BACKGROUND:The optimal long-term antithrombotic strategy in patients with atrial fibrillation (AF) and coronary artery disease (CAD) after successful catheter ablation (CA) remains uncertain. OBJECTIVE:This study aimed to compare the effectiveness and safety of single antiplatelet therapy (SAPT) vs oral anticoagulation (OAC) monotherapy in this population. METHODS:This cohort study used a target trial emulation framework based on data from the China Atrial Fibrillation Registry. Patients with nonvalvular AF and CAD who underwent index CA were screened. Those free from AF recurrence, thromboembolism, or bleeding 12 months after ablation were included and categorized according to antithrombotic regimen at the 12-month landmark. The primary effectiveness outcome was thromboembolism (ischemic stroke or systemic embolism), and the primary safety outcome was bleeding (International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding). Secondary outcomes included all-cause mortality and net clinical benefit. Inverse probability of treatment weighting was used for confounding adjustment. RESULTS:Among 998 patients (mean age 66.8 years; 26.5% women), 706 received SAPT and 292 OAC monotherapy. Over a mean follow-up of 3.0 years, 19 thromboembolic and 29 bleeding events occurred. After weighting, no statistically significant difference in thromboembolism was observed (hazard ratio [HR], 0.54; 95% confidence interval [CI], 0.18-1.61), whereas SAPT was associated with lower bleeding risk (HR, 0.40; 95% CI, 0.18-0.91). No significant differences were observed in mortality (HR, 0.77; 95% CI, 0.35-1.72) or net clinical benefit (HR, 0.66; 95% CI, 0.36-1.20). CONCLUSION:In this stable postablation population with AF and CAD, SAPT was associated with lower bleeding risk vs OAC monotherapy, whereas no statistically significant difference in thromboembolism was observed.

INTRODUCTION:The cryoballoon catheter is a gold-standard single-shot device for pulmonary vein isolation (PVI). Pulsed-field ablation (PFA) is a tissue-selective, nonthermal cardiac ablation modality. We assessed the preclinical safety and durability of a novel conformal, balloon-shaped, single-shot PFA catheter for PVI and circular atrial lesions. METHODS:A 13 Fr balloon-shaped PFA catheter (PFBalloonTM, 20 electrodes, 24 mm diameter, EnChannel Medical) was applied using a biphasic waveform of microsecond scale (± 750 V, 4.9 s per application). In 10 swine, superior vena cava (SVC), left superior PV (LSPV), right superior PV (RSPV) and right atrial appendage (RAA) were targeted for isolation. Localization of PFBalloon was evaluated by fluoroscopy and intracardiac echocardiography (ICE). PFA was delivered in a novel tailored configuration (small ring, large ring, or global pulse) to minimize diaphragm stimulation and optimize pulse efficiency. Five swine were assessed at 30 days post-procedure for lesion durability, gross pathology, and histologic examination, while the remaining five swine were evaluated at 90 days to assess longer term outcomes. RESULTS:In all 10 swine, PFA resulted in 100% successful acute isolation of the SVC, RSPV, and LSPV using 4.2 ± 0.6, 5.0 ± 1.1, and 4.4 ± 1.8 applications per vein, respectively, and acute isolation of RAA in 9/10 swine using 5.3 ± 2.0 applications. At 30 days post-procedure, 14 out of 20 targeted sites (70.0%) remained isolated in five pigs. At 90 days, 19 out of 20 sites (95.0%) remained isolated in the remaining five pigs. The overall pulse configurations were 9.0% small ring, 25.4% large ring, and 65.6% global. PFA did not affect phrenic nerve function, with very few microbubbles recorded on ICE. No major complications were observed. CONCLUSIONS:In this preclinical study, a novel conformal, balloon-shaped catheter designed for single-shot PVI can create durable isolation without complications.

QuestionIs discontinuation of guideline-directed medical therapy (GDMT) after catheter ablation feasible and safe in patients with atrial fibrillation (AF) with improved cardiac function?FindingsIn this randomized clinical trial of 50 patients with AF and heart failure (HF) with improved ejection fraction (suspected with AF-mediated cardiomyopathy), phased GDMT withdrawal in those with normalized left ventricular ejection fraction and sinus rhythm resulted in HF deterioration in 3 of 23 patients (13%) compared with none in the continuation group. This was not a statistically significant difference.MeaningAlthough this study did not find significantly more HF deterioration in patients who discontinued GDMT vs those who continued, further studies are needed to determine whether GDMT can be safely discontinued in this population. This pilot randomized clinical trial assesses whether phased withdrawal of heart failure medication in patients who have undergone catheter ablation for atrial fibrillation (AF) and experienced improvements in cardiac function is feasible and safe. ImportanceWithdrawal of guideline-directed medical therapy (GDMT) for heart failure (HF) is common after atrial fibrillation (AF) catheter ablation and recovery of cardiac function, but safety remains uncertain.ObjectiveTo assess the feasibility and safety of phased GDMT withdrawal in patients with AF with highly suspected AF-mediated cardiomyopathy after catheter ablation.Design, Setting, and ParticipantsThis open-label pilot randomized clinical trial included adult patients who were enrolled and randomized from April 13, 2023, to September 19, 2024, at Beijing Anzhen Hospital, China, with a 6-month follow-up. Eligible patients were those with suspected AF-mediated cardiomyopathy at 3 months after ablation, defined by sinus rhythm at 3 months after ablation, absence of other suspected cardiomyopathies, improvement of left ventricular ejection fraction (LVEF) from 45% or less to 55% or more, normalized LV end-diastolic diameter (LVEDD), N-terminal pro-brain natriuretic peptide (NT-proBNP) levels less than 250 ng/L, and no HF symptoms or signs.InterventionsPatients were randomly assigned in a 1:1 ratio to phased GDMT withdrawal or GDMT continuation.Main Outcomes and MeasuresThe primary end point was HF deterioration, defined as LVEF decline more than 10% to less than 55%, LVEDD increase more than 10% and beyond normal, NT-proBNP levels doubling to more than 400 ng/L, or worsening HF signs or symptoms. Secondary outcomes included cardiovascular events, changes in echocardiographic and cardiac magnetic resonance (CMR) parameters, NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scores, atrial arrhythmia recurrence, and adverse drug events.ResultsAmong 50 patients enrolled and randomized, 47 completed follow-up (median [IQR] age, 56.0 [48.0-60.5] years; 37 males [78.7%]), including 23 (48.9%) in the GDMT withdrawal group and 24 (51.1%) in the continuation group. HF deterioration occurred in 3 patients with GDMT withdrawal (13.0%) and 0 with GDMT continuation (0%) (P = .11). Early GDMT reinitiation in 3 patients with HF deterioration showed recovery of LVEF or NT-proBNP. No cardiovascular events occurred. Median (IQR) echocardiographic (LVEF: 0% [-3.0% to 3.5%] vs 1.5% [-5.0% to 5.0%]), CMR (LVEF: -2.1% [-7.2% to 4.6%] vs 2.9% [-2.6% to 7.4%]), and KCCQ-12 score (0 [0 to 0.5] vs 0) changes were similar between groups. Median (IQR) NT-proBNP levels declined more in the GDMT continuation group than the withdrawal group (-25.7 [-33.6 to -6.7] pg/mL vs 2.7 [-21.4 to 24.2] pg/mL; P = .03). Adverse drug events were more frequent in the GDMT continuation group than the withdrawal group (5 [20.8%] vs 0 [0%]; P = .050). Arrhythmia recurrence rates were comparable (GDMT withdrawal: 3 [13.0%] vs continuation: 3 [12.5%]).Conclusions and RelevanceIn this pilot randomized clinical trial of carefully selected patients with AF with normalized cardiac function and sinus rhythm after catheter ablation, 13% of patients with GDMT withdrawal experienced HF deterioration, whereas drug-related complications were more common in the continuation group, suggesting that further studies are needed to determine whether GDMT can be safely discontinued in this population.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2300077439

The role of prophylactic cavotricuspid isthmus (CTI) ablation remains controversial in atrial fibrillation (AF) patients without atrial flutter (AFL). Given the strong association between AF, AFL, and age, this study aimed to evaluate the impact of additional CTI ablation on recurrence-free survival, with a focus on age-stratified outcomes. Between June 2020 and June 2022, 1226 paroxysmal AF patients without AFL who underwent first AF catheter ablation at Beijing Anzhen Hospital were enrolled. 899 patients underwent pulmonary vein isolation (PVI) alone (PVI group) and remaining 327 patients underwent additional CTI ablation (PVI + CTI group). Both groups were stratified into four age quartiles to assess age-related recurrence risk. Over a median 36.6-month follow-up, prophylactic CTI ablation did not have a better outcome in overall population. In the PVI + CTI group, the oldest age quartile (> 70 years) was independently associated with a lower risk of recurrence compared with the youngest quartile (≤ 56 years; adjusted HR 0.41, 95

This study investigated the association between serum uric acid (UA) levels and atrial fibrillation (AF) burden in Chinese patients with AF. In this cross-sectional study, AF burden was defined as the proportion of AF duration to total monitoring time, recorded by a patch device over ≥24 hours. Serum UA levels were measured at the start of monitoring. Multivariate logistic regression was used to assess associations. A total of 952 patients with AF (66.4% women; median age 64 years) were included. A 1-SD increase in UA (91.4 μmol/L) was associated with elevated risk of persistent AF (adjusted OR: 1.32; 95% CI: 1.12–1.55; P < 0.001). The highest UA quintile had a greater risk of persistent AF than the lowest quintile of patients (adjusted OR: 2.43; 95% CI: 1.49–3.98; P for trend < 0.001). Serum UA levels are positively associated with AF burden in a dose-dependent manner. UA might serve as an accessible biomarker and potential therapeutic target for AF burden assessment.

BACKGROUND:Despite the growing use of catheter ablation for atrial fibrillation, large-scale studies assessing the efficacy and safety of oral anticoagulation (OAC) after ablation, particularly in patients with high stroke risk, remain limited. METHODS:This prospective study enrolled consecutive patients from the China-AF (China Atrial Fibrillation) registry between August 2011 and June 2022. Stroke risk was stratified by CHA2DS2-VA score as low (0-1), intermediate (2), or high (≥3). The study end points were thromboembolism (ischemic stroke or systemic embolism), and bleeding (International Society on Thrombosis and Hemostasis major bleeding and clinically relevant non-major bleeding). A 6-month landmark analysis was applied to evaluate the association of OAC with end points using incidence rates and Cox models. RESULTS:Among 13 669 patients (median follow-up, 4.0 years), 2637 continued and 11 032 discontinued OAC at the 6-month landmark. OAC was not associated with reduced thromboembolism risk across low- (adjusted hazard ratio [aHR], 1.11 [95% CI, 0.70-1.77]; P=0.649), intermediate- (aHR, 0.64 [95% CI, 0.36-1.16]; P=0.141) or high-stroke risk patients (aHR, 1.05 [95% CI, 0.74-1.48]; P=0.801). In contrast, continued OAC was associated with higher bleeding risk, including clinically relevant non-major bleeding across stroke risk strata, and International Society on Thrombosis and Hemostasis major bleeding among high-risk patients (aHR, 2.32 [95% CI, 1.19-4.50]; P=0.013). These results were consistent across subgroups and sensitivity analyses. CONCLUSIONS:In this large, real-world cohort of patients with atrial fibrillation undergoing catheter ablation, continued OAC was not associated with lower thromboembolic risk, but with higher major bleeding risk among patients with CHA2DS2-VA scores ≥3. These findings support individualized post-ablation anticoagulation strategies and warrant future investigation. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique Identifier: NCT06987825.

Atrial fibrillation (AF) increases the risk of stroke and heart failure, yet accurate quantification of AF burden in daily life remains difficult. Although smartwatch photoplethysmography (PPG) supports continuous monitoring, complex rhythms and signal noise can impair burden estimation. We developed an AI-enhanced dual-modal framework that combines continuous watch-based PPG (W-PPG) with intermittent single-lead watch-based ECG (W-ECG). A hybrid convolutional neural network-long short-term memory model uses high-fidelity W-ECG segments as dynamic anchors to correct long-term W-PPG classifications. In this prospective validation study, 1,054 patients with AF undergoing catheter ablation (mean age, 62.1 years) were evaluated against patch-based ECG as the reference standard. After ECG-based correction, the system achieved 98.60% sensitivity and 99.27% specificity. The mean absolute percentage error of AF burden decreased by 23.4%, from 1.11% to 0.85%, while the Pearson correlation remained 0.9988. This dual-modal approach offers a scalable and clinically practical solution for long-term AF monitoring, improving burden estimation beyond PPG-only devices without requiring continuous multi-lead ECG. It may support personalized AF management and large-scale cardiovascular screening in real-world settings. (NCT06552468)

AIMS:Though pulsed-field ablation (PFA) has demonstrated an excellent safety profile in reducing collateral injury to the oesophagus and phrenic nerve, it is still associated with specific effects, including electrode heating, haemolysis, and electrolysis due to excessive energy dispersion. This study aims to assess whether saline irrigation during PFA application could mitigate these risks. METHODS AND RESULTS:To comprehensively evaluate the effect of irrigation with the variable-loop circular catheter (VLCC), the following experiments were performed: (i) ex-vivo potato model: to evaluate the lesion depth, bubble formation, and thermal effects in different irrigation regimens; (ii) in vitro blood pool and cardiac ablation: to determine the haemolysis status and tissue temperature change after PFA; (iii) in vivo swine ablation (n = 8), and (iv) clinical randomized trial (n = 25): to compare the efficacy and safety profile between low (4 mL/min) and high (30 mL/min) flow irrigation using the VLCC. Though peak core temperatures at 5 mm depth were all < 50°C under low- and high-irrigation, high irrigation significantly mitigated the instant electrode and deep tissue heating both in the potato and isolated cardiac models. Ex vivo potato slices showed that high-flow irrigation produced the deepest lesion sets when compared to low-flow irrigation (5.94 ± 0.29 mm vs. 5.36 ± 0.33 mm, P = 0.043). Assessment from a high-speed camera and bubble detector demonstrated that high-flow irrigation significantly reduced the total number of gaseous bubbles (54.50 IQR 53.00-56.75 vs. 82.00 IQR 72.00-83.00, P < 0.001) and eliminated the occurrence of larger bubbles. The high-flow irrigation group showed a smaller increase in the level of free haemoglobin immediately after the procedure across the blood pool, swine, and clinical models. Haptoglobin and lactate dehydrogenase levels were also attenuated by high irrigation in the in vivo swine model and clinical trial. One swine in the low-irrigation group developed an acute cerebral lesion (3 mm). The clinical trial confirmed that the incidence of silent cerebral lesions was significantly lower in the high-flow irrigation group (16.7% vs. 66.7%, P = 0.036). CONCLUSION:Proper saline irrigation during PFA with VLCC may mitigate electrode-associated haemolysis, reduce electrode and tissue temperature, limit bubble aggregation, and be associated with a lower incidence of silent cerebral lesions, the clinical significance of which remains unclear.

BACKGROUND:Nonvalvular atrial fibrillation (NVAF) patients with low CHA2DS2-VASc scores still have a risk of atrial thrombus formation. This study aims to identify these patients' risk factors for intracardiac thrombus or sludge. METHODS:We conducted a retrospective study of 919 consecutive hospitalized NVAF or atrial flutter patients with a CHA2DS2-Vas score ≤ 1 (male) and ≤ 2 (female) who underwent transesophageal echocardiogram (TEE) before catheter ablation at Beijing An Zhen Hospital from November 2016 to December 2017. We collected the clinical and echocardiographic characteristics of the patients. RESULTS:Excluding seven patients with hypertrophic cardiomyopathy, 919 patients, including 17 identified left atrial appendage (LAA) thrombus/sludge and 902 without LAA thrombus/sludge, were included. Among 17 patients with LAA thrombus/sludge, 16 (94.1%) had non-paroxysmal AF. A subgroup analysis was conducted in 403 non-paroxysmal atrial fibrillation (AF) patients. 87.8% had spontaneous echo contrast (SEC), 59.3% had severe or more severe SEC, and 4.0% had thrombus/sludge. In the multivariable model, female (odds ratio [OR] 4.612, 95% [CI] 1.454-14.627, p = 0.009) and LA diameter ≥ 45 mm (OR 13.340, [CI] 3.601, 49.415, p < 0.001) remained significantly independently associated with LAA thrombus/sludge. CONCLUSION:Among patients with NVAF and CHA2DS2-VASc scores ≤ 1 (male) and ≤ 2 (female), those non-paroxysmal AF patients who were female and had an LA ≥ 45 mm still had a risk of LAA thrombus/sludge formation.

Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) often coexist, worsening each other’s progression and contributing to poor outcomes. Frailty, a syndrome characterized by vulnerability to stressors, is highly prevalent in AF and HFpEF patients and has been associated with adverse outcomes such as stroke, hospitalization, and mortality. However, the specific prognostic implications of varying degrees of frailty in AF comorbid HFpEF patients remain unclear. This study investigates the relationship between frailty, measured using a deficit accumulation frailty index (FI), and adverse outcomes, particularly stroke, in this patient population. This post hoc analysis of the TOPCAT randomized control trial included 721 patients with AF and HFpEF from the Americas classified into three groups based on FI: Group 1 (FI < 0.3), Group 2 (FI 0.3–0.4), and Group 3 (FI ≥ 0.4). The primary outcome was stroke, and secondary outcomes included heart failure hospitalization, cardiovascular death, and all-cause mortality. Cox proportional hazards models and Kaplan–Meier analyses were used to assess the association between frailty status and outcomes. A dose–response relationship was evaluated using restricted cubic splines. 97.8

Importance:Although Valsalva maneuver (VM) remains the guideline-directed emergent treatment for supraventricular tachycardia (SVT), its success rate remains suboptimal. Objective:To assess the efficacy of a novel handheld Valsalva assist device, which can assist in achieving and maintaining target intrathoracic pressures, in improving sinus rhythm restoration rates in patients with SVT. Design, Setting, and Participants:This single-center, open-label randomized clinical trial conducted at Beijing Anzhen Hospital randomized patients with SVT (aged 16-80 years, enrolled between April 2022 and April 2023) undergoing electrophysiological study at a tertiary hospital. Data analysis was completed from January 2024 to January 2025. Intervention:Participants received either device-assisted VM (n = 106) or standard VM (n = 106) during induced SVT. Main Outcomes and Measures:The primary outcome was immediate cardioversion success (12-lead electrocardiogram-confirmed sinus rhythm within 1 minute) postintervention by intention-to-treat analysis. Results:A total of 212 patients were randomized, among whom 210 completed the randomly assigned VM and were included in the primary analysis (106 in the standard VM group and 104 in the device-assisted VM group). Mean (SD) patient age was 48.4 (14.0) years, and 114 patients (54.8%) were female. After 2 VMs, 67 of 106 participants in the VM with device assist group (63.2%) vs 31 of 106 participants in the standard VM group (29.2%) converted to sinus rhythm within 1 minute (odds ratio, 4.16; 95% CI, 2.36-7.47; P < .001). Conclusions and Relevance:Per the results of this randomized clinical trial, the handheld Valsalva assist device significantly enhances VM effectiveness, providing a potentially implementable solution for SVT management. Trial Registration:ClinicalTrials.gov Identifier: NCT06622772.

BACKGROUND:Catheter ablation restores sinus rhythm in atrial fibrillation (AF), but long-term cardiovascular risk remains incompletely defined. The prognostic value of high-sensitivity C-reactive protein (hs-CRP) after ablation is uncertain. OBJECTIVE:This study aimed to investigate the association between preprocedural hs-CRP levels and long-term cardiovascular outcomes after AF ablation. METHODS:We analyzed 4612 patients with nonvalvular AF undergoing first-time radiofrequency ablation in the prospective Chinese Atrial Fibrillation Registry (2011-2023), with a median follow-up of 5.0 years. Baseline hs-CRP was measured using a high-sensitivity immunoturbidimetric assay and analyzed as log-transformed continuous values and tertiles. The primary endpoint was a composite of cardiovascular death and ischemic stroke. Secondary endpoints included life-threatening bleeding, AF recurrence, and cardiovascular readmission. Cox models adjusted for demographic factors, comorbidities, AF type, and medications. RESULTS:Higher baseline hs-CRP was independently associated with an increased risk of the primary endpoint (adjusted hazard ratio, 1.21; 95% confidence interval, 1.10-1.33; P < .001) with a significant dose-response relationship across tertiles. The association was stronger in patients aged <65 years (interaction P = .006) and remained significant in patients without AF recurrence (hazard ratio, 1.26; P = .006). Elevated hs-CRP was also associated with a higher risk of cardiovascular readmission. Associations with life-threatening bleeding and AF recurrence were weaker. CONCLUSION:Preprocedural hs-CRP independently predicts long-term cardiovascular death and ischemic stroke after AF ablation, even in patients without recurrence. These findings support inflammation-based risk stratification beyond rhythm outcomes.

BACKGROUND:Ethanol infusion of the vein of Marshall (EIVOM) improves outcomes in atrial fibrillation (AF) ablation. However, its association with delayed pericardial effusion (PE)-specifically its incidence, clinical features, and mechanism-remains poorly defined. OBJECTIVES:This study sought to investigate the risk of delayed PE associated with EIVOM and characterize its clinical profile, management, and outcomes. METHODS:This study analyzed 15,101 patients with persistent AF from the China-AF Registry, stratified into an EIVOM group (n = 8,151) and a non-EIVOM group (n = 6,950). The primary endpoint was delayed PE, defined as newly detected PE >10 mm occurring ≥7 days after ablation and resulting in rehospitalization. Propensity score overlap weighting was applied to balance baseline covariates between groups. RESULTS:Delayed PE occurred in 0.17% of the total cohort, with a higher incidence in the EIVOM group compared with the non-EIVOM group (0.25% vs 0.07%). EIVOM was an independent risk factor for delayed PE (overlap-weighted HR: 3.18; 95% CI: 1.15-8.74; P = 0.025). Delayed PE in the EIVOM group tended to manifest late (median 38 days vs 14 days), with large effusion size and severe systemic inflammation. Management in the EIVOM group frequently required invasive intervention (17 of 20 [85%]). Notably, 20% (4 of 20) of patients with EIVOM-related delayed PE experienced recurrence post-discharge, requiring prolonged management. CONCLUSIONS:EIVOM is associated with an increased risk of delayed PE, characterized by late onset, systemic inflammation, frequent need for invasive management, and high recurrence risk. These findings support the need for extended echocardiographic monitoring beyond the standard postprocedural period.

BACKGROUND:Tumor necrosis factor superfamily 14 (TNFSF14) has been implicated in the pathogenesis of cardiovascular disease, including atrial fibrillation (AF). However, its role in predicting AF recurrence after catheter ablation (CA) remains unexplored. OBJECTIVE:This study aimed to evaluate the predictive value of TNFSF14 for AF recurrence post-ablation. METHODS:A total of 263 AF patients undergoing CA were enrolled and stratified into two groups based on AF recurrence during a mean follow-up of 363 ± 144 days. Plasma TNFSF14 levels were measured by enzyme-linked immunosorbent assay (ELISA). Cox proportional hazards models were employed to examine the association between TNFSF14 levels and AF recurrence, while Receiver Operating Characteristic (ROC) analysis was used to assess predictive performance. RESULTS:AF recurrence occurred in 81 patients (30.8%). Patients with recurrence exhibited significantly higher baseline TNFSF14 levels (1.21 ± 0.24 vs. 1.02 ± 0.29 ng/mL, p < 0.001). Elevated TNFSF14 levels were independently associated with AF recurrence (Adjusted hazard ratio (aHR): 3.65, 95% CI: 2.19-6.09, p < 0.001). ROC analysis demonstrated moderate predictive power for TNFSF14 (AUC: 0.70). Incorporating TNFSF14 levels into the ATLAS score and BNP significantly enhanced the predictive performance for recurrence, as evidenced by improved time-dependent AUC, decision curve analysis, net reclassification improvement (NRI: 0.36, p < 0.001) and integrated discrimination improvement (IDI: 0.08, p = 0.012). CONCLUSIONS:TNFSF14 is a promising biomarker for predicting AF recurrence after CA. It holds potential for inclusion in future personalized risk models for AF recurrence.

Importance:Withdrawal of guideline-directed medical therapy (GDMT) for heart failure (HF) is common after atrial fibrillation (AF) catheter ablation and recovery of cardiac function, but safety remains uncertain. Objective:To assess the feasibility and safety of phased GDMT withdrawal in patients with AF with highly suspected AF-mediated cardiomyopathy after catheter ablation. Design, Setting, and Participants:This open-label pilot randomized clinical trial included adult patients who were enrolled and randomized from April 13, 2023, to September 19, 2024, at Beijing Anzhen Hospital, China, with a 6-month follow-up. Eligible patients were those with suspected AF-mediated cardiomyopathy at 3 months after ablation, defined by sinus rhythm at 3 months after ablation, absence of other suspected cardiomyopathies, improvement of left ventricular ejection fraction (LVEF) from 45% or less to 55% or more, normalized LV end-diastolic diameter (LVEDD), N-terminal pro-brain natriuretic peptide (NT-proBNP) levels less than 250 ng/L, and no HF symptoms or signs. Interventions:Patients were randomly assigned in a 1:1 ratio to phased GDMT withdrawal or GDMT continuation. Main Outcomes and Measures:The primary end point was HF deterioration, defined as LVEF decline more than 10% to less than 55%, LVEDD increase more than 10% and beyond normal, NT-proBNP levels doubling to more than 400 ng/L, or worsening HF signs or symptoms. Secondary outcomes included cardiovascular events, changes in echocardiographic and cardiac magnetic resonance (CMR) parameters, NT-proBNP levels, Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) scores, atrial arrhythmia recurrence, and adverse drug events. Results:Among 50 patients enrolled and randomized, 47 completed follow-up (median [IQR] age, 56.0 [48.0-60.5] years; 37 males [78.7%]), including 23 (48.9%) in the GDMT withdrawal group and 24 (51.1%) in the continuation group. HF deterioration occurred in 3 patients with GDMT withdrawal (13.0%) and 0 with GDMT continuation (0%) (P = .11). Early GDMT reinitiation in 3 patients with HF deterioration showed recovery of LVEF or NT-proBNP. No cardiovascular events occurred. Median (IQR) echocardiographic (LVEF: 0% [-3.0% to 3.5%] vs 1.5% [-5.0% to 5.0%]), CMR (LVEF: -2.1% [-7.2% to 4.6%] vs 2.9% [-2.6% to 7.4%]), and KCCQ-12 score (0 [0 to 0.5] vs 0) changes were similar between groups. Median (IQR) NT-proBNP levels declined more in the GDMT continuation group than the withdrawal group (-25.7 [-33.6 to -6.7] pg/mL vs 2.7 [-21.4 to 24.2] pg/mL; P = .03). Adverse drug events were more frequent in the GDMT continuation group than the withdrawal group (5 [20.8%] vs 0 [0%]; P = .050). Arrhythmia recurrence rates were comparable (GDMT withdrawal: 3 [13.0%] vs continuation: 3 [12.5%]). Conclusions and Relevance:In this pilot randomized clinical trial of carefully selected patients with AF with normalized cardiac function and sinus rhythm after catheter ablation, 13% of patients with GDMT withdrawal experienced HF deterioration, whereas drug-related complications were more common in the continuation group, suggesting that further studies are needed to determine whether GDMT can be safely discontinued in this population. Trial Registration:Chinese Clinical Trial Registry Identifier: ChiCTR2300077439.

BACKGROUND:Smartwatches integrated with photoplethysmography (PPG) can effectively identify the occurrence of atrial fibrillation (AF). However, the accuracy of their continuous monitoring of AF burden is still unclear. OBJECTIVES:This study sought to verify the effectiveness of a smartwatch integrated with the PPG algorithm in continuously monitoring AF burden. METHODS:This prospective study included patients diagnosed with AF at Beijing Anzhen Hospital between January and December 2024. Each participant continuously wore a smartwatch integrated with the PPG algorithm on the day prior to radiofrequency catheter ablation, together with patch-based electrocardiography (P-ECG) as the reference to validate algorithm performance for estimation of AF burden. The watch-based PPG data were segmented into 30-second intervals and verified with the data from P-ECG to analyze its accuracy, sensitivity, and specificity. RESULTS:The study recruited 728 participants, with a mean age of 62.0 ± 10.5 years, of whom 412 (56.6%) had paroxysmal AF. The average monitoring time for each participant was 20.4 ± 4.5 hours. The overall validity rate for P-ECG was 96.2%, while the overall validity rate for watch-based PPG was 62.5%. After segmentation, a total of 1,440,826 PPG records were generated. At the interval level, sensitivity was 98.70% (95% CI: 98.66%-98.73%) and specificity was 99.56% (95% CI: 99.54%-99.57%). At the individual level, sensitivity was 91.73% (95% CI: 88.89%-94.15%) and specificity was 96.96% (95% CI: 95.09%-98.59%). The Bland-Altman analysis showed excellent agreement between the AF burden estimates from PPG and electrocardiography (ECG), with a mean difference of -1.34% and 95% limits of agreement ranging from -6.45% to 3.77%. A strong correlation (r = 0.999) was observed between PPG-based and ECG-measured AF burden (NCT05333380). CONCLUSIONS:Smartwatches integrated with the PPG algorithm offer a practical and noninvasive approach for continuous AF burden monitoring. The results suggest that PPG can be an effective approach for long-term AF management, providing an accessible alternative to traditional ECG monitoring.