Risk stratification for mitral valve transcatheter edge-to-edge repair (M-TEER) is paramount in the decision-making process to appropriately select patients with severe secondary mitral regurgitation ...(SMR). This study sought to develop and validate an artificial intelligence-derived risk score (EuroSMR score) to predict 1-year outcomes (survival or survival + clinical improvement) in patients with SMR undergoing M-TEER.
An artificial intelligence-derived risk score was developed from the EuroSMR cohort (4172 and 428 patients treated with M-TEER in the derivation and validation cohorts, respectively). The EuroSMR score was validated and compared with established risk models.
The EuroSMR risk score, which is based on 18 clinical, echocardiographic, laboratory, and medication parameters, allowed for an improved discrimination of surviving and non-surviving patients (hazard ratio 4.3, 95% confidence interval 3.7-5.0; P < .001), and outperformed established risk scores in the validation cohort. Prediction for 1-year mortality (area under the curve: 0.789, 95% confidence interval 0.737-0.842) ranged from <5% to >70%, including the identification of an extreme-risk population (2.6% of the entire cohort), which had a very high probability for not surviving beyond 1 year (hazard ratio 6.5, 95% confidence interval 3.0-14; P < .001). The top 5% of patients with the highest EuroSMR risk scores showed event rates of 72.7% for mortality and 83.2% for mortality or lack of clinical improvement at 1-year follow-up.
The EuroSMR risk score may allow for improved prognostication in heart failure patients with severe SMR, who are considered for a M-TEER procedure. The score is expected to facilitate the shared decision-making process with heart team members and patients.
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•We aimed to identify the real-life target population for a selective cMI in HCM.•We studied 1059 adult patients with HCM enrolled in REMY (a French HCM registry)•325 (30.7%) of these ...patients were potential candidates for a cMI.•9% more became eligible for a cMI during follow-up.
The efficacy of current pharmacological therapies in hypertrophic cardiomyopathy is limited. A cardiac myosin inhibitor, mavacamten, has recently been approved as a first-in-class treatment for symptomatic hypertrophic obstructive cardiomyopathy.
To assess the profile and burden of cardiac myosin inhibitor candidates in the hypertrophic cardiomyopathy prospective Register of hypertrophic cardiomyopathy (REMY) held by the French Society of Cardiology.
Data were collected at baseline and during follow-up from patients with hypertrophic cardiomyopathy enrolled in REMY by the three largest participating centres.
Among 1059 adults with hypertrophic cardiomyopathy, 461 (43.5%) had obstruction; 325 (30.7%) of these were also symptomatic, forming the “cardiac myosin inhibitor candidates” group. Baseline features of this group were: age 58±15years; male sex (n=196; 60.3%); diagnosis-to-inclusion delay 5 (1–12)years; maximum wall thickness 20±6mm; left ventricular ejection fraction 69±6%; family history of hypertrophic cardiomyopathy or sudden cardiac death (n=133; 40.9%); presence of a pathogenic sarcomere gene mutation (n=101; 31.1%); beta-blocker or verapamil treatment (n=304; 93.8%), combined with disopyramide (n=28; 8.7%); and eligibility for septal reduction therapy (n=96; 29%). At the end of a median follow-up of 66 (34–106) months, 319 (98.2%) were treated for obstruction (n=43 13.2% received disopyramide), 46 (14.2%) underwent septal reduction therapy and the all-cause mortality rate was 1.9/100 person-years (95% confidence interval 1.4–2.6) (46 deaths). Moreover, 41 (8.9%) patients from the initial hypertrophic obstructive cardiomyopathy group became eligible for a cardiac myosin inhibitor.
In this cohort of patients with hypertrophic cardiomyopathy selected from the REMY registry, one third were eligible for a cardiac myosin inhibitor.
•Trend to fewer periprocedural complications over the years.•Significant decrease of thromboembolic and haemorrhagic events post procedure.•Almost half of haemorrhagic events occur during the first 3 ...months.
Percutaneous left atrial appendage closure may be considered in selected patients with atrial fibrillation at significant risk of both thromboembolism and haemorrhage.
To report the experience of a tertiary French centre in percutaneous left atrial appendage closure and to discuss the outcomes compared with previously published series.
This was a retrospective observational cohort study of all patients referred for percutaneous left atrial appendage closure between 2014 and 2020. Patient characteristics, procedural management and outcomes were reported, and the incidence of thromboembolic and bleeding events during follow-up were compared with historical incidence rates.
Overall, 207 patients had left atrial appendage closure (mean age 75.3±8.6 years; 68% men; CHA2DS2-VASc score 4.8±1.5 ; HAS-BLED score 3.3±1.1), with a 97.6% (n=202) success rate. Twenty (9.7%) patients had at least one significant periprocedural complication, including six (2.9%) tamponades and three (1.4%) thromboembolisms. Periprocedural complication rates decreased from earlier to more recent periods (from 13% before 2018 to 5.9% after; P=0.07). During a mean follow-up of 23.1±20.2 months, 11 thromboembolic events were observed (2.8% per patient-year), a 72% risk reduction compared with the estimated theoretical annual risk. Conversely, 21 (10%) patients experienced bleeding during follow-up, with almost half of the events occurring during the first 3 months. After the first 3 months, the risk of major bleeding was 4.0% per patient-year, a 31% risk reduction compared with the expected estimated risk.
This real-world evaluation emphasizes the feasibility and benefit of left atrial appendage closure, but also illustrates the need for multidisciplinary expertise to initiate and develop this activity.
Management of young adults with hypertrophic cardiomyopathy (HCM) is challenging.
To evaluate the profile of young adults (16–25 years) with HCM included in the French prospective HCM registry.
...Patients were compared according to occurrence of major adverse cardiac events (MACE), comprising sudden cardiac death (SCD) events (implantable cardioverter defibrillator ICD discharge, SCD, sustained ventricular tachycardia), atrial fibrillation/embolic stroke, heart failure hospitalisation and unexplained syncope, at a mean follow-up of 4.4±2.2 years.
At baseline, among 61 patients (20.5±3.0 years; 16 women, 26.2%), 13 (21.3%) had a prophylactic ICD, 24.6% a family history of SCD, 29.5% obstruction, 86.0% magnetic resonance imaging myocardial fibrosis, 11.8% abnormal exercise blood pressure and 52.8% a European Society of Cardiology (ESC) 5-year SCD score<4% (24.5%≥6%). At follow-up, 15 patients (24.6%; seven women; all with fibrosis) presented 17 MACE, comprising: SCD events (n=7, 41.2%; including three patients with an ICD, five with at least one SCD major classical risk factor and an ESC score≥5% and two with no risk factors and an ESC score<4%); atrial fibrillation/stroke (n=6, 35.3%); heart failure (n=1, 5.9%); syncope (n=3, 17.6%). An ICD was implanted in 11 patients (four for secondary prevention), but in only 61.5% of patients with a score≥6%. Only obstruction significantly increased MACE risk (odds ratio 3.96; P=0.035), with a non-significant trend towards a lower risk in men (OR 0.29; P=0.065).
In young adults with HCM, MACE are common in the short term, especially in obstructive HCM and women, mostly arrhythmic in origin. Prophylactic ICD implantation is frequent and does not strictly follow the guidelines, while the use of European/USA guidelines is helpful but imperfect in identifying SCD risk.
La prise en charge des jeunes adultes atteints de cardiomyopathie hypertrophique (CMH) reste difficile.
Évaluer le profil des jeunes adultes (16–25 ans) atteints de CMH sarcomèrique et inclus dans le registre prospectif français des CMH.
Les caractéristiques initiales ont été comparées selon la survenue à 4,4±2,2 ans d’évènements cardiaques majeurs (ECM) : mort subite (MS) (décharge de défibrillateur cardiaque DAI, MS, tachycardie ventriculaire soutenue) ; fibrillation atriale (FA) ou accident vasculaire cérébral (AVC) ; hospitalisation pour insuffisance cardiaque (IC) ; ou syncope.
À l’inclusion, parmi 61 patients (20,5±3.0 ans ; 16 femmes, 26,2 %), 21,3 % avaient un DAI (n=13), 24,6 % des antécédents familiaux de MS, 29,5 % une obstruction, 86.0 % une fibrose en IRM, 11,8 % une réponse tensionnelle anormale d’effort, 52,8 % un score ESC de MS à 5 ans<4 % (24,5 %≥6 %). En fin de suivi, 15 patients (24.6 % ; 7 femmes ; tous avec fibrose) avaient présenté 17 ECM : 7 MS (41,2 % ; 3 patients avec DAI, 5 avec ≥1 facteur de risque majeur de MS FRM et score>5 %, 2 sans FRM et score<4 %); 6 FA/AVC (35,3 %) ; 1 IC (5,9 %) ; 3 syncopes (17,6 %). Un DAI était posé chez 11 patients (4 en prévention secondaire), 61,5 % des patients avec score ≥6 %. Seule l’obstruction augmentait le risque d’ECM (OR 3,96 ; p=0,035), avec une tendance pour un moindre risque chez l’homme (OR 0,29 ; p=0,065).
Chez les jeunes adultes avec CMH, les ECM sont fréquents à court terme, en particulier en cas d’obstruction et chez la femme, essentiellement rythmiques. L’implantation d’un DAI prophylactique est fréquente, non strictement basée sur les recommandations internationales, utiles mais imparfaites pour identifier le risque de MS.
To identify independent electrocardiogram (ECG) predictors of long-term clinical outcome based on standardized analysis of the surface ECG in a large multicentre cohort of patients with sarcomeric ...hypertrophic cardiomyopathy (HCM).
Retrospective observational study from the REMY French HCM clinical research observatory. Primary endpoint was a composite of all-cause mortality, major non-fatal arrhythmic events, hospitalization for heart failure (HF), and stroke. Secondary endpoints were components of the primary endpoint. Uni- and multivariable Cox proportional hazard regression analysis was performed to identify independent predictors. Among 994 patients with HCM, only 1.8% had a strictly normal baseline ECG. The most prevalent abnormalities were inverted T waves (63.7%), P-wave abnormalities (30.4%), and abnormal Q waves (25.5%). During a mean follow-up of 4.0 ± 2.0 years, a total of 272 major cardiovascular events occurred in 217 patients (21.8%): death or heart transplant in 98 (9.8%), major arrhythmic events in 40 (4.0%), HF hospitalization in 115 (11.6%), and stroke in 23 (2.3%). At multivariable analysis using ECG covariates, prolonged QTc interval, low QRS voltage, and PVCs of right bundle branch block pattern predicted worse outcome, but none remained independently associated with the primary endpoint after adjustment on main demographic and clinical variables. For secondary endpoints, abnormal Q waves independently predicted all-cause death hazard ratio (HR) 2.35, 95% confidence interval (CI) 1.23-4.47; P = 0.009 and prolonged QTc the risk of HF hospitalization (HR 1.006, 95% CI 1.001-1.011; P = 0.024).
The 12-lead surface ECG has no independent value to predict the primary outcome measure in patients with HCM. The 12-lead surface ECG has been widely used as a screening tool in HCM but its prognostic value remains poorly known. The value of baseline surface ECG to predict long-term clinical outcomes was studied in a cohort of 994 patients with sarcomeric HCM. The surface ECG has no significant additional value to predict outcome in this patient population.
There is increased evidence that the effects of stem cells can mostly be duplicated by administration of their secretome which might streamline the translation towards the clinics.
The 12-patient ...SECRET-HF phase 1 trial has thus been designed to determine the feasibility and safety of repeated intravenous injections of the extracellular vesicle (EV)-enriched secretome of cardiovascular progenitor cells differentiated from pluripotent stem cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. Here we report the case of the first treated patient (baseline NYHA class III; LV Ejection Fraction:25%) in whom a dose of 20 × 109 particles/kg was intravenously infused three times three weeks apart.
In addition to demonstrating the feasibility of producing a cardiac cell secretome compliant with Good Manufacturing Practice standards, this case documents the excellent tolerance of its repeated delivery, without any adverse events during or after infusions. Six months after the procedure, the patient is in NYHA Class II with improved echo parameters, a reduced daily need for diuretics (from 240 mg to 160 mg), no firing from the previously implanted automatic internal defibrillator and no alloimmunization against the drug product, thereby supporting its lack of immunogenicity.
The rationale underlying the intravenous route is that the infused EV-enriched secretome may act by rewiring endogenous immune cells, both circulating and in peripheral organs, to take on a reparative phenotype. These EV-modified immune cells could then traffic to the heart to effect tissue repair, including mitigation of inflammation which is a hallmark of cardiac failure.
This trial is funded by the French Ministry of Health (Programme Hospitalier de Recherche CliniqueAOM19330) and the “France 2030” National Strategy Program (ANR-20-F2II-0003). It is sponsored by Assistance Publique-Hôpitaux de Paris.
A 67-year-old patient with history of heart transplantation was referred for symptomatic severe tricuspid regurgitation. Diagnostic workup showed chordal ruptures on the septal and anterior leaflets, ...most likely related to endomyocardial biopsies. Given the high surgical risk, the patient was treated percutaneously, with good results persisting at 3 months. (Level of Difficulty: Intermediate.)
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Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics ...and clinical outcomes over time are limited.
The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.
TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.
A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation EuroSCORE: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium–defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.
The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter FRANCE TAVI; NCT01777828)
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