Dataset Information

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

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.

SUBMITTER: Leung LWM

PROVIDER: S-EPMC7868886 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Leung Lisa W M LWM Bajpai Abhay A Zuberi Zia Z Li Anthony A Norman Mark M Kaba Riyaz A RA Akhtar Zaki Z Evranos Banu B Gonna Hanney H Harding Idris I Sohal Manav M Al-Subaie Nawaf N Louis-Auguste John J Hayat Jamal J Gallagher Mark M MM

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20210201 2

<h4>Aims</h4>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.<h4>Methods and results</h4>A single-centre, prospective, double-blinded randomized trial was used to investigate the ...[more]

PMID: 33205201

Similar Datasets

Project description:BackgroundThe strongest risk factor for oesophageal adenocarcinoma is reflux disease, and the rising incidence of this coincides with the eradication of Helicobacter pylori, both of which might alter the oesophageal microbiota. We aimed to profile the microbiota at different stages of Barrett's carcinogenesis and investigate the Cytosponge as a minimally invasive tool for sampling the oesophageal microbiota.MethodsIn this case-control study, 16S rRNA gene amplicon sequencing was done on 210 oesophageal samples from 86 patients representing the Barrett's oesophagus progression sequence (normal squamous controls [n=20], non-dysplastic [n=24] and dysplastic Barrett's oesophagus [n=23], and oesophageal adenocarcinoma [n=19]), relevant negative controls, and replicates on the Illumina MiSeq platform. Samples were taken from patients enrolled in the BEST2 study at five UK hospitals and the OCCAMS study at six UK hospitals. We compared fresh frozen tissue, fresh frozen endoscopic brushings, and the Cytosponge device for microbial DNA yield (qPCR), diversity, and community composition.FindingsThere was decreased microbial diversity in oesophageal adenocarcinoma tissue compared with tissue from healthy control patients as measured by the observed operational taxonomic unit (OTU) richness (p=0·0012), Chao estimated total richness (p=0·0004), and Shannon diversity index (p=0·0075). Lactobacillus fermentum was enriched in oesophageal adenocarcinoma (p=0·028), and lactic acid bacteria dominated the microenvironment in seven (47%) of 15 cases of oesophageal adenocarcinoma. Comparison of oesophageal sampling methods showed that the Cytosponge yielded more than ten-times higher quantities of microbial DNA than did endoscopic brushes or biopsies using quantitative PCR (p<0·0001). The Cytosponge samples contained the majority of taxa detected in biopsy and brush samples, but were enriched for genera from the oral cavity and stomach, including Fusobacterium, Megasphaera, Campylobacter, Capnocytophaga, and Dialister. The Cytosponge detected decreased microbial diversity in patients with high-grade dysplasia in comparison to control patients, as measured by the observed OTU richness (p=0·0147), Chao estimated total richness (p=0·023), and Shannon diversity index (p=0·0085).InterpretationAlterations in microbial communities occur in the lower oesophagus in Barrett's carcinogenesis, which can be detected at the pre-invasive stage of high-grade dysplasia with the novel Cytosponge device. Our findings are potentially applicable to early disease detection, and future test development should focus on longitudinal sampling of the microbiota to monitor for changes in microbial diversity in a larger cohort of patients.FundingCancer Research UK, National Institute for Health Research, Medical Research Council, Wellcome Trust, The Scottish Government (RESAS).

Project description:BackgroundFever is an important vital sign and often the first one to be assessed in a sick child. In acutely ill children, caregivers are expected to monitor a child's body temperature at home after an initial medical consult. Fever literacy of many caregivers is known to be poor, leading to fever phobia. In children with a serious illness, the responsibility of periodically monitoring temperature can add substantially to the already stressful experience of caring for a sick child.ObjectiveThe objective of this pilot study was to assess the feasibility of using the iThermonitor, an automated temperature measurement device, for continuous temperature monitoring in postoperative and postchemotherapy pediatric patients.MethodsWe recruited 25 patient-caregiver dyads from the Pediatric Surgery Department at the Massachusetts General Hospital (MGH) and the Pediatric Cancer Centers at the MGH and the Dana Farber Cancer Institute. Enrolled dyads were asked to use the iThermonitor device for continuous temperature monitoring over a 2-week period. Surveys were administered to caregivers at enrollment and at study closeout. Caregivers were also asked to complete a daily event-monitoring log. The Generalized Anxiety Disorder-7 item questionnaire was also used to assess caregiver anxiety at enrollment and closeout.ResultsOverall, 19 participant dyads completed the study. All 19 caregivers reported to have viewed temperature data on the study-provided iPad tablet at least once per day, and more than a third caregivers did so six or more times per day. Of all participants, 74% (14/19) reported experiencing an out-of-range temperature alert at least once during the study. Majority of caregivers reported that it was easy to learn how to use the device and that they felt confident about monitoring their child's temperature with it. Only 21% (4/9) of caregivers reported concurrently using a device other than the iThermonitor to monitor their child's temperature during the study. Continuous temperature monitoring was not associated with an increase in caregiver anxiety.ConclusionsThe study results reveal that the iThermonitor is a highly feasible and easy-to-use device for continuous temperature monitoring in pediatric oncology and surgery patients.Trial registrationClinicalTrials.gov NCT02410252; https://clinicaltrials.gov/ct2/show/NCT02410252 (Archived by WebCite at http://www.webcitation.org/73LnO7hel).

Dataset Information

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

Aims

Methods and results

Conclusion

Publications

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

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets