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Introduction: Deep venous thrombosis treatment using catheter-directed thrombolysis is advocated over systemic thrombolysis because it reduces bleeding complications. With the development of a catheter that combines ultrasound vibrations and the local delivering of thrombolytics, new and safer treatments appear that are suitable for more complex problems. Report: An adolescent male presented with bilateral iliofemoral thrombosis based on a hypoplastic inferior vena cava that had existed for more than two weeks. He was succesfully treated by bilateral ultrasound-accelerated catheterdirected thrombolysis using EkoSonic® (Small Vessel) Endovascular System (EKOS) and stenting of the inferior vena cava. After eight months of follow-up, the inferior vena cava is still patent. Conclusion: EKOS thrombolysis of longer existing bilateral deep venous thrombosis in the central venous system is a succesful treatment modality in congenital inferior vena cava anomalies. [ABSTRACT FROM AUTHOR]

Objective: This study aims to compare the 5-year outcomes of endoluminal bypass (EB) using heparin-bonded self-expanding covered stents versus bypass surgery for extensive femoropopliteal disease, including technical and clinical outcomes and health status., Background: The surgical femoropopliteal bypass was the gold standard to treat peripheral arterial disease (PAD) for decades; however, endovascular treatment modalities are now recommended for most femoropopliteal lesions. One-year data of a randomized controlled trial comparing EB with surgical bypass (SB) have shown a faster recovery, less morbidity, and comparable patency rates between the two techniques. To date, long-term randomized controlled data regarding both techniques are lacking., Methods: Five-year results of a multicenter randomized controlled trial comparing EB with SB in patients with femoropopliteal artery disease were evaluated based on intention-to-treat and per-protocol analyses., Results: At 5-year follow-up, primary, primary-assisted, and secondary patency rates were 36.2%, 52.4%, and 68.1% for EB and 49.4%, 72.2%, and 77.8% for SB, respectively (p=0.608). Freedom from target lesion revascularization (fTLR) was 34.1% for EB and 57.6% for SB (p=0.365). In both groups, the ankle-brachial index, Rutherford classification, and walking distance significantly improved compared with baseline without differences between groups at follow-up. Freedom from major amputation rate was 92.6% in the EB group and 96.2% in the SB group (p=0.361). The 36-Item Short-Form Health Survey showed no significant differences between groups., Conclusion: Treatment of extensive femoropopliteal disease with self-expanding covered stents provides comparable clinical-related and health-related questionnaire outcomes when compared with SB through 5 years of follow-up. However, the EB is related to a higher number of reinterventions., Clinical Impact: This present study is the first to report five-year outcomes comparing an endoluminal (EB) using heparin-bonded self-expanding covered stents with surgical bypass (SB) for long and complex femoropopliteal disease. Although the advantages of treatment with EB are mostly seen in the early period after treatment, the outcomes support the use of EB for this indication and seems to be a valid and safe alternative for bypass surgery. Future trials comparing various endovascular strategies may provide further guidance for the development of an evidence-based treatment algorithm., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This is an investigator-sponsored study supported in part by W.L. Gore and Associates. Dr Reijnen IS consulting for W.L. Gore and Associates. Dr van Walraven has received speakers fees from W.L. Gore and Associates. Dr Zeebregts recieved research grants from W.L.gore and Associates. All other authors have reported that they have no relationships relevant to the contents of the paper to disclose.

Purpose: The gold standard for the treatment of complex (TASC II C and D) atherosclerotic aortoiliac lesions is still open surgical repair. Endovascular techniques have a lower mortality and morbidity rate but this comes at the cost of worse patency rates when compared with open repair. Improved short- and mid-term results have been reported using the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. The aim of this study was to report our initial experience with the CERAB technique and report long-term patency rates., Materials and Methods: All patients treated with the CERAB technique between 2012 and 2018 were prospectively registered in an institutional database and included in this study. Patient demographics, characteristics, symptoms, procedural, and follow-up details were collected and analyzed retrospectively. Perioperative complications and reinterventions were also identified. The Kaplan-Meier survival method was used to assess cumulative rates of patency., Results: A total of 44 patients were treated with the CERAB technique and included in this study. The majority of the treated aortoiliac occlusions were classified as complex: TASC II C (n=7; 15.9%) or TASC II D (n=25; 56.8%). Primary patency rate at 60 months was 83.3%, assisted primary patency was 90.9% and secondary patency 95%. No significant differences were found in patency rates comparing noncomplex (TASC II A and B) and complex (TASC II C and D) aortoiliac lesions. Seven patients (15.9%) required at least one additional procedure to maintain either assisted primary patency or secondary patency during follow-up. The 30-day complication rate in this series was 20.5% (n=9), of which 55.6% (n=5) were minor complications. All major 30-day complications (n=4) occurred during or directly after the CERAB procedure. Thirty-day mortality was 0%. No limb occlusions occurred within 30 days of the procedure., Conclusion: Good long-term patency rates can be achieved with the CERAB technique to treat aortoiliac stenosis or occlusions while maintaining advantages associated with endovascular interventions. This remains true even when a CERAB is used to treat complex aortoiliac lesions. An endo-first approach to treat complex aortoiliac lesions seems viable.

Background: Endovascular aneurysm repair (EVAR) has become the preferred treatment for infrarenal abdominal aortic aneurysms (AAA) over open surgical repair. The Endurant stent graft is widely used, and large registries report low rates of aneurysm-related mortality and reinterventions at midterm follow-up. Reports of long-term follow-up are limited. The aim of this study is to report our experiences and share our results, reintervention rate and mortality at long-term follow-up after using the Endurant stent graft., Methods: All consecutive patients treated between 2009 and 2013 with the Medtronic Endurant I and II stent graft for an infrarenal AAA in an elective setting were included. Primary outcomes were overall and aneurysm-related survival and reintervention rates., Results: One hundred sixty-five consecutive patients (median age 74; IQR: 68-79) with an aneurysm diameter of 62 mm (IQR: 58-70) and neck length of 29 mm (IQR: 21-40) were electively treated with the Endurant I or II stent graft. One hundred thirty-four patients (81.2%) were treated inside IFU (instructions for use) and 31 (18.8%) outside IFU. At median follow-up of 76 months (IQR: 50-97), 60 patients (36.4%) were deceased. Kaplan-Meier estimates at 10 years follow-up of overall survival and freedom from aneurysm-related mortality were respectively 48.5% (CI: 43.7-53.3%) and 97.3% (CI: 95.7-98.9%). Freedom from reintervention was 86.0% with an CI: 83.1-88.9% at 5 years follow-up and 75.6% with a CI: 70.2-81.0% at 10 years follow-up. A total of 25 (15.2%) patients had an EVAR-related reintervention; indications were endoleak (EL) type 1A (N.=11), EL type 1B (N.=3), EL type 2 (N.=6), EL type 3 (N.=1) and limb occlusion (N.=4). We found no significant differences in outcome between the inside and outside IFU groups. At 5 years follow-up 92.6% of patients had stable or decreased diameter, and 7.4% had an increased diameter., Conclusions: This large cohort single-center study demonstrates the effectiveness and safety of the Endurant stent graft system at long-term follow-up with low reintervention rates and aneurysm-related mortality.

Objective: The new 2019 guideline of the European Society for Vascular Surgery (ESVS) recommends consideration for elective iliac artery aneurysm (eIAA) repair when the iliac diameter exceeds 3.5 cm, as opposed to 3.0 cm previously. The current study assessed diameters at time of eIAA repair and ruptured IAA (rIAA) repair and compared clinical outcomes after open surgical repair (OSR) and endovascular aneurysm repair (EVAR)., Methods: This retrospective observational study used the nationwide Dutch Surgical Aneurysm Audit (DSAA) registry that includes all patients who undergo aorto-iliac aneurysm repair in the Netherlands. All patients who underwent primary IAA repair between 1 January 2014 and 1 January 2018 were included. Diameters at time of eIAA and rIAA repair were compared in a descriptive fashion. The anatomical location of the IAA was not registered in the registry. Patient characteristics and outcomes of OSR and EVAR were compared with appropriate statistical tests., Results: The DSAA registry comprised 974 patients who underwent IAA repair. A total of 851 patients were included after exclusion of patients undergoing revision surgery and patients with missing essential variables. eIAA repair was carried out in 713 patients, rIAA repair in 102, and symptomatic IAA repair in 36. OSR was performed in 205, EVAR in 618, and hybrid repairs and conversions in 28. The median maximum IAA diameter at the time of eIAA and rIAA repair was 43 (IQR 38-50) mm and 68 (IQR 58-85) mm, respectively. Mortality was 1.3% (95% CI 0.7-2.4) after eIAA repair and 25.5% (95% CI 18.0-34.7) after rIAA repair. Mortality was not significantly different between the OSR and EVAR subgroups. Elective OSR was associated with significantly more complications than EVAR (intra-operative: 9.8% vs. 3.6%, post-operative: 34.0% vs. 13.8%, respectively)., Conclusion: In the Netherlands, most eIAA repairs are performed at diameters larger than recommended by the ESVS guideline. These findings appear to support the recent increase in the threshold diameter for eIAA repair., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: The current treatment strategy for many patients with varicose veins is endovenous thermal ablation. The most common forms of this are endovenous laser ablation (EVLA) and radiofrequency ablation (RFA). However, at present there is no clear consensus on which of these treatments is superior. The objective of this study was to compare EVLA with two forms of RFA: direct RFA (dRFA; radiofrequency-induced thermotherapy) and indirect RFA (iRFA; VNUS ClosureFast™)., Methods: Patients with symptomatic great saphenous vein (GSV) incompetence were randomized to receive EVLA, dRFA or iRFA. Patients were followed up at 2 weeks, 6 and 12 months. The primary outcome was GSV occlusion rate. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) score and adverse events., Results: Some 450 patients received the allocated treatment (EVLA, 148; dRFA, 152; iRFA, 150). The intention-to-treat analysis showed occlusion rates of 75·0 (95 per cent c.i. 68·0 to 82·0), 59·9 (52·1 to 67·7) and 81·3 (75·1 to 87·6) per cent respectively after 1 year (P = 0·007 for EVLA versus dRFA, P < 0·001 for dRFA versus iRFA, P = 0·208 for EVLA versus iRFA). VCSS improved significantly for all treatments with no significant differences between them. AVVQ scores also improved significantly for all treatments, but iRFA had significantly better scores than dRFA at 12 months. Significantly more adverse events were reported after treatment with EVLA (103) than after dRFA (61) and iRFA (65), especially more pain., Conclusion: Primary GSV occlusion rates were better after iRFA and EVLA than dRFA. All three interventions were effective in improving the clinical severity of varicose veins at 1 year., (© 2019 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.)

Objectives: This study sought to compare heparin-bonded endografts with femoropopliteal bypass, including quality of life, using general health and disease-specific questionnaires as well as patency rates., Background: Endovascular treatment continues to advance and is gaining acceptance as primary treatment for long occlusive or stenotic lesions in the superficial femoral artery. Heparin-bonded expanded polytetrafluoroethylene endografts have been related to outcomes comparable to bypass surgery, but this has not been tested in a randomized fashion., Methods: A multicenter randomized-controlled trial was performed comparing femoropopliteal bypass with heparin-bonded expanded polytetrafluoroethylene endografts. Data were analyzed on an intention-to-treat and per-protocol manner., Results: A total of 129 patients were randomized and 125 patients were treated, 63 in the endoluminal and 62 in the surgical group (42 venous, 20 prosthetic). Enrollment was terminated before reaching the predefined target number for patency. Baseline characteristics and anatomical data were similar. Patients were treated for critical limb ischemia in 38.1% and 32.2% in the endoluminal and surgical arms, respectively. Mean lesion length was 23 cm in both groups and lesions were largely TransAtlantic Inter-Society Consensus II D. Hospitalization time and 30-day morbidity were significantly lower in the endoluminal group, without differences in serious adverse events (n = 5 each; surgical: 4 venous and 1 polytetrafluoroethylene bypass). There were no significant differences in Rutherford category between groups at any time point. At 30 days the endoluminal group showed a greater improvement in quality-of-life scores. At 1 year, these differences had largely disappeared and no differences in primary (endoluminal: 64.8%; surgical: 63.6%), assisted primary (endoluminal: 78.1%; surgical: 79.8%), secondary patency (endoluminal: 85.9%; surgical: 83.3%), and target vessel revascularization (endoluminal: 72.1%; surgical: 71.0%) were observed. Limb salvage rate was 100% in both groups., Conclusions: Heparin-bonded endoluminal bypass for long segment lesions shows promising results (less morbidity, faster recovery, and improvement in quality of life with indistinguishable patency rates at 1 year) compared with surgical bypass. Long-term results have to be awaited., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To investigate the 5-year outcome of patients treated with self-expanding covered stents for superficial femoral artery (SFA) occlusive disease and identify parameters that could predict loss of primary patency., Methods: In a dual-center study, 315 consecutive patients (mean age 69.0±10.1 years; 232 men) treated for SFA occlusive disease in 334 limbs with Viabahn self-expanding covered stents between 2001 and 2014 were retrospectively analyzed. Mean lesion length was 11.7±8.8 cm, and half of the lesions were classified as TASC II C/D. Five-year patency rates were calculated, and Cox regression analyses were performed to assess potential factors affecting patency., Results: All-cause mortality at 5 years was 14.1%. Primary patency rates at 1, 3, and 5 years were 72.2%, 51.8%, and 47.6%, respectively, with secondary patency rates of 86.2%, 78.7%, and 77.5%. Parameters predicting loss of primary patency in a univariate analysis were covered stent diameter (p=0.001), the number of covered stents per lesion (p=0.015), and TASC II D classification (p=0.007). Covered stent diameter was the only parameter predicting loss of primary patency in the multivariate regression analysis (p=0.001), with 7-mm covered stents having superior performance., Conclusion: Five-year patency rates of self-expanding covered stents inserted for SFA occlusive disease are within an acceptable range. Covered stent diameter is the most relevant factor in predicting loss of primary patency, and thus, an adequate diameter of the distal landing site seems to be among the most important factors in the decision-making process. In smaller vessels, one should not use covered stents but venous conduits, as oversizing may be detrimental., (© The Author(s) 2015.)

Objectives. Groin wounds following vascular surgery are highly susceptible to healing disturbances, with reported site infections reaching 30%. Negative pressure incision management systems (NPIMS) are believed to positively influence the prevention of surgical wound-healing disturbances (WHD) and surgical site infections (SSI). NPIMS placed directly after closure of the surgical wound is thought to result in fewer infections; we analysed its effect on postoperative wound infections in patients after vascular surgery via the groin. Methods. From May 2012 to March 2013 we included 90 surgical patients; 40 received a NPIMS. All patients with WHDs were labelled and subanalysed for surgical site infection in case of positive microbiological culture. These infections were graded according to Szilagyi. Number of WHDs and SSIs were compared across cohorts. Results. Patient and perioperative characteristics were equal, except for a significantly higher number of emergency procedures among non-NPIMS patients. We found no significant differences in number of WHDs, SSIs, or Szilagyi grades between the two cohorts. Conclusion. The equal number of SSIs across cohorts showed that NPIMS could not reduce the number of surgical site infections after vascular groin surgery.

Purpose: To evaluate the efficacy and outcome of thrombolysis and thrombectomy for thrombosed polytetrafluoroethylene stent-grafts inserted in the superficial femoral artery (SFA) for occlusive disease., Methods: A retrospective review was conducted of 79 consecutive patients with a thrombosed SFA endograft between November 2001 and December 2011. Of these, 46 (58%) were treated with thrombolysis (n=40, 87%) or thrombectomy (n=6, 13%) and form the study group (33 men; median age 66.8 years, range 30-80). Median time from stent-graft insertion to thrombosis was 3 months (range 0-53)., Results: Thrombolysis was successful in 38 (95%) patients over a mean 24 hours (range 3-48); one patient had failed lysis and another died during lytic treatment. Thrombectomy was successful in all 6 patients. Thrombosis without a causal lesion was significantly more common in occlusions that presented <30 days after insertion (p=0.01). Over a median follow-up of 14 months (range 1-69), reinterventions were performed for restenosis in 12 patients and reocclusion in 14 patients, all within 18 months after thrombolytic treatment. More than a third of patients (16/45) had definitive failures (2/6 from the thrombectomy group); 4 were treated conservatively (no/minor symptoms) and 12 had bypass grafts. Three (7%) patients eventually required a major amputation. The primary, assisted primary, and secondary patency rates of thrombolysis at 6 months were 56%, 56%, and 68%, respectively. Secondary patency for the entire cohort was 58% at 1 year., Conclusion: Thrombolysis and thrombectomy of thrombosed endografts in the SFA is effective and safe. Patency rates after treatment are moderate, but prolonged secondary patency can be achieved.

Objective: Endografts represent a relatively new treatment modality for occlusive disease of the superficial femoral artery, with promising results. However, endografts may occlude collateral arteries, which may affect outcome in case of failure. The purpose of this study was to analyze the clinical outcome of failed endografts in patients with superficial femoral artery occlusive disease., Methods: All patients treated with one or more polytetrafluorethylene-covered stents between November 2001 and December 2011 were prospectively included in a database. Patients with a failure of the endograft were retrospectively analyzed. Clinical and hemodynamic parameters were assessed before the initial procedure and at the time of failure. Outcome of secondary procedures was analyzed., Results: Among the 341 patients who were treated during the study period, 49 (14.4%) failed during follow-up. Mean (standard deviation) Rutherford category at failure did not differ from the category as scored before the initial procedure (3.1 [1.3] vs 3.3 [0.6]; P = .33). Forty-three percent of patients (n = 21) presented with the same Rutherford category as before the initial procedure, 37% (n = 18) with an improved category, and 20% (n = 10) with a deteriorated category. The ankle-brachial index was significantly lower at the time of failure (0.66 [0.19] vs 0.45 [0.19[; P <.002). Seventy-six percent of patients with a failure needed secondary surgery, of which 25% were below knee. The 1-year primary, primary-assisted, and secondary patency rates of secondary bypasses were 55.1%, 62.3%, and 77.7%, respectively. The amputation rate was 4.1% (n = 2)., Conclusions: Failure of endografts is not associated with a deterioration in clinical state and is related to a low amputation rate. The hypothesis that covered stents do not affect options for secondary reconstructions could not be confirmed, as 25% of patients with a failure underwent a below-knee bypass. Secondary surgical bypasses are correlated with poor patency. The amputation rate after failure is low., (Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: The purpose of this study was to assess the 1-year patency rates of heparin-bonded covered stents in the treatment of chronic occlusive disease of the superficial femoral artery (SFA)., Methods: All patients treated with a heparin-bonded endograft between April 2009 and October 2010 for chronic occlusive disease of the SFA were prospectively gathered in a database and retrospectively analyzed. Primary, primary-assisted, and secondary patency rates, assessed by ultrasound scanning, were analyzed at 1-year, as were the complication rates and mortality., Results: A total of 56 limbs were treated with a heparin-bonded covered stent in 53 patients for chronic ischemia Rutherford category 3 (n = 36), 4 (n = 5), 5 (n = 11), and 6 (n = 1). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC)-2-B (n = 9), C (n = 14), and D (n = 33), and the mean treated lesion length was 18.5 ± 7.7 cm. Postoperative complications occurred in 7.5%, including hematoma (n = 1), edema (n = 1), pneumonia (n = 1), and urinary retention (n = 1), and the 30-day mortality rate was 0%. The mean follow-up was 413 ± 208 days. At 1 year, the primary patency was 76%, the primary-assisted patency 82%, and the secondary patency 89%. The limb salvage rate was 100%., Conclusions: Heparin-bonded covered stents seem to provide a valid alternative to surgical treatment of long occlusive lesions in the SFA. Randomized trials and long-term data are required before considering the technique as a new standard of care., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Endovascular treatment options for the superficial femoral artery are evolving rapidly. For long lesions, the venous femoropopliteal bypass considered to be superior above the prosthetic bypass. An endoluminal bypass, however, may provide equal patency rates compared to the prosthetic above knee bypass. The introduction of heparin-bonded endografts may further improve patency rates. The SUrgical versus PERcutaneous Bypass (SuperB) study is designed to assess whether a heparin-bonded endoluminal bypass provides equal patency rates compared to the venous bypass and to prove that it is associated with improved quality of life, related to a decreased complication rate, or not., Methods/design: Two-hundred-twenty-two patients with peripheral arterial occlusive disease, category 3-6 according to Rutherford, will be randomized in two treatment arms; 1. the surgical femoro-popliteal bypass, venous whenever possible, and 2. the heparin-bonded endoluminal bypass. The power analysis was based on a non-inferiority principle, with an effect size of 90% and 10% margins (alpha 5%, power 80%). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is primary patency and quality of life evaluated by the RAND-36 questionnaire and the Walking Impairment Questionnaire. Secondary endpoints include secondary patency, freedom-from-TLR and complications., Discussion: The SuperB trial is a multicentre randomized controlled trial designed to show non-inferiority in patency rates of the heparin-bonded endograft compared to the surgical bypass for treatment of long SFA lesions, and to prove a better quality of life using the heparin bonded-endograft compared to surgically treatment, related to a reduction in complications., Trial Registration: Clinicaltrials: NCT01220245.

Background: Lower extremity amputation is often performed in patients with end-stage vascular disease and is considered a high-risk procedure. Uncertainty exists about the rate of venous thromboembolism (VTE) in these patients., Objectives: To establish the incidence of death and venous thromboembolism after lower extremity amputation., Methods: A prospective cohort study was performed to establish the incidences of death and VTE after lower extremity amputation, as detected by bilateral complete compression ultrasonography and ventilation-perfusion scintigraphy performed preoperatively and around day 14 postoperatively. Standard low-molecular-weight heparin thromboprophylaxis was given during the study period. A secondary outcome was the incidences of mortality and symptomatic venous thromboembolic complications during 8 weeks of postoperative follow-up., Results: Forty-nine patients (53 amputations) were ultimately included in the intention-to-treat analysis. Five patients died within the 2-week period and an additional seven patients died during the 8 weeks clinical follow-up period. The total mortality rate therefore was 12 of 53 amputations [22.6%; 95% confidence interval (CI), 12.3-36.2%]. Six patients developed pulmonary embolisms (of which two were fatal) and one patient developed an asymptomatic contralateral distal deep venous thrombosis, resulting in a total VTE rate of 7 out of 53 amputations (13.2%; 95% CI, 5.47-25.3%)., Conclusion: Lower extremity amputation is accompanied by a high mortality rate from sepsis, and respiratory and vascular causes. This study shows that VTE substantially contributes to the morbidity and mortality after lower extremity amputation despite adequate pharmacological thromboprophylaxis in this vulnerable population of patients., (© 2010 International Society on Thrombosis and Haemostasis.)

Aim: Feasibility of ePTFE-covered endoprosthesis for treatment of atherosclerotic stenosis or occlusions of the SFA. This was a prospective follow-up study on intention-to-treat basis. ePTFE-covered endoprosthesis were used., Methods: From November 2001 to December 2006, 96 patients were treated for invalidating claudication, critical ischemia or gangrene. ABI and ischemia severity score according to Rutherford were defined. Morphology of the lesions was classified according to the Trans-Atlantic InterSociety Consensus. Clinical outcome was investigated by ABI, Duplex-ultrasound, and luminal diameter measurements inside grafts. Follow-up visits were conducted at six weeks and six months, and yearly thereafter., Results: Significant clinical improvement was achieved in all patients. ABI increased to normal, and did not fall during three-year follow-up. Kaplan-Meier estimates for primary patency were 76% (N.=77), 70% (N.=56) and 67.7% (N.=40), and for secondary patency 86.9% (N.=85), 82.2 (N.=63) and 79.8% (N.=45) at 1, 2, and 3 years. Intraluminal graft diameters did not decrease significantly during follow-up. Graft occlusion was seen in 21/96 endografts; 20 patients underwent additional PTAs, only three patients had intragraft stenosis. Occluded grafts did not show reduction of luminal diameters on follow-up examinations before occlusion., Conclusion: ePTFE-covered endografts have excellent properties for treatment of SFA stenosis or occlusions. There was no intimal hyperplasia inside endografts, and graft occlusion occurred due to progression of atherosclerotic disease outside the graft.

Background: Evaluation of the long-term results of a (semi-) closed endarterectomy of the aortoiliac segment with the use of the arterial disobliteration device., Methods: From 1984 until 2005, a total of 157 patients (mean age, 53 years) with aortoiliac occlusive disease underwent a (semi-)closed endarterectomy of the aortoiliac segment. The primary operation indication was disabling claudication in 60.5% and advanced symptoms of ischemia or gangrene in 39.5%. The (semi-) closed endarterectomy was performed in 75% through a standard left retroperitoneal approach., Results: Mean follow-up time was 18.2 years. Primary patency was 96% after 5 and 92% after 10 years. Fourteen patients underwent a reintervention within 30 days. The operative 30-day mortality rate was 1.5%. A reintervention for recurrence of occlusive disease during follow-up was necessary in 22 patients. At follow-up after an average of 18.2 years, 105 patients were alive, with 52 not related deaths., Conclusion: Retroperitoneal (semi-) closed disobliteration, with the use of the arterial disobliteration device, of the aortoiliac segment for stenotic and occlusive vascular disease is a safe and successful procedure the results of which are comparable with the implantation of a vascular aortic prosthesis. We consider this technique a valuable tool in vascular surgery., (Copyright © 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.)

An above-knee femoropopliteal bypass graft constructed of great saphenous vein became dilated in 2 patients 12 and 25 years after surgery. Both patients had several concomitant disorders. The dilations were treated by insertion of an expanded polytetrafluoroethylene-covered nitinol endoprosthesis. There were no major procedural complications. One minor endoleak that developed immediately after endograft placement resolved within 6 weeks. The leg swelling subsided, and the endoprostheses have remained patent for 18 and 24 months, respectively. To our knowledge, these were the first cases in which an endoprosthesis was used to treat dilation of a venous bypass graft.

Introduction: The practice of carotid endarterectomy (CEA) with patch angioplasty is more effective compared to primary closure. However, the type of patch material remains a controversy. The Fluoropassiv thin wall carotid patch is a polyester patch with an interpenetrating, nanometer-scale, solvent-applied surface modification, based on a biocompatible fluoropolymer. The present pilot study is the first clinical trial evaluating results of CEA with Fluoropassiv versus venous patch., Materials/methods: Eighty-seven patients were randomized to 42 Fluoropassiv patching and 45 venous patching. Patients were observed by a vascular surgeon and a neurologist and scanned using duplex ultrasound with a follow-up of 2 years. No patients were lost to follow-up. Restenosis was defined as a Peak Systolic Velocity ratio >2.6, lumen reduction >50%., Results: Perioperative stroke rate was 2.4% in the Fluoropassiv group and 8.9% in the venous group (p=0.02; 1 regressive, 4 non-regressive strokes). Multivariate analysis showed that bilateral carotid stenosis and stroke as indication for CEA were related to perioperative stroke. There was no link between perioperative stroke and patch type after correction for these factors. Patch type had no influence on operation time, clamp time, cranial nerve damage, hypertension, hematoma, infections, time to discharge, or early thromboembolic events. There were no significant differences between the Fluoropassiv and the venous group for cumulative mortality (respectively 4.4 vs 4.8%), patch occlusion (4.8 vs 2.2%), or stroke rate during 2 year follow-up (2.2 vs 2.4%)., Conclusion: This first clinical study with the Fluoropassiv thin wall carotid patch showed no enhanced thrombogenicity compared to a venous patch. The Fluoropassiv patch is not related to a higher rate of postoperative bleeding events either.

A 34-year-old patient underwent a knee exarticulation amputation and developed symptoms of pain, redness and swelling of the stump in combination with a feeling of tightness in the chest. These symptoms were first attributed to muscle pain and exertion but further examination revealed deep venous thrombosis (DVT) of the stump and a pulmonary embolism for which he was treated with nadroparine and acenocoumarol. Shortly after treatment he could resume the use of the prosthesis. A DVT in the amputation stump is not frequently encountered, but is a serious complication that can, together with a pulmonary embolism, be life threatening. The literature mentions an incidence ranging from 0-12%. Physical examination is often not conclusive and further examination of the patient with duplex scanning is necessary, with a ventilation-perfusion scan if a pulmonary embolism is suspected. Patients with a lower extremity amputation have a higher risk of developing a DVT because of immobility and increased venous pooling in the residual limb. Symptoms of a red, swollen, warm and painful stump should trigger the physician to suspect a DVT.

In this report, we describe a patient with adventitial cystic disease of the popliteal artery, in which direct communication via a duct-like structure between the cystic lesion and the knee-joint synovium resulted in recurrent episodes of intermittent claudication and complete symptom-free intervals (intermittent claudication intermittence). This unusual observation could shed more light on the debated etiology of the disease. Moreover, it emphasizes the importance of complete excision of the cyst along with the presenting anatomic connection with the knee joint.

Objective: The construction of an autogenous radial-cephalic direct wrist arteriovenous fistula (RCAVF) is the primary and best option for vascular access for hemodialysis. However, 10%-24% of RCAVFs thrombose directly after operation or do not function adequately due to failure of maturation. In case of poor arterial and/or poor venous vessels for anastomosis, the outcome of RCAVFs may be worse and an alternative vascular access is probably indicated. A prosthetic graft implant may be a second best option. Therefore, a randomized multicenter study comparing RCAVF with prosthetic (polytetrafluoroethylene [PTFE]) graft implantation in patients with poor vessels was performed., Methods: A total of 383 consecutive new patients needing primary vascular access were screened for enrollment in a prospective randomized study. According to defined vessel criteria from the preoperative duplex scanning, 140 patients were allocated to primary placement of an RCAVF and 61 patients to primary prosthetic graft implantation. The remaining 182 patients were randomized to receive either an RCAVF (n = 92) or prosthetic graft implant (n = 90). Patency rate was defined as the percentage of AVFs that functioned well after implantation., Results: Primary and assisted primary 1-year patencies were 33% +/- 5.3% vs 44% +/- 6.2% (P = .03) and 48% +/- 5.5% vs 63% +/- 5.9% (P = .035) for the RCAVF and prosthetic AVF, respectively. Secondary patencies were 52% +/- 5.5% vs 79% +/- 5.1% (P = .0001) for the RCAVF and prosthetic AVF, respectively. Patients with RCAVFs developed a total of 102 (1.19/patient-year [py]) vs 122 (1.45/py; P = .739) complications in the prosthetic AVFs. A total of 43 (0.50/py) interventions in the RCAVF group and 79 (0.94/py) in the prosthetic graft group were needed for access salvage (P = .077)., Conclusions: Although there were more interventions needed for access salvage in the patients with prosthetic graft implants, we may conclude that patients with poor forearm vessels do benefit from implantation of a prosthetic graft for vascular access.

A method for processing and embedding alginate-polylysine microencapsulated pancreatic tissue in glycol methacrylate resin (GMA) is described. Fixation in 4% phosphate buffered formaldehyde, processing in ascending concentrations of glycol methacrylate monomer and embedding in Technovit 7100 results in well preserved morphological details of hydrogels, hydrogel-cell interfaces, and encapsulated pancreatic tissue. Routine staining with Loeffler's methylene blue, hematoxylin and eosin, and Romanovsky-Giemsa gave excellent images of the GMA embedded alginate polylysine membrane and tissues allowing cells on the outside of the capsule to be analyzed effectively as part of the foreign body reaction against the capsule membrane.

This study investigates whether capsular overgrowth on alginate-polylysine microencapsulated islets is influenced by (1) the presence of islet tissue, (2) MHC incompatibility between donor and recipient, or (3) the presence of autoimmune diabetes. Encapsulated Albino Oxford (AO, n = 6, isografts) and Lewis (n = 6, allografts) rat islets, and encapsulated human islets (n = 5, xenografts) were implanted intraperitoneally into streptozotocin-diabetic AO rats. Also, encapsulated AO islets were implanted into autoimmune diabetic Bio Breeding/Organon (BB/O) rats (n = 5, allografts). Five isografts, five allografts, and three xenografts in AO recipients and five allografts in BB/O recipients resulted in normoglycemia. Two weeks after implantation, islets containing capsules were retrieved by peritoneal lavage, after which all animals that had become normoglycemic after transplantation returned to a state of hyperglycemia. Recovery rates of the capsules of these successful grafts, expressed as percentages of the initially implanted graft volume, varied from 72% +/- 7% to 80% +/- 9%. The associated pericapsular infiltrates (PCI) were similar in all groups and varied from 3.2% +/- 1.4% to 8.3% +/- 2.6%. Similar recovery rates and PCI were also found with empty capsules. However, the recovery rates of recipients with graft failures were lower and showed more PCI. Immunohistological staining of PCI showed no differences in the types of cells in the PCI on capsules with or without islets. We conclude that this early PCI is a capsule-induced foreign body reaction that is not influenced by MHC incompatibility or by the presence of autoimmune diabetes, and it should be avoided by improving the biocompatibility of the capsules.

Several factors stand in the way of successful clinical transplantation of alginate-polylysine-alginate microencapsulated pancreatic islets. These obstacles can be classified into three categories. The first regards the technical aspects of the production process. Limiting factors are the insufficient ability to produce small capsules with an adequate production rate, and insufficient insight into the factors determining the optimal chemical and mechanical properties of the capsules. The second category regards the functional aspects of the microencapsulated islets, such as the limitations of the transplantation site and the absence of a physiologic insulin response of the encapsulated islets to elevated blood glucose levels. The third category regards the fact that survival times of encapsulated islet grafts are still limited to several weeks or months, which is mainly explained by a pericapsular fibrotic overgrowth reaction as a consequence of the bioincompatibility of the capsule membrane. This study describes these obstacles, and thereby summarizes the requirements needed for successful clinical application of encapsulated islet transplantation.

Rat pancreatic islet yields obtained with dextran gradient purification were compared after suspending the digest into either the top or the bottom layer of the gradient. A 5-layer discontinuous gradient was used, which consisted of 16 ml 31% dextran as bottom layer, overlayered with 25%, 23%, 20% and 11% dextran (4 ml each). When the digest of 1 rat pancreas was suspended into the top layer of the gradient, the total number of islets obtained from the 11-20, 20-23 and 23-25% interfaces was 862 +/- 38, 240 +/- 39 and 54 +/- 5, respectively. From this gradient, also 1409 +/- 81 islets were retrieved from the bottom layer (i.e., exocrine pellet). In contrast, when the pancreas digest was suspended into the bottom layer of the gradient, 1964 +/- 63, 435 +/- 42, and 177 +/- 34 islets were obtained from the successive interfaces, and only 50 +/- 20 islets from the exocrine pellet. The total islet volume obtained from the two uppermost interfaces was 3.46 +/- 0.31 microliters after top-loading, and 4.93 +/- 0.16 microliters after bottom-loading (n = 7, p < 0.01). When the islets retrieved from one bottom loaded gradient were transplanted into either 1 (n = 6) or 2 (n = 9) diabetic recipients, glucose levels normalized in all instances. We therefore conclude that a bottom-loaded dextran gradient separates islets from exocrine tissue effectively, resulting in significantly higher islet yields than obtained with a top-loaded dextran gradient.

Alginate beads for immunoisolation of pancreatic islets by microencapsulation should be small, smooth, and spherical in order to ensure that around the islets a strong alginate-polylysine-alginate capsule will be formed with optimal biocompatibility and diffusion of nutrients and hormones. However, the preparation of small capsules around islets is difficult. Our newly designed air jet droplet generator allows for variations in the length and diameter of the alginate nozzle and the air jacket and is in this way adaptable to a required bead size. Alginate droplets are converted into rigid beads in a 100 mM CaCl 2 solution. Their size depends upon the diameter of the jacket, the air flow rate, and the outer diameter of the nozzle, whereas the production rate depends upon the pressure on the alginate, and on the diameter and the length of the nozzle. When the air flow or the alginate flow surpasses a certain rate, the droplets are fragmented. This study describes the mutual relationship of these variables and defines their optimal range for reproducible production of smooth and spherical beads for microencapsulation of islets at an acceptable production rate.

The peritoneal cavity is of renewed interest for pancreatic islet transplantation, since it is the preferable site for transplantation of immunoisolated islets. In this study we investigated the minimum islet graft volume needed to restore normoglycemia after free intraperitoneal isogenic transplantation in streptozotocin diabetic rats. Furthermore, graft function was tested by measuring glucose and insulin response to an intravenous glucose load and spontaneously ingested carbohydrate-rich meal. Three graft volumes were used: 8.0-10.0 (group A); 4.0-5.0 (group B); and 2.0-2.3 microliters (group C); 1 microliter contained about 300 islets. All 10 rats in group A and 7 out of 9 rats in group B became normoglycemic for at least 6 months posttransplant, with blood glucose levels not significantly different from normal control animals. Only 3 out of 9 animals in group C became normoglycemic and never for longer than 3 months. The insulin responses to IVGTT in group A and group B were proportional to the grafted islet volume and always significantly lower than those of normal control rats. The insulin response to the test meal showed a similar tendency, which was found to be associated with the absence of preabsorptive insulin secretion. Maximum postprandial blood glucose levels in group A and group B were 0.8 and 1.5 mM higher than in normal control rats. We conclude that intraperitoneal transplantation of at least 4.0-5.0-microliters islet tissue is needed to reverse blood glucose in streptozotocin diabetic rats, and that glucose and insulin levels on IVGTT and test meal in rats with islet grafts of 8.0-10.0 microliters are not completely normalized. It is suggested that the impaired glucose tolerance is due to an insufficient beta-cell mass and a lack of parasympathetic innervation of the transplanted islet tissue.

Albino Oxford rats made diabetic with 75 mg/kg streptozotocin were intraperitoneally transplanted with 2500-2900 alginate-polylysine microencapsulated Lewis islets (n = 9, total islet tissue volume 8.0-11.0 microliters), or a similar volume of non-encapsulated Lewis islets (n = 5). All rats with microencapsulated islets became normoglycaemic, and remained normoglycaemic for 5-16 weeks. In rats with non-encapsulated islet grafts, only a temporary decrease in blood glucose was observed, and all were again severely hyperglycaemic at 1 week after implantation. At 5-6 weeks after transplantation, glucose tolerance in rats with microencapsulated islets was tested by intravenous glucose infusion (10 mg/min over 20 min) and test meal administration (n = 4). During glucose infusion, maximum glucose levels were 13.0 +/- 0.4 mmol/l in rats with microcapsules and 8.9 +/- 0.4 mmol/l in healthy control rats (p less than 0.01). Concomitant maximum plasma insulin levels were 215 +/- 17 pmol/l in rats with microcapsules and 715 +/- 85 pmol/l in controls (p less than 0.001). After the test meal, maximum blood glucose was 10.6 +/- 0.9 mmol/l in rats with microcapsules and 6.2 +/- 0.1 mmol/l in controls (p less than 0.001), with concomitant maximum plasma insulin levels of 247 +/- 11 pmol/l and 586 +/- 59 pmol/l, respectively (p less than 0.001). In conclusion, although the glucose tolerance is impaired and plasma insulin responses to intravenous glucose-load and test-meal are reduced, the alginate-polylysine membrane does provide adequate immunoisolation for the prolongation of allograft survival, resulting in prolonged normoglycaemia in streptozotocin diabetic rats.

We investigated the effect of alginate-polylysine-alginate microencapsulation on glucose-induced insulin secretion by rat islets. Applying the encapsulation method originally described by Lim, we found severely reduced in vitro insulin release (expressed as picomoles of insulin.10 islets-1.45 min-1 when incubated in 16.5 mM glucose), because the insulin release with encapsulated islets was 1.42 +/- 0.49 compared to 13.58 +/- 0.80 with free control islets. This could not be explained by inadequate permeability of the capsule, because insulin release was also severely reduced (2.12 +/- 0.61) when islets were subjected to the procedure but without the membrane-forming polylysine step. Therefore, islets were tested after having been subjected separately to each of the steps of the procedure. Insulin release was not affected by either alginate or CaCl2 but was severely reduced after prolonged suspension in saline or treatment with citrate. When saline and citrate were replaced by Ca2(+)-free Krebs-Ringer bicarbonate buffer (KRBB) and 1 mM EGTA, respectively, insulin release improved significantly both with complete and with incomplete (no polylysine step) encapsulation. This outcome was verified in a set of experiments run in parallel with islets derived from the same isolation procedure. Insulin release was 1.20 +/- 0.23 from islets encapsulated with the method of Lim and 10.73 +/- 1.04 from free control islets. With the modified procedure, insulin release was 9.17 +/- 0.52 vs. 9.61 +/- 1.27 for complete versus incomplete encapsulation, respectively. We conclude that Ca2(+)-free KRBB instead of saline and EGTA instead of citrate should be used to obtain an adequate insulin response from encapsulated islets and that the capsule membrane as such has no influence on glucose and insulin diffusion.

From 1970 to 1986, 3 males and 6 females, ranging in age from 13 to 69 years (median 45 years), underwent heart surgery for a primary cardiac tumor. Six patients had a left atrial myxoma; a lipofibroma, a lymphosarcoma and a rhabdomyosarcoma were found each in 1 patient. The following complaints were present: congestive heart failure in 8, fatigue in 7, cardiac arrhythmia in 3, palpitations in 3, fever in 2 and finally weight loss, nocturnal perspiration and clubbing were each in one patient. The duration of symptoms ranged from 6 weeks to more than 2 years (median 10.8 months). All patients were operated with the aid of extracorporeal circulation as soon as they were diagnosed. One patient with extensive tumor growth died at the end of the procedure. During the follow-up period all patients with a primary malignant tumor died within 3 months. Those with myxoma or fibroma are still alive with a follow-up period extending to 13 years (median 7 years). All surviving patients are asymptomatic and well. Malignant cardiac tumors do have a very poor prognosis, they are only amenable for palliative resection and even then prognosis remains poor. When an endocardial biopsy confirms the diagnosis of a cardiac malignancy, the indication for operation is questionable, although there is an absolute indication in case of obstruction. Cardiac myxoma should be resected after diagnosis because the potential embolic complications may be debilitating or lethal. The operative risk is small, and the long term results are excellent.