Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.

BACKGROUND: The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials. METHODS: Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used. RESULTS: Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups. CONCLUSIONS: This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.

Redundant nerve roots on magnetic resonance imaging can predict ongoing denervation in patients with lumbar spinal stenosis.

INTRODUCTION/AIMS: Redundant nerve roots (RNRs) are abnormally elongated and tortuous nerve roots that develop secondary to degenerative spinal stenosis. RNRs have been associated with poorer clinical outcomes after decompression surgery; however, studies on their clinical characteristics are limited. This study aimed to investigate the association between RNRs and denervation potentials, that is, abnormal spontaneous activity (ASA), on electromyography. METHODS: We retrospectively reviewed data of patients who underwent an electrodiagnostic study of the lower extremities between January 2020 and March 2023. Of these, patients with lumbar central spinal stenosis, as seen on magnetic resonance imaging, were included. We analyzed clinical and imaging data, including presence of ASA, and compared them according to the presence of RNRs. Multivariable logistic regression analysis was employed to identify factors associated with development of ASA. RESULTS: Among the 2003 patients screened, 193 were included in the study. RNRs were associated with advanced age (p < .001), longer symptom duration (p = .009), smaller cross-sectional area of the dural sac at the stenotic level (p < .001), and higher frequency of ASA (p < .001). Higher probability of ASA was correlated with greater RNR severity (p < .001). In the multivariable logistic regression analysis, ASA occurrence was associated with smaller cross-sectional area, multiple stenotic sites, and severe-grade RNRs. DISCUSSION: The presence of RNRs, particularly severe-grade RNRs, was identified as a significant risk factor for the development of ASA on electromyography. This finding may aid physicians in estimating the prognosis of patients with central spinal stenosis.

Consensus Statement on Renal Denervation by the Joint Committee of Japanese Society of Hypertension (JSH), Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT), and the Japanese Circulation Society (JCS).

This is the first consensus statement of the Joint Committee on Renal Denervation of the Japanese Society of Hypertension (JSH)/Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT)/Japanese Circulation Society (JCS). The consensus is that the indication for renal denervation (RDN) is resistant hypertension or "conditioned" uncontrolled hypertension, with high office and out-of-office blood pressure (BP) readings despite appropriate lifestyle modification and antihypertensive drug therapy. "Conditioned" uncontrolled hypertension is defined as having one of the following: 1) inability to up-titrate antihypertensive medication due to side effects, the presence of complications, or reduced quality of life. This includes patients who are intolerant of antihypertensive drugs; or 2) comorbidity at high cardiovascular risk due to increased sympathetic nerve activity, such as orthostatic hypertension, morning hypertension, nocturnal hypertension, or sleep apnea (unable to use continuous positive airway pressure), atrial fibrillation, ventricular arrythmia, or heart failure. RDN should be performed by the multidisciplinary Hypertension Renal Denervation Treatment (HRT) team, led by specialists in hypertension, cardiovascular intervention and cardiology, in specialized centers validated by JSH, CVIT, and JCS. The HRT team reviews lifestyle modifications and medication, and the patient profile, then determines the presence of an indication of RDN based on shared decision making with each patient. Once approval for real-world clinical use in Japan, however, the joint RDN committee will update the indication and treatment implementation guidance as appropriate (annually if necessary) based on future real-world evidence.

Pictorial Review of Cranial Nerve Denervation in the Head and Neck.

Of the twelve cranial nerves, nine supply motor innervation to the muscles of the head and neck. Loss of this motor nerve supply, or denervation, follows a series of predictable chronologic changes in the affected muscles. Although the length of time between each change is markedly variable, denervation is typically classified into three distinct time points: (a) acute, (b) subacute, and (c) chronic. These muscle changes produce characteristic findings on images, with contrast-enhanced MRI being the preferred modality for assessment. Imaging allows radiologists to not only identify denervation but also evaluate the extent of denervation and localize the potential site of insult. However, these findings may be easily mistaken for other diseases with similar manifestations, such as neoplasm, infection, and inflammatory conditions. As such, it is fundamental for radiologists to be familiar with cranial nerve anatomy and denervation patterns so that they can avoid these potential pitfalls and focus their imaging search on the pathway of the affected nerve. In this article, the anatomy and muscles innervated by motor cranial nerves in the head and neck, denervation, and the associated expected imaging patterns are reviewed, and examples of potential pitfalls and denervation mimics are provided. ©RSNA, 2024.

Shoulder terminal sensory articular nerve radiofrequency ablation for nonsurgical refractory shoulder pain due to rotator cuff pathology and osteoarthritis: a technical note.

BACKGROUND: Given the high prevalence of chronic shoulder pain and encouraging early results of terminal sensory articular branch radiofrequency ablation to treat shoulder pain, research is warranted to refine the procedural technique on the basis of updated neuroanatomic knowledge with the goal of further improving patient outcomes. OBJECTIVE: We describe an updated radiofrequency ablation protocol that accounts for varied locations of the terminal sensory articular branches of the suprascapular, axillary, subscapular, and lateral pectoral nerves within individual patients. DESIGN: Technical note. METHODS: Cadaveric studies delineating the sensory innervation of the shoulder joint were reviewed, and a more comprehensive radiofrequency ablation protocol is proposed relative to historical descriptions. CONCLUSIONS: The proposed radiofrequency ablation protocol, which is based on neuroanatomic dissections of the shoulder joint, will provide a safe means of more complete sensory denervation and potentially improve clinical outcomes compared with historical descriptions, the efficacy of the new protocol must be confirmed in prospective studies.

Systematic Review and Meta-Analysis of the Effectiveness of Radiofrequency Ablation of the Sacroiliac Joint.

PURPOSE OF REVIEW: To evaluate the effectiveness of radiofrequency neurotomy in managing sacroiliac joint pain utilizing a systematic review with meta-analysis of randomized controlled trials (RCTs) and observational studies. RECENT FINDINGS: The prevalence of sacroiliac joint pain is estimated at around 25% of low back pain cases, and its diagnosis lacks a gold standard. Treatments include exercise therapy, injections, ablation, and fusion, with variable effectiveness. COVID-19 altered utilization patterns of interventions, including sacroiliac joint procedures, and the evidence for these interventions remains inconclusive. Recently, Medicare has issued its local coverage determinations (LCDs) in the United States, which provides noncoverage of sacroiliac joint radiofrequency neurotomy. Additionally, a recent systematic review of sacroiliac joint injections showed Level III or fair evidence. The sacroiliac joint, a critical axial joint linking the spine and pelvis, contributes to low back pain. Its complex innervation pattern varies among individuals. Sacroiliac joint dysfunction, causing pain and stiffness, arises from diverse factors.The present systematic review and meta-analysis aimed to evaluate radiofrequency neurotomy's effectiveness for sacroiliac joint pain management by applying rigorous methodology, considering both RCTs and observational studies. Despite methodological disparities, the evidence from this review, supported by changes in pain scores and functional improvement, suggests Level III evidence with fair recommendation for radiofrequency neurotomy as a treatment option. The review's strengths include its comprehensive approach and quality assessment. However, limitations persist, including variations in criteria and technical factors, underscoring the need for further high-quality studies in real-world scenarios.

Investigations of Laser-Assisted Renal Denervation for Treatment of Resistant Hypertension.

BACKGROUND AND OBJECTIVES: Renal denervation (RDN) is an emerging surgical treatment for resistant hypertension. However, the current RDN using radiofrequency can cause undesirable thermal damage to the medial and luminal layers due to direct contact between the arterial lumen and energy source. The aim of this study is to evaluate the feasibility of the new laser-assisted RDN by exploring the potential treatment conditions. METHODS: For ex vivo testing, six different treatment conditions (10 and 20 W applied for delivery of 300, 450, and 600 J) were tested on the porcine liver and renal artery (RA) by using a continuous wave 1064 nm laser wavelength. The ablated area in the liver tissue was measured to estimate the extent of the coagulated area. Histological evaluation was performed on the treated RA tissues to confirm the extent of thermal nerve damage. RESULTS: The ablated depth, length, and area in the liver tissue increased with laser power and total energy. According to the histological results, 20 W groups yielded more significant damage to the RA nerves than 10 W groups at the total energy of 300 J (0.0 ± 0.0 mm for 10 W vs. 2.9 ± 1.0 mm for 20 W), 450 J (1.9 ± 0.6 mm for 10 W vs. 6.8 ± 1.5 mm for 20 W), and 600 J (2.9 ± 0.4 mm for 10 W vs. 7.3 ± 0.8 mm for 20 W). The treated RA exhibited insignificant medial injury in depth (medial thinning ≤ 25%), and no difference in the medial thinning was found among the six groups (p = 0.4). CONCLUSION: The current study demonstrated that the 1064 nm laser at 20 W with delivery of 450 J could effectively damage the RA nerves with no or minimal injury to the surrounding tissue. The proposed laser-assisted RDN may enhance physiological effects with insignificant complications in in vivo situations. Further in vivo studies will be conducted to validate the current findings by evaluating the extent of blood pressure reduction and norepinephrine changes after the laser-assisted RDN on a large animal model.

Interventional treatments for low back pain due to sacroiliac joint dysfunction: a systematic review of the literature.

PURPOSE: This systematic review aimed to report the current evidence in the literature about the efficacy of interventional treatments in the management of low back pain (LBP) due to sacroiliac joint dysfunction. METHODS: A systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Medline, EMBASE, Scopus, CINAHL, Cochrane Library, and CENTRAL bibliographic databases were searched. The search was performed from October to December 2021, and articles from the inception of the database to December 2021 were searched. RESULTS: Fourteen studies were included for qualitative synthesis. Five studies used the traditional radiofrequency approach (tRF), five studies used cooled radiofrequency approach (cRF), one study used botulinum toxin (BT), two studies used steroid injection, triamcinolone (TA) and local anesthetics injections, and one study used pulsed radiofrequency (PRF) denervation. Two studies used sham as a comparator. CONCLUSIONS: Cooled radiofrequency seems to be the most effective treatment in improving pain and functionality, while intra-articular injections are helpful only as diagnostic tools. However, due to the lack of high-quality studies, it was not possible to draw significant conclusions.

Patient reported and functional outcome measures after surgical salvage procedures for posttraumatic radiocarpal osteoarthritis - a systematic review.

BACKGROUND: Posttraumatic wrist osteoarthritis is an irreversible and often progressive condition. Many surgical treatments, used in (daily) practice, aim to relieve symptoms like pain and restore function. The aim of this systematic review is to assess the patient reported and functional outcomes of the most common surgical interventions in patients with posttraumatic wrist osteoarthritis. This overview can help clinicians select the best treatment and manage patient's expectations. METHODS: A literature search was performed in Pubmed, Embase and Cochrane for articles published between 1990 and November 2022 according to the PRISMA guidelines. The study protocol has been registered in the PROSPERO database (CRD42017080427). Studies that describe patient reported outcomes (pain and Disability of Arm, Shoulder and Hand (DASH) -score) and functional outcomes (range of motion (ROM) and grip strength) after surgical intervention with a minimal follow-up of 1 year were included. The identified surgical procedures included denervation, proximal row carpectomy, interpositional- and total arthroplasty, and midcarpal-, radiocarpal- and total arthrodesis. The pre-and postoperative outcomes were pooled and presented per salvage procedure. RESULTS: Data from 50 studies was included. Pain score improved after all surgeries except denervation. Flexion/extension decreased after radiocarpal arthrodesis, did not show significant changes after proximal row carpectomy, and improved for all other surgeries. DASH score improved after arthroplasty, proximal row carpectomy and midcarpal arthrodesis. Grip strength improved after interposition arthroplasty and partial arthrodesis. CONCLUSION: Evidence from this review did not support the indication for denervation in this particular patient population. In patients with SLAC/SNAC II, proximal row carpectomy might be favourable to a midcarpal arthrodesis solely based on better FE ROM of the radiocarpal joint after proximal row carpectomy. In terms of radiocarpal mobility, total wrist arthroplasty might be preferred to radiocarpal arthrodesis in patients with osteoarthritis after a distal radius fracture. More uniform measurements of outcomes would improve the understanding of the effect of surgical treatments of the posttraumatic osteoarthritic wrist.

Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Since the publication of the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) Guidelines for the Management of Arterial Hypertension, several high-quality studies, including randomised, sham-controlled trials on catheter-based renal denervation (RDN) were published, confirming both the blood pressure (BP)-lowering efficacy and safety of radiofrequency and ultrasound RDN in a broad range of patients with hypertension, including resistant hypertension. A clinical consensus document by the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on RDN in the management of hypertension was considered necessary to inform clinical practice. This expert group proposes that RDN is an adjunct treatment option in uncontrolled resistant hypertension, confirmed by ambulatory BP measurements, despite best efforts at lifestyle and pharmacological interventions. RDN may also be used in patients who are unable to tolerate antihypertensive medications in the long term. A shared decision-making process is a key feature and preferably includes a patient who is well informed on the benefits and limitations of the procedure. The decision-making process should take (i) the patient's global cardiovascular (CV) risk and/or (ii) the presence of hypertension-mediated organ damage or CV complications into account. Multidisciplinary hypertension teams involving hypertension experts and interventionalists evaluate the indication and facilitate the RDN procedure. Interventionalists require expertise in renal interventions and specific training in RDN procedures. Centres performing these procedures require the skills and resources to deal with potential complications. Future research is needed to address open questions and investigate the impact of BP-lowering with RDN on clinical outcomes and potential clinical indications beyond hypertension.

A meta-analysis and review on the effectiveness and safety of renal denervation in managing heart failure with reduced ejection fraction.

OBJECTIVE: This study aimed to systematically evaluate the effectiveness and safety of renal denervation (RDN) in managing heart failure with reduced ejection fraction (HFrEF). METHODS: A comprehensive search was done in multiple databases: Cochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Database for Chinese Technical Periodicals. All clinical trials investigating RDN treatment for HFrEF through 15 March 2024 were gathered. The quality of the included studies was evaluated utilizing the Cochrane risk assessment tool. The pertinent data were gathered, and a meta-analysis was done using Review Manager 5.3, accompanied by sensitivity and publication bias analyses. RESULTS: After applying the inclusion and exclusion criteria, eight randomized controlled trials (RCTs) were selected for analysis, encompassing 314 patients; 154 patients underwent RDN treatment during hospitalization, while 150 were randomized to the control group to receive medication therapy. The meta-analysis demonstrated that compared to medication therapy, RDN contributed to a 9.59% increase in left ventricular ejection fraction (LVEF) (95% CI: 7.92-11.27, Z = 11.20, p < 0.01); a decrease in brain natriuretic peptide (BNP) (95% CI: -364.19--191.75, Z = 6.32, p < 0.01); a decrease in N-terminal pro B-type natriuretic peptide (NT-proBNP) (95% CI: -1300.15--280.95, Z = 3.04, p < 0.01); a decrease in the New York Heart Association (NYHA) classification (95% CI: -1.58--0.34, Z = 3.05, p < 0.01); a 90.00-m increase in 6-min walk test (6MWT) (95% CI: 68.24-111.76, Z = 8.11, p < 0.01); a reduction of 4.05 mm in left ventricular end-diastolic diameter (LVEDD) (95% CI: -5.65--2.48, Z = 5.05, p < 0.01); a decrease of 4.60 heart beats·min-1 (95% CI: -8.83--0.38, Z = 2.14, p < 0.05); and a 4.67-mm reduction in left atrial diameter (LAD) (95% CI: -6.40--2.93, Z = 5.27, p < 0.01). Left ventricular end-systolic diameter (LVESD) and systolic/diastolic blood pressure (OSBP/ODBP) were similar between groups (p > 0.01). As the safety indicator, estimated glomerular filtration rate (eGFR) improved by 7.11 in the RDN group [ml/(min·1.73 m2)] (95% CI: 1.10-13.12, Z = 2.32, p < 0.05). LVEF, BNP, 6MWT, LVEDD, LAD and eGFR were meta-analyzed using a fixed-effects model, the other indicators a random-effects model. CONCLUSION: RDN significantly ameliorated cardiac function in HFrEF patients while exhibiting commendable safety.

Small Joint Denervation of the Hand and Thumb Base: History, Anatomy, Technique, and Outcomes.

Painful arthritis of the small joints of the hand is a common condition affecting older adults, with distal interphalangeal joint and thumb carpometacarpal joint being the two most common locations. Younger adults may also develop painful arthritis after trauma and with inflammatory arthropathy. Traditional surgical approaches address the structure of the joints with either arthrodesis or arthroplasty with or without an implant. In recent decades, denervation has been reported as an alternative treatment for painful small joints that are mobile and stable. Publications on denervation often report faster surgery and recovery times than traditional surgeries that manipulate the small joint bony structures. This article reviews the history, anatomy, surgical techniques, and outcomes of denervation of the small joints of the hand.

The neural regulation and impact of posterior nasal neurectomy on nasal ciliary motion in vivo in a murine allergic rhinitis model.

BACKGROUND: Posterior nasal neurectomy (PNN) is a commonly employed surgical approach for the treatment of allergic rhinitis (AR). Due to its denervation effect on the nasal mucosa, PNN may potentially alter the motion and defensive capability of cilia. Previous research on the effects of neural regulation and denervation on cilia has been limited by the absence of a feasible in vivo evaluation method for assessing ciliary function. METHODOLOGY: Utilizing a new system developed by our team for visualizing and analyzing ciliary motion in vivo, we analysed ciliary beat frequency and distance in vivo and histomorphological changes in a murine PNN and AR model. Ovalbumin, histamine and neurotransmitters (acetylcholine chloride, α receptor agonist and ß receptor agonist) were applied to investigate the responsiveness and neural regulation of the nasal mucosa. RESULTS: Denervation resulting from PNN led to a reduction in nasal ciliary beat frequency (CBF) to 78% of the control, as well as diminished response towards allergens and histamine. Among neurotransmitters examined, α receptor agonists exhibited inhibitory effects on in vivo ciliary motion while acetylcholine and ß receptor agonists demonstrated stimulatory effects. PNN did not affect the reactivity of in vivo cilia towards these neurotransmitters. CONCLUSIONS: PNN-induced denervation can reduce ciliary motion, potentially compromising the defensive capability of nasal mucosa. Neural regulation and the neurotransmitters involved have significant effect on ciliary motion.

Efficacy of radiofrequency in lumbar facet joint pain: a systematic review and meta-analysis of placebo-controlled randomized controlled trials.

BACKGROUND: Lumbar facet joint pain (LFJP) is one of the main causes of chronic low back pain (LBP) and can be treated using radiofrequency (RF) sensory denervation. The aim of this work is to analyze the efficacy of RF in LFJP through a systematic review and meta-analysis of randomized controlled trials (RCTs) with placebo control. MATERIALS AND METHODS: A systematic search was conducted in the Medline (PubMed), Scopus, Web of Science databases, and the Cochrane Central Register of Controlled Trials (CENTRAL). The variables of interest were pain, functional status, quality of life (QoL), and global perceived effect (GPE) measured at different time intervals: short (< 3 months), medium (> 3 and < 12 months), and long term (> 12 months). RESULTS: Eight RCTs with placebo control were included. RF showed significant benefits over placebo in pain relief in the short (MD - 1.01; 95% CI - 1.98 to -0.04; p = 0.04), medium (MD - 1.42; 95% CI - 2.41 to - 0.43; p = 0.005), and long term (MD - 1.12; 95% CI - 1.57 to - 0.68; p < 0.001), as well as improvement in functional disability in the short (SMD - 0.94; 95% CI - 1.73 to - 0.14; p = 0.02) and long term (SMD - 0.74; 95% CI - 1.09 to - 0.39; p < 0.001). No statistically significant differences were observed in QoL or quantitative GPE, but benefits for RF were observed in dichotomous GPE in the medium (OR 0.19; 95% CI 0.07-0.52; p = 0.001) and long term (OR 0.22; 95% CI 0.06-0.78; p = 0.02). Subgroup analyses showed more benefits for RF in LBP < 1 year in the short term and in RCTs that did not require performing an MRI for patient selection. CONCLUSIONS: RF demonstrated significant improvement in pain and functionality, but the benefits in terms of QoL and GPE are inconclusive. Future clinical trials should investigate the long-term effects of RF, its impact on quality of life, and define appropriate criteria for patient selection.

Anatomical study of the motor branches of the tibial nerve and incision design for hyperselective neurectomy.

PURPOSE: Selective tibial neurotomy (STN) is a surgical procedure for treating spastic equinovarus foot. Hyperselective neurectomy (HSN) of tibial nerve is a modified STN procedure, which was rarely discussed. This study aimed to describe the branching patterns of the tibial nerve and propose an optimal surgical incision of HSN for treatment of spastic equinovarus foot. METHODS: Sixteen lower limbs were dissected to determine the various branching patterns of the tibial nerve and categorized according to these branching patterns. The mean distances from the nerve entry points to the tip of femur's medial epicondyle were measured, as well as their percentage to the overall length of the leg. The surgical incision was designed according to the range of these nerve entry points. RESULTS: The tibial nerve sent out proximal and distal motor branches based on their position relative to the soleus muscle's tendinous arch. For proximal motor branches, the branches innervating the medial gastrocnemius, lateral gastrocnemius and proximal soleus were categorized into types I (9/16), II (5/16) and III (2/16). Measurements from the medial epicondyle to the nerve entry points into the medial gastrocnemius, lateral gastrocnemius and proximal soleus ranged from 14 to 33 mm (4-9% of leg length), 22-45 mm (6-12%) and 35-81 mm (10-22%), respectively. Distal motor branches including the distal soleus, posterior tibialis, flexor digitorum longus and flexor hallucis longus, were classified as types A (8/14), B (4/14) and C (2/14), with the distances from their respective terminal points to the medial epicondyle were 67-137 mm (19-39%), 74-125 mm (20-35%), 116-243 mm (33-69%) and 125-272 mm (35-77%). CONCLUSIONS: The motor branches of tibial nerve were classified into two groups and each subdivided into three types. Detailed location parameters may serve as an anatomical basis for designing incision of HSN.

[Construction of a predictive model for postoperative pain relief after microscopic spermatic cord surgery for spermatic cord pain].

OBJECTIVE: To explore the relevant factors affecting the efficacy of microscopic spermatic cord surgery and build a predictive model for postoperative pain relief. METHODS: A retrospective analysis was conducted on the clinical data of 324 patients with spermatic cord pain who visited the Department of Urology at Peking University People's Hospital between October 2015 and April 2023. This cohort included 212 patients with varicocele-related spermatic cord pain and 112 patients with idiopathic spermatic cord pain. All the patients underwent microsurgical procedures: varicocele-related pain was treated with microsurgical varicocelectomy, and idiopathic pain was treated with microsurgical denervation of the spermatic cord. The patients were categorized into effective and ineffective groups based on whether their pain had decreased by more than 50% six months post-surgery compared with pre-surgery levels. Baseline data were preliminarily screened for clinical indicators using t tests and univariate analysis. Clinical predictor variables [age, duration of pain, diameter of varicocele, patient health questionnaire-9 (PHQ-9) score, generalized anxiety disorder-7 (GAD-7) score] were selected using Lasso regression. A clinical prediction model for effective pain relief following microscopic spermatic cord surgery was constructed using Logistic regression and presented as a nomogram. The model's internal validation was performed using the bootstrap method. Its predictive power and clinical utility were evaluated through the concor-dance index, the area under the receiver operating characteristic curve, and calibration plots. RESULTS: Post-microscopic varicocele ligation, 156 patients (73.58%) experienced significant pain relief, as did 94 patients (83.93%) following microscopic denervation. Independent predictors for postoperative outcomes included age, PHQ-9 score, GAD-7 score, chronic pain duration, and varicocele diameter, differing slightly between varicocele-related and idiopathic pain groups. The models demonstrated excellent predictive ability, with areas under the curve of 0.909 and 0.913 for varicocele and idiopathic groups, respectively, and high concordance indices. CONCLUSION: The postoperative efficacy prediction model based on age, pain duration, PHQ-9 score, GAD-7 score, and varicocele diameter has good predictive ability and clinical applicability, and can be used in clinical practice.

Pulsed radiofrequency or surgery for anterior cutaneous nerve entrapment syndrome: Long-term results of a randomized controlled trial.

PURPOSE: Patients with anterior cutaneous nerve entrapment syndrome (ACNES) often require a step-up treatment strategy including abdominal wall injections, pulsed radiofrequency (PRF) or a neurectomy. Long-term success rates of PRF and surgery are largely unknown. The aim of the current study was to report on the long-term efficacy of PRF and neurectomy in ACNES patients who earlier participated in the randomized controlled PULSE trial. METHODS: Patients who completed the PULSE trial were contacted about pain status and additional treatments in the following years. Treatment success was based on numerical rating scale (NRS) following IMMPACT recommendations and Patient Global Impression of Change (PGIC) scores. RESULTS: A total of 44 of the original 60 patients were eligible for analysis (73.3%). Median follow-up was 71.5 months. One patient (4.3%) was still free of pain after a single PRF session, and five additional patients (21.7%) were free of pain by repetitive PRF treatments. By contrast, 13 patients (61.9%) in the neurectomy group were still free of pain without additional treatments. All pain recurrences and therefore primary re-interventions occurred in the first 2 years after the initial treatment. CONCLUSION: Approximately one in five ACNES patients undergoing PRF treatment reports long-term success obviating the need of surgical intervention. Surgery for ACNES is long-term effective in approximately two of three operated patients. Recurrent ACNES beyond 2 years after either intervention is rare.

Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.

BACKGROUND: Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group. METHODS: This randomised, single-blind, sham-controlled trial enrolled patients from 25 clinical centres in the USA, Germany, Japan, the UK, Australia, Austria, and Greece, with uncontrolled hypertension and office systolic blood pressure between 150 mm Hg and 180 mm Hg and diastolic blood pressure of 90 mm Hg or higher. Eligible patients had to have 24-h ambulatory systolic blood pressure between 140 mm Hg and less than 170 mm Hg, while taking one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned (1:1) to radiofrequency renal denervation or a sham control procedure. Patients and physicians were unmasked after 12-month follow-up and sham control patients could cross over after 12-month follow-up completion. The primary endpoint was the treatment difference in mean 24-h systolic blood pressure at 6 months between the renal denervation group and the sham control group. Statistical analyses were done on the intention-to-treat population. Long-term efficacy was assessed using ambulatory and office blood pressure measurements up to 36 months. Drug surveillance was used to assess medication use. Safety events were assessed up to 36 months. This trial is registered with ClinicalTrials.gov, NCT02439775; prospectively, an additional 260 patients are currently being randomly assigned as part of the SPYRAL HTN-ON MED Expansion trial. FINDINGS: Between July 22, 2015, and June 14, 2017, among 467 enrolled patients, 80 patients fulfilled the qualifying criteria and were randomly assigned to undergo renal denervation (n=38) or a sham control procedure (n=42). Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs. The medication burden at 36 months was 2·13 medications (SD 1·15) in the renal denervation group and 2·55 medications (2·19) in the sham control group (p=0·26). 24 (77%) of 31 patients in the renal denervation group and 25 (93%) of 27 patients in the sham control group adhered to medication at 36 months. At 36 months, the ambulatory systolic blood pressure reduction was -18·7 mm Hg (SD 12·4) for the renal denervation group (n=30) and -8·6 mm Hg (14·6) for the sham control group (n=32; adjusted treatment difference -10·0 mm Hg, 95% CI -16·6 to -3·3; p=0·0039). Treatment differences between the renal denervation group and sham control group at 36 months were -5·9 mm Hg (95% CI -10·1 to -1·8; p=0·0055) for mean ambulatory diastolic blood pressure, -11·0 mm Hg (-19·8 to -2·1; p=0·016) for morning systolic blood pressure, and -11·8 mm Hg (-19·0 to -4·7; p=0·0017) for night-time systolic blood pressure. There were no short-term or long-term safety issues associated with renal denervation. INTERPRETATION: Radiofrequency renal denervation compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. Renal denervation could provide an adjunctive treatment modality in the management of patients with hypertension. FUNDING: Medtronic.

Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial.

BACKGROUND: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results. METHODS: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261. FINDINGS: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group. INTERPRETATION: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control. FUNDING: Medtronic.

Renal denervation: recent developments in clinical and preclinical research.

PURPOSE OF REVIEW: Renal denervation represents a new dimension to hypertension treatment, with multiple device manufacturers seeking premarket FDA approval currently. Interest in the efficacy and safety of the treatment has spurred compelling mechanistic studies into the function of renal nerves and downstream impacts of denervation. RECENT FINDINGS: A trial of the ultrasound Paradise Catheter system (RADIANCE II) found a 6.3 mmHg reduction in SBP relative to sham controls. A trial of the Symplicity Spyral system (SPYRAL HTN-ON MED) found an insignificant reduction in SBP relative to sham controls. Individuals were taking antihypertensive medications during the study, and investigators note the sham group experienced a larger medication burden than the denervated group. Recent preclinical studies have evaluated potential risks of renal denervation, how sympathetic activity broadly is affected, as well as identifying possible biomarkers to identify individuals where denervation would be more successful. SUMMARY: Studies of renal denervation continue to find a robust antihypertensive effect, especially in studies wherein medications are withdrawn. Further investigation into mechanisms and indicators for usage of the technique will be important in identifying the patient population most likely to benefit from usage of renal denervation.