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5. Valvulotomy of the great saphenous vein in ex situ non-reversed and in situ setting: a multicenter post-market study to assess the safety and efficacy of the AndraValvulotome™".

Author

Souri, Yaser, Liebetrau, Dominik, Hyhlik-Dürr, Alexander, Vascular Investigators, Weigang, E., Kemke, J., Branzan, D., Wilhelmi, M., Classen, S., Pfister, K., Kuhnert, M., Seifert, S., Derwich, W., and Stavroulakis, K.

Subjects
SAPHENOUS vein, PERIPHERAL vascular diseases, PULSATILE flow, DUPLEX ultrasonography, BLOOD flow
Abstract

Purpose: To evaluate the safety and technical success of the AndraValvulotome™ device (Andramed GmbH, Reutlingen, Germany) in patients with peripheral arterial disease (PAD) requiring bypass surgery using the great saphenous vein (GSV) as graft. Methods: This was a multicenter, post-market observational study conducted in 2021 in 11 German centers. Safety and efficacy data were prospectively collected and analyzed. Primary endpoints were the absence of device-related serious adverse events until 30 ± 7 days follow-up, the clinical efficacy of valvulotomy, which was defined as pulsatile blood flow in the bypass and the number of insufficiently destroyed vein valves. Secondary endpoints were the number of valvulotomy passages, the primary patency rate of the venous bypass (determined by a color-duplex sonography showing a normal blood flow through the bypass and absence of stenosis or occlusion), and the primary technical success defined as the absence of product-specific (serious) adverse events and clinical efficacy. Results: Fifty-nine patients were enrolled. The mean age of the patients was 71 years (46–91), and 74.6% were males. The vein material used for bypass grafting had a median length of 47.5 cm (range 20–70 cm) with a median diameter of 5.0 mm (range 3–6 mm) and 4.0 mm (range 2–6 mm) in the proximal and distal segments, respectively. The technical success rate was 96.6%. The primary patency rate was 89.9% at 30 days follow-up. The clinical efficacy was rated as very good in 81% of patients, fair in 17%, and poor in 2%. Between 1 and 5 (average 2.9) valvulotome passages were performed. One product-related serious adverse event was recorded (bypass vein dissection). Conclusion: The AndraValvulotome™ can be considered a safe and effective device to disrupt venous valves during in situ non-reversed bypass surgeries using GSV grafts in patients with PAD. [ABSTRACT FROM AUTHOR]

Published
2023
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6. Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers

Author

Behrendt, C.-A., Heidemann, F., Haustein, K., Grundmann, R. T., Debus, E. S., Balzer, K. M., Banafsche, R., Barbera, L., Baumhäkel, M., Blajan, E., Böhner, H., Breuer, P., Brune, U., Brunkwall, J., Bürger, T., Classen, S., Cöster, A., Dahl, P., Dus, E. S., Delgado, J. P., Dill, H., Eder, S., Fährenkemper, T., Feidicker, B., Forkel, J., Gahlen, J., Geier, B., Ghoi, R., Görtz, H., Gräbedünkel, J., Gunkel, W., Hader, O., Hammermüller, T., Hatzl, J., Hoffmann, J., Hofmann, M., Huberts, U., Jacobs, M., Kiechle, V., Kindermann, M., Kleemann, M., Kolka, P., Krahl, M., Krönert, T., Krupski-Berdien, G., Kuffner, H., Kuhnert, M., Lange, T., Lauff, V. K., Lesser, T., Liewald, F., Lommel, D., Naundorf, M., Nitschmann, K., Nöldeke, S., Noppeney, T., Oberhuber, A., Ockert, D. M., Orend, K.-H., Ossig, U., Petridis, C., Pflugradt, A., Quellmalz, U., Reimer, P., Remig, J., Richter, P., Riepe, G., Rümenapf, G., Schaefer, T., Schelzig, H., Schmidt, G., Schneider, M., Schofer, J., Seifert, S., Siggelkow, M., Sixt, S., Stautner, E., Stehr, A., Storck, M., Teßarek, J., Teebken, O. E., Thom, K.-D., Tigges, W. P., Voshage, G., Wagenbreth, K.-D., Walluscheck, K. P., Walter, D., Weidenhagen, R., Weis-Müller, B., Wenk, H., Wenk, M., Wiedner, M., Wilde, J., Wittstock, F. T., and PSI Collaborators

Published
2017
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7. Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial

Author

Alric, P., Canaud, L., Janotta, M., Raithel, D., Malina, M., Resch, Ti., Eckstein, H.-H., Ockert, S., Larzon, T., Carlsson, F., Schumacher, H., Classen, S., Schaub, P., Lammer, J., Lönn, L., Clough, R.E., Rampoldi, V., Trimarchi, S., Fabiani, J.-N., Böckler, D., Kotelis, D., von Tenng-Kobligk, H., Mangialardi, N., Ronchey, S., Dialetto, G., Matoussevitch, V., Brunkwall, J., Kasprzak, P., Verhoeven, E., Heijmen, R., and Taylor, P.

Published
2014
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9. Partial reduction in BRCA1 gene dose modulates DNA replication stress level and thereby contributes to sensitivity or resistance

Author

Classen, S. (Sandra), Rahlf, E. (Elena), Jungwirth, J. (Johannes), Albers, N. (Nina), Hebestreit, L. P. (Luca Philipp), Zielinski, A. (Alexandra), Poole, L. (Lena), Groth, M. (Marco), Koch, P. (Philipp), Liehr, T. (Thomas), Kankel, S. (Stefanie), Cordes, N. (Nils), Petersen, C. (Cordula), Rothkamm, K. (Kai), Pospiech, H. (Helmut), Borgmann, K. (Kerstin), Classen, S. (Sandra), Rahlf, E. (Elena), Jungwirth, J. (Johannes), Albers, N. (Nina), Hebestreit, L. P. (Luca Philipp), Zielinski, A. (Alexandra), Poole, L. (Lena), Groth, M. (Marco), Koch, P. (Philipp), Liehr, T. (Thomas), Kankel, S. (Stefanie), Cordes, N. (Nils), Petersen, C. (Cordula), Rothkamm, K. (Kai), Pospiech, H. (Helmut), and Borgmann, K. (Kerstin)

Abstract

BRCA1 is a well-known breast cancer risk gene, involved in DNA damage repair via homologous recombination (HR) and replication fork protection. Therapy resistance was linked to loss and amplification of the BRCA1 gene causing inferior survival of breast cancer patients. Most studies have focused on the analysis of complete loss or mutations in functional domains of BRCA1. How mutations in non-functional domains contribute to resistance mechanisms remains elusive and was the focus of this study. Therefore, clones of the breast cancer cell line MCF7 with indels in BRCA1 exon 9 and 14 were generated using CRISPR/Cas9. Clones with successful introduced BRCA1 mutations were evaluated regarding their capacity to perform HR, how they handle DNA replication stress (RS), and the consequences on the sensitivity to MMC, PARP1 inhibition, and ionizing radiation. Unexpectedly, BRCA1 mutations resulted in both increased sensitivity and resistance to exogenous DNA damage, despite a reduction of HR capacity in all clones. Resistance was associated with improved DNA double-strand break repair and reduction in replication stress (RS). Lower RS was accompanied by increased activation and interaction of proteins essential for the S phase-specific DNA damage response consisting of HR proteins, FANCD2, and CHK1.

Published
2022

10. Partial Reduction in BRCA1 Gene Dose Modulates DNA Replication Stress Level and Thereby Contributes to Sensitivity or Resistance

Author

Classen, S., Rahlf, E., Jungwirth, J., Albers, N., Hebestreit, L., Zielinski, A., Poole, L., Groth, M., Koch, P., Liehr, T., Kankel, S., (0000-0001-5684-629X) Cordes, N., Petersen, C., Rothkamm, K., Pospiech, H., Borgmann, K., Classen, S., Rahlf, E., Jungwirth, J., Albers, N., Hebestreit, L., Zielinski, A., Poole, L., Groth, M., Koch, P., Liehr, T., Kankel, S., (0000-0001-5684-629X) Cordes, N., Petersen, C., Rothkamm, K., Pospiech, H., and Borgmann, K.

Abstract

BRCA1 is a well-known breast cancer risk gene, involved in DNA damage repair via homologous recombination (HR) and replication fork protection. Therapy resistance was linked to loss and amplification of the BRCA1 gene causing inferior survival of breast cancer patients. Most studies have focused on the analysis of complete loss or mutations in functional domains of BRCA1. How mutations in non-functional domains contribute to resistance mechanisms remains elusive and was the focus of this study. Therefore, clones of the breast cancer cell line MCF7 with indels in BRCA1 exon 9 and 14 were generated using CRISPR/Cas9. Clones with successful introduced BRCA1 mutations were evaluated regarding their capacity to perform HR, how they handle DNA replication stress (RS), and the consequences on the sensitivity to MMC, PARP1 inhibition, and ionizing radiation. Unexpectedly, BRCA1 mutations resulted in both increased sensitivity and resistance to exogenous DNA damage, despite a reduction of HR capacity in all clones. Resistance was associated with improved DNA double-strand break repair and reduction in replication stress (RS). Lower RS was accompanied by increased activation and interaction of proteins essential for the S phase-specific DNA damage response consisting of HR proteins, FANCD2, and CHK1.

Published
2022

23. Mitos y evidencias en el empleo de la toxina botulinica: espasticidad del adulto y del nintilde;o con paralisis cerebral

Author

Martinez-Castrillo JC, Pena-Segura JL, Sanz-Cartagena P, Xenia Alonso, Arbelo-Gonzalez JM, Arriola-Pereda G, Coll-Bosch MD, Conejero-Casares JA, Garcia-Ribes A, Jauma-Classen S, Pagonabarraga J, Vidal-Valls J, and Garcia-Ruiz PJ

Abstract

INTRODUCTION: Spasticity is a medical problem with a high incidence that significantly impact on the quality of life of patients and their families. AIM: To analyze and to answer different questions about the use of botulinum toxin type A (BTA) in our clinical practice. DEVELOPMENT: A group of experts in neurology develop a list of topics related with the use of BTA. Two big groups were considered: spasticity in adults and in children with cerebral palsy. A literature search at PubMed for English, French, and Spanish language articles published up to June 2016 was performed. The manuscript was structured as a questionnaire that includes those questions that, according to the panel opinion, could generate more controversy or doubt. The initial draft was reviewed by the expert panel members to allow for modifications, and after subsequent revisions for achieving the highest degree of consensus, the final text was then validated. Different questions about diverse aspects of spasticity in adults, such as methods for evaluating spasticity, infiltration techniques, doses, number of infiltration points, etc. Regarding spasticity in children with cerebral palsy, the document included questions about minimum age of infiltration, methods of analgesia, etc. CONCLUSIONS: This review is a tool for continuous training for neurologist and rehabilitation specialist and residents of both specialties, about different specific areas of the management of BTA.

Published
2017

25. Erratum to “Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial” [Eur J Vasc Endovasc Surg 48 (3) (September/2014) 285–291]

Author

Brunkwall, J., primary, Kasprzak, P., additional, Verhoeven, E., additional, Heijmen, R., additional, Taylor, P., additional, Alric, P., additional, Canaud, L., additional, Janotta, M., additional, Raithel, D., additional, Malina, M., additional, Resch, Ti., additional, Eckstein, H.-H., additional, Ockert, S., additional, Larzon, T., additional, Carlsson, F., additional, Schumacher, H., additional, Classen, S., additional, Schaub, P., additional, Lammer, J., additional, Lönn, L., additional, Clough, R.E., additional, Rampoldi, V., additional, Trimarchi, S., additional, Fabiani, J.-N., additional, Böckler, D., additional, Kotelis, D., additional, von Tengg-Kobligk, H., additional, Mangialardi, N., additional, Ronchey, S., additional, Dialetto, G., additional, and Matoussevitch, V., additional

Published
2015
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26. Carnosinase concentration and activity in CNDP1 (CTG)5 homozygous T2DM patients with and without nephropathy

Author

Zhang, S, primary, Pfister, F, additional, Lindner, H, additional, Albrecht, T, additional, Classen, S, additional, Kabtni, S, additional, Peters, V, additional, Klessens, C, additional, van den Born, J, additional, Navis, G, additional, Bakker, S, additional, de Heer, E, additional, Krämer, B, additional, Yard, B, additional, and Hauske, S, additional

Published
2015
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27. Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial

Author

Brunkwall, J., Kasprzak, P., Verhoeven, E., Heijmen, R., Taylor, P., Alric, P., Canaud, L., Janotta, M., Raithel, D., Malina, M., Resch, Ti, Eckstein, H. -H., Ockert, S., Larzon, T., Carlsson, F., Schumacher, H., Classen, S., Schaub, P., Lammer, J., Lonn, L., Clough, R. E., Rampoldi, V., Trimarchi, S., Fabiani, J. -N., Boeckler, D., Kotelis, D., von Tenng-Kobligk, H., Mangialardi, N., Ronchey, S., Dialetto, G., Matoussevitch, V., Brunkwall, J., Kasprzak, P., Verhoeven, E., Heijmen, R., Taylor, P., Alric, P., Canaud, L., Janotta, M., Raithel, D., Malina, M., Resch, Ti, Eckstein, H. -H., Ockert, S., Larzon, T., Carlsson, F., Schumacher, H., Classen, S., Schaub, P., Lammer, J., Lonn, L., Clough, R. E., Rampoldi, V., Trimarchi, S., Fabiani, J. -N., Boeckler, D., Kotelis, D., von Tenng-Kobligk, H., Mangialardi, N., Ronchey, S., Dialetto, G., and Matoussevitch, V.

Abstract

Objectives: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. Methods: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. Results: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). Conclusions: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of

Published
2014

28. Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling:1 Year Results of the ADSORB Trial

Author

Brunkwall, J, Kasprzak, P, Verhoeven, E, Heijmen, R, Taylor, P, Alric, P, Canaud, L, Janotta, M, Raithel, D, Malina, W, Resch, Ti, Eckstein, H-H, Ockert, S, Larzon, T, Carlsson, F, Schumacher, H, Classen, S, Schaub, P, Lammer, J, Lönn, Lars Birger, Clough, R E, Rampoldi, V, Trimarchi, S, Fabiani, J-N, Böckler, D, Kotelis, D, von Tenng-Kobligk, H, Mangialardi, N, Ronchey, S, Dialetto, G, Matoussevitch, V, Brunkwall, J, Kasprzak, P, Verhoeven, E, Heijmen, R, Taylor, P, Alric, P, Canaud, L, Janotta, M, Raithel, D, Malina, W, Resch, Ti, Eckstein, H-H, Ockert, S, Larzon, T, Carlsson, F, Schumacher, H, Classen, S, Schaub, P, Lammer, J, Lönn, Lars Birger, Clough, R E, Rampoldi, V, Trimarchi, S, Fabiani, J-N, Böckler, D, Kotelis, D, von Tenng-Kobligk, H, Mangialardi, N, Ronchey, S, Dialetto, G, and Matoussevitch, V

Abstract

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year.METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB.RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062).CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device

Published
2014

29. Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial

Author

Brunkwall, J., primary, Kasprzak, P., additional, Verhoeven, E., additional, Heijmen, R., additional, Taylor, P., additional, Alric, P., additional, Canaud, L., additional, Janotta, M., additional, Raithel, D., additional, Malina, M., additional, Resch, Ti., additional, Eckstein, H.-H., additional, Ockert, S., additional, Larzon, T., additional, Carlsson, F., additional, Schumacher, H., additional, Classen, S., additional, Schaub, P., additional, Lammer, J., additional, Lönn, L., additional, Clough, R.E., additional, Rampoldi, V., additional, Trimarchi, S., additional, Fabiani, J.-N., additional, Böckler, D., additional, Kotelis, D., additional, von Tenng-Kobligk, H., additional, Mangialardi, N., additional, Ronchey, S., additional, Dialetto, G., additional, and Matoussevitch, V., additional

Published
2014
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43. Predictive relevance of soluble CD44v6 serum levels for the responsiveness to second line hormone- or chemotherapy in patients with metastatic breast cancer

Author

Kopp R, Classen S, Wolf H, Patrick Gholam, Possinger K, and Wilmanns W

Subjects
Adult, Antineoplastic Agents, Hormonal, Breast Neoplasms, Antigens, Neoplasm, Predictive Value of Tests, Risk Factors, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Humans, Neoplasm Metastasis, Cyclophosphamide, Aged, Glycoproteins, L-Lactate Dehydrogenase, Liver Neoplasms, Remission Induction, Middle Aged, Alkaline Phosphatase, Combined Modality Therapy, Neoplasm Proteins, Hyaluronan Receptors, Logistic Models, Methotrexate, Treatment Outcome, Solubility, Doxorubicin, Organ Specificity, Female, Fluorouracil
Abstract

Concentrations of soluble CD44 standard (sCD44std) and CD44 variant 6 (sCD44v6) isoforms were determined in the sera of 59 patients with distant metastasis from breast cancer receiving second line hormone- or chemotherapy, in comparison to 46 breast cancer patients without detectable recurrent disease and 21 healthy blood donors. The sera of non-metastatic breast cancer, patients contained sCD44std and sCD44v6 concentrations similiar to those of healthy blood donors. In sera of patients with distant metastasis from recurrent breast cancer the median values of sCD44std and sCD44v6 were significantly higher (sCD44std: 502 ng/ml, p=0.03; sCD44v6: 193 ng/ml, p = 0.002) in comparison to healthy blood donors and patients with non-metastatic disease (p0.001 for both parameters). A significant correlation was observed between sCD44v6 serum concentrations and the number of metastasized organs (p=0.0018), serum LDH concentrations (p0.0001), tumor grading (p=0.025) and the presence of hepatic metastasis (p=0.028). Furthermore, sCD44v6 expression was associated with the patient's responsiveness to second line hormone- or chemotherapy. Non-responders had significantly higher sCD44v6 levels compared with the responder group (median: 447 ng/ml vs 171 ng/ml; p=0.0007). Logistic regression analysis indicated that sCD44v6 serum levels above 250 ng/ml (p =0.033) and the presence of hepatic metastasis (p=0.009) were independent factors predicting an unfavourable response to therapy.

Published
2001

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