Introduction
Materials and methods
Study population
Sedation management and monitoring protocol
Cryoballoon pulmonary vein isolation
Electroanatomical mapping procedure
Statistical analysis
Ethics
Results
Baseline characteristics of the study population
Total | Cryoballoon PVI | 3D-mapping | p value | |
---|---|---|---|---|
Patients, n | 125 | 67 | 58 | |
Age, years | 66.8 ± 12.3 | 66.6 ± 12.1 | 67.0 ± 12.5 | 0.84 |
Male, n (%) | 73 (58) | 39 (58) | 34 (59) | 0.96 |
BMI (Body mass index), kg/m2 | 28.5 ± 6.0 | 28.6 ± .5.7 | 28.5 ± 6.2 | 0.96 |
Obesity (BMI ≥ 30 kg/m2), n (%) | 32 (26) | 20 (30) | 12 (21) | 0.33 |
Normal LVEF, n (%) | 91 (73) | 46 (69) | 45 (78) | 0.36 |
Coronary artery disease, n (%) | 49 (39) | 28 (42) | 21 (36) | 0.65 |
Hypertension, n (%) | 91 (73) | 50 (75) | 41 (71) | 0.77 |
Diabetes mellitus, n (%) | 31 (25) | 18 (27) | 13 (22) | 0.71 |
Smoker, n (%) | 6 (5) | 5 (7) | 1 (2) | 0.21 |
Former-Smoker, n (%) | 28 (22) | 14 (21) | 14 (24) | 0.83 |
Pulmonary disease | ||||
COPD, n (%) | 4 (3) | 2 (3) | 2 (2) | 1.00 |
Asthma, n (%) | 4 (3) | 1 (2) | 3 (5) | 0.34 |
Sleep apnea, n (%) | 4 (3) | 3 (4) | 1 (2) | 0.62 |
Liver function | ||||
AST, (U/L) | 25.2 ± 7.7 | 25.2 ± 8.0 | 25.3 ± 7.3 | 0.97 |
γGT, (U/L) | 48.1 ± 40.1 | 46.2 ± 31.0 | 50.3 ± 48.6 | 0.57 |
Renal function | ||||
Creatinine,, (µmol/L) | 99.7 ± 46.6 | 100.1 ± 57.7 | 99.2 ± 28.9 | 0.91 |
GFR, (mL/min) | 67.4 ± 22.4 | 68.8 ± 22.0 | 65.9 ± 22.8 | 0.48 |
CKD ≥ 2, n (%) | 105 (84) | 57 (85) | 48 (83) | 0.91 |
Longer procedure duration and higher propofol use in EAM procedures with the same safety level
Total | Cryoballoon PVI | EAM | p value | |
---|---|---|---|---|
Procedure duration, minutes | 125.8 ± 54.3 | 96.3 ± 34.5 | 159.9 ± 53.0 | < 0.001 |
Sedative medication | ||||
Midazolam, mg | 4.9 ± 0.6 | 4.9 ± 0.8 | 4.9 ± 0.4 | 0.81 |
Propofol, mg | 575.7 ± 297.0 | 484.5 ± 200.9 | 681.0 ± 350.5 | < 0.001 |
Fentanyl, µg | 74.6 ± 32.8 | 74.6 ± 32.8 | – | |
Remifentanyl, µg | 189 ± 92 | – | 189 ± 92 | |
Morphine equivalent dose, mg | 44.2 ± 24.1 | 9.0 ± 3.9 | 35.3 ± 20. 2 | < 0.001 |
Time course of hemodynamic and respiratory parameters
Electroanatomical mapping procedures and cryoballoon ablation procedures are similar in hemodynamic and respiratory safety endpoints
Total | Cryoballoon PVI | EAM | p value | |
---|---|---|---|---|
125 | 68 | 57 | ||
MAP < 65 mmHg, patients | 59 (47) | 29 (43) | 30 (53) | 0.43 |
Hypercapnia tpCO2 > 70 mmHg, patients | 4 (3) | 2 (3) | 2 (4) | 0.86 |
Hypoxia tSpO2 < 90%, patients | 43 (34) | 24 (35) | 19 (33) | 0.97 |
Cumulative hypoxia time, minutes | 343 | 189 | 155 | 0.86 |