Randomized Pilot Trial to Assess the Effect of Esophageal ......Daniel Moura, Maria Cazco, Renner...

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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, min 31.85 (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 3 2 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

Transcript of Randomized Pilot Trial to Assess the Effect of Esophageal ......Daniel Moura, Maria Cazco, Renner...

Page 1: Randomized Pilot Trial to Assess the Effect of Esophageal ......Daniel Moura, Maria Cazco, Renner Pereira, Lucas de Moura, Ítalo Souza, Pedro Linhares, Nathalia Monge, Muhieddine

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