Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.

BACKGROUND: Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. METHODS: This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2-4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. FINDINGS: Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45-72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3-25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5-27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78-1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. INTERPRETATION: Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. FUNDING: Medtronic.

Case report: Diagnosis, management and evolution of a bulky and invasive cardiac mass complicated by complete atrioventricular block.

Introduction: Cardiac lymphoma is a rare but serious disease that is usually located in the right heart. The symptoms (dyspnea, respiratory distress, fatigue, syncope…) are not specific and depend on the mass location. Cardiac magnetic resonance has a crucial role in the diagnostic strategy but biopsy is mandatory to confirm the diagnosis. Case presentation: We report the case of a 63-yeart old man who presented with severe dyspnea and complete atrioventricular block (AVB). A bulky and invasive mass was found in the left atrium extending to the right atrium through the interatrial septum. A cardiac lymphoma was suspected by cardiac magnetic resonance (CMR) imaging and confirmed by transvenous biopsy. The patient was treated with urgent chemotherapy (R-CHOP) and pacemaker implantation. After 4 cycles of R-CHOP the patient was in complete remission with total disappearance of the mass and return of a spontaneous sinus rhythm. Conclusion: lymphoma is a therapeutic emergency as appropriate treatment can lead to complete remission even when the mass is extensive and invasive. Complete AVB is a potentially reversible complication of cardiac lymphoma, and the decision to implant a pacemaker must be carefully weighed.

Safety, feasibility, and prognostic value of stress perfusion CMR in patients with MR-conditional pacemaker.

AIMS: To assess the safety, feasibility, and prognostic value of stress cardiovascular magnetic resonance (CMR) in patients with pacemaker (PM). METHODS AND RESULTS: Between 2008 and 2021, we conducted a bi-centre longitudinal study with all consecutive patients with MR-conditional PM referred for vasodilator stress CMR at 1.5 T in the Institut Cardiovasculaire Paris Sud and Lariboisiere University Hospital. They were followed for the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death or non-fatal myocardial infarction. Cox regression analyses were performed to determine the prognostic value of CMR parameters. The quality of CMR was rated by two observers blinded to clinical details. Of 304 patients who completed the CMR protocol, 273 patients (70% male, mean age 71 ± 9 years) completed the follow-up (median [interquartile range], 7.1 [5.4-7.5] years). Among those, 32 experienced a MACE (11.7%). Stress CMR was well tolerated with no significant change in lead thresholds or pacing parameters. Overall, the image quality was rated good or excellent in 84.9% of segments. Ischaemia and late gadolinium enhancement (LGE) were significantly associated with the occurrence of MACE (hazard ratio, HR: 11.71 [95% CI: 4.60-28.2]; and HR: 5.62 [95% CI: 2.02-16.21], both P < 0.001). After adjustment for traditional risk factors, ischaemia and LGE were independent predictors of MACE (HR: 5.08 [95% CI: 2.58-14.0]; and HR: 2.28 [95% CI: 2.05-3.76]; both P < 0.001). CONCLUSION: Stress CMR is safe, feasible and has a good discriminative prognostic value in consecutive patients with PM.

Evaluation of an Ambulatory ECG Analysis Platform Using Deep Neural Networks in Routine Clinical Practice.

Background Holter analysis requires significant clinical resources to achieve a high-quality diagnosis. This study sought to assess whether an artificial intelligence (AI)-based Holter analysis platform using deep neural networks is noninferior to a conventional one used in clinical routine in detecting a major rhythm abnormality. Methods and Results A total of 1000 Holter (24-hour) recordings were collected from 3 tertiary hospitals. Recordings were independently analyzed by cardiologists for the AI-based platform and by electrophysiologists as part of clinical practice for the conventional platform. For each Holter, diagnostic performance was evaluated and compared through the analysis of the presence or absence of 5 predefined cardiac abnormalities: pauses, ventricular tachycardia, atrial fibrillation/flutter/tachycardia, high-grade atrioventricular block, and high burden of premature ventricular complex (>10%). Analysis duration was monitored. The deep neural network-based platform was noninferior to the conventional one in its ability to detect a major rhythm abnormality. There were no statistically significant differences between AI-based and classical platforms regarding the sensitivity and specificity to detect the predefined abnormalities except for atrial fibrillation and ventricular tachycardia (atrial fibrillation, 0.98 versus 0.91 and 0.98 versus 1.00; pause, 0.95 versus 1.00 and 1.00 versus 1. 00; premature ventricular contractions, 0.96 versus 0.87 and 1.00 versus 1.00; ventricular tachycardia, 0.97 versus 0.68 and 0.99 versus 1.00; atrioventricular block, 0.93 versus 0.57 and 0.99 versus 1.00). The AI-based analysis was >25% faster than the conventional one (4.4 versus 6.0 minutes; P<0.001). Conclusions These preliminary findings suggest that an AI-based strategy for the analysis of Holter recordings is faster and at least as accurate as a conventional analysis by electrophysiologists.

Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated.

INTRODUCTION: The evolution of atrioventricular conduction disorders after transcatheter aortic valve implantation (TAVI) remains poorly understood. We sought to identify factors associated with late (occurring ≥7 days after the procedure) high-grade atrioventricular blocks after TAVI, based on specific pacemaker memory data. METHODS AND RESULTS: STIM-TAVI (NCT03338582) was a prospective, multicentre, observational study that enrolled all patients (from November 2015 to January 2017) implanted with a specific dual chamber pacemaker after TAVI, with the SafeR algorithm activated, allowing continuous monitoring of atrioventricular conduction. The primary endpoint was the occurrence of centrally adjudicated late high-grade atrioventricular blocks during the year after TAVI. Among 197 patients, 138 (70.1%) had ≥1 late high-grade atrioventricular block. Whereas oversizing (p = .005), high-grade atrioventricular block during TAVI (p < .001), and early (within 6 days) high-grade atrioventricular block (p < .001) were associated with occurrence of late high-grade atrioventricular block, self-expanding prothesis (p = .88), prior right bundle branch block (p = .45), low implantation (p = .06), and new or wider left bundle branch block and lengthening of PR interval (p = .24) were not. In multivariable analysis, only post-TAVI early high-grade atrioventricular block remained associated with late high-grade atrioventricular blocks (Days 0-1: odds ratio [OR], 3.25; 95% confidence interval [CI], 1.57-6.74; p = .001; Days 2-6: OR, 4.13; 95% CI, 2.06-8.31; p < .001), whereas other conventionally used predictors were not. CONCLUSION: One-third of pacemaker-implanted patients do not experience late high-grade atrioventricular block. Our findings suggest that post-TAVI early high-grade atrioventricular block is the main factor associated with occurrence of late high-grade atrioventricular blocks.

Preventing the risk of coronary injury in posteroseptal accessory pathway ablation in children: different strategies and advantages of fluoroscopy integrated 3D-mapping system (CARTO-UNIVU™).

PURPOSE: To evaluate various strategies in order to minimize the risk of coronary injury during posteroseptal accessory pathways ablation in children. METHODS: We retrospectively reviewed 68 posteroseptal accessory pathways ablation procedures (20 decremental and 48 typical accessory pathways) performed in 62 pediatric patients at our institution between July 2009 and December 2016. Only posteroseptal accessory pathways targeted near or within the coronary sinus were included and ablation was mostly performed using irrigated tip radiofrequency. RESULTS: Median patient age was 11 years with a median body weight of 39 kg. Thirty patients underwent a coronary angiogram, 21 were coupled to the 3D navigation system CARTO-UNIVU™. The coronary angiogram showed a distance of less than 5 mm between the coronary artery and the ablation site in 40% of our cases; 3 patients had a coronary injury related to RF ablation, 6 patients were switched for cryoablation, 3 patients received limited RF energy (20 W). There were no demographic data predicting the proximity of the coronary artery to the ablation site. CONCLUSION: Ablation of posteroseptal accessory pathways specifically in children carries a risk of coronary artery injury which is probably underestimated. The use of merged 3D images and coronary angiograms, the reduction of RF energy or the switch to cryoablation are possible alternatives to limit the risk of coronary injury.

Automated Detection of Complex Fractionated Atrial Electrograms In Substrate-Based Atrial Fibrillation Ablation: Better Discrimination with a New Setting of CARTO® Algorithm.

Background and purpose: Up until recently complex fractionated atrial electrogram (CFAE) ablation has been considered as time consuming and its achievement as challenging, especially for non experimented operators. Moreover, results of substrate ablation based on CFAE detection in atrial fibrillation (AF) are very disparate, mainly because of the operator's subjective electrogram visual analysis and the difficult distinction between CFAEs really involved in AF perpetuation from other CFAE. Automatic detection provided by 3D mapping system (CARTO® algorithm) can be helpful but is not selective enough, drawing too wide CFAE areas. We sought to demonstrate a better selectivity of a new CFAE algorithm setting in order to better discriminate CFAEs really involved in AF perpetuation from other CFAE. Methods and subjects: A population of 32 patients (60.4±12.7 years) with paroxysmal (n=3) AF (PAF), persistent (n=16) AF (PeAF) or long-standing persistent (n=13) AF (LSPeAF), and AF history =56±65 months, underwent CFAE ablation based on visual analysis. Before ablation, left atrium CFAE mapping was performed on CARTO® shortest complex interval (SCI) algorithm and reanalyzed after ablation with the two different settings: nominal (SCI 60-120ms/0.05-0.15mV) vs. customized setting (SCI 30-40ms/0,04-0.15mV). CFAE areas automatically detected by both settings (CFAE-CARTO® areas) were respectively measured. The decision to ablate CFAE was only based upon the operator's electrogram visual analysis taken as reference because of high AF termination rate (93.7%) due to operator's CFAE selection experience. These ablation points drawn reference-CFAE areas involved in AF perpetuation (ablation point=60mm2) allowing to compare the selectivity of the two previous automatic maps. Results: With the customized CARTO® SCI setting, we observed a significant reduction of CFAE areas detected by CARTO® (CFAE-CARTO® areas) and of the ablated CFAE surface inside non-CFAE CARTO® areas, (30.6±20.5cm2 vs. 68.8±24.5cm2, p<0.0001, and 1.86±1.82% vs. 3±3%, p=0.003). Furthermore the proportion of ablated areas/detected CFAE-CARTO® areas were higher with customized setting (38.2±19.6% vs. 20.4±17.5%, p=0.008). Conclusions: This new customized CFAE algorithm setting is significantly more selective than the nominal one and allows an automated detection of CFAE really involved in AF perpetuation truer to an efficient experienced operator's electrogram visual analysis.

Correlation between AF substrate ablation difficulty and left atrial fibrosis quantified by delayed-enhancement cardiac magnetic resonance.

BACKGROUND: Studies have shown that the presence of left atrial (LA) fibrosis can be assessed by LA delayed-enhancement cardiac magnetic resonance (LA DE-CMR) and may be predictive of outcome after ablation for atrial fibrillation (AF). We sought to test the hypothesis that the amount of LA fibrosis evaluated by DE-CMR correlates with the difficulty of complex fractionated atrial electrograms (CFAE) ablation. METHODS: Twenty-two consecutive patients (86.4% nonparoxysmal AF) underwent substrate CFAE radiofrequency (RF) ablation (±Pulmonary veins isolation) with AF termination as the endpoint. LA DE-CMR was performed prior to ablation. A global index of DE was defined by an average of six LA segmental scores based on a four-grade scale (no enhancement to maximum enhancement). Time between first RF application and AF termination, and RF duration until AF termination, was recorded. CFAE area/total LA surface was also measured on CARTO maps (Biosense Webster, Diamond Bar, CA, USA). These measures served to evaluate ablation difficulty, and were correlated with CMR images by double-blinded analysis. RESULTS: Ablation restored sinus rhythm in 20 of 22 patients (91%), with a time to terminate AF of 140 ± 91 minutes. There was a significant correlation between the global averaged DE-CMR fibrosis grade and the electrophysiological substrate indexes such as "time to terminate AF" (Rho = 0.70, P = 0.0003), "RF duration until AF termination" (Rho = 0.65, P = 0.001), and a trend toward correlation with "CFAE area/LA surface" (Rho = 0.47, P = 0.03). CONCLUSIONS: LA DE-CMR can predict increased difficulty of CFAE ablation in AF. This tool may be beneficial in both selection of patients and ablation strategy.