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ObjectiveTo evaluate the longer-term disease relapse of ultrasound (US)-guided high-intensity focused ultrasound (HIFU) ablation as a treatment for persistent/relapsed Graves’ disease (GD).MethodsAfter ethics approval, consecutive patients with persistent or relapsed GD who underwent bilateral US-guided HIFU ablation from 2016 to 2017 were retrospectively analyzed. Altogether, 75 patients received HIFU ablation of the central portion of the right and left thyroid lobes with areas near the trachea–esophageal groove and common carotid artery un-ablated. They were followed for 24 months or longer. Baseline thyrotropin (TSH), free T4, anti-thyroid autoantibodies, and TSH receptor (TSHR) antibody were checked. Primary outcome was the 24-month relapse rate. Relapse referred to hyperthyroidism (free T4 (FT4) > 23 pmol/L) afterwards. Variables associated with relapse were analyzed by binary logistic regression.ResultsThe cohort comprised mostly females (84.0%) with a mean age of 42.05 ± 10.74 years. The 24-month relapse rate was 41.3% with 31 patients suffering a relapse. No patient suffered from hypothyroidism. Three patients (4.0%) suffered from temporary vocal cord palsy but these injuries recovered spontaneously after 2 months. In univariate analysis, higher daily dose of carbimazole (OR = 1.125, 95% CI = 1.023–1.237, p = 0.015) and higher baseline TSHR level (OR = 1.085, 95% CI = 1.022–1.152, p = 0.007) were significant factors for disease relapse. In the multivariate analysis, higher baseline TSHR level was a significant independent factor for disease relapse within 24 months (OR = 1.079, 95% CI = 1.014–1.148, p = 0.016).ConclusionsUS-guided HIFU of the thyroid gland was a safe and relatively efficacious treatment in the longer term for patients with persistent or relapsed GD.Key Points• US-guided HIFU ablation is relatively efficacious in the longer term.• US-guided HIFU ablation of the thyroid is safe.• Higher TSHR level may lead to higher disease relapse after treatment.

ObjectivesAssessing the efficacy of single high-intensity focused ultrasound (HIFU) ablation in benign thyroid nodules beyond 12 months.MethodsOne hundred and eight patients underwent single HIFU treatment. Extent of nodule shrinkage [by volume reduction ratio (VRR)] and obstructive symptom score [by 0-10 visual analogue scale (VAS)] were evaluated for 24 months after treatment. VRR (%) was calculated based on the formula: [baseline volume – volume at visit] / [baseline volume] × 100. Binary logistic regression was performed to evaluate factors associated with 24-month treatment success (VRR ≥ 50%).ResultsAfter treatment, the mean (± SD) VRR at 3, 6, 12 ,18 and 24 months were 51.32 ± 20.71%, 62.99 ± 22.05%, 68.66 ± 18.48%, 69.76 ± 17.88% and 70.41 ± 17.39%, respectively, while the median (IQR) VAS at baseline, 6, 12 and 24 months was gradually lowered from 4.0 (2.0), 2.0 (1.0), 2.0 (1.0) to 1.0 (2.0), respectively. Sixty-three (58.3%) nodules had a further volume reduction (i.e. > 4.5%) from 12 to 24 months, while 22 (20.4%) nodules had a volume increase of > 4.5% from 12 to 24 months. Small pre-ablation nodule volume was a significant determinant for treatment success at 24 months (OR=1.045, 95% CI=1.021–1.092, p = 0.038).ConclusionsA majority of nodules had further volume reduction beyond 12 months after single HIFU ablation, but since one-fifth of nodules had a notable volume increase beyond 12 months, a longer period of surveillance would be necessary. Small pre-ablation nodule volume was a significant factor determining 24-month treatment success.Key Points• Small but significant nodule shrinkage continues beyond 12 months after single treatment.• Obstructive symptom continues to improve beyond 12 months after single treatment• Smaller-sized nodules have a greater chance of treatment success at 24 months

Abstract Context Adipocyte fatty acid-binding protein (AFABP), fibroblast growth factor 21 (FGF21), and pigment epithelium–derived factor (PEDF) are 3 diabetes-related biomarkers whose circulating levels had been shown to associate with nephropathy progression in Chinese patients with type 2 diabetes. Objective Here, we evaluated and compared their prospective associations with the development of sight-threatening DR (STDR), another important diabetic microvascular complication. Methods Baseline serum AFABP, PEDF, and FGF21 levels were measured in 4760 Chinese individuals with type 2 diabetes and without STDR at baseline. The associations of these biomarkers with incident STDR were analyzed using Cox regression analysis. Results Among these 4760 participants (mean diabetes duration of 11 years and ≥ 50% with nonproliferative DR at baseline), 172 participants developed STDR over a median follow-up of 8.8 years. Participants with incident STDR had comparable baseline serum FGF21 levels but significantly higher baseline serum AFABP and PEDF levels (both P < .001) than those without. However, in multivariable Cox regression analysis, only serum AFABP remained independently associated with incident STDR (hazard ratio 1.28; 95% CI, 1.05-1.55; P = .013). The addition of serum AFABP to a clinical model of conventional STDR risk factors including diabetes duration, glycemic control, albuminuria, and baseline DR status significantly improved the c statistics (P < .001), net reclassification index (P = .0027), and integrated discrimination index (P = .033) in predicting incident STDR among participants without DR or with mild DR at baseline. Conclusion Among the 3 diabetes-related biomarkers, serum AFABP level appeared to be a more clinically useful biomarker for predicting incident STDR in type 2 diabetes.

Objective Assessing the 6-month efficacy of combined high-intensity focused ultrasound (HIFU) ablation with percutaneous ethanol injection (PEI) in benign thyroid nodules by comparing it with HIFU ablation alone. Methods One hundred and eighty-one (55.2%) patients underwent HIFU alone (group I) while 147 (44.8%) underwent concomitant HIFU and PEI treatment for solid or predominantly solid nodules (group II). Intravenous sedation and analgesia were given before the start of treatment. Extent of nodule shrinkage (by volume reduction ratio (VRR)), pain scores (by 0–10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting were compared between the two groups. Results The mean amount of ethanol injected in group II was 1.3 ± 0.7 ml. The 3- and 6-month VRR were significantly greater in group II (60.41 ± 20.49% vs. 50.13 ± 21.06%, p  = 0.001; and 71.08 ± 21.25% vs. 61.37 ± 22.76%, p  = 0.001, respectively), and “on-beam” treatment time was significantly shorter in group II (26.55 min vs. 30.26 min, p  = 0.001). Group II patients reported significantly lower pain score during treatment (2.24 ± 3.07 vs. 4.97 ± 3.21, p  < 0.001) and 2 h after treatment (2.23 ± 2.50 vs. 2.97 ± 4.39, p  = 0.044). Rates of VCP, skin burn, and nausea or vomiting were not significantly different ( p  > 0.05). Conclusions The combined HIFU and PEI approach with improved administration of intravenous sedation and analgesia was associated with a significantly better 6-month efficacy than HIFU alone in benign thyroid nodules without compromising the safety and comfort of patients. Key Points • Concomitant HIFU and PEI have a better treatment efficacy than HIFU alone. • Concomitant HIFU and PEI have a comparable safety profile as HIFU alone.

ObjectiveTo assess severity and factors of pain during high-intensity focused ultrasound (HIFU) ablation of benign thyroid nodules.Methods128 patients who underwent a HIFU ablation for a benign thyroid nodule were analysed. All patients received a bolus of intravenous pethidine and diazepam before treatment. After treatment, patients were asked to rate their overall pain experience on a visual analogue scale (0–100) (0 = no pain; 100 = worse possible pain) during treatment, 2 h after treatment and the following morning. Binary logistic regression was performed to evaluate associated factors for pain including patient demographics, nodule size, body mass index (BMI) and treatment parameters.ResultsAt T1, median (range) pain score was 65.0 (0.00–100.00). Only 16 (12.5 %) patients had a pain score of zero. In multivariate analysis, only lower BMI (OR 1.265, 95 % CI 1.102–1.452, p=0.001) and longer nodule diameter (OR 1.462, 95 % CI 1.071–1.996, p=0.017) were independent factors for pain score at T1 ≤ 65.0.ConclusionsA moderate to severe amount of pain was reported during ablation of benign thyroid nodules in over 50 % of patients. Patients’ BMI and length of nodule diameter were independent variables for pain during HIFU ablation.Key Points• Pain was moderate to severe during HIFU ablation of thyroid nodules.• Only one in eight patients reported no pain during ablation.• Level of energy per pulse did not affect pain.• Patients with lower BMI and larger nodules had less pain.

BackgroundWe aimed to assess the efficacy and safety of second high-intensity focused ultrasound (HIFU) ablation treatment in benign thyroid nodules that had failed to shrink by > 50% 6 months after the first treatment.MethodsTwenty-eight patients who did not achieve 50% volume reduction at 6 months after the first HIFU treatment underwent a second HIFU treatment. Nodule volume was measured on ultrasound at baseline, 3 months and 6 months. Extent of nodule shrinkage (by volume reduction ratio) (VRR) = [Baseline volume – volume at 6 months]/[Baseline volume] * 100. Treatment success was defined as VRR > 50%. Obstructive symptom score (by 0–10 visual analogue scale, VAS) was evaluated for 6 months after treatment.ResultsNo complications occurred after the second treatment. The mean 6-month VRR was 21.78 ± 16.87% with a median (range) of 16.16 (1.63–54.07)%. At 6 months, only two (7.1%) patients achieved treatment success, while nine (32.1%) patients had VRR < 10%. However, relative to baseline (3.96 ± 1.04), the mean VAS significantly improved at 3 and 6 months (2.96 ± 1.43, p<0.001 and 2.58 ± 1.39, p<0.001, respectively). There was a significant correlation between VRR and improvement in VAS score at 6 months (ρ=0.438, p=0.025). Greater nodule volume before the second treatment (OR=1.169, 95% CI=1.004–1.361, p=0.045) was a significant factor for greater VRR after the second treatment.ConclusionsAlthough subjective obstructive symptoms continued to improve after the second treatment, the actual extent of nodule shrinkage was small. Larger-volume nodules tended to shrink more significantly than smaller-volume nodules in the second treatment.Key Points• Second treatment resulted in small shrinkage in unsatisfactory nodules after first treatment.• Obstructive symptoms tended to continue to improve after second treatment.• Larger-size nodules tended to respond better in the second treatment.

ObjectivesAssessing the efficacy and safety of sequential high-intensity focused ultrasound (HIFU) ablation in a multinodular goitre (MNG) by comparing them with single HIFU ablation.MethodsOne hundred and four (84.6%) patients underwent single ablation of a single nodule (group I), while 19 (15.4%) underwent sequential ablation of two relatively-dominant nodules in a MNG (group II). Extent of shrinkage per nodule [by volume reduction ratio (VRR)], pain scores (by 0-10 visual analogue scale) during and after ablation, and rate of vocal cord palsy (VCP), skin burn and nausea/vomiting were compared between the two groups.ResultsAll 19 (100%) sequential ablations completed successfully. The 3- and 6-month VRR of each nodule were comparable between the two groups (p > 0.05) and in group II, the 3- and 6-month VRR between the first and second nodules were comparable (p = 0.710 and p = 0.548, respectively). Pain score was significantly higher in group II in the morning after ablation (2.29 vs 1.15, p = 0.047) and nausea/vomiting occurred significantly more frequently in group II (15.8% vs 0.0%, p = 0.012). However, VCP and skin burn were comparable (p > 0.05).ConclusionsSequential ablation had comparable efficacy and safety as single ablation. However, patients undergoing sequential ablation are at higher likelihood of pain in the following morning and nausea/vomiting after ablation.Key Points• Sequential HIFU ablation is well-tolerated in patients with two dominant thyroid nodules• More pain is experienced in the morning following sequential HIFU ablation• More nausea/vomiting is experienced following sequential HIFU ablation

ObjectiveTo assess whether perithyroidal lignocaine infusion (PLI) could provide additional analgesia in high-intensity focused ultrasound (HIFU) treatment of benign thyroid nodules for patients already receiving their usual intravenous doses of Pethidine and Diazemuls.MethodsTwo hundred and five patients who underwent HIFU ablation for a benign thyroid nodule were analyzed. Among them, 104 (50.7%) patients received PLI in addition to their boluses of Pethidine and Diazemuls before treatment (group I), while the rest (n = 101, 49.3%) received intravenous Pethidine and Diazemuls only (group II). After treatment, patients were asked to rate their overall pain experience on a visual analogue scale (VAS) (0–100) (0, no pain; 100, worse possible pain) during treatment. Binary logistic regression was performed to evaluate significant determinants for treatment pain including demographics, doses of medications, and treatment parameters.ResultsVAS was significantly lower in group I (51.30 vs. 63.79, p = 0.002). In the multivariate analysis, older age at treatment (OR = 1.036, 95%CI = 1.008–1.065, p = 0.011), lower BMI (OR = 1.202, 95%CI = 1.083–1.334, p = 0.001), higher Diazemuls dose (OR = 1.066, 95%CI = 1.018–1.114, p = 0.006), and use of PLI (OR = 2.096, 95%CI = 1.121–3.922, p = 0.020) were independent determinants of less treatment pain.ConclusionsPLI can provide additional analgesia in patients already receiving their usual intravenous doses of Pethidine and Diazemuls during HIFU ablation of benign thyroid nodules. Older age, lower body mass index, and greater Diazemuls (i.e., a sedative) dose are significantly associated with less treatment pain.Key Points• PLI provided an additional analgesic effect in HIFU ablation of thyroid nodules.• Older age and lower BMI were significantly associated with less pain.• Higher doses of Diazemuls lessened pain during HIFU ablation.

ObjectiveHigh-intensity focused ultrasound (HIFU) ablation is a promising treatment for benign thyroid nodules but single application is less effective in larger-sized nodules. We aimed to assess the efficacy and safety of two sequential applications in larger-sized nodules.MethodsFifty patients underwent ablation of a large-sized nodule (baseline volume ≥ 20 mL and diameter ≤ 50 mm). Thirty-one (62.0%) patients underwent single application (group I) while 19 (38.0%) underwent two sequential applications (group II). Nodule shrinkage (by volume reduction ratio or VRR), pain scores during and after ablation, and rate of vocal cord palsy (VCP), skin burn, and nausea/vomiting were compared between the two groups. t test or the Mann-Whitney U test was used for continuous variables while chi-square test was used for categorical variables. To determine factors for VRR, multivariate analysis was done by logistic regression analysis.ResultsTotal energy delivered and treatment time were significantly more in group II (p < 0.001 and p = 0.001, respectively). Total energy per nodule volume (kJ/mL) was also significantly greater in group II (1.01 kJ/mL vs. 0.57 kJ/mL, p < 0.001). The 6-month VRR was significantly greater in group II (56.74 ± 11.47% vs. 43.49 ± 12.03%, p = 0.004). Pain severity and rates of VCP, skin burn, and nausea/vomiting were comparable between the two groups (p > 0.05). Sequential application was an independent determinant of 6-month VRR (OR = 13.936, 95% CI = 1.738–197.399, p = 0.036).ConclusionsSequential application led to better 6-month treatment efficacy than single application in large-sized nodules. Patients undergoing sequential application are not at greater risks of treatment-related side effects afterwards.Key Points• Sequential application produces better 6-month efficacy over single application for large-sized nodules.• Sequential HIFU application is well-tolerated and safe in patients with large-sized nodules.• Sequential application takes longer and requires larger amount of pethidine and diazepam.

ObjectiveTo examine the association between the appearance of hyperechoic marks (HEMs) during high-intensity focused ultrasound (HIFU) ablation of benign thyroid nodules and nodule shrinkage at 6 months.MethodsOne hundred and thirty-six patients who underwent HIFU for benign thyroid nodule were analysed. An independent person carefully examined the B-mode ultrasonography screen for the appearance of HEMs after each pulse. The proportion of HEMs (%) was calculated by: [(Number of pulses that resulted in HEMs) / (Total number of pulses given per treatment) × 100] while the nodule shrinkage was measured by volume reduction ratio (VRR) = [Baseline volume–volume at 6 months]/[Baseline volume] * 100. Treatment success was defined as VRR ≥ 50 %.ResultsPatients with HEMs (n=91) had significantly greater 6-month VRR than those without HEMs (n=45) (65.76 % vs. 36.76 %, p<0.001). By regression analysis, after adjusting for age and energy per pulse, smaller nodule volume at baseline (OR 1.143, 95 % CI 1.038–1.256, p=0.006) and appearance of HEMs (OR 275.44, 95 % CI 26.63–2848.98, p<0.001) were independent predictors for treatment success.ConclusionsThe appearance of HEMs during treatment was an independent determinant of treatment success following single-session HIFU ablation of benign thyroid nodule.Key Points• HIFU is a safe and effective treatment for benign thyroid nodules.• Lower BMI and greater applied power increase likelihood of hyperechoic marks.• The appearance of hyperechoic marks during HIFU affects subsequent treatment outcome.