Dierk Scheinert

Heart & Vascular Center, Göttingen, Lower Saxony, Germany

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Publications (153)675.62 Total impact

  • [Show abstract] [Hide abstract]
    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. · 1.21 Impact Factor
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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). · 14.95 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. · 3.59 Impact Factor
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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;
  • Martin Werner, Dierk Scheinert
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    ABSTRACT: 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.
    Advanced Drug Delivery Reviews 11/2014; · 12.71 Impact Factor
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    ABSTRACT: 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).
    CardioVascular and Interventional Radiology 10/2014; · 1.97 Impact Factor
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    ABSTRACT: 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.
    The Journal of cardiovascular surgery. 10/2014;
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    ABSTRACT: Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.
    Journal of the American College of Cardiology 10/2014; 64(15):1568-76. · 15.34 Impact Factor
  • Journal of the American College of Cardiology 09/2014; 66:B245. · 15.34 Impact Factor
  • VASA.: Zeitschrift für Gefässkrankheiten. Journal for vascular diseases 09/2014; 43:24. · 1.21 Impact Factor
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    ABSTRACT: This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms.
    Journal of Vascular Surgery 07/2014; · 2.98 Impact Factor
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    ABSTRACT: Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) has emerged as an alternative to open surgery. However, a small subset of patients exists who undergo conversion either in the first 30 postoperative days or later during the course of postoperative surveillance. In the present study, we review our experience with late conversion operations.
    Interactive Cardiovascular and Thoracic Surgery 06/2014; · 1.11 Impact Factor
  • International journal of cardiology 04/2014; · 6.18 Impact Factor
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    ABSTRACT: Purpose : To investigate the effect of renal denervation (RDN) on blood pressure and renal function in refractory hypertension after renal artery recanalization and optimal medical therapy. Methods : Ten patients (6 women; mean age 70.0±5.1 years) with an office systolic blood pressure >160 mmHg despite taking ≥3 antihypertensive drugs and uni- or bilateral renal artery stenting were treated with RDN. Radiofrequency (RF) energy was delivered to the native segment of the artery keeping a 5-mm safe distance from the stented segments. Standardized office (OBP) and ambulatory (ABP) blood pressure measurements, medication, and renal assessment, including renal duplex ultrasound and renal function, were determined at baseline and on follow-up to 12 months. Results : OBP (systolic/diastolic) at baseline was 190.0±20.4 / 84.2±10.1 mmHg. It decreased to 171.1±28.7* / 82.2±8.7, 165.5±28.4(†) / 76.1±7.4, and 158.3±14.2(†) / 75.5±9.5(†) mmHg (*p<0.001; (†)p<0.01) at 3, 6, and 12 months after RDN, respectively. Average ABP (systolic/diastolic) after 6 and 12 months decreased by -7.6(‡) / -3.1 and -11.3(‡) / -5.1(‡) mmHg ((‡)p<0.05). There was no renal artery (re)stenosis, dissection, or aneurysm within 12 months. Creatinine, cystatin C, and glomerular filtration rate remained unchanged. Urine albumin excretion decreased in 4/10 patients. Renal resistive indices improved in native, but not in stented renal arteries within the follow-up period. Conclusion : This proof-of-concept study demonstrates that RF-based RDN can be safely and effectively delivered in patients with resistant hypertension and previous renal artery stenting.
    Journal of Endovascular Therapy 04/2014; 21(2):181-90. · 3.59 Impact Factor
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    ABSTRACT: Purpose : To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). Methods : The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions. Results : A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (<30% residual stenosis) was achieved in 90.0%. There were no in-hospital major adverse events. Primary patency (defined as a peak systolic velocity ratio <2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months. Conclusion : In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.
    Journal of Endovascular Therapy 04/2014; 21(2):202-12. · 3.59 Impact Factor
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    ABSTRACT: Aims: To examine the efficacy and durability of an interwoven self-expanding nitinol stent in the treatment of complex femoropopliteal artery lesions in unselected patients. Methods and results: Five hundred and twenty-seven limbs in 470 patients with femoropopliteal arterial disease were treated with SUPERA stents. Follow-up data were prospectively collected in a single-centre registry and were available for 439 patients (492 limbs). The patients were followed by Doppler ultrasound, stent roentgenograms, estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). Total occlusions were present in 277 limbs (52.6%) and 52.4% had either moderate or severe calcification. The mean lesion length was 126.4 mm. The primary patency (PP) rates were 83.3% after 12 months and 72.8% at two years. The secondary patency rates were 98.1% after 12 months and 92.0% at two years. Patency rates did not differ between superficial femoral artery (SFA) and popliteal lesions. Between baseline and a mean of 21 months of follow-up, mean ABI increased from 0.53 to 0.91, and mean RBC decreased from 3.0 to 1.9 (p<0.001 for both comparisons). Radiographs performed on 229 patients at a mean of 16.6 months confirmed the absence of stent fractures in all patients. Conclusions: Over a two-year surveillance period, the patency rate and fracture resistance of SUPERA stents implanted for complex femoropopliteal artery disease were high.
    EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2014; · 3.17 Impact Factor
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    ABSTRACT: The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/design: IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT AmphirionTM paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI. This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed.. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registration: NCT00941733.
    Trials 02/2014; 15(1):63. · 2.12 Impact Factor
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    ABSTRACT: The goal of this study was to evaluate the safety and performance of the Igaki-Tamai (Igaki Medical Planning Company, Kyoto, Japan) biodegradable stent in patients with occlusive superficial femoral artery (SFA) disease. Poly-L-lactic acid (PLLA) biodegradable stents have been shown to be effective in the coronaries, but no data are available regarding their efficacy in the femoral artery. A prospective, multicenter, nonrandomized study enrolled 30 patients with symptomatic de novo SFA disease undergoing implantation of Igaki-Tamai bioresorbable stents. Clinical examinations and duplex ultrasound were prospectively performed after 1, 6, 9, and 12 months. The main study endpoints were technical success, restenosis rate, rate of target lesion revascularization (TLR), changes in ankle-brachial index (ABI), and quality of life by evaluating the walking impairment questionnaire (WIQ). Safety was assessed by monitoring the occurrence of major adverse clinical events and serious adverse events. The mean age of the patients was 67.7 years, and 77% were male. The mean lesion length was 5.9 cm. Mean diameter stenosis was reduced from 89.9% to 6.2%, after stent implantation. Technical success was 96.7%. Binary restenosis rate for the 6 and 12 months follow-up was 39.3% and 67.9%, respectively. The TLR rate was 25.0% after 6 months and 57.1% after 12 months. All TLR were successful; the secondary patency rate after 1 year was 89.3%. Between baseline and 12 months, ABI increased in 53.6% of patients. Functional endpoints (WIQ), even if affected by a relatively high reintervention rate, showed improvement in most of the patients. The GAIA study shows that when using biodegradable PLLA stents (Igaki-Tamai), the immediate angiographic results are comparable to the results of metal stents, achieving a high secondary patency rate after 1 year. Modifications of stent characteristics and technical modifications are needed with the goal to reduce the restenosis rate during the reabsorption period.
    JACC. Cardiovascular Interventions 02/2014; · 1.07 Impact Factor
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    ABSTRACT: Purpose : To evaluate the performance of the Turbo Elite laser catheter in combination with the Turbo-Booster guiding catheter for the treatment of femoropopliteal in-stent restenosis (ISR). Methods : The PATENT study (Photoablation Using the Turbo-Booster and Excimer Laser for In-Stent Restenosis Treatment) was a multicenter prospective industry-sponsored registry involving 5 European centers. Patients with symptomatic femoropopliteal ISR (Rutherford categories 2-5) and an ankle-brachial index ≤0.8 were treated with excimer laser atherectomy (ELA). Ninety patients (65 men; mean age 69.5±9.3 years) were enrolled. The majority of patients were Rutherford category 3 (63, 71.6%), and 32 (35.6%) patients had previous treatment for ISR. The average lesion length was 123±95.9 mm, and 30 (34.1%) lesions were total occlusions. The main efficacy outcome was primary patency at 12 months as measured by duplex ultrasonography. The primary safety outcome was freedom from major adverse events (MAE) during hospitalization and at 30-day follow-up to include all death, unplanned major amputation, or target lesion revascularization (TLR). Results : The Turbo Elite laser catheter created a pilot channel in 87 (96.7%) of 90 lesions, with a mean of 1.5 passes, followed by the Turbo Booster with a mean of 5.7 passes. Adjunctive balloon dilation was performed in 79 (87.8%) lesions. Procedure success (<30% residual stenosis without stenting) was 96.7%. The mean percentage stenosis improved from a baseline of 87.0% to 32.3% after laser atherectomy and to 7.4% after final treatment. The MAE rate through 30 days was 2.2%. Nine (10.0%) patients experienced distal embolization. Estimates of freedom from TLR at 6 and 12 months were 87.8% and 64.4%, respectively. Primary patency at 6 and 12 months was 64.1% and 37.8%, respectively. Only a history of prior intervention for ISR (p<0.01) was a predictor of TLR at 12 months. Conclusion : The PATENT study has established excimer laser atherectomy as safe for the treatment of femoropopliteal ISR, achieving high procedure success. Recurrence of restenosis indicates that removing hyperproliferative tissue alone does not solve the problem of ISR. New concepts, such as the combination of ELA with drug-eluting balloons, may prove beneficial.
    Journal of Endovascular Therapy 02/2014; 21(1):52-60. · 3.59 Impact Factor
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    ABSTRACT: Purpose : To report outcomes of a multicenter, nonrandomized study evaluating the safety and effectiveness of a guidewire-mounted mechanical recanalization device with a rotating distal tip (TruePath) in facilitating the crossing of infrainguinal chronic total occlusions (CTOs). Methods : Eligible patients had lower extremity ischemia and an angiographically confirmed occlusion, with no antegrade flow for at least 30 days, in an infrainguinal artery. Enrollment occurred when a previous or concurrent attempt to cross the CTO with a conventional guidewire had failed. A total of 85 patients with 85 lesions were enrolled; 61 (71.8%) target lesions were in the superficial femoral artery and 68 (80%) were considered moderately or heavily calcified. Clinical evaluations were assessed immediately post procedure and at 30-day follow-up. Results : Freedom from clinical perforation at the time of the procedure was achieved in 98.8% of patients. The device facilitated CTO crossing into the distal true lumen (technical success) in 68 (80.0%) patients, with subsequent distal guidewire positioning in 65 (76.5%). The average ABI (n=58) improved from 0.65 (range 0.35-1.20) at baseline to 1.00 (range 0.50-2.00) through 30-day follow-up. Symptoms improved in 70 (82.4%) patients upon treatment, and improvement was maintained in 57/70 (81.4%) through 30 days. Conclusion : The ReOpen Study demonstrated that the TruePath device is safe and effective for facilitating crossing of CTOs resistant to conventional guidewire maneuvers.
    Journal of Endovascular Therapy 02/2014; 21(1):61-70. · 3.59 Impact Factor

Publication Stats

3k Citations
675.62 Total Impact Points

Institutions

  • 2014
    • Heart & Vascular Center
      Göttingen, Lower Saxony, Germany
  • 2010–2014
    • Park-Krankenhaus, Leipzig
      Leipzig, Saxony, Germany
  • 2012–2013
    • Universitäts-Herzzentrum Freiburg - Bad Krozingen
      باد کروزینگن, Baden-Württemberg, Germany
  • 2011–2013
    • Stanford Medicine
      Stanford, California, United States
    • University of Münster
      Muenster, North Rhine-Westphalia, Germany
    • az Sint Blasius
      Termonde, Flanders, Belgium
  • 2003–2013
    • University of Leipzig
      • • Department of Cardiac Surgery
      • • Institut für Sozialmedizin, Arbeitsmedizin und Public Health
      Leipzig, Saxony, Germany
  • 2010–2012
    • University of California, Davis
      • School of Medicine
      Davis, California, United States
  • 2006–2010
    • Kunststoff-Zentrum in Leipzig
      Leipzig, Saxony, Germany
  • 2009
    • Universität Witten/Herdecke
      Witten, North Rhine-Westphalia, Germany
  • 2005
    • University of Tuebingen
      • Department of Radiology
      Tübingen, Baden-Württemberg, Germany
    • Azienda ULSS numero 13 Mirano
      Mirano, Veneto, Italy
  • 1998–2004
    • Humboldt-Universität zu Berlin
      • Department of Biology
      Berlín, Berlin, Germany
  • 1999–2002
    • Friedrich-Alexander Universität Erlangen-Nürnberg
      Erlangen, Bavaria, Germany