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JAMA Feb 2023Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment.
OBJECTIVE
To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension.
DESIGN, SETTING, AND PARTICIPANTS
Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms.
INTERVENTIONS
Ultrasound renal denervation vs a sham procedure.
MAIN OUTCOMES AND MEASURES
The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months.
RESULTS
Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group.
CONCLUSIONS AND RELEVANCE
In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03614260.
Topics: Female; Humans; Male; Middle Aged; Antihypertensive Agents; Denervation; Endovascular Procedures; Hypertension; Kidney; Ultrasonography, Interventional; Vascular Surgical Procedures; Single-Blind Method
PubMed: 36853250
DOI: 10.1001/jama.2023.0713 -
Animals : An Open Access Journal From... Apr 2018Acceptable methods for the euthanasia of cattle include overdose of an anesthetic, gunshot and captive bolt. The use of anesthetics for euthanasia is costly and... (Review)
Review
Acceptable methods for the euthanasia of cattle include overdose of an anesthetic, gunshot and captive bolt. The use of anesthetics for euthanasia is costly and complicates carcass disposal. These issues can be avoided by use of a physical method such as gunshot or captive bolt; however, each requires that certain conditions be met to assure an immediate loss of consciousness and death. For example, the caliber of firearm and type of bullet are important considerations when gunshot is used. When captive bolt is used, a penetrating captive bolt loaded with the appropriate powder charge and accompanied by a follow up (adjunctive) step to assure death are required. The success of physical methods also requires careful selection of the anatomic site for entry of a “free bullet” or “bolt” in the case of penetrating captive bolt. Disease eradication plans for animal health emergencies necessitate methods of euthanasia that will facilitate rapid and efficient depopulation of animals while preserving their welfare to the greatest extent possible. A portable pneumatic captive bolt device has been developed and validated as effective for use in mass depopulation scenarios. Finally, while most tend to focus on the technical aspects of euthanasia, it is extremely important that no one forget the human cost for those who may be required to perform the task of euthanasia on a regular basis. Symptoms including depression, grief, sleeplessness and destructive behaviors including alcoholism and drug abuse are not uncommon for those who participate in the euthanasia of animals.
PubMed: 29673140
DOI: 10.3390/ani8040057 -
JAMA Oct 2021Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness.
OBJECTIVE
To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).
DESIGN, SETTINGS, AND PARTICIPANTS
Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized.
INTERVENTIONS
All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311).
MAIN OUTCOMES AND MEASURES
The primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks.
RESULTS
Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, -0.4% [95% CI, -5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, -4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.
CONCLUSIONS AND RELEVANCE
Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03176784.
Topics: Carbon Monoxide; Combined Modality Therapy; Confidence Intervals; Double-Blind Method; Female; Humans; Male; Middle Aged; Nausea; Nicotinic Agonists; Odds Ratio; Placebos; Self Report; Sleep Initiation and Maintenance Disorders; Smoking Cessation; Temperance; Time Factors; Tobacco Use Cessation Devices; Varenicline; Wisconsin
PubMed: 34665204
DOI: 10.1001/jama.2021.15333 -
Neurosurgery Clinics of North America Jul 2020The past decade has seen a significant shift in the number of centers performing intracranial electroencephalography from subdural grids and strips to... (Review)
Review
The past decade has seen a significant shift in the number of centers performing intracranial electroencephalography from subdural grids and strips to stereoelectroencephalography (SEEG). Unlike grid and strip insertion or other stereotactic procedures in which the cortical surface is visualized, SEEG involves insertion of an electrode through a bolt anchored into the skull. Due to the multidisciplinary nature of SEEG trajectory planning, it often is time-consuming and iterative. Computer-assisted planning improves time taken and efficacy of SEEG trajectory planning. This article provides an overview of the considerations, controversies, and practicalities of implementing an automated computer-assisted planning solution for SEEG planning.
Topics: Electrodes, Implanted; Electroencephalography; Epilepsy; Humans; Neurosurgical Procedures; Preoperative Care; Stereotaxic Techniques; Surgery, Computer-Assisted
PubMed: 32475489
DOI: 10.1016/j.nec.2020.03.005 -
JACC. Cardiovascular Interventions Feb 2023A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence... (Review)
Review
A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site. In addition, evaluation of distal vessels, including their diameters and quality, and the presence of calcification or stents within the occlusion zone. Three, antegrade wiring strategies, guidewire (GW) and support catheter technology, as well as GW escalation strategies. Stop the antegrade attempt depending on clinical indication for peripheral artery disease treatment and the presence of retrograde options. Four, retrograde access site, support catheter, or sheath insertion and wiring technology from distally. Five, considering strategy change when progress cannot by achieved, using advanced bidirectional techniques and re-entry devices. Six, in case of successful GW passage from retrograde, GW externalization and treatment from antegrade. Management of the retrograde access by internal or external hemostasis at the end of the procedure. Alternatively, stop the procedure if no progress can be obtained within 3 hours or in case of specific complications. By establishing the algorithm in the daily routine of endovascular specialists, improvements in vessel- and patient-specific outcomes are anticipated. In addition, future research, and continuous collaboration between experts is warranted.
Topics: Humans; Expert Testimony; Treatment Outcome; Endovascular Procedures; Peripheral Arterial Disease; Algorithms; Chronic Disease
PubMed: 36792256
DOI: 10.1016/j.jcin.2022.11.036 -
JACC. Cardiovascular Interventions Apr 2023Left main coronary artery (LMA) disease jeopardizes a large area of myocardium and increases the risk of major adverse cardiovascular events. LMCA disease is found in 5%... (Review)
Review
Left main coronary artery (LMA) disease jeopardizes a large area of myocardium and increases the risk of major adverse cardiovascular events. LMCA disease is found in 5% to 7% of all diagnostic coronary angiographies, and more than 80% of the patients enrolled in recent large randomized controlled left main trials had distal left main bifurcation or trifurcation disease. Emerging clinical evidence from prospective all-comer registries and randomized trials has provided a solid basis for percutaneous coronary intervention as a treatment option in selected patients with unprotected LMCA disease; however, to date, no uniform recommendations as to optimal stenting strategy for LMCA bifurcation lesions exist. This review provides an overview of provisional stenting technique and escalation to 2-stent strategies in LMCA bifurcation lesions. Data from randomized controlled trials and registries are reviewed. Technical characteristics of optimal provisional LMCA stenting technique and angiographic and intravascular determinants of escalation are also summarized.
Topics: Humans; Prospective Studies; Treatment Outcome; Coronary Artery Disease; Coronary Angiography; Stents; Percutaneous Coronary Intervention; Risk Factors
PubMed: 37045495
DOI: 10.1016/j.jcin.2022.12.022 -
Materials (Basel, Switzerland) Dec 2023Many designs of anchor cables are currently in use for rock support in civil and mining operations. Because of the exposed surface and weak shear performance of the...
Many designs of anchor cables are currently in use for rock support in civil and mining operations. Because of the exposed surface and weak shear performance of the cable bolt's free section (CBFS) in end-anchored structures, breaking failure frequently occurs. Numerical simulations and laboratory experiments were performed in this study to develop measures to improve CBFS resistance to shear failure. Analysis of shear characteristics of the CBFS showed that higher axial tension weakens the cable bolt's shear resistance, and that shear damage on the cable surface and uneven distribution of shear stress aggravate CBFS tensile-shear failure. A high-strength steel pipe is proposed to protect the shear cable bolt, and the preliminary design of a CBFS-strengthening device (CFSD) is presented. Numerical simulation revealed that the CFSD effectively improved CBFS shear resistance and provided protection from harmful shear damage. The optimal performance of a Q-type (slotted steel pipe) CFSD was confirmed. The mechanism of improvement of the cable's shear resistance to surrounding rock by employing the CFSD was analyzed. Double-shear tests were carried out on a bare cable bolt and a cable bolt with a Q-CFSD. The results revealed that the CFSD increased the peak shear force on the joint plane, cable peak axial force, and ultimate shear displacement by 31%, 18%, and 11%, respectively. The proposed device is effective in improving the shear performance of end-anchored cable bolts and enhancing surrounding rock stability.
PubMed: 38204050
DOI: 10.3390/ma17010197 -
JACC. Clinical Electrophysiology Aug 2023Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed...
BACKGROUND
Device-related thrombus (DRT) after left atrial appendage closure (LAAC) procedures is a rare but potentially serious event. Thrombogenicity and delayed endothelialization play a role in the development of DRT. Fluorinated polymers are known to have thromboresistant properties that may favorably modulate the healing response to an LAAC device.
OBJECTIVES
The goal of this study was to compare the thrombogenicity and endothelial coverage (EC) after LAAC between the conventional uncoated WATCHMAN FLX (WM) and a novel fluoropolymer-coated WATCHMAN FLX (FP-WM).
METHODS
Canines were randomized for implantation with WM or FP-WM devices and given no postimplant antithrombotic/antiplatelet agents. The presence of DRT was monitored by using transesophageal echocardiography and verified histologically. The biochemical mechanisms associated with coating were assessed by using flow loop experiments to quantify albumin adsorption, platelet adhesion, and porcine implants to quantify EC and the expression of markers of endothelial maturation (ie, vascular endothelial-cadherin/p120-catenin).
RESULTS
Canines implanted with FP-WM exhibited significantly less DRT at 45 days than those implanted with WM (0% vs 50%; P < 0.05). In vitro experiments showed significantly greater albumin adsorption (52.8 [IQR: 41.0-58.3] mm vs 20.6 [IQR: 17.2-26.6] mm; P = 0.03) and significantly less platelet adhesion (44.7% [IQR: 27.2%-60.2%] vs 60.9% [IQR: 39.9%-70.1%]; P < 0.01) on FP-WM. Porcine implants showed significantly greater EC by scanning electron microscopy (87.7% [IQR: 83.4%-92.3%] vs 68.2% [IQR: 47.6%-72.8%]; P = 0.03), and higher vascular endothelial-cadherin/p120-catenin expression after 3 months on FP-WM compared with WM.
CONCLUSIONS
The FP-WM device showed significantly less thrombus and reduced inflammation in a challenging canine model. Mechanistic studies indicated that the fluoropolymer-coated device binds more albumin, leading to reduced platelet binding, less inflammation, and greater EC.
Topics: Animals; Dogs; Swine; Fluorocarbon Polymers; Prosthesis Design; Atrial Fibrillation; Atrial Appendage; Treatment Outcome; Thrombosis; Inflammation
PubMed: 37204356
DOI: 10.1016/j.jacep.2023.04.013 -
Frontiers in Neurology 2023External ventricular drainage (EVD) is a common emergency neurosurgical procedure, but it is not free of adverse events. The aim of this study is to compare the...
BACKGROUND
External ventricular drainage (EVD) is a common emergency neurosurgical procedure, but it is not free of adverse events. The aim of this study is to compare the complication rate of two frequently used EVD types, namely, tunneled antibiotic-impregnated catheters (Bactiseal) and bolt-connected non-coated devices (Camino).
METHODS
All EVDs placed between 1 March 2015 and 31 December 2017 were registered. Procedures performed with any catheter different from Bactiseal or Camino EVD with incomplete follow-up and those EVDs placed due to infectious disease were excluded. Demographic and clinical variables, as well as the overall complication rate (infection, hemorrhage, obstruction, malposition of the catheter, and involuntary pull-out of the device) and the need for replacement of the EVD, were collected.
RESULTS
A total of 77 EVDs were finally considered for analysis (40 Bactiseal and 37 Camino). There was a statistically significant difference in diagnosis and also in the location of the procedure, as more bolt-connected EVD was placed outside the operating room (97.3 vs. 23.5%, < 0.001) due to emergent pathologies such as vascular diseases and spontaneous hemorrhages. In the univariate analysis, a statistically significantly higher rate of catheter involuntary pull-out (29.7 vs. 7.5%, = 0.012) and the need for EVD replacement (32.4 vs. 12.5%, = 0.035) was found in the Camino cohort. However, those differences could not be confirmed with multivariable analysis, which showed no association between the type of catheter and any of the studied complications. Ventriculostomy duration was identified as a risk factor for infection (OR 1.09, 95% CI 1.02-1.18).
CONCLUSION
No significant differences were observed regarding infection, hemorrhage, obstruction, malposition, involuntary catheter pull-out, and the need for EVD replacement when comparing non-impregnated bolt-connected EVDs (Camino) with tunneled antibiotic-impregnated catheters (Bactiseal). The duration of EVD was associated with an increased risk of infection.
PubMed: 37638173
DOI: 10.3389/fneur.2023.1202954 -
Translational Animal Science Apr 2022The definition of animal welfare includes how an animal dies. As such, euthanasia is intrinsically linked to animal welfare, and ensuring a good death through effective,...
The definition of animal welfare includes how an animal dies. As such, euthanasia is intrinsically linked to animal welfare, and ensuring a good death through effective, safe, and validated practices is a critical piece of promoting positive animal welfare. The objective of this review is to provide a better understanding of the literature on the euthanasia of swine via penetrating captive bolt () and nonpenetrating captive bolt (), as well as a history of captive bolt use, and indicators of sensibility and insensibility. To do this, we performed a systematic review that included 30 peer-reviewed articles and 17 other publications. NPCB devices have been validated as an effective single-step euthanasia method for neonatal and preweaning swine, as well as a two-step euthanasia method for nursery swine. PCB devices have been validated as an effective euthanasia method for nursery and market swine up to 120 kg, but further investigation is required for the use of captive bolt devices on mature breeding sows and boars.
PubMed: 35755133
DOI: 10.1093/tas/txac065