Dittmar Böckler

evaplan at the University Hospital Heidelberg, Heidelburg, Baden-Württemberg, Germany

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Publications (298)527.53 Total impact

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    ABSTRACT: Endovascular aneurysm sealing (EVAS) using the Nellix system is a new and different method of abdominal aortic aneurysm repair. Normal postoperative imaging has unique appearances that change with time; complications also have different and specific appearances. This consensus document on the imaging findings after Nellix EVAS is based on the collective experience of the sites involved in the Nellix EVAS Global Forward Registry and the US Investigational Device Exemption Trial. The normal findings on computed tomography (CT), duplex ultrasound, magnetic resonance imaging, and plain radiography are described. With time, endobag appearances change on CT due to contrast migration to the margins of the hydrogel polymer within the endobag. Air within the endobag also has unique appearances that change over time. Among the complications after Nellix EVAS, type I endoleak usually presents as a curvilinear area of flow between the endobag and aortic wall, while type II endoleak is typically small and usually occurs where an aortic branch artery lies adjacent to an irregular aortic blood lumen that is not completely filled by the endobag. Procedural aortic injury is an uncommon but important complication that occurs as a result of overfilling of the endobags during Nellix EVAS. The optimum imaging surveillance algorithm after Nellix EVAS has yet to be defined but is largely CT-based, especially in the first year postprocedure. However, duplex ultrasound also appears to be a sensitive modality in identifying normal appearances and complications.
    Journal of Endovascular Therapy 11/2015; DOI:10.1177/1526602815616251 · 3.35 Impact Factor
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    ABSTRACT: Objective: To evaluate accuracy and feasibility of fusion imaging during thoracic endovascular aortic repair (TEVAR). Methods: From January 2013 to January 2015 fusion imaging was used in 18 TEVAR procedures. Patients were prospectively enrolled for the survey and informed consent was obtained. Planning of the procedure and computed tomography (CT) angiography (CTA) segmentation with determination of all relevant surgical landmarks that should be displayed on fusion imaging was done using the preoperative CTA data. The registration was done with an intraoperative noncontrast-enhanced cone beam CT and CTA (three-dimensional [3D]-3D registration; n = 15) or with two fluoroscopic images in anteroposterior and lateral projection and the CTA (two-dimensional-3D registration; n = 3). An intraoperative digital subtraction angiography was performed to adjust fusion imaging and to allow accuracy measurement. Results: Fusion imaging was possible in all included patients. The median dose for noncontrast-enhanced cone beam CT imaging was 28.6 Gy/cm(2) (range, 17.9-43.3) and 0.46 Gy cm(2) for two fluoroscopic images in the two-dimensional-3D group. Full accuracy was achieved in two cases (11%), with a median deviation of 11.7 mm (range, 0.0-37.2). Manual realignment was possible in all cases. Conclusions: This early experience shows that fusion imaging is feasible in TEVAR procedures using different registration methods. However, it shows a significant deviation in thoracic procedures because of different sources of error, making confirmation of fusion overlay with a digital subtraction angiography necessary in any case.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 11/2015; DOI:10.1016/j.jvs.2015.08.089 · 3.02 Impact Factor
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    ABSTRACT: Objectives: To analyse early and long-term results of thoracic endovascular aortic repair (TEVAR) in patients with pseudoaneurysms after open aortic coarctation (CoA) repair. Methods: A total of 11 patients of 418 patients who had been treated with TEVAR during the period from January 1998 to April 2015 (8 males; median age 53 years) were retrospectively analysed. Dacron patch aortoplasty was primarily performed in 9 patients and sub-clavian flap aortoplasty in 2 patients. Seven of the 11 patients had asymptomatic pseudoaneurysms (median diameter 56 mm, range 20-65 mm) diagnosed by routine screening. Symptomatic patients presented with haemoptysis, lower limb ischaemia, haemodynamic collapse and back pain and underwent emergency repair (4/11). Adjunctive procedures at the proximal landing zone were required in 7/11 patients. The median number of implanted endoprostheses per patient was 1 (range: 1-5). The median follow-up was 60 months (range 6-161 months). Results: Technical success was achieved in 91% (10/11; 1 secondary elective open conversion). The 30-day mortality was 0%. The stroke rate was 18% (2 non-disabling strokes). In 2 patients (20%), stent-graft displacement during deployment was observed. The reintervention rate was 33% (Type Ib endoleak, left arm claudication, partial coverage of the left common carotid artery). Clinical success during follow-up was achieved in 10/11 patients. In 9/10 patients, aneurysm sac shrinkage was observed. The Type II endoleak rate was 10% (1/10; intercostal artery). The overall mortality rate was 9% (1 patient died of amyotrophic lateral sclerosis). Conclusions: Endovascular treatment of post-coarctation pseudoaneurysms is feasible in elective and emergency cases, yielding durable results in the long term. Due to anatomical specifics, implantation may be challenging and requires careful procedural planning. On-site cardiothoracic surgery backup is essential in case open conversion is required.
    Interactive Cardiovascular and Thoracic Surgery 10/2015; DOI:10.1093/icvts/ivv297 · 1.16 Impact Factor
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    ABSTRACT: Purpose: To associate regions of highest local rupture risk from finite element analysis (FEA) to subsequent rupture sites in abdominal aortic aneurysms (AAA). Methods: This retrospective multicenter study analyzed computed tomography angiography (CTA) data from 13 asymptomatic AAA patients (mean age 76 years; 8 men) experiencing rupture at a later point in time between 2005 and 2011. All patients had CTA scans before and during the rupture event. FEA was performed to calculate peak wall stress (PWS), peak wall rupture risk (PWRR), rupture risk equivalent diameters (RRED), and the intraluminal thrombus volume (ILTV). PWS and PWRR locations in the prerupture state were compared with subsequent CTA rupture findings. Visible contrast extravasation was considered a definite (n=5) rupture sign, while a periaortic hematoma was an indefinite (n=8) sign. A statistical comparison was performed between the 13-patient asymptomatic AAA group before and during rupture and a 23-patient diameter-matched asymptomatic AAA control group that underwent elective surgery. Results: The asymptomatic AAAs before rupture showed significantly higher PWRR and RRED values compared to the matched asymptomatic AAA control group (median values 0.74 vs 0.52 and 77 vs 59 mm, respectively; p<0.0001 for both). No statistical differences could be found for PWS and ILTV. Ruptured AAAs showed the highest maximum diameters, PWRR, and RRED values. In 7 of the ruptured AAAs (2 definite and 5 indefinite rupture signs), CTA rupture sites correlated with prerupture PWRR locations. Conclusion: The location of the PWRR in unruptured AAAs predicted future rupture sites in several cases. Asymptomatic AAA patients with high PWRR and RRED values have an increased rupture risk.
    Journal of Endovascular Therapy 10/2015; DOI:10.1177/1526602815612196 · 3.35 Impact Factor
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    ABSTRACT: Objective: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. Methods: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). Results: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). Conclusions: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 10/2015; DOI:10.1016/j.jvs.2015.07.096 · 3.02 Impact Factor
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    ABSTRACT: Objective: The purpose of this study was to evaluate the radiation exposure of vascular surgeons' eye lens and fingers during complex endovascular procedures in modern hybrid operating rooms. Methods: Prospective, nonrandomized multicenter study design. One hundred seventy-one consecutive patients (138 male; median age, 72.5 years [interquartile range, 65-77 years]) underwent an endovascular procedure in a hybrid operating room between March 2012 and July 2013 in two vascular centers. The dose-area product (DAP), fluoroscopy time, operating time, and amount of contrast dye were registered prospectively. For radiation dose recordings, single-use dosimeters were attached at eye level and to the ring finger of the hand next to the radiation field of the operator for each endovascular procedure. Dose recordings were evaluated by an independent institution. Before the study, precursory investigations were obtained to simulate the radiation dose to eye lens and fingers with an Alderson phantome (RSD, Long Beach, Calif). Results: Interventions were classified into six treatment categories: endovascular repair of infrarenal abdominal aneurysm (n = 65), thoracic endovascular aortic repair (n = 32), branched endovascular aortic repair for thoracoabdominal aneurysms (n = 17), fenestrated endovascular aortic repair for complex abdominal aortic aneurysm, (n = 25), iliac branched device (n = 8), and peripheral interventions (n = 24). There was a significant correlation in DAP between both lens (P < .01; r = 0.55) and finger (P < .01; r = 0.56) doses. The estimated fluoroscopy time to reach a radiation threshold of 20 mSv/y was 1404.10 minutes (90% confidence limit, 1160, 1650 minutes). According to correlation of the lens dose with the DAP an estimated cumulative DAP of 932,000 mGy/m(2) (90% confidence limit, 822,000, 1,039,000) would be critical for a threshold of 20 mSv/y for the eyes. Conclusions: Radiation protection is a serious issue for vascular surgeons because most complex endovascular procedures are delivering measurable radiation to the eyes. With the correlation of the DAP obtained in standard endovascular procedures a critical threshold of 20 mSv/y to the eyes can be predicted and thus an estimate of a potential harmful exposure to the eyes can be obtained.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 10/2015; DOI:10.1016/j.jvs.2015.08.051 · 3.02 Impact Factor
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    ABSTRACT: Background Chronic low-grade inflammation is considered a driver of many age-related disorders, including vascular diseases (inflammaging). Inhibition of autophagic capacity with ageing was postulated to generate a pro-inflammatory condition via activation of inflammasomes, a group of Interleukin-1 activating intracellular multi-protein complexes. We thus investigated gene expression of inflammasome components in PBMC of 77 vascular patients (age 22–82) in association with age. Findings Linear regression of real-time qRT-PCR data revealed a significant positive association of gene expression of each of the inflammasome components with age (Pearson correlation coefficients: AIM2: r = 0.245; P = 0.032; NLRP3: r = 0.367; P = 0.001; ASC (PYCARD): r = 0.252; P = 0.027; CASP1: r = 0.296; P = 0.009; CASP5: r = 0.453; P = 0.00003; IL1B: r = 0.247; P = 0.030). No difference in gene expression of AIM2, NLRP3, ASC CASP1, and CASP5 was detected between PBMC of patients with advanced atherosclerosis and other vascular patients, whereas IL1B expression was increased in PBMC of the latter group (P = 0.0005). Conclusion The findings reinforce the systemic pro-inflammatory phenotype reported in elderly by demonstrating an increased phase-1 activation of inflammasomes in PBMC of vascular patients. Electronic supplementary material The online version of this article (doi:10.1186/s12979-015-0043-y) contains supplementary material, which is available to authorized users.
    Immunity & Ageing 10/2015; 12(1). DOI:10.1186/s12979-015-0043-y · 3.54 Impact Factor
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    ABSTRACT: Carotid atherosclerotic disease is highly related to cerebrovascular events. Carotid endarterectomy is the common operation method to treat this disease. In this study, hemodynamics analyses are performed on the carotid arteries in three patients, whose right carotid artery had been treated by carotid endarterectomy and the left carotid artery remained untreated. Flow and loading conditions are compared between these treated and untreated carotid arteries and evaluation of the operative results is discussed. Patient-specific models are reconstructed from MDCT data. Intraoperative ultrasound flow measurements are performed on the treated carotid arteries and the obtained data are used as the boundary conditions of the models and the validations of the computational results. Finite volume method is employed to solve the transport equations and the flow and loading conditions of the models are reported. The results indicate that: (i) in two of the three patients, the internal-to-external flow rate ratio in the untreated carotid artery is larger than that in the treated one, and the average overall flow split ratio by summing up the data of both the left and right carotid arteries is about 2.15; (ii) in the carotid bulb, high wall shear stress occurs at the bifurcation near the external carotid artery in all of the cases without hard plaques; (iii) the operated arteries present low time-averaged wall shear stress at the carotid bulb, especially for the treated arteries with patch technique, indicating the possibility of the recurrence of stenosis; (iv) high temporal gradient of wall shear stress (>35 Pa/s) is shown in the narrowing regions along the vessels; and (v) in the carotid arteries without serious stenosis, the maximum velocity magnitude during mid-diastole is 32~37% of that at systolic peak, however, in the carotid artery with 50% stenosis by hard plaques, this value is nearly doubled (64%). The computational work quantifies flow and loading distributions in the treated and untreated carotid arteries of the same patient, contributing to evaluation of the operative results and indicating the recurrent sites of potential atheromatous plaques.
    Bio-medical materials and engineering 09/2015; 26(s1):S299-S309. DOI:10.3233/BME-151317 · 1.09 Impact Factor
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    ABSTRACT: Objective: This study aims to report the management of patients with spontaneous isolated dissection of the abdominal aorta (sIAAD). Methods: A cohort of 18 consecutive patients (12 male, mean age 58 years) with sIAAD was treated between 1990 and 2009. Dissection was asymptomatic in ten and symptomatic in eight patients. Retrospective data analysis from patient charts was performed. Follow-up included clinical examination, ultrasound, and/or CT-angiography. Mean follow-up was 54 months (range 1-211). Results: In total, eight out of 18 received invasive treatment. All asymptomatic patients initially underwent conservative treatment and surveillance. Spontaneous false lumen thrombosis occurred in four (40 %), and three patients showed relevant aneurysmatic progression and underwent elective invasive treatment (open n = 2, endovascular n = 1), representing a crossover rate of 30 %. Late mortality was 20 % (n = 2) in this group. In symptomatic patients, five underwent urgent treatment due to persistent abdominal or back pain (n = 4) or contained rupture (n = 1); one was treated for claudication. The remaining two patients presented with irreversible spinal cord ischemia and were treated conservatively. Three patients were treated by open surgery and three by endovascular interventions (two stentgrafts, one Palmaz XXL stent). Early and late morbidity and mortality was 0 % in this group. There were no reinterventions CONCLUSION: The majority of patients with sIADD require invasive treatment, with EVAR being the preferable treatment option today. In asymptomatic IADD, primary surveillance is justifiable, but close surveillance due to expansion is necessary.
    Langenbeck s Archives of Surgery 09/2015; DOI:10.1007/s00423-015-1335-6 · 2.19 Impact Factor
  • P. Erhart · T.C. Gasser · M. Auer · D. Böckler · A. Hyhlik-Dürr ·

    Gefässchirurgie 09/2015; DOI:10.1007/s00772-015-0064-z · 0.24 Impact Factor
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    ABSTRACT: Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model. The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI) <6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0). The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI <6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 07/2015; 62(4). DOI:10.1016/j.jvs.2015.04.441 · 3.02 Impact Factor
  • N. Attigah · T. Knoch · M. Wortmann · C. Wieker · P. Geisbüsch · D. Böckler ·
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    ABSTRACT: The trend in vascular surgery away from open procedures towards endovascular treatment for most indications in vascular diseases also implies a fundamental change in the working environment in the operating theater. In order to perform complex endovascular procedures moveable high-performance X-ray imaging systems or hybrid operating rooms are now necessary. This fact and in addition the increased endovascular workload, lead to considerably extended exposure times for vascular surgeons comparable to those otherwise only encountered in interventional radiology and cardiology. Therefore, it is important that the vascular specialist is not only aware of all measures of radiation protection for the patient and also for the operating room personnel but is also fully informed on the topic of radiation protection at the administrative and legal levels. This review article gives an overview of possible measures of radiation protection for the operating room personnel and also outlines the most important administrative and legal requirements for operating X-ray equipment.
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    ABSTRACT: Klippel-Trénaunay-Weber syndrome (KTWS), also known as angioosteohypertrophy syndrome, is a rare congenital malformation with unknown etiology characterized by the combination of capillary malformations (port-wine strain), venous varicosities, and a soft tissue or bony hypertrophy of the affected limb. It is known to be rarely associated with abdominal aortic aneurysm (AAA) in adults. We report the first published case of KTWS and a rapidly progressing symptomatic AAA undergoing open repair in a child. This underlines the importance of AAA screening and treatment rather than surveillance in patients with KTWS.
    06/2015; 185(2). DOI:10.1016/j.jvsc.2015.04.013
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    ABSTRACT: To identify morphologic factors affecting aortic expansion in patients with uncomplicated type B aortic dissections. Computed tomography data of 24 patients (18 male; median age: 61 years), diagnosed with acute uncomplicated type B aortic dissections between 2002 and 2013, were retrospectively reviewed. All patients had at least two computed tomography angiography scans and six months of uneventful follow-up. Computed tomography scans were assessed by two independent readers with regard to presence and number of entry tears. Thoracic and abdominal aortic diameters were derived using image processing software. Twenty-two of 24 patients showed aortic expansion over a median computed tomography angiographic follow-up of 33.2 months. Annual rates showed an increase of 1.7 mm for total aortic diameter, 2.1 mm for the false and a decrease of -0.4 mm for the true lumen. In three patients (12.5%), aortic diameter exceeded 60 mm during follow-up, and all three patients underwent thoracic endovascular aortic repair. Patients with a maximum aortic diameter <4 cm at baseline showed a significantly higher expansion rate compared to cases with an initial maximum aortic diameter of ≥4 cm (p=0.0471). A median of two entries (range: 1-5) was recognized per patient. Presence of more than two entry tears (n = 13) was associated with faster overall diameter expansion (mean annual rates: 2.18 mm vs. 1.16 mm; p = 0.4556), and decrease of the cross-sectional surface of the true lumen over time (annual rate for > 2 entries vs. ≤2 entries: -7.8 mm(2) vs. +37.5 mm(2); p = 0.0369). Median size of entry tears was 12 mm (range: 2-53 mm). The results presented herein suggest that uncomplicated type B aortic dissection patients with more than two entry tears and/or an initial maximum aortic diameter of<4 cm are at risk for aortic dilatation and, therefore, may require stricter follow-up including the possible need for early intervention. © The Author(s) 2015.
    Vascular 06/2015; DOI:10.1177/1708538115591941 · 0.80 Impact Factor
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    ABSTRACT: Somatic DNA-alterations are known to occur in atherosclerotic carotid artery lesions; however their significance is unknown. The accumulation of microsatellite mutations in coding DNA regions may reflect a deficiency of the DNA mismatch repair (MMR) system. Alternatively, accumulation of these coding microsatellite mutations may indicate that they contribute to the pathology. To discriminate between these two possibilities, we compared the mutation frequencies in coding microsatellites (likely functionally relevant) with that in non-coding microsatellites (likely neutral). Genomic DNA was isolated from carotid endarterectomy (CEA) specimens of 26 patients undergoing carotid surgery, and from 15 non-atherosclerotic control arteries. Samples were analyzed by DNA fragment analysis for instability at three non-coding (BAT25, BAT26, CAT25) and five coding (AIM2, ACVR2, BAX, CASP5, TGFBR2) microsatellite loci with proven validity for detection of microsatellite instability in neoplasms.We found an increased frequency of coding microsatellite mutations in CEA specimens, compared with control specimens (34.6% versus 0%; p= 0.0013). Five CEA specimens exhibited more than one frameshift mutation, and ACVR2 and CASP5 were affected most frequently (5/26 and 6/26). Moreover, the rate of coding microsatellite alterations (15/130) differed significantly from that of non-coding alterations (0/78) in CEA specimens (p= 0.0013). In control arteries, no microsatellite alterations were observed, neither in coding nor in non-coding microsatellite loci. In conclusion, the specific accumulation of coding mutations suggests that these mutations play a role in the pathogenesis of atherosclerotic carotid lesions, since the absence of mutations in non-coding microsatellites argues against general microsatellite instability, reflecting MMR deficiency.
    Molecular Medicine 06/2015; 21. DOI:10.2119/molmed.2014.00258 · 4.51 Impact Factor

  • Journal of Vascular Surgery 06/2015; 61(6). DOI:10.1016/j.jvs.2015.04.008 · 3.02 Impact Factor
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    ABSTRACT: Despite improvements in endograft devices, operator technique, and patient selection, endovascular repair has not achieved the long-term durability of open surgical aneurysm repair. Persistent or recurrent aneurysm sac flow from failed proximal sealing, component failure, or branch vessel flow underpins a significant rate of reintervention after endovascular repair. The Nellix device (Endologix, Irvine, Calif) employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow. This retrospective analysis represents the initial experience in consecutive patients treated with the device in real-world practice. This study was performed at six clinical centers in Europe and one in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with computed tomography and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. Clinical and imaging end points included technical success (successful device deployment and absence of any endoleak at completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and reintervention. During a 17-month period, 171 patients with abdominal aortic aneurysms were treated with the Nellix device and observed for a median of 5 months (range, 0-14 months). The 153 male and 18 female patients with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infrarenal neck length of 28 ± 15 mm and infrarenal angulation of 37 ± 22 degrees. Technical success was achieved in all but two patients (99%); one patient had a type Ib endoleak and another had a type II endoleak. Through the last available follow-up, type Ia endoleak was observed in five patients (3%), type Ib endoleak in four patients (2%), and type II endoleak in four patients (2%). There were eight limb occlusions (5%), among which seven were evident at the 1-month follow-up visit. Aneurysm-related reinterventions were performed in 15 patients (9%). There were no aneurysm ruptures or open surgical conversions. This first multicenter postmarket report of the Nellix device for infrarenal abdominal aortic aneurysm repair demonstrates satisfactory results during the initial learning phase of this new technology. The rate of aneurysm exclusion was high, and frequency of complications was low. More definitive conclusions on the value of this novel device await the results of the ongoing Nellix EVAS FORWARD Global Registry and the EVAS FORWARD investigational device exemption trial. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 05/2015; 62(2). DOI:10.1016/j.jvs.2015.03.031 · 3.02 Impact Factor
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    ABSTRACT: To report initial experience with automatic pressure-controlled cerebrospinal fluid drainage (CSFD) during thoracic endovascular aortic repair (TEVAR). A prospective nonrandomized study enrolled 30 consecutive patients (median age 68 years, range 42-89; 18 men) who underwent TEVAR between March 2012 and July 2013 and were considered to be at high risk for postoperative spinal cord ischemia (SCI), fulfilling 2 of the following criteria: stent-graft length >20 cm, left subclavian artery coverage, and previous infrarenal aortic repair. All patients received perioperative CSFD via the LiquoGuard system. The protocol aimed for a CSF pressure of 10 mm Hg and duration of CSFD of 3 or 7 days in asymptomatic or symptomatic patients, respectively. Muscle strength of the lower extremities was assessed with the Oxford muscle strength grading scale. Completion of the CSFD protocol was achieved in 26 (87%) of 30 patients. CSFD was prematurely stopped due to catheter dislocation in 1 patient and bloody spinal fluid in 3 patients. CSFD was performed for a median of 3 days (range 1-7). Median total CSFD volume was 714 mL (range 13-2369), with a median 192 mL drained per 24 hours. The SCI rate was 3% (1/30). CSFD-related complications were observed in 33% of the patients: 1 fatal intracranial hemorrhage, 3 bloody spinal fluid episodes, 3 persistent CSF leaks requiring epidural blood patch, and 3 post lumbar puncture headaches. Mortality during a median follow-up of 16 months (range 10-25) was 3% (1/30). Prophylactic CSFD was associated with a low SCI rate in a high-risk patient collective undergoing TEVAR. Monitoring and drainage by an automatic modus was feasible, reproducible, and reliable but associated with relevant drainage-associated complications. © The Author(s) 2015.
    Journal of Endovascular Therapy 04/2015; 22(3). DOI:10.1177/1526602815579904 · 3.35 Impact Factor
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    ABSTRACT: To report the occurrence of a type IIIb endoleak after endovascular repair of a thoracic aortic aneurysm caused by endoanchor dislocation. An 84-year old female patient underwent thoracic endovascular repair for aneurysmal disease of her thoracic aorta. The procedure included primary left subclavian artery revascularization and the placement of endoanchors in order to enhance fixation of the endograft within the aortic arch. Dislocation of one of the endoanchors resulted in a graft defect leading to a type IIIb endoleak and aortic diameter expansion. Endoanchors represent a promising adjunct in endovascular repair settings. However, their use requires careful procedure planning and special attention during follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.
    Annals of Vascular Surgery 03/2015; 29(5). DOI:10.1016/j.avsg.2015.01.018 · 1.17 Impact Factor
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    ABSTRACT: The purpose of this study was to identify morphologic factors affecting type I endoleak formation and bird-beak configuration after thoracic endovascular aortic repair (TEVAR). Computed tomography (CT) data of 57 patients (40 males; median age, 66 years) undergoing TEVAR for thoracic aortic aneurysm (34 TAA, 19 TAAA) or penetrating aortic ulcer (n = 4) between 2001 and 2010 were retrospectively reviewed. In 28 patients, the Gore TAG® stent-graft was used, followed by the Medtronic Valiant® in 16 cases, the Medtronic Talent® in 8, and the Cook Zenith® in 5 cases. Proximal landing zone (PLZ) was in zone 1 in 13, zone 2 in 13, zone 3 in 23, and zone 4 in 8 patients. In 14 patients (25 %), the procedure was urgent or emergent. In each case, pre- and postoperative CT angiography was analyzed using a dedicated image processing workstation and complimentary in-house developed software based on a 3D cylindrical intensity model to calculate aortic arch angulation and conicity of the landing zones (LZ). Primary type Ia endoleak rate was 12 % (7/57) and subsequent re-intervention rate was 86 % (6/7). Left subclavian artery (LSA) coverage (p = 0.036) and conicity of the PLZ (5.9 vs. 2.6 mm; p = 0.016) were significantly associated with an increased type Ia endoleak rate. Bird-beak configuration was observed in 16 patients (28 %) and was associated with a smaller radius of the aortic arch curvature (42 vs. 65 mm; p = 0.049). Type Ia endoleak was not associated with a bird-beak configuration (p = 0.388). Primary type Ib endoleak rate was 7 % (4/57) and subsequent re-intervention rate was 100 %. Conicity of the distal LZ was associated with an increased type Ib endoleak rate (8.3 vs. 2.6 mm; p = 0.038). CT-based 3D aortic morphometry helps to identify risk factors of type I endoleak formation and bird-beak configuration during TEVAR. These factors were LSA coverage and conicity within the landing zones for type I endoleak formation and steep aortic angulation for bird-beak configuration.
    Langenbeck s Archives of Surgery 02/2015; 400(4). DOI:10.1007/s00423-015-1291-1 · 2.19 Impact Factor

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  • 2007-2015
    • evaplan at the University Hospital Heidelberg
      Heidelburg, Baden-Württemberg, Germany
  • 2003-2015
    • Universität Heidelberg
      • • Department of Diagnostic and Interventional Radiology
      • • Department of Vascular Surgery (Mannheim)
      • • Department of Vascular Surgery (Heidelberg)
      Heidelburg, Baden-Württemberg, Germany
  • 2013
    • University of Pittsburgh
      Pittsburgh, Pennsylvania, United States
  • 2012
    • Friedrich-Alexander Universität Erlangen-Nürnberg
      Erlangen, Bavaria, Germany
  • 2011
    • University of Kragujevac
      • Department of Mechanical Engineering
      Krabujevac, Central Serbia, Serbia
  • 2009
    • Technische Universität München
      München, Bavaria, Germany
  • 2008-2009
    • Ethianum Klinik Heidelberg
      Heidelburg, Baden-Württemberg, Germany
  • 2007-2009
    • Vascular and Endovascular Surgery Institute of São Paulo
      San Paulo, São Paulo, Brazil
  • 2006
    • Klinikum Hanau GmbH
      Hanau, Hesse, Germany
  • 2005
    • German Cancer Research Center
      • Division of Radiology
      Heidelberg, Baden-Wuerttemberg, Germany
  • 2004
    • Universität Mannheim
      Mannheim, Baden-Württemberg, Germany