randomized pilot trial to assess the effect of esophageal ......daniel moura, maria cazco, renner...
TRANSCRIPT
Erythema (Stage 1) Bruise (Stage 2)
Erosion (Stage 3) Ulcer (Stage 4)
Daniel Moura, Maria Cazco, Renner Pereira, Lucas de Moura, Ítalo Souza, Pedro Linhares, Nathalia Monge, Muhieddine Chokr, Carina Hardy, Sissy de Melo, Cristiano Pisani and Mauricio Scanavacca.
Heart Institute, University of São Paulo Medical School, São Paulo, Brazil
Introduction➢ Esophageal thermal injury (ETI) is a known
complication of radiofrequency catheter ablation
(RFA) for AF. The role of luminal esophageal
temperature monitoring (LET) on ETI it’s not well
established.
Objectives➢ To evaluate if the esophageal temperature
monitoring with a multipolar thermometer
decrease the rate of ETI on patients (pts)
submitted to RFA for AF compared to a single
probe or no LET monitoring.
➢Esophageal temperature monitoring using a multi-
probe thermometer reduces the rate of
esophageal thermal injury during RF pulmonary
vein isolation.
Methods ➢ This is a prospective and randomized pilot
trial.
➢ All pts referred for a first RFA for AF were
evaluated and included considering inclusions
and exclusions criteria and underwent AF
ablation with CARTO 3 SmartTouch ST-SF
catheter, between July/2017 and
October/2018.
➢ Esophagogastroduodenoscopy was performed
in up three days in all pts.Results
➢ All 60 pts did EGD and all had PVI; 30% in the single-
probe group had ETI, 25% in the no probe e none at
the multipolar probe (p=0.006).
➢ In the single-probe, 2 pts had ETI stage 2; 4 had ETI
stage 3 and one had stage 4. In the no probe group,
one had ETI stage 1; 2 had stage 3 and 2 had stage 4.
➢ In some pts the operator choose to ablate the carina
to achieve PVI but, there was no difference between
the groups. In the multi-probe group the LET was
higher, the RF time and the time to achieve PVI was
lower but it wasn’t statistically significant.
Methods➢ P-values of <0.05 were considered statistically
significant, and the trial was registered at
ClinicalTrials.gov #NCT03645070
➢ Esophageal thermal injury was classified as none
(Stage 0) and:
Results
Clinical Characteristics Multi-probe Single-probe No probe P
Age, y (Q1;Q3) 58 (51 - 65) 58 (46 - 64) 59 (52 - 63) 0.938
Male, n (%) 13 (65%) 17 (85%) 19 (95%) 0.040
Hypertension, n (%) 8 (40%) 6 (30%) 8 (40%) 0.750
Diabetes, n (%) 2 (10%) 1 (5%) 2 (10%) 0.789
CHA2DS2-VASC, n (%) 0.350
0 8 (40%) 11 (55%) 12 (60%)
1 3 (15%) 5 (25%) 4 (20%)
2 6 (30%) 2 (10%) 4 (20%)
≥2 3 (15%) 2 (10%) 0 (0%)
Left atrium, mm (Q1;Q3) 41 (39 - 48) 42 (38 - 45) 43 (36 - 47) 0.815
Ejection fraction, % (Q1;Q3)
65 (62 - 67) 64 (59 - 68) 64 (60 - 66) 0.650
Paroxysmal AF, n (%) 16 (80%) 18 (90%) 15 (75%) 0.053
BMI, Kg/m2 29.5 (26.5 – 33.1) 28.6 (26.7 – 31.3) 27.6 (24.6 – 29.9) 0.116
Procedure Characteristics Multi-probe Single-probe No probe P
Maximum esophageal temperature, °C
38.45
(38 – 39.45)
37.9
(37.55 – 38.8)0.018
RF time, min31.85
(26.87 – 36.52)
37.47
(28.63 – 41.85)
34.7
(28.77 – 42.32)0.253
Time to achieve PV, min 63 (55 - 80) 68 (61 - 91) 78 (57 - 105) 0.250
PVI, n (%) 100% 100% 100%
Left Carina, n(%) 5 (26.3%) 2 (10%) 5 (25%) 0.333
Right Carina, n(%) 5 (26.3%) 6 (30%) 7 (35%) 0.839
ETI 0 (0%) 6 (30%) 5 (25%) 0.006
Severe ETI (Stage 3 and 4) 0 (0%) 4 (20%) 4 (20%) 0.029
Conclusion
Randomized Pilot Trial to Assess the Effect of Esophageal Temperature Monitoring on Esophageal Injury During Atrial Fibrillation Ablation
➢ No Esophageal temp monitoring:
➢ 30W 43°C – PW 20W
➢ Single probe:
➢ 30W 43°C - Temp increase over 37.5 °C -
20W application
➢Multipolar probe (CIRCA S-CATH):
➢ 30W 43°C - Temp increase over 37.5°C –
20W application
Three groups with 20 pts each
15 14
20
1 2
2 32 1
0
2
4
6
8
10
12
14
16
18
20
No probe Single-probe Multi-probe
ETI Stage 0 - None
ETI Stage 1 and 2
ETI Stage 3
ETI Stage 4* **
* P=0.006