08 Fakultät Mathematik und Physik

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    Is minimally invasive multi-vessel off-pump coronary surgery as safe and effective as MIDCAB?
    (2024) Rufa, Magdalena I.; Ursulescu, Adrian; Dippon, Juergen; Aktuerk, Dincer; Nagib, Ragi; Albert, Marc; Franke, Ulrich F. W.
    The safety and efficacy of minimally invasive direct coronary artery bypass (MIDCAB) surgery has been confirmed in numerous reports. However, minimally invasive multi-vessel off-pump coronary artery bypass grafting (MICS CABG) has lower uptake and has not yet gained widespread adoption. The study aimed to investigate the non-inferiority of MICS CABG to MIDCAB in long-term follow-up for several clinical outcomes, including angina pectoris, major adverse cardiac and cerebrovascular events (MACCE) and overall survival. Methods This is an observational, retrospective, single center study of 1,149 patients who underwent either MIDCAB (n= 626) or MICS CABG (n= 523) at our institution between 2007 and 2018. The left internal thoracic artery and portions of the radial artery and saphenous vein were used for the patients’ single-, double-, or triple-vessel revascularization procedures. We used gradient boosted propensity-score estimation to account for possible interactions between variables. After propensity-score adjustment, the two groups were similar in terms of preoperative demographics and risk profile. Long-term follow-up (mean 5.87, median 5.6 years) was available for 1,089 patients (94.8%). Results A total of 626, 454 and 69 patients underwent single, double and triple coronary revascularization, respectively. The long-term outcomes of freedom from angina pectoris, acute myocardial infarction, and revascularization rate were similar between the two groups. During follow-up, there were 123 deaths in the MIDCAB group and 96 in the MICS CABG group. The 1-, 3-, 5-, and 10-year survival rates were 97%, 92%, 85%, and 69% for the MIDCAB group and 97%, 93%, 89%, and 74% for the MICS CABG group, respectively. The hazard ratio of overall survival for patients with two or more bypass grafts compared to those with one bypass graft was 1.190 (p -value = 0.234, 95% CI: 0.893-1.586). This indicates that there was no significant difference in survival between the two groups. Furthermore, if we consider a hazard ratio of 1.2 to be clinically non-relevant, surgery with two or more grafts was significantly non-inferior to surgery with just one graft (p-value = 0.0057). Conclusion In experienced hands, MICS CABG is a safe and effective procedure. Survival and durability are comparable with MIDCAB.
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    Integrative medicine during the intensive phase of chemotherapy in pediatric oncology in Germany : a randomized controlled trial with 5-year follow up
    (2022) Seifert, Georg; Blakeslee, Sarah B.; Calaminus, Gabriele; Kandil, Farid I.; Barth, Andrea; Bernig, Toralf; Classen, Carl Friedrich; Corbacioglu, Selim; Föll, Jürgen; Gottschling, Sven; Gruhn, Bernd; vom Hoff-Heise, Claudia; Lode, Holger N.; Martin, David; Nathrath, Michaela; Neunhoeffer, Felix; Pekrun, Arnulf; Wulff, Beate; Zuzak, Tycho; Henze, Günter; Längler, Alfred
    Background. Integrative medicine is used frequently alongside chemotherapy treatment in pediatric oncology, but little is known about the influence on toxicity. This German, multi-center, open-label, randomized controlled trial assessed the effects of complementary treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients. Methods. Intervention and control were given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients and additional on-demand treatment tailored to the intervention malignancy groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales. Results. Data of 288 patients could be analyzed. Analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow up. Discussion. In this trial findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.