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Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. ReCor Medical.

Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease. This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS–UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871. Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS–UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5]). MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease. Fundación de investigación HM Hospitales and Insightec.

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure–lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts—SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018.

Background The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5–7 mm blood vessels in thoracic surgery. Methods This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. Discussion This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5–7 mm blood vessels in thoracic surgery. Trial registration ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www.clinicaltrials.gov/study/NCT06002737 .

Objective To compare the postoperative pain following bipolar diathermy scissors tonsillectomy (higher temperature dissection) with harmonic scalpel tonsillectomy (lower temperature dissection). Methods Sixty patients aged 7–40 years planned for tonsillectomy with no other concurrent surgery were randomised to either bipolar diathermy scissors or harmonic scalpel as surgical technique. Blinded to the surgical technique, the patients recorded their pain scores (VAS, 0–10) at awakening and the worst pain level of the day in the postoperative period. All intake of pain medication was also recorded. Results No statistically significant differences were found between the two groups regarding postoperative pain levels or consumption of pain medication. Conclusion Usage of the harmonic scalpel does not render less postoperative pain following tonsillectomy when compared with usage of the bipolar diathermy scissors.

Background The aim of the study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in gastric cancer surgery. Methods Patients with resectable adenocarcinoma of the stomach were randomly assigned to ultrasonic scalpel or conventional technique. We used the HARMONIC FOCUS® (Ethicon Endo-Surgery, Inc.) as ultrasonic scalpel. Results Between February 2010 and December 2010, 60 patients with resectable gastric cancer were enrolled into the study. Operative time was significantly shorter with the ultrasonic arm than with the conventional arm (median 238.5 vs. 300.5 min; P  = 0.0004). Blood loss was also significantly lower in the ultrasonic arm than in the conventional arm (median 351.0 vs. 569.5 ml; P  = 0.016). Clavien–Dindo grades of postoperative complications were similar in the two groups. From a questionnaire survey of operators, the ultrasonic scalpel significantly reduced the stress of lymph node dissection (3.67 vs. 2.87; P  = 0.0006). However, in assisting surgeons, the contributions to surgery, study, and technical improvement of the ultrasonic group were lower than in the conventional group. Conclusions This study shows that the ultrasonic scalpel is a reliable and safe tool for open gastric cancer surgery.

Background Previous studies regarding ultrasonically activated shears (UAS) were performed without controlled surgical procedures or consideration of potential thermal injury due to high temperature of active blade of UAS. The purpose of this study was to evaluate the efficacy and safety of UAS through a comparison with conventional monopolar electrocautery (CME) in open distal gastrectomy for gastric cancer. Methods From October 2011 to November 2012, 56 gastric cancer patients eligible for open distal gastrectomy were randomized into UAS or CME groups. Primary endpoints were estimated blood loss (EBL) during surgery and amount of drainage through the fifth postoperative day. Secondary endpoints were operation time, length of hospital stay, postoperative morbidity, changes in cytokine levels in serum, peritoneal irrigation saline, and peritoneal drainage, and inflammatory markers of serum. (Registration-number of ClinicalTrials.gov: NCT01971775). Results EBL was lower in the UAS group than that in the CME group (339.8 ± 201.2 vs. 428.6 ± 165.8 mL, p  = 0.021). However, the amount of postoperative drainage was not significantly different between the two groups. Although the complication rate was not different between the two groups, there were three cases of intra-abdominal bleeding requiring transfusion only in the CME group. Inflammatory markers from the cytokine assays and serum laboratory tests showed no significant differences between the two groups. Conclusions UAS reduced EBL without increasing inflammatory reactions.

To examine the effects of classical technique, electrocautery, and ultrasonic dissection on endothelial integrity, function, and preparation time for harvesting the radial artery (RA) during coronary artery bypass grafting (CABG). Forty-five patients who underwent isolated CABG and whose RA was suitable for use were studied and divided into three groups: Group 1, classical method (using sharp dissection); Group 2, electrocautery; and Group 3, ultrasonic cautery. Levels of prostacyclin and nitric oxide derivatives were examined biochemically; vascular cell adhesion molecule 1 (VCAM-1) and endothelial nitric oxide synthetase (eNOS) values were assessed using immunohistochemical staining. RA preparation time, RA length/harvesting time ratio, and drainage amounts at the site of RA removal were compared. Differences in RA preparation time (Group 1: 25±6 min, Group 2: 18±3 min, Group 3: 16±3 min, P<0.001) and length/harvesting time ratio (Group 1: 0.76±0.19 cm/min, Group 2: 0.98±0.16 cm/min, Group 3: 1.13±0.09 cm/min, P<0.001) were statistically significant among the groups. Levels of prostacyclin and nitric oxide derivatives were not statistically significant different, VCAM-1 and eNOS expressions were observed to be similar among the groups, and endothelial damage was detected in only one patient per group. Use of ultrasonic cautery during RA preparation considerably reduces the preparation time and postoperative drainage amount. However, the superiority of one method over the others could not be demonstrated when the presence of endothelial damage with both biochemical and histopathological evaluations was considered.

There are several different surgical procedures that are used to treat essential tremor (ET), including deep brain stimulation (DBS) and thalamotomy procedures with radiofrequency (RF), radiosurgery (RS) and most recently, focused ultrasound (FUS). Choosing a surgical treatment requires a careful presentation and discussion of the benefits and drawbacks of each. We conducted a literature review to compare the attributes and make an appraisal of these various procedures. DBS was the most commonly reported treatment for ET. One-year tremor reductions ranged from 53% to 63% with unilateral Vim DBS. Similar improvements were demonstrated with RF (range, 74%–90%), RS (range, 48%–63%) and FUS thalamotomy (range, 35%–75%). Overall, bilateral Vim DBS demonstrated more improvement in tremor reduction since both upper extremities were treated (range, 66%–78%). Several studies show continued beneficial effects from DBS up to five years. Long-term follow-up data also support RF and gamma knife radiosurgical thalamotomy treatments. Quality of life measures were similarly improved among patients who received all treatments. Paraesthesias, dysarthria and ataxia were commonly reported adverse effects in all treatment modalities and were more common with bilateral DBS surgery. Many of the neurological complications were transient and resolved after surgery. DBS surgery had the added benefit of programming adjustments to minimise stimulation-related complications. Permanent neurological complications were most commonly reported for RF thalamotomy. Thalamic DBS is an effective, safe treatment with a long history. For patients who are medically unfit or reluctant to undergo DBS, several thalamic lesioning methods have parallel benefits to unilateral DBS surgery. Each of these surgical modalities has its own nuance for treatment and patient selection. These factors should be carefully considered by both neurosurgeons and patients when selecting an appropriate treatment for ET.

Background Use of ultrasonically activated shears (UAS) is gaining popularity in open surgery but without concrete evidence. We conducted a prospectively randomized study to assess the efficacy of ultrasonic dissection in open gastrectomy for gastric cancer. Methods Patients with gastric cancer who were to undergo gastrectomy with D2 lymph node dissection were enrolled and assigned to either the conventional surgery group ( n  = 125) or the UAS group ( n  = 128). Results The mean operating time was significantly reduced in the UAS group (89.3 ± 15.6 min) when compared to the conventional group (97.8 ± 17.2 min; p  < 0.001). However, we did not find any significant difference in operative blood loss, the amount of postoperative abdominal drainage, or the rate of postoperative complications between the groups. A multivariate analysis for operating time revealed that the use of UAS, female gender and BMI less than 25 were significantly associated with reduced operating time. The operating time was significantly longer in the conventional group than in the UAS group (B 7.786; 95 % CI 4.103–11.468; p  < 0.001). In the subgroup analysis, the use of UAS significantly reduced the operating time, especially in male patients, regardless of the BMI status. Conclusions The use of UAS in gastrectomy for gastric cancer was a safe and efficient method, especially in terms of reducing operating time for male patients.