Introduction
In 1972, the delegates of 13 European ultrasound societies met in Basel, Switzerland
for the formal foundation of the European Federation of Societies for Ultrasound in
Medicine and Biology (EFSUMB). Today the federation comprises 29 national societies
with almost 20 000 members. EFSUMB is the largest society within the World Federation
for Ultrasound in Medicine and Biology (WFUMB). The European federation's purpose
has always been to promote the exchange of scientific knowledge in the field of ultrasound
[1 ].
EFSUMB guidelines
Over the last decade EFSUMB has produced a series of guidelines and recommendations
[2 ]
[3 ]
[4 ]
[5 ]
[6 ]
[7 ]
[8 ].
General
The introduction of any new diagnostic or treatment tool into clinical practice has
always resulted in debate in the medical literature, both by clinicians and health
care managers. This generally follows a pattern. The first phase is characterized
by enthusiasm and optimism driven by the authors performing and promoting the new
technique often reporting convincing outcomes, suggesting significant improvement
over previous techniques in the same field. This author optimism is frequently counteracted
by the skepticism of clinicians not directly involved in the technique. The second
phase, often occurring many years later, is characterized by a more equilibrate evaluation
prompting learned scientific societies to produce appropriate clinical guidelines,
in which a consensus general agreement on the advantages and limitations of the technique
and its diagnostic accuracy has been reached [9 ]
[10 ].
CEUS
Contrast-enhanced ultrasound (CEUS) guidelines were first introduced by EFSUMB in
2004 [2 ]. The CEUS liver guidelines were updated in 2008 [3 ] and 2012 [5 ]
[11 ]. The current version was a successful joint WFUMB/EFSUMB venture simultaneously
published in Ultraschall in der Medizin/European Journal of Ultrasound (EJU) [5 ] and Ultrasound in Medicine and Biology (UMB) [11 ]. The EFSUMB CEUS non-liver guidelines were also recently published and expand the
clinical indications for CEUS to almost 30 applications [4 ]. These guidelines and recommendations provide general advice on the use of all currently
clinically available ultrasound contrast agents (UCA). They are intended to create
standard protocols for the use and administration of UCA in clinical applications
on an international basis and improve the management of patients worldwide.
Elastography
In addition, the first elastography guidelines worldwide were introduced and published
by EFSUMB in 2013 [7 ]
[8 ]. All EFSUMB guidelines and good clinical practice recommendations are freely available
to download from the EFSUMB website (www.efsumb.org).
Atlas
An image is worth a thousand words, and an image supplemented by an appropriate number
of words is the most effective source of information. For this reason, EFSUMB has
begun setting up an atlas of images to illustrate the various published clinical recommendations
and guidelines, which includes a variety of contrast-enhanced ultrasound and elastographic applications.
The published recommendations have printed page restrictions preventing the inclusion
of enough clinical images. In the EFSUMB Atlas you can find pictures and video clips
illustrating the typical patterns of most of the ultrasound findings described in
the guidelines, with the display indexed according to the structure of the guidelines,
to allow easy and rapid access directly to your topic of interest. We are confident
that visiting these web pages will be fruitful for your professional activity regardless
of your particular field of ultrasound application. We also refer to the current published
textbook on interventional ultrasound which was also a motivation for more evidence-based
recommendations [12 ]
[13 ].
Impact factor
The successful EFSUMB guidelines published in our official journal “Ultraschall in
der Medizin/European Journal of Ultrasound” have gained widespread attention. The
impact factor (IF) of our journal has climbed to an impressive 4.9, which is the highest
IF of an interdisciplinary ultrasound journal worldwide.
Interventional ultrasound (INVUS)
It is now pertinent to present the EFSUMB guidelines on ultrasound-guided interventions,
procedures that have revolutionized everyday clinical practice in recent decades.
The advantages of ultrasound-guided interventions include an unsurpassed sharpness
of detail and excellent controllability consequent to the real-time visual display,
the wide availability of ultrasound equipment, and a simple and straightforward practical
technique. Endoscopic ultrasound has made “hidden places” accessible for diagnostic
and therapeutic interventions. This makes it even more surprising that interventional
ultrasound guidelines have not been previously published.
EFSUMB has accessed a wealth of experience from their expert contributors, who present
the subject matter as concretely as possible and offer vivid descriptions of practical
techniques. A challenge in the process has been to both unify and respect the differences
(national and even regional) often existing in the varied methods of performing INVUS
procedures. Particular attention has been given to clinical significance (level of
evidence and the more practical grade of recommendation).
The guidelines were discussed during an intensive two-day meeting, attended by all
the experts.
The guidelines consist of six main parts:
Part I: General aspects
Part II: Abdominal diagnostic procedures
Part III: Abdominal treatment procedures using the transcutaneous approach
Part IV: EUS-guided interventions: General aspects and EUS-guided sampling
Part V: EUS-guided therapeutic interventions
Part VI: Ultrasound-guided vascular interventions
Methodology
The INVUS guidelines were commissioned by the executive committee of EFSUMB. A steering
committee was then appointed with the purpose of defining the disposition and general
content of the guidelines, with subsequent invitation of European experts, based on
their publications records and expertise in the different fields, to partake in guideline
development. Six author subgroups of authors were established with specific responsibility
for each section of the INVUS guidelines. Together with the steering committee, the
section leaders defined the subchapters and key topics of the 6 guidelines sections.
Small groups of 2 – 3 authors were responsible for each subchapter. A literature search
was performed systematically in PubMed using predefined key words and MeSH terms and
also manually using reference lists of articles retrieved by systematic search, books
and reviews. In principle, the search was restricted to English language papers, in
particular guidelines, meta-analyses and systematic reviews, original research articles
(randomized controlled trials, prospective studies, retrospective studies, case series
≥ 6 cases), and results of clinical registries and surveys. English abstracts and
single case studies were included only in select circumstances. Evidence tables were
generated for each key topic. The Levels of Evidence of the Oxford Centre for Evidence-Based
Medicine (March 2009 edition) were used to judge the level of evidence (LoE) and grade
of recommendations (GoR) [http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009].
Drafts of recommendations and comments were provided by one author, revised by the
other members of the small author groups and reviewed by the section leaders. After
approval by the subgroup members, the revised drafts were submitted to the whole expert
group approximately 2 weeks before the expert meeting, held in Frankfurt, Germany
on January 30 – 31, 2015 ([Fig. 1 ]). All recommendations were discussed, improved, and finally subjected to a vote
by the expert panel. Consensus was graded using a simple system: strong consensus = > 95 %
of experts’ votes; broad agreement = > 75 – 95 % of experts’ votes; majority consensus = > 50 – 75 %
of experts’ votes; dissent = < 50 % of experts’ votes in favor of the respective recommendation.
Only recommendations with strong consensus or broad agreement were included in the
final version of the guidelines. Following the consensus meeting, comments were adapted
to the final recommendations and shortened. LoE and GoR were checked by the authors
and subgroup leaders. Finally, external experts not involved in the development of
the INVUS guidelines reviewed the final drafts with a special focus on LoE and GoR.
Fig. 1 The guidelines were discussed during an intensive two-day meeting, attended by all
the experts.
It is worth mentioning that, not surprisingly, new and often valid methods are not
always or rarely supported by the highest ranking level of scientific evidence, namely
randomized controlled trials. Often these innovations are so obviously of benefit
that randomized controlled trials involving older, less safe or less effective techniques
could be deemed unethical. A provocative example of this is that no randomized controlled
trial ever demonstrated that surgical resection of an early stage colon cancer provides
longer survival than best supportive care, but nobody questions the use of surgery.
In other settings, the question could be raised as to the relevance of setting up
a costly randomized controlled trial, e. g. for the comparison of similar but not
identical types of needles. Thus, for many important recommendations reported in these
guidelines, the strength of evidence may appear relatively weak in comparison to the
value of the recommendation based on clinical expert judgement.
Part I: General aspects
This part deals with generalities that are important and relevant for all kind of
INVUS procedures, diagnostic as well as therapeutic: B-mode imaging and the use of
CEUS in INVUS procedures; guiding techniques including fusion imaging; patient information,
informed consent, and patient preparation; local anesthesia and sedation; hygiene
management; puncture routes and accessing techniques; how to reduce and/or eliminate
complications; and finally how INVUS is organized locally.
Part II: Abdominal diagnostic procedures
This part deals with the workup both in clinical terms and in imaging, prior to the
use of an interventional procedure to either diagnose or treat an abnormality. The
section is divided into an organ-specific discussion and particular targeted ‘niche’
areas that will concern readers of the guidelines. All imaging modalities play a role
in the workup of these patients, and an ultrasound-guided procedure will not always
be the most appropriate imaging tool. This is clearly detailed with evidence-based
assessment of the diagnostic route and the final image approach to resolve the clinical
situation.
Part III: Abdominal treatment procedures (using the transcutaneous approach)
Therapeutic abscess drainage and the drainage of pancreatic pseudocysts, interventional
tumor ablation techniques, interventional treatments for cysts in general and specifically
also parasitic diseases (PAIR for echinococcosis) enrich our daily practice as do
established therapeutic procedures such as PTCD, PEG, PUG, biliary and urinary bladder
drainage and nephrostomy. In the matter of interventional guidance and approach, it
is often necessary to decide between the competing modalities of CT guidance and other
imaging techniques, which in some cases can and should be used to complement or supplement
one another. The role of ultrasound contrast agents in the preparation, support and
guidance of interventional procedures is also addressed. Symptom-oriented palliative
care interventions are an important issue discussed at the end of the chapter.
Part IV: EUS-guided interventions: General aspects and EUS-guided sampling
EUS-guided sampling was introduced in the early 1990 s and 20 years later was proclaimed
to have afforded a “disruptive innovation effect” for pancreatic pathology [14 ]. It combines the most advanced high-resolution ultrasound imaging of lesions within
the wall and in the vicinity of the gastrointestinal tract and provides safe and effective
tissue acquisition. The guidelines deal with the indications and clinical impact of
EUS-guided sampling and try to balance advantages and drawbacks in comparison with
image-guided percutaneous biopsy. Needle choice and biopsy technique as well as specimen
processing are crucial for success, and therefore evidence-based recommendations are
given for almost all steps of EUS-guided sampling as well as for safe performance.
Part V: EUS-guided therapeutic interventions
Soon after the introduction of EUS-guided fine-needle aspiration, the therapeutic
potential of EUS guidance was discovered, and the first successful attempts at EUS-guided
celiac plexus neurolysis, pseudocyst drainage, and cholangiopancreatography were reported.
The spectrum of EUS-guided therapeutic procedures has broadened since those first
steps, and scientific literature on EUS-guided treatment is prospering. This is reflected
by evidence-based recommendations on EUS-guidance of tumor ablation therapy, injection
treatment of the celiac plexus, vascular interventions, drainage of pancreatic and
non-pancreatic fluid collections and – last but not least – drainage procedures of
the biliary tree and pancreatic duct. EUS-guided therapeutic techniques are compared
with their percutaneous alternatives to help the clinician to choose the most appropriate
solutions for challenging therapeutic problems.
Part VI: US-guided vascular interventions
Real-time US guidance for central venous access was performed for the first time in
1986 [15 ] and, supported by overwhelming evidence, is now regarded as a key safety measure
in modern medicine. Systematic analysis of scientific literature shows that US guidance
may also facilitate efficacy and reduce adverse events in peripheral venous access
and endovascular interventions. Moreover, recommendations endorse the use of ultrasound
to detect complications of vascular access and US-guided treatment of arterial pseudoaneurysms.
Online and in-print versions of the guidelines
The INVUS guidelines will be published in EJU in a detailed online-only version followed
by a condensed printed version. Furthermore, some chapters and multimedia material
are also intended only for the EFSUMB website. Online versions will help provide more
details that do not fit in the limited print space, which will focus on the main issues
supporting the recommendations. Revision of the INVUS guidelines is intended in 5
years.
All contributors signed a form to declare any potential conflicts of interest with
the guidelines. Financial interest information can be obtained on request from EFSUMB.
Conclusion
The guidelines are an expression of interdisciplinary and multiprofessional viewpoints,
some of which represent different approaches. This reflects the reality in all its
diversity. The principle of “do no harm” is expressed in repeated pleas to apply the
techniques judiciously in everyday practice and not to become fascinated with technology
for its own sake. The decision to proceed with an interventional procedure is always
an individual one and should be made on the basis of its benefit for the patient [12 ].
