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.

Multivariable Analysis of Pre-operative Brain Atrophy as a Predictor of Long Term Mortality After Carotid Endarterectomy.

OBJECTIVE: Brain atrophy is associated with an increased mortality rate in elderly trauma patients and in patients treated with mechanical thrombectomy for acute ischaemic stroke. In the setting of ischaemic stroke, the association between brain atrophy and death is stronger than that of sarcopenia. It has previously been shown that lower masseter area, as a marker of sarcopenia, is linked to lower survival after carotid endarterectomy (CEA). The aim of this study was to investigate whether brain atrophy is also associated with long term mortality in patients undergoing CEA. METHODS: A cohort of patients treated with CEA between 2004 and 2010 was retrieved from the Tampere University Hospital vascular registry and those with available pre-operative computed tomography (CT) imaging were analysed retrospectively. CT images were evaluated for brain atrophy index (BAI) and masseter muscle surface area and density. The association between BAI and mortality was investigated with Cox regression. RESULTS: Two hundred and thirty-three patients with a median (interquartile range [IQR]) age of 71 years (64.0, 77.0) were included. Most patients were operated on for symptomatic stenosis (n = 203; 87.1%). The median (IQR) duration of follow up was 115.0 months (66.0, 153.0), and 155 patients (66.5%) died during follow up. BAI was statistically significantly correlated with age (r = .489), average masseter density (r = -.202), and smoking (r = -.186; all p <.005). Increased BAI was statistically significantly associated with overall mortality (hazard ratio [HR] 1.45, 95% confidence interval [CI] 1.25 - 1.68, per one standard deviation [SD] increase) in the univariable analysis, and the association remained (HR 1.23, 95% CI 1.04 - 1.46, per one SD increase) in the multivariable models. Age, peripheral artery disease, and chronic obstructive pulmonary disease were also independently associated with mortality. The optimal cutoff value for BAI was 0.133. CONCLUSION: Brain atrophy independently predicts the long term post-operative mortality rate after CEA in a cohort containing mainly symptomatic patients. Future studies are needed to validate the results in prospective settings and in asymptomatic patients.

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.

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.

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.

Statin use, development of sarcopenia, and long-term survival after endovascular aortic repair.

OBJECTIVE: Statin therapy, associated with improved short-term survival after treatment of abdominal aortic aneurysms, may also predispose to muscle side effects. Evidence on statin-related sarcopenia is limited mainly to muscle function, and it is subject to several sources of bias. In the long term, postoperative development of sarcopenia is linked to mortality after endovascular repair (EVAR). We investigated statin use and long-term postoperative mortality after EVAR in relation to objective measurable markers of sarcopenia (psoas muscle surface area and density). METHODS: Altogether 216 abdominal aortic aneurysm patients treated with EVAR between 2006 and 2014 at Tampere University Hospital (Finland) were retrospectively studied. Psoas muscle parameters at the L3 level were evaluated from baseline and mainly 1- to 3-year follow-up computed tomography studies. Cox regression was used to study the association between statin medication, psoas muscle changes, and all-cause mortality. RESULTS: The majority of patients were male (87%), and the mean age was 77.7 years (standard deviation, 7.4). The median duration of follow-up was 6.3 years (interquartile range, 3.5) with a total mortality of 54.2% (n = 117). Regardless of a higher burden of comorbidities, statin users (n = 119) had lower mortality when compared with nonusers (multivariable hazard ratio [HR]: 0.69, 95% confidence interval: 0.48-0.99, P = .048). Furthermore, statin use was not associated with inferior muscle parameter values, and the relative change in psoas muscle area was actually lower in statin users compared with nonusers (-15.7% and -21.1%, P < .046). CONCLUSIONS: Statin use is associated with lower long-term mortality among patients undergoing EVAR without predisposing to increased sarcopenia.

Association of masseter area and radiodensity with three-month survival after proximal anterior circulation occlusion.

BACKGROUND: Masseter area (MA), a surrogate for sarcopenia, appears to be useful when estimating postoperative survival, but there is lack of consensus regarding the potential predictive value of sarcopenia in acute ischemic stroke (AIS) patients. We hypothesized that MA and density (MD) evaluated from pre-interventional CT angiography scans predict postinterventional survival in patients undergoing mechanical thrombectomy (MT). MATERIALS AND METHODS: 312 patients treated with MT for acute occlusions of the internal carotid artery (ICA) or the M1 segment of the middle cerebral artery (M1-MCA) between 2013 and 2018. Median follow-up was 27.4 months (range 0-70.4). Binary logistic (alive at 3 months, OR <1) and Cox regression analyses were used to study the effect of MA and MD averages (MAavg and MDavg) on survival. RESULTS: In Kaplan-Meier analysis, there was a significant inverse relationship with both MDavg and MAavg and mortality (MDavg P<0.001, MAavg P=0.002). Long-term mortality was 19.6% (n=61) and 3-month mortality 12.2% (n=38). In multivariable logistic regression analysis at 3 months, per 1-SD increase MDavg (OR 0.61, 95% CI 0.41 to 0.92, P=0.018:) and MAavg (OR 0.57, 95% CI 0.35 to 0.91, P=0.019) were the independent predictors associated with lower mortality. In Cox regression analysis, MDavg and MAavg were not associated with long-term survival. CONCLUSIONS: In acute ischemic stroke patients, MDavg and MAavg are independent predictors of 3-month survival after MT of the ICA or M1-MCA. A 1-SD increase in MDavg and MAavg was associated with a 39%-43% decrease in the probability of death during the first 3 months after MT.

Brain atrophy predicts mortality after mechanical thrombectomy of proximal anterior circulation occlusion.

BACKGROUND: Brain atrophy is associated with an inferior functional outcome in patients undergoing mechanical thrombectomy (MT) for acute ischemic stroke. We hypothesized that brain atrophy determined from pre-interventional non-contrast-enhanced CT scans would also be linked to increased mortality in this cohort. METHODS: A total of 204 patients treated with MT for acute occlusions of the internal carotid artery (ICA) or the M1 segment of the middle cerebral artery (M1) at Tampere University Hospital, Finland between 2013 and 2017 were retrospectively studied. Brain atrophy index (BAI), masseter muscle surface area and density, chronic ischemic lesions, and white matter lesions were evaluated from pre-interventional CT studies. Logistic regression was applied in analyzing the association of BAI with 3-month mortality. RESULTS: Median age at baseline was 69.9 years (IQR 15.6) and mortality at 3 months was 13.2% (n=27). BAI, measured with excellent reproducibility (intraclass correlation coefficient ≥0.894, p<0.001), was significantly associated with age (r=0.54), white matter lesions (r=0.43), dental status (r=-0.31), masseter area (r=-0.24), masseter density (r=-0.28), and chronic ischemic lesions (r=0.24) (p≤0.001 for all). In univariable analysis, BAI demonstrated a strong association with mortality (OR 2.02, 95% CI 1.34 to 3.05, per 1 SD increase), and none of the other factors associated with mortality remained as significant when included in the same multivariable model. The results remained similar when extending the follow-up up to 2.5 years. CONCLUSIONS: Brain atrophy predicts 3-month mortality after MT of the ICA or the M1 independent of age, masseter sarcopenia, chronic ischemic lesions, or white matter lesions.

Developing sarcopenia predicts long-term mortality after elective endovascular aortic aneurysm repair.

BACKGROUND: Preoperatively detected sarcopenia as reflected by psoas muscle area (PMA) is associated with postoperative mortality after abdominal aortic aneurysm (AAA) repair. We studied, whether changes in PMA and lean PMA (LPMA) after endovascular aortic repair (EVAR) are associated with postoperative survival. METHODS: In 122 AAA patients treated between 2008 and 2016 (90% male; median age, 77.8 years; interquartile range, 11.5; rupture 2.5%) PMA and LPMA at L3 level were measured retrospectively from preoperative and 1- and 3-year follow-up computed tomography (CT) studies. The median duration of follow-up was 6.0 years (interquartile range, 3.5) and all-cause mortality was 46.7%. Association of radiologic muscle parameters with all-cause mortality was evaluated with Cox regression. Clinical data were collected from an institutional database and patient record databases. RESULTS: There was a significant decrease in PMA and LPMA at L3 level (mean, -4.4 cm2 [-26.8%] for PMA and -130.4 cm2 × Hounsfield units [-21.6%] for LPMA, respectively; P < .001) and the greatest decline occurred during the first postoperative year after EVAR. Relative PMA change during follow-up (ΔPMA/baseline CT muscle parameter) was independently associated with mortality in multivariable analysis (hazard ratio, 0.977 for a 1% unit increase; 95% confidence interval, 0.960-0.995; P = .011). CONCLUSIONS: The most significant loss of skeletal muscle occurs during the first year after EVAR. The relative change in PMA from baseline is an independent predictor of mortality. For every 10% unit increase in ΔPMA/baseline CT muscle parameter bilaterally, there was a 21% decrease in the probability of death during follow-up. Early detection (from CT studies) and prevention of sarcopenia may potentially improve survival in EVAR-treated patients.

TREVO and Capture LP have equal technical success rates in mechanical thrombectomy of proximal and distal anterior circulation occlusions.

PURPOSE: Mechanical thrombectomy (MT) is a proven method to treat large vessel occlusions in acute anterior circulation stroke. We compared the technical, imaging, and clinical outcomes of MT performed with either TREVO or Capture LP devices. METHODS: There were 42 and 43 patients in the TREVO and Capture LP groups, respectively. Baseline variables, technical outcome (Thrombolysis In Cerebral Infarction, TICI), 24 hours imaging outcome, and 3-month clinical outcome (modified Rankin Scale, mRS) were prospectively recorded. The patients were stratified according to clot location, groups compared, and logistic regression models devised to study the effect of device selection on the clinical outcome. RESULTS: The technical success rates were equal in both proximal (internal carotid artery and proximal M1 segment) and distal occlusions (distal M1 and M2 segments). The proportion of TICI 2b or 3 was 96% and 87% with TREVO and 87% and 89% with Capture LP (p=0.25 and p=0.80, respectively). Device selection did not significantly predict good clinical outcome (mRS ≤2) in either proximal or distal occlusions. In multivariate analysis, selecting Capture LP borderline significantly increased the odds of an excellent outcome close to sixfold both in proximal and distal occlusions (OR 6.7, 95% CI 0.82 to 53.7, p=0.08 and OR 5.7, 95% CI 0.88 to 37.8, p=0.07, respectively). CONCLUSIONS: TREVO and Capture LP perform equally well in proximal and distal occlusions in the anterior circulation when technical and good clinical outcome are considered. Capture LP may have a small advantage in reaching mRS ≤1 at 3 months. However, this needs to be confirmed in a randomized study.