AIMS:CAR-T cell therapy is becoming a key pillar of medical oncology, used for an expanding range of indications. Considering the increased risk of cardiovascular disease with increasing age, assessing the impact of cardiac comorbidities can help minimizing complications and improve treatment outcomes. METHODS:We evaluated cardiovascular outcomes in patients undergoing CD19- or BCMA-directed CAR T-cell therapy from two large independent databases (DESTATIS (Germany) and the TriNetX network (US)). RESULTS:Among 2,545 CAR T-cell cases from Germany and 1,335 patients from the US, we identified 51 respective 20 short-term severe cardiac events with early death documented in 135 (5%) and 16 (1.2%) patients. Patients with preexisting cardiac conditions did not show an increased risk for immune-related complications like cytokine release (OR 1.19, 95%CI 0.77-1.82) or neurotoxicity syndrome (OR 1.59, 95%CI 0.94-2.69). They faced higher long-term risks for major cardiovascular events (OR 1.89, 95%CI 1.23-2.91) and kidney failure (OR 2.98, 95%CI 1.85-4.81). CONCLUSION:Cardiovascular complications in CAR T-cell therapy were rare and primarily affected patients with preexisting cardiac conditions. Serious cardiac events were uncommon acutely but increased over time. The analysis underscores the need for risk-adapted follow-up and cardiological assessments to improve outcomes in patients with cardiac comorbidities. Inherent with the databases used, these results should be interpreted with caution, as underreporting and overreporting could introduce bias regarding risik factors and outcomes in both directions.
AIMS:Patients at high bleeding risk (HBR) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of adverse outcomes. We investigated the clinical outcomes and their consistency after biodegradable polymer sirolimus-eluting (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES) implantation in HBR patients with or without ACS. METHODS AND RESULTS:The per-protocol population of the BIOFLOW-DAPT randomized control trial (RCT) consisted of HBR patients with (n = 541) or without ACS (n = 1245) who were randomized to BP-SES or DP-ZES and underwent 1 month dual antiplatelet therapy (DAPT). The primary efficacy and safety endpoints were target lesion failure (TLF), defined as the composite endpoint of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (cd-TLR) as well as major bleeding defined as BARC 3 or 5 (according to Bleeding Academic Research Consortium classification) and definite/probable stent thrombosis (ST). At 1 year, patients with ACS suffered from higher cardiac death rates (3.4 vs. 1.3%, log-rank P = 0.004) but similar TLF (6.8 vs. 6.7%, P = 0.992), TV-MI (2.8 vs. 4.5%, P = 0.100), cd-TLR (1.4 vs. 2.1%, P = 0.300), major bleeding (4.2 vs. 3.1%, P = 0.266), and ST (0.2 vs. 0.9%, P = 0.098) compared with no ACS patients. The rate of TLF and of all secondary endpoints was consistent with BP-SES or DP-ZES across ACS strata. CONCLUSION:HBR patients with ACS are at higher risk of cardiac death than those without ACS and experience a consistent outcome with BP-SES or DP-ZES followed by 1 month DAPT at 1 year follow-up. CLINICAL TRIAL REGISTRATION:NCT04137510.
Increasingly, transcatheter options are available for the treatment of valvular heart disease. The role of the Clinical Valve Coordinator is ideally positioned to improve access to care, quality of outcomes and patient experiences, and contribute to the efficient cardiac programmes and the growing number of heart valve centres. International societies and guidelines recommend the inclusion of the Clinical Valve Coordinator in multidisciplinary Heart Teams to support patients, contribute unique expertise to team-based care, and help programmes expand access to care. The role of the Clinical Valve Coordinator is unevenly adopted in Europe. In this context, we outline a comprehensive framework of the competencies and professional development aligned with the needs of patients with aortic, mitral and tricuspid disease, discuss requirements for infrastructure and successful organisational integration in valvular heart disease teams and programmes, and propose preliminary indicators to measure role impact and address the current gap in evidence to guide role development across diverse regions. The Clinical Valve Coordinator plays a vital role as a central member of the multidisciplinary team to support the care requirements of people with complex valvular heart disease in the rapidly evolving clinical context of treatment options and management strategies. The document provides a roadmap for the development, implementation and evaluation of a pan-European initiative to improve the delivery of valvular heart disease services and optimise the experience of care of patients and their family.
Patients undergoing transcatheter edge-to-edge repair (TEER) of the mitral or tricuspid valve are predominantly elderly and exhibit high rates of frailty. The procedure regularly involves general anaesthesia, necessitating the monitoring of patients on an intensive or intermediate care unit (ICU/ImCU). This study aimed to investigate the outcome of patients being admitted to a general ward as opposed to an ICU/ImCU for postprocedural care after TEER. This is a retrospective study analysing the course of 209 patients that underwent TEER at a university hospital centre in Germany from January 2022 to February 2024. Patients were assigned to either intended postprocedural care at ICU/ImCU (n = 113) or streamlined care (n = 95) based on a cut-off date unrelated to this study. In comparison to the ICU/ImCU group, patients in the streamlined group exhibited a significantly reduced total hospital stay (median 4 [IQR 3, 9] vs. 3 [IQR 3, 5] days, p = 0.009) and a reduced postprocedural length of stay without an elevated rate of unplanned ICU/ImCU admissions. Postprocedural care in the streamlined group was not associated with a higher rate of complications nor a higher mortality rate at 30 days (0.9
BACKGROUND:The effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain. METHODS:We randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group). The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio. If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years. RESULTS:A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. The win ratio for the first primary end point was 2.42 (95% confidence interval [CI], 1.76 to 3.33; P<0.001), favoring tricuspid-valve repair. The Kaplan-Meier estimate for freedom from death from any cause or hospitalization for heart failure (second primary end point) through 3 years was 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group and 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group (hazard ratio for death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group. CONCLUSIONS:Among patients with symptomatic severe tricuspid regurgitation, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone with respect to a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year and was also associated with a lower risk of a composite of death from any cause or hospitalization for heart failure through 3 years. (Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.).
Transcatheter aortic valve implantation (TAVI) has evolved into the dominant therapeutic option for severe aortic stenosis, with procedural refinements and expanding indications increasingly supporting shorter post-procedural monitoring and discharge. International evidence from randomized trials, multi-center registries, and consensus guidelines demonstrates that reduced length of stay (LOS), including next-day or early discharge, can be safely achieved in selected patients when supported by standardized workflows, careful patient selection, and structured outpatient monitoring. In Germany, LOS remains among the longest in Europe, driven by structural, reimbursement, and cultural barriers. With increasing TAVI volumes, demographic pressures, and workforce constraints, these barriers inhibit health system sustainability, procedural capacity, and patient experience. Early discharge below the currently defined thresholds often results in financial disadvantages under the Diagnosis-Related Group (DRG) reimbursement mechanism, thereby disincentivizing standardized adoption and pathway innovation. Yet, a reduction in LOS would yield meaningful system-level advantages, including increased procedural capacity, improved resource allocation, and lower post-procedural bed occupancy costs, all leading to better and more efficient patient pathways. This narrative, practice- and policy-oriented critical perspective evaluates the current German landscape and outlines pragmatic strategies to enable safe early discharge. It synthesizes relevant international evidence, identifies system-level barriers specific to Germany, and proposes a structured roadmap including: (1) standardized eligibility criteria, (2) protocolized peri- and post-procedural pathways, (3) pilot implementation in carefully selected centers with outcome reporting, and (4) reimbursement realignment to avoid wrong financial incentives. Supported by professional medical societies and aligned with international standards, early discharge pathways could enhance efficiency and improve patient-centered care, offering Germany a timely opportunity to modernize TAVI experience and delivery.
Marfan syndrome (MFS) is a connective tissue disorder caused by FBN1 mutations, characterised by aortic aneurysms leading to life-threatening dissections. Asprosin is the C-terminal propeptide of fibrillin-1 that was shown to function as a glucogenic hormone with critical implications in vascular pathology. However, its role in MFS remains unknown. Here, we investigate the effect of asprosin overexpression in vascular smooth muscle cells (VSMCs) and in the Marfan mouse model mgR/mgR via endothelial-targeted transduction by adeno-associated viruses (AAVs). In both human and murine VSMCs, asprosin overexpression did not alter VCAM1 or MMP9 expression, while TNF-α-stimulated asprosin-overexpressing MOVAS cells exhibited reduced IL6 levels. In mgR/mgR mice, asprosin overexpression did not affect aortic diameter or elastin integrity. Molecular analyses revealed no significant change in inflammatory or epithelial-to-mesenchymal transition (EMT) markers at the mRNA or protein level, with VCAM1 and MMP9 remaining unchanged. Together, these findings indicate that asprosin overexpression does not ameliorate the aneurysmal phenotype in MFS.
Objective: Self-expanding (SE) transcatheter aortic prostheses (THV) have been associated with an increased risk of new permanent pacemaker implantation (PPMI), particularly with deeper implantations in the left ventricular outflow tract (LVOT) that result in more atrioventricular conduction system damage, leading to higher rates of post-procedural conduction disturbances (CDs) and subsequently more PPMIs. The cusp-overlap technique (COT) is designed to provide better visualisation of the LVOT during implantation, aiming to achieve a shallower implantation depth (ID) and potentially reduce both post-procedural CDs and PPMIs. This study seeks to compare the traditional three-cusp coplanar view technique (3CT) with the newer COT in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: From March 2018 to April 2020, a total of 586 patients underwent TAVR at the university clinic in Kiel. Among them, 226 patients who received SE prostheses were included in the study. After applying exclusion criteria, a final cohort of 203 patients was analysed. Of these, 106 patients underwent TAVR using the COT, while 97 patients underwent TAVR using the 3CT. The primary endpoints of the study were the occurrence of new CD and PPMI within 30 days post-procedure. Secondary endpoints included various post-TAVR events as defined by the Valve Academic Research Consortium 3 (VARC-3) safety criteria. A specific focus was placed on assessing the risk of high valve implantation according to VARC-3 criteria, specifically paravalvular insufficiency, valve embolisation, and coronary occlusion. Statistical analysis was conducted to compare outcomes between the COT and 3CT groups. Results: Implantation depths were significantly lower in the COT group compared to the 3CT group, with ID values from the NCC and LCC being 2.7 mm (±1.5) and 2.8 mm (±1.5) for the COT, and 5.4 mm (±3) and 6.6 mm (±2.6) for the 3CT (p < 0.001 for both). The incidence of high-grade CD, particularly Atrioventricular Block (AVB) II and III, was significantly higher in the 3CT group (26.8%) compared to the COT group (13.2%) (p = 0.023). The overall 30-day PPMI rate was 18.2% (n = 37), with a significant difference between the COT and 3CT groups (12.2% vs. 24.7%, p = 0.021). The primary indication for PPMI was permanent high-grade AVB occurring during or after TAVR, accounting for 95% of cases. No cases of TAVR embolisation, acute coronary occlusion or related syndromes were observed within the first 30 days post-procedure. There were no significant differences in 30-day mortality or post-procedural paravalvular insufficiency between the groups. In multivariable logistic regression analysis, the COT remained independently associated with lower odds of new post-procedural CD after adjustment for prior right bundle branch block (RBBB), prior first-degree AVB, predilatation, valve size and coronary artery disease (odds ratio [OR] 0.45, 95% confidence interval [CI] 0.24-0.82, p = 0.009). For 30-day PPMI, the cusp-overlap technique demonstrated a borderline association with lower adjusted odds (OR 0.46, 95% CI 0.20-1.02, p = 0.057), while prior RBBB was independently associated with increased PPMI risk (OR 3.54, 95% CI 1.22-10.28, p = 0.020). Conclusions: The COT was associated with shallower implantation depth and lower rates of new post-procedural CD after multivariable adjustment. The association with reduced 30-day PPMI remained directionally consistent but was borderline after adjustment. These findings support the potential value of COT as a procedural strategy to reduce conduction-related complications after TAVR with self-expanding prostheses.
Abstract Background Chimeric antigen receptor (CAR) T-cell therapy has substantially improved outcomes in refractory hematologic malignancies but may cause cardiovascular complications, particularly in the context of cytokine release syndrome (CRS). Real-world data on incidence, severity, and prognostic relevance of cancer therapy–related cardiovascular toxicity (CTR-CVT) defined by the 2022 ESC cardio-oncology guidelines remain in the context of CAR-T cell therapy limited. Methods This retrospective single-center study includes 104 patients treated with CAR T-cells between 09/2019 and 02/2024 for acute lymphoblastic leukemia, non-Hodgkin lymphoma and multiple myeloma. The primary endpoint was new-onset CTR-CVT during hospital stay, defined as cancer therapy–related cardiac dysfunction (CTRCD), arrhythmia, myocardial infarction, cardiogenic shock, or cardiovascular death. Clinical characteristics, biomarkers, echocardiographic parameters, CRS/ICANS severity, and survival outcomes were analyzed. Results Fifty-two patients (50%) met criteria for CTR-CVT, predominantly due to asymptomatic biomarker elevation. CTRCD occurred in 48.1%, whereas clinically significant events were rare: three patients developed symptomatic CTRCD, one experienced cardiogenic shock, and no myocardial infarctions or cardiovascular deaths were observed. Cardiovascular events occurred early and were associated with higher-grade CRS and ICANS, as well as elevated inflammatory markers. Reduced baseline left ventricular ejection fraction, elevated systolic pulmonary artery pressure, impaired performance status, and beta-blocker use were associated with increased CTR-CVT risk. Survival was numerically lower in patients with CTR-CVT but did not reach statistical significance. Conclusion Although half of patients fulfilled ESC criteria for CTR-CVT, clinically relevant cardiac events after CAR T-cell therapy were uncommon. These findings suggest potential overclassification driven by biomarker elevations and underscore the importance of emphasizing clinical relevance when assessing cardiotoxicity in CAR T-cell recipients.
BackgroundStrengthening peritoneal dialysis (PD) utilization in Germany is crucial to ensure dialysis care for patients with kidney failure in an aging population with a predicted decline in the number of health care professionals. PD catheter implantations are a key indicator for the utilization of PD. We performed the first comprehensive study on PD catheter implantation rates and inpatient outcomes in Germany.MethodsFor this retrospective study we queried the diagnosis related group statistics of the Federal Statistical Office of Germany for the years 2011 to 2021, which includes demographics and information on the medical course from all German inpatient cases.ResultsDuring the observation period, 14,158 PD catheters were implanted, with an average of 1272 ± 127 (mean ± standard deviation) per year. Nationally, annual implantation rates were stable, without notable changes over time. Notably, there were significant regional differences in implantation rates within Germany. The average patient age at the time of PD catheter implantation was 59.7 years, with a male-to-female ratio of 1.7:1. During the hospital stay for PD catheter implantation, 517 patients (3.7%) died. Centers with higher implantation rates had more favorable outcomes. Age, number of comorbidities and certain comorbidities (e.g., cancer and heart failure) were associated with higher mortality. The length of stay in the hospital for PD catheter implantation was 19.5 (±22.3) days.ConclusionOur analysis reveals that relatively few PD catheters are implanted in Germany each year. Over the observation period, there was no substantial increase, indicating a continued underutilization of PD in Germany.
Background: Transcatheter aortic valve implantation (TAVI) has become the standard treatment of persons aged 75 and above with severe aortic valvular stenosis. In this study, we analyzed temporal trends in risk profiles and treatment results from 2013 to 2023. Methods: We carried out a retrospective analysis of patient characteristics, periprocedural complications, and 30-day mortality after 33 079 TAVI procedures that were carried out in seven German cardiac care centers. Results: TAVI case numbers rose from 1605 in 2013 to 4459 in 2023. The mean age of the patients remained constant at 81 years, while the operative risk (STS score) fell from 5.9% to 4.1%. The percentage of low-risk patients (STS < 4%) rose from 47% to 66%. From 2013 to 2023, there was a steady decline in periprocedural complications including severe bleeding of VARC types 3 and 4 (8.5% to 2.9%), vascular complications (17.2% to 4.9%), stroke (4.2% to 2.1%), and pacemaker implantations (15.5% to 11.4%). Over the same period, the risk-adjusted 30-day mortality fell from 3.8% to 3.2%. Conclusion: The improved short-term results of TAVI from 2013 to 2023 are attributable to a change in patients' risk profiles as well as the increasing experience of the interventionists and refinements of the procedure. The mortality rate, which has remained unchanged in recent years, indicates that the care of older patients with severe aortic stenosis has been largely optimized.
IntroductionSuperior vena cava isolation (SVCI) is associated with complications such as sinus node (SN) and phrenic nerve (PN) injury or SVC stenosis. Our study assessed the electrophysiological properties of the SVC and use of high-density mapping for targeted SVCI by ablating preferential conduction sites to avoid these complications.MethodsEighty-three consecutive patients, undergoing HD mapping of the SVC during AF re-ablation procedures were prospectively included. Conduction block (CB) lines between the right atrium and SVC, location of the sinus node (SN) and phrenic nerve (PN), and their spatial relationship to the ablation line (AbL) were assessed.ResultsCB lines were present in 98% of patients, with gaps identified in all SVC segments, most frequently posterior (73%), with a median gap width of 23.9 (14.3-37.8) mm. All gaps expressed decremental properties in the EP study. Ablation was performed in 35 (42%) patients and was achieved in all cases using targeted segmental ablation, closing the gaps between the CB lines.Median ablation duration was 88 (66; 161) seconds with a median of 8 (6-12) radiofrequency applications. SN was separated from SVC with CB line in 98% of cases, what excluded necessity to ablate in this area, distance from the AbL to the SN exit zone was 8.9 (6-14.7) mm. PN was located outside the areas of preferential conduction in all cases, distance from AbL to the PN was 10.4 (6.7-12.1) mm. No complications occurred.ConclusionsHD mapping-guided, targeted segmental SVCI using RF energy is feasible and safe.
Bioresorbable stents (BRS) have been explored in cardiovascular intervention to provide temporary mechanical support while reducing long-term foreign material. The coronary experience has shown both the potential and the limitations of this strategy. First-generation polymeric stents demonstrated feasibility but were limited by thick struts, insufficient radial strength, delayed healing, and increased scaffold thrombosis. In contrast, metallic bioresorbable platforms improved mechanical performance, but each material system still faces trade-offs between strength, degradation rate, and biological response. Transcatheter pulmonary valve replacement (TPVR) may represent a clinically meaningful setting for renewed BRS development. Patients with congenital heart disease often require repeated pulmonary valve interventions over a lifetime, and permanent metallic frames may increase cumulative implant burden and complicate future treatment. However, TPVR imposes distinct requirements, including large-diameter expansion, stable anchoring, fatigue resistance, controlled degradation, and leaflet-frame integration. This review summarizes the lessons learned from coronary BRS, discusses material considerations for TPVR-oriented stent design, and evaluates current preclinical evidence for bioresorbable and regenerative pulmonary valve platforms. Particular attention is given to magnesium-zinc alloys as a tunable material strategy for future bioresorbable TPVR frames. Although direct evidence for fully bioresorbable metallic TPVR devices remains limited, this approach provides a rational framework for next-generation pulmonary valve intervention.