St. Bonifatius Hospital

Introduction: Brain metastases occur in approximately 20% to 40% of individuals annually diagnosed with cancer. This poor prognostic feature can severely reduce life expectancy and quality of life. Stereotactic radiosurgery (SRS) has been shown to provide excellent tumor control and clinical outcomes. ZAP-X (Zap Surgical Systems Inc., San Carlos, CA, USA) is an innovative self-shielded gyroscopic stereotactic radiosurgery (GRS) system to help further address these needs. In this study, we evaluate the clinical outcomes of patients with brain metastases who have undergone treatment with ZAP-X in a single institution.Methods: Medical records of all patients with brain metastases treated with GRS between May 2021 and May 2023 were reviewed as a retrospective case series. Demographics, clinical symptoms, treatment trajectory, and follow-up data were collected and analyzed.Results: A total of 46 patients with 140 combined brain metastases were included in this cohort. Of them, 58.7% (N=27) were female patients, and the mean age was 63 years (range 36-82). The primary pathologies were non-small cell lung cancer (NSCLC; N22, 47.8%), breast cancer (N11, 23.9%), melanoma (N5, 10.9%), and others (N8, 17.4%). The prescription dose was 18 Gy if the patient previously received whole-brain radiotherapy (WBRT); otherwise, 20 Gy. All patients received dexamethasone (3x4 mg PO). The most common symptoms included headache (45.7%), motor disturbances (30.4%), and seizures (21.7%). Mean follow-up time was 8.5 months (range 0-19). Systemic response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria was 17.3% complete response, 10.9% partial response, 45.7% stable disease, and 26.1% progression of disease. Tumor control was 73.9% according to the Response Assessment in Neuro-Oncology (RANO) criteria for brain metastases.Conclusions: GRS is a novel image-guided linear accelerator-based, self-shielding gyroscopic radiosurgery platform that does not require a vault. This study shows that GRS achieves comparable results to traditional SRS platforms in the treatment of brain metastases.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients. We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention. Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions. The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

Background: The objective of the study was to analyze mid-term results of unselected patients treated with the TREO (Terumo Aortic, Florida, USA) device at six German hospital sites. Methods: A multicenter, retrospective analysis of patients treated within and outside instructions for use (IFU) from January 2017 to November 2020 was performed. Primary outcomes were technical success, mortality and endograft related complications according to IFU status. Secondary outcomes were aneurysm/procedure related re-interventions. Results: 150 patients (92% male, mean age 73 ±8 years) were treated (within IFU 84% vs. outside IFU 16%) with the TREO device for abdominal aortic aneurysms (n=127 intact, n=17 symptomatic and n=6 ruptured; p=0.30). Technical success was achieved in 147/150 (within IFU 99% vs. outside IFU 92%, p=0.08). 30-day mortality was 2%, one year and overall mortality was 3% and 5%. During a mean follow-up of 28.4 months (range: 1-67.4 months), 35 (25%; within IFU 23% vs. outside IFU 35%, p=0.23) patients suffered from endoleaks. The majority were endoleaks type II (n=33), the remaining type Ia (n=5) and type Ib (n=3). No endoleaks type III-V, migrations or aneurysm ruptures occurred. Overall, 19 patients (13%; within IFU 13% vs. 15% outside IFU, p=0.70) received a secondary intervention: nine endoleak related endovascular procedures, three open conversions, two endograft limb related interventions, four surgical revisions of the femoral access sites and two bowl ischemia related procedures, respectively. Conclusions: This non industry-sponsored, multicenter trial indicates that using the TREO device in a real-world setting (both within and outside IFU) seems feasible in the treatment of patients suffering from AAA. While the rate of complications and secondary interventions is in line with previously published data, the findings highlight the fact that standard EVAR is associated with serious adverse events.

Abstract Purpose Guidelines on management of heart failure patients support intensive patient education on self-care. To evaluate the short and long-term impact of a structured education by a qualified heart failure nurse on patient´s self-care and disease knowledge. Methods 131 patients (66±12 years) hospitalized for heart failure participated in a structured one hour education program by a heart failure nurse. Patients completed a questionnaire consisting of 15 questions, nine of the European Heart Failure Self-Care Behaviour Scale (EHFScB-9) and additionally six questions on the patient´s disease knowledge 1 day before, 6 months and 12 months after the education course. Possible responses ranged from 1 (complete agreement) to 5 (complete disagreement). Clinical events during the 12 months follow-up period were determined. Factors predicting with potential impact on the teaching effect were evaluated. Seven patients refused further participation during follow-up, 13 patients were lost during follow-up, and one patient was excluded from the study due to progressive dementia. Results Nine patients died during the study and 33 patients had recurrent hospitalization for heart failure. EHFScB-9 scale improved from 24.0±7.2 at baseline to 17.0±7.4 (p&amp;lt;0.001) at 6 months, and 17.2±6.1 (p&amp;lt;0.001 vs. baseline) after 12 months. Concerning the disease knowledge score, it improved from 17.9±5.3 at baseline to 12.1±4.3 (p&amp;lt;0.05) at 6 months follow-up, and to 12.0±5.5 (p&amp;lt;0.05) at 12 months after education. Scores to individual questions prior to education ranged from 1.2±0.8 on adherence to the medication protocol to 2.7±1.4 on everyday weighting habits. Greatest improvement after education were obtained on reaction to weight gains (-1.9±1.3), daily weight control (-1.6±1.4) and knowledge on the reason of patient’s heart failure (-1.6±1.2). The NYHA-classification improved from 2.8±0.8 before teaching to 2.2±0.7 (p&amp;lt;0.001) at 12-months follow-up. No predictor of an insufficient teaching effect could be defined. Patients with a clinical event (death, recurrent hospitalization) had a combined EHFScB-9 and disease knowledge score of 32.6±8.1vs. 28.9±9.9 in those patients without a clinical event. Patients with more than one hospitalization due to acute decompensated heart failure during the follow-up period express insignificant improvement of the combined EHFScB-9 and disease knowledge score immediately after the education session. Conclusions A qualified nurse education program improves self-care behaviour and patient´s disease knowledge with a persisting effect at 6 and 12 months follow-up. There are no patient characteristics which preclude the implementation of an educational session.

PurposeTo report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions.Materials and methodsPatients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed.Results220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503).ConclusionEven at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.Graphical

Durch die steigende Lebenserwartung und den damit verbundenen demografischen Wandel sind immer mehr Menschen auf Pflege angewiesen. Um erste Hinweise auf einen möglichen notwendigen zahnärztlichen Behandlungsbedarf zu geben, haben sich im zahnmedizinischen Bereich Kaufunktionstests als Assessmentinstrumente bewährt. Im vorliegenden Beitrag wird dem Leser eine Übersicht über vorhandene Kaufunktionstests und deren Durchführung gegeben. An dieser Stelle ist darauf hinzuweisen, dass ein Patient mit Schmerzen unabhängig von einem Kaufunktionstest unverzüglich einer Zahnärztin/einem Zahnarzt vorgestellt werden sollte. Weiterhin ersetzen Kaufunktionstests keine zahnärztlichen Routineuntersuchungen, könnten jedoch auch (zahn-)medizinischen Laien Hinweise darauf geben, ob ein Termin in einer Zahnarztpraxis vereinbart werden sollte oder ein zahnärztliches Konsil notwendig ist.

e16549 Background: The efficacy and safety of tivozanib (TIVO) have been evaluated in pivotal randomized, clinical trials in first-line treatment of mRCC. We previously reported on effectiveness of our real-world T-Rex study. Here, we assessed the quality of life of tivozanib in a real-world patient population in Germany using NCCN-FACT FKSI-19 (FKSI-19) and tailored PRO-CTCAE questionnaires. Methods: Patients with mRCC were treated with tivozanib according to routine care in this non-interventional study (registered at BfARM #7296). Adverse events (AEs) were assessed by CTCAE 4.03. Patient reported outcomes (PRO) were assessed by Functional Kidney Cancer Symptom Index (FKSI)-19 and tailored PRO-CTCAE questionnaires, which were scored according to corresponding guidelines. Patients who reported detriments on PRO scales at any time during treatment were counted as impaired. The study was performed in accordance with the declaration of Helsinki. Results: A total of N = 32 pts. (59.4% male) received at least one cycle of treatment and were analysed. The mean age was 75.4 years (61-89) and 17 pts. (53.1%) were ≥75 years old. 93.8% had ECOG 0-1. IMDC risk was favourable/intermediate/poor in 21.8/68.8/9.4%. The most common G1/2 AEs reported by physicians were: diarrhea 34.4%, nausea 21.9%, hypotension/hypertension 15.6%. The most common G3/4 AEs were diarrhea 6.3%, cardiac dysfunction 6.3% and other 15.6%. CTCAE PRO revealed dry mouth 91.3%, fatigue 82.6%, anorexia 82.6% and dry skin 82.6% as the most frequent symptoms. CTCAE PRO that patients reported to be severe were fatigue 43.5%, dry mouth 39.1%, anorexia 34.8%, dry skin 34.8% and dysphonia 34.8%. The most frequent CTCAE PRO that interfered with usual activities were fatigue 78.3%, dyspnea 69.6% and problems with concentration 69.6%. The return rate for FKSI-19 questionnaires was 71%. Longitudinal assessment of FKSI-19 items will be reported at the meeting. Functional/wellbeing subscale indicated that all patients (100%) reported impairment for their ability to work, to enjoy life or their quality of life. FKSI-19 disease related symptom scores reported lack of appetite, lack of energy and sleep disturbances among respondents in 92.3%, 92.3% and 88.5%, respectively. Shortness of breath and diarrhea were recognized in 61.5% and 69.2% of respondents, respectively. Haematuria was reported in 7.7% and no patient complaint of fever (0%). Detailed analysis will be shown at the meeting. Conclusions: Our findings support the use of PROs to assess patient’s condition and well-being. CTCAE-PRO and FKSI-19 were able to describe impairments, which were highly relevant to patients, but may not routinely reported by physicians. Each tool adds valuable information to the complex pattern of patient’s experience during treatment. However, some items had a very low response rate and should be reconsidered for their relevance. Clinical trial information: 7296 .

The gold standard for the treatment of carotid artery stenosis is the carotid endarterectomy (CEA). According to current guidelines, carotid artery stenting (CAS) is an alternative. Randomized control trials (RCTs) show significantly higher rates of peri-interventional strokes after CAS compared to CEA. However, these trials were usually characterized by a great heterogeneity in the CAS procedure. In this retrospective analysis from 2012 to 2020, 202 symptomatic and asymptomatic patients were treated with CAS. Patients were carefully pre-selected according to anatomical and clinical criteria. In all cases, the same steps and material were used. All interventions were performed by five experienced vascular surgeons. Primary endpoints of this study were perioperative death and stroke. Asymptomatic carotid stenosis was present in 77% of the patients and symptomatic in 23%. The mean age was 66 years. The average degree of stenosis was 81%. The CAS technical success rate was 100%. Periprocedural complications occurred in 1.5% of cases, including one major stroke (0.5%) and two minor strokes (1%). The results of this study indicate that through a strict patient selection based on anatomical and clinical criteria, CAS can be performed with very low complication rates. Furthermore, standardization of the materials and the procedure itself is crucial.