Long-term effect of posterior nasal neurectomy for perennial allergic rhinitis.

BACKGROUND: Surgical treatment is recommended for patients with severe allergic rhinitis (AR) refractory to medical treatment. Endoscopic posterior nasal neurectomy (PNN) is primarily performed to improve rhinorrhea in severe perennial AR, however studies on its long-term prognosis are lacking. AIMS/OBJECTIVES: This study aimed to investigate the long-term prognosis of PNN. MATERIALS AND METHODS: A questionnaire survey was administered to 17 patients (12 men and 5 women) at least 1 year after PNN. Nasal symptoms and medications, as well as patient satisfaction with surgery at the time of survey, were scored. Furthermore, scores were compared between patients with postoperative periods of >5 years and <5 years. RESULTS: Nasal symptoms and medication scores significantly improved after surgery. There was no significant difference between patients with a postoperative period of >5 years and <5 years in both preoperative and postoperative nasal symptoms and medication scores. No correlation was found between patient satisfaction with surgery and postoperative period. CONCLUSIONS AND SIGNIFICANCE: PNN improved nasal symptoms and medication scores in patients with severe perennial AR. Furthermore, the study results suggest that the long-term effect of PNN for perennial AR lasts for >5 years. J. Med. Invest. 71 : 62-65, February, 2024.

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.

[Selective Neurectomy in Spastic Paralysis of the Upper Extremity]. / Die hyperselektive Neurektomie bei spastischen Lähmungen der oberen Extremität.

Selective neurectomy refers to the targeted transection of motor nerve fibres at their entry into the muscle in order to reduce the increased muscle tone in cases of spastic paralysis. This procedure has regained popularity in recent years, especially in the upper extremity. First and foremost, it requires an exact knowledge of the topographical anatomy of muscle innervation. To be able to control the extent and localisation of the denervation, the terminal nerve branches must be visualized precisely during the procedure. For a meaningful reduction of muscle tone, 2/3 to 4/5 of nerve fibres must be resected. This article presents the historical development, principles and operative details of this technique as well as clinical results.

Impact of renal denervation on patients with coronary microvascular dysfunction: study rationale and design.

AIMS: Long-standing hypertension may cause an impairment in microvascular coronary circulation, which is involved in many different cardiac conditions. Renal sympathetic denervation (RDN) has been successfully proven as a valuable therapeutic choice for patients with resistant hypertension; moreover, the procedure looks promising in other settings, such as heart failure and atrial fibrillation, given its ability to downregulate the sympathetic nervous system, which is a recognized driver in these conditions as well as in microvascular dysfunction progression. The aim of this study is to explore the effect of RDN on coronary physiology in patients with ascertained coronary microvascular dysfunction and resistant hypertension. METHODS: This is a multicenter, prospective, nonrandomized, open-label, interventional study. Consecutive patients with resistant hypertension, nonobstructive coronary artery disease (NOCAD) and documented microvascular dysfunction will be enrolled. Patients will undergo RDN by Spyral Symplicity 3 (Medtronic Inc, Minneapolis, Minnesota, USA) and reassessment of coronary microvascular function 6 months after the procedure. Primary endpoint will be the difference in the index of microcirculatory resistance. CONCLUSION: The IMPRESSION study seeks to evaluate if there is any pleiotropic effect of the RDN procedure that results in modulation of microvascular function; if observed, this would be the first evidence showing RDN as a valuable therapy to revert hypertension-related microvascular dysfunction.

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.

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.

BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44). CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.

Salt sensitivity risk derived from nocturnal dipping and 24-h heart rate predicts long-term blood pressure reduction following renal denervation.

BACKGROUND: Renal denervation (RDN) has been consistently shown in recent sham-controlled clinical trials to reduce blood pressure (BP). Salt sensitivity is a critical factor in hypertension pathogenesis, but cumbersome to assess by gold-standard methodology. Twenty-four-hour average heart rate (HR) and mean arterial pressure (MAP) dipping, taken by ambulatory blood pressure monitoring (ABPM), stratifies patients into high, moderate, and low salt sensitivity index (SSI) risk categories. OBJECTIVES: We aimed to assess whether ABPM-derived SSI risk could predict the systolic blood pressure reduction at long-term follow-up in a real-world RDN patient cohort. METHODS: Sixty participants had repeat ABPM as part of a renal denervation long-term follow-up. Average time since RDN was 8.9 ±â€Š1.2 years. Based on baseline ABPM, participants were stratified into low (HR < 70 bpm and MAP dipping > 10%), moderate (HR ≥70 bpm or MAP dipping ≤ 10%), and high (HR ≥ 70 bpm and MAP dipping ≤ 10%) SSI risk groups, respectively. RESULTS: One-way ANOVA indicated a significant treatment effect ( P  = 0.03) between low ( n  = 15), moderate ( n  = 35), and high ( n  = 10) SSI risk with systolic BP reduction of 9.6 ±â€Š3.7 mmHg, 8.4 ±â€Š3.5 mmHg, and 28.2 ±â€Š9.6 mmHg, respectively. Baseline BP was not significantly different between SSI Risk groups ( P  = 0.18). High SSI risk independently correlated with systolic BP reduction ( P  = 0.02). CONCLUSIONS: Our investigation indicates that SSI risk may be a simple and accessible measure for predicting the BP response to RDN. However, the influence of pharmacological therapy on these participants is an important extraneous variable requiring testing in prospective or drug naive RDN cohorts.

Comparison of the efficacy of continuous radiofrequency thermocoagulation, pulsed radiofrequency denervation applications, and TENS therapies for lumbar facet syndrome: A single-blind randomized controlled trial.

OBJECTIVES: We aimed to compare the effectiveness of TENS, used in physical therapy departments, and continuous radiofrequency thermocoagulation (CRF) and pulsed radiofrequency denervation (PRF), used in algology departments, in patients with lumbar facet syndrome (LFS). METHODS: Subjects were selected from patients with LFS visiting outpatient clinics of physical therapy and algology departments at Ege University School of Medicine, whose pain was refractory to medical treatment for at least 3 months. Subjects were randomized into 3 groups. A total of 60 patients, with 20 in each group, were enrolled. The first group received CRF, the second group received TENS for 30 minutes a day for 15 days, and the third group received PRF. Patients were assessed at baseline, at the end of the first and sixth months, for a total of three times. RESULTS: Improvements at month 1 and month 6 were found to be statistically significant in all three treatment groups with respect to their pain scores, Oswestry Disability Indexes, hand-floor distance measurements, 20-meter walking times, 6-min walking distances, Beck Depression Inventory, and most of the SF-36 domain scores (p<0.05). A comparison of the treatment groups showed no superiority of any group over the others in any assessment parameters (p>0.05). CONCLUSION: We suggest that it might be more appropriate to use TENS, a non-invasive treatment, before trying more invasive procedures like CRF and PRF in these patients. However, it has been stated that further studies involving a larger patient sample are needed.

Renal denervation restores biomechanics of carotid arteries in a rat model of hypertension.

The prevalence of hypertension increases with aging and is associated with increased arterial stiffness. Resistant hypertension is presented when drug treatments fail to regulate a sustained increased blood pressure. Given that the mechanisms between the sympathetic nervous system and the kidney play an important role in blood regulation, renal denervation (RDN) has emerged as a therapeutic potential in resistant hypertension. In this study, we investigated the effects of RDN on the biomechanical response and microstructure of elastic arteries. Common carotid arteries (CCA) excised from 3-month, 8-month, and 8-month denervated rats were subjected to biaxial extension-inflation test. Our results showed that hypertension developed in the 8-month-old rats. The sustained elevated blood pressure resulted in arterial remodeling which was manifested as a significant stress increase in both axial and circumferential directions after 8 months. RDN had a favorable impact on CCAs with a restoration of stresses in values similar to control arteries at 3 months. After biomechanical testing, arteries were imaged under a multi-photon microscope to identify microstructural changes in extracellular matrix (ECM). Quantification of multi-photon images showed no significant alterations of the main ECM components, elastic and collagen fibers, indicating that arteries remained intact after RDN. Regardless of the experimental group, our microstructural analysis of the multi-photon images revealed that reorientation of the collagen fibers might be the main microstructural mechanism taking place during pressurization with their straightening happening during axial stretching.

The role of renal denervation in cardiology and beyond: An updated comprehensive review and future directives.

Renal denervation (RDN) is a minimally invasive intervention performed by denervation of the nervous fibers in the renal plexus, which decreases sympathetic activity. These sympathetic nerves influence various physiological functions that regulate blood pressure (BP), including intravascular volume, electrolyte composition, and vascular tone. Although proven effective in some trials, controversial trials, such as the Controlled Trial of Renal Denervation for Resistant Hypertension (SYMPLICITY-HTN3), have demonstrated contradictory results for the effectiveness of RDN in resistant hypertension (HTN). In the treatment of HTN, individuals with primary HTN are expected to experience greater benefits compared to those with secondary HTN due to the diverse underlying causes of secondary HTN. Beyond its application for HTN, RDN has also found utility in addressing cardiac arrhythmias, such as atrial fibrillation, and managing cases of heart failure. Non-cardiogenic applications of RDN include reducing the intensity of obstructive sleep apnea (OSA), overcoming insulin resistance, and in chronic kidney disease (CKD) patients. This article aims to provide a comprehensive review of RDN and its uses in cardiology and beyond, along with providing future directions and perspectives.

Bipolar radiofrequency ablation of genicular nerves in chronic knee pain: A novel technique for more complete sensory denervation.

BACKGROUND: Monopolar radiofrequency ablation (MRFA) of the genicular nerves has been considered the main interventional treatment for chronic knee pain. However, the variable locations of these nerves could suggest that traditional MRFA of genicular nerves may be insufficient to cover the area needed to provide complete sensory denervation. For these reasons, some alternatives have been proposed to achieve an increase in the lesion area that offers better outcomes such a bipolar radiofrequency ablation (BRFA). OBJECTIVE: To describe the efficacy and safety of the bipolar radiofrequency ablation (BRFA) of the genicular nerves in the patients with chronic knee pain. METHODS: A retrospective study was conducted in the Pain Medicine Department. Institutional review board approval from the Hospital Ethical Committee and informed consent were obtained. We reviewed our database for BRFA of genicular nerves from January 2018 to December 2021 for patients with chronic knee pain. The cannulas were placed using ultrasound guidance (10 cm, 22-gauge and 10 mm active curved tip), and each pair of cannulas were subjected to BRFA for 90 seconds at 80∘C. Data analysis was conducted using T-test for paired variables (Visual analogue scale and EuroQol, an instrument intended to complement other forms of quality-of-life measures). RESULTS: Twenty-five patients met inclusion criteria after excluding 7 based on the study design. The mean improvement of our patients according to the VAS was -3.98 (95%CI: -4.37 to -3.59) p< 0.0001 and EuroQol +0.416 (95%CI: 0.364 to 0.468) p< 0.0001. The mean duration of improvement was 8 (6-11) months after BRFA. There were no reported serious adverse events related to the procedure, only local pain for 24 to 48 hours in 3 patients. CONCLUSIONS: We can conclude that BRFA reduces procedural pain and increases the treatment area, providing more complete sensory denervation and improved clinical outcomes.

Endoscopic vidian and vidian-branch neurectomy for refractory allergic rhinitis: A systematic review.

BACKGROUND: Endoscopic vidian neurectomy is expected to provide good therapeutic relief in patients with allergic rhinitis (AR) being refractory to medication therapy or conservative surgery. However, the evidence bases for its benefit remain debatable. In this study, we conducted a systematic review and meta-analysis to clarify the therapeutic role of various forms of vidian neurectomy in refractory AR. METHOD: Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines were used to conduct a systematic review of primary studies that reported original patient data for endoscopic vidian neurectomy (EVN) and vidian-branch neurectomy, which includes selective vidian neurectomy (SVN) and posterior nasal neurectomy (PNN). The primary outcome was patient-reported outcome measures (PROMs), including the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Visual Analog Scale (VAS), to assess an improvement in nasal symptom severity and quality of patient's life. The incidence of surgical complications and other objective outcomes were considered secondary outcomes. RESULTS: This review included 24 clinical studies involving 1677 patients with refractory AR, of which 510 patients in six studies had combined chronic rhinosinusitis with nasal polyps (CRSwNP) and 95 patients in one study had combined asthma. Postoperative PROMs were significantly better than preoperatively in almost all patients who underwent vidianp (RQLQ: standardized mean difference [SMD] = 2.66, 95% confidence interval [CI] = 2.40-2.92, p < 0.001; VAS: SMD = 5.15, 95% CI = 4.29-6.02, p < 0.001) or vidian-branch neurectomy (RQLQ in PNN: SMD = 3.29, 95% CI = 2.45-4.13, p < 0.001; VAS in PNN: SMD = 4.38, 95% CI = 3.41-5.34, p < 0.001), and were generally better than in the conservative treatment group. Dividing with 18 months as the cutoff point, a subgroup analysis of the follow-up period was conducted, and the results showed that both long-term and short-term postoperative patients had considerably reduced symptoms compared to the preoperative period. The two surgical procedures, SVN and PNN, attributed to vidian-branch neurectomy have extremely few complications. However, EVN is more likely to cause dry eyes and palatal numbness, with no other serious complications. In patients with AR and CRSwNP, vidian or selective vidian neurectomy combined with functional endoscopic sinus surgery (FESS) is more effective than conventional FESS (RQLQ: SMD = 2.17, 95% CI = 1.66-2.69, p < 0.001; VAS: SMD = 6.42, 95% CI = 4.78-8.06, p < 0.001). For patients who have both AR and asthma, SVN with pharyngeal branch excision is a potential treatment option. CONCLUSION: EVN and vidian-branch neurectomy (including SVN and PNN) are effective treatments, but the former has a higher risk of complications. Additionally, vidian-branch neurectomy with FESS is beneficial for patients with mixed CRSwNP. SVN is a potential approach for patients with coexisting AR and asthma.

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.

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.

Renal Denervation in the Treatment of Resistant Hypertension and Difficult-to-Control Hypertension - Consensus Document of the Croatian Hypertension League - Croatian Society of Hypertension, Croatian Cardiac Society, Croatian Endovascular Initiative, Croatian Society for Diabetes and Metabolic Diseases, Croatian Renal Association, and Croatian Society of Family Physicians of the Croatian Medical Association.

Renal denervation (RDN) as a method of treating arterial hypertension (AH) was introduced in Croatia in 2012. A multidisciplinary team and a network of hospitals that diagnose and treat patients with severe forms of AH were established, and a very strict diagnostic-treatment algorithm was prepared. At monthly meetings patients with truly resistant hypertension who were candidates for RDN were discussed. According to the 2021 ESH position statement and 2023 ESH guidelines, RDN is considered an alternative and additional, not a competitive method of treating patients with various forms of AH which must be performed by following a structured procedure and the patient's preference should be considered. In view of the changes in the global scientific community, the Croatian Hypertension League brings this consensus document on RDN conducted with radiofrequency-based catheter, the only currently available method in Croatia. In this document, exclusion and inclusion criteria are shown, as well as three groups of patients in whom RDN could be considered. The new diagnostic-treatment algorithm is prepared and follow-up procedure is explained. In Croatia, RDN is reimbursed by the national insurance company, thus pharmacoeconomic analyses is also shown. Criteria required by an individual centre to be approved of RDN are listed, and plans for prospective research on RDN in Croatia, including the Croatian registry for RDN, are discussed.

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.

BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).

The effect of consecutive facet medial branch radiofrequency denervation and dorsal root ganglion pulse radiofrequency therapy on lumbar facet joint pain.

OBJECTIVES: The aim of this study was to evaluate the efficacy of consecutive facet medial branch (FMB) radiofrequency denervation (RFD) and dorsal root ganglion pulse radiofrequency (DRG PRF) therapy in patients with chronic lumbar facet joint pain. METHODS: The study included 27 patients with chronic lumbar pain who had ≥50% pain reduction after FMB block for suspected lumbar facet syndrome and subsequently underwent FMB RFD together with PRF to the adjacent DRG. The patients were retrospectively analyzed in terms of age, gender, pre-procedure symptom duration, history of previous back surgery, FMB RFD and DRG PRF level and side, and numerical rating scale scores immediately before and at 1, 3, and 6 months after the procedure, and subjective pain reduction at 6 months post-treatment. Treatment success was defined as ≥50% subjective pain reduction at 6 months. RESULTS: A total of 19 women and 8 men with a mean age of 57.7±12.4 years were analyzed. Twenty patients (74.1%) had no prior history of low back surgery. The success rate of the procedure in terms of subjective pain reduction at 6 months was 82.5% (n=25). The subjective percentage of pain reduction at post-procedure 6 months was significantly lower in patients with a pre-procedure symptom duration of 12 months or longer compared to those whose pre-procedure symptom duration was <12 months (p=0.04). CONCLUSION: Our study results show that the analgesic efficiency of DRG PRF added to FMD RFD treatment can be increased in patients with short symptom durations.

Regeneration of neuromuscular synapses after acute and chronic denervation by inhibiting the gerozyme 15-prostaglandin dehydrogenase.

To date, there are no approved treatments for the diminished strength and paralysis that result from the loss of peripheral nerve function due to trauma, heritable neuromuscular diseases, or aging. Here, we showed that denervation resulting from transection of the sciatic nerve triggered a marked increase in the prostaglandin-degrading enzyme 15-hydroxyprostaglandin dehydrogenase (15-PGDH) in skeletal muscle in mice, providing evidence that injury drives early expression of this aging-associated enzyme or gerozyme. Treating mice with a small-molecule inhibitor of 15-PGDH promoted regeneration of motor axons and formation of neuromuscular synapses leading to an acceleration in recovery of force after an acute nerve crush injury. In aged mice with chronic denervation of muscles, treatment with the 15-PGDH inhibitor increased motor neuron viability and restored neuromuscular junctions and function. These presynaptic changes synergized with previously reported muscle tissue remodeling to result in a marked increase in the strength of aged muscles. We further found that 15-PGDH aggregates defined the target fibers that are histopathologic hallmarks of human neurogenic myopathies, suggesting that the gerozyme may be involved in their etiology. Our data suggest that inhibition of 15-PGDH may constitute a therapeutic strategy to physiologically boost prostaglandin E2, restore neuromuscular connectivity, and promote recovery of strength after acute or chronic denervation due to injury, disease, or aging.

Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study.

INTRODUCTION: A major issue confronting clinicians treating hypertension in pregnancy is the limited number of pharmacological options. Endovascular catheter-based renal denervation (RDN) is a new method to lower blood pressure (BP) in patients with hypertension by reducing the activity of the renal sympathetic nervous system. Drugs that affect this system are safe in pregnant women. So there is reasonable evidence that RDN performed before pregnancy should not have deleterious effects for the fetus. Because the efficacy of RDN may be greater in younger patients and in women, we may expect a larger proportion of BP normalisation in young hypertensive women, but this remains to be proven. Our primary objective is to quantify the proportion of BP normalisation with RDN in this population. METHODS AND ANALYSIS: WHY-RDN is a multicentre randomised sham-controlled trial conducted in six French hypertension centres that will include 80 women with essential hypertension treated or untreated, who are planning a pregnancy in the next 2 years and will be randomly assigned to RDN or classic renal arteriography and sham RDN in a ratio of 1:1. The primary outcome is the normalisation of 24-hour BP (<130/80 mm Hg) at 2-month post procedure off treatment. Sample size is calculated with the following assumptions: 5% one-sided significance level (α), 80% power (1-ß), expected responder rates of 24% and 3% in the treatment and control group, respectively. Secondary outcomes include the absence of adverse outcomes for a future pregnancy, the variations of BP in ambulatory and home BP measurements and the evaluation of treatment prescribed. ETHICS AND DISSEMINATION: WHY-RDN has been approved by the French Ethics Committee (Tours, Region Centre, Ouest 1- number 2021T1-28 HPS). This project is being carried out in accordance with national and international guidelines. The findings of this study will be disseminated by publication. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05563337.