Optical Coherence Tomography-Guided or Intravascular Ultrasound-Guided Percutaneous Coronary Intervention: The OCTIVUS Randomized Clinical Trial.

BACKGROUND: Intravascular imaging-guided percutaneous coronary intervention (PCI) with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) showed superior clinical outcomes compared with angiography-guided PCI. However, the comparative effectiveness of OCT-guided and IVUS-guided PCI regarding clinical outcomes is unknown. METHODS: In this prospective, multicenter, open-label, pragmatic trial, we randomly assigned 2008 patients with significant coronary artery lesions undergoing PCI in a 1:1 ratio to undergo either an OCT-guided or IVUS-guided PCI. The primary end point was a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year, which was powered for noninferiority of the OCT group compared with the IVUS group. Safety outcomes were also assessed. RESULTS: At 1 year, primary end point events occurred in 25 of 1005 patients (Kaplan-Meier estimate, 2.5%) in the OCT group and in 31 of 1003 patients (Kaplan-Meier estimate, 3.1%) in the IVUS group (absolute difference, -0.6 percentage points; upper boundary of one-sided 97.5% CI, 0.97 percentage points; P<0.001 for noninferiority). The incidence of contrast-induced nephropathy was similar (14 patients [1.4%] in the OCT group versus 15 patients [1.5%] in the IVUS group; P=0.85). The incidence of major procedural complications was lower in the OCT group than in the IVUS group (22 [2.2%] versus 37 [3.7%]; P=0.047), although imaging procedure-related complications were not observed. CONCLUSIONS: In patients with significant coronary artery lesions, OCT-guided PCI was noninferior to IVUS-guided PCI with respect to the incidence of a composite of death from cardiac causes, target vessel-related myocardial infarction, or ischemia-driven target-vessel revascularization at 1 year. The selected study population and lower-than-expected event rates should be considered in interpreting the trial. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique number: NCT03394079.

The impact of statin-ezetimibe combination therapy versus statin monotherapy on coronary plaque regression in patients with acute coronary syndrome: a meta-analysis.

OBJECTIVE: To investigate the effects of statin monotherapy and statin-ezetimibe combination therapy on coronary plaque regression in acute coronary syndrome patients. METHODS: The systematic review was conducted from July to September 2022 and comprised search on PubMed, ScienceDirect and Cochrane databases to identify studies from January 2010 to July 2022 assessing the effects of statin-ezetimibe combination therapy versus statin monotherapy on coronary plaque regression in patients with acute coronary syndrome. The outcomes of interest were total atheroma volume, plaque volume, and percent atheroma volume assessed by intravascular ultrasound. Meta-analyses were performed on the studies, and mean differences with 95% confidence interval were estimated using Review Manager v5.4. RESULTS: Of the 730 studies identified, 12(1.64%) were shortlisted, and, of them, 5(41.7%) were analysed in detail. There were a total of 557 patients with a mean follow-up of 9 ± 2.43 months. The difference between baseline and follow-up showed significant lowering in total atheroma volume, plaque volume, and percent atheroma volume (p<0.05) in the patients who were receiving statin-ezetimibe combination therapy. CONCLUSIONS: Adding ezetimibe to statin medication was found to be significantly more successful in reducing coronary plaque than statin monotherapy.

A multicenter 10-year oncologic outcome of ultrasound-guided percutaneous microwave ablation of clinical T1 renal cell carcinoma: will it stand the test of time?

OBJECTIVES: We updated the experience on percutaneous microwave ablation for renal cell carcinoma with five-center data and long-term follow-up. METHODS: This retrospective study reviewed the T1N0M0 renal cell carcinoma patients who underwent microwave ablation between April 2006 and December 2019. Clinicopathological and procedural data were collected. Technical effectiveness and complications were assessed, and the Kaplan-Meier method was used for cancer-specific survival, disease-free survival, overall survival, and local neoplastic process analyses. RESULTS: A total of 323 consecutive patients (mean age, 62.9 years ± 14.0) with 371 biopsy-proved tumors (mean diameter, 2.9 cm ± 1.2) were enrolled, and 42.6% of the tumors were located adjacent to collecting system/bowel and technical effectiveness was achieved in 360 (97.0%) tumors. For 275 cT1a patients, during median follow-up time of 66.0 months (IQR, 58.4-73.6), 10-year local neoplastic processes, cancer-specific survival, disease-free survival, and overall survival rates were 1.9%, 87.4%, 71.8, and 67.5%, respectively. For 48 cT1b patients, during the median follow-up time of 30.4 months (IQR, 17.7-44.8), 5-year local tumor progression, cancer-specific survival, disease-free survival, and overall survival rates were 11.3%, 91.4%, 69.1, and 89.2%, respectively. Major complications showed no differences between cT1a (3.5%) and cT1b (6.9%) patients (p = 0.28). A clinical risk stratification system was developed based on multivariable model to predict DFS and CSS with c-indexes of 0.78 (95% CI: 0.71-0.85) and 0.77 (95% CI: 0.65-0.90), respectively. CONCLUSIONS: With matured follow-up at five institutions, ultrasound-guided percutaneous microwave ablation is a reliable treatment option for cT1a renal cell carcinoma even in dangerous location and appears to be promising for cT1b tumors. KEY POINTS: • To our knowledge, this is the first multicenter cohort of long-term oncologic outcomes with percutaneous MWA of cT1 RCC. • The predicting model we developed is accurate to predict the long-term DFS and CSS, which can help to provide a better MWA prognostication over routinely available clinical information. • The available evidence shows that microwave ablation of clinical stage T1 RCC is safe and reliable with promising long-term oncologic outcomes, especially for cT1a RCC with excellent 10-year results.

Ensuring competence in ultrasound-guided procedures-a validity study of a newly developed assessment tool.

OBJECTIVES: To investigate the validity of the Interventional Ultrasound Skills Evaluation (IUSE) tool for assessment of procedural competence in ultrasound-guided procedures in a clinical environment, including a pass/fail score. METHODS: Novices and experienced radiologists were recruited from four hospitals and were observed and assessed while performing ultrasound-guided procedures. Performances were assessed using the IUSE tool by two independent raters. Validity evidence was gathered in accordance with Messick's framework: response process was ensured by standardisation of written rater instructions. Internal structure was explored using Cronbach's alpha for internal consistency reliability; inter-rater reliability was calculated as Pearson's r independently across all ratings, and test-retest reliability was reported using Cronbach's alpha. Relationship to other variables was investigated by comparing performances of the participants in each group. Consequences evidence was explored by calculating a pass/fail standard using the contrasting groups method. RESULTS: Six novices and twelve experienced radiologists were enrolled. The IUSE tool had high internal consistency (Cronbach's alpha = 0.96, high inter-rater reliability (Pearson's r = 0.95), and high test-retest reliability (Cronbach's alpha = 0.98), and the mean score was 33.28 for novices and 59.25 for experienced with a highly significant difference (p value < 0.001). The pass/fail score was set at 55 resulting in no false positives or false negatives. CONCLUSIONS: Validity evidence from multiple sources supports the use of the IUSE tool for assessment of competence in ultrasound-guided procedures in a clinical environment and its use in high-stakes assessment such as certification. A credible pass/fail criterion was established to inform decision-making. KEY POINTS: • A multi-site validity investigation established that the Interventional Ultrasound Skills Evaluation (IUSE) tool can be used to assess procedural competence in ultrasound-guided procedures. • Validity evidence was gathered according to Messick's framework validity from the following sources: response process, internal structure, relationship to other variables, and consequences evidence. • The IUSE tool can be used for both formative and summative assessment, and a credible pass/fail score was established to help inform decision-making such as certification.

Minimally invasive removal of deep contraceptive implants under continuous ultrasound guidance is effective, quick, and safe.

OBJECTIVES: The aim of this study was to assess the feasibility, performance, and complications of a non-surgical, minimally-invasive procedure of deep contraceptive implant removal under continuous ultrasound guidance. METHODS: The ultrasound-guided procedure consisted of local anesthesia using lidocaine chlorhydrate 1% (10 mg/mL) with a 21-G needle, followed by hydrodissection using NaCl 0.9% (9 mg/mL) and implant extraction using a Hartmann grasping microforceps. The parameters studied were the implant localization, success and complication rates, pain throughout the intervention, volumes of lidocaïne and NaCl used, duration of the procedure, and size of the incision. Between November 2019 and January 2021, 45 patients were referred to the musculoskeletal radiology department for ultrasound-guided removal of a deep contraceptive implant and were all retrospectively included. RESULTS: All implants were successfully removed en bloc (100%). The mean incision size was 2.7 ± 0.5 mm. The mean duration of the extraction procedure was 7.7 ± 6.3 min. There were no major complications (infection, nerve, or vessel damage). As a minor complication, 21 patients (46.7%) reported a benign superficial skin ecchymosis at the puncture site, spontaneously regressing in less than 1 week. The procedure was very well-tolerated, with low pain rating throughout (1.0 ± 1.5/10 during implant extraction). CONCLUSIONS: Minimally invasive removal of deep contraceptive implants under continuous ultrasound guidance alone is feasible, effective, and safe. In the present cohort, all implants were successfully removed, whatever the location, with short procedural time, small incision size, low pain levels, and no significant complications. This procedure could become a gold standard in this indication. KEY POINTS: • Minimally invasive removal of deep contraceptive implants under continuous ultrasound guidance alone is feasible, which led to a success rate of 100% whatever the location (even close to neurovascular structures), with only a small skin incision (2.7 ± 0.5 mm). • The procedure was safe, quick, without any major complications, and very well tolerated in terms of pain. • This minimally invasive ultrasound-guided procedure could become the future gold standard for the removal of deep contraceptive implants, as an alternative to surgical extraction, even for implants in difficult locations such as subfascial ones or those close to neurovascular structures.

Treatment of chronic lateral epicondylosis: a randomized trial comparing the efficacy of ultrasound-guided tendon dry needling and open-release surgery.

OBJECTIVE: Evaluate the efficacy of ultrasound-guided dry needling and open-release surgery in reducing pain and improving function in workers with lateral epicondylosis refractory to at least 6 months of nonsurgical management. METHODS: We randomly assigned participants in a 1:1 ratio to receive dry needling or surgery. The primary outcome was the Patient Rated Tennis Elbow Evaluation (PRTEE) score at 6 months. Secondary outcome measures examined the impact of these techniques on professional activity, grip strength, and Global Rating of Change and Satisfaction scales. Statistical analyses included mixed-effects models and Fisher's exact tests. RESULTS: From October 2016 through June 2019, we enrolled 64 participants. Two participants were excluded, and data from 62 participants (48 ± 8 years, 33 men) with a mean duration of symptoms of 23 ± 21 months were analyzed. Baseline characteristics were similar in both groups. In the intention-to-treat analysis, no treatment-by-time interaction was observed (F(4,201) = 0.72; p = .58). The least-squares mean difference from baseline in PRTEE scores at 6 months was 33.4 (CI 25.2 - 41.5) in the surgery group and 26.9 (CI 19.4 - 34.4) in the dry needling group (p = .25). The proportion of successful treatment was 83% (CI 63 - 95%) and 81% (CI 63 - 93%) in the surgery and dry needling groups, respectively (p = 1.00). Changes in secondary outcomes were in the same direction as those of the primary outcome. No adverse event occurred. CONCLUSIONS: Ultrasound-guided dry needling resulted in comparable improvement in outcome scores on scales of pain, physical function, and global assessment of change and satisfaction than open-release surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02710682 KEY POINTS: • In patients with chronic lateral epicondylosis, ultrasound-guided tendon dry needling provides comparable therapeutic efficacy to open-release surgery. • Ultrasound-guided tendon dry needling allows for an earlier return to work and may be less costly than open-release surgery. • Care management guidelines should recommend treatment by ultrasound-guided tendon dry needling before open-release surgery.

Incidence of infectious complications following ultrasound-guided percutaneous musculoskeletal interventions with the use of an uncovered transducer footprint.

OBJECTIVES: To determine the incidence of infectious complications following ultrasound-guided musculoskeletal interventions performed with a disinfected uncovered ultrasound transducer footprint. METHODS: Electronic medical records of all patients who underwent an ultrasound-guided musculoskeletal procedure (including injection, calcific lavage, or ganglion cyst aspiration) performed by any of the 14 interventional musculoskeletal radiologists at our institution between January 2013 and December 2018 were retrospectively reviewed to identify procedure site infections. Biopsies and joint aspirations were excluded. The procedures were performed using a disinfected uncovered transducer footprint. First, an automated chart review identified cases with (1) positive answers to the nurse's post-procedure call, (2) an International Classification of Diseases (ICD) diagnostic code related to a musculoskeletal infection, or (3) an antibiotic prescription within 30 days post-procedure. Then, these cases were manually reviewed for evidence of procedure site infection. RESULTS: In total, 6511 procedures were included. The automated chart review identified 3 procedures (2 patients) in which post-procedural fever was reported during the nurse's post-procedure call, 33 procedures (28 patients) with an ICD code for a musculoskeletal infection, and 220 procedures (216 patients) with an antibiotic prescription within 30 post-procedural days. The manual chart review of these patients revealed no cases of confirmed infection and 1 case (0.015%) of possible site infection. CONCLUSIONS: The incidence of infectious complications after an ultrasound-guided musculoskeletal procedure performed with an uncovered transducer footprint is extremely low. This information allows radiologists to counsel their patients more precisely when obtaining informed consent. KEY POINTS: • Infectious complications after ultrasound-guided musculoskeletal procedures performed with a disinfected uncovered transducer footprint are extremely rare.

Supraclavicular versus infraclavicular approach for ultrasound-guided right subclavian venous catheterisation: a randomised controlled non-inferiority trial.

Infraclavicular and supraclavicular approaches are used for subclavian venous catheterisation. We hypothesised that the supraclavicular approach is non-inferior to the infraclavicular approach in terms of safety during ultrasound-guided right subclavian venous catheterisation. We randomly allocated 401 neurosurgical patients undergoing ultrasound-guided right subclavian venous catheterisation into supraclavicular (n = 200) and infraclavicular (n = 201) groups. We assessed catheterisation-related complications (primary outcome measure) including catheter misplacement and mechanical complications (arterial puncture, haematoma formation, pneumothorax and haemothorax). We also recorded catheterisation success rates and time required for venous puncture and catheterisation. The number (proportion) of patients with catheterisation-related complications was six (3.0%) in the supraclavicular group and 27 (13.4%) in the infraclavicular group, mean difference (95%CI) -10.4% (-15.7 to -5.1%), p < 0.001, with a significant difference also seen for catheter misplacement. Except for a shorter time (median (IQR [range]) required for venous puncture in the supraclavicular group, being 9 (6-20 [2-138]) vs. 13 (8-20 [3-99]) s, the incidence of mechanical complications and other catheterisation characteristics were similar between the two groups. We recommend the supraclavicular approach for ultrasound-guided right subclavian venous catheterisation.

Optimizing Spatial Biopsy Sampling for the Detection of Prostate Cancer.

PURPOSE: The appropriate number of systematic biopsy cores to retrieve during magnetic resonance imaging (MRI)-targeted prostate biopsy is not well defined. We aimed to demonstrate a biopsy sampling approach that reduces required core count while maintaining diagnostic performance. MATERIALS AND METHODS: We collected data from a cohort of 971 men who underwent MRI-ultrasound fusion targeted biopsy for suspected prostate cancer. A regional targeted biopsy (RTB) was evaluated retrospectively; only cores within 2 cm of the margin of a radiologist-defined region of interest were considered part of the RTB. We compared detection rates for clinically significant prostate cancer (csPCa) and cancer upgrading rate on final whole mount pathology after prostatectomy between RTB, combined, MRI-targeted, and systematic biopsy. RESULTS: A total of 16,459 total cores from 971 men were included in the study data sets, of which 1,535 (9%) contained csPCa. The csPCa detection rates for systematic, MRI-targeted, combined, and RTB were 27.0% (262/971), 38.3% (372/971), 44.8% (435/971), and 44.0% (427/971), respectively. Combined biopsy detected significantly more csPCa than systematic and MRI-targeted biopsy (p <0.001 and p=0.004, respectively) but was similar to RTB (p=0.71), which used on average 3.8 (22%) fewer cores per patient. In 102 patients who underwent prostatectomy, there was no significant difference in upgrading rates between RTB and combined biopsy (p=0.84). CONCLUSIONS: A RTB approach can maintain state-of-the-art detection rates while requiring fewer retrieved cores. This result informs decision making about biopsy site selection and total retrieved core count.

Ultrasound-guided transthoracic needle biopsy of the lung: sensitivity and safety variables.

OBJECTIVES: Variables affecting the performance of ultrasound-guided transthoracic needle biopsy (US-TTNB) are not well established. We examined clinical and imaging variables affecting the sensitivity and the complication rates of US-TTNB. METHODS: We retrospectively reviewed a consecutive series of 528 US-TTNBs performed from 2008 to 2017. Univariate analyses were used to assess the influence of clinical and imaging variables on sensitivity and complication rates. Multivariate logistic regression was used to account for possible confounding variables. RESULTS: In 397 malignant lesions, the sensitivity of US-TTNB was 72% (95% CI 68-77%; 285/397). The overall pneumothorax rate was 15% (95% CI 12-18%; 77/528), leading to a chest tube in 2% (95% CI 1-3%; 9/528). Multivariate analysis showed that increasing pleural contact length (up to 30 mm) was associated with increased sensitivity (OR 1.08 per mm; 95% CI 1.04-1.12; p < 0.001), and pleural contact length (OR 0.98 per mm; 95% CI 0.97-0.99; p = 0.013), lesion size (OR 0.98 per mm; 95% CI 0.96-0.99; p = 0.006), and core needle diameter of 18G (OR 0.47 as compared with 20G; 95% CI 0.26-0.83; p = 0.010) were associated with a decreased pneumothorax rate. Graphical inspection of cubic splines showed that the probability of a positive biopsy rose sharply with increasing pleural contact length up to 30 mm and was stable thereafter. A similar, but inverse, relationship was observed for the probability of a pneumothorax. CONCLUSION: Pleural contact length is a key variable predicting the sensitivity of US-TTNB and pneumothorax rate after US-TTNB. Lesion size also predicts pneumothorax rates. KEY POINTS: • US-TTNB has a high sensitivity and a low complication rate for pleural and pulmonary lesions with pleural contact. • Pleural contact length is a key variable predicting the sensitivity of US-TTNB and pneumothorax rate after US-TTNB. • This study suggests that relying on US-TTNB may not be optimal for lesions < 10 mm for which the risk of pneumothorax is as high as the chance of obtaining diagnosis.

Ultrasound-guided percutaneous irrigation of calcific tendinopathy: redefining predictors of treatment outcome.

OBJECTIVES: To identify prognostic factors affecting the clinical outcome in patients treated with rotator cuff ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT), by evaluating the degree of calcium removal, the size and consistency of calcific deposits, and baseline level of shoulder pain and functionality. METHODS: From January 2017 to December 2019, 79 patients (23 males, 56 females; mean age, 45.7 years) who underwent US-PICT were prospectively enrolled. The calcifications' location, consistency, and size were evaluated. For US-PICT, local anesthesia, lavage of calcific material, and intrabursal steroid injection were performed. The degree of calcium removal was graded as total/partial. Shoulder pain and functionality were assessed with the visual analogue scale (VAS) in all and Constant score (CS) in a subset of patients, respectively, at 4 time-points. Mann-Whitney U test, Fisher's test, and linear and binary logistic regression were utilized for analysis. RESULTS: Pain improvement correlated with the presence of larger calcifications and lower baseline VAS score, at 1 week (p = 0.001, p < 0.001, respectively) and 1 year (p < 0.001, p = 0.002, respectively). Improved functionality correlated with total calcification retrieval, higher baseline CS, and fluid/soft calcific consistency at 1 week (p = 0.013, p = 0.003, p = 0.019, respectively). Increased calcification size, cystic appearance, and lower baseline VAS scores independently predicted complete pain resolution at 1 year. CONCLUSION: Large calcifications and low-grade pain at baseline correlated with short- and long-term pain improvement. The degree of calcium removal did not impact pain or functional improvement beyond 1 week. Increased calcification size, cystic appearance, and low-grade baseline pain predicted complete pain recovery at 1 year. KEY POINTS: • The presence of larger calcifications and lower-grade baseline pain appear to correlate with pain improvement at 1 week and 1 year after ultrasound-guided irrigation of rotator cuff calcific tendinopathy (US-PICT). • Total calcification retrieval, less affected baseline shoulder functionality, and presence of fluid/soft consistency of calcific deposits appear to correlate with improved shoulder functionality at 1 week post-treatment. • Baseline pain intensity and calcifications' morphologic characteristics, but not the degree of calcium retrieval, represent predictors of complete pain recovery at 1 year after US-PICT.

Evaluation of competence in ultrasound-guided procedures-a generic assessment tool developed through the Delphi method.

OBJECTIVES: To develop a generic and objective tool for assessing competence in percutaneous ultrasound-guided procedures. METHODS: Interventional ultrasound experts from the Nordic countries were invited to participate in a three-round Delphi process. A steering committee was formed to manage the process. In round 1, the experts were asked to suggest all aspects to consider when assessing competence in US-guided procedures. Suggestions were analyzed and condensed into assessment items. In round 2, the expert panel rated these items on a 1-5 scale and suggested new items. Items with a mean rating of ≤ 3.5 were excluded. In round 3, the expert panel rated the list items and suggested changes to the items. RESULTS: Twenty-five experts were invited, and response rates in the three rounds were 68% (17 out of 25), 100% (17 out of 17), and 100% (17 out of 17). The three-round Delphi process resulted in a 12-item assessment tool, using a five-point rating scale. The final assessment tool evaluates pre-procedural planning, US technique, procedural technique, patient safety, communication, and teamwork. CONCLUSIONS: Expert consensus was achieved on a generic tool for assessment of competence in percutaneous ultrasound-guided procedures-the Interventional Ultrasound Skills Evaluation (IUSE). This is the initial step in ensuring a valid and reliable method for assessment of interventional US skill. KEY POINTS: • Through a Delphi process, expert consensus was achieved on the content of an assessment tool for percutaneous ultrasound-guided procedures-the Interventional Ultrasound Skills Evaluation (IUSE) tool. • The IUSE tool is comprehensive and covers pre-procedural planning, US technique, procedural technique, patient safety, communication, and teamwork. • This is an important step in ensuring valid and reliable assessment of interventional US skills.

Portable ultrasound-guided high-intensity focused ultrasound with functions for safe and rapid ablation: prospective clinical trial for uterine fibroids-short-term and long-term results.

OBJECTIVES: To investigate the efficacy and safety of a new portable ultrasound-guided high-intensity focused ultrasound system (USgHIFU) with advanced targeting and beam steering technology for the treatment of uterine fibroids. METHODS: Fifty-nine uterine fibroids from 36 participants (mean age, 44.9 ± 4.1 years) were included from November 2013 to November 2015. All participants were treated with HIFU, with 3D electronic steering. MR imaging studies were performed before HIFU, immediately after HIFU, and 1 month and 3 (or 5) months after the HIFU treatment. The non-perfused volume ratio (NPVR), fibroid volume shrinkage (FVS), symptom improvement, quantified life quality assessment, and safety were analyzed. A long-term follow-up was conducted in July to December 2017 (mean, 32.2 months). RESULTS: The volume of the treated uterine fibroids ranged from 7.5 to 274.4 cm3 (mean, 69.8 cm3; SD, 64.3 cm3). The mean NPVR on the immediate post-HIFU MR imaging was 74.8 ± 25.2%. The mean FVS was 17.3% at 1 month, 33.3% at 3 months, and 45.1% at 5 months after HIFU treatment. The mean treatment time was 44.6 ± 28.2 min per fibroid and 72.9 ± 31.4 min per participant. Uterine fibroid-related symptoms and quality of life showed statistically significant improvement after the HIFU treatment. No significant symptoms related to safety or complications occurred. In the long-term follow-up, 78.8% of those surveyed were satisfied with their HIFU treatment. CONCLUSION: This clinical trial showed that a portable USgHIFU with advanced functions may safely and effectively treat uterine fibroids. KEY POINTS: • A portable compact ultrasound-guided high-intensity focused ultrasound (HIFU) can effectively and safely treat uterine fibroids. • Advanced functions, such as portability, targeted forecasting, electronic beam steering, and interleaved scanning, might be helpful in enhancing the clinical applicability of ultrasound-guided high-intensity focused ultrasound. • In the long-term follow-up of more than 2 years, approximately 80% of those surveyed were satisfied with their HIFU treatment.

Laser Ablation of Benign Thyroid Nodules: A Prospective Pilot Study With a Preliminary Analysis of the Employed Energy.

BACKGROUND AND OBJECTIVES: To assess the effectiveness of ultrasound (US)-guided laser ablation of benign thyroid nodules (TNs) under different amounts of applied energy. STUDY DESIGN/MATERIALS AND METHODS: Thirty-four euthyroid patients with 5-18 ml TNs were enrolled: 21 (laser ablation) and 13 (clinical follow up) patients with a mean age of 56.2 ± 12.0 and 54.7 ± 14.7 years, respectively. The laser ablation protocol used a 1.064 mm wavelength diode laser source; 3.5 W output power; 1,100-1,500 J and 5-8 min/illumination; and one or two fibers/session. Clinical, laboratory, and US data were obtained immediately before treatment and at 6 and 12 months follow-up and were analyzed by Student's t test and Fisher's exact test. Low- and high-energy subgroups were subsequently defined, and the receiver operating characteristic (ROC) curves were calculated. RESULTS: Laser ablation follow-up showed an overall nodule volume reduction of more than 50%; improvement of symptoms and cosmetic complaints (P = 0.001); and stable laboratory data compared with the baseline and control groups. Minor complications were 9.5% ( n = 2). One or two fibers/session resulted in a similar nodule volume reduction among 10-18 ml nodules. Analysis of the applied energy suggested a 398.8 J/ml inferior cutoff (ROC curve: 0.889 sensitivity; 0.545 specificity) for the high-energy subgroup ( n = 14, mean 599.9 ± 136.5 J/ml) to reduce the nodule volume over time (-55.1% vs. -58.4%, P = 0.55). The low-energy subgroup ( n = 7, mean 240.2 ± 74.6 J/ml) did not show a persistent volume reduction ( P < 0.05) from the 6- to 12-month follow-ups (-56.6% vs. -53.7%). CONCLUSIONS: Laser ablation of benign TNs achieved technique efficacy at 12 months posttreatment, with clinical improvement and few minor side effects. A single fiber in a single session with a high deployed energy (>398.8 J/ml) may be associated with improved results, a finding to be confirmed with a larger series. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

[Comparative study on three implantation approaches of the totally implantable venous access ports using dual-guided technique].

Objective: To compare the clinical application effect of totally implantable venous access ports (TIVAP) via the internal jugular vein,the subclavian vein and the brachiocephalic veins under the guidance of ultrasound combined with DSA. Methods: The clinical materials of 346 patients (162 males and 184 females) who implanted TIVAP in intervention Department of Jiangsu Cancer Hospital between August 2018 and January 2019 were retrospectively reviewed and the average age was (57±12) years (17 to 83 years). The patients were divided into three groups according to the different implantation approaches. One hundred and twenty-six patients (67 males and 59 females) were group A who implanted from the internal jugular vein and the average age was (52±11) years,114 patients (52 males and 62 females) were group B who implanted from the subclavian vein and the average age was (58±10) years,106 patients (43 males and 63 females) were group C who implanted from the brachiocephalic vein and the average age was (60±9) years.The first-puncture success rate,operating time,implanting length,intraoperative pain score, one month comfort rating after surgery, unscheduled decannulation rates, early and late complication rates were compared among three groups. Results: All the patients implanted the TIVAP successfully.There were no significant differences about the first-puncture success rate (χ(2)=1.375,P=0.503),operating time (F=0.968, P=0.624), unscheduled decannulation rates (χ(2)=1.570, P=0.456), and the total pipe length among the three groups (F=0.821, P=0.441),while the catheter length inside the blood vessel were the shortest in group C (F= 263.618, P=0.000), and the one month comfort rating after surgery of group C were higher compared with group A and B (F=52.248,P=0.000).Pitch-off syndrome was a unique complication of group B (χ(2)=6.159,P=0.046) and other complications were no significant differences (P>0.05). Conclusion: There are high accuracy and safety among three implantation approaches,and the approach via brachiocephalic vein under the guidance of ultrasound combined with DSA is more comfortable and lower complication rates, which could be priority to choose.

[The value of ultrasound-guided puncture biopsy in alpha-fetoprotein negative liver occupying lesions].

Objective: To investigate the accuracy and safety of ultrasound-guided puncture biopsy and enhanced MRI in the diagnosis of alpha-fetoprotein (AFP) negative liver occupying lesions. Methods: Retrospective analysis was conducted on the clinical data of 59 patients with liver occupying lesions who were admitted to the Fifth Medical Center of the PLA General Hospital from February 2015 to November 2017 and received ultrasound-guided coarse needle biopsy with AFP negative. Among them, 35 cases were males and 24 cases were females, the age range was from 25 to 67 years,with an average age of (51±3) years. Serum AFP in all patients were within the normal range. The difference between the pathological results of ultrasound-guided biopsy and the diagnosis of lesions by enhanced MRI was compared, and the diagnostic value of ultrasound-guided biopsy was analyzed. Meanwhile, complications during and after puncture were recorded. SPSS 24.0 software was used for statistical analysis.The measurement data were expressed as x±s and enumeration data were expressed as rate,if the P value was less than 0.05, it indicated that the difference was statistically significant. Results: There were 32 malignant cases and 27 benign cases based on the final pathological diagnosis. The sensitivity and specificity of ultrasound-guided needle biopsy were 100%, in contrast, the enhanced MRI was 96.9% and 81.5%, respectively, with the former significantly higher than the latter. There were no abdominal bleeding,infections and pneumothoraxduring and after the puncture. Conclusion: Ultrasound-guided puncture biopsy and enhanced MRI are both safe for the diagnosis of AFP negative liver occupying lesions,but the former is more sensitive than the latter.When the clinical symptoms of the patient are relatively mild and there is uncertainty in the diagnosis due to the lack of specific enhanced imaging, ultrasound-guided puncture is more conducive to identifying the nature of the lesion.

Procedures in COVID-19 Patients: Part-II.

Critical care in the era of novel coronavirus disease-2019 (COVID-19) infection has multiple challenges including management of the patient, underlying comorbidities, and the complications. With no end in sight to the pandemic, intensive care unit (ICU) practitioners and hospital administrators have to join hands to prepare for the long battle ahead. Critically ill COVID-19 patients need imaging or image-guided interventions in one form or the other including X-rays, ultrasonography (USG), echocardiography (ECHO), and CT scan. These patients often require renal replacement therapy (RRT) for either the preexisting chronic renal insufficiency or acutely developing kidney injury. Another important component of care is transfer of the patient to and fro from the ICU or to higher care centers. Most of the ICUs are equipped with modern facilities but with increasing number of patients a large number of makeshift arrangements are being made for managing these patients. This position paper outlines important tips to formulate protocols and procedures for critically ill patients, who are managed in the ICU. How to cite this article: Pande RK, Bhalla A, Myatra SN, Yaddanpuddi LN, Gupta S, Sahoo TK, et al. Procedures in COVID-19 Patients: Part-II. Indian J Crit Care Med 2020;24(Suppl 5):S272-S279.

Short term comparison between blind and ultrasound guided injection in morton neuroma.

OBJECTIVE: The aim of this work is to compare the effectiveness of blind and ultrasound-guided injection for Morton's neuroma (MN) to determine which is more appropriate as the initial procedure in conservative treatment. METHODS: This is an evaluator-blinded randomised trial. Of the 56 included patients, 27 were assigned to the blind group (A) and 29 to the ultrasound-guided group (B). Injection includes 1 ml of 2% mepivacaine and 40 mg of triamcinolone in each web space with MN. The included patients were assessed clinically by VAS score and the Manchester Foot Pain and Disability Score (MFPDS). The follow-up was performed at 15 days, 1 month, 45 days, 2 months, 3 months and 6 months after the initial injection. RESULTS: No differences in age or clinical measurements were found at presentation between group A and group B. At the follow-up, the ultrasound-guided group showed greater symptomatic relief at several stages of the follow-up: 45 days (VAS 3.0 ± 0.5 versus 5.5 ± 0.5, p = 0.001; MFPDS: 32.2 ± 1.8 versus 38.8 ± 2.0, p = 0.018), 2 months (VAS: 3.1 ± 0.5 versus 5.6 ± 0.5, p = 0.002; MFPDS: 31.5 ± 1.9 versus 38.5 ± 2.1, p = 0.020) and 3 months (VAS: 3.1 ± 0.4 versus 5.2 ± 0.6, p = 0.010; MFPDS: 31.2 ± 1.9 versus 37.7 ± 2.4, p = 0.047). CONCLUSION: Injection of MN under ultrasound guidance provides a statistically significant improvement at some stages of the follow-up (45 days, 2 and 3 months), compared with blind injection. KEY POINTS: • Ultrasound-guided steroid injections in Morton's neuroma provide short-term pain relief to over 60% of the patients. • Ultrasound-guided injections in Morton's neuroma lead to a higher percentage of short-term pain relief than blind injections. • Ultrasound-guided injections in Morton's neuroma lead to a lower percentage of skin side effects than blind injections.

Long-term clinical outcomes in patients with untreated non-culprit intermediate coronary lesion and evaluation of predictors by using virtual histology-intravascular ultrasound; a prospective cohort study.

BACKGROUND: It is uncertain whether the coronary lesion with intermediate stenosis is more likely to cause cardiovascular events than a normal or minimal lesion. We conducted a single-center, prospective cohort study to identify long-term clinical outcomes of patients with untreated non-culprit intermediate lesion and evaluate its predictor of cardiovascular events by using virtual histology-intravascular ultrasound (VH-IVUS). METHODS: Subjects with non-culprit intermediate lesion underwent VH-IVUS were prospectively registered after percutaneous coronary intervention at the culprit lesion. Intermediate lesion was defined as 30 to 70% stenosis in coronary angiography and primary outcome was an occurrence of major adverse cardiovascular events (MACE) defined as all-cause death, intermediate lesion revascularization (InLR), minimal lesion revascularization (MnLR, unplanned revascularization elsewhere in the target vessel or in other coronary arteries which looked normal or minimal stenosis), cerebrovascular events, or non-fatal myocardial infarction (MI). The mean follow-up period was 4.2 years. RESULTS: Total 25 MACE, approximately 7% incidence annually, were identified during a follow-up period in 86 patients with 89 intermediate lesions. InLR (n = 13) was a most common event followed by MnLR (n = 6), non-fatal MI (n = 4), all-cause death (n = 3), and cerebrovascular events (n = 1). Diameter stenosis (OR 1.07, 95% CI 1.01-1.12, p = 0.015), plaque burden (PB, OR 1.07, 95% CI 1.00-1.15, p = 0.040), fibrofatty area (FFA, OR 1.61, 95% CI 1.10-2.38, p = 0.016), PB ≥ 70% (OR 3.93, 95% CI 1.28-12.07, p = 0.018), and area stenosis ≥ 50% (OR 2.94, 95% CI 1.01-8.56, p = 0.042) showed significant relationships with an occurrence of MACE. In multivariable Cox-proportional hazard analysis, FFA in intermediate lesion was an only independent predictor of MACE (HR 1.36, 95% CI 1.05-1.77, p = 0.019). CONCLUSIONS: Untreated intermediate lesions had a significantly higher chance for requiring revascularization compared with a normal or minimal lesion. And also, a large FFA in intermediate lesion was a significant predictor of cardiovascular events and which finding was mainly driven by coronary-related events, in particularly intermediate lesion progression.

[Plaque features in saphenous vein graft evaluated by virtual histology intravascular ultrasound].

Objective: To investigate the features of plaques of saphenous venous graft (SVG) with virtual histology intravascular ultrasound (VH-IVUS) in patients underwent coronary artery bypass graft surgery. Methods: From March 2016 to March 2018, a total of 45 patients ((64.4±7.9) years old, 88.9% male (40 cases)) with ischemic symptoms after coronary artery bypass graft surgery and with coronary artery angiography evidenced SVG stenosis greater than or equal to 50%, who received percutaneous coronary intervention in Tianjin chest hospital were continuously included in this study, and the clinical data were retrospectively analyzed. VH-IVUS was performed before PCI to analyze plaque composition. The patients were divided into no smoking group (21 cases) and smoking group (24 cases), no diabetes group (30 cases) and diabetes group (15 cases), normal very low density lipoprotein cholesterin (VLDL-C) group (24 cases) and elevated VLDL-C group (21 cases), stable angina pectoris group (5 cases) and acute coronary syndrome group (40 cases), plaque burden (PB) < 70% group (11 cases) and PB ≥ 70% group (34 cases), without thin-cap fibroatheroma group (35 cases) and thin-cap fibroatheroma group (10 cases), and plaque features were compared between different groups. Results: The graft age was (8.9±3.7) years.The stenosis degree of SVG lesions was 90 (90, 98) %. The minimum lumen diameter was 1.6 (1.5, 1.8) mm. The vessel cross-sectional area was (12.1±4.0) mm(2). The plaque area was 8.6 (5.7,12.0) mm(2). The minimum lumen area was 2.5 (2.1,3.3) mm(2). The plaque burden was (75.3±8.3)%. The fibrotic tissue (FI) ratio was (65.1±10.1)%, fibrofatty plaque (FF) ratio was 13.8 (5.4,25.3) %, necrotic core tissue (NC) ratio was 12.0 (5.4,24.0)%, and dense calcium tissue (DC) ratio was1.0 (0.2,3.8)% in SVG lesions. There were no significant differences in SVG plaque area, FI area,FF area,NC area,and DC area between no smoking group and smoking group, no diabetes group and diabetes group, and normal VLDL-C group and elevated VLDL-C group. SVG plaque volume was significantly higher in acute coronary syndrome group than in stable angina pectoris group (262.2 (148.5,401.2) mm(3) vs. 93.1 (50.6,155.9) mm(3),P=0.006), and plaque area (10.1 (6.6,13.3) mm(2) vs. 5.0 (3.6,6.9) mm(2), P<0.001), FI area(4.8 (3.2,6.8) mm(2) vs. 2.8 (1.9,3.0) mm(2), P<0.001),and FF area (1.15 (0.60, 2.07) mm(2) vs. 0.30 (0.10,0.90) mm(2), P=0.009) were significantly larger in PB ≥ 70% group than in PB < 70% group.The NC area (1.75(0.40,2.78) mm(2) vs. 0.60 (0.20,1.30) mm(2), P=0.030) and DC area (0.35 (0.10,0.50) mm(2) vs. 0.00 (0.00,0.10) mm(2), P=0.006) were significantly larger in thin-cap fibroatheroma group than that in without thin-cap fibroatheroma group. Spearman correlation analysis showed that the plaque area of SVG lesion was positively correlated with FF area (r=0.64, P<0.001) and NC area (r=0.43, P=0.003). PB was positively correlated with FF area (r=0.50, P<0.001) and NC area (r=0.33, P=0.028). Graft age was positively correlated with FF area (r=0.30, P=0.047). Conclusions: The main components of SVG plaque are fibrotic tissue, conversely, calcified tissue is rare in patients with SVG stenosis after coronary artery bypass graft surgery. Fibrofatty tissue is increased in the plaque in patients with PB ≥ 70%. The necrotic component is also increased in patients with thin-cap fibroatheroma. The fibrofatty component increases and the plaque tends to be unstable in proportion with increaing age of the graft in this patient cohort.