Possible implications of device-specific variability in post-endovascular aneurysm repair sac regression and endoleaks for surveillance categorization.

OBJECTIVE: Significant sac regression during early surveillance has been shown to best predict reintervention-free long-term surveillance after endovascular aneurysm repair (EVAR). Furthermore, a persistent endoleak has been related to a worse outcome. Individualized surveillance algorithms based on these findings have been suggested. There are no studies comparing the performance of different stent grafts regarding sac regression, the presence of type II endoleaks, and their possible implications for individualized surveillance. The objective of this study was to evaluate device-specific differences and how these may affect patient categorization for surveillance. METHODS: Patients were treated electively with standard EVAR between 2005 and 2015 using three different devices (Zenith by Cook, Excluder by Gore, and Endurant by Medtronic). The data were reviewed retrospectively until 2020. Patients' computed tomography angiographies (CTAs) at 30 days and at 2 years were analyzed for freedom from endoleaks and for sac regression of ≥5 mm. Reinterventions during long-term surveillance were counted. Patients were categorized according to the presence of any endoleak and sac regression at 30 days and 2 years, and the probability of reintervention-free long-term surveillance was evaluated based on these findings. RESULTS: A total of 435 patients were treated for an abdominal aortic aneurysm with EVAR during the study period. At 30 days, 80.0% (n = 339) of the patients were free from endoleaks, and at 2 years, 78.9% (n = 273) were free from endoleaks. There was a significant difference in endoleak rate at 30 days and 2 years between the devices (P < .001 and P = .001). There was no significant difference in sac regression between the devices at 2 years (P = .096). The categorization at 30 days based on endoleak status had a sensitivity of 44.9%, specificity of 87.4%, and negative predictive value of 84.1% for finding a reintervention-requiring complication during long-term follow-up. The corresponding figures at 2 years were 63.3%, 91.4%, and 89.4%, respectively. The combination of freedom from endoleaks and sac regression of ≥5 mm in the 2-year CTA best predicted an uneventful long-term surveillance. Patients who met this criterion had a 95.6% probability (negative predictive value) of having a reintervention-free long-term surveillance. CONCLUSIONS: There are significant differences in the prevalence of endoleaks between devices at 30 days and 2 years, but there is no difference in sac regression. Patients with sac regression of ≥5 mm and no endoleaks in the 2-year CTA can be safely categorized for infrequent surveillance regardless of the stent graft model that has initially been used.

Routine Inferior Mesenteric Artery Embolisation is Unnecessary Before Endovascular Aneurysm Repair.

OBJECTIVE: A type II endoleak is the most common complication during surveillance after endovascular aneurysm repair (EVAR), and a patent inferior mesenteric artery (IMA) is a known risk factor for an endoleak. The effect of routine IMA embolisation prior to EVAR on overall outcome is unknown. The aim of the study was to compare two strategies: routine attempted IMA embolisation prior to EVAR (strategy in centre A) and leaving the IMA untouched (strategy in centre B). METHODS: Patients were treated with EVAR in two centres during the period 2005 - 2015, and the data were reviewed retrospectively. The primary endpoints were re-intervention rate due to type II endoleaks and the late IMA embolisation rate. Secondary endpoints included EVAR related re-intervention, sac enlargement, aneurysm rupture, and open conversion rates. RESULTS: Strategy A was used to treat 395 patients. The IMA was patent in 268 (67.8%) patients, and embolisation was performed in 164 (41.5%). The corresponding figures for strategy B were 337 patients with 279 (82.8%) patent IMAs, two (0.6%) of which were embolised. The mean duration of follow up was 70 months for strategy A and 68.2 months for strategy B. The re-intervention rates due to a type II endoleak were 12.9% and 10.4%, respectively (p = .29), with no significant difference in the rate of re-interventions to occlude a patent IMA (2.0% and 4.7%, respectively; p = .039). The EVAR related re-intervention rate was similar, regardless of strategy (24.1% and 24.6%, respectively; p = .93). Significant sac enlargement was seen in 20.3% of cases treated with strategy A and in 19.6% treated with strategy B (p = .82). The rupture and conversion rates were 2.5% and 2.1% (p = .69) and 1.0% and 1.5% (p = .40), respectively. CONCLUSION: The strategy of routinely embolising the IMA does not seem to yield any significant clinical benefit and should therefore be abandoned.

The effect of suprarenal graft fixation during endovascular aneurysm repair on short- and long-term renal function.

OBJECTIVE: The effect of suprarenal fixation (SR) compared with infrarenal fixation (IR) on renal function during endovascular aneurysm repair (EVAR) remains controversial. This study aims to compare the renal outcomes between fixation types in short- and long-term follow-up. METHODS: Patients undergoing EVAR for infrarenal abdominal aortic aneurysm between 2005 and 2013 were included. The estimated glomerular filtration rate (eGFR) was measured at baseline and during a follow-up of 5 years. A decline in renal function was defined as a 20% or greater decrease in the eGFR. Changes in the eGFR were compared between SR and IR groups at 1 to 7 days, 30 days, and 1 to 5 years postoperatively. Preoperative renal insufficiency was defined as an eGFR of less than 60 mL/min/1.73 m2, and those patients were included in the subanalyses. RESULTS: A total of 358 patients were included. Among these, 267 (74.6%) had SR and 91 (25.4%) had IR fixation. A decrease in renal function occurred more commonly after SR than after IR in 1 to 7 days postoperatively (P = .009), but no difference was noticed at 30 days and 1 to 5 years. Regardless of the fixation method, renal function steadily decreased steadily over time after EVAR (estimate -3.13 per a year; 95% confidence interval, -3.40 to -2.85; P < .001). Patients with preexisting renal insufficiency were included in subgroup analyses, and those with SR were more often found to have a decline in eGFR 5 years postoperatively than their counterparts with IR (59.5% vs 20.0%; P = .036). CONCLUSIONS: An immediate postoperative decrease in renal function was seen more often after SR fixation than IR fixation but this difference was transient. SR fixation is a safe method for patients with normal renal function. Long-term results seems to favor IR over SR in patients with preexisting renal insufficiency.

Long-term outcomes of endovascular aneurysm repair according to instructions for use adherence status.

OBJECTIVE: Endovascular aneurysm repair (EVAR) has become the standard treatment for abdominal aortic aneurysms (AAAs). Endovascular device manufacturers have defined specific anatomic criteria for the aneurysm characteristics that should be observed as instructions for use (IFU) for specific grafts. In clinical practice, the prevalence of performing EVAR outside the IFU has been high. In the present study, we aimed to determine the effects of nonadherence to the IFU on the outcomes. METHODS: Patients who had undergone EVAR for an infrarenal AAA between 2005 and 2013 were included. IFU nonadherence was defined as any violation of device-specific IFU criteria and was compared with IFU adherence. The primary outcomes were all-cause mortality, aneurysm-related mortality, AAA rupture, graft-related adverse events (GRAEs), including limb-related adverse events, and type Ia endoleaks. A second aim was to study whether the prevalence of EVAR performed outside the IFU has increased over time. RESULTS: A total of 258 patients were included, 144 (55.8%) of whom had been treated according to the IFU and 114 (44.2%) outside the IFU. In the IFU nonadherence group, all-cause mortality (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.02-1.89; P = .037) and aneurysm-related mortality (HR, 5.1; 95% CI, 1.4-18.6; P = .015), and the incidence of AAA rupture (HR, 5.4; 95% CI, 1.1-26.6; P = .036) and GRAEs (HR, 1.7; 95% CI, 1.1-2.8; P = .025). No significant association was found between the incidence of type Ia endoleaks and neck-related IFU or limb-related adverse events and iliac-related IFU. However, neck length was a risk factor for type Ia endoleaks (HR, 18.2, 95% CI, 6.3-52.2; P < .001), aneurysm-related mortality (HR, 8.7; 95% CI, 1.8-41.6; P = .007), AAA rupture (HR, 21.7; 95% CI, 2.8-166; P = .003), and GRAEs (HR, 4.4; 95% CI, 2.0-9.7; P < .001). An IFU violation regarding neck angulation was also a risk factor for all-cause mortality (HR, 2.0; 95% CI, 1.1-3.7; P = .032), aneurysm-related mortality (HR, 7.6; 95% CI, 1.4-42.8; P = .021), AAA rupture (HR, 79.4; 95% CI, 6.3-999; P = .001), and GRAEs (HR, 4.3; 95% CI, 1.9-9.5; P < .001). The prevalence of EVAR performed outside the IFU did not increase over time. CONCLUSIONS: Performing EVAR outside the IFU had a negative effect on outcomes, including all-cause mortality, aneurysm-related mortality, AAA rupture, and GRAEs. Neck angulation and neck length seemed to be the most crucial aneurysm characteristics.

Early and Long-Term Outcomes of Endovascular Aortic Repair in Young and Low Surgical Risk Patients in the Global Registry for Endovascular Aortic Treatment.

PURPOSE: To investigate early- and long-term outcomes of endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) in young and low surgical risk patients. METHODS: The global registry for endovascular aortic treatment (GREAT) was queried for all patients with AAA undergoing standard EVAR; patients were excluded if had previous AAA repair or underwent concomitant procedures. Young patients were defined if age <60; surgical risk was assessed through the validated Medicare perioperative risk score (MPRS) based on age, sex, renal function, heart failure, and peripheral vascular disease. Patients were classified as low (MPRS<3), average (MPRS 3-11), or high (MPRS>11) risk. Young versus older patients and low-risk versus average/high-risk patients were compared. The primary endpoints were early (30 days) major adverse events (MAEs), 5-year freedom from overall mortality, aortic-related mortality, and freedom from device-related reinterventions. Time-to-event endpoints were calculated by Kaplan-Meier curves. RESULTS: Of 3217 included patients, 182 (6%) were <60 years old, 956 (30%) had a low surgical risk, 1561 (49%) an average risk, 700 (22%) a high risk. Young patients had a less angulated proximal neck (27.2±18.4° vs 30.9±21.5°; p=0.05); in low-risk compared to average/high-risk patients, a longer neck length (3±1.8 vs 2.8±1.4 cm; p=0.01) and lower neck angulation (29.7±21.8° vs 33.2±22.2°; p=0.01) were present. Young age alone had no significant impact on early mortality (0% vs 0.6%; p=0.62.) and MAEs (3.9% vs 6.1%; p=0.20), while these were significantly lower in low-risk compared to average/high-risk patients (early mortality: 0.1% vs 0.7%, p=0.04; MAEs: 4.1% vs 6.7%, p=0.005). At 5 years, overall survival was significantly higher in young (88% vs 76%; p<0.001) and lower-risk (77% vs 54%; p<0.001) patients; low-risk patients also had significantly decreased aortic-related mortality (0% vs 2%; p=0.04) and reintervention rates (6% vs 11%; p=0.007). There were no statistically significant differences in mortality (0% vs 2%; p=0.42) and reintervention rate (10% vs 10%; p=1.00) between young and older patients. CONCLUSION: In this real-world registry, EVAR was more often offered in cases with suitable anatomy in young and low-risk patients. Low operative risk, rather than young age alone, predicted excellent early outcomes and low 5-year mortality, aortic-related mortality, and reintervention rates.

Reliability and Safety of Individualized Follow-up Based on the 30-day Computed Tomography Angiogram after Endovascular Aneurysm Repair.

BACKGROUND: Most patients undergo uneventful surveillance after endovascular aneurysm repair (EVAR), and therefore, unmodified surveillance protocols are ineffective. An example of a modified follow-up protocol was introduced by the European Society for Vascular Surgery (ESVS) in January 2019. One feature of this protocol is that for the patients with adequate sealing and without any detectable endoleak at 30 days, the next scheduled follow-up could be at 5 years. The purpose of this study was to analyze retrospectively the applicability of this protocol. METHODS: Between 2005 and 2013, 348 patients were treated electively for abdominal aortic aneurysm (AAA) with a standard EVAR. All patients were annually followed and they were retrospectively fitted into the ESVS follow-up protocol based on imaging findings. RESULTS: The mean follow-up was 74 months (standard error 2.1; range, 0-165 months). Thirty-day mortality was 1.1% (n = 4). Imaging data for those surviving the first 30 days were available for 98.8% (n = 340) subjects. At a 1-month control examination, 79.3% (n = 276) of the patients had no detectable endoleak and sealing was adequate (≥1 cm). Of those patients, with the lowest risk, 11.6% (n = 32) required reintervention for graft-related complication during the next 5 years. In all, complications requiring treatment that would have been missed by following the suggested protocol included type 1A endoleak (n = 7), type 1B (n = 10), type 2 (n = 7), migration (n = 2), thrombosis (n = 10), kinking (n = 1), and ruptured AAA (n = 6). The sensitivity of 30-day computed tomography angiogram was 34.9% (95% confidence interval 21.01-50.93%) and specificity 83.3% (95% confidence interval 78.57-87.41%) for finding significant complications during first 5 years. CONCLUSIONS: Based on our findings, by following the example ESVS follow-up protocol, we would have missed major life-threatening complications. Significant stent-graft failures occur during the first 5 years, even for those with noncomplicated post-EVAR findings in the first computed tomography angiogram at 1 month.

Postoperative imaging follow-up at 2 years as a predictor of long-term outcomes after endovascular aneurysm repair.

OBJECTIVE: Lifelong imaging follow-up remains the reference standard after endovascular aneurysm repair (EVAR). Because the number of EVARs has been increasing, an individually optimized follow-up protocol is desirable. The aim of the present study was to investigate the possibility of creating such a protocol by evaluating patients' follow-up images and to compare the findings with their freedom from reintervention and abdominal aortic aneurysm (AAA) rupture. METHODS: From 2000 to 2010, 282 patients with an AAA had undergone elective EVAR with the Zenith stent-graft. The patients were followed up annually until the end of 2019. The patients were categorized into two groups according to the presence of any endoleak or sac shrinkage at 2 years. Group A included those with no detectable endoleak plus aneurysm sac shrinkage of ≥5 mm (n = 137; 63%), and group B included those with any type of endoleak and/or no significant aneurysm sac shrinkage (<5 mm; n = 82; 37%). RESULTS: The mean follow-up was 83 months (range, 0-229 months), and the overall survival at 2 years was 84% (n = 237). No significant difference was found in overall survival between groups A and B (P = .73). However, a significant difference was found in freedom from AAA rupture at 12 years, favoring group A (group A, 100%; group B, 91%; P = .002). Furthermore, in group A, the freedom from reintervention was 95% at 12 years compared with only 31% in group B (P < .001). The sensitivity of the categorization was 89% and the specificity was 74% for the finding of a complication requiring a reintervention during long-term follow-up. CONCLUSIONS: Patients without an endoleak and a reduction of ≥5 mm in aneurysm size at 2 years had significantly fewer late reinterventions and ruptures during long-term follow-up compared with their counterparts using the Zenith stent-graft (Cook Medical, Bloomington, Ind). This finding suggests that, for these patients, the follow-up interval can be personalized and safely extended after 2 years.

Prognostic risk factors for recurrent acute lower limb ischemia in patients treated with intra-arterial thrombolysis.

OBJECTIVE: The objective of this study was to assess factors predisposing patients to recurrent acute lower limb ischemia (RALLI). METHODS: Acute lower limb ischemia patients treated with catheter-directed thrombolysis (CDT) at Tampere University Hospital and Turku University Hospital between March 2002 and December 2015 were included. The patients' baseline demographics, comorbidities, and other characteristics were assessed retrospectively. Significant factors revealed by univariable analysis were tested in a multivariable model for associations with RALLI. A patency analysis was performed, and the risks of reocclusion were identified. The limb salvage rates after reocclusion were evaluated. RESULTS: Altogether, 303 consecutive patients with a mean age of 71 years (standard deviation, 11.8 years) were included. Of them, 159 (52.5%) were men. A total of 164 (54.1%) native arterial and 139 (45.9%) bypass graft occlusions were initially treated with CDT. On completion of CDT, 204 additional endovascular or conventional surgical procedures on 203 patients were performed to obtain adequate distal perfusion. During a median follow-up of 40 months (interquartile range, 69 months), 40 (24.4%) cases of RALLI occurred in native arteries and 90 (64.7%) in bypass graft patients (P < .001). In native arteries, the absence of appropriate anticoagulant and antiplatelet medication was independently associated with the development of acute reocclusions (hazard ratio, 6.51) in the Cox multivariable regression analysis. The patency rates were 86.6%, 72.2%, and 68.0% at 1 year, 5 years, and 9 years, respectively. In bypass grafts, worsened tibial runoff (crural index III: hazard ratio, 2.40) was independently associated with RALLI. The respective patency rates were 60.5%, 34.0%, and 29.2% for synthetic conduits and 30.8%, 20.5%, and 13.7% for autologous vein grafts at 1 year, 5 years, and 9 years. Altogether, 38 (29.2%) major amputations were performed on patients with reocclusions. Patients with synthetic conduits demonstrated superior limb salvage rates after reocclusion in comparison to native arteries or vein grafts (P = .025). CONCLUSIONS: Appropriate post-thrombolytic antiplatelet or anticoagulant treatment after native arterial events is of great importance, but additional data are needed to improve treatment algorithms. Adequate outflow in bypass graft patients is crucial. Patients with prosthetic bypass grafts have superior limb salvage rates after reocclusion.

Overall outcome after endovascular aneurysm repair with a first-generation stent graft (Vanguard): A 20-year single-center experience.

OBJECTIVE: The problems with first-generation stent grafts for endovascular aneurysm repair are well known, but their long-term outcome remains to be established. The purpose of the study was to characterize the outcome of patients treated for abdominal aortic aneurysm (AAA) with a first-generation stent graft, Vanguard (Boston Scientific, Natick, Mass), in a single academic center with a follow-up of up to 20 years. METHODS: There were 48 AAA patients electively treated with a Vanguard stent graft between February 1997 and November 1999. The patients were monitored annually until the end of 2018. The outcomes were overall survival and the number of graft-related complications and reinterventions. RESULTS: The mean age was 70 years (range, 54-85 years), and the mean follow-up was 107 months (range, 6-262 months). All stent grafts were successfully implanted, but 90% of the patients encountered graft-related complications during follow-up. The most common complications were endoleaks (type I, 27%; type II, 29%; type III, 31%), stent fracture (46%), graft thrombosis (31%), and migration (40%). A total of 40 (83%) patients required a secondary procedure during long-term follow-up. The endovascular method for treating the complication was successful in 73 (87%) of 84 cases. There were no primary conversions, but 10 patients (21%) required a late conversion. In five cases, the complications required relining with a newer device. There were four AAA ruptures (8.3%), two of them fatal. The cumulative overall survival rates were 94%, 69%, 33%, 15%, and 13% at 1 year, 5 years, 10 years, 15 years, and 20 years, respectively. CONCLUSIONS: The use of the Vanguard, a first-generation stent graft, was associated with multiple graft-related complications. However, these complications could mainly be treated by endovascular means. The Vanguard stent graft is a good example of how new technology can cause unpredictable problems that can magnify the workload and endanger the patient's well-being even decades after the initial procedure.

Systematic Long-term Follow Up After Endovascular Abdominal Aortic Aneurysm Repair With the Zenith Stent Graft.

OBJECTIVE/BACKGROUND: Although endovascular aneurysm repair (EVAR) has been widely adopted, long-term data remain limited. This study analyses the long-term outcome (16 years) after EVAR with the Zenith stent graft in a single academic centre. METHODS: From 2000 to 2010, 282 patients with an abdominal aortic aneurysm (AAA) were treated electively and monitored annually. Primary outcomes were overall and AAA rupture free survival; the secondary outcomes were complication and re-intervention free survival. Kaplan-Meier analysis was used to examine survival. RESULTS: The median patient age was 76 years (range 49-92 years) and mean aneurysm diameter 61 mm (range 40-110 mm). Patients were followed for a median of 76 months (range 0-201 months). Overall survival was 93% (SE 0.02), 61% (SE 0.08), 25% (SE 0.16), and 9% (0.19) at 1, 2, 5, 10, and 16 years, respectively. Ten (3.5%) AAA ruptures occurred, and the cumulative AAA rupture free survival was 100%, 98% (SE 0.01), 96% (SE0.02), and 79% (SE 0.12) at 1, 5, 10, and 16 years, respectively. The mean annual AAA rupture rate was 0.5%. Freedom from any stent graft related complications was 68% (SE 0.03), 58% (SE 0.09), 54% (SE 0.17), and 52% (SE 0.21), respectively; freedom from graft related re-interventions was 95% (SE 0.01), 80% (SE 0.08), 73% (SE 0.11), 70% (SE 0.16), at 1, 5, 10, and 16 years, respectively. Five (1.8%) late conversions were required during follow up. The variables that significantly and independently correlated with ruptured AAA were pre-operative aneurysm size and primary type II endoleak. The latter was the only independent significant factor to increase the risk of re-intervention. CONCLUSION: The number of graft related complications is high after EVAR, and new complications keep appearing years after the initial procedure. Even though fatal AAA rupture after EVAR is rare, it cannot be totally avoided despite systematic follow up.

Survival of Patients and Treatment-Related Outcome After Intra-Arterial Thrombolysis for Acute Lower Limb Ischemia.

BACKGROUND: The aim of this study is to evaluate the long-term survival and treatment-related outcome in patients treated with intra-arterial thrombolysis for acute lower limb ischemia. METHODS: The study was based on a prospective vascular database with retrospectively obtained supplementary information from the patients' files. Additionally, data on the patients' date and cause of death were obtained from Statistics Finland. A total of 155 patients with symptoms or signs of category I-IIa acute lower limb ischemia and angiographic evidence of native artery or bypass graft thromboembolic events were treated with intra-arterial catheter-directed thrombolysis (CDT). Patients with severe ischemic stages at admission or those with contraindications for thrombolysis (n = 185) were treated with conventional surgical modalities and excluded from further analysis. RESULTS: The mean age of the patients at admission was 73 years (95% confidence interval 70.1-74.6). For descriptive purposes, age quartiles were used (≤64, 65-74, 75-82.5, ≥83). The mean follow-up time was 126.3 months. The primary patency rates of native arteries/bypass grafts were 59.8%/31.7%, 35.4%/17.1%, and 18.7%/15.2% at 1, 5, and 10 years, respectively (P = 0.01). Correspondingly, the respective secondary patency rates were 65.2%/55.6%, 46.7%/39.8%, and 22.8%/30.5% (P = 0.88). A total of 190 additional procedures on 122 patients were required to preserve the patency after hospital discharge. At 1 year the cumulative survival was 78%, at 5 years 56%, and at 10 years 29%. The most common cause of death was cardiovascular (68.5%), predominantly presented by an acute coronary syndrome, while 9.6% died of cancer, 6.8% of pulmonary diseases, 8.2% of cerebrovascular causes, and 19.2% owing to trauma and other reasons. Atrial fibrillation (hazards ratio [HR] 2.31) and age over 83 years (HR 5.23 per age category) were significantly and independently associated with poorer cumulative post-procedural survival. Bypass graft thrombosis was associated with an increase in major amputations after CDT (HR 14.77). However, the presence of synthetic bypass grafts had a protective influence on limb salvage (HR 0.086). A total of 39 (25.2%) major amputations were performed during the follow-up period. Age over 75 years was the only significant and independent factor to negatively impact on amputation-free survival (HR 2.01), which was 24% at 10 years. CONCLUSIONS: The long-term patency after CDT is unfavorable, and additional procedures are needed to preserve adequate distal perfusion. Approximately 30% of the patients are alive at 10 years after the initial CDT. Increasing age and atrial fibrillation have a negative effect on the patients' survival.

The incidence and effect of noncylindrical neck morphology on outcomes after endovascular aortic aneurysm repair in the Global Registry for Endovascular Aortic Treatment.

BACKGROUND: The Gore Global Registry for Endovascular Aortic Treatment (GREAT) was designed to evaluate real-world outcomes after treatment with Gore aortic endografts used in a real-world, global setting. We retrospectively analyzed the GREAT data to evaluate the incidence and effects of noncylindrical neck anatomy in patients undergoing endovascular aortic aneurysm repair. METHODS: The present analysis included patients with data in the GREAT who had been treated with the EXCLUDER endograft from August 2010 to October 2016. A noncylindrical neck was defined when the proximal aortic landing zone diameter had changed ≥2 mm over the first 15 mm of the proximal landing zone, indicating a tapered, conical, or hourglass morphology. Cox multivariate regression analyses were performed for any reintervention (including reinterventions on aortic branch vessels), device-related reinterventions, and reintervention specifically for endoleak. Independent binary (cylindrical vs noncylindrical necks) and continuous (percentage of neck diameter change) variables were assessed. The abdominal aortic aneurysm (AAA) diameter, proximal neck length, maximal infrarenal neck angle, gender, and use of aortic extender cuffs were also assessed. RESULTS: Of 3077 GREAT patients with available proximal aortic landing zone diameter measurements available, 1765 were found to have cylindrical necks and 1312 had noncylindrical necks. The noncylindrical neck cohort had a significantly greater proportion of women (17.4% vs 12.6%; P < .001) and more severe infrarenal angulation (33.8° vs 28.4°; P < .001). A total 14.7% of noncylindrical neck patients and 11.2% cylindrical neck patients underwent implantation outside of the EXCLUDER instructions for use regarding the anatomic inclusion criteria (P = .004). The procedural characteristics were similar between the two cohorts; however, noncylindrical neck patients required significantly more aortic extender cuffs (P = .004). The average follow-up was 21.2 ± 17.5 months and 17.8 ± 15.8 months for the cylindrical and noncylindrical cohorts, respectively (P < .001). The Cox multivariate regression models demonstrated female gender and maximum AAA diameter were significant risk factors for subsequent reintervention (overall, device-related, and endoleak-specific). Women were 2.2 times as likely to require device-related intervention during the follow-up period compared with men (P < .001). Neck shape morphology was not a significant predictor, except for device-related intervention, for which cylindrical necks (binary definition) resulted in a slightly elevated risk (1.5 times; P = .03). CONCLUSIONS: Noncylindrical neck morphology was more common in women and was associated with an increased use of aortic extender cuffs but did not increase the risk of intervention. Female gender and AAA diameter were associated with an increased need for reintervention.

Bacterial signatures in thrombus aspirates of patients with lower limb arterial and venous thrombosis.

OBJECTIVE: Increasing data supports the role of bacterial inflammation in adverse events of cardiovascular and cerebrovascular diseases. In our previous research, DNA of bacterial species found in coronary artery thrombus aspirates and ruptured cerebral aneurysms were mostly of endodontic and periodontal origin, where Streptococcus mitis group DNA was the most common. We hypothesized that the genomes of S mitis group could be identified in thrombus aspirates of patients with lower limb arterial and deep venous thrombosis. METHODS: Thrombus aspirates and control blood samples taken from 42 patients with acute or acute-on-chronic lower limb ischemia (Rutherford I-IIb) owing to arterial or graft thrombosis (n = 31) or lower limb deep venous thrombosis (n = 11) were examined using a quantitative real-time polymerase chain reaction to detect all possible bacterial DNA and DNA of S mitis group in particular. The samples were considered positive, if the amount of bacterial DNA in the thrombus aspirates was 2-fold or greater in comparison with control blood samples. RESULTS: In the positive samples the mean difference for the total bacterial DNA was 12.1-fold (median, 7.1), whereas the differences for S mitis group DNA were a mean of 29.1 and a median of 5.2-fold. Of the arterial thrombus aspirates, 57.9% were positive for bacterial DNA, whereas bacterial genomes were found in 75% of bypass graft thrombosis with 77.8% of the prosthetic grafts being positive. Of the deep vein thrombus aspirates, 45.5% contained bacterial genomes. Most (80%) of bacterial DNA-positive cases contained DNA from the S mitis group. Previous arterial interventions were significantly associated with the occurrence of S mitis group DNA (P = .049, Fisher's exact test). CONCLUSIONS: This is the first study to report the presence of bacterial DNA, predominantly of S mitis group origin, in the thrombus aspirates of surgical patients with lower limb arterial and deep venous thrombosis, suggesting their possible role in the pathogenesis of thrombotic events. Additional studies will, however, be needed to reach a final conclusion.

Extended Serum Lipid Profile Predicting Long-Term Survival in Patients Treated for Abdominal Aortic Aneurysms.

BACKGROUND: Individuals treated for abdominal aortic aneurysms (AAAs) are high-risk patients in whom better risk prediction could improve survival. Contemporary serum lipid parameters, such as apolipoproteins and lipoprotein subfractions, may improve or complement the prognostic value of traditional serum lipids. The aim of this study was to ascertain the extended serum lipid profiles, long-term prognosis and their association in AAA patients. METHODS: Altogether 498 patients treated for AAAs and with available serum lipid values were retrospectively analysed. Contemporary lipid parameters were estimated using a neural network model, the extended Friedewald formula. RESULTS: Younger age, smoking and urgent or emergency surgery were associated with an unfavourable, and coronary disease and previous stroke with a favourable lipid profile. In multivariable analysis-in addition to advanced age, aneurysm rupture, smoking, pulmonary disease and diabetes-high triglycerides and traditional LDL cholesterol were significant independent risk factors for mortality, HR 1.84 (95% CI 1.20-2.81) and 1.79 (95% CI 1.18-2.73), respectively, while higher EFW-IDL cholesterol was associated with better survival, HR 0.31 (95% CI 0.19-0.65). Including serum lipid parameters improved the prediction of 5-year survival (NRI = 17.7%, p = 0.016). CONCLUSIONS: Extended serum lipid parameters complement risk prediction of patients treated for AAAs. An unfavourable lipid profile is associated with treatment of AAA earlier in life and with inferior long-term survival.

Muraglitazar-eluting bioabsorbable vascular stent inhibits neointimal hyperplasia in porcine iliac arteries.

PURPOSE: To evaluate the biocompatibility of a new muraglitazar-eluting polylactide copolymer stent and investigate its ability to prevent the formation of intimal hyperplasia. MATERIALS AND METHODS: Ten self-expandable muraglitazar-eluting poly-96 L/4D-lactic acid (PLA96) stents and 10 self-expandable control PLA96 stents were implanted into porcine common iliac arteries. After 28 days follow-up, all stent-implanted iliac arteries were harvested and prepared for quantitative histomorphometric analysis. RESULTS: Angiographic analysis revealed that one control PLA96 stent had occluded and one had migrated. Histomorphometric analysis demonstrated that, with the control PLA96 stent, the luminal diameter and area were decreased versus the muraglitazar-eluting PLA96 stents (means ± standard error of the mean, 3.58 mm ± 0.34 vs 4.16 mm ± 0.14 and 9.83 mm(2) ± 2.41 vs 13.75 mm(2) ± 0.93, respectively). The control PLA96 stent induced more intimal hyperplasia than the bioactive muraglitazar-eluting PLA96 stent (557 µm ± 122 vs 361 µm ± 32). Vascular injury scores demonstrated only mild vascular trauma for both stents (muraglitazar-eluting, 0.68 ± 0.07; control, 0.75 ± 0.08). Inflammation scores also showed mild inflammation for both stents (muraglitazar-eluting, 1.05 ± 0.17; control, 1.23 ± 0.19). CONCLUSIONS: This new muraglitazar-eluting PLA96 stent was shown to be biocompatible with a tendency for better patency and less intimal hyperplasia compared with the control PLA96 stents.

Independent factors predicting early lower limb intra-arterial thrombolysis failure.

BACKGROUND: Risk factors for early catheter-directed intra-arterial thrombolysis failure in acute lower limb ischemia remain unclear. METHODS: One hundred forty-nine limbs with acute artery or bypass graft thrombosis underwent catheter-directed thrombolysis (maximum of 48 hours). A retrospective data analysis was carried out to assess possible risk factors for early, 30-day treatment failure. RESULTS: Seventy-nine men (53%) and 70 women (47%) with a median age of 70 (range 32-93) years were treated. Treatment outcomes were determined as success (N = 115, 77%) or failure (N = 34, 23%). The failure criteria comprised rapid progression of ischemia (N = 4, 2.7%) and major bleeding complications (N = 2, 1.3%), both requiring thrombolysis termination and surgery. Inability to reopen native arteries/grafts (N = 10, 6.7%), run-off vessels (N = 10, 6.7%), in-hospital death (N = 4, 2.7%), the need for major amputation (N = 13, 8.7%), and reocclusions (N = 5, 3.4%) within the 30-day follow-up period were also considered as failures. Multivariate analysis of the risk factors' impact on the success of thrombolysis revealed such independent parameters as hypercholesterolemia (OR 0.16, 95% CI 0.06-0.42, P < 0.0001), previous bypass grafting of the ipsilateral limb (OR 0.18, 95% CI 0.06-0.53, P = 0.002), and duration of ischemia prior to the initiation of thrombolysis (OR 0.95, 95% CI 0.91-0.99, P = 0.009, per day). CONCLUSION: According to our results, factors independently predicting early failure include hypercholesterolemia, previous bypass grafting, and a delay in treatment initiation. Moreover, catheter-directed intra-arterial thrombolysis can be considered safe and effective in the treatment of acute lower limb ischemia.

The Safety and Effectiveness of the Prostar XL Closure Device Compared to Open Groin Cutdown for Endovascular Aneurysm Repair.

OBJECTIVE: The aim of this study is to compare the outcomes of percutaneous femoral closure with the Prostar XL for endovascular aneurysm repair (EVAR) to those of open femoral cutdown, and to evaluate factors which may predict the failure of percutaneous closure. METHODS: Patients undergoing endovascular aneurysm repair for an infrarenal abdominal aortic aneurysm between 2005 and 2013 were included. Patient characteristics, anatomic femoral artery measurements, and postoperative complications were recorded retrospectively. Operator experience was defined with a cut-off point of >30 Prostar XL closures performed. Comparisons were made per access site. RESULTS: A total of 443 access sites were included, with percutaneous closure used in 257 cases (58.0%) and open cutdown in 186 cases (42.0%). The complication rate was 2.7% for the percutaneous and 4.3% for the open cutdown group (P = .482). No significant differences between groups were found with respect to 30-day mortality, wound infections, thrombosis, seromas, or bleeding complications. Fourteen failures (5.4%) of percutaneous closure occurred. The success rates were similar for experienced and unexperienced operators (94.2% vs 95.5%, P = .768). Renal insufficiency was more common in the failed than in the successful percutaneous closure group (64.3% vs 24.7%, P = .003). Common femoral artery calcification or diameter, BMI, sheath size, or operator experience did not predict failure. No further complications were seen in follow-up CT at 1-3 years postoperatively. CONCLUSION: The use of the Prostar XL is safe compared to open cutdown. The success rate is 94.6%. Operator experience, sheath size, obesity, or femoral artery diameter or calcification do not appear to predict a failure of percutaneous closure. Complications seem to occur perioperatively, and late complications are rare.

Incidence, predictors, and prognostic impact of in-hospital serious adverse events in patients ≥75 years of age undergoing elective endovascular aneurysm repair.

BACKGROUND: This study sought to identify the factors associated with the occurrence of in-hospital serious adverse events after elective endovascular aortic repair (EVAR) in older patients within the Global Registry for Endovascular Aortic Treatment. METHODS: Consecutive patients ages ≥75 years who received GORE EXCLUDER AAA Endoprosthesis (W.L. Gore & Associates, Inc, Flagstaff, AZ) for elective EVAR. Based on the age at index elective EVAR, patients were categorized into 3 groups for subsequent analyses: those ages 75 to 79, 80 to 84, and ≥85 years. The primary end points for this study were the incidence of serious adverse events and all-cause mortality. In-hospital complications were defined according to the International Organization for Standardization 14155 standard (https://www.iso.org/standard/71690.html) and considered serious adverse events if they led to any of the following: (1) a life-threatening illness or injury, (2) a permanent impairment of a body structure or a body function, (3) in-patient or prolonged hospitalization, or (4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function. RESULTS: Overall, 1,333 older patients (ages 75-79: n = 601; 80-84: n = 474; and ≥85: n = 258) underwent elective EVAR in the Global Registry for Endovascular Aortic Treatment data set and were included in the present analysis. In total, 12 patients (0.9%) died perioperatively, and 103 patients (7.7%) experienced ≥1 in-hospital serious adverse event, with 18 patients (1.3%) experiencing >1 in-hospital complications. No significant differences were seen between the age groups in the rates of in-hospital serious adverse events (7.3% vs 8.2% vs 7.8%; P = .86). In logistic regression analysis, a history of chronic obstructive pulmonary disease (odds ratio = 2.014; 95% confidence interval, 1.215-3.340; P = .006) and prior requirement for dialysis (odds ratio = 4.655; 95% confidence interval, 1.087-19.928; P = .038) resulted as predictors for occurrence of in-hospital serious adverse events. In the whole cohort, the 5-year survival was 63% for patients who did not experience any in-hospital serious adverse events compared with 51% for those who experienced any complications (P = .003). Using multivariable Cox proportional hazards models, it was found that the occurrence of in-hospital serious adverse events (hazard ratio = 6.2; 95% confidence interval, 1.8-21.317; P = .003) and being underweight (hazard ratio = 7.0; 95% confidence interval, 1.371-35.783; P = .019) were the only independent predictors of death in ≤30 days from the initial intervention. Although age did not independently affect the risk for all-cause mortality in ≤180 days after the initial intervention, increasing age was associated with a higher risk for long-term death (ie, ≥181 days from index elective EVAR) in the multivariable analysis (ages 75-79: hazard ratio = 0.379; 95% confidence interval, 0.281-0.512; P < .001; and 80-84: hazard ratio = 0.562; 95% confidence interval, 0.419-0.754; P < .001). CONCLUSION: After elective EVAR in older patients (ie, ≥75 years), the occurrence of in-hospital serious adverse events appears to increase the risk of death, particularly in ≤180 days after the initial elective EVAR intervention, and might be related to patient baseline characteristics, including history of pulmonary and renal disease.

Long-term experience of endovascular aneurysm repair with Zenith prosthesis: diminishing graft-related complications over time.

BACKGROUND: Only limited data on the long-term results after endovascular aneurysm repair exist to date. MATERIALS: Data on 282 patients with an abdominal aortic aneurysm treated with a Zenith endoprosthesis between March 2000 and March 2010 were retrospectively analyzed from a prospective database. Operative, total, and aneurysm-related mortality was assessed, as were graft-related complications and reinterventions. RESULTS: All procedures were performed successfully without primary conversions. Median follow-up was 40 months (range: 1-119 months). Thirty-day mortality was 1.4%, and aneurysm-related mortality was 0.7%. Cumulative survival was 62% at 5 years and 52% at 8 years. Graft-related complications occurred in 107 (38%) patients. The most common finding was a type II endoleak (n = 73) that sealed mainly spontaneously (n = 46, 63%). Most endoleaks, and complications in general (87%), appeared during the first 3 years of follow-up, and no events occurred after 6 years. Altogether, 59 additional procedures, mainly embolizations (n = 35), in 38 patients (24%) were required owing to graft-related complications. Of all the reinterventions, 82% were performed during the first 4 years, and no new complications were treated after 6 years. CONCLUSION: Complications and reinterventions related to endovascular aneurysm repair become practically nonexistent after 5 to 6 years. This finding suggests that a lifelong follow-up may not always be needed after treatment with a Zenith endoprosthesis.

Challenging treatment of multiple late complications after endovascular aneurysm repair.

BACKGROUND: To report a case of multiple additional procedures after successful endovascular treatment of abdominal aortic aneurysm. METHODS: An endovascular abdominal aortic aneurysm repair with a bifurcated aortic Vanguard endograft successfully performed in 1999 resulted in multiple complications, including endoleaks and a row separation, treated endovascularly. Subsequently, tuberculosis sepsis and prosthesis infection resulted in long-term antibiotic treatment. Additional graft leaks, aneurysm sack growth, and sack ruptures were also treated endovascularly because the patient consistently denied open repair. Endovascular procedures, however, did not solve the problem, turning to be increasingly challenging. The patient finally approved open graft removal and aortobifemoral reconstruction that were successfully performed 11 years after the initial endograft implantation. RESULTS: The patient has recovered from surgery well and is asymptomatic. No evidence of bacterial colonization was found according to the specimen taken during the laparotomy. CONCLUSION: Vanguard and other first-generation aortic endografts are associated with high incidence of complications and reinterventions. Open surgery is a method of choice in similar cases.