients presenting with an index admission of AAS from 2010 to 2020. Cases from the Ministry of Health National Minimum Dataset, National Mortality Collection, and the Australasian Vascular Audit were cross-verified with hospital notes. Poisson regression adjusted for sex and age was used to investigate trends over time. RESULTS: During the study interval, 1295 patients presented to hospital with confirmed AAS, including 790 with type A (61.0 per cent) and 505 with type B (39.0 per cent) AAS. A total of 290 patients died out of hospital between 2010 and 2018. The overall incidence of aortic dissection including out-of-hospital cases was 3.13 (95 per cent c.i. 2.96 to 3.30) per 100 000 person-years, and this increased by an average of 3 (95 per cent c.i. 1 to 6) per cent per year after adjustment for age and sex adjustment on Poisson regression, driven by increasing type A cases. Age-standardized rates of disease were higher in men, and in Maori and Pacific populations. The management strategies used, and 30-day mortality rates among patients with type A (31.9 per cent) and B (9.7 per cent) disease have remained constant over time. CONCLUSION: Mortality after AAS remains high despite advances over the past decade. The disease incidence and burden are likely to continue to increase with an ageing population. There is impetus now for further work on disease prevention and the reduction of ethnic disparities.