PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study.

BACKGROUND: Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific). OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial. METHODS: Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days. RESULTS: A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03). CONCLUSIONS: In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).

Severe Periprocedural Complications After Ablation for Atrial Fibrillation: An International Collaborative Individual Patient Data Registry.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) including pulmonary vein isolation and possibly further substrate ablation is the most common electrophysiological procedure. Severe complications are uncommon, but their detailed assessment in a large worldwide cohort is lacking. OBJECTIVES: The aim of this study was to determine the incidence of periprocedural severe complications and to provide a detailed characterization of the diagnostic evaluation and management of these complications in patients undergoing AF ablation. METHODS: Individual patient data were collected from 23 centers worldwide. Limited data were collected for all patients who underwent catheter ablation, and an expanded series of data points were collected for patients who experienced severe complications during periprocedural follow-up. Incidence, predictors, patient characteristics, management details, and overall outcomes of patients who experienced ablation-related complications were investigated. RESULTS: Data were collected from 23 participating centers at which 33,879 procedures were performed (median age 63 years, 30% women, 71% radiofrequency ablations). The incidence of severe complications (n = 271) was low (tamponade 6.8‰, stroke 0.97‰, cardiac arrest 0.41‰, esophageal fistula 0.21‰, and death 0.21‰). Age, female sex, a dilated left atrium, procedure duration, and the use of radiofrequency energy were independently associated with the composite endpoint of all severe complications. Among patients experiencing tamponade, 13% required cardiac surgery. Ninety-three percent of patients with complications were discharged directly home after a median length of stay of 5 days (Q1-Q3: 3-7 days). CONCLUSIONS: This large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest, esophageal fistula, and death are rare after AF ablation. Older age, female sex, procedure duration, a dilated left atrium, and the use of radiofrequency energy were associated with severe complications in this multinational cohort. One in 8 patients with tamponade required cardiac surgery.

Repeat catheter ablation after very late recurrence of atrial fibrillation after pulmonary vein isolation.

AIMS: Atrial fibrillation (AF) recurs in about one-third of patients after catheter ablation (CA), mostly in the first year. Little is known about the electrophysiological findings and the effect of re-ablation in very late AF recurrences (VLR) after more than 1 year. The aim of this study was to determine the characteristics and outcomes of the first repeat CA after VLR of AF after index CA. METHODS AND RESULTS: We analysed patients from a prospective Swiss registry that underwent a first repeat ablation procedure. Patients were stratified depending on the time to recurrence after index procedure: early recurrence (ER) for recurrences within the first year and late recurrence (LR) if the recurrence was later. The primary endpoint was freedom from AF in the first year after repeat ablation. Out of 1864 patients included in the registry, 426 patients undergoing a repeat ablation were included in the analysis (28% female, age 63 ± 9.8 years, 46% persistent AF). Two hundred and ninety-one patients (68%) were stratified in the ER group and 135 patients (32%) in the LR group. Pulmonary vein reconnections were a common finding in both groups, with 93% in the ER group compared to 86% in the LR group (P = 0.052). In the LR group, 40 of 135 patients (30%) had a recurrence of AF compared to 90 of 291 patients (31%) in the ER group (log-rank P = 0.72). CONCLUSION: There was no association between the time to recurrence of AF after initial CA and the characteristics and outcomes of the repeat procedure.

Biomarkers to predict improvement of left ventricular ejection fraction after atrial fibrillation ablation.

BACKGROUND: Atrial fibrillation (AF) and heart failure frequently coexist. Prediction of left ventricular ejection fraction (LVEF) recovery after catheter ablation (CA) for AF remains difficult. OBJECTIVE: The purpose of this study was to evaluate the value of biomarkers, alone and in combination with the Antwerp score, to predict LVEF recovery after CA for AF. METHODS: Patients undergoing CA for AF with depressed LVEF (<50%) were included. Plasma levels of 13 biomarkers were measured immediately before CA. Patients were categorized into "responders" and "nonresponders" in a similar fashion to the Antwerp score performance derivation and validation cohorts. The predictive power of the biomarkers alone and combined in outcome prediction was evaluated. RESULTS: A total of 208 patients with depressed LVEF were included (median age 63 years; 39-19% female; median indexed left atrial volume 42 (33-52) mL/m2; median LVEF 43 (38-46)%). At a median follow-up time of 30 (20-34) months, 161 (77%) were responders and 47 (23%) were nonresponders. Of 13 biomarkers, -4-angiopoietin 2 (ANG2), growth differentiation factor 15 (GDF15), fibroblast growth factor 23, and myosin binding protein C3-were significantly different between responders and nonresponders (P ≤ .001) and their combination could predict the end point with an area under the curve of 0.72 (95% confidence interval [CI] 0.64-0.81) overall, 0.69 (95% CI 0.59-0.78) in heart failure with mildly reduced ejection fraction, and 0.88 (95% CI 0.77-0.98) in heart failure with reduced ejection fraction. Only ANG2 and GDF15 remained significantly associated with LVEF recovery after adjustment for age, sex, and Antwerp score and significantly improved the accuracy of the Antwerp score predictions (P < .001). The area under the curve of the Antwerp score in the outcome prediction improved from 0.75 (95% CI 0.67-0.83) to 0.78 (95% CI 0.70-0.86). CONCLUSION: A biomarker panel (ANG2 and GDF15) significantly improved the accuracy of the Antwerp score.

Impact of implantation depth and calcium burden on infranodal conduction delay after transcatheter aortic valve replacement.

Background: Infranodal conduction disorders are common after transcatheter aortic valve replacement (TAVR). Risk factors are incompletely understood. Objective: The purpose of this study was to assess the impact of valve implantation depth and calcium burden of the device landing zone on infranodal conduction intraprocedure pre- and post-TAVR. Methods: In all patients undergoing TAVR between June 2020 and June 2021, the His-ventricle (HV) interval was measured pre- and post-valve deployment. The difference between the 2 measurements defined delta HV, whereas infranodal conduction delay was defined as HV interval >55 ms. Valve implantation depth was measured as the distance between the aortic annular plane and the ventricular prosthesis end. Calcium burden was quantified as the volume of calcium in 6 regions of interest: the non-, right, and left coronary cusps (NCC, RCC, and LCC, respectively) and the corresponding regions of the left ventricular outflow tract (LVOT) underlying each cusp (LVOTNCC, LVOTRCC, LVOTLCC, respectively). Results: Of 101 patients (mean age 81 ± 5.7 years; 47% women), 37 demonstrated infranodal conduction delay intraprocedure post-TAVR. Overall, mean implantation depth was 5 ± 3.1 mm, median calcium volume was 2080 mm3 [interquartile range 632-2400]. Delta HV showed no correlation with implantation depth or calcium burden (r = -0.08 and r = 0.12, respectively). However, LVOTNCC calcification was a significant predictor for infranodal conduction delay post-valve deployment in a multivariable logistic regression model (odds ratio 1.62 per 100-mm3 increase (95% confidence interval 1.06-2.69; P = .04). Conclusion: Assessment of LVOTNCC calcification may identify patients at risk for infranodal conduction delay after TAVR, whereas implantation depth did not predict infranodal conduction delay.

Reducing the burden of inconclusive smart device single-lead ECG tracings via a novel artificial intelligence algorithm.

Background: Multiple smart devices capable of automatically detecting atrial fibrillation (AF) based on single-lead electrocardiograms (SL-ECG) are presently available. The rate of inconclusive tracings by manufacturers' algorithms is currently too high to be clinically useful. Method: This is a prospective, observational study enrolling patients presenting to a cardiology service at a tertiary referral center. We assessed the clinical value of applying a smart device artificial intelligence (AI)-based algorithm for detecting AF from 4 commercially available smart devices (AliveCor KardiaMobile, Apple Watch 6, Fitbit Sense, and Samsung Galaxy Watch3). Patients underwent a nearly simultaneous 12-lead ECG and 4 smart device SL-ECGs. The novel AI algorithm (PulseAI, Belfast, United Kingdom) was compared with each manufacturer's algorithm. Results: We enrolled 206 patients (31% female, median age 64 years). AF was present in 60 patients (29%). Sensitivity and specificity for the detection of AF by the novel AI algorithm vs manufacturer algorithm were 88% vs 81% (P = .34) and 97% vs 77% (P < .001) for the AliveCor KardiaMobile, 86% vs 81% (P = .45) and 95% vs 83% (P < .001) for the Apple Watch 6, 91% vs 67% (P < .01) and 94% vs 82% (P < .001) for the Fitbit Sense, and 86% vs 82% (P = .63) and 94% vs 80% (P < .001) for the Samsung Galaxy Watch3, respectively. In addition, the proportion of SL-ECGs with an inconclusive diagnosis (1.2%) was significantly lower for all smart devices using the AI-based algorithm compared to manufacturer's algorithms (14%-17%), P < .001. Conclusion: A novel AI algorithm reduced the rate of inconclusive SL-ECG diagnosis massively while maintaining sensitivity and improving the specificity compared to the manufacturers' algorithms.

Left atrial posterior wall isolation using pulsed-field ablation: procedural characteristics, safety, and mid-term outcomes.

BACKGROUND: Non-pulmonary vein (PV) ablation targets such as posterior wall isolation (PWI) have been tested in patients with persistent atrial fibrillation (AF). Pulsed-field ablation (PFA) offers a novel ablation technology possibly able to overcome the obstacles of incomplete PWI and concerns of damage to adjacent structures compared to thermal energy sources. Our aim was to assess procedural characteristics, safety, and mid-term outcomes of patients undergoing PWI using PFA in a clinical setting. METHODS: Patients undergoing PFA-PVI with PWI were included. First-pass isolation was controlled using a multipolar mapping catheter. RESULTS: One hundred consecutive patients were included (median age 69 [IQR 63-75] years, 33 females (33%), left atrial size 43 [IQR 39-47] mm, paroxysmal AF 24%). Median procedure time was 66 (IQR 59-77) min, and fluoroscopy time was 11 (8-14) min. PWI using PFA was achieved in 100% of patients with a median of 19 applications (IQR 14-26). There were no major complications. Overall, in 15 patients (15%), recurrent AF/AT was noted during a median follow-up of 144 (94-279) days. CONCLUSIONS: PWI using PFA appears safe and results in high acute isolation rates and high arrhythmia survival during mid-term follow-up. Further randomized trials are essential and warranted.

Efficacy and safety of pulmonary vein isolation with pulsed field ablation vs. novel cryoballoon ablation system for atrial fibrillation.

AIMS: Pulsed-field ablation (PFA) has emerged as a novel treatment technology for patients with atrial fibrillation (AF). Cryoballoon (CB) is the most frequently used single shot technology. A direct comparison to a novel CB system is lacking. We aimed to compare pulmonary vein isolation (PVI) using PFA vs. a novel CB system regarding efficiency, safety, myocardial injury, and outcomes. METHODS AND RESULTS: One hundred and eighty-one consecutive patients underwent PVI and were included (age 64 ± 9.7 years, ejection fraction 0.58 ± 0.09, left atrial size 40 ± 6.4 mm, paroxysmal AF 64%). 106 patients (59%) underwent PFA (FARAPULSE, Boston Scientific) and 75 patients (41%) underwent CB ablation (PolarX, Boston Scientific). The median procedure time, left atrial dwell time and fluoroscopic time were similar between the PFA and the CB group with 55 [interquartile range (IQR) 43-64] min vs. 58 (IQR 48-69) min (P < 0.087), 38 (30-49) min vs. 37 (31-48) min, (P = 0.871), and 11 (IQR 9.3-14) min vs. 11 (IQR 8.7-16) min, (P < 0.81), respectively. Three procedural complications were observed in the PFA group (two tamponades, one temporary ST elevation) and three complications in the CB group (3× reversible phrenic nerve palsies). During the median follow-up of 404 days (IQR 208-560), AF recurrence was similar in the PFA group and the CB group with 24 vs. 30%, P = 0.406. CONCLUSION: Procedural characteristics were very similar between PFA and CB in regard to procedure duration fluoroscopy time and complications. Atrial fibrillation free survival did not differ between the PFA and CB groups.

Durability of pulmonary vein isolation for atrial fibrillation: a meta-analysis and systematic review.

AIMS: Pulmonary vein isolation (PVI) plays a central role in the interventional treatment of atrial fibrillation (AF). Uncertainties remain about the durability of ablation lesions from different energy sources. We aimed to systematically review the durability of ablation lesions associated with various PVI-techniques using different energy sources for the treatment of AF. METHODS AND RESULTS: Structured systematic database search for articles published between January 2010 and January 2023 reporting PVI-lesion durability as evaluated in the overall cohort through repeat invasive remapping during follow-up. Studies evaluating only a proportion of the initial cohort in redo procedures were excluded. A total of 19 studies investigating 1050 patients (mean age 60 years, 31% women, time to remap 2-7 months) were included. In a pooled analysis, 99.7% of the PVs and 99.4% of patients were successfully ablated at baseline and 75.5% of the PVs remained isolated and 51% of the patients had all PVs persistently isolated at follow-up across all energy sources. In a pooled analysis of the percentages of PVs durably isolated during follow-up, the estimates of RFA were the lowest of all energy sources at 71% (95% CI 69-73, 11 studies), but comparable with cryoballoon (79%, 95%CI 74-83, 3 studies). Higher durability percentages were reported in PVs ablated with laser-balloon (84%, 95%CI 78-89, one study) and PFA (87%, 95%CI 84-90, 2 studies). CONCLUSION: We observed no significant difference in the durability of the ablation lesions of the four evaluated energies after adjusting for procedural and baseline populational characteristics.

Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial.

INTRODUCTION: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system. METHODS: COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a composite of cardiac tamponade, persistent phrenic nerve palsy >24 h, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula or death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) procedure and fluoroscopy times, (2) AF burden, (3) proportion of patients with recurrence in the blanking period, (4) proportion of patients undergoing repeat ablation, and (5) quality of life changes at 12 months compared to baseline. CONCLUSION: COMPARE CRYO will compare the efficacy and safety of the novel PolarX cryoballoon and the standard-of-practice Arctic Front cryoballoon for first PVI performed in patients with symptomatic paroxysmal AF. TRIAL REGISTRATION: (ClinicalTrials.gov ID: NCT04704986).

Accuracy in detecting atrial fibrillation in single-lead ECGs: an online survey comparing the influence of clinical expertise and smart devices.

BACKGROUND: Manual interpretation of single-lead ECGs (SL-ECGs) is often required to confirm a diagnosis of atrial fibrillation. However accuracy in detecting atrial fibrillation via SL-ECGs may vary according to clinical expertise and choice of smart device. AIMS: To compare the accuracy of cardiologists, internal medicine residents and medical students in detecting atrial fibrillation via SL-ECGs from five different smart devices (Apple Watch, Fitbit Sense, KardiaMobile, Samsung Galaxy Watch, Withings ScanWatch). Participants were also asked to assess the quality and readability of SL-ECGs. METHODS: In this prospective study (BaselWearableStudy, NCT04809922), electronic invitations to participate in an online survey were sent to physicians at major Swiss hospitals and to medical students at Swiss universities. Participants were asked to classify up to 50 SL-ECGs (from ten patients and five devices) into three categories: sinus rhythm, atrial fibrillation or inconclusive. This classification was compared to the diagnosis via a near-simultaneous 12-lead ECG recording interpreted by two independent cardiologists. In addition, participants were asked their preference of each manufacturer's SL-ECG. RESULTS: Overall, 450 participants interpreted 10,865 SL-ECGs. Sensitivity and specificity for the detection of atrial fibrillation via SL-ECG were 72% and 92% for cardiologists, 68% and 86% for internal medicine residents, 54% and 65% for medical students in year 4-6 and 44% and 58% for medical students in year 1-3; p <0.001. Participants who stated prior experience in interpreting SL-ECGs demonstrated a sensitivity and specificity of 63% and 81% compared to a sensitivity and specificity of 54% and 67% for participants with no prior experience in interpreting SL-ECGs (p <0.001). Of all participants, 107 interpreted all 50 SL-ECGs. Diagnostic accuracy for the first five interpreted SL-ECGs was 60% (IQR 40-80%) and diagnostic accuracy for the last five interpreted SL-ECGs was 80% (IQR 60-90%); p <0.001. No significant difference in the accuracy of atrial fibrillation detection was seen between the five smart devices; p = 0.33. SL-ECGs from the Apple Watch were considered as having the best quality and readability by 203 (45%) and 226 (50%) participants, respectively. CONCLUSION: SL-ECGs can be challenging to interpret. Accuracy in correctly identifying atrial fibrillation depends on clinical expertise, while the choice of smart device seems to have no impact.

Validation of a clinical model for predicting left versus right ventricular outflow tract origin of idiopathic ventricular arrhythmias.

BACKGROUND: Prediction of the chamber of origin in patients with outflow tract ventricular arrhythmias (OTVA) remains challenging. A clinical risk score based on age, sex and presence of hypertension was associated with a left ventricular outflow tract (LVOT) origin. We aimed to validate this clinical score to predict an LVOT origin in patients with OTVA. METHODS: In a two-center observational cohort study, unselected patients undergoing catheter ablation (CA) for OTVA were enrolled. All procedures were performed using an electroanatomical mapping system. Successful ablation was defined as a ≥80% reduction of the initial overall PVC burden after 3 months of follow-up. Patients with unsuccessful ablation were excluded from this analysis. RESULTS: We included 187 consecutive patients with successful CA of idiopathic OTVA. Mean age was 52 ± 15 years, 102 patients (55%) were female, and 74 (40%) suffered from hypertension. A LVOT origin was found in 64 patients (34%). A score incorporating age, sex and presence of hypertension reached 73% sensitivity and 67% specificity for a low (0-1) and high (2-3) score, to predict an LVOT origin. The combination of one ECG algorithm (V2 S/V3 R-index) with the clinical score resulted in a sensitivity and specificity of 81% and 70% for PVCs with R/S transition at V3 . CONCLUSION: The published clinical score yielded a lower sensitivity and specificity in our cohort. However, for PVCs with R/S transition at V3, the combination with an existing ECG algorithm can improve the predictability of LVOT origin.

Electroanatomical voltage mapping with contact force sensing for diagnosis of arrhythmogenic right ventricular cardiomyopathy.

BACKGROUND: Three-dimensional electroanatomical mapping (EAM) can be helpful to diagnose arrhythmogenic right ventricular cardiomyopathy (ARVC). Yet, previous studies utilizing EAM have not systematically used contact-force sensing catheters (CFSC) to characterize the substrate in ARVC, which is the current gold standard to assure adequate tissue contact. OBJECTIVE: To investigate reference values for endocardial right ventricular (RV) EAM as well as substrate characterization in patients with ARVC by using CFSC. METHODS: Endocardial RV EAM during sinus rhythm was performed with CFSC in 12 patients with definite ARVC and 5 matched controls without structural heart disease. A subanalysis for the RV outflow tract (RVOT), septum, free-wall, subtricuspid region, and apex was performed. Endocardial bipolar and unipolar voltage amplitudes (BVA, UVA), signal characteristics and duration as well as the impact of catheter orientation on endocardial signals were also investigated. RESULTS: ARVC patients showed lower BVA vs. controls (p = 0.018), particularly in the subtricuspid region (1.4, IQR:0.5-3.1 vs. 3.8, IQR:2.5-5 mV, p = 0.037) and RV apex (2.5, IQR:1.5-4 vs. 4.3,IQR:2.9-6.1 mV, p = 0.019). BVA in all RV regions yielded a high sensitivity and specificity for ARVC diagnosis (AUC 59-78%, p < 0.05 for all), with the highest performance for the subtricuspid region (AUC 78%, 95% CI:0.75-0.81, p < 0.001, negative predictive value 100%). A positive correlation between BVA and an orthogonal catheter orientation (46°-90°:r = 0.106, p < 0.001), and a negative correlation between BVA and EGM duration (r = -0.370, p < 0.001) was found. CONCLUSIONS: EAM using CFSC validates previous bipolar cut-off values for normal endocardial RV voltage amplitudes. RV voltages are generally lower in ARVC as compared to controls, with the subtricuspid area being commonly affected and having the highest discriminatory power to differentiate between ARVC and healthy controls. Therefore, EAM using CFSC constitutes a promising tool for diagnosis of ARVC.

Association of bone morphogenetic protein 10 and recurrent atrial fibrillation after catheter ablation.

AIMS: Atrial remodelling, defined as a change in atrial structure, promotes atrial fibrillation (AF). Bone morphogenetic protein 10 (BMP10) is an atrial-specific biomarker released to blood during atrial development and structural changes. We aimed to validate whether BMP10 is associated with AF recurrence after catheter ablation (CA) in a large cohort of patients. METHODS AND RESULTS: We measured baseline BMP10 plasma concentrations in AF patients who underwent a first elective CA in the prospective Swiss-AF-PVI cohort study. The primary outcome was AF recurrence lasting longer than 30 s during a follow-up of 12 months. We constructed multivariable Cox proportional hazard models to determine the association of BMP10 and AF recurrence. A total of 1112 patients with AF (age 61 ± 10 years, 74% male, 60% paroxysmal AF) was included in our analysis. During 12 months of follow-up, 374 patients (34%) experienced AF recurrence. The probability for AF recurrence increased with increasing BMP10 concentration. In an unadjusted Cox proportional hazard model, a per-unit increase in log-transformed BMP10 was associated with a hazard ratio (HR) of 2.28 (95% CI 1.43; 3.62, P < 0.001) for AF recurrence. After multivariable adjustment, the HR of BMP10 for AF recurrence was 1.98 (95% CI 1.14; 3.42, P = 0.01), and there was a linear trend across BMP10 quartiles (P = 0.02 for linear trend). CONCLUSION: The novel atrial-specific biomarker BMP10 was strongly associated with AF recurrence in patients undergoing CA for AF. CLINICALTRIALS.GOV IDENTIFIER: NCT03718364; https://clinicaltrials.gov/ct2/show/NCT03718364.

Clinical validation of an artificial intelligence algorithm offering cross-platform detection of atrial fibrillation using smart device electrocardiograms.

BACKGROUND: Several smart devices are able to detect atrial fibrillation automatically by recording a single-lead electrocardiogram, and have created a work overload at the hospital level as a result of the need for over-reads by physicians. AIM: To compare the atrial fibrillation detection performances of the manufacturers' algorithms of five smart devices and a novel deep neural network-based algorithm. METHODS: We compared the rate of inconclusive tracings and the diagnostic accuracy for the detection of atrial fibrillation between the manufacturers' algorithms and the deep neural network-based algorithm on five smart devices, using a physician-interpreted 12-lead electrocardiogram as the reference standard. RESULTS: Of the 117 patients (27% female, median age 65 years, atrial fibrillation present at time of recording in 30%) included in the final analysis (resulting in 585 analyzed single-lead electrocardiogram tracings), the deep neural network-based algorithm exhibited a higher conclusive rate relative to the manufacturer algorithm for all five models: 98% vs. 84% for Apple; 99% vs. 81% for Fitbit; 96% vs. 77% for AliveCor; 99% vs. 85% for Samsung; and 97% vs. 74% for Withings (P<0.01, for each model). When applying our deep neural network-based algorithm, sensitivity and specificity to correctly identify atrial fibrillation were not significantly different for all assessed smart devices. CONCLUSION: In this clinical validation, the deep neural network-based algorithm significantly reduced the number of tracings labeled inconclusive, while demonstrating similarly high diagnostic accuracy for the detection of atrial fibrillation, thereby providing a possible solution to the data surge created by these smart devices.

Echocardiographic pattern of left ventricular function recovery in tachycardia-induced cardiomyopathy patients.

AIMS: Tachycardia-induced cardiomyopathy (TCM) represents a partially reversible type of cardiomyopathy (CM) that is often underdiagnosed and cardiac chamber remodelling in TCM remains incompletely understood. We aim to explore differences in the dimensions of the left ventricle and functional recovery in patients with TCM compared with patients with other forms of CM. METHODS AND RESULTS: We identified patients with reduced ejection fraction (≤50%) and/or atrial fibrillation or flutter with a left ventricular ejection fraction that improved from baseline (≥15% in left ventricular ejection fraction at follow-up or normalization of cardiac function with at least 10% improvement). Patients were then divided into two groups: (A) TCM patients and (B) patients with other forms of CM (controls). Two hundred thirty-eight patients were included (31% female, 70 years median age), 127 patients had TCM, and 111 had other forms of CM. Patients with TCM did not significantly improve indexed left ventricular volume (LVEDVI) after treatment (60 [45, 84] mL/m2 versus 56 [45, 70] mL/m2 , P = ns) compared with controls (67 [54, 81] mL/m2 versus 52 [42, 69] mL/m2 , P < 0.001). Patients with TCM patients had significantly worse fractional shortening at baseline than controls (15.5 [12, 23] vs. 20 [13, 30], P = 0.01) and higher indexed left atrial volume (LAVI) at baseline than controls (48 [37, 58] vs. 41 [33, 51], P = 0.01) that remained dilated at follow-up (follow-up LAVI 41 [33, 52] mL/m2 ). Good predictors of TCM were: normal LVEDVI (LVEDVI < 58 mL/m2 (M) and < 52 mL/m2 (F)) (odds ratio [OR] 5.2; 95% confidence interval [CI] 2.2-13.3, P < 0.001), fractional shortening < 30% (OR 3.5; 95% CI 1.4-9.2, P = 0.009), LAVI >40 mL/m2 (OR 3.4; 95% CI 1.6-7.3, P = 0.001) and normal wall thickness left ventricle (OR 3.2; 95% CI 1.4-7.8, P = 0.008). 54% of patients with TCM demonstrated diastolic dysfunction at follow-up, without differences from controls (54% vs. 43%, P = ns). 21% of patients with TCM showed persistent heart failure symptoms at follow-up compared with 4.5% of controls, P = 0.004. CONCLUSIONS: TCM patients have a specific pattern of functional recovery with persistent remodelling of the left atria and left ventricle. Several echocardiographic parameters might help identify TCM before treatment.