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In a randomized trial of imaging-guided or angiography-guided PCI for complex coronary lesion revascularization procedures, imaging-guided PCI led to a lower risk of target-vessel failure than angiography-guided PCI.

Percutaneous coronary intervention (PCI) is most commonly guided by angiography alone. Intravascular ultrasound (IVUS) guidance has been shown to reduce major adverse cardiovascular events (MACE) after PCI, principally by resulting in a larger postprocedure lumen than with angiographic guidance. Optical coherence tomography (OCT) provides higher resolution imaging than does IVUS, although findings from some studies suggest that it might lead to smaller luminal diameters after stent implantation. We sought to establish whether or not a novel OCT-based stent sizing strategy would result in a minimum stent area similar to or better than that achieved with IVUS guidance and better than that achieved with angiography guidance alone. In this randomised controlled trial, we recruited patients aged 18 years or older undergoing PCI from 29 hospitals in eight countries. Eligible patients had one or more target lesions located in a native coronary artery with a visually estimated reference vessel diameter of 2·25–3·50 mm and a length of less than 40 mm. We excluded patients with left main or ostial right coronary artery stenoses, bypass graft stenoses, chronic total occlusions, planned two-stent bifurcations, and in-stent restenosis. Participants were randomly assigned (1:1:1; with use of an interactive web-based system in block sizes of three, stratified by site) to OCT guidance, IVUS guidance, or angiography-guided stent implantation. We did OCT-guided PCI using a specific protocol to establish stent length, diameter, and expansion according to reference segment external elastic lamina measurements. All patients underwent final OCT imaging (operators in the IVUS and angiography groups were masked to the OCT images). The primary efficacy endpoint was post-PCI minimum stent area, measured by OCT at a masked independent core laboratory at completion of enrolment, in all randomly allocated participants who had primary outcome data. The primary safety endpoint was procedural MACE. We tested non-inferiority of OCT guidance to IVUS guidance (with a non-inferiority margin of 1·0 mm2), superiority of OCT guidance to angiography guidance, and superiority of OCT guidance to IVUS guidance, in a hierarchical manner. This trial is registered with ClinicalTrials.gov, number NCT02471586. Between May 13, 2015, and April 5, 2016, we randomly allocated 450 patients (158 [35%] to OCT, 146 [32%] to IVUS, and 146 [32%] to angiography), with 415 final OCT acquisitions analysed for the primary endpoint (140 [34%] in the OCT group, 135 [33%] in the IVUS group, and 140 [34%] in the angiography group). The final median minimum stent area was 5·79 mm2 (IQR 4·54–7·34) with OCT guidance, 5·89 mm2 (4·67–7·80) with IVUS guidance, and 5·49 mm2 (4·39–6·59) with angiography guidance. OCT guidance was non-inferior to IVUS guidance (one-sided 97·5% lower CI −0·70 mm2; p=0·001), but not superior (p=0·42). OCT guidance was also not superior to angiography guidance (p=0·12). We noted procedural MACE in four (3%) of 158 patients in the OCT group, one (1%) of 146 in the IVUS group, and one (1%) of 146 in the angiography group (OCT vs IVUS p=0·37; OCT vs angiography p=0·37). OCT-guided PCI using a specific reference segment external elastic lamina-based stent optimisation strategy was safe and resulted in similar minimum stent area to that of IVUS-guided PCI. These data warrant a large-scale randomised trial to establish whether or not OCT guidance results in superior clinical outcomes to angiography guidance. St Jude Medical.

Intravascular ultrasound-guided percutaneous coronary intervention has been shown to result in superior clinical outcomes compared with angiography-guided percutaneous coronary intervention. However, insufficient data are available concerning the advantages of intravascular ultrasound guidance for patients with an acute coronary syndrome. This trial aimed to investigate whether the use of intravascular ultrasound guidance, as compared with angiography guidance, improves the outcomes of percutaneous coronary intervention with contemporary drug-eluting stents in patients presenting with an acute coronary syndrome. In this two-stage, multicentre, randomised trial, patients aged 18 years or older and presenting with an acute coronary syndrome at 58 centres in China, Italy, Pakistan, and the UK were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention or angiography-guided percutaneous coronary intervention. Patients, follow-up health-care providers, and assessors were masked to random assignment; however, staff in the catheterisation laboratory were not. The primary endpoint was target vessel failure, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularisation at 1 year after randomisation. This trial is registered at ClinicalTrials.gov, NCT03971500, and is completed. Between Aug 20, 2019 and Oct 27, 2022, 3505 patients with an acute coronary syndrome were randomly assigned to intravascular ultrasound-guided percutaneous coronary intervention (n=1753) or angiography-guided percutaneous coronary intervention (n=1752). 1-year follow-up was completed in 3504 (>99·9%) patients. The primary endpoint occurred in 70 patients in the intravascular ultrasound group and 128 patients in the angiography group (Kaplan-Meier rate 4·0% vs 7·3%; hazard ratio 0·55 [95% CI 0·41–0·74]; p=0·0001), driven by reductions in target vessel myocardial infarction or target vessel revascularisation. There were no significant differences in all-cause death or stent thrombosis between groups. Safety endpoints were also similar in the two groups. In patients with an acute coronary syndrome, intravascular ultrasound-guided implantation of contemporary drug-eluting stents resulted in a lower 1-year rate of the composite outcome of cardiac death, target vessel myocardial infarction, or clinically driven revascularisation compared with angiography guidance alone. The Chinese Society of Cardiology, the National Natural Scientific Foundation of China, and Jiangsu Provincial & Nanjing Municipal Clinical Trial Project. For the Mandarin translation of the abstract see Supplementary Materials section.

In a randomized trial of fractional flow reserve versus IVUS to guide PCI, the use of FFR resulted in fewer coronary interventions and was noninferior to IVUS with respect to clinical outcomes at 2 years.

Prostate cancer diagnosis requires biopsy, traditionally performed under local anaesthetic with ultrasound guidance via a transrectal approach (TRUS). Local anaesthetic ultrasound-guided transperineal biopsy (LATP) is gaining popularity in this setting; however, there is uncertainty regarding prostate sampling, infection rates, tolerability, side-effects, and cost-effectiveness. TRANSLATE was a randomised clinical trial that aimed to compare detection of Gleason Grade Group (GGG) 2 or higher prostate cancer, side-effects, tolerability, and patient-reported outcomes, after LATP versus TRUS biopsy. In this randomised clinical trial which was done at ten hospitals in the UK, patients aged 18 years or older were eligible if investigated for suspected prostate cancer based on elevated age-specific prostate-specific antigen or abnormal digital rectal examination, and if biopsy-naive having received pre-biopsy MRI on a 1·5 or higher Tesla scanner. Individuals were excluded if they had any previous prostate biopsy, extensive local disease easily detectable by any biopsy (prostate-specific antigen >50 ng/mL or entire gland replaced by tumour on MRI), symptoms of concurrent or recent urinary tract infection, history of immunocompromise, need for enhanced antibiotic prophylaxis, absent rectum, or inability to position in lithotomy. Participants were randomly assigned in a 1:1 ratio to receive LATP or TRUS biopsy, using web-based software with a randomisation sequence using a minimisation algorithm to ensure balanced allocation across biopsy groups for minimisation factors (recruitment site, and location of the MRI lesion). The primary outcome was detection of GGG 2 or higher prostate cancer, analysed in the modified intention-to-treat population (all randomly assigned to treatment who had a biopsy result available). Key secondary endpoints assessing post-biopsy adverse events were infection, bleeding, urinary and sexual function, tolerability, and patient-reported outcomes. This trial is registered with ClinicalTrials.gov (NCT05179694) and at ISRCTN (ISRCTN98159689), and is complete. Between Dec 3, 2021, and Sept 26, 2023, 2078 (76%) of 2727 assessed individuals were eligible, and 1126 (41%) of 2727 agreed to participate. 1044 (93%) of the 1126 participants were White British. Participants were allocated to TRUS (n=564) or LATP (n=562) biopsy, and were followed up at time of biopsy, and at 7 days, 35 days, and 4 months post-biopsy. We found GGG 2 or higher prostate cancer in 329 (60%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54%) of 540 participants with biopsy results randomly assigned to TRUS biopsy (odds ratio [OR] 1·32 [95% CI 1·03–1·70]; p=0·031). Infection requiring admission to hospital within 35 days post-biopsy occurred in 2 (<1%) of 562 participants in the LATP group compared with 9 (2%) of 564 in the TRUS group. No statistically significant difference was observed in the reporting of overall biopsy-related complications (LATP 454 [81%] of 562 vs TRUS 436 [77%] of 564, OR 1·23 [95% CI 0·93 to 1·65]), urinary retention requiring catheterisation (LATP 35 [6%] of 562 vs TRUS 27 [5%] of 564), urinary symptoms (median International Prostate Symptom Score: LATP 8 [IQR 4–14] vs TRUS 8 [4–13], OR 0·36 [95% CI –0·38 to 1·10]), nor sexual function (median International Index of Erectile Function score: LATP 5 [2–25] vs TRUS 8 [3–24], OR –0·60 [–1·79 to 0·58]) at 4 months after biopsy. Trial participants more commonly reported LATP biopsy to be immediately painful and embarrassing compared with TRUS (LATP 216 [38%] of 562 vs TRUS 153 [27%] of 564; OR 1·84 [95% CI 1·40 to 2·43]). Serious adverse events occurred in 14 (2%) of 562 participants in the LATP group and 25 (4%) of 564 in the TRUS group. Among biopsy-naive individuals being investigated for possible prostate cancer, biopsy with LATP led to greater detection of GGG 2 or higher disease compared with TRUS. These findings will help to inform patients, clinicians, clinical guidelines, and policy makers regarding the important trade-offs between LATP and TRUS prostate biopsy. National Institute for Health and Care Research (NIHR) Health Technology Assessment.

Abstract BACKGROUND Magnetic resonance-guided focused ultrasound thalamotomy (FUS-T) is an emerging treatment for essential tremor (ET). OBJECTIVE To determine the predictors of outcomes after FUS-T. METHODS Two treatment groups were analyzed: 75 ET patients enrolled in the pivotal trial, between 2013 and 2015; and 114 patients enrolled in the postpivotal trials, between 2015 and 2016. All patients had medication-refractory, disabling ET, and underwent unilateral FUS-T. The primary outcome (hand tremor score, 32-point scale with higher scores indicating worse tremor) and the secondary outcome variables (Clinical Rating Scale for Tremor Part C score: 32-point scale with higher scores indicating more disability) were assessed at baseline and 1, 3, 6, and 12 mo. The operative outcome variables (ie, peak temperature, number of sonications) were analyzed. The results between the 2 treatment groups, pivotal and postpivotal, were compared with repeated measures analysis of variance and adjusted for confounding variables. RESULTS A total of 179 patients completed the 12-mo evaluation. The significant predictors of tremor outcomes were patient age, disease duration, peak temperature, and number of sonications. A greater improvement in hand tremor scores was observed in the postpivotal group at all time points, including 12 mo (61.9% ± 24.9% vs 52.1% ± 24.9%, P = .009). In the postpivotal group, higher energy was used, resulting in higher peak temperatures (56.7 ± 2.5 vs 55.6 ± 2.8°C, P = .004). After adjusting for age, years of disease, number of sonications, and maximum temperature, the treatment group was a significant predictor of outcomes (F = 7.9 [1,165], P = .005). CONCLUSION We observed an improvement in outcomes in the postpivotal group compared to the pivotal group potentially reflecting a learning curve with FUS-T. The other associations of tremor outcomes included patient age, disease duration, peak temperature, and number of sonications.

Recently, genicular nerve block and radiofrequency ablation were introduced to alleviate knee pain in patients with chronic knee osteoarthritis. Both ultrasound- and fluoroscopy-guided genicular nerve blocks have been used. However, whether one is superior to the other remains unknown. The present study compares the efficacy of ultrasound- vs fluoroscopy-guided genicular nerve blocks. This research used a prospective randomized comparison design. The study took place at a single pain clinic within a tertiary medical center in Seoul, Republic of Korea. From July 2015 to September 2017, a randomized controlled study was performed to analyze the difference in the efficacy of ultrasound- vs fluoroscopy-guided genicular nerve blocks. The Numeric Rating Scale (NRS-11), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Global Perceived Effect Scales (GPES), and complications were evaluated pre-procedure, and 1 and 3 months after genicular nerve block. A total of 80 patients were enrolled and randomly distributed to groups U (ultrasound-guided, n = 40) and F (fluoroscopy-guided, n = 40). Those who were lost to follow-up or had undergone other interventions were excluded, resulting in 31 and 30 patients in groups U and F, respectively. No differences in NRS-11 or WOMAC were observed between the 2 groups at baseline or during the follow-up period. GPES and complication rates were also similar between both groups. We were unable to perform double-blind randomization and did not evaluate patients' baseline emotional states. Pain relief, functional improvement, and safety were similar between groups receiving ultrasound- and fluoroscopy-guided genicular nerve blocks. Therefore, either of the 2 imaging devices may be utilized during a genicular nerve block for chronic knee pain relief. However, considering radiation exposure, ultrasound guidance may be superior to fluoroscopic guidance.The study protocol was approved by our institutional review board (2015-0369), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002846). This work was presented in part as D-H Kim's MS thesis at the University of Ulsan College of Medicine (2018). Genicular nerve block, ultrasound, fluoroscopy, knee osteoarthritis, Numeric Rating Scale, The Western Ontario and McMaster Universities Osteoarthritis Index.

To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder. Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months. Six hospitals in Norway and Sweden. 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months. Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises. The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated. Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported. This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder. NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Laparoscopic cholecystectomy (LC) is a frequently applied minimally invasive surgery. Intraoperative access is provided with small keyhole entries on the abdominal wall. However, LC causes moderate to severe postoperative pain. The subcostal approach of TAP block was described by Hebbard et al. for postoperative analgesia especially for upper abdominal surgeries. Ultrasound-guided erector spinae plane (US-ESP) block is a novel technique targeting ventral rami, dorsal rami and rami communicantes of the spinal nerves. Single-blinded, prospective, randomized study. Tertiary university hospital, postoperative recovery room and surgical ward. Seventy-six patients (ASA I-II) were divided into two equal groups. After applying the exclusion criteria, 68 patients were included in final analysis (34 patients in ESP group and 34 in OSTAP group). Erector spinae plane block was performed in the ESP group and oblique subcostal transversus abdominis block was performed in the OSTAP group. Measurements: Postoperative tramadol consumption and pain scores between groups were compared. In addition, intraoperative fentanyl need was measured. Postoperative tramadol consumption was 139.1 ± 21.9 mg in the ESP group and 199.4 ± 27.7 mg in the OSTAP group (mean difference 60.29 mg, 95% confidence interval - 72.40 to - 48.19; p < 0.001). NRS scores at almost all time-points were lower in the ESP group according to the repeated measures analysis. Integration of AUC and Mann Whitney U test results have revealed that there was no time wise difference between ESP and OSTAP groups even though NRS scores by itself and time-wise linear area under curve scores were higher in the OSTAP group compare to ESP group. There were no differences in intraoperative fentanyl need. Ultrasound-guided ESP block reduced postoperative tramadol consumption and pain scores more effectively than OSTAP block after laparoscopic cholecystectomy surgery. •Laparoscopic cholecystectomy causes moderate to severe postoperative pain.•OSTAP block provides analgesia especially for upper abdominal surgeries.•ESP is a novel block which extends cranially and caudally over several dermatomal levels.•Both ESP and OSTAP blocks are effective for analgesia after cholecystectomy.

Background Central venous catheterization is the most common invasive procedure in intensive care units but remains burdened by infectious, thrombotic, and mechanical complications. Although real-time ultrasound guidance is now widely adopted, its effect on site-specific differences in overall complication rates has not been established. The 3SITES randomized clinical trial previously demonstrated lower infection and thrombosis rates with subclavian access but higher mechanical complications. However, as only a third of its procedures were ultrasound-guided in this study, these findings may not apply to current practice. The objective of the study was to compare complication rates across these three sites under a counterfactual framework assuming universal ultrasound guidance. Methods This study was an emulated a target trial using the 3SITES dataset. Inverse probability weighting was applied to adjust for confounders of site assignment and ultrasound guidance. Weighted outcomes across catheter sites were compared under a counterfactual framework assuming universal ultrasound guidance. The primary outcome was a composite of time to catheter-related bloodstream infection or symptomatic deep-vein thrombosis. Secondary outcomes included each component separately, asymptomatic thrombosis, and major mechanical complications. Results A total of 3409 catheters were included: 1153 in the femoral, 1267 in the internal jugular, and 989 in the subclavian site. Subclavian site showed a lower incidence of the primary outcome compared with femoral ( P  =  .02 ) and jugular ( P  =  .001 ) sites. The primary composite outcome did not differ between internal jugular and femoral sites ( P  =  .97 ). Catheter-related bloodstream infections were significantly fewer with subclavian versus jugular access ( P  =  .001 ). Asymptomatic thrombosis was more frequent at femoral and jugular sites. Major mechanical complications were rare and did not differ significantly across sites. Conclusion Assuming universal real-time ultrasound-guided central venous catheterization, subclavian access retains lower infectious and thrombotic risk without an observed increase in mechanical complications, supporting its preferential use in intensive care units.