Prediction of diagnosis and diastolic filling pressure by AI-enhanced cardiac MRI: a modelling study of hospital data.

BACKGROUND: With increasing numbers of patients and novel drugs for distinct causes of systolic and diastolic heart failure, automated assessment of cardiac function is important. We aimed to provide a non-invasive method to predict diagnosis of patients undergoing cardiac MRI (cMRI) and to obtain left ventricular end-diastolic pressure (LVEDP). METHODS: For this modelling study, patients who had undergone cardiac catheterisation at University Hospital Heidelberg (Heidelberg, Germany) between July 15, 2004 and March 16, 2023, were identified, as were individual left ventricular pressure measurements. We used existing patient data from routine cardiac diagnostics. From this initial group, we extracted patients who had been diagnosed with ischaemic cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, or amyloidosis, as well as control individuals with no structural phenotype. Data were pseudonymised and only processed within the university hospital's AI infrastructure. We used the data to build different models to predict either demographic (ie, AI-age and AI-sex), diagnostic (ie, AI-coronary artery disease and AI-cardiomyopathy [AI-CMP]), or functional parameters (ie, AI-LVEDP). We randomly divided our datasets via computer into training, validation, and test datasets. AI-CMP was not compared with other models, but was validated in a prospective setting. Benchmarking was also done. FINDINGS: 66 936 patients who had undergone cardiac catheterisation at University Hospital Heidelberg were identified, with more than 183 772 individual left ventricular pressure measurements. We extracted 4390 patients from this initial group, of whom 1131 (25·8%) had been diagnosed with ischaemic cardiomyopathy, 1064 (24·2%) had been diagnosed with dilated cardiomyopathy, 816 (18·6%) had been diagnosed with hypertrophic cardiomyopathy, 202 (4·6%) had been diagnosed with amyloidosis, and 1177 (26·7%) were control individuals with no structural phenotype. The core cohort only included patients with cardiac catherisation and cMRI within 30 days, and emergency cases were excluded. AI-sex was able to predict patient sex with areas under the receiver operating characteristic curves (AUCs) of 0·78 (95% CI 0·77-0·78) and AI-age was able to predict patient age with a mean absolute error of 7·86 years (7·77-7·95), with a Pearson correlation of 0·57 (95% CI 0·56-0·57). The AUCs for the classification tasks ranged between 0·82 (95% CI 0·79-0·84) for ischaemic cardiomyopathy and 0·92 (0·91-0·94) for hypertrophic cardiomyopathy. INTERPRETATION: Our AI models could be easily integrated into clinical practice and provide added value to the information content of cMRI, allowing for disease classification and prediction of diastolic function. FUNDING: Informatics for Life initiative of the Klaus-Tschira Foundation, German Center for Cardiovascular Research, eCardiology section of the German Cardiac Society, and AI Health Innovation Cluster Heidelberg.

Development and Preclinical Evaluation of [211At]PSAt-3-Ga: An Inhibitor for Targeted α-Therapy of Prostate Cancer.

The application of prostate-specific membrane antigen (PSMA)-targeted α-therapy is a promising alternative to ß--particle-based treatments. 211At is among the potential α-emitters that are favorable for this concept. Herein, 211At-based PSMA radiopharmaceuticals were designed, developed, and evaluated. Methods: To identify a 211At-labeled lead, a surrogate strategy was applied. Because astatine does not exist as a stable nuclide, it is commonly replaced with iodine to mimic the pharmacokinetic behavior of the corresponding 211At-labeled compounds. To facilitate the process of structural design, iodine-based candidates were radiolabeled with the PET radionuclide 68Ga to study their preliminary in vitro and in vivo properties before the desired 211At-labeled lead compound was formed. The most promising candidate from this evaluation was chosen to be 211At-labeled and tested in biodistribution studies. Results: All 68Ga-labeled surrogates displayed affinities in the nanomolar range and specific internalization in PSMA-positive LNCaP cells. PET imaging of these compounds identified [68Ga]PSGa-3 as the lead compound. Subsequently, [211At]PSAt-3-Ga was synthesized in a radiochemical yield of 35% and showed tumor uptake of 19 ± 8 percentage injected dose per gram of tissue (%ID/g) at 1 h after injection and 7.6 ± 2.9 %ID/g after 24 h. Uptake in off-target tissues such as the thyroid (2.0 ± 1.1 %ID/g), spleen (3.0 ± 0.6 %ID/g), or stomach (2.0 ± 0.4 %ID/g) was low, indicating low in vivo deastatination of [211At]PSAt-3-Ga. Conclusion: The reported findings support the use of iodine-based and 68Ga-labeled variants as a convenient strategy for developing astatinated compounds and confirm [211At]PSAt-3 as a promising radiopharmaceutical for targeted α-therapy.

Few-Shot and Prompt Training for Text Classification in German Doctor's Letters.

To classify sentences in cardiovascular German doctor's letters into eleven section categories, we used pattern-exploiting training, a prompt-based method for text classification in few-shot learning scenarios (20, 50 and 100 instances per class) using language models with various pre-training approaches evaluated on CARDIO:DE, a freely available German clinical routine corpus. Prompting improves results by 5-28% accuracy compared to traditional methods, reducing manual annotation efforts and computational costs in a clinical setting.

A distributable German clinical corpus containing cardiovascular clinical routine doctor's letters.

We present CARDIO:DE, the first freely available and distributable large German clinical corpus from the cardiovascular domain. CARDIO:DE encompasses 500 clinical routine German doctor's letters from Heidelberg University Hospital, which were manually annotated. Our prospective study design complies well with current data protection regulations and allows us to keep the original structure of clinical documents consistent. In order to ease access to our corpus, we manually de-identified all letters. To enable various information extraction tasks the temporal information in the documents was preserved. We added two high-quality manual annotation layers to CARDIO:DE, (1) medication information and (2) CDA-compliant section classes. To the best of our knowledge, CARDIO:DE is the first freely available and distributable German clinical corpus in the cardiovascular domain. In summary, our corpus offers unique opportunities for collaborative and reproducible research on natural language processing models for German clinical texts.

Initial experience with transcatheter tricuspid valve repair in patients with cardiac amyloidosis.

AIMS: Wildtype transthyretin amyloid cardiomyopathy is an under-recognized cause of heart failure in elderly patients. Transcatheter tricuspid valve repair is a newly emerging therapeutic option for severe tricuspid regurgitation (TR). We present first insights into safety and possible benefits of this procedure in patients with cardiac amyloidosis. METHODS AND RESULTS: Eight patients with cardiac non-hereditary (wildtype) transthyretin (ATTRwt) amyloidosis and severe to torrential TR, undergoing successful transcatheter tricuspid valve repair, were included in the analysis and compared to a control group of 21 patients without cardiac amyloidosis. All patients presented with an advanced stage of amyloid cardiomyopathy. Primary endpoint was reduction in TR at 3 months follow-up. Secondary endpoints were feasibility, safety, hospitalization or death, clinical improvement, cardiac biomarkers, and structural and functional right heart parameter obtained by echocardiography. Transcatheter tricuspid valve repair resulted in a significant reduction of TR (IV to II, P = 0.008) in all eight patients with cardiac amyloidosis (100%). Device success (amyloidosis 75% vs. control group 86%, P = 0.597) and overall probability of hospitalization or death (amyloidosis 13% vs. control group 25%, P = 0.646) were similar compared with those in the control group at 3 months follow-up. Transcatheter tricuspid valve repair led to an improvement of New York Heart Association functional class (P = 0.031) and 6 min walking distance (from 313 ± 118 to 337 ± 106, P = 0.012). TR reduction in amyloidosis patients was less extensive compared with that in control group (TR-reduction 1.6 ± 0.3, P = 0.008 vs. control group 2.3 ± 0.3, P < 0.0001). Furthermore, these patients showed no significant improvement of structural right heart parameters. CONCLUSIONS: Transcatheter tricuspid valve repair is a safe and feasible new treatment option in patients with amyloid cardiomyopathy and has the potential to improve TR-grade and clinical status. However, the benefit appears to be less pronounced compared with patients without cardiac amyloidosis.

Long-Term Patency of Venous Conduits Targeting the Right Coronary Artery System-Single Is Superior to Sequential bypass Grafting.

Objective: Little is known about the fate of bypass grafts to the right coronary system. To investigate the long-term patency of venous bypass grafts directed to the right coronary artery (RCA) based on postoperative angiograms and to identify predictors of graft occlusion. Methods: In this single-center study, all patients who underwent coronary angiography from 2005 to 2021 after previously undergoing isolated coronary artery bypass grafting (CABG) were included. The primary endpoint was graft occlusion over a median follow-up of 9.1 years. Results: Among a total of 1106 patients (17.0% women, 64 (57−71) years median age), 289 (26.1%) received a sequential vein graft and 798 (72.2%) a single graft. Multivariate regression revealed age (HR 1.019, CI 95% 1.007−1.032), the urgency of CABG (HR 1.355, CI 95% 1.108−1.656), and severely impaired left ventricular function (HR 1.883, CI 95% 1.290−2.748), but not gender and chronic total occlusion (CTO) as predictive factors for graft occlusion. Single conduits were found to be a predictor of graft patency (HR 0.575 CI 95% 0.449−0.737). The angiographic outcome showed an overall 10-year freedom from graft occlusion of 73.4% ± 1.6%. The 5-year (10-year) freedom from graft occlusion was 76.9% ± 2.8% (57.8% ± 4.0%) for sequential grafts and 90.4% ± 1.1% (77.8% ± 1.7%) for single grafts (log-rank p < 0.001). Conclusions: In symptomatic patients with renewed angiography, venous bypass grafting of the RCA showed acceptable long-term patency rates. Single bypass grafting of the RCA was superior to sequential grafting, which needs to be further investigated.

Impact of Percutaneous Mitral Valve Repair Using the MitraClipTM System on Ventricular Arrhythmias and ICD Therapies.

Transcatheter edge-to-edge repair (TEER) using the MitraClip™ device has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high or prohibitive surgical risk. Only limited information regarding the impact of TEER on ventricular arrhythmias (VA) has been reported. The aim of the present study was to assess the impact of TEER using the MitraClipTM device on the burden of VA and ICD (Implantable Cardioverter Defibrillator) therapies. Among 600 MitraClipTM implantations performed in our clinic between September 2009 and October 2018, we identified 86 patients with successful TEER and an active implantable cardiac device (pacemaker, ICD, CRT-P/D (Cardiac Resynchronization Therapy-Pacemaker/Defibrillator)) eligible for retrospective VA analyses. These patients presented with mainly functional MR (81.4%) and severely reduced left ventricular ejection fraction (mean LVEF 22.1% ± 10.3%). The observation period comprised 456 ± 313 days before and 424 ± 287 days after TEER. The burden of ventricular arrhythmias (sustained ventricular tachycardia (sVT) and ventricular fibrillation (VF)) was significantly reduced after TEER (0.85 ± 3.47 vs. 0.43 ± 2.03 events per patient per month, p = 0.01). Furthermore, the rate of ICD therapies (anti-tachycardia pacing (ATP) and ICD shock) decreased significantly after MitraClipTM implantation (1.0 ± 3.87 vs. 0.32 ± 1.41, p = 0.014). However, reduction of VA burden did not result in improved two-year survival in this patient cohort with severely reduced LVEF. Mitral valve TEER using the MitraClip™ device was associated with a significant reduction of ventricular arrhythmias and ICD therapies.

One-year results following PASCAL-based or MitraClip-based mitral valve transcatheter edge-to-edge repair.

AIMS: Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER. METHODS AND RESULTS: Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04). CONCLUSIONS: Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.

Automatic extraction of 12 cardiovascular concepts from German discharge letters using pre-trained language models.

OBJECTIVE: A vast amount of medical data is still stored in unstructured text documents. We present an automated method of information extraction from German unstructured clinical routine data from the cardiology domain enabling their usage in state-of-the-art data-driven deep learning projects. METHODS: We evaluated pre-trained language models to extract a set of 12 cardiovascular concepts in German discharge letters. We compared three bidirectional encoder representations from transformers pre-trained on different corpora and fine-tuned them on the task of cardiovascular concept extraction using 204 discharge letters manually annotated by cardiologists at the University Hospital Heidelberg. We compared our results with traditional machine learning methods based on a long short-term memory network and a conditional random field. RESULTS: Our best performing model, based on publicly available German pre-trained bidirectional encoder representations from the transformer model, achieved a token-wise micro-average F1-score of 86% and outperformed the baseline by at least 6%. Moreover, this approach achieved the best trade-off between precision (positive predictive value) and recall (sensitivity). CONCLUSION: Our results show the applicability of state-of-the-art deep learning methods using pre-trained language models for the task of cardiovascular concept extraction using limited training data. This minimizes annotation efforts, which are currently the bottleneck of any application of data-driven deep learning projects in the clinical domain for German and many other European languages.

Re-do MitraClip in patients with functional mitral valve regurgitation and advanced heart failure.

AIM: Percutaneous mitral valve repair (PMVR) via MitraClip implantation is a therapeutic option for severe mitral regurgitation (MR) in advanced stages of heart failure (HF). However, progressive left ventricular dilation in these patients may lead to recurrent MR after PMVR and consequent re-do MitraClip implantation. Here, we describe the characteristics and outcomes of this clinical scenario. METHODS AND RESULTS: Patients with systolic HF and functional MR undergoing a re-do MitraClip procedure were retrospectively analysed. Inclusion criteria were age ≥18 years, technical, device and procedural success at first MitraClip procedure, functional MR and systolic HF with an ejection fraction (EF) of <45%. Seventeen out of 684 patients undergoing PMVR with the MitraClip device at our institution between September 2009 and July 2019 were included. All patients displayed advanced HF with an EF of 20% (±9.9) and highly elevated N-terminal pro-brain natriuretic peptide. Technical success of the re-do MitraClip procedure was 100%, whereas procedural and device success were only achieved in 11 patients (65%). Unsuccessful re-do procedures were related to lower EF and implantation of more than one clip at initial procedure. However, despite reduction in MR grade and no occurrence of significant mitral stenosis after the procedure, the mortality during 12 months follow-up remained high (8 of 17; 47%). CONCLUSIONS: In a cohort of patients with advanced HF undergoing PMVR, re-do MitraClip procedure was feasible, but procedural success was unsatisfactory and morbidity and mortality remained high, possibly reflecting the advanced stage of HF in these patients.

Initial Experience With the PASCAL Ace Implant System for Treatment of Severe Tricuspid Regurgitation.

[Figure: see text].

PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results.

AIMS: We investigated short and mid-term safety and efficacy of the PASCAL system for percutaneous mitral valve repair (PMVr) in severe mitral regurgitation (MR) in an all-comer population. METHODS AND RESULTS: In the first consecutive 41 patients undergoing PMVr using the PASCAL system in our centre, procedural success and safety were assessed. Efficacy in improving MR and functional class were evaluated. Median patient age was 74 years, 58.5% were male patients, and median European System for Cardiac Operative Risk Evaluation Score II was 5.1%. All patients suffered from severe MR with 59% functional MR, 29% degenerative MR, and 12% of mixed aetiology MR. The technical success rate was 90%, limited by four cases where PASCAL implantation was aborted due to a prohibitive mitral gradient. On average, 1.16 PASCAL devices per patient were implanted. All patients successfully implanted with a PASCAL device were discharged with MR grade ≤ 2 and 79% with MR grade ≤ 1. Mean follow-up was 8.7 ± 4.9 months. Ninety-seven per cent of patients remained at MR ≤ 2 at follow-up, which translated into a significantly improved New York Heart Association functional class as well as a significant reduction of systolic pulmonary artery pressure and brain natriuretic peptide levels. The procedure-related rate for major adverse events was 3%. Neither early nor late single-leaflet detachment was found. In one patient, air embolism occurred, resulting in modification of the PASCAL instructions for use. CONCLUSIONS: Percutaneous mitral valve repair using PASCAL in a real-world, all-comer population was feasible and safe, resulting in a significant mid-term reduction of MR with persistent clinical improvement.

PSMA-Targeting Radiopharmaceuticals for Prostate Cancer Therapy: Recent Developments and Future Perspectives.

Prostate cancer (PC) is the second most common cancer among men, with 1.3 million yearly cases worldwide. Among those cancer-afflicted men, 30% will develop metastases and some will progress into metastatic castration-resistant prostate cancer (mCRPC), which is associated with a poor prognosis and median survival time that ranges from nine to 13 months. Nevertheless, the discovery of prostate specific membrane antigen (PSMA), a marker overexpressed in the majority of prostatic cancerous tissue, revolutionised PC care. Ever since, PSMA-targeted radionuclide therapy has gained remarkable international visibility in translational oncology. Furthermore, on first clinical application, it has shown significant influence on therapeutic management and patient care in metastatic and hormone-refractory prostate cancer, a disease that previously had remained immedicable. In this article, we provide a general overview of the main milestones in the development of ligands for PSMA-targeted radionuclide therapy, ranging from the firstly developed monoclonal antibodies to the current state-of-the-art low molecular weight entities conjugated with various radionuclides, as well as potential future efforts related to PSMA-targeted radionuclide therapy.

Initial experience with percutaneous mitral valve repair in patients with cardiac amyloidosis.

BACKGROUND: Percutaneous mitral valve repair (PMVR) is a therapeutic option for severe mitral regurgitation (MR) in patients with heart failure due to differential aetiologies. However, only little is known about the safety and efficacy of this procedure in patients with amyloid cardiomyopathy. METHODS: Five patients with cardiac amyloidosis and moderate to severe or severe MR undergoing PMVR were analysed retrospectively and compared to seven patients with cardiac amyloidosis and severe MR without intervention. Clinical and functional data, renal function and cardiac biomarkers as well as established risk scores for cardiac amyloidosis were assessed. Primary endpoint was the reduction in MR one year after PMVR. Secondary endpoints were safety, overall mortality after 12 months compared with the control group, as well as changes in clinical and functional parameters. RESULTS: Amyloidosis risk assessment documented amyloid cardiomyopathy at an advanced stage in all patients. Procedural, technical and device success of PMVR were all 100% and residual MR remained mild to moderate at 12 months follow-up (P = .038 vs before PMVR). Differences in survival compared with the control (no PMVR) group pointed to a possible survival benefit in the PMVR group (P = .02). CONCLUSION: PMVR is a feasible and safe procedure in patients with cardiac amyloidosis and might carry a possible survival benefit in this patient group.

Percutaneous mitral valve repair in recurrent severe mitral valve regurgitation after mitral annuloplasty : MitraClip-in-the-ring as a complementary strategy.

BACKGROUND: Patients with reduced left ventricular (LV) function undergoing coronary artery bypass graft surgery or/and aortic valve replacement occasionally show severe mitral valve (MV) regurgitation and thus also undergo surgical mitral annuloplasty. Over time, further deterioration of LV function and additional ischemic events cause recurrence of severe MV regurgitation due to the Carpentier IIIb morphology of the MV that is not adequately addressed by the previously implanted annuloplasty ring. METHODS: Seven patients (Society of Thoracic Surgeons score: 7.5 ± 1.5%) with Carpentier type-IIIb recurrent severe MV regurgitation, having undergone prior cardiothoracic surgery (median: 40 months) including mitral annuloplasty, were treated with the MitraClip device. RESULTS: MitraClip implantation resulted in significantly reduced MV regurgitation and improved New York Heart Association functional state, translating into an increased exercise capability and improved cardiac biomarkers. The morphology of the MV was adequately addressed without causing relevant MV stenosis, while the MV annulus area remained unaltered. The procedure was safe with a 30-day mortality rate of 0%. CONCLUSION: MitraClip-in-the-ring is feasible and in principle safe for treating Carpentier type IIIb severe MV regurgitation after surgical MV repair using mitral annuloplasty. MitraClip-in-the-ring resulted in immediate amelioration of clinical symptoms and increased physical exercise capacity.

Broken Heartstrings-Post-Traumatic Stress Disorder and Psychological Burden after Acute Mitral Regurgitation Due to Chordae Tendineae Rupture.

Chordae tendineae rupture (CTR) is a potentially life-threatening cardiac event often resulting in Acute mitral regurgitation (AMR). We assessed Post-traumatic stress disorder (PTSD), depression, and anxiety symptoms in n=21 CTR patients with AMR (age 82.3 ± 4.2 years; 66.7% men) and compared them to n=23 CTR patients with Chronic mitral regurgitation (CMR) and n=35 Myocardial infraction (MI) patients. Regression analyses revealed that PTSD scores were significantly higher in CTR patients with AMR than in CTR patients with CMR or MI patients. CTR patients with CMR had the lowest levels of PTSD-symptoms. Depression and anxiety scores were elevated across all three groups. Our results suggest that psychosocial factors need to be considered in CTR patients' care.

MitraClip implantation followed by insertion of a left ventricular assist device in patients with advanced heart failure.

AIMS: Mitral valve regurgitation (MR) is common in patients with advanced heart failure (HF). Percutaneous mitral valve repair (PMVR) via MitraClip (MC) has emerged as a feasible treatment strategy for these high-risk patients. However, as HF often further progresses, there is a frequent need for left ventricular assist device (LVAD) implantation in these patients. We aimed to investigate whether prior MC implantation affects the subsequent LVAD implantation and outcome. METHODS AND RESULTS: Thirty-seven patients with advanced HF and significant MR who underwent LVAD implantation were retrospectively analysed. Follow-up data were collected at 1 year after LVAD implantation. Primary endpoint was all-cause mortality. Secondary endpoint included peri-operative parameters and clinical development depicted as New York Heart Association (NYHA) class and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level. Seventeen patients initially received a MC device (MC group), resulting in a significant reduction in MR grade. After MC, NYHA class and INTERMACS level further worsened, leading to subsequent LVAD implantation after a median time of 475 days in the MC group. At LVAD implantation, overall characteristics were comparable with those of the patients undergoing LVAD implantation without prior MC placement (no-MC group). Procedural data revealed a higher incidence of right ventricular (RV) failure needing mechanical RV assistance and a longer need for nitric oxide ventilation in the MC group after LVAD implantation. One-year survival was slightly better in the no-MC group compared with the MC group [41% (n = 7/17) vs. 65% (n = 13/20); P = 0.15], albeit event-free survival was comparable between both groups, MC and no-MC. CONCLUSIONS: LVAD implantation after MC is feasible and safe. However, in patients with advanced HF and severe MR, PMVR may only delay a needed LVAD implantation and thereby lead to poorer peri-operative RV function and impaired outcome. Arguably, these patients might benefit from the timely management of advanced HF by the means of early LVAD implantation or heart transplantation.

Temporary oral anticoagulation after MitraClip - a strategy to lower the incidence of post-procedural stroke?

Background: Incidence of stroke within 30 days after percutaneous mitral valve repair using the MitraClip varies from 0.7% and 2.6% between registries. Standard medical treatment after the MitraClip procedure, in the absence of risk factors requiring antithrombotic therapy such as atrial fibrillation, is dual antiplatelet therapy using aspirin and clopidogrel. ESC/EACTS and ACC/AHA surgical guidelines show a Class IIa indication for temporary antithrombotic therapy after mitral valve repair/bioprosthetic valve replacement within the first three months even in patients with no additional risk factors.Methods: 470 patients were treated with the MitraClip receiving oral anticoagulation (Coumadin: INR 2.0-3.0) instead of dual antiplatelet therapy for at least 30 days after the procedure. The incidence of stroke, as well as major adverse events such as bleeding, were analysed in comparison to large registries and multi-centre studies.Results: Incidence of stroke within 30 days was significantly reduced as compared to comparative cohorts (0.2% vs. Median 1.3% [0.7-2.6%]; p < .05). Cardiovascular risk factors such as age, atrial fibrillation, hypertension, diabetes, STS score and prior stroke did not differ significantly between cohorts (ns). Bleeding complications were not increased due to 30 days oral anticoagulation treatment (4.6% vs. Median 7.4% [3.4-13.6%]; ns).Conclusions: Temporary oral anticoagulation might be a strategy to reduce the incidence of stroke within the first 30 days after the MitraClip procedure. Bleeding events were not significantly altered due to temporary oral anticoagulation.

MedEx - Data Analytics for Medical Domain Experts in Real-Time.

Translational research in the medical sector is dependent on clear communication between all participants. Visualization helps to represent data from different sources in a comprehensible way across disciplines. Existing tools for clinical data management are usually monolithic and technically challenging to set up, others require a transformation into specific data models while providing mostly non-interactive visualizations or being specialized to very particular use cases. Statistical programming languages (R, Julia) on the other hand offer great flexibility in data analytics, but are harder to access for clinicians with little to no programming expertise. Our software, the Medical Data Explorer (MedEx), aims to fill this gap as light-weight, intuitive, web-based solution with simple data import routes. We couple a modern dynamic web interface with an in-memory database solution for near real-time responsiveness. MedEx provides multiple visualization options (Scatterplot, correlation heatmap, bar chart, grouped boxplot, grouped histogram, coplot) to get an easy overview on the loaded data as well as to perform pattern discovery and elementary statistics. We demonstrate the utility of MedEx, by example, on data from the cardiology research warehouse of Heidelberg University Hospital. In summary, our tool empowers clinicians to conduct their own interactive exploratory data analysis.

Effects of MitraClip on cognitive and psychological function in heart failure patients: the sicker the better.

PURPOSE: Cognitive impairment and reduced quality of life is a common condition in patients with heart failure (HF). Percutaneous mitral valve repair using (PMVR) MitraClip (MC) has emerged as a promising interventional tool, reducing all-cause mortality and hospitalization as well as increasing cognitive functioning and quality of life. However, the benefit of HF patients with severely depressed cognitive functioning remains unknown. METHODS: We assessed cognitive functioning (figural memory-FGT, executive function-TOL, TMT B), psychosocial functioning (depression-PHQ-9, quality of life-SF36), and clinical parameters (echocardiography, 6-min walk test distance, and cardiac biomarkers) 1 day before (t0) and 6 weeks after (t1) MC intervention in HF patients (n = 40). First, paired sample t tests were conducted to uncover improvements in cognitive functioning post-MC intervention. Second, the COGBAT Norm-sample, a representative age-matched healthy sample, was used to compare participants' individual scores. Third, bivariate linear regressions were calculated for all key predictors of the detected improvements in cognitive functioning post-MC intervention (t1-t0). RESULTS: Following the MC intervention, we found significant improvements in figural memory, executive functioning, and psychosocial functioning. Most of the patients with depressed executive functioning before the MC intervention showed post-intervention test scores within the normal range (> 50th percentile; t0 22.5% vs. t1 60%) as compared to the normative COGBAT sample. Regression analyses revealed that lower baseline scores in planning ability before the MC intervention (t0) were associated with greater planning ability (TOL; B = - 0.78, 95% CI - 1.04 to - 0.53), figural memory (FGT; B = - 0.26, 95% CI - 0.44 to - 0.07), and cognitive flexibility (TMT B; B = - 0.36, 95% CI - 0.50 to - 0.23) improvement post-MC intervention (t1-t0). Psychosocial functioning and age were not associated with these improvements. CONCLUSIONS: Patients with depressed executive functioning showed the greatest benefit from the MC intervention regarding cognitive functioning. Age and psychological functioning seem less important for cognitive performance improvements post-MC intervention. Hence, severely depressed cognitive functioning in patients is not a contraindication for PMVR using MitraClip.