BACKGROUND:Long-term rhythm outcomes following cryoballoon ablation (CBA) in early persistent atrial fibrillation (AF) remain incompletely characterized. OBJECTIVE:To evaluate 3-year AF burden trajectories, subsequent recurrence patterns detected by implantable loop recorder (ILR), and association with healthcare resource utilization (HCRU). METHODS:The COOL-PER trial was a prospective, multicenter, single-arm study enrolling patients with early persistent AF (duration ≤3 years). An ILR was implanted 7-90 days before CBA for continuous rhythm monitoring. RESULTS:Among 130 enrolled patients, 123 completed 3-year follow-up (mean age 60.5±8.4 years; 25.2% female). Median AF burden decreased from 99.9% [IQR 53.1-100.0] at baseline to 0.1% [0.0-4.2], 0.5% [0.0-9.1], and 0.7% [0.0-9.5] at 1, 2, and 3 years (all P<0.001). Of 47 patients recurrence-free at 1 year, 25 (53.2%) developed subsequent recurrence, and 20 (80.0%) detected by ILR alone. Compared with first-year recurrence, subsequent recurrence was less often persistent (4.0% vs 28.9%; P=0.001) with lower AF burden (0.1% [0.0-1.6] vs 2.8% [0.4-18.7]; P=0.010). Persistent-type recurrence and AF burden ≥10% were both associated with more additional rhythm control interventions (78.3% vs. 30.8% vs. 0%; 78.6% vs. 39.1% vs. 0%; both P<0.001) and cardiovascular hospitalization (17.4% vs. 3.8% vs. 0%, P=0.045; 14.3% vs. 4.3% vs. 0%, P=0.029). CONCLUSIONS:CBA achieved durable AF burden suppression over 3-years in early persistent AF. Subsequent recurrence after the first year was common, predominantly detectable by ILR only. Subsequent recurrences were often paroxysmal with lower AF burden and associated with lower HCRU, supporting the value of continuous long-term rhythm monitoring for characterizing rhythm status beyond the first post-ablation year.
Background:Artificial intelligence-augmented electrocardiogram (AI-ECG) models for detecting left ventricular systolic dysfunction (LVSD) often exhibit degraded performance in patients with comorbidities. Objective:This study aimed to introduce and validate a recalibration method using longitudinal patient data to enhance prediction accuracy and simulate its clinical utility for ongoing monitoring. Methods:We conducted a multicenter, retrospective cohort study using data from 2 hospitals in Korea. A dataset of paired transthoracic echocardiograms (TTEs) and electrocardiograms (ECGs) matched within a 2-week interval was constructed, separating pairs into baseline (first for each patient) and follow-up assessments. In addition to conventional supervised learning, we developed a patient-wise recalibration strategy that incorporated historical left ventricular ejection fraction measurements and prior AI-ECG outputs to adjust for future predictions, thus empirically mitigating confounding effects. Pretraining was also implemented to enhance the model's performance. Results:The recalibrated 12-lead DeepECG LVSD model achieved an area under the receiver operating curve of 0.956 (95% CI 0.946-0.965) for internal validation and 0.940 (95% CI 0.936-0.945) for external validation of follow-up TTE-ECG pairs. The uncalibrated 12-lead DeepECG LVSD model also showed modest performance, with an area under the receiver operating curve of 0.953 (95% CI 0.941-0.965) in the internal validation and 0.947 (95% CI 0.943-0.951) in the external validation when tested on baseline TTE-ECG pairs. Recalibration yielded statistically significant improvements in the 12-lead DeepECG LVSD models (P<.001), with enhanced and more balanced performance across all clinical subgroups. Conclusions:Patient-wise recalibration improved accuracy and consistency across various comorbidities by mitigating performance degradation and bias. This broadens the application of AI-ECG for LVSD detection from low-risk screening to high-risk longitudinal monitoring.
Background Direct oral anticoagulants (DOACs) are the cornerstone of thromboembolic prevention in patients with atrial fibrillation, venous thromboembolism, or other cardiovascular conditions. However, DOAC use is associated with an increased risk of bleeding, with gastrointestinal (GI) bleeding being the most common site of major bleeding. Proton pump inhibitors (PPIs) are reasonably used during combined antithrombotic therapy or based on individual bleeding risk; nonetheless, evidence supporting their benefit in patients receiving DOAC therapy remains limited. Methods The Gastrointestinal protection Using proton-pump inhibitor in pAtients who RequireD Oral AntiCoagulants (GUARD-OAC) trial is a prospective, multicenter, open-label, randomized controlled trial evaluating the GI protective effect of PPI coadministration with DOAC. Eligible participants are patients with cardio- or cerebrovascular disease requiring long-term anticoagulation (≥ 1 year), who are currently receiving or initiating DOAC therapy, and have a HAS-BLED score of ≥ 1. The primary outcome is a composite of upper GI clinical events, including bleeding, symptomatic gastroduodenal ulcer, persistent pain of presumed GI origin with underlying multiple erosive disease, obstruction, or perforation. The secondary outcomes are the individual components of the primary outcome, GI symptoms or signs, cardiovascular or all bleeding events, and all-cause mortality. Assuming a 40% relative risk reduction of the primary outcome in the PPI plus DOAC group compared to the DOAC alone group, a total of 3,846 patients will be enrolled and followed for one year. A Clinical Events Committee will adjudicate clinical outcomes and adverse events for causality and attribution, and an independent Data Safety Monitoring Board will oversee the study. The GUARD-OAC trial is funded by the Ministry of Health & Welfare, Republic of Korea. Conclusions The GUARD-OAC trial is the first randomized controlled trial exploring the efficacy of PPI cotherapy in patients receiving DOACs, providing evidence that may inform future guidelines on GI protection in this population. Trial registration Clinical Research Information Service, Identifier KCT0006848
BACKGROUND AND OBJECTIVES:In the PERIXa study, a standardized periprocedural interruption protocol for factor Xa (FXa) inhibitors led to very low major bleeding rates and no thromboembolic events among patients undergoing procedures with minimal to low bleeding risk. However, dental procedures showed the highest all-bleeding rate. This sub-analysis assessed bleeding outcomes by dental procedure type, FXa inhibitor, and dosing regimen to inform tailored anticoagulation strategies in dental practice. METHODS:This analysis included atrial fibrillation (AF) patients from PERIXa who underwent dental procedures managed with a standardized FXa inhibitor interruption protocol. All-bleeding events-comprising major, clinically relevant non-major, and minor bleeding-as well as thromboembolic events and all-cause death, were evaluated within 30 days. Intraoperative bleeding severity was reported by dentists using standardized questionnaires. RESULTS:Among 820 patients (mean age 71.3 ±9.4 years; 42.0% female) undergoing dental procedures with periprocedural direct oral anticoagulant (DOAC) interruption per the PERIXa protocol, the overall all-bleeding rate was 5.0%, with major bleeding occurring in only 0.2%. No thromboembolic events or deaths were reported. Bleeding risk did not differ significantly by procedure type, DOAC agent, or regimen, though numerically higher all-bleeding rates were observed with implants and combined procedures. Most dentists reported no or manageable bleeding, with no significant variation across groups. CONCLUSIONS:Dental procedures performed under the PERIXa protocol were associated with low bleeding risk and excellent thromboembolic safety. These findings support the applicability of the protocol across various dental interventions and DOAC regimens in patients with AF.
IMPORTANCE: Discontinuation of oral anticoagulant treatment is common in clinical practice due to concerns about bleeding, even for procedures with minimal to low bleeding risk. OBJECTIVE: To explore whether perioperative discontinuation of factor Xa inhibitors is associated with major bleeding and thromboembolic events in patients with atrial fibrillation (AF) undergoing procedures with minimal to low bleeding risk. DESIGN, SETTING, AND PARTICIPANTS: This prospective, multicenter, single-arm cohort study conducted in Korea included patients with AF who planned to undergo a procedure with minimal to low bleeding risk between September 25, 2020, and April 5, 2024. EXPOSURE: The PERIXa (Perioperative Factor Xa Inhibitor Discontinuation in Patients With Atrial Fibrillation Undergoing Minimal to Low Bleed Risk Procedures) protocol recommending giving the last dose of factor Xa inhibitor (ie, apixaban, edoxaban, or rivaroxaban) 24 hours before the procedure (ie, endoscopy, dental procedure, or ocular surgery) and restarting treatment with the inhibitor the next day. MAIN OUTCOMES AND MEASURES: The primary outcome was major bleeding, and the secondary outcome included a composite of thromboembolic events 30 days after the index procedure with minimal to low bleeding risk. RESULTS: In total, 1902 patients were included in the modified intention-to-treat analysis set encompassing all patients who underwent the intended procedure (mean [SD] age, 70.4 [8.8] years; 1135 [59.7%] male; mean [SD] CHA2DS2-VASc [congestive heart failure, hypertension, age 75 years or older, diabetes, stroke, vascular disease, age 65-74 years, and female sex; range, 0-9, with higher scores indicating higher risk of stroke] score, 2.8 [1.3]; mean [SD] HAS-BLED [hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65 years, and drug or alcohol use; range, 0-9, with higher scores indicating higher risk of bleeding] score, 1.6 [0.7]). Among them, 921 (48.4%) were receiving apixaban, 616 (32.4%) were receiving edoxaban, and 365 (19.2%) were receiving rivaroxaban. Of the total procedures, 948 (49.8%) were endoscopy, 820 (43.1%) were dental procedures, and 120 (6.3%) were ocular surgery. The 30-day event rate of major bleeding was 0.1% (n = 2), and there were no composite thromboembolic events. The results were consistent in the per-protocol analysis, and no differences were observed by procedure category or factor Xa inhibitor type. CONCLUSIONS AND RELEVANCE: In this cohort study, patients with AF receiving a factor Xa inhibitor and undergoing a procedure with minimal to low bleeding risk had low rates of major bleeding and thromboembolism when following the standardized PERIXa protocol for perioperative management of oral anticoagulant treatment, suggesting that this may be a safe and reasonable option for this patient population.
BACKGROUND AND OBJECTIVES:Cryoballoon ablation (CBA) is considered an effective rhythm control treatment for atrial fibrillation (AF) and is increasing exponentially. However, data regarding the efficacy and safety of CBA in elderly patients are limited. METHODS:A total of 2,652 patients (55.2% with non-paroxysmal AF) from the Korean CBA registry database with follow-up of ≥12-months after de novo CBA were divided into 2 groups based on age (<75 and ≥75 years old). Procedure related complications and clinical outcomes were compared. RESULTS:Compared to the control group (n=2,403), the elderly group (n=249) had female predominance (41.8% vs. 21.1%, p<0.001), a higher CHA₂DS₂-VASc scores (4.0 [3.0-5.0] vs. 2.0 [1.0-3.0]; p<0.001), and a higher prevalence of heart failure (33.3% vs. 21.9%; p<0.001) and chronic kidney disease (42.2% vs. 10.4%; p<0.001). A total of 120 procedure-related minor complications were reported, but no significant difference was observed between the 2 groups (6.4% vs. 4.3%; p=0.18). Recurrence of atrial tachyarrhythmias was observed in 67 patients (27.2%) in the elderly group and 788 patients (33.3%) in the control group. After adjusting for confounding variables, the freedom from atrial tachyarrhythmias during 24-month was similar between the 2 groups (67.0% vs. 62.7%; adjusted hazard ratio, 0.91; 95% confidence interval, 0.62-1.34; p=0.63). CONCLUSIONS:CBA showed a reasonable efficacy and safety profile in elderly population with AF, comparable to that in younger patients.
OBJECTIVE:This study aimed to compare the lipid-lowering effect and safety of low-intensity atorvastatin (5 mg) plus ezetimibe (10 mg) combination therapy (A5E10) with monotherapy regimens-atorvastatin 5 mg [A5], ezetimibe 10 mg [E10], and atorvastatin 10 mg [A10])-in dyslipidemia patients. METHODS:A randomized, double-blind, placebo-controlled trial involving 252 dyslipidemia patients was conducted at 25 centers in South Korea (NCT05970679). Participants aged ≥ 19 years were randomized into four groups: A5E10, A5, E10, and A10. The primary endpoint was the percentage change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 8 weeks. Secondary endpoints included changes in other lipid parameters, lipid ratios, LDL-C goal achievement rates and safety assessments. RESULTS:The mean age of the patients was 63 years, and 51.2% were male. The A5E10 group showed significantly greater LDL-C reduction (47.6%) compared with A5 (33.4%), E10 (19.4%), and A10 (40.1%) at 8 weeks (p < 0.0001). A5E10 also significantly reduced triglyceride, non-high-density lipoprotein cholesterol, and apolipoprotein B levels. In addition, a significant reduction in LDL-C levels was observed over the 4 weeks, with a 46.7% reduction in LDL-C levels after 4 weeks of A5E10 administration. No severe adverse events were observed in the A5E10 group. CONCLUSION:The combination of low-intensity atorvastatin and ezetimibe was more effective than moderate-intensity atorvastatin monotherapy in lowering LDL-C levels and improving other lipid parameters. It was well-tolerated and demonstrated rapid benefits within a month, offering a promising alternative for patients with low to moderate cardiovascular risk who do not achieve adequate control with statin monotherapy.
BACKGROUND AND OBJECTIVES:Optimal anticoagulation in very elderly patients is challenging due to the high risk of anticoagulant-induced bleeding. The aim of this study was to assess outcomes of on-label reduced-dose edoxaban (30 mg) in very elderly patients who had additional risk factors for bleeding. METHODS:This was a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of on-label reduced-dose edoxaban in atrial fibrillation (AF) patients 80 years of age or older and who had more than 1 risk factor for bleeding. RESULTS:A total of 2448 patients (mean age 75.0±8.3 years, 801 [32.7%] males) was included in the present study, and 586 (23.9%) were 80 years of age or older with additional risk factors for bleeding. Major bleeding events occurred frequently among very elderly AF patients who had additional bleeding risk factors compared to other patients (unadjusted hazard ratio [HR], 2.16; 95% confidence interval [CI], 1.16-4.02); however, there were no significant differences in stroke incidence (HR, 1.86; 95% CI, 0.98-3.55). There were no significant differences for either factor after adjusting for age and sex (adjusted HR, 1.65; 95% CI, 0.75-3.62 for major bleeding; adjusted HR, 1.13; 95% CI, 0.51-2.50 for stroke). CONCLUSIONS:In very elderly AF patients with comorbidities associated with greater risk of bleeding, the incidence of major bleeding events was significantly increased. In addition, risk of stroke showed tendency to increase in same population. Effective anticoagulation therapy might be important in these high-risk population, and close observation of bleeding events might also be required. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03554837.
Background and Objectives: Although a single -lead electrocardiogram (ECG) patch may provide advantages for detecting arrhythmias in outpatient settings owing to user convenience, its comparative effectiveness for real-time telemonitoring in inpatient settings remains unclear. We aimed to compare a novel telemonitoring system using a single -lead ECG patch with a conventional telemonitoring system in an inpatient setting. Methods: This was a single -center, prospective cohort study. Patients admitted to the cardiology unit for arrhythmia treatment who required a wireless ECG telemonitoring system were enrolled. A single -lead ECG patch and conventional telemetry were applied simultaneously in hospitalized patients for over 24 hours for real-time telemonitoring. The basic ECG parameters, arrhythmia episodes, and signal loss or noise were compared between the 2 systems. Results: Eighty participants (mean age 62 +/- 10 years, 76.3% male) were enrolled. The three most common indications for ECG telemonitoring were atrial fibrillation (66.3%), sick sinus syndrome (12.5%), and atrioventricular block (10.0%). The intra-class correlation coefficients for detecting the number of total beats, atrial and ventricular premature complexes, maximal, average, and minimal heart rates, and pauses were all over 0.9 with p values for reliability <0.001. Compared to a conventional system, a novel system demonstrated significantly lower signal noise (median 0.3% [0.1-1.6%] vs. 2.4% [1.4-3.7%], p<0.001) and fewer episodes of signal loss (median 22 [2-53] vs. 64 [22-112] episodes, p=0.002). Conclusions: The novel telemonitoring system using a single -lead ECG patch offers performance comparable to that of a conventional system while significantly reducing signal loss and noise. Trial Registration: Clinical Research Information Service Identifier: KCT0008176
The ROsulord® sAfety for patients with Dyslipidemia study (ROAD study) in the Republic of Korea investigated the safety and efficacy of rosuvastatin in routine clinical practice. This non-interventional, multicenter, prospective, observational study was conducted over a period of approximately 4.6 years and involved 14,243 participants. During this study, we assessed the adverse events, changes in laboratory test results, and efficacy endpoints associated with rosuvastatin use. The findings revealed a notably low adverse event rate of 1.63
Although the adverse effects of long-term use of vitamin K oral anticoagulant (OAC), warfarin, on the coronary vasculature are well-established, it remains unknown whether nonvitamin K oral anticoagulants play a role in the attenuation of plaque progression and coronary calcification. This study aimed to compare the changes in atherosclerotic plaques and calcification of the coronary arteries in patients with atrial fibrillation (AF) treated with edoxaban and warfarin. A total of 150 OAC-naïve patients with AF and atherosclerotic lesions on coronary computed tomography angiography (CCTA) were enrolled and randomly assigned to the edoxaban or warfarin treatment groups. All enrolled patients received rosuvastatin 10 mg and 119 patients completed the entire study protocol. A total of 12 months after the assigned OAC treatment, follow-up CCTA was performed and changes in plaque and calcium volumes of the coronary arteries were analyzed. The baseline characteristics of the 2 groups were well-balanced. The percentage of time in therapeutic range in the warfarin group was 61.1%. Compared with the baseline CCTA, there was a significant reduction in plaque volume after 12 months of OAC and rosuvastatin administration in both groups, and the extent of regression did not differ significantly between the groups. The increase in calcium volume was greater in the warfarin group than in the edoxaban group; however, the difference was not significant. In OAC-naïve patients with AF and atherosclerotic coronary lesions who were treated with moderate-intensity statin, edoxaban use did not have a positive effect on atherosclerotic plaques and coronary calcification compared with warfarin use over a 12-month follow-up period.
BACKGROUND AND OBJECTIVES Previous studies have reported an association between impaired renal function and poor outcomes after radiofrequency catheter ablation in patients with atrial fibrillation (AF). However, outcomes of cryoballoon ablation (CBA) in patients with renal insufficiency are not fully elucidated. This study aimed to compare outcomes of CBA in AF patients with chronic kidney disease (CKD) versus those without CKD and to assess changes in renal function over 12 months following CBA. METHODS A total of 839 patients (65.1% with non-paroxysmal AF [PAF]) who underwent de novo CBA were prospectively enrolled. We divided patients into two groups based on creatinine clearance rate (CCr) and performed intracardiac echocardiography (ICE)-guided contrast agent-free CBA. RESULTS In comparison with patients without CKD (CCr >50, n=722), those with CKD (CCr ≤50, n=117) were older and predominantly female, had a lower body mass index, and showed a higher prevalence of heart failure and hypertension. Mean CHA2DS2-VAS score was significantly higher in CKD group than in non-CKD group. Procedure-related complications were not significantly different between two groups. During a mean follow-up period of 25.4±11.9 months, clinical recurrence occurred in 182 patients (21.7%) and not significantly different between two groups. In multivariate analysis, non-PAF and left atrial size were independent predictors of AF recurrence. CCr levels significantly improved over 12 months after CBA in CKD group. CONCLUSIONS ICE-guided contrast-agent-free CBA showed comparable long-term clinical outcomes without increasing procedure-related complications and improvement of renal function over 12 months following CBA in AF patients with CKD.
Aims The development of intracardiac echocardiography (ICE) has enabled fluoroless atrial fibrillation (AF) ablation using three-dimensional electroanatomical mapping systems. However, fluoroless cryoballoon ablation (CBA) remains challenging, mainly because of the lack of a visual mapping system. Hence, this study aimed to investigate the safety and efficacy of fluoroless CBA for AF under ICE guidance. Methods and results Patients (n = 100) who underwent CBA for paroxysmal AF were randomly assigned to zero-fluoroscopic (Zero-X) and conventional groups. Intracardiac echocardiography was used to guide the transseptal puncture and catheter and balloon manipulation in all enrolled patients. The patients were prospectively followed for 12 months after CBA. The mean age was 60.4 years, and the left atrial (LA) size was 39.4 mm. Pulmonary vein isolation (PVI) was achieved in all patients. In the Zero-X group, fluoroscopy was used in only one patient because of unstable phrenic nerve capture during right-sided PVI. The procedure time and LA indwelling time in the Zero-X group were not statistically different compared with that in the conventional group. Fluoroscopic time (9.0 vs. 0.008 min) and radiation exposure (29.4 vs. 0.02 mGy) were significantly shorter in the Zero-X group than in the conventional group (P < 0.001). The complication rate did not differ between the two groups. During a mean follow-up of 663.3 +/- 172.3 days, the recurrence rate was similar (16.0 vs. 18.0%; P = 0.841) between the groups. Multivariate analysis revealed that LA size was the only independent predictor of clinical recurrence. Conclusion Intracardiac echocardiography-guided fluoroless CBA for AF was a feasible strategy without compromising acute and long-term success or complication rates.
Aims Posterior wall isolation (PWI) of the left atrium (LA) adjunct to pulmonary vein isolation (PVI) by radiofrequency catheter ablation has shown favourable outcomes in patients with persistent atrial fibrillation (PeAF). This study was sought to investigate the efficacy and safety of additional PWI by cryoballoon ablation (CBA) alone in patients with PeAF. Methods and results Patients who underwent de novo CBA for PeAF (n = 100) were randomly assigned (1 : 1) to the PVI only group and PVI combined with PWI (PVI+PWI) group. Procedural and clinical outcomes were prospectively compared over a 12-month follow-up. Baseline characteristics, including mean AF duration (56.2 ± 43.2 months) and LA size (48.2 ± 7.7 mm), were well-balanced between the groups. Successful PVI was achieved in all patients. In the PVI+PWI group, complete PWI by CBA was achieved in 31 (62%) patients. The LA indwelling and procedure times were significantly longer in the PVI+PWI group. The complication rates were not different between groups. During a mean follow-up of 457.9 ± 61.8 days, the recurrence rate of atrial tachyarrhythmia was significantly lower in the PVI+PWI group than in the PVI only group (24% vs. 46%; P = 0.035). The recurrence-free survival rate was significantly higher in the PVI+PWI group compared with the PVI only group, irrespective of complete PWI (log-rank P = 0.013). Multivariate analysis showed that adjunctive PWI [hazard ratio (HR) 0.255; P = 0.003] and LA size (HR 1.079; P = 0.014) were independent predictors of clinical recurrence. Conclusion Compared with PVI only, adjunctive PWI achieved exclusively by CBA resulted in better clinical outcomes without increasing complications in patients with PeAF.
Single-shot ablation has emerged as an effective technique for index atrial fibrillation (AF) ablation, with an advantage of short procedure time. Although recent guidelines recommend peri-procedural uninterrupted oral anticoagulants (OACs), the intra-procedural anticoagulation strategy remains uncertain under non-vitamin K OACs (NOACs). We investigated procedural safety of a single bolus administration of heparin without activated clotting time (ACT) measurement during cryoballoon ablation (CBA). Two hundred patients (64.2 ± 10.0 years, 70% with non-paroxysmal AF) who underwent CBA with uninterrupted NOACs were randomly assigned to No-ACT group and ACT group. A bolus of heparin (100 U/kg) was routinely administered immediately after transseptal puncture. In the ACT group, an additional injection of heparin (30 U/kg) was administered if ACT at 30 min after the initial bolus was < 300 s. There were no differences in baseline characteristics including CHA2DS2-VASc score between the two groups. The left atrium indwelling and procedure times were 60.4 ± 13.1 min and 78.9 ± 13.9 min, respectively, and not significantly different between the two groups. The mean ACT was 335.2 ± 59.9 s in the ACT group. Any bleeding rate was 3.2% in all patients and there was no statistically significant difference in bleeding complications between the two groups. In the ACT group, groin hematoma, laryngopharyngeal bleeding, and hemoptysis occurred in 3, 1, and 1 patient, respectively. Cardiac tamponade occurred in 1 patient in the No-ACT group. No thromboembolic events occurred during the 30-day follow-up after CBA. Single bolus administration of heparin without ACT measurement is a feasible anticoagulation strategy for CBA in patients with uninterrupted NOAC intake.
Introduction: Integration of electroanatomical map (EAM) with preacquired three-dimensional (3D) cardiac images provides detailed appreciation of the complex anatomy of the left atrium (LA) and pulmonary vein (PV). High-density (HD) multi-electrode mapping catheters have enabled creating more accurate EAM reflecting real-time volume-rendered LA-PV geometry during atrial fibrillation (AF) ablation. However, no study has compared the outcomes of AF ablation using HD-EAM versus 3D-merged map. We aimed to investigate the procedural and clinical outcomes of AF ablation with HD-EAM (HD-EAM group) versus 3D-merged map (Merge group). Methods: One hundred patients (59.5±11.5years, 53% with paroxysmal AF [PAF]) were randomly assigned (1:1) to HD-EAM or Merged group. HD multi-electrode mapping and contact force (CF)-sensing catheters were used to create virtual LA-PV chamber and to perform wide antral circumferential ablation (WACA), respectively. Results: The two groups showed no significant differences in baseline characteristics and procedural data including ablation time, fluoroscopy time, LA voltage, and CF. PV isolation with a single WACA line was achieved in 21 (42%) and 27 (54%) patients in the Merge and HD-EAM groups, respectively (P=NS). CF was significantly lower in lesions with gap than lesions without gap after a single WACA (7.3±7.3 g vs. 16.0±8.3, respectively, P<0.001). During the 12-month follow-up, no significant difference in AF recurrence was observed between two groups, irrespective of AF type. In multivariate analysis, non-PAF was an independent risk factor for AF recurrence. Conclusion: Integration of 3D cardiac imaging did not improve procedural and clinical outcomes. HD-EAM provides an accurate real-time LA geometry.
There are limited data regarding the association between brain natriuretic peptide (BNP) levels obtained after weaning from extracorporeal membrane oxygenation (ECMO) and the outcomes of patients with acute coronary syndrome (ACS)-associated cardiogenic shock. We prospectively obtained data regarding patients (aged >= 19 years) with ACS-associated cardiogenic shock who received ECMO and were subsequently weaned off the treatment. BNP levels were collected at 5 time points: pre-ECMO implantation, post-ECMO implantation, pre-ECMO weaning, day 1 after ECMO weaning, and day 5 after ECMO weaning. Of 48 patients with ACS-related cardiogenic shock, 33 were included in this analysis. Mean patient age was 59.0 (50.0-66.5) years, and 5 patients (15.2%) were women. Eight patients had asystole/pulseless electrical activity before ECMO and 14 (42.4%) had 3-vessel disease on coronary angiography. During the 6-month follow up, 12 (36.4%) patients died. BNP levels after ECMO weaning were significantly different between 6-month survivors and non-survivors. Cox proportional hazards model revealed that BNP levels (tertiles) on days 1 and 5 after ECMO weaning were significantly associated with 6-month mortality (hazard ratio, 7.872; 95% confidence interval, 1.870-32.756; 8.658 and 1.904-39.365, respectively). According to the Kaplan-Meier curves, the first tertile had significantly longer survival compared to the third tertile for both days 1 and 5 after ECMO weaning. Post-ECMO weaning BNP levels (days 1 and 5) were significantly associated with increased 6-month mortality in patients with ACS complicated by refractory cardiogenic shock who were weaned off ECMO.
BACKGROUND:This study aimed to identify the determinant factors of survival in patients with acute myocardial infarction (AMI) and refractory cardiogenic shock (RCS) who underwent veno-arterial extracorporeal membrane oxygenation (ECMO). METHODS:Sixty-nine consecutive patients with AMI-related RCS were enrolled in the study. They were treated with ECMO and primary percutaneous coronary intervention (PCI). The clinical scores and coronary angiography (CAG) factors related to 100-day survival were evaluated. RESULTS:Thirty patients (43.5%) survived for more than 100 days. The CAG showed that 19 (27.5%) patients had left main disease (LMD). There were 17 (24.6%), 27 (39.1%), and 25 (36.3%) patients with one-vessel, two-vessel, and three-vessel disease, respectively. There were significant differences between the survivors and non-survivors in the simplified acute physiology score II (SAPSII) (65.4±17.2 vs. 83.1±13.0, P<0.001), sepsis-related organ failure assessment score (SOFA) (10.4±2.7 vs. 12.3±2.5, P=0.004), survival after veno-arterial extracorporeal membrane oxygenation score (SAVE) (-4.4±4.3 vs. -8.4±3.1, P<0.001), CPR time (15.8±16.6 vs. 30.0±29.5, P=0.048), LMD [4 (13.3%) vs. 15 (38.5%), P=0.029], and number of coronary artery disease (NCAD) (P<0.001). Multivariate logistic regression analysis showed that NCAD (OR 3.788, P=0.008) was one of the independent predictors of mortality. The ROC analysis showed that SAPSII (AUC 0.786, P<0.001), SOFA (AUC 0.715, P=0.002), and SAVE (AUC 0.766, P<0.001) equally predict mortality. The combined NCAD parameters more accurately predicted mortality and differences in the AUC values (d-AUC) between SAPSII plus NCAD vs. SAPSII (d-AUC 0.073, z=2.256, P=0.024), SOFA plus NCAD vs. SOFA (d-AUC 0.058, z=2.773, P=0.006), and SAVE plus NCAD vs. SAVE (d-AUC 0.036, z=2.332, P=0.020). CONCLUSIONS:The SAPSII, SOFA, and SAVE scores predict the prognosis of ECMO-treated AMI patients with RCS. The CAG findings reinforce the predictive power of each score.
AIMS The formation of radiofrequency lesions depends on the power and duration of ablation, and the contact force (CF). Although high power (HP) creates continuous and transmural lesions, most centres still use 25-30 W for 30-40 s for safety reasons. We evaluated the clinical efficacy and safety of a HP and short-duration (HPSD) strategy for atrial fibrillation (AF) ablation. METHODS AND RESULTS One hundred and fifty patients [58.2 ± 10.0 years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter were randomly assigned to three groups [30 W, 40 W, and 50 W at ablation sites of anterior, roof, and inferior segments of pulmonary vein (PV) antra and roof line between each upper PV]. In 25-30 W for ≤20 s was applied at posterior wall ablation site in all subjects. Compared with the 30 W and 40 W groups, procedure (P < 0.001) and ablation times (P < 0.001) were shorter and ablation number for PV isolation (P < 0.001) was smaller in the 50 W group. There were no significant differences in the CF and ablation index (AI) among the three groups. There were no significant differences in the procedure-related complication rates. During the 12-month follow-up, AF recurred in 24 (16%) patients with no significant difference among the groups (P = 0.769). In the multivariate analysis, non-PAF [hazard ratio (HR) 2.836, P = 0.045] and AI (HR 0.983, P = 0.001) were independent risk factors for AF recurrence. CONCLUSION Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.