Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Echocardiography
2.3. Ablation Procedure
2.3.1. LB Ablation
2.3.2. RFA
2.4. Patient Follow-Up
2.5. Statistical Analysis
3. Results
3.1. Baseline Characteristics
3.2. Ablation Procedure Characteristics
3.3. Ablation Results
4. Discussion
4.1. Main Results
- ▪
- LB demonstrated similar success rates at one-year follow-up than contact-force RF in paroxysmal AF ablation.
- ▪
- Complications rates were low in each group, suggesting a satisfying safety profile for LB technology.
- ▪
- Procedure durations were much shorter for LB, especially using the X3 balloon, than for RF, but required a longer fluoroscopic duration.
4.2. Efficacy
4.3. Safety
4.4. Procedure Duration
4.5. Second and Third-Generation of LB
4.6. Limitations
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Laser-Balloon N = 50 | Radiofrequency N = 50 | p-Value |
---|---|---|---|
Demographics | |||
Age—years | 63 (54–68) | 61 (53–65) | 0.201 |
Male sex—no. (%) | 35 (70) | 35 (70) | 1 |
BMI—kg/m2 | 26.4 (23.6–30.0) | 26.2 (24.0–30.2) | 0.890 |
Comorbidities | |||
Hypertension—no. (%) | 18 (36) | 21 (42) | 0.682 |
Diabetes—no. (%) | 3 (6) | 1 (2) | 0.617 |
Dyslipidemia—no (%) | 8 (16) | 19 (38) | 0.023 |
CHA2DS2-VASc Score | 1 (0–2) | 1 (0–3) | 0.627 |
Active smoking—no. (%) | 4 (8) | 10 (20) | 0.148 |
Obstructive sleep apnea—no. (%) | 4 (8) | 6 (12) | 0.739 |
COBP—no (%) | 5 (10) | 1 (2) | 0.204 |
Obesity—no (%) | 14 (28) | 13 (26) | 1 |
Stroke—no (%) | 1 (2) | 5 (10) | 0.204 |
HFrEF—no. (%) | 4 (8) | 3 (6) | 1 |
Coronary artery disease—no (%) | 2 (4) | 8 (16) | 0.092 |
Renal failure—no (%) | 3 (6) | 3 (6) | 1 |
Previous Medication | |||
B-blocker—no (%) | 25 (50) | 24 (48) | 1 |
Amiodarone—no (%) | 17 (34) | 20 (40) | 0.534 |
Flecainide—no (%) | 24 (48) | 20 (40) | 0.420 |
Sotalol—no (%) | 5 (10) | 2 (4) | 0.436 |
Echocardiography features | |||
LVEF—% | 60 (55–65) | 60 (56–65) | 0.908 |
LVEF < 50%—no (%) | 3 (6) | 1 (2) | 0.617 |
Left atrial dilatation—no (%) | 22 (44) | 22 (44) | 1 |
Left atrial surface area—cm2 | 20 (17–23.5) | 20.5 (16.9–24) | 0.861 |
Left atrial volume indexed—mL/m2 | 33 (25–40) | 32.9 (27.2–40.6) | 0.532 |
Variable | Laser-Balloon N = 50 | Radiofrequency N = 50 | p-Value |
---|---|---|---|
Cardiac rhythm | |||
Heart rate at the beginning of procedure—bpm | 60 (55–68) | 60 (53–66) | 0.991 |
AF at the beginning of procedure—no (%) | 7 (14) | 2 (4) | 0.160 |
AF at the end of procedure—no (%) | 5 (10) | 2 (4) | 0.436 |
Cardiac anatomy | |||
Left pulmonary veins—no (%) | 0.480 | ||
1 (Left pulmonary trunk) | 6 (12) | 8 (16) | |
2 | 44 (88) | 40 (82) | |
3 | 0 | 1 (2) | |
Right pulmonary veins—no (%) | 0.393 | ||
1 (Right pulmonary trunk) | 0 | 1 (2) | |
2 | 47 (94) | 48 (96) | |
3 | 2 (4) | 0 | |
4 | 1 (2) | 1 (2) | |
Procedure characteristics | |||
Procedure duration—min | 129 (110–160) | 160 (119–198) | 0.007 |
Iodinated contrast media—ml | 2 (2–3) | 2 (1–2) | <0.001 |
Fluroscopy duration—min | 16.1 (12.2–24) | 9.8 (6.9–13.6) | <0.001 |
Dose-area product—cGy.cm2 | 439 (250–851) | 761 (334–1315) | 0.324 |
Radiofrequency duration—min | x | 29 (22.9–37.7) | |
Number of RF applications—no (%) | x | 52 (36–64) | |
Complication—no (%) | 2 (4) | 2 (4) | 1 |
Cardiac tamponade | 1 (2) | 2 (4) | |
Transient phrenic nerve palsy | 1 (2) | 0 | |
In hospital follow-up | |||
Electrical cardioversion after AF ablation—no (%) | 4 (8) | 0 (0) | 0.117 |
Antiarrhythmic drug at hospital discharge—no (%) | 44 (88) | 38 (76) | 0.192 |
Amiodarone—no (%) | 13 (26) | 17 (34) | 0.513 |
Flecainide—no (%) | 27 (54) | 17 (34) | 0.069 |
Sotalol—no (%) | 3 (6) | 2 (4) | 1 |
Beta-blockers at discharge—no (%) | 17 (34) | 12 (24) | 0.271 |
Hospital stay duration—days | 4 (4–4) | 4 (4–4) | 0.871 |
One-year follow-up | |||
AF recurrence—no (%) | 7 (14) | 14 (28) | 0.14 |
Time to AF recurrence—days | 186 (114–284) | 190 (98–216) | 0.860 |
Redo procedure—no (%) | 2 (2) | 2 (2) | 1 |
Excalibur N = 26 | X3 N = 24 | p | |
---|---|---|---|
Ablation | |||
Laser duration on left pulmonary veins—min | 33 (21.5–37) | 11.6 (9–17.5) | <0.001 |
Laser duration on right pulmonary veins—min | 35 (27–42) | 9 (6.6–13.5) | <0.001 |
Total Laser duration—min | 69 (55–76) | 22 (19–29) | <0.001 |
Number of left veins manual shots | 49 (39–55.8) | 8 (0–13) | <0.001 |
Number of right veins manual shots | 51 (41–58) | 0 (0–6) | <0.001 |
Number of manual shots | 101 (89–109.8) | 14 (8.3–21.3) | <0.001 |
Number of left veins RAPID shots | 0 | 2.5 (0–6) | |
Number of right veins RAPID shots | 0 | 3 (0–5.8) | |
Number of RAPID shots | 0 | 12 (0–19.5) | |
All PV isolated at first pass | 15 (58) | 17 (71) | 0.388 |
All PV isolated at procedure end | 24 (92) | 22 (92) | 1 |
AF onset during procedure | 3 (12) | 2 (8) | 1 |
Procedure data | |||
Procedure duration—min | 151.5 (128.5–167) | 111 (100–128) | <0.001 |
Iodinated contrast media—ml | 2 (2–3) | 2 (2–3.8) | 0.501 |
Fluroscopy duration—min | 17.8 (12.9–23.3) | 14.9 (11.5–24.4) | 0.382 |
Dose-area product—cGy.cm2 | 443.5 (268.3–775.5) | 439 (220–869) | 0.645 |
Complication—no (%) | 1 (4) | 1 (4) | |
Cardiac tamponade | 1 (4 | 0 | |
Transient phrenic nerve palsy | 0 | 1 (4) | |
AF recurrence—no (%) | 4 (15) | 3 (13) | 1 |
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Guenancia, C.; Hammache, N.; Docq, C.; Benali, K.; Hooks, D.; Echivard, M.; Pace, N.; Magnin-Poull, I.; de Chillou, C.; Sellal, J.-M. Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort. J. Cardiovasc. Dev. Dis. 2021, 8, 183. https://doi.org/10.3390/jcdd8120183
Guenancia C, Hammache N, Docq C, Benali K, Hooks D, Echivard M, Pace N, Magnin-Poull I, de Chillou C, Sellal J-M. Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort. Journal of Cardiovascular Development and Disease. 2021; 8(12):183. https://doi.org/10.3390/jcdd8120183
Chicago/Turabian StyleGuenancia, Charles, Nefissa Hammache, Clémence Docq, Karim Benali, Darren Hooks, Mathieu Echivard, Nathalie Pace, Isabelle Magnin-Poull, Christian de Chillou, and Jean-Marc Sellal. 2021. "Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort" Journal of Cardiovascular Development and Disease 8, no. 12: 183. https://doi.org/10.3390/jcdd8120183
APA StyleGuenancia, C., Hammache, N., Docq, C., Benali, K., Hooks, D., Echivard, M., Pace, N., Magnin-Poull, I., de Chillou, C., & Sellal, J. -M. (2021). Efficacy and Safety of Second and Third-Generation Laser Balloon for Paroxysmal Atrial Fibrillation Ablation Compared to Radiofrequency Ablation: A Matched-Cohort. Journal of Cardiovascular Development and Disease, 8(12), 183. https://doi.org/10.3390/jcdd8120183