Publications (56) View all
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Article: Randomized trial of Legflow(R) paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial.
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ABSTRACT: BACKGROUND: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(R) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm. METHODS: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5--15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(R) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention. DISCUSSION: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.Trial registration: ISRCTN47846578.Trials 03/2013; 14(1):87. · 2.02 Impact Factor -
Article: Periprocedural Prophylactic Antithrombotic Strategies in Interventional Radiology: Current Practice in the Netherlands and Comparison with the United Kingdom.
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ABSTRACT: PURPOSE: The use of prophylactic antithrombotic drugs to prevent arterial thrombosis during the periprocedural period during (percutaneous) peripheral arterial interventions (PAIs) is still a matter of dispute, and clear evidence-based guidelines are lacking. To create those guidelines, a study group was formed in the Netherlands in cooperation with the Dutch Society of Vascular Surgery and the Society of Interventional Radiology. The study group is called "Consensus on Arterial PeriProcedural Anticoagulation (CAPPA)." MATERIALS AND METHODS: The CAPPA study group devised and distributed a comprehensive questionnaire amongst Dutch interventional radiologists (IRs). RESULTS: One hundred forty-two IRs responded (68 %) to the questionnaire. Almost no IR stopped acetyl salicylic acid before interventions, and 40 % stopped clopidogrel before PAI but not before carotid artery stenting (CAS). A flushing solution on the sideport of the sheath was used routinely by 30 % of IRs in PAI and by 50 % of IRs during CAS. A minority of IRs used a heparinised flushing solution (28 %). Unfractionated heparin was used by 95 % of IRs as bolus; 5000 IU was the most used dosage. Timing of administration varied widely. A majority of IRs (75 %) repeated heparin administration after 1 h. CONCLUSION: A substantial variety exists amongst IRs in the Netherlands regarding the use of prophylactic periprocedural antithrombotic drugs to prevent arterial thrombosis during PAI. When compared with varying results regarding the use of heparin in the United Kingdom, the variety in the Netherlands showed a different pattern. The proven variety in these countries, and also between these countries, emphasises the need for authoritative studies to develop evidence-based practical guidelines.CardioVascular and Interventional Radiology 02/2013; · 2.09 Impact Factor -
Article: Incidence and treatment results of Endurant endograft occlusion.
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ABSTRACT: OBJECTIVE: The Endurant endograft (Medtronic Inc, Minneapolis, Minn) is a new-generation device specifically developed to perform well in complex abdominal aortic aneurysm anatomy. Previous reports on the 1- and 2-year results of endovascular aneurysm repair (EVAR) with the Endurant endograft showed excellent outcome, including prevention of migration and type I endoleaks, but occurrence and outcome of post-EVAR occlusion have not been determined in a large multicenter patient cohort with midterm follow-up, which is the objective of this study. METHODS: Data of consecutive patients treated with the Endurant from December 2007 to April 2012 in three Dutch tertiary vascular referral hospitals were prospectively gathered and retrospectively analyzed. Follow-up consisted of regular office visits, computed tomography angiography at 1 and 12 months after EVAR, and subsequently, duplex ultrasound imaging or computed tomography angiography at regular intervals. Patients with ruptured aneurysms or with earlier abdominal aortic surgery were excluded. The incidence and clinical outcome of endograft occlusions were analyzed. An expert review board assessed all cases in the search for possible causes of occlusion. RESULTS: Included were 496 patients (87.7% male), who were a median age of 74 years (range, 68-78 years). Median follow-up was 1.7 years (range, 0-4.6 years). Twenty graft occlusions (4.0%) occurred during follow-up. Median time between primary EVAR and detection of the occlusion was 1 month, with 55% occurring ≤60 postoperative days and 90% ≤1 year. No association was found between occlusion and sex (P = .28), age (P = .96), or use of an aortouniiliac device (P = .66). Technical error was the considered cause of the occlusion in 12 patients (60%). The estimated freedom from occlusion was 98.4% at 30 days, 95.7% at 1 year, and 95.3% at 3 years. Presenting symptoms of occlusion were acute limb ischemia in 50%. Treatment was surgical (75%) or percutaneous (25%). Successful revascularization was achieved in 17 of 20 patients, but reocclusions occurred in five, resulting in a transfemoral amputation in one patient. Occlusion-related mortality was 0.6% (3 of 496). CONCLUSIONS: At a median follow-up of 1.7 years, Endurant endograft occlusion occurred in 4.0% of 496 patients. Most occlusions occurred ≤2 months after EVAR, and rarely after 1 year. A technical justification for occlusion could be found for 60% of patients. A more liberal intraoperative and early postoperative (re)intervention strategy may reduce the occlusion rates and improve outcome.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 02/2013; · 3.52 Impact Factor -
Article: DISCOVER: Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents in the common iliac artery: study protocol for a randomized controlled trial.
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ABSTRACT: BACKGROUND: Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy or bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, that is, long or multiple stenoses or occlusions, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery [1]. Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH, USA) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates [2-4]. However, only one RCT, of mediocre quality has been published on this stent in the common iliac artery [5,6]. Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents. METHODS: This is a prospective, randomized, controlled, double-blind, multi-center trial. The study population consists of human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included.The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment.The primary endpoint is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure-related parameters.Trial registrationDutch Trial Register, NTR3381.Trials 11/2012; 13(1):215. · 2.02 Impact Factor -
Article: Fenestrated endograft repair of suprarenal aortic patch aneurysm in a patient with Marfan syndrome.
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ABSTRACT: We present a case of a 4-fenestrated endograft repair of a suprarenal aortic patch aneurysm as useful alternative for complex open reoperation in a patient with Marfan syndrome.Vascular and Endovascular Surgery 12/2011; 46(1):66-9. · 0.99 Impact Factor
