ABSTRACT Background Left bundle branch area pacing (LBBAP) has emerged as a promising alternative to conventional biventricular pacing (BIVP) for cardiac resynchronization therapy (CRT). While previous data suggest LBBAP may provide superior outcomes, existing evidence needs more data. Methods This retrospective study included all patients who underwent de‐novo CRT at two centers in France (2022–2024). Procedural and clinical outcomes were compared between LBBAP and BIVP groups for de‐novo CRT indications, using inverse probability weighting propensity score. Results A total of 314 patients were included (75 LBBAP, 239 BIVP). Patients receiving LBBAP were older and more likely to have atrial fibrillation. Compared to BIVP, LBBAP was associated with shorter procedure time (96 vs. 128 min; p < 0.001), narrower paced QRS (128 vs. 139 ms; p < 0.001), and lower post‐discharge device‐related complications (1% vs. 11%; HR 0.10, 95% CI 0.01–0.84; p = 0.033). At 1‐year, improvement in left ventricular ejection fraction (LVEF) was similar between groups (median ΔLVEF +15%; p = 0.438), as were hyper‐response rates (52% vs. 60%; p = 0.231). After IPW‐PS, no significant differences were observed in heart failure hospitalization (HR 0.99, 95% CI 0.40–2.64; p = 0.999), new‐onset atrial fibrillation (HR 1.69, 95% CI 0.41–6.94; p = 0.492), sustained ventricular arrhythmias (HR 1.23, 95% CI 0.15–6.49; p = 0.828), overall (HR 1.10, 95% CI 0.44–2.62; p = 0.801), and cardiovascular deaths (HR 0.92, 95% CI 0.27–2.79; p = 0.927). Conclusion LBBAP is associated with comparable resynchronization and clinical outcomes to BIVP, with fewer late complications.
Background/Objectives: Coronary artery disease (CAD) remains the leading global cause of mortality, underscoring the need for functional assessments that extend beyond anatomical evaluation. The Hyperemic Stenosis Resistance (HSR) index combines invasive pressure and flow parameters to assess stenosis severity but faces limitations due to methodological and standardization challenges. This study aimed to introduce and validate a novel non-invasive computational equivalent of HSR (cHSR), derived from coronary computed tomography angiography (CCTA), and to compare its diagnostic performance with fractional flow reserve derived from computational fluid dynamics (FFRCFD) and quantitative flow ratio (QFR). Methods: A retrospective analysis was conducted on 64 patients (106 coronary lesions) with suspected chronic coronary syndrome (CCS) who underwent both CCTA and invasive coronary angiography (ICA). Computational simulations incorporated patient-specific boundary conditions based on CCTA-derived left ventricular and aortic flow data. Diagnostic accuracy for predicting revascularization was compared among cHSR, FFRCFD, and QFR. Results: FFRCFD showed a strong correlation with invasive FFR (r = 0.87, p < 0.0001). The cHSR index achieved the highest diagnostic accuracy (96.2%) at an optimal cut-off of 0.75 mmHg/cm·s−1, outperforming both FFRCFD and QFR. No significant correlation was found between cHSR and shear stress parameters, including the Oscillatory Shear Index (OSI) and Time-Averaged Wall Shear Stress (TAWSS), indicating complex hemodynamic interactions beyond simple flow–pressure relationships. Conclusions: The computational hyperemic stenosis resistance (cHSR) index represents a promising non-invasive tool for the functional assessment of CAD, demonstrating superior diagnostic performance compared with existing imaging-based indices. Prospective multicenter studies with larger populations are warranted to confirm its clinical applicability and prognostic value in chronic coronary syndrome management.
Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe complication of pulmonary embolism (PE), often diagnosed late due to nonspecific symptoms and limitations of current screening tools like V/Q scintigraphy. This study investigated whether computational fluid dynamics (CFD)-derived hemodynamic parameters, specifically time-averaged wall shear stress (TAWSS) and oscillatory shear index (OSI), in the proximal pulmonary arteries could serve as noninvasive biomarkers for CTEPH and chronic thromboembolic disease without pulmonary hypertension (CTEPD, non-CTEPH with V/Q mismatches). We retrospectively analyzed 90 patients (30 CTEPH, 30 CTEPD, and 30 controls without mismatch) using patient-specific 3D CFD models reconstructed from CTPA, with RCR boundary conditions tuned to RHC data. We found significantly reduced median TAWSS in CTEPH (16.5 dyn/cm2) and CTEPD (27.5 dyn/cm2) groups compared to controls (42.0 dyn/cm2) (p < 0.001), with TAWSS also significantly lower in CTEPH versus CTEPD. OSI showed no significant inter-group differences. Importantly, TAWSS exhibited a strong inverse correlation with V/Q mismatch status (ρ = -0.673, p < 0.001). ROC analysis revealed that TAWSS accurately predicted perfusion mismatches (AUC = 0.918), with an optimal cutoff of 27.0 dyn/cm2 yielding 100.0% specificity and 70.0% sensitivity. These findings demonstrate that CFD-derived proximal pulmonary artery TAWSS is a promising noninvasive indicator of chronic thromboembolic burden, including subclinical perfusion abnormalities, offering a potential tool to enhance early detection and management of CTEPH.
AIMS:In the Tri.FR trial, tricuspid transcatheter edge-to-edge repair (T-TEER) reduced severity of tricuspid regurgitation (TR) and improved the composite clinical score, driven by patient-reported outcomes. The purpose of this study was to describe the longitudinal impact of T-TEER on different dimensions and items of quality of life compared with guideline-directed medical treatment (OMT) alone. METHODS AND RESULTS:Patients were randomized to T-TEER +OMT (n = 152) or OMT alone (n = 148). Health status was assessed at baseline, 6 weeks, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Minnesota Living with Heart Failure (MLHF) Questionnaire. Mixed effects linear regression analysed changes over time. Patients receiving T-TEER + OMT experienced a significant increase in KCCQ overall summary score (KCCQ-OS) at all time points: +17.0 points (95% confidence interval [CI] 13.1-21.5) at 6 weeks, +15.9 points (95% CI 11.2-20.6) at 6 months, and +18.7 points (95% CI 13.8-23.6) at 1 year. The mean between-group difference in KCCQ-OS was +10.3 points (95% CI 5.6-15.0) in favour of T-TEER + OMT, evident at 6 weeks and sustained for 1 year. Similarly, MLHF total scores improved significantly in the T-TEER group (mean between-group difference -8.61 points, 95% CI -12.6 to -4.6), including physical (-3.9, 95% CI -5.9 to -1.9) and emotional (-2.2, 95% CI -3.4 to -1.0) subscales. CONCLUSIONS:Compared with OMT alone, T-TEER resulted in substantial, multidimensional, and sustained improvements in patient-reported quality of life. These findings reinforce the value of T-TEER in managing severe symptomatic TR.
Aortic stenosis (AS) frequently coexists with coronary artery disease (CAD), complicating revascularization decisions. The use of coronary physiology indices, such as the fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and coronary flow reserve (CFR), in AS patients remains debated, particularly after transcatheter aortic valve implantation (TAVI). In this study, we employ computational fluid dynamics (CFD) to evaluate coronary hemodynamics and assess changes in the wall shear stress (WSS) before and after TAVI. Our analysis demonstrates strong agreement between CFD-derived and invasive FFR measurements, confirming CFD’s reliability as a non-invasive tool for coronary physiology assessment. Furthermore, our results show no significant changes in FFR (p=0.92), iFR (p=0.67), or CFR (p=0.34) post-TAVI, suggesting that these indices remain stable following aortic valve intervention. However, a significant reduction in high WSS exposure (59% to 40.8%, p<0.001) and the oscillatory shear index (OSI: 0.32 to 0.21, p<0.001) was observed, indicating improved hemodynamic stability. These findings suggest that coronary physiology indices remain reliable for revascularization guidance post-TAVI and highlight a potential beneficial effect of aortic stenosis treatment on plaque shear stress dynamics. Our study underscores the clinical utility of CFD modeling in CAD management, paving the way for further research into its prognostic implications.
Abstract Aims to explore the value of dobutamine stress-echocardiography (DSE) to identify severe aortic stenosis (AS) in patients with discordant low-gradient AS and preserved left ventricular ejection fraction (LVEF>50%). Methods Among 52 patients (age 79±7 years; males 46%, mean aortic gradient: 31±5 mmHg) with low gradient AS stenosis and preserved LVEF prospectively enrolled in the ROTAS trial, 42 underwent both DSE and CT aortic calcium score. An aortic calcium score > 1200 AU in women and > 2000 AU in men was used as a referral limit to identify severe AS. The Youden method was used to identify the best cut-off rest and stress echocardiography aortic parameters able to predict AS severity. Results In the overall population, DSE-parameters such as aortic valve area (AVA), indexed AVA (AVAi), aortic maximal velocity (AVMax), mean aortic gradient (MAG) and projected AVA (AVAproj) were modest predictors of AS severity Limiting the analysis to patients with stroke volume index < 35 ml/m², a DSE AVMax> 4.5 m/sec was a fair predictor of AS severity (AUC 0.73, Se 60%, Sp 95%, PPV 86%, NPV 81%, accuracy 82%) (Table1). Conclusions in patients with discordant low-gradient AS and preserved LVEF, echo-derived parameters have a modest predictive value for the detection of severe AS. A slightly better performance is observed when limiting the analysis to patients with low-flow.
Importance Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes. Objective To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation. Design, Setting, and Participants Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER + OMT vs OMT alone in adult patients with severe, symptomatic tricuspid regurgitation. The trial was conducted at 24 centers in France and Belgium (March 2021 to March 2023; latest follow-up in April 2024). Intervention Patients were randomized to T-TEER + OMT or OMT alone. Main Outcomes and MeasuresThe primary outcome was a composite clinical end point at 1 year comprising change in New York Heart Association class, change in patient global assessment, or occurrence of major cardiovascular events. Tricuspid regurgitation severity was the first of 6 secondary outcomes analyzed in a hierarchical closed-testing procedure, including Kansas City Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a composite outcome of all-cause death, tricuspid valve surgery, KCCQ score improvement, or time to hospitalization for heart failure. Results Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone. At 1 year, 109 patients (74.1%) in the T-TEER + OMT group had an improved composite score compared with 58 patients (40.6%) in the OMT-alone group. Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER + OMT group and in 53.5% of those in the OMT-alone group (P < .001). Mean overall KCCQ summary score at 1 year was 69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the OMT-alone group (P < .001). The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) (P < .001). Conclusions and Relevance T-TEER reduces tricuspid regurgitation severity and improves a composite score driven by improved patient-reported outcome measures in patients with severe, symptomatic tricuspid regurgitation. Trial Registration ClinicalTrials.gov Identifier: NCT04646811
AIMS:Fifteen to thirty percentage of patients with severe aortic stenosis (AS) have preserved left ventricular ejection fraction (LVEF) and a discordant AS pattern at Doppler echocardiography, which is characterized by a small (<1 cm2) aortic area and low mean aortic gradient (<40 mmHg). The 'Randomized study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic Stenosis and preserved left ventricular ejection fraction' (ROTAS trial) aims at demonstrating the superiority of aortic valve replacement vs. a 'watchful waiting strategy' in symptomatic patients with low-gradient (LS), severe AS, and preserved LVEF, stratified according to indexed stroke volume, in terms of all-cause mortality or cardiovascular-related hospitalization during follow-up (FU). METHODS AND RESULTS:The ROTAS trial will be a multicentre randomized non-blinded study involving 16 reference centres. AS severity will be confirmed by a multimodality approach (rest and stress echocardiography, calcium scoring, and cardiac magnetic resonance imaging for optimally characterize the population), which could provide important inputs to improve the pathophysiological understanding of this complex disease. Well-characterized patients will be randomized according to the management strategy. The primary endpoint will be the occurrence of all-cause mortality or cardiac related-hospitalizations during 2-year FU. One hundred and eighty subjects per group will be included. CONCLUSION:The management of patients with LS severe AS and preserved LVEF is largely debated. ROTAS trial will allow a comprehensive evaluation of this particular pattern of AS and will establish which is the most appropriate management of these patients.
Trial RegistrationClinicalTrials.gov Identifier: NCT05564507
BACKGROUND:Primary mitral regurgitation (MR) is a heterogeneous clinical disease requiring integration of echocardiographic parameters using guideline-driven recommendations to identify severe disease. OBJECTIVES:The purpose of this preliminary study was to explore novel data-driven approaches to delineate phenotypes of MR severity that benefit from surgery. METHODS:The authors used unsupervised and supervised machine learning and explainable artificial intelligence (AI) to integrate 24 echocardiographic parameters in 400 primary MR subjects from France (n = 243; development cohort) and Canada (n = 157; validation cohort) followed up during a median time of 3.2 years (IQR: 1.3-5.3 years) and 6.8 (IQR: 4.0-8.5 years), respectively. The authors compared the phenogroups' incremental prognostic value over conventional MR profiles and for the primary endpoint of all-cause mortality incorporating time-to-mitral valve repair/replacement surgery as a covariate for survival analysis (time-dependent exposure). RESULTS:High-severity (HS) phenogroups from the French cohort (HS: n = 117; low-severity [LS]: n = 126) and the Canadian cohort (HS: n = 87; LS: n = 70) showed improved event-free survival in surgical HS subjects over nonsurgical subjects (P = 0.047 and P = 0.020, respectively). A similar benefit of surgery was not seen in the LS phenogroup in both cohorts (P = 0.70 and P = 0.50, respectively). Phenogrouping showed incremental prognostic value in conventionally severe or moderate-severe MR subjects (Harrell C statistic improvement; P = 0.480; and categorical net reclassification improvement; P = 0.002). Explainable AI specified how each echocardiographic parameter contributed to phenogroup distribution. CONCLUSIONS:Novel data-driven phenogrouping and explainable AI aided in improved integration of echocardiographic data to identify patients with primary MR and improved event-free survival after mitral valve repair/replacement surgery.
Dilated cardiomyopathy (DCM) is a hereditary heart disease characterized by abnormal dilation of cardiac chambers, impaired cardiac function, and heart failure. Genetic testing has identified numerous genetic mutations associated with DCM, but its impact on patient care is still uncertain. Our aim is to describe the characteristics, management, and follow-up of patients with DCM who underwent genetic testing and to compare outcomes based on the presence of mutations. This is a local registry analysis of 53 patients with DCM who underwent genetic testing between March 2013 and October 2021. Genetic testing was performed in the same reference laboratory, and a panel of 80 major genes was analyzed. Clinical and paraclinical characteristics, management, and follow-up were collected. The study included a total of 53 patients, with a sex ratio of 1:1. The median age at diagnosis was 49 years, and the median follow-up duration was 40.5 months. The results showed that 43% of genetic tests were positive, with 11 identified genes, with TTN, LMNA, and MYH7 being the most frequently mutated genes. There was no significant difference between the mutated and non-mutated DCM groups in terms of clinical or paraclinical features. However, for a comparable LVEF, mutation carriers had more events during their follow-up than non-carriers (57 vs. 16%, P < 0.01). The genes LMNA, MYH7, DSP, and ABCC9 were the most associated with events. In addition, there was a significant correlation between mutation carriers and the occurrence of rhythm events (Spearman coefficient of 0.495) but no significant correlation between the presence of mutations and LVEF (Spearman coefficient of 0.125). In this study, it was not possible to distinguish patients with DCM with mutations from those without identified mutations. This finding reinforces the hypothesis of a multifactorial and non-Mendelian pathology. The risk stratification of sudden death is a complex task in DCM. Mutation carriers would have more events, particularly rhythm events. Future technological advances could also improve the identification of genetic risk factors and facilitate the implementation of personalized therapies for patients with DCM.
Aortic stenosis (AS) is a prevalent disease with significant implications for patients' prognosis, particularly when accompanied by coronary artery disease. However, the optimal revascularization strategy remains uncertain, especially with the emergence of transcatheter valve implantation (TAVI). In this study, we aimed to investigate the hemodynamics of proximal coronary lesions in the context of AS and their response to aortic valve replacement (AVR) using computational fluid dynamics (CFD) based on patient-specific data. Patient-specific CT scans and invasive coronary angiograms were utilized to create 3D models of the coronary arteries and aortic valve, enabling CFD simulations to provide pressure, flow, and shear stress data. The results demonstrated excellent agreement between CFD-estimated fractional flow reserve (FFR) and invasive measurements, affirming the accuracy of CFD methods.No noticeable variation of iFR (0.901 vs. 0.901, p = 0.89), CFR (1.97 vs. 1.98,p=0.49) nor FFR (0.805 vs. 0.804, p=0.81) values post-procedure were found. Additionally, AVR led to a reduction in the areas of coronary arteries exposed to high shear stress. These findings suggest that a post TAVI revascularization approach to non-critical proximal lesions (<70\%) may be deemed safe. This study underscores the potential benefits of CFD in preoperative planning for patients with AS and concomitant coronary artery disease, offering valuable insights into coronary physiology and the hemodynamic impact of TAVI.
Objective: To investigate the glycemic balance before, during and after the 2016 Paris Marathon using a real-time continuous glucose monitoring (RT-CGM) system in patients with type 1 diabetes mellitus in a prospective single-center observational study. Methods: Inclusion criteria were as follows: type 1 diabetes mellitus; age >= 18 years; HbA1c < 9%. Participants performed two 2h-preparatory races (PR) before the Marathon and were monitored with RT-CGM 24h before, during and 72h after each race. Hypoglycemic events were prevented via carbohydrate intake / insulin dose adjustments. The primary outcome was area under the curve (AUC) < 70 and > 200 mg/dl and percentage of time spent in euglycemia, hypoglycemia, and hyperglycemia during the races. Results: Twelve patients (2F/10M; median HbA1c=6.8%) were included and completed the study. Median AUC < 70 and time spent in hypoglycemia (< 70 mg/dl) during the PRs and Marathon were equal to 0. However, no hypoglycemic episodes occurred during Marathon, while two patients experienced hypoglycemia during PR1 and PR2. There was a significant increase in AUC > 200 mg/dl during races between PR2 and Marathon (P = 0.009) although the median time spent > 200mg/dl was not statistically different in Marathon versus PR2 (48.4% versus 18.4%; P = 0.09). Median time spent in euglycemia (70-200 mg/dl) was lower in Marathon versus PR2 (51.6 versus 58%; P= 0.03). Conclusion: Our study proposes a medical support protocol for extreme endurance physical activity in patients with type 1 diabetes mellitus. Our results suggest that RT-CGM, coupled with adjustments in carbohydrate intake and insulin doses, appears to be effective to prevent hypoglycemia during and after exercise. (C) 2022 Elsevier Masson SAS. All rights reserved.
Abstract Background Evidence on the impact of simulation-based training in transesophageal echocardiography (TEE) is scarce. Purpose We aimed to assess the efficacy of simulation-based versus traditional teaching on TEE knowledge and skills for cardiology residents. Methods Between November 2020 and November 2021, all consecutive cardiology residents inexperienced from TEE were randomised (1:1, n=324) through 42 French University Centers into two groups with or without simulation support (either a simulation group or a traditional group). The coprimary outcomes were the scores in the final theoretical and practical tests 3 months after the training. TEE duration and the feelings of residents were also assessed. An economic analysis was also performed. Results While the theoretical and practical test scores were similar between the two groups before the training (respectively P=0.80 and P=0.51), the residents in the simulation group displayed higher theoretical test and practical test scores after the training than those in the traditional group (respectively 47.2±15.6% vs. 38.3±19.8%, P<0.0001 and 74.5±17.7% vs. 59.0±25.1%, P<0.0001). Subgroups analyses showed that the efficacy of the simulation training was even greater when performed at the beginning of residency (P<0.0001). After the training, the duration to perform a complete TEE was significantly lower in the simulation group than in the traditional group (respectively 8.3±1.4 min vs. 9.4±1.2 min, P<0.0001). Finally, residents' feelings were better in the simulation group than in the traditional group across all components (P<0.0001). Compared to the traditional group, the average additional cost per resident of the simulation program was respectively €1,785, €942 or €662 for 20, 40 and 60 residents. Conclusion Simulation-based teaching on TEE showed a significant improvement in knowledge, skills, and feelings of cardiology residents as well as a reduction in the duration to complete the examination. Funding Acknowledgement Type of funding sources: None.
Complications related to syncope vary according to its etiology, which remains undetermined in approximately 20% of cases. The use of a risk stratification and patient referral protocol, such as the one proposed in the ESC 2018 recommendations, could be a solution to improve the management of syncope. To evaluate the use of syncope risk stratification protocols in an emergency department. The secondary objective is to evaluate the applicability of the ESC recommendations and their ability to stratify the risk of complications after an episode of syncope. Observational, retrospective, monocentric study conducted in the emergency department of the university hospital of Brest during February 2018 for the reasons “discomfort with or without loss of consciousness”, “chest pain”, “tachycardia”, “bradycardia”, and “suspected pulmonary embolism”. Patients who presented with a real episode of syncope or presyncope were classified into three risk groups (low, intermediate and high) according to the ESC recommendations. In total, 436 patients met the initial search criteria, of which 100 were included. No records mentioned the use of a risk stratification protocol. ESC recommendations were applicable to 87% of the records. Thirty-one percent of patients were classified as low risk, and of these, 3 patients (10%) were rehospitalized or had a complication at 1 year. Twenty-three percent of the patients were classified as intermediate risk, among them 8 patients (35%) were rehospitalized or had a complication at 1 year. Forty-six percent of the patients were at high-risk, among them 23 (50%) were rehospitalized or had a complication at 1 year (Fig. 1). The use of risk stratification protocols for syncope management is not a common practice in the emergency department. According to our study, the ESC recommendations are easily applicable and seem to effectively classify patients into three risk groups. A larger study therefore seems warranted to confirm these findings.
BACKGROUND:Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening complication of a pulmonary embolism (PE) whose incidence and predictors are not precisely determined. OBJECTIVE:To determine the frequency and predictors for CTEPH after a first unprovoked PE. PATIENTS/METHODS:In a randomized trial comparing an additional 18-month warfarin versus placebo in patients after a first unprovoked PE initially treated with vitamin K antagonist for 6 months, we applied recommended CTEPH screening strategies through an 8-year follow-up to determine cumulative incidence of CTEPH. CTEPH predictors were estimated using Cox models. Pulmonary vascular obstruction (PVO) and systolic pulmonary arterial pressure (sPAP) at PE diagnosis and 6 months were studied by receiver operating curves analysis. All CTEPH cases and whether they were incident or prevalent were adjudicated. RESULTS:During a median follow-up of 8.7 years, nine CTEPH cases were diagnosed among 371 patients, with a cumulative incidence of 2.8% (95% confidence interval [CI] 0.95-4.64), and of 1.31% (95% CI 0.01-2.60) after exclusion of five cases adjudicated as prevalent. At PE diagnosis, PVO > 45% and sPAP > 56 mmHg were associated with CTEPH with a hazard ratio (HR) of 33.00 (95% CI 1.64-667.00, p = .02) and 12.50 (95% CI 2.10-74.80, p < .01), respectively. Age > 65 years, lupus anticoagulant antibodies and non-O blood groups were also predictive of CTEPH. PVO > 14% and sPAP > 34 mmHg at 6 months were associated with CTEPH (HR 63.90 [95% CI 3.11-1310.00, p < .01]and HR 17.2 [95% CI 2.75-108, p < .01]). CONCLUSION:After a first unprovoked PE, CTEPH cumulative incidence was 2.8% during an 8-year follow-up. PVO and sPAP at PE diagnosis and at 6 months were the main predictors for CTEPH diagnosis.