Dataset Information

Safety and clinical impact of FEES - results of the FEES-registry.

ABSTRACT:

Background

At present, the flexible endoscopic evaluation of swallowing (FEES) is one of the most commonly used methods for the objective assessment of swallowing. This multicenter trial prospectively collected data on the safety of FEES and also assessed the impact of this procedure on clinical dysphagia management.

Methods

Patients were recruited in 23 hospitals in Germany and Switzerland from September 2014 to May 2017. Patient characteristics, professional affiliation of the FEES examiners (physicians or speech and language therapists), side-effects and cardiorespiratory parameters, severity of dysphagia and clinical consequences of FEES were documented.

Results

2401 patients, mean age 69.8 (14.6) years, 42.3% women, were included in the FEES-registry. The most common main diagnosis was stroke (61%), followed by Parkinson's disease (6.5%). FEES was well tolerated by patients. Complications were reported in 2% of examinations, were all self-limited and resolved without sequelae and showed no correlation to the endoscopist's previous experience. In more than 50% of investigations FEES led to changes of feeding strategies, in the majority of cases an upgrade of oral diet was possible.

Discussion

This study confirmed that FEES, even when performed by less experienced clinicians is a safe and well tolerated procedure and significantly impacts on the patients' clinical course. Implementation of a FEES-service in different clinical settings may improve dysphagia care.

Trial registration

ClinicalTrials.gov NCT03037762, registered January 31st 2017.

SUBMITTER: Dziewas R

PROVIDER: S-EPMC7650078 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Safety and clinical impact of FEES - results of the FEES-registry.

Dziewas Rainer R Auf dem Brinke Matthias M Birkmann Ulrich U Bräuer Götz G Busch Kolja K Cerra Franziska F Damm-Lunau Renate R Dunkel Juliane J Fellgiebel Amelie A Garms Elisabeth E Glahn Jörg J Hagen Sandra S Held Sophie S Helfer Christine C Hiller Mirko M Horn-Schenk Christina C Kley Christoph C Lange Nikolaus N Lapa Sriramya S Ledl Christian C Lindner-Pfleghar Beate B Mertl-Rötzer Marion M Müller Madeleine M Neugebauer Hermann H Özsucu Duygu D Ohms Michael M Perniß Markus M Pfeilschifter Waltraud W Plass Tanja T Roth Christian C Roukens Robin R Schmidt-Wilcke Tobias T Schumann Beate B Schwarze Julia J Schweikert Kathi K Stege Holger H Theuerkauf Dirk D Thomas Randall S RS Vahle Ulrich U Voigt Nancy N Weber Hermann H Werner Cornelius J CJ Wirth Rainer R Wittich Ingo I Woldag Hartwig H Warnecke Tobias T

Neurological research and practice 20190426

<h4>Background</h4>At present, the flexible endoscopic evaluation of swallowing (FEES) is one of the most commonly used methods for the objective assessment of swallowing. This multicenter trial prospectively collected data on the safety of FEES and also assessed the impact of this procedure on clinical dysphagia management.<h4>Methods</h4>Patients were recruited in 23 hospitals in Germany and Switzerland from September 2014 to May 2017. Patient characteristics, professional affiliation of the F ...[more]

PMID: 33324882

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Project description:AIMS:Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation. METHODS AND RESULTS:Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)]. CONCLUSIONS:The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation.

Dataset Information

Safety and clinical impact of FEES - results of the FEES-registry.

Background

Methods

Results

Discussion

Trial registration

Publications

Safety and clinical impact of FEES - results of the FEES-registry.

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