Elisabeth-Krankenhaus Essen

Background: Patients with inflammatory rheumatic diseases (IRD) are susceptible to influenza infections and their complications. However, they may avoid vaccination for fear of exacerbating their IRD. This study evaluates the 2023/24 influenza vaccine in IRD patients, aiming to provide recommendations for this group in the upcoming season. Methods: In this prospective, longitudinal study, we assessed the self-reported impact of influenza vaccination on patients with IRD. Participants were recruited nationwide between October and December 2023 and completed an online questionnaire after vaccination as well as at three and six months of follow-up. Results: Among 633 patients, 87.5% were female, with a median age of 50.4 (18-84) years. Post-vaccination, 50% experienced injection site pain; 41% reported no side effects. IRD flares occurred in 5%, with 1% requiring changes to immunomodulation. Among 428 patients with follow-up, influenza infections were reported in 38 patients (8.9%), including 10 (2.3%) with reinfections. No severe cases requiring hospitalization were reported. Spondyloarthritis patients had higher susceptibility to influenza (p = 0.002), accounting for 55.3% of infections. IRD flare-ups in the 12 months before vaccination predicted infections (p = 0.002). Conclusions: The 2023/24 vaccine was well tolerated by IRD patients, with no impact on the course of the disease in 95% of cases. Only 9% of patients reported influenza infections, none of which were severe. In light of these findings, physicians are advised to recommend vaccination to eligible IRD patients prior to or in the respective season.

BackgroundFunctional mitral regurgitation (FMR) has limited effective treatment options. As a transcatheter indirect annuloplasty, the Carillon Mitral Contour System reduces FMR and improves symptoms, but long-term safety and effectiveness are incompletely characterized.MethodsThis prospective, multicenter CINCH registry enrolled heart failure patients with FMR treated with the Carillon Mitral Contour System across 22 centers in Germany. Main outcomes included change in New York Heart Association (NYHA) class and MR severity, heart failure hospitalization (HFH), all-cause mortality rates, and device- or procedure-related serious adverse events at 1 year. Median follow-up was 2.0 years (range, 0-5 years).ResultsAmong 228 patients (age 78 ± 8 years; 51% female; 51% with left ventricular ejection fraction ≥50%), Carillon implantation improved clinical and echocardiographic variables. The rate of NYHA class III or IV symptoms decreased from 81 to 29% at 1 year, and the rate of moderate-to-severe MR (grade 3+/4+) decreased from 84 to 9% at 1 year, with ≥92% showing stable or improved NYHA class and ≥97% showing stable or improved MR grade over 5 years. Decreases in MR grade were associated with improvements in NYHA class (p = 0.048). Kaplan–Meier estimates over 5 years were 54.0% for HFH, 46.9% for all-cause mortality, and 68.3% for the composite of HFH or death. The proportion of patients experiencing any serious device- or procedure-related serious adverse event at 1 year was 1.8%.ConclusionsThe CINCH registry provides real-world evidence supporting the long-term safety, effectiveness, and durability of the Carillon Mitral Contour System in treating FMR.

Aim of the randomized controlled pilot study was to investigate general feasibility in terms of adherence to a 12-week unsupervised aerobic exercise training program in participants with persistent symptoms (fatigue, concentration problems, breathing problems or headache) > 12 months after SARS-CoV-2 infection. Multiple symptom-related, psychosocial, spiroergometric and body composition parameters were collected at baseline and follow-up examination. The intervention group underwent a 12-week unsupervised aerobic exercise training program. The control group kept their regular physical activity. Both groups maintained an online training diary. Data was evaluated descriptively using intention-to-treat, per protocol and as-treated analysis. Feasibility of an unsupervised aerobic exercise training intervention was limited, as a large number of participants in the intervention group did not strictly adhere to the training plan. Therefore, statements about the efficacy were restricted. However, there was some weak indication for efficacy of the intervention to reduce self-rated severity of symptoms and to improve overall wellbeing. In the present study, an unsupervised aerobic exercise training intervention can be recommended only to a limited extend. The study results can be used to inform future studies designed to evaluate the efficacy of unsupervised aerobic exercise training programs in participants with persistent symptoms after SARS-CoV-2 infection.

Patients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option. TriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR. The TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year. Enrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001). The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

Interventional closure of symptomatic paravalvular leaks (PVL) after valve replacement has developed to an attractive treatment option for patients at high operative risk. However, prospective and long-term data are sparse. We analysed data from a multicentre prospective registry on interventional PVL closure. 41 patients with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 50 interventions with 67 plug implantations were recorded, 46.3% of procedures were performed for aortic and 53.7% for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% twice and 2% underwent three procedures. Indication for PVL closure was symptomatic heart failure with NYHA class ≥ II (63.4%), haemolysis (4.9%), or NYHA class ≥ II and haemolysis (31.7%). PVL closure was completely successful in 76%, partially successful in 10% and failed in 14%. Acute improvement of one NYHA class was achieved in 56.4% and of two NYHA classes in 15.4%. Postprocedural no residual severe aortic PVL was described and residual severe mitral PVL was seen in 4.8%. Postinterventional complications occurred in 21.9%. In-hospital mortality rate was 4.9%. A follow-up was performed after 30days, 12months, 3 and 5years. Calculated mortality rates were 10.1% at 1-year-, 18.5% at 3-year- and 32.5% at 5-year-follow-up. The estimated rates for mortality and/or reintervention (surgical or interventional) were 25.6% at 1-year, 36.8% at 3-year and 45.1% at 5-year follow-up. The multicentre German Plug-Registry describes a high procedural success rate with clinical improvement in most patients and acceptable long-term outcomes after percutaneous PVL closure. NCT03179969.

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disorder associated with significant morbidity and mortality. This review highlights the essential role of multimodal imaging-transthoracic echocardiography (TTE), cardiac magnetic resonance (CMR), and cardiac computed tomography (CCT)-in the diagnosis, risk stratification, and management of HCM. TTE remains the first-line tool, while advanced techniques like CMR and CCT offer enhanced accuracy in tissue characterization, fibrosis detection, and procedural planning. By integrating these imaging modalities, clinicians can adopt a precision medicine approach, enabling tailored treatment strategies that address individual patient needs. This comprehensive use of imaging not only enhances clinical decision-making but also holds the potential to improve long-term outcomes for patients with HCM.

BackgroundFor the management of acute coronary syndrome, literature shows lower healthcare providers’ guideline adherence for women than for men. Since less is known about the management of chronic coronary syndrome (CCS), this study investigated patient-related sex differences in providers’ guideline adherence for invasive coronary angiography (CA) performed in patients with suspected CCS.MethodsUsing data from the German ENLIGHT-KHK trial, patients with suspected CCS who underwent a CA were analysed. To assess the association between patient sex and physicians’ adherence to the German National Disease Management Guideline “Chronic coronary artery disease” of 2019, binary logistic regression models were developed. Covariates included age, symptoms, risk factors, comorbidities, and non-invasive testing and its results. To examine sex differences in predictors of guideline adherence, models were run separately for women and men.ResultsTwo hundred seventy-three women and three hundred eighty-six men were included (aged 67 ± 10 years). Physicians’ guideline adherence for CA was lower for women than for men (19.4% vs. 30.1%, p = 0.002). CAs were less likely to be guideline-adherent for women with suspected CCS than men (OR 0.4, p < 0.05). Guideline adherence predictors differed between women and men. For example, men’s predictors included non-invasive testing and its results, age, typical angina and smoking; of these, only a positive non-invasive test result had an impact for women.ConclusionOur results indicate a less guideline-adherent diagnostic workup of CA for women with suspected CCS than men. This might reflect a limited awareness of CCS in women and insufficiently sex-specific guideline recommendations.Trial registrationGerman Clinical Trials Register DRKS00015638, Registered February 19, 2019; Universal Trial Number (UTN): U1111-1227-8055.Graphical abstractSupplementary InformationThe online version contains supplementary material available at 10.1007/s00392-025-02655-y.

ObjectiveLaparoscopic sacrocolpopexy (SCP) is considered the gold standard for the correction of middle compartment (apical) prolapse. The extent to which simultaneous correction of the anterior compartment is necessary remains unclear. The aim of this study was to examine the anatomical and functional outcomes of the SCP on the anterior compartment with respect to the correction of central and lateral defects as well as stress urinary incontinence (SUI).MethodsThis was a retrospective clinical follow-up with records of recurrences and complications as well as effects on SUI after laparoscopic SCP with and without simultaneous vaginal correction at Elisabeth Hospital, Essen, Germany, from 2014–2020 in 65 of 86 patients, with an average follow-up of 3.3 years.ResultsWithout simultaneous vaginal correction of the anterior compartment, recurrence was more common in women with central defect POP-Q Ba > − 2.0 [4 of 8 patients without correction (50% recurrence) vs. 1 of 23 patients with correction (4% recurrence)]. The OR for recurrence with surgery was 0.05 (95% CI 0.01; 0.52, p < 0,001). In women with lateral defects of the anterior compartment with a POP-Q Ba > − 2.0, simultaneous vaginal correction was not necessary, with a low recurrence rate (1 of 18 recurrences, 6%). Preexisting SUI grade ≥ 1 could be corrected in 27 of 36 patients. (75%, p < 0,001) according to the SCP.Mesh erosion with reoperation (Clavien–Dindo IIIb) occurred in three patients (4.6%).ConclusionOverall, this study suggests that patients with a central defect of the anterior vaginal wall can benefit from additional vaginal correction as part of the SCP. Furthermore, existing incontinence improves with the correction of prolapse.