Segeberger Kliniken

There is a paucity of data regarding the longer-term durability of transcatheter heart valves. This analysis aimed to describe the 5-year clinical outcomes and valve durability for patients treated with the Portico transcatheter heart valves across 3 studies harmonized in their prospective enrollment, inclusion/exclusion criteria, centralized independent core laboratory echocardiographic analysis, and independent clinical events committee adjudication. Patient-level data from the PORTICO IDE randomized controlled trial, the PORTICO I postmarket study, and the PORTICO continued access protocol were pooled using a random-effects meta-analysis model. All 3 studies collected follow-up data at discharge, 30 days, and annually through 5 years. Adverse events and pooled echocardiographic data were assessed using Valve Academic Research Consortium-2 definitions. Durability definitions were adapted from Valve Academic Research Consortium-3 and European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery consensus guidelines. A total of 1464 patients with severe symptomatic aortic stenosis and high or extreme surgical risk were included. Median age was 83 years, 61.7% were women, and the median Society of Thoracic Surgeons score was 4.9%. At 5 years, all-cause mortality and stroke rates were 49.4% and 12.3%, respectively. Transvalvular gradient and effective orifice area at 5 years were 6.2 mm Hg and 1.83 cm2, respectively, with paravalvular leak ≥moderate severity occurring in 1.9%. The 5-year bioprosthetic valve failure rate was 2.7%, including a 0.7% valve-related death rate and a 2.0% valve reintervention rate, but no patients with severe hemodynamic structural valve deterioration. Moderate hemodynamic structural valve deterioration occurred in 0.9% of the patients at 5 years. Hemodynamic performance and transcatheter heart valve durability remained stable irrespective of annular size. The use of the Portico transcatheter heart valve system in patients at high or extreme surgical risk demonstrated favorable clinical outcomes and hemodynamic performance with low transvalvular gradients and greater than mild paravalvular leak. Furthermore, bioprosthetic valve failure rates were low with no incidence of severe hemodynamic structural valve deterioration at 5 years, irrespective of annular size. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02000115 and NCT01802788.

Acknowledgements We thank all the local investigators and assistant personnel for their great effort. Furthermore, we thank all the POTTER-AF collaborators.

This paper reports linear shear-modulus rheological data for three adhesives. The data were obtained using a recently developed one-disk piezo-ceramic shear transducer that measures the complex shear modulus in a broad dynamical range, reaching frequencies up to 70 kHz [M. Mikkelsen et al., J. Rheol. 66, 983–1003 (2022)]. We first demonstrate consistency with data obtained by a standard rheometer. The paper proceeds to discuss new insights which the high-frequency data give rise to, with a focus on two questions important for applications: To which degree does time-temperature superposition apply? What is the temperature dependence of the high-frequency plateau shear modulus? For both questions, it is demonstrated that reliable predictions are much easier to arrive if high-frequency data are available. Thus, we show that the commonly used master-curve construction may lead to erroneous conclusions if based only on standard rheometer data. Finally, the data for the high-frequency plateau modulus are used to investigate the shoving-model prediction for the non-Arrhenius temperature dependence of the average relaxation time, which is found to apply to a reasonable approximation for all three samples.

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.

Ethanol is widely used in cosmetic formulations as a solvent, preservative, and penetration enhancer, yet its effects on atopic skin remain controversial. This study explores the impact of ethanol in skin care products on skin physiology, microbiome composition and subjective perception. A two-part investigation was conducted: (I) ex vivo analysis using porcine skin models exposed to varying ethanol concentrations, and (II) a double blinded, placebo controlled, randomized clinical pilot study on 9 patients with Atopic Dermatitis (AD) comparing creams with and without 12% ethanol. The ex vivo study revealed that ethanol concentrations above 15% negatively affected epidermal barrier integrity, increasing stratum corneum (SC) permeability and transepidermal water loss (TEWL). In the clinical trial, 12% ethanol demonstrated no significant adverse effects on SC hydration, erythema, pH, or TEWL over 30 days. Microbiome analysis revealed a localized increase in Xanthomonas species associated with ethanol use, while no significant community-wide changes were observed. The implications of increased Xanthomonas abundance in response to the application of a 12% ethanol cream for atopic dermatitis remain unclear. Subjective evaluations reported similar perceptions for both formulations, with no notable exacerbations in non-lesional AD skin. These findings indicate that ethanol in concentrations ≤ 12% is safe for atopic skin.

Diabetic patients with ST-segment elevation myocardial infarction (STEMI) are at an increased risk of cardiovascular events as compared to non-diabetic patients. This analysis investigated outcomes of diabetic patients presenting with multivessel disease (MVD) and STEMI in a contemporary trial and the relevance of an immediate versus staged multivessel PCI strategy in this high-risk population. Patients enrolled in the MULTISTARS AMI trial were stratified according to the presence/absence of diabetes. Baseline characteristics and outcomes of diabetic and non-diabetic patients were compared. The primary end point was a composite of all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, or hospitalization for heart failure at 1year. In the MULTISTARS AMI trial, out of a total of 840 patients, 131 (15.6%) patients had diabetes. Patients with diabetes had a higher cardiovascular risk profile and worse kidney function. The occurrence of the primary end point was similar between patients with and without diabetes (HR, 1.14 (95% CI, 0.69-1.90), p-value = 0.60). Rates of non-cardiovascular death (HR, 6.53 (95% CI, 2.00-21.33)) and acute renal failure (HR, 3.23 (95% CI, 1.49-7.04)) were higher in diabetic patients as compared to non-diabetic patients. Comparing an immediate with a staged PCI strategy in diabetic patients, a numerically lower number of patients in the immediate PCI group experienced a primary end point event (10.6% vs. 16.9%, HR, 0.60 (95% CI, 0.23-1.53), p-value = 0.28). Among diabetic patients with STEMI and MVD, a strategy of immediate multivessel PCI may be safe and comparable to a strategy of staged multivessel PCI. Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275.

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.

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months.

The treatment of strokes is based on two pillars: the efficient management of acute strokes to minimize permanent neurological deficits, and secondary prevention to avoid recurrence. To summarize current recommendations for secondary stroke prevention. Guidelines and recent studies on the most common causes of strokes, and their treatment and prevention are reviewed. Special attention is given to endovascular therapy and cardioembolic strokes. Abrief overview of recommended therapies is provided.