Abstract
Background: The application of radiofrequency ablation for pulmonary vein isolation (PVI) under general anesthesia (GA) has shown a lower recurrence rate of atrial fibrillation (AF) compared with deep sedation (DS). However, the effect of the different anesthesia methodology on catheter stability remains unclear.
Methods and Results: We enrolled 32 patients (16 in each group) who underwent PVI using radiofrequency ablation with the CARTO system. The contact force (CF) at each ablation point and catheter tip movement distance were analyzed using VISITAGTM. A total of 1,863 points (GA: 964 points, DS: 899 points) were analyzed for the CF, and 1,969 points (GA: 1,000 points, DS: 969 points) were analyzed for the catheter tip movement distance. The GA group demonstrated a significantly higher mean CF (GA: 12.94±5.27 g vs. DS: 11.93±5.11 g; P<0.01), as well as a higher minimum CF (GA: 4.61±3.85 g vs. DS: 3.79±3.98 g, P<0.01), compared with the DS group. Additionally, catheter tip movement distance was significantly shorter in the GA group than in the DS group (GA: 1.65±0.76 mm vs. DS: 2.29±1.10 mm, P<0.01).
Conclusions: Catheter ablation under GA ensures better maintenance of adequate CF and catheter stability than DS.
Catheter ablation of atrial fibrillation (AF) is a standard therapeutic strategy, and periprocedural anesthetic management plays an important role in achieving both safety and efficacy. Various sedation techniques, including general anesthesia (GA), deep sedation (DS), and conscious sedation (CS), are used during AF ablation. According to a global survey, GA is utilized in 40.5% of cases, followed by CS in 32.0% and DS in 27.5%. The choice of sedation method is influenced by regional practices, institutional protocols, availability of anesthesia specialists, and individual patient factors.1
Several studies have suggested that performing pulmonary vein isolation (PVI) under GA is associated with a lower recurrence rate of AF than when performed under CS.2 That improved outcome is thought to result from enhanced catheter stability and lesion formation, facilitated by controlled patient movement and precise respiratory management under GA. However, there are few detailed comparative analyses of catheter stability, including contact force (CF) and catheter movement, across different sedation methods during PVI.
In this study, we aimed to examine the differences in catheter stability under GA and DS during PVI, to provide deeper insights into the effect of anesthetic technique on procedural outcomes.
Methods
Subjects
This single-center, retrospective, observational study included 32 patients who underwent initial AF ablation between March 2022 and April 2023. The patients were categorized into groups according to anesthesia method: 16 consecutive patients underwent GA, for whom ablation data were successfully collected, and the other 16 patients received DS during the same period. To minimize potential confounding factors, we selected DS cases performed during a period that closely matched the timing of GA procedures, as differences in procedural strategy, catheters and sheaths used could influence catheter stability and procedural outcomes. The choice of anesthesia was based on the patient’s preference and the discretion of the attending physician, considering factors such as the availability of an anesthesiologist on the procedure day, the patient’s body habitus, personality traits, and medical history.
Procedure for PVI
Catheter ablation was performed following a standardized procedural protocol to minimize variations among the facilities and operators. An electroanatomical mapping system (CARTO 3, [Biosense Webster, Irvine, CA, USA]) was used for catheter navigation, ablation guidance, and mapping. Ipsilateral encircling PVI was performed in all patients using an open-irrigated ablation catheter with a CF sensor (THERMOCOOL SMARTTOUCH SF®; Biosense Webster). The radiofrequency (RF) energy applications were guided by the VISITAG SURPOINT® module (Biosense Webster). The target ablation index was set at ≥450 for the anterior wall and ≥400 for the posterior wall with a CF of 5–20 g and an interlesion distance of ≤4–6 mm. The PVI was deemed complete when both entrance and exit blocks were confirmed after a waiting period ≥20 min. Electrical cardioversion was performed if AF persisted at the end of the PVI procedure.
Following the completion of PVI, AF or atrial tachycardia (AT) induction was attempted using atrial burst stimulation and intravenous administration of isoproterenol. Induced AT and non-PV AF triggers were ablated at the discretion of the attending operator. Additionally, cavotricuspid isthmus (CTI) ablation was performed when tricuspid isthmus-dependent atrial flutter was clinically observed. For superior vena cava (SVC) isolation, muscle relaxants were discontinued, and ablation was initiated only after confirming phrenic nerve capture.
Anesthesia Protocols
All GA management procedures were performed by anesthesiologists. With GA, induction of anesthesia was initiated with 6–10 mg/kg/h of remimazolam, 0.1 mg of fentanyl, and 0.6–0.9 mg/kg of rocuronium, followed by the insertion of an i-gelTM
(Intersurgical Ltd., Wokingham, Berkshire, UK). Anesthesia was subsequently maintained with remimazolam (0.6–2 mg/kg/h) and rocuronium (20–25 mg/h). The use of remifentanil was permitted at the discretion of the anesthesiologist. The depth of anesthesia was controlled using the Bispectral indexTM
(BIS; Aspect Medical Systems Inc., Natick, MA, USA). BIS values between 60 and 40 were targeted. If >2 mg/kg/h of remimazolam was required, we considered using propofol in combination. The ventilator was set in volume-controlled ventilation mode with a tidal volume of 6–8 mL/kg and adjusted to maintain an ETCO2 level of 35–45 mmHg. In addition to the BIS and ETCO2, blood pressure, ECG, and oxygen saturation were continuously monitored throughout the procedure by the anesthesiologist. After the ablation procedure, remimazolam and rocuronium were discontinued, and remimazolam was antagonized by 0.5 mg of flumazenil and rocuronium by 200 mg of sugammadex. Extubation was performed when adequate consciousness, spontaneous breathing, and circulation were confirmed. All DS procedures were performed by cardiologists. DS was initiated with 100–150 mg of thiopental and 6 μg/kg/h of dexmedetomidine for 15 min, followed by 0.2–0.7 μg/kg/h for maintenance. If the level of sedation was insufficient, thiopental was administered as needed. An intravenous injection of pentazocine hydrochloride was performed before starting the PVI. Patients were managed with adaptive servo-ventilation. If sedation led to a decrease in oxygenation, we considered inserting an oral or nasal airway.
CF and Catheter Tip Movement Distance
The CF parameters for each ablation point were automatically recorded at a frequency of 60/s. The ablation points were categorized into 8 regions: posterior wall, roof, anterior wall, and bottom of the left and right PVs. For each ablation point, the maximum, minimum, average, and median CF values were measured. The movement distance of the catheter tip was determined by the catheter 3D position recorded by the VISITAGTM
module (Biosense Webster) sampled at the same frequency of 60/s. Similar to the CF analysis, the average movement distance was calculated for the 8 different regions.
Follow-up
Patients were followed for 12 months and were required to visit the cardiology outpatient clinic at 6 and 12 months for a medical assessment. A standard 12-lead ECG in the supine resting position and 24-hour Holter ECG during daily life were performed before each outpatient visit. The Holter ECG was recorded using 2 leads: CM5 and 15 NASA.
Endpoints
We evaluated the rate of a first-pass isolation, CF, and the catheter tip movement distance. Additionally, the procedure time, complication rate, and freedom from AF/AT during follow-up were analyzed. AF/AT recurrence was defined as 1 of the following events: (1) AF/AT indicated on a scheduled or symptom-triggered ECG or (2) AF/AT ≥30 s duration on Holter ECG. AF/AT episodes during the 3 months after the initial or repeat ablation were not included as recurrence events (blanking period). Antiarrhythmic drug use was not recommended for 3 months after the ablation procedure.
Statistical Analysis
Continuous data are presented as the mean±standard deviation, and as counts and percentage if categorical. Data were compared using the Student’s t-test, χ2
test, and Fisher’s exact test for examining the differences between groups. After a 3-month blanking period, a Kaplan-Meier curve was plotted for the time to the first AF/AT recurrence following the initial ablation procedure, and the groups were compared by log-rank test. All tests were two-sided, and P<0.05 was considered statistically significant. Analyses were performed using R software (R Foundation for Statistical Computing, Vienna, Austria).
Results
Characteristics of the Patients
The baseline characteristics of the patients in this study are summarized in Table 1. Female patients were more common in the GA group, while the DS group had a higher prevalence of a heart failure history and higher CHADS2
scores. There were no significant differences between the groups regarding the frequency of paroxysmal AF or echocardiographic parameters.
Table 1.
Baseline Characteristics of Study Patients
| |
General anesthesia
(n=16) |
Deep sedation
(n=16) |
P value |
| Age, years |
66±12 |
70±10 |
0.36 |
| Female sex, n (%) |
6 (37.5) |
3 (18.8) |
0.03 |
| Body mass index, kg/m2 |
22.7±3.4 |
23.7±3.5 |
0.43 |
| Hypertension, n (%) |
7 (43.8) |
9 (56.2) |
0.72 |
| Diabetes mellitus, n (%) |
1 (6.2) |
2 (12.5) |
1.00 |
| History of heart failure, n (%) |
1 (6.2) |
8 (50) |
0.02 |
| CHADS2 score |
0.94±0.93 |
1.69±0.95 |
0.03 |
| Paroxysmal AF, n (%) |
5 (31.2) |
10 (62.5) |
0.16 |
| eGFR, mL/min/1.73 m2 |
61.6±13.5 |
60.0±12.1 |
0.73 |
| NT-proBNP, pg/mL, median (IQR) |
746.6 [282.8–1,233] |
551.5 [219.0–724] |
0.36 |
| LA diameter, mm |
42.7±9.1 |
45.1±5.5 |
0.39 |
| LVEF, % |
65.7±6.0 |
60.6±16.0 |
0.29 |
| E/e′ (septal) |
9.53±2.7 |
11.1±3.7 |
0.19 |
| LA volume, cm3 |
141.9±48.4 |
137.8±36.3 |
0.80 |
Values are mean±standard deviation, n (%), or median (interquartile range). BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; LA, left atrium; LVEF, left ventricular ejection fraction.
In the GA group, beyond PVI procedures were performed in 4 cases: SVC isolation in 2 cases, CTI ablation in 1 case, and ablation for low-voltage area in 1 case. In the DS group, beyond PVI procedures were performed in 9 cases: SVC isolation in 2 cases, CTI ablation in 3 cases, posterior wall isolation in 1 case, posterior wall isolation and CTI ablation in 2 cases, and ablation targeting premature atrial contractions in 1 case.
Rate of First-Pass Isolation
The success rate of first-pass isolation was 75% (12/16 cases) in the GA group and 81.2% (13/16 cases) in the DS group, with no significant difference between groups (P=1.0). This trend was consistent for both the left and right PVs (Table 2).
Table 2.
Rate of First-Pass Isolation
| |
General anesthesia
(n=16) |
Deep sedation
(n=16) |
P value |
| LPV, n (%) |
15 (93.8) |
13 (81.2) |
0.60 |
| RPV, n (%) |
13 (81.2) |
15 (93.8) |
0.60 |
| Total, n (%) |
12 (75.0) |
13 (81.2) |
1.00 |
LPV, left pulmonary vein; RPV, right pulmonary vein.
CF Analysis
Our analysis included 1,863 data points representing CF: 964 points from the GA group and 899 points from the DS group. The average, median, maximum, and minimum CF values are summarized in Table 3. The average CF was significantly higher in the GA group than in the DS group (12.94±5.27 g vs. 11.93±5.11 g; P<0.001). However, there was no significant difference in the maximum CF values between groups, suggesting comparable peak CF values.
Table 3.
Comparison of Contact Force Parameters Between the GA and DS Groups
| |
General anesthesia
(n=964) |
Deep sedation
(n=899) |
P value |
| Average CF, g |
12.94±5.27 |
11.93±5.11 |
<0.01 |
| Maximum CF, g |
25.92±13.22 |
25.67±13.67 |
0.69 |
| Minimum CF, g |
4.61±3.85 |
3.79±3.98 |
<0.01 |
Values are mean±standard deviation.
The GA group also had higher minimum CF values, indicating a consistently higher baseline CF than the DS group. Additionally, the proportion of CF values <5 g was analyzed for each of the 8 regions shown in Figure 1. This proportion was significantly lower in the GA group across all regions, except for the roof and bottom of the left PV.
Analysis of the Catheter Tip Movement Distance
We analyzed 1,969 data points representing the catheter tip movement distance: 1,000 points from the GA group and 969 points from the DS group. The average movement distance for each PV segment is summarized in Table 4. The GA group had a significantly shorter average movement distance than the DS group (1.65±0.76 mm vs. 2.29±1.10 mm; P<0.001). Consistent with the CF findings, segmental analysis of the PVs revealed significantly shorter catheter tip movement distances in the GA group across all segments.
Table 4.
Comparison of Catheter Tip Movement Distance Between the GA and DS Groups
| |
General anesthesia
(n=1,000) |
Deep sedation
(n=969) |
P value |
| All segments, mm |
1.65±0.76 |
2.29±1.10 |
<0.01 |
| LPV |
| Anterior, mm |
1.66±0.84 |
2.18±1.18 |
<0.01 |
| Bottom, mm |
1.82±0.99 |
2.52±1.40 |
<0.01 |
| Posterior, mm |
1.62±0.80 |
2.28±1.22 |
<0.01 |
| Roof, mm |
1.47±0.76 |
2.28±0.89 |
<0.01 |
| RPV |
| Anterior, mm |
1.60±0.63 |
1.99±0.83 |
<0.01 |
| Bottom, mm |
1.48±0.53 |
2.09±0.70 |
<0.01 |
| Posterior, mm |
1.70±0.71 |
2.48±1.15 |
<0.01 |
| Roof, mm |
1.84±0.78 |
2.76±0.98 |
<0.01 |
Values are mean±standard deviation. LPV, left pulmonary vein; RPV, right pulmonary vein.
Periprocedural Parameters and Follow-up
The procedure times for the GA and the DS groups were compared and analyzed based on the following parameters: the time from catheterization laboratory entry to procedure initiation, the time required for PVI, the time from catheter completion to exiting the catheterization laboratory, and the total time spent in the catheterization laboratory.
The time from catheterization laboratory entry to procedure initiation reflects the anesthesia induction time, while the time from catheter completion to exiting the laboratory reflects the anesthesia emergence time. In the GA group, the time from entry to procedure initiation was significantly longer than in the DS group. However, there was no significant difference between groups regarding the time from catheter completion to laboratory exit. Similarly, the time required for PVI and total time spent in the catheterization laboratory did not differ significantly between groups (Table 5).
Table 5.
Comparison of Procedure Time Between the GA and DS Groups
| |
General anesthesia |
Deep sedation |
P value |
| Entry-to-initiation time, min |
23.5±6.5 |
14.5±3.6 |
<0.01 |
| PVI time, min |
44.9±22.2 |
38.9±17.4 |
0.42 |
| Completion-to-exit time, min |
32.3±7.4 |
27.3±6.4 |
0.053 |
| Total procedure time, min |
150.1±44.0 |
159.0±61.3 |
0.64 |
Values are the mean±standard deviation. PVI, pulmonary vein isolation.
No major complications were observed in either the GA or DS group. The mean follow-up duration for all patients in the study was 362±130 days. During this period, AF or AT recurrence was observed in 3 of 16 patients (18.8%) in the GA group and 5 of 16 patients (31.2%) in the DS group. Kaplan-Meier survival curve analysis showed no significant difference in the AF/AT recurrence rates between groups (P=0.49, Figure 2).
In the GA group, all 3 patients with recurrence underwent a second procedure, and a PV reconnection was observed in 1 of them. In the DS group, only 1 of the 5 patients with recurrence underwent a second procedure, and a PV reconnection was also observed in that case.
Discussion
In this study, we analyzed the effect of GA compared with DS on PVI of AF. To the best of our knowledge, this is the first study to evaluate the utility of GA administered by anesthesiologists for PVI of AF, focusing on both CF and catheter stability using VISITAGTM
(Biosense Webster) at all ablation points.
A previous analysis of the National Anesthesia Clinical Outcomes Registry, which included 51,070 cases of AF ablations between 2013 and 2018, reported that 94% of the ablation cases were performed under GA in the USA.3 In contrast, in Japan and Europe, GA is less commonly utilized for PVI, with DS or CS being more prevalent.4 GA offers advantages, including minimizing patient body movement and enabling stable respiratory management, both of which are essential for maintaining catheter stability and consistent CF. Our study demonstrated that GA provided a more stable CF and improved catheter tip stability compared with DS.
Importance of CF
CF is a key determinant of effective lesion formation during PVI. Previous studies have demonstrated that the CF significantly influences the size and quality of RF ablation lesions.5 Insufficient or intermittent CF can lead to ineffective or non-uniform lesion formation, whereas a stable CF within the optimal range is strongly associated with successful clinical outcomes.6 However, an excessively high CF does not necessarily improve the outcome and may increase the risk of complications such as cardiac tamponade or steam pops.7
In our study, the GA group exhibited a higher average minimum CF compared with the DS group, but the maximum CF exhibited no significant difference between groups. These findings suggest that GA facilitates continuous and safe maintenance of the target CF, which is essential for an effective and safe ablation procedure.
Catheter Stability and Ventilation Strategies
Catheter stability is another essential factor for effective lesion formation. Previous studies have indicated that catheter excursion during lesion placement is a significant predictor of AF recurrence after PVI.8 In our study, the catheter stability was significantly higher in the GA group compared with the DS group across all regions. This improvement can be attributed to the reduction in patient movement and consistent respiratory management achieved with GA.
Although standard ventilator settings were used in this study, some reports suggest that high-frequency, low-tidal-volume ventilation may further enhance catheter stability and improve clinical outcomes.9 Optimizing ventilator settings under GA could potentially yield even better results. Additionally, factors such as increased body surface area, heavier body weight, and the presence of congestive heart failure have been associated with greater catheter excursion.8 In such cases, the proactive application of GA may be particularly beneficial.
Limitations of GA and the Role of Remimazolam
Despite its advantages, GA has certain limitations compared with DS. One concern is the potential for longer procedure times and increased personnel requirements. In our study, the time from catheterization laboratory entry to procedure initiation was significantly longer in the GA group than in the DS group. This difference reflected the additional time required for mask ventilation, i-gelTM
insertion, and ventilator setup during GA induction by the anesthesiologist. However, the time from catheter completion to exiting the catheterization laboratory did not differ significantly between groups, indicating that awakening and i-gelTM
removal under GA were as efficient as the recovery process with DS.
A unique aspect of this study was the use of remimazolam for GA. Although propofol is commonly used for GA during catheter ablation, remimazolam was selected by our anesthesiologists. Remimazolam, a benzodiazepine receptor agonist, is characterized by its rapid onset and recovery due to a short context-sensitive half-life.10,11 Additionally, the availability of its antagonist, flumazenil, allows for rapid reversal of sedation. These properties may have contributed to the comparable awakening times observed between the GA and DS groups. Another notable characteristic of remimazolam is its hemodynamic stability compared with propofol. Remimazolam reduces the occurrence of hypotension,12 which may contribute to procedural stability, especially in patients with heart failure or impaired cardiac function.
Clinical Outcomes and Future Directions
In this study the observed improvements in CF stability and catheter stability under GA suggested that GA is an optimal choice for achieving a safer, more effective, and refined treatment compared with DS. Previous studies have compared either CF or catheter tip movement between GA and DS,13,14 but to the best of our knowledge, no study has simultaneously evaluated both CF and catheter tip movement, which is one of the strengths of our study, because both parameters are essential for achieving optimal lesion formation. For instance, insufficient CF may compromise catheter stability, whereas excessive CF may reduce catheter mobility. However, in this study no significant differences were observed in the first-pass isolation rate or clinical outcomes. This lack of statistical significance may be attributed to the small sample size. Although the analysis of approximately 1,900 ablation points provided a comprehensive and statistically reliable assessment, the clinical outcomes were assessed in only 32 patients, which may have limited the ability to detect significant differences. Nevertheless, in PVI, which is predominantly performed using a point-by-point ablation approach, maintaining the quality of each ablation point is considered essential for improving clinical outcomes.
Another important feature of our study is that GA was managed by anesthesiologists, which allowed for the optimal selection of anesthetic agents suitable for catheter ablation. The use of appropriate anesthetic agents, such as remimazolam, can facilitate the procedure without significantly prolonging the overall procedure time. Our findings indicated that the benefits of GA outweighed its limitations.
The advantages observed with GA could potentially result in better long-term clinical outcomes, and further studies with larger sample sizes and optimized ventilator settings are warranted to confirm the clinical benefits of GA for PVI of AF.
Study Limitations
This study had several limitations that should be taken into account. It was a single-center, non-randomized study with a relatively small number of patients. The choice between GA and DS was left to the discretion of the attending physician, introducing the potential for selection bias. To validate these findings, future studies with larger sample sizes and randomized designs are required. Moreover, a more comprehensive analysis of optimal anesthesia techniques and respiratory settings for catheter ablation procedures is crucial to refine and standardize approaches, ensuring safer and more effective outcomes.
Conclusions
GA with muscle relaxants and remimazolam provided significant advantages over DS in maintaining stable CF and catheter position during PVI of AF. By minimizing patient movement and optimizing respiratory management, GA enhanced procedural precision, which may improve the clinical outcomes.
Acknowledgments
The authors extend their appreciation to the hospital’s clinical engineers (Mr. Riku Iwami, Mr. Naoya Kurata, Mr. Kentaro Kobayashi, and Mr. Hiroaki Fukuchi) and to Mr. Yosuke Inagawa (Biosense Webster, Osaka, Japan) for their invaluable support during the ablation procedure and data acquisition.
Disclosures
T. Kanda has received personal fees from Daiichi Sankyo, Medtronic, Johnson & Johnson, Abbott, and Boston Scientific outside the submitted work; H.M. is a member of Circulation Reports’ Editorial Team and has received personal fees from Medtronic, Abbott, Nihon Kohden, Biotronik, Japan Lifeline, Boston Scientific, Philips, Cook Medical, Bayer Daiichi Sankyo, Johnson & Johnson and Microport outside the submitted work.
IRB Information
The study was approved by the Institutional Review Board of Osaka Keisatsu Hospital. Reference number: 1603. Written informed consent was obtained from all individual participants included in the study.
Data Availability
Deidentified participant data will not be shared.
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