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Contains fulltext : 297667.pdf (Publisher’s version ) (Open Access), Radboud University, 30 november 2023, Promotores : Thijssen, D.H.J., Reijnen, M.M.P.J. Co-promotor : Jägers-Holewijn, S., 233 p.

Contains fulltext : 282329.pdf (Publisher’s version ) (Open Access), BACKGROUND: High-quality evidence from trials directly comparing single antiplatelet therapies in symptomatic peripheral arterial disease (PAD) to dual antiplatelet therapies or acetylsalicylic acid (ASA) plus low-dose rivaroxaban is lacking. Therefore, we conducted a network meta-analysis on the effectiveness of all antithrombotic regimens studied in PAD. METHODS: A systematic search was conducted to identify randomized controlled trials. The primary endpoints were major adverse cardiovascular events (MACE) and major bleedings. Secondary endpoints were major adverse limb events (MALE) and acute limb ischaemia (ALI). For each outcome, a frequentist network meta-analysis was used to compare relative risks (RRs) between medication and ASA. ASA was the universal comparator since a majority of studies used ASA as in the reference group. RESULTS: Twenty-four randomized controlled trials were identified including 48,759 patients. With regard to reducing MACE, clopidogrel [RR 0.78, 95% confidence interval (CI) 0.66-0.93], ticagrelor (RR 0.79, 95% CI 0.65-0.97), ASA plus ticagrelor (RR 0.79, 95% CI 0.64-0.97), and ASA plus low-dose rivaroxaban (RR 0.84, 95% CI 0.76-0.93) were more effective than ASA, and equally effective to one another. As compared to ASA, major bleedings occurred more frequently with vitamin K antagonists, rivaroxaban, ASA plus vitamin K antagonists, and ASA plus low-dose rivaroxaban. All regimens were similar to ASA concerning MALE, while ASA plus low-dose rivaroxaban was more effective in preventing ALI (RR 0.67, 95% CI 0.55-0.80). Subgroup analysis in patients undergoing peripheral revascularization revealed that ≥ 3 months after intervention, evidence of benefit regarding clopidogrel, ticagrelor, and ASA plus ticagrelor was lacking, while ASA plus low-dose rivaroxaban was more effective in preventing MACE (RR 0.87, 95% CI 0.78-0.97) and MALE (RR 0.89, 95% CI 0.81-0.97) compared to ASA. ASA plus clopidogrel was not superior to ASA in preventing MACE ≥

Purpose: To evaluate the association between aortic curvature and other preoperative anatomical characteristics and late (>1 year) type Ia endoleak and endograft migration in endovascular aneurysm repair (EVAR) patients. Methods: Eight high-volume EVAR centers contributed 116 EVAR patients (mean age 81±7 years; 103 men) to the study: 36 patients (mean age 82±7 years; 31 men) with endograft migration and/or type Ia endoleak diagnosed >1 year after the initial EVAR and 80 controls without early or late complications. Aortic curvature was calculated from the preoperative computed tomography scan as the maximum and average curvature over 5 predefined aortic segments: the entire infrarenal aortic neck, aneurysm sac, and the suprarenal, juxtarenal, and infrarenal aorta. Other morphological characteristics included neck length, neck diameter, mural neck calcification and thrombus, suprarenal and infrarenal angulation, and largest aneurysm sac diameter. Independent risk factors were identified using backward stepwise logistic regression. Relevant cutoff values for each of the variables in the final regression model were determined with the receiver operator characteristic curve. Results: Logistic regression identified maximum curvature over the length of the aneurysm sac (>47 m-1; p=0.023), largest aneurysm sac diameter (>56 mm; p=0.028), and mural neck thrombus (>11° circumference; p<0.001) as independent predictors of late migration and type Ia endoleak. Conclusion: Aortic curvature is a predictor for late type Ia endoleak and endograft migration after EVAR. These findings suggest that aortic curvature is a better parameter than angulation to predict post-EVAR failure and should be included as a hostile neck parameter.

Item does not contain fulltext, OBJECTIVE: Kissing stents (KS) are commonly used to treat aortoiliac occlusive disease, but patency results are often lower than those of isolated stents. The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was recently introduced to reconstruct the aortic bifurcation in a more anatomical and physiological fashion. The aim of this study is to compare the geometrical consequences of various stent configurations in vitro. METHODS: Anatomic vessel phantoms of the aortoiliac bifurcation were created to accommodate stent configurations. Self-expandable nitinol KS, balloon-expandable covered KS, and two versions of the CERAB configuration were deployed, one with the iliac legs positioned inside the tapered part of the aortic cuff (1) and one with the legs deployed above this level (2). Computed tomography data were obtained to assess the geometry. The conformation ratio (D-ratio) was calculated by use of the ratio of the major and minor axes. The proximal mismatch area, mean mismatch area, and total mismatch volume were calculated. RESULTS: The highest D-ratios were observed in the nitinol KS and the CERAB configuration, implying an ideal "double-D" shape. The proximal and mean mismatch areas were four- to sixfold lower in the CERAB (1) configuration when compared with nitinol KS and CERAB (2), respectively, whereas the covered KS had the highest mismatch area. Nitinol and covered KS had the largest mismatch volume, whereas the mismatch volume was the lowest in the CERAB (1) configuration. CONCLUSIONS: Although nitinol self-expandable stents have a high stent conformation, the lowest radial mismatch was found in the CERAB (1) configuration, supporting the hypothesis that the CERAB configuration is the most anatomical and physiological reconstruction of the aortic bifurcation. Within the CERAB configuration, the two limbs are ideally positioned inside the tapering portion of the cuff, minimizing mismatch.

Item does not contain fulltext, OBJECTIVE: Self-expanding covered stents for superficial femoral artery (SFA) occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73% to 78% in long lesions. The aim of this study was to present the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease. METHODS: All patients treated with a heparin-bonded Viabahn in three centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes, and duplex ultrasound scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end points of the study were the 3-year primary, primary assisted, and secondary patency rates. RESULTS: A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study. Fifty-four patients were male (77%), and the mean age was 70.0 +/- 9.1 years. The mean lesion length was 17.4 +/- 7.0 cm, and 84% were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range, 2-55 months). The 3-year primary, primary assisted, and secondary patency rates were 59%, 71%, and 82%, respectively, with a 3-year freedom from amputation of 100%. CONCLUSIONS: The use of a heparin-bonded Viabahn for SFA occlusive disease is related to patency rates within limits of surgical reconstruction. The procedure is related to low morbidity and amputation rates.

Item does not contain fulltext, 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

1 mei 2012, Item does not contain fulltext, Redo femoropopliteal bypass surgery is associated with increased morbidity and related to a poorer outcome than primary procedures. Endografts might provide an alternative, avoiding dissection of a previously operated groin. Patients treated with a polytetrafluoroethylene-covered stents for superficial femoral artery occlusive disease between February 2009 and September 2011 were prospectively gathered. Demographics, clinical status, procedural aspects, and follow-up were retrieved. Seventy-four patients were included of which 5 (7%) were treated before with a femoropopliteal bypass. Indication for intervention was Rutherford category 3 in all patients and the median ankle-brachial index (ABI) was 0.68. Technical success was achieved in all cases. The postoperative course was uneventful in all and the ABI increased to 0.95. After a follow-up period of 18 months, 4 of 5 endografts remained patent. The use of endografts after failed femoropopliteal bypass surgery is feasible and safe and could be used to avoid or minimize a difficult and hazardous dissection of a previously operated area.

1 juli 2012, Item does not contain fulltext, 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.

Item does not contain fulltext, The endoluminal femoropopliteal bypass is a minimally invasive treatment modality for occlusive superficial femoral artery disease. Technical failure of endovascular treatment of chronic total occlusions is often caused by the inability to re-enter the true lumen. Re-entry devices have a high technical success-rate, but increased procedural costs. We describe an alternative technique using an ipsilateral combined antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass. In a supine position, with the leg elevated at 30 degrees, the popliteal artery is punctured and a 4F introducer sheath is introduced. The occlusion is crossed from distal to proximal and the wire is advanced through a 6F sheath that is positioned in the common femoral artery. The occlusion is predilated from proximal and the "re-entry" site is identified on an angiogram. The wire is then withdrawn into the balloon catheter and advanced intraluminally into one of the crural vessels. After confirming the intraluminal position of the wire, the 4F sheath is removed, and the endoluminal bypass is created in a standardized fashion. The ipsilateral antegrade-retrograde approach is a fast, inexpensive, and easy-to-learn technique, using standard materials only. The distal entry of the occlusion will lead to a minimization of the length of the endoluminal bypass, thereby possibly sparing collaterals and future surgical options.

Item does not contain fulltext, PURPOSE: To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence. METHODS: The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment. RESULTS: Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n = 2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p < 0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale. CONCLUSION: This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.

1 juni 2011, Item does not contain fulltext, PURPOSE: To review all available literature on catheter-directed ultrasound-accelerated thrombolysis for peripheral artery occlusions, stroke, deep venous thrombosis, and pulmonary embolism. METHODS: A systematic literature search was performed, using MEDLINE, EMBASE and Cochrane databases. A total of 77 reports focusing on catheter-delivered ultrasound-accelerated thrombolysis were identified. RESULTS: Experimental studies show that high intensity ultrasound may induce thrombolysis, with and without the addition of plasminogen activators, mainly by acoustic cavitation and mechanical disruption, while low intensity, high frequency ultrasound waves may actually enhance plasmin-mediated thrombolysis. In a total of 340 clinical cases of various thromboembolic conditions, catheter-directed ultrasound-accelerated thrombolysis was related to rapid revascularization and a reduction in treatment time, drug dosage, hospitalization time, and possibly major bleeding complications compared to standard thrombolysis. Reported complication rates, including bleeding and embolization, were low. CONCLUSION: Ultrasound enhanced thrombolysis seems to be a promising concept in the treatment of various thromboembolic conditions. The technique has shown to be safe and efficacious in vitro, in vivo, and in clinical studies. Randomized controlled trials are warranted and should be awaited before considering catheter-directed ultrasound-accelerated thrombolysis as a new standard treatment.

9 september 2011, Promotor : Bleichrodt, R.P. Co-promotores : Goor, H. van, Reijnen, M.M.P.J., Contains fulltext : 90827.pdf (publisher's version ) (Open Access)

Contains fulltext : 96315.pdf (publisher's version ) (Open Access), 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.

1 januari 2011, Item does not contain fulltext, BACKGROUND: Laparoscopic surgery has been incorporated into common surgical practice. The peritoneum is an organ with various biologic functions that may be affected in different ways by laparoscopic and open techniques. Clinically, these alterations may be important in issues such as peritoneal metastasis and adhesion formation. METHODS: A literature search using the Pubmed and Cochrane databases identified articles focusing on the key issues of laparoscopy, peritoneum, inflammation, morphology, immunology, and fibrinolysis. Results : Laparoscopic surgery induces alterations in the peritoneal integrity and causes local acidosis, probably due to peritoneal hypoxia. The local immune system and inflammation are modulated by a pneumoperitoneum. Additionally, the peritoneal plasmin system is inhibited, leading to peritoneal hypofibrinolysis. CONCLUSION: Similar to open surgery, laparoscopic surgery affects both the integrity and biology of the peritoneum. These observations may have implications for various clinical conditions.

Background: The use of thrombolytic therapy in the treatment of thrombosed infrainguinal native arteries and bypass grafts has increased over the years. Main limitation of this treatment modality, however, is the occurrence of bleeding complications. Low intensity ultrasound (US) has been shown to accelerate enzymatic thrombolysis, thereby reducing therapy time. So far, no randomized trials have investigated the application of US-accelerated thrombolysis in the treatment of thrombosed infra-inguinal native arteries or bypass grafts. The DUET study (Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thrombo-embolic infrainguinal disease) is designed to assess whether US-accelerated thrombolysis will reduce therapy time significantly compared with standard catheter-directed thrombolysis.Methods/design: Sixty adult patients with recently (between 1 and 7 weeks) thrombosed infrainguinal native arteries or bypass grafts with acute limb ischemia class I or IIa, according to the Rutherford classification for acute ischemia, will be randomly allocated to either standard thrombolysis (group A) or US-accelerated thrombolysis (group B). Patients will be recruited from 5 teaching hospitals in the Netherlands during a 2-year period. The primary endpoint is the duration of catheter-directed thrombolysis needed for uninterrupted flow in the thrombosed infrainguinal native artery or bypass graft, with outflow through at least 1 crural artery.Discussion: The DUET study is a randomized controlled trial that will provide evidence of whether US-accelerated thrombolysis will significantly reduce therapy time in patients with recently thrombosed infrainguinal native arteries or bypass grafts, without an increase in complications. Trial registration: Current Controlled Trials ISRCTN72676102.