Publications by authors named "Ralph Stephan Von Bardeleben"
Background: Atrial secondary mitral valve regurgitation (ASMR) is a distinct anatomical subset of secondary mitral regurgitation (SMR). Evidence of the effect of transcatheter edge-to-edge repair (TEER) on left atrial (LA) anatomy and function, especially reverse remodelling (LARR), is still sparse.
Methods And Results: We retrospectively evaluated all consecutive patients treated with TEER for mitral regurgitation (MR) in our centre between January 2013 and October 2023.
Aims: To assess the association between right heart failure (RHF) and mortality in patients with severe tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI), and to determine whether clinical RHF status reduces the survival benefit of successful versus failed TTVI.
Methods And Results: The TriValve International Registry (Transcatheter Tricuspid Valve Therapies) is a multicenter registry collecting data of patients with symptomatic, severe or greater TR undergoing TTVI. The population was stratified according to RHF status defined by the following clinical criteria: history of previous hospitalization for RHF (<1 year) OR presence of signs of RHF (jugular venous distension, ascites, peripheral oedema) OR high dose diuretic (≥125 mg/day of furosemide or equivalent).
Background: Treating anterior and bileaflet mitral valve disease in patients with primary or degenerative mitral regurgitation (DMR) is considered more challenging than posterior leaflet repair.
Objectives: The aim of this analysis was to evaluate the impact of anterior, posterior, or bileaflet disease on outcomes following mitral transcatheter edge-to-edge repair (M-TEER) in the EXPANDed studies.
Methods: EXPANDed is a pooled, patient-level analysis of subjects undergoing M-TEER with the MitraClip G3 or G4 system as part of the contemporary EXPAND and EXPAND G4 studies.
Background: Vascular access site complications are associated with increased morbidity and mortality after transcatheter aortic valve implantation (TAVI). Current results comparing strategies with plug- (P-VCD; MANTA) and suture-based vascular closure devices (S-VCD; Perclose ProGlide) remain inconsistent.
Aims: It was our aim to assess the incidence of access-related vascular complications after P-VCD or S-VCD strategies after transfemoral TAVI.
Background: Transcatheter edge-to-edge repair (TEER) using the TriClip tricuspid valve repair system has emerged as a therapy for tricuspid regurgitation (TR). Patients with TR undergoing TEER commonly present with an endocardial lead across the tricuspid valve (TV).
Aims: We sought to examine the effectiveness and safety of tricuspid TEER (T-TEER) in subjects with endocardial leads in the bRIGHT EU Post-Approval Study (PAS).
Background: The role of the surgical technique and anatomy in transapical mitral valve replacement (TA-TMVR) are scarcely investigated.
Methods: Computed tomography scans, surgical reports and planning slides of 127 patients undergoing TA-TMVR with the Tendyne valve system at 15 centers, participating at a European observational study, were retrospectively analyzed and compared between patients with (cohort A) and without (cohort B) apical access complications (AAC).
Results: A total of 8 (6.
Aims: The impact of malnutrition in patients with tricuspid regurgitation (TR) undergoing tricuspid transcatheter edge-to-edge repair (T-TEER) is not well established. We evaluated the impact of malnutrition among patients with symptomatic TR undergoing T-TEER.
Methods And Results: Baseline nutritional status was evaluated using the geriatric nutritional risk index (GNRI), based on serum albumin concentrations and body weight to ideal body weight ratio, among patients with symptomatic TR undergoing T-TEER, enrolled in the multicentre EuroTR registry between March 2016 and February 2024.
The European Union (EU) Medical Device Regulation increased regulatory scrutiny to improve the safety and performance of new medical devices. An equally important goal is providing timely access to innovative devices to benefit patient care. The European Society of Cardiology strongly advocates for the evolution of the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) medical devices in EU countries.
View Article and Find Full Text PDFBackground: Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a treatment option for patients with severe tricuspid regurgitation (TR). However, randomized trials have not shown a survival benefit, possibly because of the inclusion of patients in an early or too advanced disease stage.
Objectives: The authors sought to investigate the association between disease stage and outcomes following T-TEER.
Aim: Diabetes mellitus (DM) represents a notable risk factor within surgical and interventional procedures. Data on its influence on survival after Transcatheter Edge-to-Edge Repair (TEER) of Mitral valve Regurgitation (MR) are sparse.
Methods: In a retrospective monocentric assessment after successful treatment of MR using TEER from 06/2010 to 03/2018 patients were stratified for DM.
Background: The net benefit of oral anticoagulation in patients with end-stage renal disease on hemodialysis (HD) is uncertain. In recent years, left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation; however, there is scant evidence of LAAC in patients on HD.
Objectives: This study aimed to assess the feasibility and safety of LAAC in patients on HD.
Background: As transcatheter aortic valve replacement is performed increasingly in younger, low-risk patients, the need for commissural alignment and coronary access has increased. Design elements of the JenaValve Trilogy (JVT) transcatheter heart valve (THV) ensure both.
Objectives: This study sought to evaluate the outcome of patients with aortic stenosis (AS) treated with this novel transfemoral, self-expanding THV.
Aims: Secondary mitral regurgitation (SMR) and tricuspid regurgitation (TR) are the most common valvular heart diseases in patients with heart failure (HF). Transcatheter edge-to-edge repair (TEER) devices designed for treating MR and TR have been successfully tested in randomized controlled trials, but methodological issues have often challenged their interpretation. This manuscript aimed to provide an overview of TEER registries on SMR and TR in HF, highlighting their key features, describing clinical characteristics and outcomes of patients receiving these devices, and exploring the available data limitations.
View Article and Find Full Text PDFArticle Synopsis
- Atrial secondary tricuspid regurgitation (A-STR) is a subtype of secondary tricuspid regurgitation (STR) that is often treated with transcatheter tricuspid valve edge-to-edge repair (T-TEER), showing distinct patient characteristics and treatment outcomes.
- A study involving 641 patients revealed that 31% had A-STR, which was linked to better heart function, a higher presence of atrial fibrillation, and more effective TR reduction post-procedure compared to nonatrial STR patients.
- A-STR patients experienced improved survival rates and lower symptomatic burdens after treatment; only 38% remained symptomatic (NYHA class ≥III) after 2 years, compared to 46
Article Synopsis
- Untreated severe tricuspid regurgitation (TR) is linked to poor health outcomes, making effective treatment essential.
- The study evaluated the 1-year results of transcatheter edge-to-edge repair (TEER) using the TriClip system in patients with complex tricuspid valve issues, finding significant improvements in patient survival and quality of life.
- Results showed that 81% of patients experienced a reduction in TR to moderate or less after one year, with no major adverse effects noted in the first 30 days post-procedure.
Tricuspid Valve S-Curves and Chamber Views: Implications for Transcatheter Tricuspid and Pulmonary Valve Interventions, Part 2 of the S-Curves and Chamber Views Series.
JACC Cardiovasc Interv
December 2024
Despite the challenges associated with periprocedural imaging, transcatheter tricuspid valve interventions have shown important impact on outcomes. A comprehensive understanding of the anatomy of the right heart and surrounding structures is crucial. One way to optimize these interventions is by identifying the optimal fluoroscopic viewing angles along the S-curve of the tricuspid valve.
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- - The MITRA-PRO registry shows that evaluating residual mitral regurgitation (MR) using 3D-Vena Contracta Area (VCA) is key for predicting patient survival after mitral valve repairs (TEER).
- - A study of 823 patients found that lower levels of residual MR (measured by 3D-VCA) correlate with reduced 1-year mortality, establishing 0.07 cm as a critical threshold for patient survival post-procedure.
- - The findings suggest that 3D-VCA is an effective tool for assessing MR during TEER, with lower residual MR levels associated with better survival outcomes.
Aims: Conventional parameters of right ventricular (RV) function are load-dependent and therefore do not accurately reflect contractility in patients with relevant tricuspid regurgitation (TR). RV adaptability to load has been characterized using the Dandel's index in patients with heart failure, but its prognostic value in patients undergoing tricuspid transcatheter edge-to-edge repair (T-TEER) has not been investigated so far.
Methods And Results: From the EuroTR registry (2019 to 2022), patients with complete datasets and a minimum of 2-years of follow-up were included.
Background: Mitral valve transcatheter edge-to-edge repair (M-TEER) reduces secondary mitral regurgitation (MR) in heart failure and impacts survival in selected patients as demonstrated in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. However, long-term outcome data after M-TEER under real-world conditions are lacking.
Objectives: This study sought to assess long-term efficacy and survival after M-TEER in a large real-world registry.
Article Synopsis
- The study examined the effects of pulmonary hypertension (PH) on patients receiving transcatheter tricuspid valve edge-to-edge repair (T-TEER), focusing on survival rates and heart failure hospitalization outcomes.
- Results showed that higher systolic pulmonary artery pressure (sPAP) was linked to increased risks of death or hospitalization within two years, with a notable threshold of sPAP > 46 mmHg identifying those at greater risk.
- However, both the severity of heart failure symptoms and tricuspid regurgitation improved after T-TEER, regardless of whether patients had pre- or postcapillary PH.