Abstract
Background: A novel multielectrode radiofrequency balloon (RFB) catheter has been released for pulmonary vein isolation (PVI).
Methods and Results: In this observational study consecutive patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) undergoing first-time PVI were enrolled in 2 high-volume ablation centers. All procedures were conducted in conjunction with a 3D-mapping system. Clinical, procedural and ablation parameters were systematically analyzed. 105 patients (58% male; 52% paroxysmal AF, 68±11.3 years mean age, left atrial volume index 38.6±14.8 mL/m2) were included. 241/412 (58.5%) PVs were successfully isolated with a single shot (SS), with a time-to-isolation of 11.6±8 s. Total number of radiofrequency applications was 892 (mean 2.2/PV), resulting in successful isolation of 408/412 (99%) PVs at the end of the procedure. Mean electrodes’ impedance drop was significantly higher in the SS-PVI compared with non-SS applications (21.5±6.6 vs. 18.6±6.5 Ohm). Concordantly, higher temperature rise was observed in the SS vs. non-SS applications (10.9±4.9℃ vs. 9.6±4.7℃).
Conclusions: In this multicenter real-world study, mean impedance drop and temperature rise were associated with successful SS-PVI applying the novel RFB catheter. These parameters may help to guide efficient usage of the new RF balloon.
Pulmonary vein isolation (PVI) is so far the only established endpoint for catheter ablation of atrial fibrillation (AF).1 With thermal radiofrequency (RF)- or cryoenergy-based ablation technologies PVI can be obtained with comparable efficacy and safety outcomes.2,3 Cryoablation is mainly based on balloon-catheter systems, which have demonstrated shorter learning curves when compared with point-by-point RF ablation, better reproducibility and a beneficial safety profile.4 On the other hand, compared with conventional RF catheters, cryoballoon technologies do not allow for energy titration and are usually not compatible with 3D mapping systems, thus potentially resulting in longer fluoroscopy times.5
The novel RF balloon (RFB) catheter combines the advantages of both systems: a balloon-based technology allowing for titratable RF energy application, embedded in a 3D mapping system. The multi-electrode RFB catheter (Heliostar, Biosense Webster) has a 28-mm compliant and irrigated balloon equipped with 10 gold electrodes attached to the balloon’s surface. A circular mapping catheter (Lassostar, Biosense Webster) can be introduced into the inner lumen to record PV potentials. Both the RFB and mapping catheter can be visualized in the Carto 3D mapping system (Biosense Webster) (Figure 1A). Each individual RFB electrode senses temperature and impedance parameters before and during RF energy application (Figure 1A), and energy can be delivered from selected electrodes and adapted to the electroanatomical characteristics of the target tissue in order to optimize efficacy and reduce the risk of collateral damage. Moreover, ablation parameters for each electrode are automatically stored and can be reviewed (Figure 1B).
To date, available acute efficacy and 1-year follow-up data are sourced from 2 studies, RADIANCE6,7 and SHINE,8 which evaluated this novel ablation platform in 2 multicenter cohorts with paroxysmal AF. However, there are no data identifying the parameters of successful PVI at first energy application.
Here, we report the initial experience with this new balloon in 2 high-volume German tertiary ablation centers in unselected patients undergoing PVI as routine care.
Methods
Patient Population
The study population comprised patients undergoing first-time PVI. All patients were enrolled prospectively at the University Heart and Vascular Center Hamburg Eppendorf and the Cardio-angiology Center Bethanien Frankfurt/Main (Germany) and gave written informed consent. Patients were included into the study from August 2021 to July 2022 (78 patients in Center 1, 27 in Center 2). The study was approved by the local ethics committees and performed in accordance with the Declaration of Helsinki.
Inclusion criteria were age ≥18 years, documented AF unresponsive to antiarrhythmic drug (AAD) treatment and suitability for peri- and postprocedural anticoagulation. Exclusion criteria included previous PVI or left atrial ablation, left atrial (LA) diameter >55 mm, AF secondary to reversible or noncardiac causes, severe structural heart disease and uncontrolled heart failure.
Preprocedural Management
All patients underwent transthoracic echocardiography (TTE) within 2 months and transesophageal echocardiography (TEE) within 48 h before the procedure. Anticoagulation therapy with novel oral anticoagulants (NOAC) was uninterrupted until the day before the procedure. For patients on vitamin K antagonists, the periprocedural target INR was 2–3.
Ablation Procedure
All procedures were performed under deep sedation using propofol, midazolam, and fentanyl. Two femoral venous accesses were obtained: one to advance a 7F steerable decapolar catheter (Parahis, Biosense Webster) into the coronary sinus and the second for single transeptal puncture using a modified Brockenbrough technique and a SL1 sheath (8.5F, St. Jude Medical). After transseptal puncture, intravenous heparin was administered to maintain an activated clotting time (ACT) >350 s.
PV ostia were identified using selective PV angiography. Pre- and post-ablation 3D mapping of the LA were obtained with the LASSO NAV catheter (Biosense Webster). After LA mapping, the regular transseptal sheath was changed for the Guidestar sheath (14F inner diameter). RFB positioning at the PV ostium was performed using both fluoroscopic and CARTO 3 mapping system guidance (Figures 1A,2A). Real-time PV electrograms were obtained by the Lassostar catheter and the RFB electrodes (Figure 1A, Left). Impedance and temperature values for each RFB electrode (Figure 1A, Right) were displayed in real time and indicated balloon-tissue contact at the PV ostium. In order to provide optimal electrode-tissue contact and RFB positioning, the following parameters were targeted: inflation index >0.8, impedance of 100±20 Ohms across all electrodes, and temperature variability across all electrodes <3℃, with a maximum temperature of 31℃. RFB applications were delivered at a temperature-controlled unipolar energy mode of 15 W, and a target electrode temperature under RF delivery of 55℃. As recommended by the manufacturer, each application lasted 60 s for the electrodes facing the anterior, superior, and inferior aspects of the targeted PV and 20–30 s for electrodes facing the posterior wall. Energy delivery was immediately stopped along the posterior wall electrodes at esophageal temperatures >39℃ as measured by an esophageal temperature probe. If the esophageal temperature further increased, the electrodes adjacent to the posterior electrodes were also switched off. Before ablation of the right-sided PVs, pacing of the anterior electrodes at maximal output (2 ms, 10 mA) was performed in order to realize potential phrenic nerve capture at the desired balloon position. During RFB applications along the right-sided PVs, phrenic nerve pacing was performed at a cycle length of 700 ms and at maximal output. After each application, all values of impedance and temperature (Figure 1B) for each electrode were reviewed.
TTE was performed after each procedure to rule out pericardial effusion. Full-dose NOAC anticoagulation was started 6 h after the procedure, maintained for at least 3 months, and thereafter according to the individual CHA2DS2-VASc score. AADs were continued, discontinued or started at the discretion of the operator.
Clinical Follow-up
Patients had scheduled follow-up at 3 and 6 months. All patients underwent 24-h ECG ambulatory monitoring at 3 and 6 months as per standard clinical practice.
Statistical Analysis
Continuous data are described as mean and standard deviation in normally distributed data, or as median, 25th and 75th percentiles otherwise. Categorical data are described with absolute and relative frequencies. Two-sided P<0.05 was considered statistically significant. All calculations were performed with GraphPad Prism 6 or Microsoft Excel 365. After proving the normal distribution of the ablation parameters through a Shapiro-Wilk test, a two-sided Student’s T-test was performed to compare the single-shot (SS) and non-SS applications.
A Kaplan-Meier curve was drawn to describe AF-free survival at the 6-month follow-up.
Results
Patients’ Characteristics
A total of 105 consecutive patients undergoing first-time PVI were enrolled. Detailed baseline characteristics are shown in Table 1. Mean age was 68±11 years, 62/105 (59%) patients were male, and 55/105 (52%) had paroxysmal AF. Mean LA volume was 38.6±14.8 mL/m2
and mean left ventricular ejection fraction (LVEF) was 56.5±9.3%, with 89% of patients having LVEF ³50%. Mean CHA2DS2-VASc score was 2.6±1.6 and comorbidities were: 24/105 (23%) coronary artery disease, 65/105 (62%) arterial hypertension, 17/105 (16%) diabetes mellitus, and 5/105 (5%) previous stroke or transient ischemic attack. At the time of the procedure all patients were under NOAC therapy.
Table 1. Baseline Characteristics and Medical Histories of the Patients (n=105)
| Variable |
Statistics |
| Age (years) |
68±11.3 |
| Male, n (%) |
61/105 (58) |
| BMI (kg/m2) |
28±5.6 |
| Paroxysmal atrial fibrillation, n (%) |
55/105 (52.4) |
| LA volume index (mL/m2) |
38.6±14.8 |
| LVEF (%) |
56.5±9.3 |
| ≥50% |
93/105 (88.6) |
| 40–49% |
7/105 (6.7) |
| CHA2DS2-VASc score |
2.6±1.6 |
| No. of failed AADs |
1±0.6 |
| AAD class (median) |
2 |
| NOAC |
105/105 (100) |
| Comorbidities, n (%) |
| Coronary artery disease |
24/105 (22.9) |
| Hypertension |
65/105 (61.9) |
| Diabetes |
17/105 (16.2) |
| Stroke/TIA |
5/105 (4.8) |
Continuous data are summarized as mean±standard deviation. Categorical data are presented as n (%). AAD, antiarrhythmic drug; BMI, body mass index; LA, left atrial; LVEF, left ventricular ejection fraction; NOAC, new oral anticoagulants; TIA, transient ischemic attack.
A total of 412 PVs were identified and targeted (105 right superior (RS) PVs, 104 right inferior (RI) PVs, 98 left superior (LS) PVs, 98 left inferior (LI) PVs, 7 left common (LC) PVs). Mean ablation time per patient was 8.1±3.9 min. Real-time electrogram recordings were obtained in 371/412 (90%) PVs (Table 2). Figure 3 and Supplementary Movie show an example of a PVI with disappearance of electrograms during RFB application. Mean procedure and fluoroscopy times were 91±31 min and 16.4±6.7 min, respectively. The mean dose–area product was 1,088.7±940 cGcm2. The mean RFB LA dwell time was of 36.2±18.3 min (Table 2).
Table 2. Characteristics of RF Applications
| Variable |
Statistics |
| Total balloon dwell time (min) |
36.2±18.3 |
| Total ablation time (min) |
8.1±3.9 |
| Acute effectiveness, n PVs isolated/total PVs (%) |
408/412 (99) |
| Online PV signal visualization, n (%) |
371/412 (90) |
| Single-shot isolation/total PVs, n (%) |
241/412 (58.5) |
| LSPV |
41/98 (41.8%) |
| LIPV |
57/98 (58.2%) |
| LCPV |
3/7 (42.9%) |
| RSPV |
63/105 (60%) |
| RIPV |
77/105 (73.3%) |
| Time-to-isolation (n) |
11.6±8 |
| LSPV |
13.9±7 |
| LIPV |
10.5±7.3 |
| LCPV |
11.5±0.7 |
| RSPV |
11.6±8.6 |
| RIPV |
11.3±8.5 |
| Applications/PV, n (%) |
892/412 (2.2) |
| LSPV |
2.9±2.4 |
| LIPV |
2.2±2.2 |
| LCPV |
3.7±3.3 |
| RSPV |
1.9±1.1 |
| RIPV |
1.7±1 |
| Bonus applications/PV, n (%) |
70/412 (17) |
| Esophageal temperature >39℃, n (%) |
75/412 (18.2) |
| LSPV |
21/98 (21.4) |
| LIPV |
36/98 (36.7) |
| LCPV |
4/7 (57.1) |
| RSPV |
2/105 (1.9) |
| RIPV |
12/105 (11.4) |
Continuous data are summarized as mean±standard deviation. Categorical data are presented as n (%). LC, left common; LI, left inferior; LS, left superior; PV, pulmonary vein; RF, radiofrequency; RI, right inferior; RS, left superior.
A total of 408/412 PVs (99%) were successfully isolated solely using the RFB catheter, with only 4/412 (1%) of PVs with failed isolation (Table 2). Two LSPVs and 2 LIPVs could not be isolated with the RFB (after 2, 5, 17 and 5 applications, respectively): 3 PVs were left non-isolated, and 1 LSPV RF touch-up ablation was performed.
The total number of applications was 892, with a mean number of 2.2 applications per PV (2.9±2.4 LSPVs, 2.2±2.2 LIPVs, 3.7±3.3 for LCPVs, 1.9±1.1 for the RSPVs, 1.7±1 LIPVs).
Although there was a trend towards less RFB applications at the right-sided vs. the left-sided PVs, it did not reach statistical significance (P>0.05; Figure 4A).
SS isolation, defined as sustained electrical block with the first RFB application, was achieved in 241/412 (58.5%) PVs (41/98 (41.8%) LSPVs, 57/98 (58.2%) LIPVs, 3/7 (42.9%) LCPVs, 63/105 (60%) RSPVs, 77/105 (73.3%) RIPVs; Figure 4B). Mean time-to-isolation TTI for applications with SS isolation was 11.6±8 s (13.9±7 s in LSPVs, 10.5±7.2 s in LIPVs, 11.5±0.7 s in LCPVs, 11.6±8.6 s in RSPVs, 11.3±8.5 s in RIPVs). In 70/412 (17%) PVs a bonus application after successful PVI was performed (Table 2).
The mean electrodes’ impedance drop (Figure 4C) was higher in the SS-PVI compared with non-SS applications (21.5±6.6 vs. 18.6±6.5Ohm, P<0.001). Concordantly, higher temperature rise (Figure 4D) was observed in the SS vs. non-SS applications (10.9±4.9℃ vs. 9.6±4.7℃, P<0.001). Per vein, the following values were respectively observed: 23.2±3.6 vs. 20.3±4.2 Ohm (P<0.001) and 11.8±2.1 vs. 10.1±2.9℃ (P value=0.002) for LSPVs, 20.8±3.8 vs. 16.2±3.7 Ohm (P<0.0001) and 11±2.5 vs. 8.8±2.7℃ (P<0.0001) for LIPVs, 23.3±4.1 vs. 19.8±6.1 Ohm (P>0.05) and 9.4±2.3 vs. 9.9±2.6℃ (P>0.05) for LCPVs, 20.7±4.9 vs. 18.6±4.3 Ohm (P value=0.030) and 9.8±3.6 vs. 9.8±3.7℃ (P>0.05) for RSPVs, and 21.7±5.8 vs. 18.2±5.4 Ohm (P=0.009) and 11.2±3.9 vs. 9.2±3.3℃ (P=0.026) for RIPVs.
Esophageal Temperature Monitoring
Esophageal temperature rise exceeding 39℃ occurred in 75/412 (18.2%) PVs (21/98 (21.4%) LSPVs, 36/98 (36.7%) LIPVs, 4/7 (57.1%) LCPVs, 2/105 (1.9%) RSPVs, 12/104 (11.4%) RIPVs) (Table 2). Mean maximal esophageal temperature in PVs exceeding 39℃ was 41.7±2.1℃ (41.2±1.8℃ for LSPVs, 42±2.3℃ for LIPVs, 40.3±1℃ for LCPVs, 39.9±1℃ for RSPVs, 42.3±1.6℃ for RIPVs).
Procedural Complications
Asymptomatic phrenic nerve paralysis occurred in 1/105 (1%) patients during ablation of the RSPV. Only 2 RF applications were necessary to isolate the PV, and the second application was immediately interrupted after appreciation of the loss of capture of the phrenic nerve. It is important to point out that this was the third patient treated in 1 of the 2 centers and in this case, due to technical problems, it was not possible to perform selective pacing from the balloon electrodes located along the anterior wall before applying RF. This was the only case in the cohort where pacing from the balloon was not performed. Nevertheless, selective pacing from a decapolar catheter located in the superior vena cava was performed during the RF application. Impedance drop and temperature rise during the culprit application were 24.5±7.1 Ohm and 22±6.9℃, respectively. In particular, the rise in temperature during this application was significantly higher than the mean values observed in both the SS and the non-SS applications (impedance drop: 21.5±6.6 Ohm and temperature rise: 10.9±4.9℃ in the SS group; impedance drop: 18.6±6.5 Ohm and temperature rise 9.6±4.7℃ in the non-SS group). From our experience we can conclude that pacing from the balloon electrodes facing the anterior wall should always be performed.
Pericardial tamponade requiring pericardiocentesis occurred in 1/105 (1%) patient, a 62-year-old man (BMI 36 kg/m2, CHA2DS2-VASc score 2 [arterial hypertension and coronary artery disease]). Tamponade was treated with pericardiocentesis, without need of thoracotomy. It was overall an uneventful procedure and a clear reason for the cardiac tamponade was unfortunately not identified. A blood gas analysis of the effusion showed PCO2, PO2, and pH values in favor of an arterial origin. In this patient, we noticed a high number of applications at the lateral PVs: 5 for the LSPV and 5 for the LIPV. Nevertheless, we cannot rule out another cause (e.g., transeptal puncture, perforation).
Stroke occurred in 2/105 (2%) patients. One patient developed dysarthria and a left-sided hemiparesis: magnetic resonance imaging revealed a mesencephalic infarction. The other patient presented a paresis of the left arm related to an embolic infarction in the right precentral gyrus. Both patients underwent preprocedural TEE with no evidence of LA/LA appendage thrombi. Both strokes were treated conservatively, and the symptoms had resolved at the 3-month follow-up. Charring at the balloon catheter was not observed in either procedure. ACT levels in both procedures were <350 s. Thereafter the target periprocedural ACT was set at >350 s. Ablation time and ablation parameters in both patients did not differ from those for the general cohort. Ablation time was 4 min (4 SS applications) in the first patient and 11 min (11 RF applications distributed as follows: 4 for the LSPV, 3 for the LIPV, 1 for the RSPV and 3 for the RIPV) in the second patient. Impedance drop values in patient 1 for all the PVs resulted in slightly above the mean of the SS group (LSPV: 24.6±10.6 Ohm and 14±9℃; LIPV: 22.7±6.5 Ohm and 10.1±3.9℃; RSPV: 28.6±7.8 Ohm and 12.1±2.2℃, RIPV: 23±3.3 Ohm and 11.8±4.7℃ vs. an impedance drop of 21.5±6.6 Ohm and a temperature rise of 10.9±4.9℃ in the SS group). In patient 2 the following ablation parameters were recorded: 23.5±6.8 Ohm and 10.2±6.5℃ for the LSPV, 17.8±5.2 Ohm and 8.5±4.6℃ for the LIPV, 30.1±11.5 Ohm and 12.3±5.1℃ for the RSPV, 21±1.9 Ohm and14.8±4.3℃ for the RIPV. The operators suspected that difficulties in handling of the Guidestar delivery sheath was the probable origin of the cardioembolic complications. Therefore, special caution was dedicated to preventing air embolism during catheter change. In particular, we performed careful balloon and delivery sheath preparation. The balloon and sheath were flushed multiple times with heparinized saline to prevent any residual air bubbles. During insertion of the balloon into the delivery sheath careful aspiration from the sheath was performed.
No atrioesophageal fistula, symptomatic gastroparesis, myocardial infarction, symptomatic PV stenosis or procedure-related death was reported. Asymptomatic PV stenosis cannot be excluded because postprocedural CT-scans were not performed. However, at 6-month follow-up, no patient reported symptoms referrable to PV stenosis.
Lastly, in the current analysis 4 major complications were reported. To be noted, all major complications in our cohort occurred in the first 25 patients treated; since patient 25 in both centers no further major complications were recorded. After case 25 the only complication was a groin hematoma: a false aneurysm was diagnosed and treated with a thrombin injection.
Rhythm Outcomes
The 6-month follow-up showed an overall freedom from AF of 74% (74/100 patients) (Figure 5); 17% (17/100) of patients experienced recurrence withing the blanking period (3 months), and 9% (9/100) after the blanking time. Data were available for 100 patients from both centers; 5 patients were lost at follow-up.
Discussion
Novel and innovative technologies designed for PVI are rapidly changing the world of AF ablation, aiming for more effective, safer and potentially easier interventions.9 In the current prospective and multicenter analysis, we demonstrated that (1) the novel RFB effectively isolated the PVs; (2) >50% of PVs can be isolated with a single, short RF application, and (3) successful isolation at first application attempt is associated with a higher impedance drop and temperature rise.
The novel RFB combines favorable characteristics of established ablation tools: it incorporates RF as the energy source, has a compliant balloon-shaped catheter design, and is fully integrated into a 3D-mapping platform. Although RF is the most established energy source and can be titrated and adapted according to individual ablation strategies and ablation targets,10 balloon-shaped catheters have proved to be very safe, highly effective and demonstrate a short learning curve.4,6 The integration into a 3D-mapping platform allows for manipulation of the ablation catheter without requiring frequent fluoroscopic guidance and therefore reduces fluoroscopy exposure for both patients and operators. Using the system in conjunction with an adapted spiral mapping catheter introduced via the central lumen of the system enables for real-time electrical information from inside the target PV and registration of the individual TTI.
First trials and publications5–7 had already demonstrated the potential of the new RFB catheter for safe and effective ablation, with an incidence of acute PVI of 99%. These results are in line with our data showing high acute PVI rates of 99% combined with a SS isolation rate of 58.5%.
The system provided the real-time temperature and impedance of each ablation electrode, and for each application the temperature and impedance dynamics are stored for further analysis. This study is the first to investigate the ablation parameters of SS isolation in a large multicenter cohort of patients, and we demonstrated a clear association between acute ablation success, defined as SS-PVI, and the impedance and temperature changes during the RF application. Ablation parameters proved to be valuable method of predicting the efficacy of the applications, and significantly differed between SS and non-SS applications. Applications with a mean impedance drop of 21.5 Ohm and a temperature rise of 10.9℃ reproducibly resulted in acute and SS-PVI, and the PV did not recover during the procedure, whereas SS-PVI was not achieved by applications with lower mean impedance drop and/or temperature rise, or the PV recovered immediately. These findings might help to further improve the quality of ablation lesions and thus the durability of PVI, which is the prerequisite for beneficial clinical outcomes. Through confirmation of tissue contact and electrogram recordings the RF balloon was constantly able to provide feedback to the operator. This is a unique characteristic of the balloon catheter’s conformation, which to date has been mainly based on anatomic occlusion of the PVs. The clinical implication of that finding could be further modification of the ablation strategy to immediate additional RFB applications for consolidation of the induced ablation lesions in cases of inadequate temperature/impedance changes in order to establish durable PVI. Whether inadequate temperature rise and impedance drop might also trigger an extension of the application duration beyond 20 s along the posterior wall and 60 s along the remaining aspects of the respective PV needs further evaluation. Apart from the application time, the energy levels could also be modified or additional energy could be applied at selected electrodes with inadequate impedance drop or temperature rise to target electrical gaps and avoid unnecessary application to the whole PV circumference. However, these questions need to be addressed in future evaluations.
Study Limitations
The current study was an observational, prospective, non-randomized analysis in a limited number of patients. Further studies are needed to support the large-scale reproducibility and to provide long-term clinical follow-up.
Conclusions
In a multicenter real-world setting, PVI by RFB is acutely highly effective, and catheter-tissue contact, evaluated in terms of ablation parameters, significantly differed between SS and non-SS PV.
Disclosures
A.M. received speaker’s honoraria and travel grants from Medtronic, Biosense Webster, EPD Solutions/Philips (KODEX-EPD) and a research grant from Farapulse. A.R. received travel grants, speaker and consultant fees from Biosense Webster, Medtronic, Cardiofocus, Ablamap and EPD Solutions/Philips (KODEX-EPD). B.S. received speaking honoraria from Abbott, Biosense Webster, Boston Scientific, Cardiofocus, and Medtronic. K.-R.J.C. received speaking honoraria from Biosense Webster, Boston Scientific, and Medtronic. B.R. received speaker’s honoraria and travel grants from Medtronic. L.D. received a research grant from Farapulse, and was supported by the Research Promotion Fund of the Faculty of Medicine (Hamburg, “Clinician Scientist Program”). S.B. received speaking honoraria from Biosense Webster, Cardiofocus, Boston Scientific, and Medtronic. I.M. received research support for basic research projects from the European Society of Cardiology. P.K. received research support for basic, translational, and clinical research projects from the European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and German Centre for Cardiovascular Research, from several drug and device companies active in atrial fibrillation, and has received honoraria from several such companies in the past, but not in the past 3 years. P.K. is listed as inventor on 2 patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783).
IRB Information
The present study was approved by the institutional ethics committee. Reference number: NCT05521451, 2020-10066-BO
Supplementary Files
Supplementary Movie. Live pulmonary vein isolation shown on the 3D mapping system.
Please find supplementary file(s);
https://doi.org/10.1253/circj.CJ-23-0220
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