Rationale and design of the French cohort of acute myocarditis diagnosed by cardiac magnetic resonance imaging (MyocarditIRM).

BACKGROUND: Acute myocarditis usually presents as chest pain with rising troponin and normal coronary arteries. Despite frequent favourable evolution at the acute phase, it is associated with heart failure and ventricular rhythm disorders, and is considered the leading cause of sudden cardiac death in young, apparently healthy, adults. There are no specific recommendations for acute myocarditis diagnosis and management, only expert consensus, given the lack of large databases. AIM: The main objective is to describe the contemporary presentation of acute myocarditis, its management and in-hospital outcomes. Secondary objectives are to investigate survival and event-free survival for up to 10years of follow-up, the determinants of prognosis, the modalities of treatment and follow-up and the gaps between expert consensus and real-life management. METHODS: MyocarditIRM is a prospective multicentre cohort that enrolled 803 consecutive patients with acute myocarditis in 49 participating centres in France between 01 May 2016 and 28 February 2019. The diagnosis of acute myocarditis was acknowledged by cardiac magnetic resonance, using the Lake Louise Criteria. Exclusion criteria were age<18years, lack of health coverage, contraindication to cardiac magnetic resonance and refusal to participate. Detailed information was collected prospectively, starting at admission. Cardiac magnetic resonance imaging (diagnosis and follow-up) is analysed centrally by the certified core laboratory IHU ICAN. Ten years of follow-up for each patient is ensured by linking with the French National Health Database, and includes information on death, hospital admissions, major clinical events and drug consumption. CONCLUSION: This prospective cohort with long-term follow-up represents the largest database on acute myocarditis worldwide, and will improve knowledge about its presentation, management and outcomes.

QRS-T angle: is it a specific parameter associated with sudden cardiac death in type 2 diabetes? Results from the SURDIAGENE and the Mini-Finland prospective cohorts.

AIMS/HYPOTHESIS: Type 2 diabetes is associated with a high risk of sudden cardiac death (SCD), but the risk of dying from another cause (non-SCD) is proportionally even higher. The aim of the study was to identify easily available ECG-derived features associated with SCD, while considering the competing risk of dying from non-SCD causes. METHODS: In the SURDIAGENE (Survie, Diabete de type 2 et Genetique) French prospective cohort of individuals with type 2 diabetes, 15 baseline ECG parameters were interpreted among 1362 participants (mean age 65 years; HbA1c 62±17 mmol/mol [7.8±1.5%]; 58% male). Competing risk models assessed the prognostic value of clinical and ECG parameters for SCD after adjusting for age, sex, history of myocardial infarction, N-terminal pro b-type natriuretic peptide (NT-proBNP), HbA1c and eGFR. The prospective Mini-Finland cohort study was used to externally validate our findings. RESULTS: During median follow-up of 7.4 years, 494 deaths occurred including 94 SCDs. After adjustment, frontal QRS-T angle ≥90° (sub-distribution HR [sHR] 1.68 [95% CI 1.04, 2.69], p=0.032) and NT-proBNP level (sHR 1.26 [95% CI 1.06, 1.50] per 1 log, p=0.009) were significantly associated with a higher risk of SCD. Nevertheless, frontal QRS-T angle was the only marker not to be associated with causes of death other than SCD (sHR 1.08 [95% CI 0.84, 1.39], p=0.553 ). These findings were replicated in the Mini-Finland study subset of participants with diabetes (sHR 2.22 [95% CI 1.05, 4.71], p=0.04 for SCD and no association for other causes of death). CONCLUSIONS/INTERPRETATION: QRS-T angle was specifically associated with SCD risk and not with other causes of death, opening an avenue for refining SCD risk stratification in individuals with type 2 diabetes.

Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction.

BACKGROUND: Inflammation is a key factor of myocardial damage in reperfused ST-segment-elevation myocardial infarction. We hypothesized that colchicine, a potent anti-inflammatory agent, may reduce infarct size (IS) and left ventricular (LV) remodeling at the acute phase of ST-segment-elevation myocardial infarction. METHODS: In this double-blind multicenter trial, we randomly assigned patients admitted for a first episode of ST-segment-elevation myocardial infarction referred for primary percutaneous coronary intervention to receive oral colchicine (2-mg loading dose followed by 0.5 mg twice a day) or matching placebo from admission to day 5. The primary efficacy outcome was IS determined by cardiac magnetic resonance imaging at 5 days. The relative LV end-diastolic volume change at 3 months and IS at 3 months assessed by cardiac magnetic resonance imaging were among the secondary outcomes. RESULTS: We enrolled 192 patients, 101 in the colchicine group and 91 in the control group. At 5 days, the gadolinium enhancement-defined IS did not differ between the colchicine and placebo groups with a mean of 26 interquartile range (IQR) [16-44] versus 28.4 IQR [14-40] g of LV mass, respectively (P=0.87). At 3 months follow-up, there was no significant difference in LV remodeling between the colchicine and placebo groups with a +2.4% (IQR, -8.3% to 11.1%) versus -1.1% (IQR, -8.0% to 9.9%) change in LV end-diastolic volume (P=0.49). Infarct size at 3 months was also not significantly different between the colchicine and placebo groups (17 IQR [10-28] versus 18 IQR [10-27] g of LV mass, respectively; P=0.92). The incidence of gastrointestinal adverse events during the treatment period was greater with colchicine than with placebo (34% versus 11%, respectively; P=0.0002). CONCLUSIONS: In this randomized, placebo-controlled trial, oral administration of high-dose colchicine at the time of reperfusion and for 5 days did not reduce IS assessed by cardiac magnetic resonance imaging. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03156816.

Virtual Reality for Sedation During Atrial Fibrillation Ablation in Clinical Practice: Observational Study.

BACKGROUND: Connected devices are dramatically changing many aspects in health care. One such device, the virtual reality (VR) headset, has recently been shown to improve analgesia in a small sample of patients undergoing transcatheter aortic valve implantation. OBJECTIVE: We aimed to investigate the feasibility and effectiveness of VR in patients undergoing atrial fibrillation (AF) ablation under conscious sedation. METHODS: All patients who underwent an AF ablation with VR from March to May 2020 were included. Patients were compared to a consecutive cohort of patients who underwent AF ablation in the 3 months prior to the study. Primary efficacy was assessed by using a visual analog scale, summarizing the overall pain experienced during the ablation. RESULTS: The AF cryoablation procedure with VR was performed for 48 patients (mean age 63.0, SD 10.9 years; n=16, 33.3% females). No patient refused to use the device, although 14.6% (n=7) terminated the VR session prematurely. Preparation of the VR headset took on average 78 (SD 13) seconds. Compared to the control group, the mean perceived pain, assessed with the visual analog scale, was lower in the VR group (3.5 [SD 1.5] vs 4.3 [SD 1.6]; P=.004), and comfort was higher in the VR group (7.5 [SD 1.6] vs 6.8 [SD 1.7]; P=.03). On the other hand, morphine consumption was not different between the groups. Lastly, complications, as well as procedure and fluoroscopy duration, were not different between the two groups. CONCLUSIONS: We found that VR was associated with a reduction in the perception of pain in patients undergoing AF ablation under conscious sedation. Our findings demonstrate that VR can be easily incorporated into the standard ablation workflow.

Prognostic value of Charlson Comorbidity Index in the elderly with a cardioverter defibrillator implantation.

BACKGROUND: Elderly patients are often underrepresented in implantable cardioverter defibrillator (ICD) trials, and ICD implantation in patients ≥75 years consequently remains controversial. We aimed to evaluate mortality, appropriate ICD therapy rates and survival gain in an elderly population after risk stratification according to the Charlson Comorbidity Index (CCI). METHODS: This monocentric retrospective study included elderly ICD patients ≥75 years. They were subdivided according to their CCI score into 3 categories (0-1, 2-3 or ≥4 points). Elderly patients were matched 1:2 with younger control ICD patients on gender, type of prevention (primary or secondary) and type of device (associated cardiac resynchronization therapy or not). RESULTS: Between January 2009 and July 2017, 121 elderly patients (mean age 78 ± 3; 83% male) matched with 242 controls (mean age 66 ± 5) were included. At 5 year follow-up after ICD implantation, overall survival was 78%, 57%, and 29% (P = 0.002) in the elderly with a CCI score of 0-1, 2-3 and ≥4 respectively, and 72% in controls. There was no significant difference regarding ICD appropriate therapy between the 3 subgroups despite a trend towards lower rates of therapy in CCI ≥ 4 points patients (34.2%, 39.7% and 22.8% respectively; P = 0.45). Median potential survival gain after an appropriate therapy was >5, 4.7 and 1.4 years, with a CCI score of 0-1, 2-3 and ≥4 respectively (P = 0.01). CONCLUSION: Elderly patients with CCI score ≥ 4 had the lowest survival after ICD implantation and little survival gain in case of appropriate defibrillator therapy. More than age alone, the burden of comorbidities assessed by the CCI could be helpful to better select elderly patients for ICD implantation.

Patient with heart failure: importance to treat valvular diseases.

COVID-19 pandemic is causing an unprecedented burden on healthcare resources and this includes treatment of heart failure and valvular heart diseases (VHD). Percutaneous procedures have broadened the number of patients with VHD who could be treated. However, COVID-19 pandemic has challenged their implementation. The risk of in-hospital infection, resources reallocation, reduced access to hospital caused a substantial delay of VHD treatment with an increased risk of clinical worsening and mortality. Now, the pandemic is not ended and subsequent waves are likely. Reorganization of our healthcare resources is needed, including a proper algorithm for patients' prioritization, based on the severity of their valve disease, their life expectancy, complexity of the intervention, and the resources available. A wider use of telemedicine for patients' selection and follow-up and any measurement that can shorten the duration of the hospital stay must be adopted. Patients' and healthcare staff screening for COVID-19 and all needed procedures to prevent infection will continue to be mandatory. Percutaneous procedures, compared to surgery, are associated with a lower risk of infection and a lower need for in-hospital resources, including a shorter duration of hospital stay. This may favour their adoption when the risk of viral infection is high.

Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study.

AIMS: Recent trials provide conflicting results on the association between glucagon-like peptide 1 receptor agonists (GLP-1RA) and diabetic retinopathy (DR). The aim of the AngioSafe type 2 diabetes (T2D) study was to determine the role of GLP-1RA in angiogenesis using clinical and preclinical models. METHODS: We performed two studies in humans. In study 1, we investigated the effect of GLP-1RA exposure from T2D diagnosis on the severity of DR, as diagnosed with retinal imaging (fundus photography). In study 2, a randomized 4-week trial, we assessed the effect of liraglutide on circulating hematopoietic progenitor cells (HPCs), and angio-miRNAs.We then studied the experimental effect of Exendin-4, on key steps of angiogenesis: in vitro on human endothelial cell proliferation, survival and three-dimensional vascular morphogenesis; and in vivo on ischemia-induced neovascularization of the retina in mice. RESULTS: In the cohort of 3154 T2D patients, 10% displayed severe DR. In multivariate analysis, sex, disease duration, glycated hemoglobin (HbA1c), micro- and macroangiopathy, insulin therapy and hypertension remained strongly associated with severe DR, while no association was found with GLP-1RA exposure (o 1.139 [0.800-1.622], P = .47). We further showed no effect of liraglutide on HPCs, and angio-miRNAs. In vitro, we demonstrated that exendin-4 had no effect on proliferation and survival of human endothelial cells, no effect on total length and number of capillaries. Finally, in vivo, we showed that exendin-4 did not exert any negative effect on retinal neovascularization. CONCLUSIONS: The AngioSafe T2D studies provide experimental and clinical data confirming no effect of GLP-1RA on angiogenesis and no association between GLP-1 exposure and severe DR.

Safeguarding continuing cardiovascular research excellence and quality publications in France: A working document from the French Society of Cardiology.

BACKGROUND: France has a long history of successful cardiovascular research and scientific innovations, but its continued success cannot be taken for granted. AIMS: To identify current obstacles to cardiovascular research in France and to crystallize the analysis into recommendations for maintained and enhanced research excellence in the future. METHODS: The French Society of Cardiology set up seven Working Groups, each comprising four to eight cardiologists, covering a spectrum of research institutes, hospitals, specialties, ages and research experience. The Working Groups met regularly in person or by conference call to analyse experiences, refine situation assessments and formulate recommendations for improvements. Results and suggestions were presented to a Core Team, which worked to synthesize, prioritize and organize the findings into a consolidated situation assessment and generate a set of action-orientated recommendations. RESULTS: Four key areas of action were identified: stronger focus on the generation of high-quality data; facilitation of future cardiovascular research; greater promotion and support for research among young cardiologists; and increased focus and support for communications. Most recommendations targeted structural shortcomings and may be implemented at low additional financial cost. CONCLUSIONS: It is possible to maintain, and even increase, the quality of cardiovascular research in France and to boost the conversion of successful projects into high-impact publications, without major increases in funding. Intense collaboration between specialties and organizations is necessary to achieve sustainable results.

Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial.

BACKGROUND: Appropriate information about the benefits and risks of invasive procedures is crucial, but limited data is available in this field. The aim of this study was to evaluate the incremental value of a short video about coronary angiography compared with standard information, in terms of patient understanding, satisfaction and anxiety. METHODS: This prospective multicenter study included patients admitted for scheduled coronary angiography, who were randomized to receive either standard information or video information by watching a three-dimensional educational video. After information was delivered, patients were asked to complete a dedicated 16-point information questionnaire, as well as satisfaction and anxiety scales. RESULTS: From 21 September to 4 October 2015, 821 consecutive patients were randomized to receive either standard information (n=415) or standard information with an added educational video (n=406). The information score was higher in the video information group than in the standard group (11.8±2.8 vs 9.5±3.1; P<.001). This result was consistent across age and education level subgroups. Self-reported satisfaction was also higher in the video information group (8.4±1.9 vs. 7.7±2.3; P<.001), while anxiety level did not differ between groups. The variables associated with a higher information score were the use of the educational video, younger age, higher level of education, previous follow-up by a cardiologist, prior information about coronary angiography and previous coronary angiography. CONCLUSIONS: In comparison with standard information, viewing a dedicated educational video improved patients' understanding and satisfaction before scheduled coronary angiography. These results are in favor of widespread use of this incremental information tool.

The impact of the development of transcatheter aortic valve implantation on the management of severe aortic stenosis in high-risk patients: treatment strategies and outcome.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has reoriented the treatment of aortic stenosis (AS) for high-risk patients. Little is known about late outcome after TAVI, surgical aortic valve replacement (AVR) or medical treatment in a single centre. We report patients' characteristics, early and 6-year survival rates after the three therapeutic strategies, and the evolution over time. We also analysed predictive factors of mortality after TAVI or surgical AVR. METHODS: Between October 2006 and December 2010, 478 high-risk consecutive patients were referred for severe symptomatic AS. After Heart Team evaluation, 253 underwent a TAVI, 102 a surgical AVR and 123 medical treatment including 33 compassionate percutaneous balloon aortic valvuloplasties (PBAVs). Follow-up was complete in 98% of patients. RESULTS: Medically treated patients had higher risk scores than the other two groups. They presented a significantly worse survival (P < 0.001), with a 1-year rate of only 30%. The 33 patients who underwent compassionate PBAV presented the lowest survival rate, even lower than patients receiving drug therapy alone. In the TAVI group, patients had more comorbidities than those in the surgical group. There was no difference in 30-day survival rates [91 ± 2% for TAVI and 88 ± 3% for surgical AVR, hazard ratio (HR) for TAVI: 1.37; 95% CI: 0.73-2.58, P = 0.32]. Predictive factors of 30-day mortality were mainly postintervention complications illustrated by higher troponin levels and infection. The 6-year survival rates were 32 ± 4 and 40 ± 6% for TAVI and surgical AVR, respectively (HR for TAVI: 0.71; 95% CI: 0.53-0.97, P = 0.03), but the difference was no longer significant after adjustment on the Charlson comorbidity index (HR: 0.94; 95% CI: 0.68-1.29, P = 0.68). Predictive factors of late mortality were patients' comorbidities for both groups and paraprosthetic aortic regurgitation ≥2/4 for the TAVI group. The number of interventions (TAVI or surgery) increases over years, driven by the number of TAVI procedures without any decrease in surgical AVR. CONCLUSIONS: In this single-centre study, medically treated patients with severe AS have a higher risk profile than those undergoing surgery or TAVI. Their survival is particularly poor and not improved by compassionate PBAV. When comparing TAVI and surgical AVR, there was no difference in 30-day and 6-year survival rates after adjusting for comorbidities.

Early and late outcomes after trans-catheter aortic valve implantation in patients with previous chest radiation.

OBJECTIVE: Surgery for aortic stenosis in patients with thoracic radiation therapy is associated with high morbi-mortality. Trans-catheter aortic valve implantation (TAVI) represents an alternative but has never been studied in this population. We aimed to compare outcomes in radiation and matched control patients undergoing TAVI and to identify predictive factors of survival. METHODS: Between 2006 and 2011, 288 consecutive patients underwent TAVI in our institution, of whom 26 had previous chest radiation. They were matched 1:1 for age, sex and TAVI approach with controls. RESULTS: In both groups, median age was 73 years, 50% of patients were male and 15% had a transapical approach. Procedural success was 88% in the radiation group versus 100% in controls (p<0.001) and 30-day survival was 92% in both groups. Five-year survival was 33%±10% in the radiation group and 42%±11% in controls (p=0.26). In radiation patients, the main cause of death was respiratory insufficiency in 40%. We identified four independent predictive factors of death in the radiation group: extracardiac arteriopathy (p=0.002) and the absence of ß-blocker therapy (p=0.005) as preprocedural variables, and infectious complications (p=0.009) and a higher peak creatinine level (p=0.009) as postprocedural variables. In the radiation group, 89% of survivors were in New York Heart Association class I-II at last follow-up. CONCLUSIONS: Patients in the radiation group displayed high mortality rates although not significantly different from the controls. Respiratory failure was the main cause of death, emphasising the need for a careful pulmonary evaluation. Finally, we show a sustained improvement in functional results after TAVI in this population.

Long-term outcome after transcatheter aortic valve implantation.

OBJECTIVE: To assess late outcome after transcatheter aortic valve implantation (TAVI) up to 6 years and to analyse its predictive factors with a particular emphasis on functional status. Very few data exist on the long-term results of TAVI, and these data are crucial for decision making. METHODS: Between October 2006 and December 2009, 123 consecutive patients were discharged alive after TAVI in our institution. Mean age was 82±8 years, and 88% of patients were highly symptomatic in New York Heart Association (NYHA) class III-IV. RESULTS: Follow-up was complete in 122 patients (99%). The overall 6-year survival rate was 31%±5%, the majority of deaths being non-cardiac. Predictive factors of late mortality were the presence of lower limb arteritis (p=0.009), a higher Charlson comorbidity index (p=0.03) and post-TAVI paraprosthetic aortic regurgitation ≥2/4 (p=0.01). Late outcomes according to Valve Academic Research Consortium-2 criteria were analysed, and the 5-year event-free survival rate was 28%±4%. Finally, the rate of good functional results, defined as survival in NYHA class I or II, was 32%±5% at 5-year follow-up. In the survivors, the EQ-5D questionnaire further confirmed the benefit in terms of quality of life. CONCLUSIONS: About one-third of patients discharged alive after TAVI were alive at 6-year follow-up, and the survivors exhibited good functional results assessed by NYHA class and quality-of-life standardised evaluation.