Klinikum Fulda

the aim of this study is to investigate the safety profile and efficacy of single-dose docetaxel augmented targeted radionuclide therapy (TRT) in the form of prostate-specific membrane antigen (PSMA)- targeted radioligand therapy (RLT) using Lutetium-177 (177Lu) in patients who have progressed on PSMA-617 RLT. A retrospective analysis was conducted on 10 mCRPC patients (median age: 68 years; range: 51–74 years) who were progressing on prior RLT. The patients received one cycle of treatment involving 50 mg/m² of docetaxel combined with [177Lu]Lu-PSMA-617. Efficacy was assessed via biochemical (PSA, PCWG3) and molecular imaging endpoints (TLP/MTV via [68Ga]Ga-PSMA-11 PET/CT). PSA-progression-free survival (PSA-PFS) and overall survival (OS) were analyzed using Kaplan–Meier statistics. Toxicity was graded by CTCAE v5.0. After single-dose docetaxel augmented [177Lu]Lu-PSMA-617 RLT, 60% of the patients showed a disease stabilization for 4–8 weeks based on PSA (10% partial remission and 50% stable disease). Based on the molecular imaging-based response assessment, 62.5% of the patients showed a disease stabilization (25% parietal response and 37.5% stable disease). The median PSA-PFS and OS thereafter were 4.4 months (95%CI: 1.3–7.6 months) and 7.2 months (95%CI: 2.9–11.5 months), respectively. The augmentation therapy was well-tolerated without any serious acute adverse events. During the first 4–8 weeks thereafter 3 patients exhibited transient grade 3 anemia and one patient a transient grade 2 nephrotoxicity. This pilot experience demonstrates that single-dose docetaxel application to [177Lu]Lu-PSMA-617 radioligand therapy is feasible and may present an option for late-stage heavily pretreated mCRPC progressing on PSMA-617 RLT. Formal study of this combination is warranted.

Introduction: Post-COVID syndrome (PCS) can lead to severe restrictions in the ability to work and participate in society and can lead to the development of depressive symptoms. The aim of this study was to investigate how many PCS patients suffer from clinically relevant depressive symptoms and to what extent PCS rehabilitation can modulate psychological symptoms as well as limitations in functional health. Methods: Prospective multicenter cohort study PoCoRe (N = 1,028). Assessment of depressiveness (PHQ-9, PHQ-2), fatigue (FSMC) and functional health and disability (WHO-DAS2.0). Frequency analyses, mean comparisons. Results: At the start of rehabilitation, 71.4% (n = 734) fulfilled the core symptoms of depressive disorders in general in the PHQ-2. In the screening-positive patients, the PHQ-9 total score was on average M = 23.74 (standard deviation = 4.43). As expected the depressive symptom burden was reduced more in depressed PCS patients (d = 0.50) than in nondepressed PCS patients (d = 0.32). Fatigue symptoms did not change. Functional health (WHO-DAS) improved above all in coping with everyday life (d = 0.71, or 1.04), and in the nondepressed patients also in mobility (d = 0.27). In the sociomedical assessment, 24.7% of the total samples were assessed as having an impaired capacity for the reference occupation and 19.5% as having an impaired capacity for the general labor market. Depressive patients had the worse sociomedical outcome. Conclusion: Depressiveness is common and can be well influenced by PCS rehabilitation. Fatigue is less easily influenced, which indicates that they are independent symptoms. Patients with persistent depression and fatigue have a poorer sociomedical prognosis.

Objective Fixation of the stimulating probe of auditory brainstem implants (ABI) is crucial to maintain beneficial stimulation. Use of Tetrafluorethylen (PTFE, TeflonTM) sheets as a fixation material was compared to fixation without PTFE-sheets. Methods Setting Tertiary referral center. Study Design Retrospective analysis. Patients 46 children with sensorineural hearing loss, not eligible for CI, received an ABI; 27 children without PTFE (Control Group, CG), 18 children with PTFE (TeflonTM Group, TG). Mean age of CG (46.6 months), TG (37.4 months), n.s. Mean follow-up 49.3 months (CG), 33 months (TG), n.s. Main Outcome Measures Number of stimulating probe dislocations, number of active electrodes, electrically evoked auditory-brainstem-response (eABR) morphology performed intraoperatively and postoperatively, maximum comfortable level (MCL), categories of auditory-performance (CAP) scores. Results TG showed no electrode dislocations, CG had one. eABR waves varied from 2 to 5 in both groups, number of active electrodes was similar. Mean MCL was sign. lower in TG (49.2 nC) vs CG (98.6 nC). CAP scores were sign. better in TG (5.0) vs CG (4.2), after 2 years and 5.4 vs 4.6 after 3 years post-activation. Conclusion PTFE sheets proved to be an effective and stable fixation material for ABI stimulating probes, resulting in potentially better auditory outcomes as indicated by significantly lower MCLs and improved CAP scores. Compared to other fixation materials used in the CG, PTFE-sheets appear to be the better choice.

Current available outcome data following laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia (IH) are comparable to a limited extent only because of a huge number of variability particulary in surgical technique and use of medical devices. In this prospective observational multicenter cohort study we evaluate the impact of a consensus driven standard protocol for IPOM, that is mesh fixation with absorbable tacks in double crown technique enforced by additional non-absorbable transfascial sutures at the edges of the mesh along with the use of Physiomesh™, on clinical and patient reported outcome measures. A total of 102 consecutive patients were screened for eligibility between September 2013 and October 2014. 85 patients (IH: EHS W1: n=39, W2: n=46) were included into the study. Clinical examination and PROM for pain and quality of life measure (Carolina Comfort Scale, CCS) were performed at baseline, during hospital stay and at 6 weeks, 6 months and 1 year follow-up. The follow-up rate was 87,1% for the primary endpoint. The Kaplan-Meier estimate for freedom-of-recurrence at 1 year was 95.9% (95%-CI: 87.9-98.7%), the cumulative recurrence rate at 1 year was 4.1% (95%-CI: 0.9-11.7%). There was no intraoperative complication. One seroma (type I; 1/84 (1,2%), 95%-CI: 0-7.1%) was diagnosed during hospital stay. 12 seroma (n=12/74 (16,2%), 95%-CI: 9.4-26.4%; n=10 type II and n=2 type IV) were diagnosed during follow-up requiring surgical intervention in 1 patient (1,4%, Clavien Dindo grade IIIb). Subcutaneous hematoma were found during follow-up in 8 patients (8/75 (10.7%); 95%-CI: 5.3-19.9) with need for surgical intervention in 2 patients (2,7%, Clavien Dindo grade IIIb). There were 3 superficial surgical site infections (3/74 (4,1%); 95%-CI: 0.9-11.7%, Clavien-Dindo grade I) without need for reoperation. Patient reported pain as measured by numeric rating scale at baseline was 1.36±1.53 and 0.35±1.04at 1 year follow-up. CCS total scores indicated a good outcome with a decrease to 2.80±6.47 (Min: 0, Q1: 0, Median: 0; Q3: 3.0; Max: 38.0) at 1 year follow-up. Subscore sensation of mesh decreased from 4.01±6.76 (min: 0, Q1: 0, Median: 0; Q3: 5.0; Max: 28.0) at 6 weeks to 1.67±3.99 (Min: 0, Q1: 0, Median: 0; Q3: 1.0; Max: 21.0) after 6 months and 0.90±2.69 (Min: 0, Q1: 0, Median: 0; Q3: 0; Max: 14.0) after 1 year follow-up. Subscores pain and movement limitation both decreased during follow-up and were significantly reduced at 1 year compared to preoperative assessment (p<0.001). This study showed favourable clinical and patient reported outcomes and a low rate of recurrences at 1 year follow-up after IPOM for elective IH applying a standardized surgical technique including the use of Physiomesh™. In view of the data leading to the market withdrawal of the Physiomesh™, one might conclude, that the described standard may have contributed to a compensation of the suspected delay in tissue integration of the Physiomesh™ resulting in a more proper mesh fixation compared to absorbable tack fixation with/without absorbable TFS. This may lead to the general appraisal, that the fixation technique has to be adapted to the individual characteristics of type of mesh and fixation devices and the planned anatomic landing zone of the mesh.

Background/Objectives: Severe obesity significantly increases the risk of complications following full sternotomy in coronary artery bypass grafting (CABG). However, these patients are frequently excluded from less invasive, sternum-sparing surgical alternatives. This study aimed to assess the safety and practicality of a newly developed technique-Total Coronary Revascularization via left Anterior miniThoracotomy (TCRAT)-that avoids sternotomy in patients with severe obesity requiring multivessel CABG. Methods: From November 2019 to May 2024, a total of 502 non-emergency patients with multivessel coronary artery disease underwent CABG through a left anterior minithoracotomy using cardiopulmonary bypass (CPB) and cardioplegic arrest. Of these, 43 patients with a body mass index (BMI) exceeding 35.0 kg/m2 were classified as severely obese and included for subgroup analysis. Their outcomes were compared to those of the remaining 459 patients with BMI below 35.0 kg/m2. Key intraoperative variables-such as total operative time, CPB duration, aortic cross-clamp time, and graft strategy-were evaluated. Postoperative outcomes, such as the incidence of major adverse cardiac and cerebrovascular events, minor complications, and length of stay in ICU and hospital, were also analyzed. Results: Severely obese patients exhibited a longer total operation time (353.5 ± 83.6 min vs. 320.4 ± 73.4 min, p < 0.05). In contrast, no statistical differences were observed in aortic cross-clamp time (97.9 ± 27.6 min vs. 95.6 ± 33.0 min; p = 0.307) or CPB time (163.3 ± 35.0 min vs. 155.0 ± 42.9 min; p = 0.078). Both groups received a similar number of distal anastomoses (3.1 ± 0.7 vs. 3.0 ± 0.8; p = 0.194), and the frequency of total arterial revascularization was comparable (34.9% vs. 40.0%; p = 0.268). There were no differences between the groups in major complications, including hospital mortality (2.3% vs. 1.1%, p = 0.227), stroke (0.0% vs. 0.6% p = 0.300), or need for re-revascularization (0.0% vs. 1.1%, p = 0.248). Similarly, minor complications, such as wound healing issues (2.3% vs. 1.1%, p = 0.233) and revisions for bleeding (4.6% vs. 7.2%, p = 0.276), were comparable between groups. ICU stay (2.7 ± 4.5 days vs. 2.2 ± 4.0 days; p = 0.225) and total hospital stay (12.3 ± 9.6 days vs. 10.8 ± 8.6 days; p = 0.142) showed no meaningful differences. Conclusions: TCRAT can be performed safely and effectively in severely obese patients, providing a feasible minimally invasive option for complete coronary revascularization in cases of multivessel disease. This approach eliminates the complications associated with sternotomy, making it a valuable surgical alternative for this high-risk patient group.