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.

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.

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.

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.

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.

Oral Dipyridamole-Associated Circulatory Collapse.

Extended-release dipyridamole plus aspirin is widely used for secondary prevention of ischemic stroke, although the molecular pharmacodynamics of dipyridamole are not completely determined. Adverse effects of fixed-dose combination of aspirin and dipyridamole include headache, bleeding, and gastrointestinal events. Previously, intravenous infusion of dipyridamole in cardiac stress testing has been associated with cardiogenic shock and pulmonary edema. Herein, we report a case study of a 72-year-old man, presented with a transient ischemic attack who suffered a circulatory collapse after an oral dose of 200 mg extended-release dipyridamole. The possible molecular mechanisms of dipyridamole on the cardiovascular system are reviewed. This is the first case report of a circulatory collapse induced by an oral intake of dipyridamole.

Hybrid Repair of Thoracoabdominal Aortic Aneurysms Is a Durable Option for High-Risk Patients in the Endovascular Era.

OBJECTIVE: To report our long-term experience in using the hybrid technique in complex thoracoabdominal aortic aneurysms (TAAAs). METHODS: Between March 2005 and September 2013, 10 patients with TAAA underwent hybrid procedures with open renovisceral revascularization and thoracoabdominal aortic endografting. Patients were analyzed retrospectively. RESULTS: Six men and 4 women with a mean age of 66 years (range 54-81 years) were treated electively during the study period. All 4 visceral vessels were revascularized in 8 patients, whereas 1 patient underwent 3-vessel revascularization and another 2-vessel revascularization. The primary technical success rate was 100%. Eight of the procedures were single staged, and the 2 most recent cases were performed in 2 stages. Perioperative and 30-day mortality was 0%. The mean follow-up was 55 months (4-133 months). None of the patients died due to aortic complications. Major complications included paraplegia (10%, n = 1) and bowel ischemia (n = 1). Postoperative cerebrospinal fluid (CSF) pressure and mean arterial pressure measurements were systematically monitored and corrected. The CSF drainage solved another 4 cases of paraparesis. Three patients required postoperative dialysis, but none of them required permanently. Postoperative spinal cord ischemia and renal complications accumulated in extensive TAAA cases. One renal graft was occluded 45 days after the initial procedure but was successfully treated with thrombolysis. One type I and 1 type III endoleak were noted and successfully treated with an additional stent graft. Two cases of type II endoleak were detected-one with a growing aneurysm sac was treated successfully and another showed no growth and further procedures were abandoned after 2 embolization attempts. In long-term follow-up, 90% of the aneurysms showed shrinkage by a mean of 23 mm (range 7-45 mm). CONCLUSION: The results of hybrid repair on high-risk patients with complex TAAAs are encouraging, and this approach is a valuable alternative when branched and fenestrated endovascular techniques are not considered an option.

Long-Term Experience of Endovascular Repair for Thoracic Aortic Aneurysms and Dissections.

PURPOSE: To report the long-term results of thoracic endovascular aortic repair (TEVAR) in both elective and emergency cases of thoracic aortic aneurysm (TAA) and type B dissection. MATERIAL AND METHODS: A prospective single-center study of 78 TEVAR patients treated between February 1998 and February 2013. Stent-graft implantation was performed in 51 (65%) patients for TAA (43 elective and 8 emergency cases) and in 27 (35%) patients for type B dissection (11 elective and 16 emergency cases). Short- and long-term results were evaluated, and a subgroup of patients with left subclavian artery (LSA) coverage was also analyzed. RESULTS: The patients were followed for a mean of 55 months (1-160 months). The technical success rate was 81% and 30-day mortality 6.4% (n = 5). The stroke rate was 7.7% (n = 6) and permanent paraparesis 2.6% (n = 2). In follow-up, there were 28 (36%) primary (15 type I and 13 type II) and 10 secondary endoleaks (8 type I and 2 type II). Multivariate analysis showed no significant predictive factors for developing a type I endoleak. Secondary interventions were required in 24% of the patients. There was 1 late thoracic aortic rupture and 1 late conversion (1.3%). Patients with LSA coverage had a higher incidence of stroke (12.5% vs 4.3%, P = .18) and paraparesis (3.1% vs 2.2%, P = .79) compared to those without LSA coverage, although this difference was not statistically significant. Stroke rates were significantly higher in patients treated in an emergency setting (P = .048). CONCLUSION: Thoracic endovascular aortic repair is a relatively safe and effective therapy for different aortic pathologies with good long-term success. The risk of stroke and paraparesis is notable whether the LSA is covered, and strokes clearly accumulate in the emergency setting. A type I endoleak is the most common complication, but there are no predictive factors for its development.

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.

Dexamethasone-eluting vascular stents.

Percutaneous transluminal angioplasty (PTA) with stenting is widely used in the treatment of vascular disorders, but restenosis remains a significant problem. Drug-eluting stents (DES) have been developed as an attempt to reduce the intimal response leading to restenosis. Drugs used in DES include mainly immunosuppressive and anti-proliferative compounds. Glucocorticoids are also an interesting possibility for those purposes because they have anti-proliferative effects in vascular smooth muscle cells and down-regulate the production of cytokines and growth factors driving inflammation and fibrosis. In this MiniReview, feasibility and safety of drug-eluting metal and biodegradable vascular stents are discussed with special emphasis on dexamethasone-eluting stents.

Effect of triclosan-coated sutures on the incidence of surgical wound infection after lower limb revascularization surgery: a randomized controlled trial.

BACKGROUND: Surgical wound infection (SWI) is a common complication after peripheral vascular surgery. In a prospective study, triclosan-coated sutures were reported to decrease the incidence of surgical site infection after various surgical procedures. The aim of our study was to test the hypothesis that use of triclosan-coated sutures decreases the incidence of SWI after lower limb vascular surgery. METHODS: This prospective, randomized, multicenter, double-blinded trial was conducted between July 2010 and January 2011 in five hospitals in Finland. We randomly allocated 276 patients undergoing lower limb revascularization surgery to a study (n = 139) or a control (n = 137) group. Surgical wounds in the study group were closed with triclosan-coated suture material, and wounds in the control group were closed with noncoated sutures. The main outcome measure was SWI. A surgical wound complication was considered to be an infection if there were bacteria isolated from the wound or if there were areas of localized redness, heat, swelling, and pain around the wound appearing within 30 days after the operative procedure. Logistic regression analysis was used to assess the independent effect of triclosan-coated sutures on the incidence of SWI. RESULTS: Altogether, 61 (22.1 %) patients developed SWI. SWI occurred in 31 (22.3 %) patients in the study group and in 30 (21.9 %) patients in the control group (odds ratio 1.10, 95% confidence interval 0.61-2.01, p = 0.75.) CONCLUSIONS: The use of triclosan-coated sutures does not reduce the incidence of SWI after lower limb vascular surgery.

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.

Preclinical evaluation of new indomethacin-eluting biodegradable urethral stent.

PURPOSE: To evaluate the effect of an indomethacin-eluting biodegradable urethral stent on the production of inflammatory cytokines in vitro and the degradation and biocompatibility of the new stent in vivo. MATERIALS AND METHODS: The effects of an indomethacin and indomethacin-eluting biodegradable stent on monocyte chemoattractant protein (MCP)-1, RANTES (regulated on activation, normal T-cell expressed and secreted), and transforming growth factor-ß were measured in THP-1 cells by enzyme-linked immunosorbent assay. Stents (copolymer of L-lactide and glycolide acid) that were coated with 50L/50D polylactic acid and two different concentrations of indomethacin were inserted into the rabbit urethra. Stents without the drug were used as controls. Scanning electron microscopy (SEM) was used to assess the degradation of the stents. Biocompatibility was evaluated using histologic analyses of the urethral specimen. The measurements were performed at 3 weeks and 3 months. RESULTS: Indomethacin and indomethacin-releasing stent material inhibited MCP-1 and RANTES production in activated THP-1 macrophages. SEM analysis revealed that indomethacin coating had no effect on the degradation process of the stents and less epithelial polyposis had developed in the indomethacin stent group. In histologic analyses at 3 weeks, indomethacin-eluting stents caused more calcification but no significant differences in other tissue reactions. At 3 months, the indomethacin-eluting stents caused less inflammatory reaction and calcification compared with the control stents. CONCLUSION: Indomethacin-eluting property can be safely added to biodegradable stents without major influence on the degradation time. The development of epithelial polyposis in the urethra can be potentially reduced by the new indomethacin-eluting urethral stents.

[Subclavian steal syndrome]. / Subclavian steal -oireyhtymä.

Subclavian steal syndrome is a circulatory disorder usually caused by atherosclerosis and accompanied by ischemic symptoms of the vertebrobasilar region and the hand. In many cases, significant vascular lesions are found also in other arteries. In more than 80% of cases the blood vessel lesion is on the left, and a significant stenosis or occlusion causes an inter-arm pressure gradient of > 20 mmHg, resulting in retrograde blood flow of the ipsilateral vertebral artery. In local stenosis, conservative treatment can be combined with an intravascular procedure, and in occlusions or other arterial lesions requiring operative treatment, with bypass surgery.

Biocompatibility of new drug-eluting biodegradable urethral stent materials.

OBJECTIVES: To investigate the effects of biodegradable stent material (poly-96L/4D-lactic acid [PLA]) on the production of cytokines and other inflammatory mediators in vitro and the biocompatibility of new drug-eluting biodegradable urethral stent materials in vivo. Indomethacin, dexamethasone, and simvastatin were used in the materials. METHODS: The effects of the biodegradable stent material on cytokines and other inflammatory mediators were measured using the Human Cytokine Antibody Array and enzyme-linked immunosorbent assay in THP-1 cells, with bacterial lipopolysaccharide as a positive control. To assess the biocompatibility of the stent materials, we used muscle implantation. Biodegradable stent materials without drug-eluting properties and silicone and latex were used as controls. The measurements were done at 3 weeks and 3 months. RESULTS: The PLA stent material induced production of inflammatory mediators, especially interleukin-8, tumor necrosis factor-alpha, and transforming growth factor-beta, in vitro. The increase in the production of these mediators with the PLA stent material was smaller than in the cells treated with lipopolysaccharide. In vivo, the effects of the biodegradable materials did not differ at 3 weeks, although, at 3 months, dexamethasone had induced more tissue reactions than had the other materials. At 3 months, fibrosis and chronic inflammatory changes were decreased in the biodegradable material groups compared with the positive control. CONCLUSIONS: PLA stent material increased the production of cytokines and other inflammatory mediators less than did positive controls in vitro. The in vivo biocompatibility of the drug-eluting biodegradable materials was better than that of the positive controls. Drug-eluting biodegradable urethral stents could potentially offer a new treatment modality in the future.