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Collected Research

Thyroid nodules are detected in up to 50 to 60% of healthy subjects. Most nodules do not cause clinically significant symptoms, and as a result, the main challenge in their management is to rule out malignancy, with ultrasonography (US) and fine-needle aspiration (FNA) biopsy serving as diagnostic cornerstones. The key issues discussed in these guidelines are as follows: (1) US-based categorization of the malignancy risk and indications for US-guided FNA (henceforth, FNA), (2) cytologic classification of FNA samples, (3) the roles of immunocytochemistry and molecular testing applied to thyroid FNA, (4) therapeutic options, and (5) follow-up strategy. Thyroid nodule management during pregnancy and in children are also addressed. On the basis of US features, thyroid nodules may be categorized into 3 groups: low-, intermediate-and high-malignancy risk. FNA should be considered for nodules ≤10 mm diameter only when suspicious US signs are present, while nodules ≤5 mm should be monitored rather than biopsied. A classification scheme of 5 categories (nondiagnostic, benign, indeterminate, suspicious for malignancy, or malignant) is recommended for the cytologic report. Indeterminate lesions are further subdivided into 2 subclasses to more accurately stratify the risk of malignancy. At present, no single cytochemical or genetic marker can definitely rule out malignancy in indeterminate nodules. Nevertheless, these tools should be considered together with clinical data, US signs, elastographic pattern, or results of other imaging techniques to improve the management of these lesions. Most thyroid nodules do not require any treatment, and levothyroxine (LT4) suppressive therapy is not recommended. Percutaneous ethanol injection (PEI) should be the first-line treatment option for relapsing, benign cystic lesions, while US-guided thermal ablation treatments may be considered for solid or mixed symptomatic benign thyroid nodules. Surgery remains the treatment of choice for malignant or suspicious nodules. The present document updates previous guidelines released in 2006 and 2010 by the American Association of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE) and Associazione Medici Endocrinologi (AME).

American Association of Clinical Endocrinologists, American College of Endocrinology, and Associazione Medici Endocrinologi Medical Guidelines for Clinical Practice for the Diagnosis and Management of Thyroid Nodules – 2016 Update

Thyroid nodules are very common and found in up to 68% of the general U.S. population on ultrasound. Although thyroidectomy has long been the mainstay of treatment for malignant and symptomatic benign thyroid nodules, various interventional ablative techniques have emerged in the last couple of decades as alternative non-surgical treatment options. Globally, the most widely adopted technique has been ultrasound-guided radiofrequency ablation (RFA). RFA of thyroid nodules was first performed in 2002, and there has been an expanding body of evidence since 2006 showing that RFA and other interventional ablative techniques are effective treatments for benign solid thyroid nodules, toxic adenomas, and thyroid cysts. More recently, evidence has emerged that these techniques may be effective treatment for low-risk thyroid cancer and recurrent disease. Despite these findings, the United States has been slow to adopt these techniques, with only a single publication on RFA more than a decade after the first series was published. EM Rogers’ Diffusion of Innovation Theory provides us the appropriate lens to carefully analyze the process of adoption of RFA for thyroid nodules-to understand where we are currently, as well as, the important next steps that must be accomplished in order for RFA and other ablative techniques to be successfully adopted into the management algorithm of thyroid nodules in the United States.

Analyzing the adoption of radiofrequency ablation of thyroid nodules using the diffusion of innovations theory: understanding where we are in the United States?

Context: Approximately 60% of adults harbor 1 or more thyroid nodules. The possibility of cancer is the overriding concern, but only about 5% prove to be malignant. The widespread use of diagnostic imaging and improved access to health care favor the discovery of small, subclinical nodules and small papillary cancers. Overdiagnosis and overtreatment is associated with potentially excessive costs and nonnegligible morbidity for patients.

Evidence acquisition: We conducted a PubMed search for the recent English-language articles dealing with thyroid nodule management.

Evidence synthesis: The initial assessment includes an evaluation of clinical risk factors and sonographic examination of the neck. Sonographic risk-stratification systems (e.g., Thyroid Imaging Reporting and Data Systems) can be used to estimate the risk of malignancy and the need for biopsy based on nodule features and size. When cytology findings are indeterminate, molecular analysis of the aspirate may obviate the need for diagnostic surgery. Many nodules will not require biopsy. These nodules and those that are cytologically benign can be managed with long-term follow-up alone. If malignancy is suspected, options include surgery (increasingly less extensive), active surveillance or, in selected cases, minimally invasive techniques.

Contemporary Thyroid Nodule Evaluation and Management

Background: Percutaneous radiofrequency thermal ablation (RFA) has been reported as an effective tool for the management of benign thyroid nodules (BTN). However, large, randomized controlled trials (RCTs) are lacking.

Objective: The aims of this study were to assess the volume reduction of BTN after a single RFA performed
using the moving-shot technique and to compare the volume reduction obtained in patients treated in two
centers with different experience of the moving-shot technique.

Method: This study was an international prospective RCT. It was carried out at the Mauriziano Hospital (Turin, Italy) and the Asan Medical Center (Seoul, Korea). Eighty patients harboring solid, compressive, nonfunctioning BTN (volume 10–20 mL) were enrolled. Twenty patients in each country were treated by RFA using a 18-Gauge internally cooled electrode (group A); 20 nontreated patients in each country were followed as controls (group B).

Efficacy and Safety of Radiofrequency Ablation Versus Observation for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial

Radiofrequency ablation (RFA) has been recently adopted into the practice of thyroidology in the United States, although its use as an alternative to traditional thyroid surgery in Asia and Europe came near the turn of the 21st century. In the United States, only a few studies with small sample sizes have been published to date. We examined outcomes of benign thyroid nodules treated with RFA from 2 North American institutions.

Efficacy and Safety of Radiofrequency Ablation of Thyroid Nodules: A Multi-institutional Prospective Cohort Study

Whether thermal ablation is effective to treat toxic thyroid nodules (TTN) is still unknown. Aim of this review was to achieve more robust evidence on the efficacy of radiofrequency ablation (RFA) in treating TTN in terms of TSH normalization, thyroid scintiscan, and volume reduction rate (VRR). A comprehensive literature search of PubMed/Medline and Scopus was performed in November 2018 to retrieve published studies. Original papers reporting TTN treated by RFA and later followed-up were eligible. Excluded were: articles not within this field, articles with unclear data, overlapping series, case/series reports.

Discordances were solved in a final collegial meeting. Information was collected concerning population features, treatment procedure, follow-up, cases with TSH normalization, cases with scintiscan  normalization, VRR of nodules. Pooled prevalence of patients with TSH or scintiscan normalization, and pooled VRR over time were calculated. For statistical analysis, the randomeffects model was used. Eight articles published between 2008 and 2018 were included. The overall number of AFTN treated by
RFA was 205. Five studies used a single session of treatment. The time of follow-up ranged from six to 24 months. The pooled rate of patients with TSH normalization was 57%. The pooled rate of patients with scintigraphically proven optimal response was 60%. The pooled VRR at 1 year was 79%. Baseline nodules volume was associated with the rate of TSH normalization. In conclusion, a moderate efficacy of RFA in treating TTN was found, and this can represent a solid starting point in this field.

Efficacy of radiofrequency ablation in autonomous functioning thyroid nodules. A systematic review and meta-analysis

Background: The primary goal of this interdisciplinary consensus statement is to provide a framework for the safe adoption and implementation of ablation technologies for benign thyroid nodules.

This consensus statement is organized around three key themes:
 (1) safety of ablation techniques and their implementation,
(2) optimal skillset criteria for proceduralists performing ablative procedures, and 
(3) defining expectations of success for this treatment option given its unique risks and benefits. 

Ablation safety considerations in pre-procedural, peri-procedural, and post-procedural settings are discussed, including clinical factors related to patient selection and counseling, anesthetic and technical considerations to optimize patient safety, peri-procedural risk mitigation strategies, post-procedural complication management, and safe follow-up practices. Prior training, knowledge, and steps that should be considered by any physician who desires to incorporate thyroid nodule ablation into their practice are defined and discussed. Examples of successful clinical practice implementation models of this emerging technology are provided.

General Principles for the Safe Performance, Training, and Adoption of Ablation Techniques for Benign Thyroid Nodules: An American Thyroid Association Statement

Currently the evaluation of the thyroid nodules is covered by insurance companies. However, radiofrequency ablation of thyroid nodules is new and is not considered a recognized benefit.  As the exciting success of thyroid RFA is recognized, the insurance companies are paying and reimbursing more frequently.

This therapy will save the patient and the entire healthcare system a considerable amount of money. As the healthcare community and patients continue to advocate for this non-surgical solution of benign thyroid nodules, the availability to utilize insurance healthcare benefits will increase.

You should demand an appeal to an insurance coverage denial.

Insurance Authorization Letter for Radiofrequency Ablation of the Thyroid Gland

Thyroid nodules are lumps in the thyroid gland. The majority are benign (not cancerous) and this must be determined using appropriate diagnostic tests. In this procedure, a small probe is inserted through the skin into a benign nodule in the neck and an electrical current is used to heat and destroy the nodule.

Radiofrequency ablation is a minimally invasive technique that aims to reduce symptoms and improve cosmetic appearance, while preserving thyroid function, and with fewer complications than surgery.
Before treatment, the thyroid nodule is confirmed as benign, typically by the use of 2 fine-needle aspiration biopsies. Ultrasound-guided percutaneous radiofrequency ablation for thyroid nodules is usually done using local anaesthesia in an outpatient setting. The patient is placed in the supine position with moderate neck extension. A radiofrequency electrode is inserted into the nodule using ultrasound guidance to visualise the electrode during the procedure. Once in position, the radiofrequency electrode is activated to heat and destroy the tissue.

Interventional procedure overview of ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules

Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs).

To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN.

This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate).

Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)

Background: Ultrasound-guided thermal ablations have become one of the main options for treating benign thyroid nodules. To determine efficacy of thermal ablation of benign thyroid nodules, we performed a meta-analysis of studies with long-term follow-up of more than 3 years.

Methods: Databases were searched for studies published up to August 25, 2019, reporting patients with benign thyroid nodules treated with thermal ablation and with follow-up data of more than 3 years. Data extraction and quality assessment were performed according to PRISMA guidelines. The analysis yielded serial volume reduction rates (VRRs) of ablated nodules for up to 3 years or more, and adverse effect of ablation during follow-up. Radiofrequency ablation (RFA) and laser ablation (LA) were compared in a subgroup analysis.

Results: The pooled VRRs for ablated nodules showed rapid volume reduction before 12 months, a plateau from 12 to 36 months, and more volume reduction appearing after 36 months, demonstrating long-term maintenance of treatment efficacy. Thermal ablation had an acceptable complication rate of 3.8%. Moreover, patients undergoing nodule ablation showed no unexpected delayed complications during the follow-up period. In the subgroup analysis, RFA was shown to be superior to LA in terms of the pooled VRR and the number of patients who underwent delayed surgery.

Long-Term Results of Thermal Ablation of Benign Thyroid Nodules: A Systematic Review and Meta-Analysis

Background: Nearly 20 years after the first feasibility study, minimally invasive ultrasound (US)-guided therapeutic techniques are now considered as a safe and effective alternative to surgery for symptomatic benign thyroid nodules. Radiofrequency ablation (RFA) is one of the most widely used treatment in specialized thyroid centers but, due to the relatively recent introduction into clinical practice, there are limited long-term follow-up studies. Aim of our work was to review the outcomes of RFA on solid nonfunctioning and on autonomous thyroid nodules (AFTN) on a long-time period for assessing the results in term of efficacy, complications, and costs and to compare them to the current indications of RFA.

Methods: A systematic review was performed using EMBASE and Medline library data between 2008 and 2021. Seventeen studies evaluated RFA for the treatment of benign solid (nonfunctioning or autonomous) thyroid nodules, with an at least 18 months of follow-up. Data extraction and quality assessment were performed by two endocrinologist according to PRISMA guidelines. Anthropometric data, safety and efficacy parameters were collected.

Results: The majority of the studies was retrospective study and reported 933 nodules, mostly solid. Baseline volume ranged between 6.1 ± 9.6 and 36.3 ± 59.8 ml. Local analgesia was used and the time duration of the treatment was between 5 ± 2 and 22.1 ± 10.9 min. The volume reduction rate at 12 months ranged from 67% to 75% for the nodule treated with a single procedure and reached to 93.6 ± 9.7% for nodules treated with repeat ablations. The regrowth rate at 12 months ranged from 0% to 34%.

Long-Term Results of Ultrasound-Guided Radiofrequency Ablation of Benign Thyroid Nodules: State of the Art and Future Perspectives-A Systematic Review

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