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.

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.

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.

Endovascular Repair of Abdominal Aortic Aneurysms is a Valid Alternative to Open Repair also in Patients Treated Outside of Instructions for Use Criteria.

PURPOSE: It remains unclear whether endovascular aneurysm repair, in the long term, is less effective than open surgery due to need for reinterventions and close monitoring. We aimed to evaluate this matter in a real-life cohort. METHODS: We collected consecutive patients treated with EVAR or OSR between January 2005 and December 2013. Primary outcomes were 30-day, 90-day and long-term all-cause mortality. Secondary outcomes were 30-day reintervention rate and reintervention-free survival. We evaluated also a subpopulation who did not adhere to IFU. RESULTS: The inclusion criteria were met by 416 patients. 258 (62%) received EVAR, while 158 (38%) underwent OSR. The 30- or 90-day mortality was similar between groups (p = 0.272 and p = 0.346), as ARM (p = 0.652). The 30-day reintervention rate was higher in the OSR group (p < 0.001), but during follow-up, it was significantly higher in the EVAR group (log-rank: 0.026). There were 114 (44.2%) non-IFU patients in the EVAR group, and we compared them with OSR group. There was no significant difference in all-cause mortality at 30 or 90 days, nor in the long term (p = 1; p = 1 and p = 0.062). ARM was not affected by the procedure technique (p = 0.136). The short-term reintervention rate was higher in the OSR group (p = 0.003), while in the long-term EVAR, patients experienced more reinterventions (log-rank = 0.0.43). CONCLUSION: No significant difference in survival was found between EVAR and OSR, independent of adherence to IFU. EVAR may be considered for surgical candidates.

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.

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.

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

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

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.

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.

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.

Risk of symptomatic venous thromboembolism after abdominal aortic aneurysm repair in long-term follow-up of 1021 consecutive patients.

OBJECTIVE: Venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism (PE), is an infrequent but consequential and potentially preventable complication after major surgical procedures. The aim of the study was to describe the long-term occurrence of symptomatic VTE in patients undergoing abdominal aortic aneurysm (AAA) repair and to ascertain patient-specific risk factors as well as to compare the rate with that of a reference population. METHODS: The study included all patients who had undergone endovascular or open AAA repair, both elective and urgent/acute cases, at the Tampere University Hospital (Finland) between February 2001 and December 2016; 59% of patients had undergone endovascular and 41% open repair, and 23% of all cases had required urgent or emergency treatment. Information about later treatment episodes for symptomatic VTE and survival data were obtained from national registries. The reference population was obtained from national registries with a random sample of inhabitants matched for age, sex, and location of residence with a 4:1 ratio and was analyzed similarly. RESULTS: Altogether, 1021 patients and 4065 controls were included (88% male; median age, 74 years in both groups). The high-risk period for VTE lasted for approximately 3 months, and during that time, its occurrence was highest in patients with coronary disease (2.5%), after open repair (2.4%), and in an urgent or emergency setting (2.6%), whereas the rate was low after endovascular aneurysm repair (1.0%). The cumulative incidence of VTE at 3 months, 1 year, 3 years, and 5 years was 1.1%, 1.6%, 2.7%, and 4.5% in patients and 0.1%, 0.3%, 1.0%, and 1.8% in the reference population, respectively (P < .001 each). Most VTE events were PE in the patient group. The 5-year mortality rates were 37.9% in patients and 23.8% in controls (P < .001). CONCLUSIONS: The incidence of symptomatic VTE, particularly PE, after AAA repair is significant, in both short-term and long-term follow-up. Open surgery, acute setting, and concomitant coronary disease appear to increase the risk.

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.

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.

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.

Lower Limb Pulse Rise Time as a Marker of Peripheral Arterial Disease.

OBJECTIVE: The aim of the study was to show if pulse rise times (PRTs) extracted from photoplethysmographic (PPG) pulse waves (PWs) have an association with peripheral arterial disease (PAD) or its endovascular treatment, percutanoeus transluminal angioplasty (PTA) of the superficial femoral artery. METHODS: Lower and upper limb PPG PWs were recorded and analyzed from 24 patients who suffered from PAD. The measurements were conducted before and after the treatment, and one month later by using transmission-mode PPG-probes placed in the index finger and second toe. Ankle-to-brachial pressure index and toe pressures were used as references in clinical patient measurements. PRTs, i.e., the time from the foot point to the peak point of the PW, were extracted from the PWs and compared bilaterally. The results from the PAD patients were also compared with 31 same-aged and 34 younger control subjects. RESULTS: Statistically significant differences were found between the pretreatment PRTs of the treated limb of the PAD patients and the same-aged control subjects ( , Mann-Whitney U-test). The changes in the PRT of the treated lower limb were observed immediately after the PTA ( , Student's t-test), and after one month ( ), whereas the PRTs of the non-treated lower limb and upper limb did not indicate changes between different examinations. CONCLUSION: Results show that a PRT greater than 240 ms indicates PAD-lesions in the lower limb. SIGNIFICANCE: This proof-of-concept study suggests that the PRT could be an effective and easy-to-use indicator for PAD and monitoring the effectiveness of its treatment.

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.

Effects of Percutaneous Transluminal Angioplasty of Superficial Femoral Artery on Photoplethysmographic Pulse Transit Times.

We analyze the changes in upper and lower limb pulse transit times (PTT) caused by peripheral artery disease (PAD) and its treatment with percutaneous transluminal angioplasty (PTA) of the superficial femoral artery. PTTs were extracted from the photoplethysmograms (PPG) recorded from an index finger and 2nd toes. PTTs were defined between the R-peaks of the ECG and different reference points of the PPG: foot and peak points, maxima of 1st and 2nd derivative, and by means of intersecting tangents method. Also the PTTs between the toe and finger pulses were analyzed. Our sample consists of 24 subjects examined before and after the PTA and in 1-month follow-up visit. Also 28 older than 65 years controls having normal ankle-to-brachial pressure index (ABI) and no history in cardiovascular diseases as well as 21 younger subjects were examined. The differences between the groups and pre- and post-treatment phases were analyzed by means of non-parametric statistical tests. The changes in the PTTs of upper limb and non-treated lower limb were negligible. The agreement with the reference values, ABI and toe pressures, was studied by kappa-analysis, resulting in kappa-values of 0.33-0.91. Differences in PTTs were found between pre-treatment state of the treated limb, post-treatment state and the follow-up visit, as well as between the pre-treatment state and controls. If patients' age and systolic blood pressure were taken into consideration, the method of lower limb PTT calculation from the peak point turns out feasible in finding the markers of PAD and monitoring post-treatment vascular remodellation.

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.