Ablation of Benign Thyroid Nodules: Evidence, Guidelines ... 1. Patients with benign thyroid nodules

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  • Ablation of Benign Thyroid Nodules: Evidence, Guidelines, Meta-analyses, and Approaches

    Auh Whan Park, MD

    Interventional Radiology

    University of Virginia

  • Disclosures

    Auh Whan Park: No relevant financial relationships with any commercial interest to disclose

    Brand names are included in this presentation for participant clarification purposes only. No product promotion should be inferred.

  • Contents

    1. History of Thyroid RFA

    - Rationale

    2. Current Guidelines

    - Indications & Contraindications

    3. Procedure & Key Techniques

    - Strategy

    - Perithyroidal lidocain injection

    - Trans-isthmic approach and moving shot

    4. Efficacy and Safety

  • History of Thyroid Ablation

    Korean Society of Thyroid Radiology (KSThR)

    - 2009: 1st recommendations for thyroid RFA

    - 2012: 1st guideline for thyroid RFA

    Tipping Point

  • Re-emergence of Thyroid Ablation

    1. A need for thyroid preservation

    2. Advanced techniques & equipment

    3. Evidence on clinical efficacy and safety

  • Prevalence of Thyroid Nodules General

    Population

    US detectable

    nodule: 19-68%

    Autopsy: 49%

    Palpable nodule :

    5-10%

    Malignancy

    1.2% lifetime

    Autopsy : 2.1 %

    Mortensen JD,et al, JCEM 15: 1270, 1955 Ezzat et al, Arch Int Med 154:1828, 1994

  • Natural History of Benign Thyroid Nodules

    • Changes in thyroid nodule size and volume

    during the first 5 years of follow-up.

    - No significant size increase

    : 174 (11.1%) of 1567 : Grew

    1188 (75.8%) of 1567 : Stable

    205 (13.1%) of 1567 : Shrank

    • Cancer diagnosis : rare

    - 5 (0.3%) of 1567

    * Incidental cancer at thyroidectomy

    in a non-visualized nodule

    ** New nodule in 93(9.3%) patients

    with one cancer

    Durant et al. JAMA. 2015

  • Benign Thyroid Nodules

    Symptoms

    :Mass or hormonal effect/

    (Cosmetic concerns/ Anxiety)

    Thyroid Hormone

    Suppressive

    Therapy

    Radioactive Iodine :Autonomous Functioning Thyroid Nodule(AFTN)

    Surgery:

    Lobar/Total Thyroidectomy

    Minimally Invasive & Thyroid Preserving Procedure?

  • Thyroidectomy Volume and Outcomes

    With a conservative assumption of 150,000 thyroidectomies per year in the USA

    à Thyroidectomy for benign nodules : 150,000 x (63.3/100) = 94,950

    Association of Surgeon Volume With Outcomes and Cost Savings Following Thyroidectomy JAMA Otolaryngol Head Neck Surg. 2016

    Increases in thyroid nodule fine-needle aspirations, operations, and diagnoses of thyroid cancer in the United States. Sosa et al. Surgery 2013

  • Benign Thyroid Nodules

    Symptoms

    :Mass or hormonal effect/

    (Cosmetic concerns/ Anxiety)

    Thyroid Hormone

    Suppressive

    Therapy

    Radioactive Iodine :Autonomous Functioning Thyroid Nodule(AFTN)

    Surgery:

    Lobar/Total Thyroidectomy

    Minimally Invasive & Thyroid Preserving Procedure?

    Chemical/

    Thermal Ablation

  • Thyroid Ablation : Tools

    Ethanol Laser Radiofrequency HIFUMicrowave

    Thyroid-dedicated probes

    with FDA clearance FDA clearance

  • Advantages of Ablation in Benign Thyroid Nodules

    Pros Cons

    No life-long medication : thyroid-preserving Gradual volume reduction : follow-up

    No general anesthesia: local anesthesia only - Immediate recovery

    Repeat sessions in untreated portion - Large tumor or marginal regrowth

    Less complication : Safe

    No surgical scar: aesthetically pleasing

    No admission : outpatient-based

    No downtime for work : economical

  • Guidelines for Thyroid RFA • Korean Society of Thyroid Radiology (KSThR)

    - 2009: 1st recommendations for thyroid RFA

    - 2012: 1st guideline for thyroid RFA

    - 2017: Revised guideline for thyroid RFA

    • 2015 : The first Italian opinion statement

    • 2016 : National Institute for Health and Care (NICE) in England

    • 2019 : Good Clinical Practice Recommendations for Austria

  • Guidelines for Thyroid RFA Indication Korea Italy Austria NICE AACE Symptomatic or cosmetic problem

    O O O O O

    Nonfunctional or pred. solid (first-line)

    O O - - -

    Cystic / pred. cystic (EA: first-line)

    O O - - -

    AFTN (toxic or pre-toxic) vs. RAI or surgery

    O –Alternative- Less

    effective in large AFTN

    O -Refusal or inoperable -Effective in small AFTN

    O -Not rec. Large (> 15 ml),

    multifocal AFTN - -

    Multinodular goiter - Selective (refusal or

    inoperable) - - -

    Required biopsy results FNA CNB FNA FNA FNA FNA

    Two benign results O O O O O

    One benign result AFTN, K-TIRADS 2 AFTN, EU-TIRADS 2,3 - - -

    Pacemaker / Pregnant women

    Monopolar: No Bipolar: Applicable

    - Monopolar (not good), Bipolar: applicable

    - -

  • Guideline by KSThR : What? Indications Contraindications

    1. Patients with benign thyroid nodules producing symptoms or cosmetic concerns

    2. Autonomous functioning thyroid nodules either toxic or pre-toxic

    1. Follicular neoplasm or malignancy on FNA or CNB

    2. A nodule with US criteria suggesting malignancy, despite FNA or CNB results

    Potential Indications Relative Contraindications

    1. Primary thyroid cancer in patients who refuse surgery or are unsuitable for surgery

    2. Recurrent thyroid cancer in the thyroidectomy bed and in cervical lymph nodes in patients at high surgical risk or who refuse surgery

    1. Pregnant woman 2. Severe heart disease or pacemaker

    * Bipolar probe 3. Existing vocal cord palsy on the contralateral

    side

  • Pre-procedure Work-up (I)

  • Pre-procedure Work-up (II)

  • Ablation Strategy : Composition of thyroid nodules

    RF ablationEthanol ablation 0% 10% 50% 100%

    Combination Therapy Ethanol ablation/RF ablation

    Cystic Solid

    Baek et al. Korean J Radiol 2015

  • Procedure

    • Out-patient procedure

    - 20-30 mins per nodule

    (volume dependent)

    • Local Anesthesia only

    - Perithyroidal lidocaine injection

    : IV conscious sedation : rarely

    • Two Key Techniques

    - Trans-isthmic approach

    - Moving Shot

    • Post-procedure observation

    - 1 hours

  • Pain Control: Can we avoid IV conscious (moderate) sedation?

    • Perithyroidal Lidocaine Injection

    Thyroid Radiofrequency Ablation: Updates on Innovative Devices and Techniques. Park et al. Korean J Radiol. 2017

  • Key Techniques (I) : Trans-Isthmic Approach

    Thermal Ablation for Benign Thyroid Nodules: Radiofrequency and Laser. Jung Hwan Baek et al. Korean journal of radiology 2011

  • Key Techniques (II) : Moving Shot • Hepatic tumor : round

    RF needle fixed over several minutes.

  • Key Techniques (II) : Moving Shot

    • Thyroid nodule : elliptical

  • Key Techniques (II) : Moving Shot

    Danger triangle Vagus N

    RLN

  • Clinical Follow-up

    • US scan: the primary tool

    - Vascularity loss

    : contrast enhanced US (CEUS)

    - Volume reduction (VR)

    : VR (%) = [Initial volume (ml)- Final volume (ml)]

    x 100 / Initial volume

    • Labs

    - TSH/ Free T4/ T3

    • Clinical evaluation

    - Symptoms and cosmetic problems

  • Clinical Efficacy : Non-Functioning Benign Nodules

    Recurrence rate: 5.6%

    RFA of Benign Non-functioning Thyroid Nodules : 4-Year Follow-up Results in 111 Patients. Lim and Baek et al. Eur Radiol 2012

    • Volume reduction (%) = ([initial

    volume (mL) -final volume (mL)]

    x 100)/initial volume (mL)

    • Therapeutic success rate

    - volume reduction > 50%

    • Mean volume reduction

    rate(VRR)

    - 80% in a systemic review

    - Greater in cystic nodules than

    in solid nodules

  • JCEM 2 March 2019

  • Baek et al. Radiology 2012 Jan;262(1):335-342

    Is Thyroid RFA Safe?

  • § 48 Complications in 1459 patients : 3.3%

    § Major complication rate: 1.4%

    Complications: Multicenter study

    Hematoma

    31%

    Voice change

    31%

    Vomiting

    19%

    Skin burn

    8%

    Tumor rupture

    6%

    Hypothyroidism

    2%

    Brachial plexus

    injury 2%

    Baek et al. Radiology 2012 Jan;262(1):335-342

  • Complications Number Incidence (%) Follow-up results Detection Recovery

    Voice change 15 1.0 recovered (13)

    FU loss (2) 1-2 1-90

    Hematoma 15 1.0 recovered 1

  • 1. Cervical/Brachial plexus

    2. Vagus nerve

    3-1. Recurrent laryngeal nerve

    3-2. Non-recurrent laryngea