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).

Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey.

AIMS: Arrhythmia-induced cardiomyopathy (AiCM) represents a subtype of acute heart failure (HF) in the context of sustained arrhythmia. Clear definitions and management recommendations for AiCM are lacking. The European Heart Rhythm Association Scientific Initiatives Committee (EHRA SIC) conducted a survey to explore the current definitions and management of patients with AiCM among European and non-European electrophysiologists. METHODS AND RESULTS: A 25-item online questionnaire was developed and distributed among EP specialists on the EHRA SIC website and on social media between 4 September and 5 October 2023. Of the 206 respondents, 16% were female and 61% were between 30 and 49 years old. Most of the respondents were EP specialists (81%) working at university hospitals (47%). While most participants (67%) agreed that AiCM should be defined as a left ventricular ejection fraction (LVEF) impairment after new onset of an arrhythmia, only 35% identified a specific LVEF drop to diagnose AiCM with a wide range of values (5-20% LVEF drop). Most respondents considered all available therapies: catheter ablation (93%), electrical cardioversion (83%), antiarrhythmic drugs (76%), and adjuvant HF treatment (76%). A total of 83% of respondents indicated that adjuvant HF treatment should be started at first HF diagnosis prior to antiarrhythmic treatment, and 84% agreed it should be stopped within six months after LVEF normalization. Responses for the optimal time point for the first LVEF reassessment during follow-up varied markedly (1 day-6 months after antiarrhythmic treatment). CONCLUSION: This EHRA Survey reveals varying practices regarding AiCM among physicians, highlighting a lack of consensus and heterogenous care of these patients.

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.

Cardioneuroablation for the management of patients with recurrent vasovagal syncope and symptomatic bradyarrhythmias: the CNA-FWRD Registry.

BACKGROUND: Cardioneuroablation has been emerging as a potential treatment alternative in appropriately selected patients with cardioinhibitory vasovagal syncope (VVS) and functional AV block (AVB). However the majority of available evidence has been derived from retrospective cohort studies performed by experienced operators. METHODS: The Cardioneuroablation for the Management of Patients with Recurrent Vasovagal Syncope and Symptomatic Bradyarrhythmias (CNA-FWRD) Registry is a multicenter prospective registry with cross-over design evaluating acute and long-term outcomes of VVS and AVB patients treated by conservative therapy and CNA. RESULTS: The study is a prospective observational registry with cross-over design for analysis of outcomes between a control group (i.e., behavioral and medical therapy only) and intervention group (Cardioneuroablation). Primary and secondary outcomes will only be assessed after enrollment in the registry. The follow-up period will be 3 years after enrollment. CONCLUSIONS: There remains a lack of prospective multicentered data for long-term outcomes comparing conservative therapy to radiofrequency CNA procedures particularly for key outcomes including recurrence of syncope, AV block, durable impact of disruption of the autonomic nervous system, and long-term complications after CNA. The CNA-FWRD registry has the potential to help fill this information gap.

Management of ventricular tachycardias: insights on centre settings, procedural workflow, endpoints, and implementation of guidelines-results from an EHRA survey.

Ventricular tachycardia (VT), and its occurrence, is still one of the main reasons for sudden cardiac death and, therefore, for increased mortality and morbidity foremost in patients with structural heart [Kahle A-K, Jungen C, Alken F-A, Scherschel K, Willems S, Pürerfellner H et al. Management of ventricular tachycardia in patients with ischaemic cardiomyopathy: contemporary armamentarium. Europace 2022;24:538-51]. Catheter ablation has become a safe and effective treatment option in patients with recurrent VT [Cronin EM, Bogun FM, Maury P, Peichl P, Chen M, Namboodiri N et al. 2019 HRS/EHRA/APHRS/LAHRS expert consensus statement on catheter ablation of ventricular arrhythmias. Heart Rhythm 2020;17:e2-154]. Previous and current guidelines provide guidance on indication for VT ablation and risk assessment and evaluation of underlying disease. However, no uniform recommendation is provided regarding procedural strategies, timing of ablation, and centre setting. Therefore, these specifics seem to differ largely, and recent data are sparse. This physician-based European Heart Rhythm Association survey aims to deliver insights on not only infrastructural settings but also procedural specifics, applied technologies, ablation strategies, and procedural endpoints. Therefore, these findings might deliver a real-world scenario of VT management and potentially are of guidance for other centres.

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.

Surpoint algorithm for improved guidance of ablation for ventricular tachycardia (SURFIRE-VT): A pilot study.

INTRODUCTION: The utility of ablation index (AI) to guide ventricular tachycardia (VT) ablation in patients with structural heart disease is unknown. The aim of this study was to assess procedural characteristics and clinical outcomes achieved using AI-guided strategy (target value 550) or conventional non-AI-guided parameters in patients undergoing scar-related VT ablation. METHODS: Consecutive patients (n = 103) undergoing initial VT ablation at a single center from 2017 to 2022 were evaluated. Patient groups were 1:1 propensity-matched for baseline characteristics. Single lesion characteristics for all 4707 lesions in the matched cohort (n = 74) were analyzed. The impact of ablation characteristics was assessed by linear regression and clinical outcomes were evaluated by Cox proportional hazard model. RESULTS: After propensity-matching, baseline characteristics were well-balanced between AI (n = 37) and non-AI (n = 37) groups. Lesion sets were similar (scar homogenization [41% vs. 27%; p = .34], scar dechanneling [19% vs. 8%; p = .18], core isolation [5% vs. 11%; p = .4], linear and elimination late potentials/local abnormal ventricular activities [35% vs. 44%; p = .48], epicardial mapping/ablation [11% vs. 14%; p = .73]). AI-guided strategy had 21% lower procedure duration (-47.27 min, 95% confidence interval [CI] [-81.613, -12.928]; p = .008), 49% lower radiofrequency time per lesion (-13.707 s, 95% CI [-17.86, -9.555]; p < .001), 21% lower volume of fluid administered (1664 cc [1127, 2209] vs. 2126 cc [1750, 2593]; p = .005). Total radiofrequency duration (-339 s [-24%], 95%CI [-776, 62]; p = .09) and steam pops (-155.6%, 95% CI [19.8%, -330.9%]; p = .08) were nonsignificantly lower in the AI group. Acute procedural success (95% vs. 89%; p = .7) and VT recurrence (0.97, 95% CI [0.42-2.2]; p = .93) were similar for both groups. Lesion analysis (n = 4707) demonstrated a plateau in the magnitude of impedance drops once reaching an AI of 550-600. CONCLUSION: In this pilot study, an AI-guided ablation strategy for scar-related VT resulted in shorter procedure time and average radiofrequency time per lesion with similar acute procedural and intermediate-term clinical outcomes to a non-AI-guided approach utilizing traditional ablation parameters.

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.

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.

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.

Determine atrial fibrillation burden with a photoplethysmographic mobile sensor: the atrial fibrillation burden trial: detection and quantification of episodes of atrial fibrillation using a cloud analytics service connected to a wearable with photoplethysmographic sensor.

Aims: Recent studies suggest that atrial fibrillation (AF) burden (time AF is present) is an independent risk factor for stroke. The aim of this trial was to study the feasibility and accuracy to identify AF episodes and quantify AF burden in patients with a known history of paroxysmal AF with a photoplethysmography (PPG)-based wearable. Methods and results: In this prospective, single-centre trial, the PPG-based estimation of AF burden was compared with measurements of a conventional 48 h Holter electrocardiogram (ECG), which served as the gold standard. An automated algorithm performed PPG analysis, while a cardiologist, blinded for the PPG data, analysed the ECG data. Detected episodes of AF measured by both methods were aligned timewise.Out of 100 patients recruited, 8 had to be excluded due to technical issues. Data from 92 patients were analysed [55.4% male; age 73.3 years (standard deviation, SD: 10.4)]. Twenty-five patients presented AF during the study period. The intraclass correlation coefficient of total AF burden minutes detected by the two measurement methods was 0.88. The percentage of correctly identified AF burden over all patients was 85.1% and the respective parameter for non-AF time was 99.9%. Conclusion: Our results demonstrate that a PPG-based wearable in combination with an analytical algorithm appears to be suitable for a semiquantitative estimation of AF burden in patients with a known history of paroxysmal AF. Trial Registration number: NCT04563572.

An augmented reality-based method to assess precordial electrocardiogram leads: a feasibility trial.

Aims: It has been demonstrated that several cardiac pathologies, including myocardial ischaemia, can be detected using smartwatch electrocardiograms (ECGs). Correct placement of bipolar chest leads remains a major challenge in the outpatient population. Methods and results: In this feasibility trial, we propose an augmented reality-based smartphone app that guides the user to place the smartwatch in predefined positions on the chest using the front camera of a smartphone. A machine-learning model using MobileNet_v2 as the backbone was trained to detect the bipolar lead positions V1-V6 and visually project them onto the user's chest. Following the smartwatch recordings, a conventional 10 s, 12-lead ECG was recorded for comparison purposes. All 50 patients participating in the study were able to conduct a 9-lead smartwatch ECG using the app and assistance from the study team. Twelve patients were able to record all the limb and chest leads using the app without additional support. Bipolar chest leads recorded with smartwatch ECGs were assigned to standard unipolar Wilson leads by blinded cardiologists based on visual characteristics. In every lead, at least 86% of the ECGs were assigned correctly, indicating the remarkable similarity of the smartwatch to standard ECG recordings. Conclusion: We have introduced an augmented reality-based method to independently record multichannel smartwatch ECGs in an outpatient setting.

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.

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).