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Background: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life., Objectives: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR., Methods: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory., Results: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.56 events/patient-year 1 year before device implantation to 0.14 events/patient-year 3 years after device implantation, representing a reduction of 75% (P < 0.0001)., Conclusions: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757)., Competing Interests: Funding Support and Author Disclosures This study was supported by Abbott Structural Heart. Dr Nickenig has received research funding and honoraria from Abbott, Edwards Lifesciences, and Medtronic; and has participated in clinical trials with Abbott, Edwards Lifesciences, and Medtronic. Dr Lurz has served as a consultant for Abbott Structural Heart, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Sorajja has served as a consultant for 4C Medical, Abbott Structural, Adona, Boston Scientific, Edwards Lifesciences, Foldax, GE Medical, GLG, Medtronic, Phillips, Siemens, WL Gore, vDyne, and xDot; and has received personal fees from Abbott Vascular (outside the submitted work). Dr von Bardeleben has received institutional research grants and speaker honorarium from Abbott Vascular and Edwards Lifesciences; and has received nonfinancial trial support from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Lifetec, and Medtronic. Dr Sitges has served as a consultant for Abbott, Edwards Lifesciences, Metronic, and General Electric; has received speaker honoraria from Abbott, Edwards Lifesciences, Medtronic, and General Electric; and has received speaker honoraria and travel and grant support from Abbott. Dr Hausleiter has received speaker honoraria and research support from Abbott Vascular and Edwards Lifesciences. Dr Trochu has received speaker honoraria, travel support, and grant support from Abbott and Novartis; has received honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and has been an unpaid member of the Corvia Medical Scientific Advisory Group. Dr Näbauer has received speaker honoraria from Abbott. Dr Heitkemper is an employee of Abbott. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; and has institutional consulting contracts for which she receives no direct compensation with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Structural changes and myocardial fibrosis quantification by cardiac imaging have become increasingly important to predict cardiovascular events in patients with mitral valve prolapse (MVP). In this setting, it is likely that an unsupervised approach using machine learning may improve their risk assessment., Objectives: This study used machine learning to improve the risk assessment of patients with MVP by identifying echocardiographic phenotypes and their respective association with myocardial fibrosis and prognosis., Methods: Clusters were constructed using echocardiographic variables in a bicentric cohort of patients with MVP (n = 429, age 54 ± 15 years) and subsequently investigated for their association with myocardial fibrosis (assessed by cardiac magnetic resonance) and cardiovascular outcomes., Results: Mitral regurgitation (MR) was severe in 195 (45%) patients. Four clusters were identified: cluster 1 comprised no remodeling with mainly mild MR, cluster 2 was a transitional cluster, cluster 3 included significant left ventricular (LV) and left atrial (LA) remodeling with severe MR, and cluster 4 included remodeling with a drop in LV systolic strain. Clusters 3 and 4 featured more myocardial fibrosis than clusters 1 and 2 (P < 0.0001) and were associated with higher rates of cardiovascular events. Cluster analysis significantly improved diagnostic accuracy over conventional analysis. The decision tree identified the severity of MR along with LV systolic strain <21% and indexed LA volume >42 mL/m 2 as the 3 most relevant variables to correctly classify participants into 1 of the echocardiographic profiles., Conclusions: Clustering enabled the identification of 4 clusters with distinct echocardiographic LV and LA remodeling profiles associated with myocardial fibrosis and clinical outcomes. Our findings suggest that a simple algorithm based on only 3 key variables (severity of MR, LV systolic strain, and indexed LA volume) may help risk stratification and decision making in patients with MVP. (Genetic and Phenotypic Characteristics of Mitral Valve Prolapse, NCT03884426; Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse [MVP STAMP], NCT02879825)., Competing Interests: Funding Support and Author Disclosures This work was supported by Foundation Coeur et Recherche (Dr Le Tourneau, 2013, Paris, France) and French Ministry of Health “PHRC-I 2012” (Dr Le Tourneau, API12/N/019, Paris, France). The STAMP study (Drs Huttin and Selton-Suty) was supported by a grant from the French Ministry of Health (APJ 2015, n°: 2016-A00954-47). Dr Huttin has received honoraria form General electric and Pfizer. Dr Girerd was supported by the French National Research Agency Fighting Heart Failure (ANR-15-RHU-0004), the French PIA project Lorraine Université d’Excellence GEENAGE (ANR-15-IDEX-04-LUE) programs, and the Contrat de Plan Etat Région Lorraine and FEDER IT2MP; and has received honoraria from Lilly, Bayer, Roche Diagnostics, Novartis, AstraZeneca, Boehringer, and Vifor. Dr Le Tourneau was supported by an INSERM Translational Research Grant (2012-2016, Paris, France). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF)., Objectives: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden., Methods: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time., Results: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up., Conclusions: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden. (A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure [REDUCE LAP-HF II]; NCT03088033)., Competing Interests: Funding Support and Author Disclosures Corvia Medical, Inc has provided funding for this work. Dr Reddy has served as a consultant to and has equity in Corvia Medical; also, unrelated to this manuscript, has served as a consultant to and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/AFTx, Circa Scientific, CoRISMA, Dinova-Hangzhou Dinova EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, and Valcare; unrelated to this work, has served as a consultant to Abbott, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, W.L. Gore & Associates, Impulse Dynamics, Medtronic, Philips, and Pulse Biosciences; and has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Komtebedde has been employed by Corvia Medical, Inc. Dr Walton has served as a proctor for Medtronic, Edwards Lifesciences, and Abbott; has served on advisory boards for Medtronic, Abbott, and Edwards Lifesciences; and has received grant support from Medtronic, Abbott, and Edwards Lifesciences. Dr Herrmann has received institutional research grants from Abbott, Bayer, Boston Scientific, Edwards Lifesciences, Highlife, Medtronic, Shockwave, and W.L. Gore & Associates; has received consultant fees from Medtronic, W.L. Gore & Associates, and Corazon; and has equity in Holistic Medical and Microinterventional Devices. Dr Trochu received consulting fees from Bayer, Bristol-Myers-Squibb, Abbott, AstraZeneca, and Novartis; lecture fees from Boehringer-Ingelheim and Vifor; and congress sponsoring from Corvia. Dr Auricchio has served as a consultant to Boston Scientific, Cairdac, Corvia, Microport CRM, EPD Philips, EP Solution, Radcliffe Publishers, and XSpline; has received speaker fees from Boston Scientific, Medtronic, and Microport CRM; has participated in clinical trials sponsored by Boston Scientific, Medtronic, EPD Philips, XSpline; and has intellectual properties with Boston Scientific, Biosense Webster, and Microport CRM. Dr Shah has received research grants from the National Institutes of Health (U54 HL160273, R01 HL107577, R01 HL127028, R01 HL140731, R01 HL149423), Actelion, AstraZeneca, Corvia, Novartis, and Pfizer; and has received consulting fees from Abbott, Actelion, AstraZeneca, Amgen, Aria CV, Axon Therapies, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardiora, Coridea, CVRx, Cyclerion, Cytokinetics, Edwards Lifesciences, Eidos, Eisai, Imara, Impulse Dynamics, GlaxoSmithKline, Intellia, Ionis, Ironwood, Lilly, Merck, MyoKardia, Novartis, Novo Nordisk, Pfizer, Prothena, Regeneron, Rivus, Sanofi, Sardocor, Shifamed, Tenax, Tenaya, and United Therapeutics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The risk of adverse cardiovascular events in patients with acute myocarditis (AM) and desmosomal gene variants (DGV) remains unknown., Objectives: The purpose of this study was to ascertain the risk of death, ventricular arrhythmias, recurrent myocarditis, and heart failure (main endpoint) in patients with AM and pathogenic or likely pathogenetic DGV., Methods: In a retrospective international study from 23 hospitals, 97 patients were included: 36 with AM and DGV (DGV[+]), 25 with AM and negative gene testing (DGV[-]), and 36 with AM without genetics testing. All patients had troponin elevation plus findings consistent with AM on histology or at cardiac magnetic resonance (CMR). In 86 patients, CMR changes in function and structure were re-assessed at follow-up., Results: In the DGV(+) AM group (88.9% DSP variants), median age was 24 years, 91.7% presented with chest pain, and median left ventricular ejection fraction (LVEF) was 56% on CMR (P = NS vs the other 2 groups). Kaplan-Meier curves demonstrated a higher risk of the main endpoint in DGV(+) AM compared with DGV(-) and without genetics testing patients (62.3% vs 17.5% vs 5.3% at 5 years, respectively; P &lt; 0.0001), driven by myocarditis recurrence and ventricular arrhythmias. At follow-up CMR, a higher number of late gadolinium enhanced segments was found in DGV(+) AM., Conclusions: Patients with AM and evidence of DGV have a higher incidence of adverse cardiovascular events compared with patients with AM without DGV. Further prospective studies are needed to ascertain if genetic testing might improve risk stratification of patients with AM who are considered at low risk., Competing Interests: Funding Support and Author Disclosures Dr Ammirati has received a grant from the Italian Ministry of Health (GR-2019-12368506) and is a consultant for Kiniksa and Cytokinetics. Dr Adler is a consultant for Abbott, Abiomed, AstraZeneca, Endotronix, Ionis, Medtronic, and Novartis; is on the board of directors of Genstem Therapeutics; and is a shareholder of Rocket Pharmaceuticals. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial., Background: It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials., Methods: In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months., Results: We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm 2 , RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients., Conclusions: In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698)., Competing Interests: Funding Support and Author Disclosures Funded by the French Ministry of Health and Research National Program and Abbott Vascular. Dr. Messika-Zeitoun has received consultant fees from Edwards Lifesciences. Dr. Iung, has received consultant fees from Edwards Lifesciences; and travel fees from Boehringer Ingelheim. Dr. Trochu has received speaker honoraria, travel, and grant support from Abbott and Novartis; honoraria for lectures or advisory boards from Amgen, Bayer, and Resmed; and grants from the EU programme Horizon 2020; and is an unpaid member of the Corvia Medical Scientific Advisory Group outside the submitted work. Dr. Donal has received research facilities from General Electric Healthcare; and consultant fees from Abbott. Dr. Brochet has served as proctor for Abbott. Dr. Piriou has received consultant fees from Abbott. Dr. Guerin has been a consultant for Abbott, Edwards Lifesciences, and Boston Scientific. Dr. Lefèvre has served as proctor for Abbott. Dr. Vahanian has been a consultant for Cardiovalve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: To prevent infective endocarditis (IE), with the exception of the United Kingdom, antibiotic prophylaxis (AP) is recommended in patients with predisposing cardiac conditions (PCCs) worldwide. To conclude on the relevance of this strategy, how the current guidelines are applied is a crucial point to investigate. The first aim of this study was to assess cardiologists' implementation of the current guidelines. The secondary objective was to identify specific areas where the training and knowledge of French cardiologists could be improved., Methods: A national online survey was carried out among the 2228 cardiologist members of the French Society of Cardiology., Results: The high risk PCCs for which IE AP is recommended were correctly identified by the vast majority of the respondents so that IE AP is mostly prescribed correctly in such patients. But only 12% identified all the right indications for IE AP according to 13 predefined PCCs (3 at high-risk, 6 at moderate-risk and 4 at low-risk of IE) so that some IE AP misuses are recorded, overprescription in particular. Only 47% prescribed the proper amoxicillin schedule and only 15% prescribed the appropriate clindamycin schedule in cases with penicillin allergy., Conclusion: This study evidenced relevant areas where the training of cardiologists could be improved such as knowledge of the risk of IE for certain PCCs and some common invasive dental procedures. Cardiologists' knowledge should be improved before any conclusion can be drawn on the relevance of this AP strategy and its influence on IE incidence., (Copyright © 2019. Published by Elsevier B.V.)

Background: Tricuspid regurgitation is a prevalent disease associated with high morbidity and mortality, with few treatment options. The aim of the TRILUMINATE trial is to evaluate the safety and effectiveness of TriClip, a minimally invasive transcatheter tricuspid valve repair system, for reducing tricuspid regurgitation., Methods: The TRILUMINATE trial is a prospective, multicentre, single-arm study in 21 sites in Europe and the USA. Patients with moderate or greater triscuspid regurgitation, New York Heart Association class II or higher, and who were adequately treated per applicable standards were eligible for enrolment. Patients were excluded if they had systolic pulmonary artery pressure of more than 60 mm Hg, a previous tricuspid valve procedure, or a cardiovascular implantable electronic device that would inhibit TriClip placement. Participants were treated using a clip-based edge-to-edge repair technique with the TriClip tricuspid valve repair system. Tricuspid regurgitation was graded using a five-class grading scheme (mild, moderate, severe, massive, and torrential) that expanded on the standard American Society of Echocardiography grading scheme. The primary efficacy endpoint was a reduction in tricuspid regurgitation severity by at least one grade at 30 days post procedure, with a performance goal of 35%, analysed in all patients who had an attempted tricuspid valve repair procedure upon femoral vein puncture. The primary safety endpoint was a composite of major adverse events at 6 months, with a performance goal of 39%. Patients were excluded from the primary safety analysis if they did not reach 6-month follow-up and did not have a major adverse event during previous follow-ups. The trial has completed enrolment and follow-up is ongoing; it is registered with ClinicalTrials.gov, number NCT03227757., Findings: Between Aug 1, 2017, and Nov 29, 2018, 85 patients (mean age 77·8 years [SD 7·9]; 56 [66%] women) were enrolled and underwent successful TriClip implantation. Tricuspid regurgitation severity was reduced by at least one grade at 30 days in 71 (86%) of 83 patients who had available echocardiogram data and imaging. The one-sided lower 97·5% confidence limit was 76%, which was greater than the prespecified performance goal of 35% (p<0·0001). One patient withdrew before 6-month follow-up without having had a major adverse event and was excluded from analysis of the primary safety endpoint. At 6 months, three (4%) of 84 patients experienced a major adverse event, which was less than the prespecified performance goal of 39% (p<0·0001). Single leaflet attachment occurred in five (7%) of 72 patients. No periprocedural deaths, conversions to surgery, device embolisations, myocardial infarctions, or strokes occurred. At 6 months, all-cause mortality had occurred in four (5%) of 84 patients., Interpretation: The TriClip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post procedure., Funding: Abbott., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: We have been intrigued by the observation that aortic stenosis (AS) may be associated with characteristic features of mitral drug-induced valvular heart disease (DI-VHD) in patients exposed to valvulopathic drugs, thus suggesting that beyond restrictive heart valve regurgitation, valvulopathic drugs may be involved in the pathogenesis of AS., Methods: Herein are reported echocardiographic features, and pathological findings encountered in a series of patients suffering from both AS (mean gradient >15mmHg) and mitral DI-VHD after valvulopathic drugs exposure. History of rheumatic fever, chest radiation therapy, systemic disease or bicuspid aortic valve disease were exclusion criteria., Results: Twenty-five (19 females, mean age 62years) patients having both AS and typical features of mitral DI-VHD were identified. Mean transaortic pressure gradient was 32+/-13mmHg. Aortic regurgitation was ≥ mild in 24 (96%) but trivial in one. Known history of aortic valve regurgitation following drug initiation prior the development of AS was previously diagnosed in 17 patients (68%). Six patients underwent aortic valve replacement and 3 both aortic and mitral valve replacement. In the 9 patients with pathology analysis, aortic valvular endocardium was markedly thickened by dense non-inflammatory fibrosis, a characteristic feature of DI-VHD., Conclusion: The association between AS and typical mitral DI-VHD after valvulopathic drug exposure may not be fortuitous. Aortic regurgitation was usually associated to AS and preceded AS in most cases but may be lacking. Pathology demonstrated the potential role of valvulopathic drugs in the development of AS., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The MESAMI 1 trial was a bicentric pilot study designed to test the feasibility and safety of intramyocardially injected autologous bone marrow-derived mesenchymal stromal cells (MSCs) for the treatment of ischemic cardiomyopathy., Methods and Results: The study included 10 patients with chronic myocardial ischemia, left ventricular (LV) ejection fractions (EFs) of ≤35%, and reversible perfusion defects who were on stable optimal medical therapy and were not candidates for revascularization. MSCs (mean: 61.5×10(6) cells per patient) were injected into 10-16 viable sites at the border of the LV scar via a NOGA-guided catheter. Both primary endpoints, feasibility (successful harvest, expansion, and injection of autologous MSCs) and safety (absence of severe adverse events [SAEs]) were met in all 10 patients at the 1-month follow-up time point, and none of the SAEs reported during the full 2-year follow-up period were attributable to the study intervention. The results of secondary efficacy endpoint analyses identified significant improvements from baseline to Month 12 in LVEF (29.4±2.0% versus 35.7±2.5%; p=0.003), LV end-systolic volume (167.8±18.8mL versus 156.1±28.6mL; p=0.04), 6-min walk test and NYHA functional class., Conclusions: Our results suggest that autologous MSCs can be safely administered to the hearts of patients with severe, chronic, reversible myocardial ischemia and impaired cardiac function and may be associated with improvements in cardiac performance, LV remodeling, and patient functional status. A randomized, double blind, multicenter, placebo-controlled clinical trial (MESAMI 2) will evaluate the efficacy of this treatment approach in a larger patient population., Clinical Trial Registration: Unique identifier: NCT01076920., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The development of artificial hearts in patients with end-stage heart disease have been confronted with the major issues of thromboembolism or haemorrhage. Since valvular bioprostheses are associated with a low incidence of these complications, we decided to use bioprosthetic materials in the construction of a novel artificial heart (C-TAH). We report here the device characteristics and its first clinical applications in two patients with end-stage dilated cardiomyopathy. The aim of the study was to evaluate safety and feasibility of the CARMAT TAH for patients at imminent risk of death from biventricular heart failure and not eligible for transplant., Methods: The C-TAH is an implantable electro-hydraulically actuated pulsatile biventricular pump. All components, batteries excepted, are embodied in a single device positioned in the pericardial sac after excision of the native ventricles. We selected patients admitted to hospital who were at imminent risk of death, having irreversible biventricular failure, and not eligible for heart transplantation, from three cardiac surgery centres in France., Findings: The C-TAH was implanted in two male patients. Patient 1, aged 76 years, had the C-TAH implantation on Dec 18, 2013; patient 2, aged 68 years, had the implantation on Aug 5, 2014. The cardiopulmonary bypass times for C-TAH implantation were 170 min for patient 1 and 157 min for patient 2. Both patients were extubated within the first 12 postoperative hours and had a rapid recovery of their respiratory and circulatory functions as well as a normal mental status. Patient 1 presented with a tamponade on day 23 requiring re-intervention. Postoperative bleeding disorders prompted anticoagulant discontinuation. The C-TAH functioned well with a cardiac output of 4·8-5·8 L/min. On day 74, the patient died due to a device failure. Autopsy did not detect any relevant thrombus formation within the bioprosthesis nor the different organs, despite a 50-day anticoagulant-free period. Patient 2 experienced a transient period of renal failure and a pericardial effusion requiring drainage, but otherwise uneventful postoperative course. He was discharged from the hospital on day 150 after surgery with a wearable system without technical assistance. After 4 months at home, the patient suffered low cardiac output. A change of C-TAH was attempted but the patient died of multiorgan failure., Interpretation: This preliminary experience could represent an important contribution to the development of total artificial hearts using bioprosthetic materials., Funding: CARMAT SA., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Meta-analyses of disease management programs have shown favorable effects in chronic heart failure. Therapeutic patient education forms an integral part of these programs and may influence mortality per se. We aimed to determine the relationship between therapeutic patient education applied in routine clinical practice and long-term mortality in chronic heart failure., Methods: From 2007 to 2010 (median follow-up: 27.2 months), heart failure patients were prospectively enrolled in a multicenter, 'real-world', French cohort by centers previously trained in therapeutic patient education. As educated and non-educated patient profiles were expected to differ, mortality was assessed using conventional multivariate analyses and analyses made on propensity-matched cohorts for the application of therapeutic patient education., Results: Of the 3237 patients who participated in the study (67.5 years; 69.5% men), 2347 were educated (72.5%) and 890 were not educated (27.5%). Non-educated patients were older, more often female, and more severely diseased than educated patients. All-cause mortality was 17.3% in the educated group vs. 31.0% in the non-educated group (adjusted HR 0.70, 95% CI 0.58-0.84, P<.001). This association remained in paired groups after adjustment for all baseline covariates excluding (model 1) or including (model 2) cardiovascular medications and propensity score (HR 0.72, 95% CI 0.58-0.90, P=.003; HR 0.73, 95% CI 0.59-0.90, P=.004, respectively)., Conclusion: In chronic heart failure, therapeutic patient education by trained healthcare professionals appears associated with lower all-cause mortality. These data may have important implications in terms of healthcare organization, because they suggest that therapeutic patient education should be developed in all types of cardiology centers., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Myocarditis is an inflammatory disease of the myocardium associated with cardiac dysfunction. Etiologies of myocarditis are numerous - viral causes being the most frequent - as well as their clinical presentations which varies from isolated increase in cardiac enzymes during a viral pericarditis, fulminant myocarditis associated with cardiogenic shock to endomyocardial biopsy proven inflammation discovered during the etiologic diagnosis of a dilated cardiomyopathy. This article will discuss the importance of recognition of specific clinical scenarios of myocarditis and their echocardiographic presentations that are very useful for the etiologic diagnosis and to decide the medical strategy. Recent advances in the field of myocarditis concern improvement in understanding the pathophysiology, in the diagnostic approach with the use of noninvasive imaging (MRI) and molecular biology. However, specific treatment is still limited. Clinical trials with antiviral medications are not conclusive, and the medical strategies remain mainly based on the symptomatic treatment of heart failure., (Copyright © 2012 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.)

Several studies suggest that the beta(3)-adrenergic stimulation could be a new therapeutic target for the treatment of cardiovascular diseases. The vascular effects induced by beta(3)-adrenergic stimulation are able to decrease the left ventricular strain allowing to reduce after-load. In addition, the increased coronary blood flow due to vasorelaxation increases the myocardial oxygene delivery. The hypothesis about the beneficial role of beta(3)-adrenoceptors is supported by recent data about a beta-blocker of third generation, nebivolol, currently used in the treatment of heart failure and hypertension. The present review presents the beta(3)-adrenoceptors characteristics as well as its involvement in the cardiovascular effects of nebivolol., (Copyright 2010. Published by Elsevier SAS.)

Background: When implanted in patients with biventricular failure, the CardioWest total artificial heart has asserted itself over time as a reliable bridge-to-transplant device that as yet is used by only a few international teams. The aim of this single-center retrospective study is to assess both the comorbidity and survival of patients awaiting heart transplants while receiving circulatory support with a CardioWest total artificial heart., Methods: From 1990 to December 2006, 42 patients received a CardioWest total artificial heart at our center. Mean age at the time of implantation was 45.7 +/- 9.5 years, and 40 patients (95%) were men. Idiopathic or dilated cardiomyopathy was diagnosed in 45.2% (n = 19) of the patients and ischemic cardiomyopathy in 42.8% (n = 18). Average body surface area was 1.9 +/- 0.22 m(2)., Results: Duration of support was 1 to 292 days (mean, 101 +/- 86 days). Twelve patients died (28.5%) while receiving device support, and 30 patients (71.5%) underwent transplantation. Actuarial survival rates for the transplanted patients were 90% (n = 25), 81% (n = 14), and 76% (n = 10) at 1, 5, and 10 years, respectively. Causes of death during device support included multiorgan failure in 6 (50%), sepsis in 2, acute respiratory distress syndrome in 2, alveolar hemorrhage in 1, and other cause in 1. There were no device malfunctions that led to patient death. Adverse events included stroke in 3 patients (7%) and infections in 35 patients (85%) during support., Conclusions: The CardioWest total artificial heart is an excellent bridge-to-transplant device for patients with biventricular failure. Our study demonstrates excellent safety, reliability, and efficiency. Exceptional outcome after transplantation underlines its capacity to aid in end-organ recovery.

Objectives: The study was conducted to determine the long-term outcome of patients who underwent heart transplantation 15 to 20 years ago, in the cyclosporine era, and identify risk factors for death., Methods: A retrospective analysis was done of 148 patients who had undergone heart transplantation between 1985 and 1991 at a single center. Operative technique and immunosuppressive treatment were comparable in all patients., Results: Actuarial survival rates were 75% (n = 111), 58% (n = 86), and 42% (n = 62) at 5, 10, and 15 years, respectively. The mean follow-up period was 12.1 +/- 5.6 years for patients who survived more than 3 months after transplantation (n = 131). The major causes of death were malignancy (35.8%) and cardiac allograft vasculopathy (24.7%). No death related to acute rejection was reported after the first month of transplantation. Graft coronary artery disease was detected on angiography in 66 (50.3%), and 7 (5.3%) had retransplantation. Malignancies developed in 131 patients (48.1%), including skin cancers in 31 (23.6%), solid tumors in 26 (19.8%), and hematologic malignancies in 14 (10.6%). Severe renal function requiring dialysis or renal transplantation developed in 27 patients (20.6%). By multivariable analysis, the only pre-transplant risk factor found to affect long-term survival was a history of cigarette use (p < 0.0004)., Conclusions: Long-term survival at 15 years after cardiac transplantation remains excellent in the cyclosporine era. Controlling acute allograft rejection can be achieved but seems to carry a high rate of cancers and renal dysfunction. History of cigarette use affects significantly long-term survival in our study.

Aim: To develop educational programs in chronic heart failure (CHF), creation of standardized tools for therapeutic education specifically dedicated to CHF patients was performed as a part of the French I-CARE project., Methods and Results: A working group was constituted of cardiologists, nurses and dieticians, specialized in both therapeutic education and CHF. The personal patient's document consisted of a ring binder with dividers containing index cards for 5 units. The unit "Educational diagnosis" comprised a guide for the user and an auto-questionnaire for the patient. The unit "Knowledge of the disease" comprised a whiteboard for explaining cardiovascular physiology, a 3D-model of heart, and a glossary. The unit "Diet control" was composed of posters, a food-card game with a game mat figuring the different meals of a day, a low-salt recipe book, and 1-g salt spoons. The unit "Physical activity and daily life" comprised recommendations for physical activity and questionable real-life situations, and a card game for evaluation. The unit "Medical treatment" consisted of index cards for different cardiovascular drugs., Conclusion: These educational tools should help multidisciplinary teams to develop therapeutic education dedicated to CHF in order to improve self-management, morbidity and quality of life in CHF patients.

Health care networks correspond to a form of horizontal and flexible organisation, which consists in dealing with complex problems of health and long-term care. Networks rest entirely on the mechanisms of coordination between the various actors of care, whose keystone is the medical information flow. The challenge of the health networks evaluation is to prove the added value of a network organization, instead of a conventional disease-centred health care. The evaluation of health care networks is legally required but not sustained by specialists. Evaluation must ensure the existence of a real management; measure the interest of health care professionals and the impact of the network on professional practices. Moreover, evaluation accompanies the development of the network and offers the advisability to the decision maker of obtaining a tool for control of management, i.e. an information tool and a decision-making help, with the aim of a continuous improvement of the quality of care. However the absence of formation of the medical coordinators to management, makes networks management problematic. Thus, health care networks cannot make the saving in a good administrative and management base. In the same way health care networks must obtain an information system adapted to their type of coordination, allowing the evaluation required by the financier.

Heart failure is a severe disease with high morbidity and mortality rates. The interest for multidisciplinary heart failure patient management is increasing in order to improve prescription of medical therapies and to allow a better quality of life. Proofs of reduction in morbi-mortality exist and some models of management have been assessed. The most important point remains the major role of therapeutic education. Training of health care professionals is needed. Tools for therapeutic education have been created and can be associated with complementary informative means. All these elements allow that a new approach of heart failure takes in place in France.

Beyond their lipid lowering properties HMG-CoA reductase inhibitors (statins) have numerous effects in the cardiovascular system. Commonly referred as "pleiotropic properties", these properties could justify the use of statins in the treatment of congestive heart failure. Excluding the beneficial effects of statins related to the prevention of coronary ischemic events, this review focuses on the emerging mechanisms which may explain the therapeutic potential of satins in heart failure, particularly their action on endothelial function, myocardial and renal energetic metabolism, inflammation, thrombosis, oxidative stress, ventricular remodeling and hypertrophy, and renal function.

Background: We compared the morbidity and mortality rates of patients who had urgent heart transplantation or transplantation after bridging with a ventricular assist device, with the rates of patients whose clinical stability allowed them to wait at home., Methods: From March 1985 to December 2000, 404 patients underwent heart transplantation in a single center. There were 273 patients with UNOS status 2 (US 2), 103 patients with UNOS Status 1A (US 1A), and 28 patients with UNOS Status 1B (US 1B). We compared the groups retrospectively with respect to pretransplantation status and operative results., Results: Despite more severely impaired hemodynamics and a significantly higher preoperative infection rate in US 1A and 1B patients, there were no statistically significant differences in survival rates among the three groups. Donor sex and age, cytomegalovirus and toxoplasmosis, mismatch rate, ischemic time, method of myocardial protection, and operative technique did not differ statistically among the three groups. Length of intensive care unit stay, postoperative morbidity, first year postoperative rejection rate, and graft occlusive vascular disease rate were statistically similar among the three groups. Although pretransplantation cancer assessment was less complete in US 1A and 1B than in US 2 patients, the late-cancer rate was not statistically different among the three groups., Conclusions: These data suggest that urgently transplanted patients have both early and long term morbidity and mortality similar to those of patients waiting for transplantation at home or with a ventricular assist device.

Over recent years, the increasing complexity of pacemakers has discouraged many cardiologists who considered that their role in the surveillance of patients with pacemakers had become minimal. Fortunately, times have changed, as this sophistication, which has how reached maturity, simplifies the cardiologist's task and should renew this interest in pacemaking. For example, improvement of electronic circuits now allows simpler pacing modes (e.g. single electrode VDD mode) and the development of automation of the main pacing parameters: automatic adjustment of the discharge current, the A-V period, protection algorithms against tachycardia due to electronic re-entry and atrial arrhythmias, automatic mode switching. Finally, the incorporation of large capacity memory functions allows the apparatus to act like an implantable "mini Holter" monitor.