These guidelines were a first publication in Thorac Cardiovasc Surg 2021;69:483–489.
Georg Thieme Verlag KG, Rüdigerstraße 14
70469 Stuttgart, Germany DOI
https://doi.org/10.1055/s-0041-1735464. ISSN 0171-6425
Udo Boeken, MD,
Department of Cardiac Surgery,
Heinrich Heine University, Medical Faculty Moorenstrasse 5
40225 Duesseldorf, Germany E-Mail:
INTRODUCTION
In Germany, a remarkable increase in the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years, with approximately 3,000 annual ECLS/ECMO implantations since 2015. Despite the widespread use of ECLS/ECMO, there is still lack of evidencebased recommendations and guidelines, particularly associated with indications, contraindications, limitations, and management [1]. Therefore, in 2015 the German Society for Thoracic and Cardiovascular Surgery (GSTCVS, DGTHG) registered the multidisciplinary S3 guideline “use of extracorporeal circulation life support/extracorporeal membrane oxygenation (ECLS/ECMO) for cardiac and circulatory failure” to create recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF) and the Medical Centre for Quality (Ärztliches Zentrum für Qualität, ÄZQ). Although the clinical application of ECMO/ECLS represents the main focus, the guideline also addresses structural and economic issues and was completed in February 2021. This report presents a summary of the methodological concept and accepted recommendations of this guideline.
METHODS
Altogether, six consensus conferences with delegates of all participating societies took place between 2016 and 2020. All conferences were moderated by a representative of the AWMF. Further details are explained in the official guideline report [2].
The most important task of the presented guideline is the implementation of evidence- and consensus-based recommendations for patients requiring ECLS due to cardiocirculatory failure.
Target audience for these recommendations are all clinicians involved in the clinical care of patients with acute cardiac and circulatory failure, particularly within the areas of cardiac surgery, cardiology, intensive care medicine, emergency medicine, pulmonology, trauma surgery, and pediatrics. Additionally, it was intended to focus on aspects relevant for clinicians in rehabilitation centers, physiotherapists, paramedics and nursing staff, as well as patients and their relatives.
With the primary literature search we analyzed all relevant publications between 2010 and 2018 (n=9.801).
However, only 68 articles (four secondary studies, 37 primary studies addressing efficacy, and 27 registry studies including >1,000 patients) were of sufficient quality for final inclusion after thorough analysis [2]. The levels of evidence (see table 1) for the different aspects of ECLS therapy were systematically assigned according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) criteria [3].
Given these evidence levels, the final recommendations were consented and classified (see table 2) according to the GRADE criteria [4].
RESULTS
General Comments
Consensus was reached on 71 recommendations for ECLS therapy in acute cardiac and circulatory failure. Details regarding background literature for all recommendations as well as explanations for the grading of recommendations and the levels of evidence are described in the separate supplement. Therefore, in this short summary we only present tables with the formulated recommendations of each chapter.
Table 1: Levels of evidence
Note: Definition of the levels of evidence referring to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) standards [2].
Table 2: Grades of recommendation
Note: Definition of the grades of recommendation referring to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) standards [3].
Indications and contraindications
Table 3: Recommendations: indications and contraindications
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
Structural and personnel requirements
Table 4: Recommendations: structural and personnel requirements
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
Therapy management and monitoring
Table 5: Recommendations: therapy management and monitoring
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
Complication management
Table 6: Recommendations: complication management
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
Weaning
Table 7: Recommendations: weaning
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
Aftercare
Table 8: Recommendations: aftercare
Abbreviations: ECLS, extracorporeal life support; Grade, grade of recommendation (see table 1); level, level of evidence.
ECLS THERAPY IN PEDIATRIC PATIENTS
This section includes the same number of recommendations as the entire adult section; therefore, we refer here to the supplement with a complete list of all pediatric recommendations.
DISCUSSION
In an interdisciplinary approach the participating societies and involved organizations established the first evidence and consensus guideline on ECLS therapy for Germany, Austria, and Switzerland according to AWMF and GRADE criteria. With this summary, we want to provide a brief overview of the methodological concept as well as the consented recommendations of this guideline.
The majority of recommendations have been approved by expert consensus due to the fact that high-level evidence is currently not available. Therefore, the urgent need for further research on all aspects of ECLS therapy is clearly evident. However, the generation of high-level evidence within a reasonable time period appears to be an intractable challenge. Low center volume and randomization difficulties in acute cardiac failure may impair the successful completion and implementation of viable studies analyzing all relevant ECLS topics. With the help of our guideline a critical appraisal of the current studies on this topic will be facilitated and it becomes obvious that high-evidence-level studies are still missing. Therefore, future research on ECMO/ECLS in collaborative efforts must be undertaken and strongly supported.
VALIDITY AND UPDATE
All presented guideline recommendations are based on the best scientific evidence currently available for ECLS therapy. The mandate holders of all participating societies as well as all boards of the scientific associations approved the entirety of recommendations, which are valid up to August 2025.
The long and short versions of the guideline including all background information are available in German language [1].
FUNDING
The preparation of this guideline was funded by institutional grants of the German Society of Thoracic and Cardiovascular Surgery (GSTCVS, DGTHG) Berlin, Germany.
CONFLICTS OF INTEREST
The authors declare no conflicts of interest.
