Dierk Scheinert

Kunststoff-Zentrum in Leipzig, Leipzig, Saxony, Germany

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Publications (184)1058.98 Total impact

  • Kenneth Rosenfield · D Christopher Metzger · Dierk Scheinert ·

    New England Journal of Medicine 10/2015; 373(18):1785-6. DOI:10.1056/NEJMc1510344 · 55.87 Impact Factor
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    ABSTRACT: Background: Evidence from large, randomized, controlled peripheral artery disease trials reporting long-term outcomes using drug-coated balloons (DCBs) is limited. Previously, the DCB showed favorable 1-year outcomes compared with conventional percutaneous transluminal angioplasty (PTA), yet durability of the treatment effect with DCBs remains unknown. Objectives: This study sought to investigate the longer-term outcomes of a paclitaxel-eluting DCB compared to PTA for femoropopliteal lesions. Methods: We enrolled 331 patients with symptomatic (Rutherford 2 to 4) femoropopliteal lesions up to 18 cm in length. Patients were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The 24-month assessments included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), major adverse events, and quality of life and functional outcomes as assessed by the EuroQOL-5D quality-of-life questionnaire, walking impairment questionnaire, and 6-min walk test. Results: At 24 months, patients treated with DCB showed significantly higher primary patency when compared with PTA (78.9% vs. 50.1%; p < 0.001). The rates of CD-TLR were 9.1% and 28.3% (p < 0.001) for the DCB and PTA groups, respectively. The overall mortality rate in the DCB group was 8.1% versus 0.9% in the PTA group (p = 0.008). There were no device- or procedure-related deaths and no major amputations in either group through 24-month follow-up. The rate of vessel thrombosis was low (1.5% DCB vs. 3.8% PTA; p = 0.243), with no new events reported between 1 and 2 years. Both groups showed similar functional improvement at 2 years, although DCB patients achieved this level of function with 58% fewer reinterventions. Conclusions: The 24-month outcomes from the trial demonstrate a durable and superior treatment effect of DCB versus PTA with significantly higher primary patency, lower CD-TLR, and similar functional status improvement with fewer repeat interventions. (Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; and IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461).
    Journal of the American College of Cardiology 10/2015; DOI:10.1016/j.jacc.2015.09.063 · 16.50 Impact Factor
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    ABSTRACT: Background: -Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) with regard to restenosis prevention for de-novo superficial femoral artery (SFA) disease. For in-stent restenosis (ISR), the benefit of DCBA over POBA remains uncertain. Methods and results: -One-hundred-nineteen patients with SFA ISR and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n = 62) or POBA (n = 57). Mean lesion length was 82.2 ± 68.4 mm. Thirty four (28.6%) lesions were totally occluded, 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary endpoint of recurrent ISR assessed by ultrasound at 6 months was 15.4% (8/52) in the DCBA and 44.7% (21/47) in the POBA group (P = 0.002). Freedom from target lesion revascularization (TLR) was 96.4 % vs. 81.0% (P = 0.0117) at 6 months and 90.8% vs. 52.6% (P < 0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥ 1 Rutherford category without the need of TLR was observed in 35/45 DCBA patients (77.8%) and 23/44 POBA patients (52.3%, P = 0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure-related. Conclusions: -DCBA for SFA ISR is associated with less recurrent restenosis and a better clinical outcome than POBA, without an apparent difference in safety. Clinical Trial Registration Information-www.clinicaltrials.gov. Identifier: NCT01305070.
    Circulation 10/2015; DOI:10.1161/CIRCULATIONAHA.115.017364 · 14.43 Impact Factor

  • Journal of the American College of Cardiology 10/2015; 66(15):B308. DOI:10.1016/j.jacc.2015.08.781 · 16.50 Impact Factor

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    ABSTRACT: Background: The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis. Methods: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention. Results: The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention. Conclusions: Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).
    New England Journal of Medicine 06/2015; 373(2). DOI:10.1056/NEJMoa1406235 · 55.87 Impact Factor

  • European Heart Journal 05/2015; DOI:10.1093/eurheartj/ehv204 · 15.20 Impact Factor
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    ABSTRACT: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery. Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n=39: 29 men; mean age 67.7±9.8 years) or a standard angioplasty balloon (n=44: 32 men; mean age 69.0±9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure. All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p=0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p<0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p<0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group). In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year. © The Author(s) 2015.
    Journal of Endovascular Therapy 02/2015; 22(1):1-10. DOI:10.1177/1526602814564385 · 3.35 Impact Factor
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    ABSTRACT: To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions. Sixty patients (34 men; mean age 70.7±10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial (ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months. At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51±0.72 vs. 1.04±1.00 mm, p=0.033) and binary restenosis (11.5% vs. 34.6%, p=0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p=0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p=0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported. The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon. © The Author(s) 2015.
    Journal of Endovascular Therapy 02/2015; 22(1):14-21. DOI:10.1177/1526602814564383 · 3.35 Impact Factor
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    ABSTRACT: To investigate the 2-year technical and clinical results of primary nitinol stent placement in comparison with percutaneous transluminal angioplasty (PTA) in the treatment of de novo lesions of the popliteal artery. The ETAP study (Endovascular Treatment of Atherosclerotic Popliteal Artery Lesions: balloon angioplasty vs. primary stenting; www.ClinicalTrials.gov identifier NCT00712309) is a prospective, randomized trial that enrolled 246 patients (158 men; mean age 72 years) who were randomly assigned to receive a nitinol stent (n=119) or PTA (n=127) for lesions averaging 42.3 mm in length. The results of the primary study endpoint were published. Secondary outcome measures and endpoints included primary patency (freedom from duplex-detected target lesion restenosis), target lesion revascularization (TLR), secondary patency, changes in ankle-brachial index and Rutherford class, and event-free survival (freedom from target limb amputation, TLR, myocardial infarction, and death). In total, 183 patients (89 stent and 94 PTA) were available for the 2-year analysis. The primary patency rate was significantly higher in the stent group (64.2%) than in the PTA group (31.3%, p=0.0001). TLR rates were 22.4% and 59.5%, respectively (p=0.0001). When provisional stent placement in the PTA arm was not considered as TLR and loss in patency, the differences prevailed between the study groups but were not significant (64.2% vs. 56.1% for primary patency, respectively; p=0.44). A significant improvement in ABI and Rutherford category was observed at 2 years in both groups. In treatment of obstructive popliteal artery lesions, provisional stenting reveals equivalent patency in comparison to primary stenting. However, the 2-year results of this trial suggest the possibility of a shift toward higher patency rates in favor of primary stenting. © The Author(s) 2015.
    Journal of Endovascular Therapy 02/2015; 22(1):22-27. DOI:10.1177/1526602814564386 · 3.35 Impact Factor

  • JACC Cardiovascular Interventions 02/2015; 8(2). DOI:10.1016/j.jcin.2014.12.013 · 7.35 Impact Factor
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    ABSTRACT: The occurrence of early post-procedural complications after carotid artery stenting (CAS) can be attributed to embolization of thrombus or plaque particles released from the stented segment. Vascular emboli can be non-invasively detected by transcranial Doppler ultrasound as microembolic signals (MES). We performed this study to discover factors predicting MES detected by transcranial Doppler (TCD)-monitoring within the early post-interventional phase. In 134 consecutive patients undergoing CAS, transcranial Doppler monitoring of the ipsilateral middle cerebral artery was performed for MES detection during the first post-interventional hour. To identify clinical, morphologic, and procedure-related parameters likely to predict the occurrence of post-interventional MES a logistic regression analysis was performed. In 134 patients (111 male, mean age 69.7 years) relevant MES were detected in 51 patients (38 %) with a median of 4 MES/h and a maximum of 62 MES/h. Three factors were observed to be associated with increased post-interventional MES-counts. These included symptomatic lesion (p < 0.05), elevated total cholesterol (p < 0.05), and aspirin monotherapy (p < 0.0005). In a binary logistic regression model, dual antiplatelet therapy (OR 5.6, p < 0.0005) and asymptomatic lesions (OR 2.6, p < 0.05) were revealed as independent predictors for the absence of post-interventional MES. Post-interventional MES were most likely in symptomatic lesions and patients with elevated cholesterol. The absence of an effective dual antiplatelet therapy and symptomatic lesions were revealed as independent predictors for post-interventional MES. An effective pre-interventional dual antiplatelet and lipid lowering therapy might improve the safety of CAS.
    VASA.: Zeitschrift für Gefässkrankheiten. Journal for vascular diseases 01/2015; 44(1):49-57. DOI:10.1024/0301-1526/a000406 · 1.00 Impact Factor
  • Andrej Schmidt · Dierk Scheinert ·

    12/2014; 01(02):135-151. DOI:10.1055/s-0034-1391211
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    ABSTRACT: -Drug-coated balloons (DCB) have shown promise in improving outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and/or popliteal artery disease. -The IN.PACT SFA Trial is a prospective, multicentre, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain due to superficial femoral and/or popliteal peripheral artery disease (PAD) were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy endpoint was primary patency, defined as freedom from restenosis or clinically-driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and percent of total occlusions for the DCB and PTA arms were 8.94±4.89 and 8.81±5.12 cm (P=.82) and 25.8% and 19.5% (P=.22), respectively. DCB resulted in higher primary patency vs. PTA (82.2% vs. 52.4%; P<.001). The rate of clinically-driven target lesion revascularization was 2.4% in the DCB arm compared with 20.6% in the PTA arm (P<.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA (P=.10)). There were no device- or procedure-related deaths and no major amputations. -In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal PAD. Clinical Trial Registration Information-ClinicalTrials.gov. Identifiers: NCT01175850 and NCT01566461.
    Circulation 12/2014; 131(5). DOI:10.1161/CIRCULATIONAHA.114.011004 · 14.43 Impact Factor
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    ABSTRACT: Atherosclerotic peripheral artery disease (PAD) is common and results in limitations in quality of life and potential progression to limb loss. Options for therapy include medical therapy, supervised exercise, surgical revascularization, and, more recently, endovascular therapies to restore arterial perfusion to the limb. Endovascular revascularization has evolved over the past 2 decades, from percutaneous transluminal angioplasty (PTA) to self-expanding stents, atherectomy, laser angioplasty, and drug-eluting stents. Despite impressive technologic advances, PTA remains the standard of care at many institutions and is the recommended primary treatment modality for femoral-popliteal PAD according to current American College of Cardiology Foundation/American Heart Association guidelines. However, restenosis after PTA is common. Therefore, a significant clinical need remains for a device that is able to achieve more durable patency than PTA but does not require a permanent implant. Drug-coated balloons (DCBs) have the potential to address this need. Several randomized controlled clinical trials of PTA balloons coated with different formulations of paclitaxel have been conducted in Europe (N Engl J Med 2008;358:689-699) (Circulation 2008;118:1358-1365) (Circ Cardiovasc Interv 2012;5:831-840) (JACC Cardiovas Interv 2014;7:10-19) and demonstrated more durable efficacy than PTA with comparable safety. These studies were limited by small sample sizes and powered solely for an angiographic primary end point. The pivotal LEVANT 2 trial was designed in collaboration with the US Food and Drug Administration to demonstrate safety and efficacy in a large population and to obtain US Food and Drug Administration approval. A prospective, multicenter, single-blind trial comparing the Lutonix DCB (Bard Lutonix; New Hope, MN) versus PTA for treatment of femoropopliteal PAD (LEVANT 2) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA. The primary efficacy end point is primary patency at 12 months. The primary safety end point is composite freedom at 12 months from perioperative death, index limb amputation, reintervention, and limb-related mortality. A series of important secondary end points include physical functioning, quality of life, revascularizations, and alternative measures of patency. To minimize bias potential for confounding variables, LEVANT 2 (1) excluded patients stented after predilation before randomization, (2) incorporated very stringent criteria for bailout stenting, (3) did not count bailout stenting as a target lesion revascularization or failure of any end point, (4) required a blinded clinician to perform clinical evaluations at follow-up, and (5) required clinical assessment before review of duplex ultrasound results. LEVANT 2 represents the first US-inclusive multicenter, randomized controlled trial to assess the safety and efficacy of a novel DCB compared with PTA as primary therapy for symptomatic PAD on the background of standard medical therapy. Copyright © 2014 Elsevier Inc. All rights reserved.
    American Heart Journal 12/2014; 169(4). DOI:10.1016/j.ahj.2014.11.016 · 4.46 Impact Factor
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    ABSTRACT: Purpose : To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods : The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7±8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5±5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within ±10% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results : The median follow-up was 12.3 months (mean 12.3±0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion : This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. One-year primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
    Journal of Endovascular Therapy 12/2014; 21(6):765-74. DOI:10.1583/14-4790R.1 · 3.35 Impact Factor
  • M Piorkowski · B Freitas · S Steiner · S Botsios · Y Bausback · D Scheinert · A Schmidt ·
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    ABSTRACT: The aim of this paper is to report the continued mid--term follow up of the first patients treated world--wide with the GORE® TIGRIS® Vascular Stent, a dual component stent, consisting of a nitinol wire frame combined with a fluoropolymer--interconnecting structure. From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow--up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford Becker class (RBC) and ankle--brachial index (ABI). Here we report the completed 6 month follow up and for the first time the first 12 months follow up. The median follow up was 418 days. During the 12 months follow up 4 patients died. Restenosis or reocclusion of the stent in this time period had been observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5% ± 6.0%. The ABI increased pre--interventional from 0.65 ± 0.18 to 0.91 ± 0.18 (p<0.0001) at the 12 months visit. The median RBC improved from 3 to 1 (p<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed. The mid term follow up of the dual component GORE® TIGRIS® Vascular Stent showed promising results with high 12 month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.
    The Journal of cardiovascular surgery 11/2014; 56(1). · 1.46 Impact Factor
  • Martin Werner · Dierk Scheinert ·
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    ABSTRACT: Objective: To review the use of drug-eluting devices in peripheral arteries of critically ill patients Findings: Drug eluting stents and drug coated balloons are promising technologies and have become an important tool for the endovascular treatment of peripheral artery disease. The concept of local drug delivery to prevent restenosis due to intimal hyperplasia has been proven in several trials for different peripheral vascular beds. Especially for the treatment of patients with critical lower limb ischemia, improved patency could presumably improve wound healing, survival and limb salvage rates. However, until now, there is a paucity of evidence regarding these devices in critically ill patients and lessons learned must be extrapolated from non-critically ill patients at this time. Conclusions: Restenosis rates can be reduced by drug eluting devices. Further study of the clinical impact of the use of drug eluting devices in the peripheral arteries will be required to determine if improved patency rates also can be translated into clinical benefit for critically ill patients.
    Advanced Drug Delivery Reviews 11/2014; 77. DOI:10.1016/j.addr.2014.07.005 · 15.04 Impact Factor
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    ABSTRACT: Purpose: This prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA). Materials and methods: The study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31-365 days), target lesion revascularization, and in-stent restenosis. Results: Of the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31-365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients. Conclusion: Results through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.
    CardioVascular and Interventional Radiology 10/2014; 38(2). DOI:10.1007/s00270-014-1000-4 · 2.07 Impact Factor
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    ABSTRACT: Aim: The MISAGO ILIAC study is a prospective, non--randomized, multi-center, bi--national, monitored trial, conducted at 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12--month follow-up time for the total cohort. The primary endpoint of the study is primary potency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months. Methods: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre--treatment of 83.76%. The demographic data were compatible for the TASC II Class A and TASC II Class B cohort. One patient with a TASC II class C was included as a protocol deviation. Results: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II Class A and TASC II Class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (p=0.6407). Conclusion: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II Class A and B aortoiliac lesions.
    The Journal of cardiovascular surgery 10/2014; · 1.46 Impact Factor

Publication Stats

5k Citations
1,058.98 Total Impact Points


  • 2006-2015
    • Kunststoff-Zentrum in Leipzig
      Leipzig, Saxony, Germany
  • 2003-2015
    • University of Leipzig
      • • Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie
      • • Department of Cardiac Surgery
      • • Institute for Social Medicine, Occupational Health and Public Health
      Leipzig, Saxony, Germany
    • Montreal Heart Institute
      Montréal, Quebec, Canada
  • 2011-2014
    • Heart & Vascular Center
      Göttingen, Lower Saxony, Germany
  • 2009-2014
    • Park-Krankenhaus, Leipzig
      Leipzig, Saxony, Germany
    • Universität Witten/Herdecke
      Witten, North Rhine-Westphalia, Germany
    • Isar Heart Center
      Münchenbernsdorf, Thuringia, Germany
  • 2013
    • University of Antwerp
      Antwerpen, Flemish, Belgium
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      باد کروزینگن, Baden-Württemberg, Germany
  • 2000-2006
    • Universitätsklinikum Erlangen
      Erlangen, Bavaria, Germany
  • 2005
    • Jagiellonian University
      Cracovia, Lesser Poland Voivodeship, Poland
    • University of Tuebingen
      • Department of Radiology
      Tübingen, Baden-Württemberg, Germany
  • 2004
    • Humboldt-Universität zu Berlin
      • Department of Biology
      Berlín, Berlin, Germany
  • 2000-2003
    • Friedrich-Alexander-University of Erlangen-Nürnberg
      Erlangen, Bavaria, Germany