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Randomized Controlled Trial
. 2021 Feb 5;23(2):205-215.
doi: 10.1093/europace/euaa276.

Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study

Lisa W M Leung  1 , Abhay Bajpai  1 , Zia Zuberi  1 , Anthony Li  1 , Mark Norman  1 , Riyaz A Kaba  1 , Zaki Akhtar  1 , Banu Evranos  1 , Hanney Gonna  1 , Idris Harding  1 , Manav Sohal  1 , Nawaf Al-Subaie  2 , John Louis-Auguste  3 , Jamal Hayat  3 , Mark M Gallagher  1
Affiliations
Randomized Controlled Trial

Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study

Lisa W M Leung et al. Europace. .

Abstract

Aims: Thermal injury to the oesophagus is an important cause of life-threatening complication after ablation for atrial fibrillation (AF). Thermal protection of the oesophageal lumen by infusing cold liquid reduces thermal injury to a limited extent. We tested the ability of a more powerful method of oesophageal temperature control to reduce the incidence of thermal injury.

Methods and results: A single-centre, prospective, double-blinded randomized trial was used to investigate the ability of the ensoETM device to protect the oesophagus from thermal injury. This device was compared in a 1:1 randomization with a control group of standard practice utilizing a single-point temperature probe. In the protected group, the device maintained the luminal temperature at 4°C during radiofrequency (RF) ablation for AF under general anaesthesia. Endoscopic examination was performed at 7 days post-ablation and oesophageal injury was scored. The patient and the endoscopist were blinded to the randomization. We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving oesophageal protection (12/60 vs. 2/60; P = 0.008), with a trend toward reduction in gastroparesis (6/60 vs. 2/60, P = 0.27). There was no difference between groups in the duration of RF or in the force applied (P value range= 0.2-0.9). Procedure duration and fluoroscopy duration were similar (P = 0.97, P = 0.91, respectively).

Conclusion: Thermal protection of the oesophagus significantly reduces ablation-related thermal injury compared with standard care. This method of oesophageal protection is safe and does not compromise the efficacy or efficiency of the ablation procedure.

Keywords: Atrial fibrillation; Atrio-oesophageal fistula; Catheter ablation; Gastroparesis; Oesophagus; Temperature control.

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Figures

Figure 1
Figure 1
Consort 2010 flow diagram for the IMPACT study. All patients attending for left atrial ablation by participating physicians were considered. Almost all agreed to participate, but 36% subsequently declined to return for their scheduled endoscopy at 1 week post-ablation.
Figure 2
Figure 2
The ensoETM device. The ensoETM device (A and B) and the connectors to the Blanketrol III mobile console (C). The white elements at the tip of the ensoETM and in a strip along its length are radio-opaque.
Figure 3
Figure 3
Radiological images of the device during use. (A) a right anterior oblique view of a device at the correct level of placement. Only the radio-opaque strip is clearly seen (white arrow). (B) a device positioned with the radio-opaque tip above the level of the diaphragm. It was advanced an additional 10 cm before ablation commenced.
Figure 4
Figure 4
The St. George’s Modified Scoring System. For the purposes of the trial, we designed a modified system for categorizing endoscopically detected iatrogenic thermal mucosal lesions. It is more finely graded than the Kansas City Classification (KCC), the classes of which are shown in comparison.
Figure 5
Figure 5
Primary endpoints of the IMPACT trial. The endpoints were all derived from endoscopy. Mucosal lesions were significantly less common after ablation carried out with the protection of the ensoETM device, with a trend toward reduction in gastroparesis. The only moderately severe lesion in a protected patient related to a protocol breach.
See this image and copyright information in PMC

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