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Dobnig 2020 Austria Thryoid RFA Guidelines s10354-019-0682-2
Dobnig 2020 Austria Thryoid RFA Guidelines s10354-019-0682-2
Dobnig 2020 Austria Thryoid RFA Guidelines s10354-019-0682-2
Harald Dobnig · Wolfgang Zechmann · Michael Hermann · Michael Lehner · Dirk Heute · Siroos Mirzaei ·
Alois Gessl · Vinzenz Stepan · Günter Höfle · Philipp Riss · Andrea Simon
Summary The present “Good Clinical Practice Rec- to perform, or who are already conducting RFA in-
ommendations” relate to radiofrequency ablation terventions as well as at thyroid specialists providing
(RFA) training, execution, and quality control, as well pre- and postoperative care to RFA patients in Austria.
as to pre- and postinterventional standards of care. Adoption of these recommendations is strongly en-
They are aimed at all physicians who intend to learn couraged by the afore-listed professional associations.
K Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria
consensus paper
All RFA interventionists who adhere to these stan- ing the probe is sometimes the left hand, and other
dards shall be listed on a homepage linked to these times the right hand. This ambidexterity must first
professional associations entitled “RFA centers in be achieved through practice on a phantom. To avoid
compliance with the GCP recommendations of the a need for ambidexterity, the nodule located ipsilat-
ÖSDG/OGNMB/ÖGES/OEGCH-ACE.” This will en- erally to the dominant hand can also be processed
sure harmonization of RFA training and quality transisthmically from the front. This, however, also
control in the performance of the treatment in demands practice. Notwithstanding these technical
Austria. challenges, the monopolar RFA intervention is, on the
other hand, relatively independent of nodule geome-
Keywords Thermoablation · RFA · Statement · GCP · try and allows for effective uniform nodule treatment.
Monopolar · Bipolar At present, virtually all knowledge concerning RFA
as a treatment method for thyroid nodules is based on
Introduction1 published findings obtained using the “monopolar”
technique [1–13].
Thermoablative techniques
Bipolar RFA Bipolar RFA—which is, by contrast,
Monopolar RFA Monopolar radiofrequency ablation a comparatively new RFA technique (first treatment
(RFA) for the treatment of thyroid nodules was de- studies published in 2016)—employs a probe con-
veloped in 2002 by Professor Baek, an interventional taining both positive and negative poles within the
radiologist at the Asan Medical Centre in Seoul. As tip that directs the flow of current solely through the
of May 2018, PubMed contained more than 130 ar- nodule tissue, thereby removing the requirement for
ticles addressing “RFA and thyroid nodules” in both current dissipation. The high-frequency current be-
benign and malignant indications. Of these contri- tween these poles creates a relatively spherical heat
butions, approximately 40 are treatment studies, 16 field within which the tissue is overheated. As the
report investigations of RFA in comparison with or water content of the treated nodule tissue decreases,
in combination with other treatment options, 29 are the electric resistance increases and the power of the
review articles, four are meta-analyses, while the re- device is regulated downward.
maining 28 studies deal with basic aspects, safety, and Bipolar RFA is, technically speaking, easier to mas-
complications. ter than monopolar RFA, because the probe tip need
In the limited number of countries in which it is only be placed in a few locations within the nodule,
presently available, the monopolar RFA technique is although also in a targeted manner (“multiple overlap-
principally carried out by specialists from a range ping shot” technique). While the first results obtained
of disciplines in an outpatient setting. Prerequi- with the bipolar technique are very promising, long-
sites are special training and high-quality equipment. term outcomes and a systematic treatment of larger
Monopolar RFA is usually performed with a water- patient populations with different nodal characteris-
cooled 18G probe driven by a high-frequency gen- tics are still lacking at present [14–16].
erator following subcutaneous and pericapsular xy-
locaine infiltration. Intravenous administration of Other thermoablative procedures Other thermoab-
analgesics, sedatives, or other drugs is, in general, lative procedures are currently subordinate in impor-
unnecessary, but it is carried out in a few centers. tance to RFA, either (a) following abandonment in fa-
The intervention is, as a rule, almost painless when vor of RFA owing to inferior results (laser ablation), or
executed using a good technique. The high-frequency (b) because their efficacy or complication rate remains
current is dissipated via earthed “pads” attached ven- insufficiently verified (microwave ablation).
trally to both thighs. Grounding is not associated with
any patient discomfort. All patients are monitored High-intensity focused ultrasound High-intensity
throughout the RFA procedure (ECG, blood pressure, focused ultrasound (HIFU) is a noninvasive treat-
pO2). ment method that uses ultrasound wave bundling to
Monopolar RFA is a technically relatively demand- induce thermal coagulation necrosis in targeted nod-
ing procedure. The target nodule must be system- ule tissue. While its complication rate is likely to be
atically “degraded” using a freehand (“moving-shot”) lower than for other thermoablative procedures, only
technique from cranial to caudal and from medial to comparatively small nodules can be treated within
lateral direction in a comparatively narrow ultrasound a given reasonable treatment timeframe. Dorsally
window without losing sight of the probe. To make located nodules are, moreover, topographically un-
matters worse, nodules can, of course, be located on favorable. Pain associated with HIFU treatment is
either side of the thyroid gland, so that the hand guid- caused by capsule and brachial plexus irritation and
is difficult to avoid. For this reason, HIFU is currently
1 To improve its readability this text has been written without performed under general anesthesia/analgosedation
gender-specific referencing. Unless stated otherwise, all terms in some treatment centers [17, 18].
apply to both women and men.
Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria K
consensus paper
Prerequisites for standardized RFA training Accompanied, detailed theoretical training (includ-
ing demonstration of long-term outcomes, discus-
Fig. 1 details a typical setting for a radiofrequency ab- sion of possible complications and special anatom-
lation of a thyroid nodule. ical features, viewing of video material).
Required: 40 documented “transisthmic” interven- Practical instruction (with phantom exercises).
tions (punctures, core needle biopsies, alcohol ab- Training of assisting personnel on at least one inter-
lations), including, ideally, five alcohol ablations. vention day.
Note: This preparatory phase should ensure ade- Four supervised on-site RFAs in the presence of the
quate practice and experience of (1) the position- trainer.
ing of the physician with respect to the neck and Note: Such standardized RFA training allows for
the nodules (distal to the patient’s head looking maximally individualized and intensive prepara-
directly at the monitor) and (2) transisthmic inter- tion. The teaching of practical content, which is
ventions—both indispensable prerequisites for the especially important in this case, would never be
performance of RFA. Acquisition of a degree of am- possible in larger “courses.” One-on-one, or maxi-
bidexterity is also a great advantage, since left- and mally one-on-two training should, therefore, ideally
right-sided nodules can be equivalently treated by take place.
the physician from the aforementioned position. Courses are, generally speaking, available in South
Desirable: “work shadowing” in an endocrine surgi- Korea and Italy (monopolar RFA), Germany (bipolar
cal center (e. g., during two operation mornings) to RFA), and in Austria (monopolar and bipolar RFA).
observe the relevant anatomical structures (in par- The courses in South Korea and Austria are the most
ticular nerve and vascular course) in the neck area. time-consuming and span a total of 3 days accord-
ing to current information.
K Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria
consensus paper
Certification Indications
Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria K
consensus paper
Fig. 2 a, b Example of a radiofrequency ablation (RFA)- nodule is important to correctly state changes in nodule vol-
treated solid nodule, prior to and 12 months after ablation. ume developments afterwards. c, d Example of RFA of a cystic
a A 50-year-old female patient, fivefold increase in nodule vol- colloid nodule. c Pre-tracheal, cystic autonomous adenoma,
ume over 8 years, multiple recommendations for surgery, nod- highly viscous content, nodule volume: 10.6 ml, thyroid-stimu-
ule clearly perceptible visually, symptom score 4 (out of 10); lating hormone (TSH): 0.6 μU/ml, symptom score 4 (out of 10),
nodule volume: 40 ml. b After 12 months the nodule is only visual score 3 (out of 3), surgery recommended. d Visual and
palpable, symptom score 0, nodule volume: 8.2 ml (–80%). symptom score 0 after 12 months, volume of transformed
This example also demonstrates that a precise setting of the residual nodule tissue: 1.2 ml (–89%), TSH: 1.0 μU/ml
caliper marks along the initially longest transverse axis of the
fore any further measures are taken. So-called be- Large solid and mixed nodules >30 ml (in a single in-
nign cysts that exhibit a uniformly smooth border tervention).
usually respond well to alcohol ablation. Alcohol Diffuse thyroid enlargement comprising multiple
ablation can, however, only treat the cystic nodule nodules (when even a successful RFA is not ex-
component and not the solid part. Early and late pected to produce a satisfactory final result).
recurrences together occur after about 26–38% of Autonomous adenomas >15 ml (in a single proce-
all alcohol ablations. dure). Good results with subsequent low-dose J131
Solid and mixed nodules up to around 30 ml (as therapy are, however, often possible in this case.
a single treatment). Multifocal autonomy (indication depending on:
Autonomous adenomas—solid or cystic up to around nodule number/size, patient age).
12–15 ml (as a single treatment). Hashimoto thyroiditis.
Growing nodules—if causing a beginning symp- Grave’s disease.
tomatology (always after repeated biopsy using FNA Pacemaker wearers (applicable to monopolar RFA).
(fine-needle aspiration) or FNCC (fine-needle capil- Pregnancy (applicable to monopolar RFA).
lary cytology), or, if necessary, core-needle biopsy!).
Patients who already had a thyroid surgery. Bipolar RFA
Elevated risk of general anesthesia. Good indications:
Known susceptibility to keloid scarring. Large, solid nodules—those in topographically dif-
ficult locations are sometimes easier to treat with
Limited or no indications: bipolar than with monopolar RFA.
Cytological report: Bethesda >II or other form of Palliative volume reduction (only in selected cases).
suspected malignancy. Pregnancy: no contraindication as with monopolar
Far caudally extending nodules, not fully accessible. RFA.
Rather narrow and cone-shaped nodules extending Pacemaker wearers: no contraindication as with
far dorsally. monopolar RFA.
Presence of prominent ventral vessels in the treat-
ment plane.
K Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria
consensus paper
Fig. 3 Example of an RFA of an autonomous adenoma. A 48- morphological changes 3 and 12 months after RFA. Since after
year-old female patient, with presence of autonomous ade- RFA the treated autonomous adenoma has been remodeled to
noma known for several years, recent significant growth, and form mainly connective tissue, the formally “hot” nodule visu-
development of subclinical hyperthyroidism. Surgery recom- alized by technetium-99m scintigraphy becomes a “warm” or,
mendation. The initial finding is a 13-ml, 40% cystic, au- ideally, even a “cold” nodule. Mon months, KV nodule vol-
tonomous adenoma, which occupies the majority of the left ume, LV lobe volume, CS visual nodule (cosmetic-)score (up
thyroid lobe, functionally decompensated. The ultrasound im- to grade 3), SS symptom score (up to grade 10)
ages show the sagittal section through the left thyroid lobe with
Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria K
consensus paper
ideally with report of a thyroid scan where necessary trasound status have been established. Nodules that
and ultrasound images). have significantly grown since FNA or FNCC, or that
exhibit sonographic abnormalities (e. g., microcalcifi-
Cytological findings cation, “taller than wide,” irregular borders), should
undergo a second, ultrasound-guided procedure. Ac-
It is important to note that RFA treatment only permits cording to the ATA guideline, a confirmed benign cy-
a prior cytological, and not a histological, investiga- tology rules out malignancy by practically 100%.
tion of the nodule in question. In the case of “cold” or Photo documentation of the needle tip at the mo-
“warm” nodules, a conclusive ultrasound-guided FNA ment of puncture is required. An FNA of “hot” nodules
or FNCC with a benign cytological result is therefore exhibiting no other indications of malignancy can be
necessary prior to RFA, in order to ensure the required omitted prior to RFA.
certainty of the cytological findings. It is thus of great importance that the evaluation
The probability that a well-performed, conclusive, encompasses the overall sonographic aspects of the
ultrasound-guided FNA delivers a false-negative cyto- nodule, including the obligatory ultrasound status of
logical finding is assumed to be 1–2% (see ATA Guide- the adjacent cervical lymph nodes, as well as the cy-
lines). In a large Austrian sample of 4518 US-guided tological findings.
FNAs collected in a high-volume thyroid out-patient
clinic a negative predictive value of 98.1% also sug- Laryngoscopic evaluation of vocal cord status
gests a high validity of a benign cytological finding in
the local population [24]. There is, as yet, no well-founded scientific literature
Since, for a variety of methodological reasons alone, supporting a routine recommendation that vocal cord
and because Austria can still be considered an en- status be assessed before and after RFA. A meta-analy-
demic goitre area a carcinoma can never be excluded sis reporting an extremely low risk of permanent vocal
with 100% certainty, the following approach is pro- cord paralysis (approx. 0.05%) is available, but, owing
posed: to a lack of systematic investigations [25], a publica-
A nodule should, in any event, only be treated with tion bias cannot be ruled out regarding this sensitive
RFA when negative cytology for this particular nodule topic.
as well as an unsuspicious cervical lymph node ul-
K Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria
consensus paper
Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria K
consensus paper
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quency ablation of benign thyroid nodules using a multiple ciation of Clinical Endocrinologists, American College of
overlapping shot technique in a 3-month follow-up. Int J Endocrinology, and Associazione Medici Endocrinologi
Hyperthermia. 2016;32:511–6. Medical guidelines for clinical practice for the diagnosis
16. Korkusuz Y, Mader A, Groner D, et al. Comparison of mono- and management of thyroid nodules—2016 update. En-
and bipolar radiofrequency ablation in benign thyroid docr Pract. 2016;22:622–39.
disease. World J Surg. 2017;41:2530–7. 23. Zhang M, Luo Y, Zhang Y, et al. Efficacy and safety
17. Barile A, Quarchioni S, Bruno F, et al. Interventional of ultrasound-guided radiofrequency ablation for treating
radiology of the thyroid gland: critical review and state of low-risk papillary thyroid microcarcinoma: a prospective
the art. Gland Surg. 2018;7:132–46. study. Thyroid. 2016;26:1581–7.
18. Gharib H, Hegedus L, Pacella CM, et al. Clinical review: 24. P. Mikosch, H. J. Gallowitsch, E. Kresnik, J. Jester, F.G. Würtz,
nonsurgical, image-guided, minimally invasive therapy for K. Kerschbaumer, O. Unterweger, H.P. Dinges, P. Lind, (2000)
thyroid nodules. J Clin Endocrinol Metab. 2013;98:3949–57. Value of ultrasound-guided fine-needle aspiration biopsy
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K Radiofrequency ablation of thyroid nodules: “Good Clinical Practice Recommendations” for Austria