Denervation Procedure Research Articles

Abstract 17044: Effect of Sham Controlled Renal Denervation in Uncontrolled Hypertension. A Systematic Review and Meta-Analysis

Introduction: Catheter-based ablation of renal artery has been studied as one of the interventions for blood pressure control in patients with uncontrolled hypertension. Previous randomized control trials (RCTs) comparing renal denervation versus sham procedure for the same have shown equivocal results. This meta-analysis summarizes the current evidence on the effect of sham-controlled renal denervation on blood pressure reduction. Methods: Pubmed, Embase and Cochrane Central databases were searched from inception until April 30, 2020. RCTs comparing catheter-based renal denervation with a sham control were included. Outcomes assessed were changes in ambulatory systolic blood pressure, change in ambulatory diastolic blood pressure, change in office systolic blood pressure and change in office diastolic blood pressure. Weighted mean differences (WMD) were calculated and pooled using inverse variance method into a random effect model meta-analysis. Results: Six studies with 1118 participants were included in the analysis. Catheter based renal denervation was associated with significant decrease in ambulatory systolic blood pressure (WMD: -3.71; 95% CI: -2.32 to -5.11, p value <.00001) and ambulatory systolic blood pressure (WMD: -1.71; 95% CI: -0.59 to -2.82, p value=0.003) compared with sham. The reduction in office systolic and office diastolic blood pressure was also significantly greater with catheter renal denervation than sham control (WMD: -5.82; 95% CI: -3.67 to -7.92; p value<0.00001 and WMD: -3.51; 95% CI: -2.29 to -4.73; p value<0.00001 respectively) Conclusion: This meta-analysis showed significant benefit of catheter-based renal denervation for uncontrolled hypertension for all the studied outcomes. Based on this data patients with uncontrolled hypertension, on lifestyle and pharmacological management may benefit from catheter-based renal denervation

The protective effects of radiofrequency pulmonary artery denervation on the progression of chronic thromboembolic pulmonary hypertension

Abstract This study aimed to assess the safety and efficacy of radiofrequency pulmonary artery denervation with the Simplicity system in patients with distal chronic thromboembolic pulmonary hypertension. Methods and results 60 chronic thromboembolic pulmonary hypertension patients with mean pulmonary artery pressure >25 mm Hg and absence of proximal artery lesion defined by pulmonary angiography were randomized into 2 groups. Group 1 included 30 patients who underwent pulmonary artery denervation procedure. The other 30 patients were assigned to the control group (only angio plus right heart catheterization). The procedure of pulmonary artery denervation was performed at the lateral wall of main pulmonary artery and ostium of the left and right pulmonary arteries using the electrode from Simplicity denervation system. The programmed ablation parameters were temperature >50°C and time = 120 s. Using the coronary guiding technique, the tip of electrode was applied at each spot rotating the tip with pace of 2 mm. The success was defined by decrease of mean pulmonary artery pressure >10%, absence of complications. The primary end point was comparison of mean pulmonary artery pressure change from baseline to 12 months in pulmonary artery denervation group compared with change from baseline to 12 months in control group. The secondary point was change in 6-min walk distance and pulmonary vascular resistance at the 12-month follow-up. There were no complications after pulmonary artery denervation. The hemodynamic success was achieved in 93% of all cases. The mean number of radiofrequency applications to achieve success was 10.3 per patient. During follow-up period 3 patients died in pulmonary artery denervation group: (1 died of gastro-intestinal bleeding, 2 – of right ventricular failure) and 3 patients in control group. The mean decreases in the mean pulmonary artery pressure were 8.7 mm Hg in the pulmonary artery denervation group and 3.1 mm Hg in control group (p<0.05). After pulmonary artery denervation in comparison with the control group was observed significant decrease in pulmonary vascular resistance (8.3±2.8 WU vs. 11.2±3.7). 6-min walk distance significantly increased by 81 m after pulmonary artery denervation and 29 m in control group (p<0.05). This improvement was associated with significant improvements in the WHO functional class. Conclusions The usage of the Simplicity denervation system in pulmonary artery denervation procedure is safe and effective. Further studies are required to determine the role of pulmonary artery denervation in the treatment of chronic thromboembolic pulmonary hypertension. The next step of pulmonary artery denervation development will be the use of this method combined with recommended treatment (medical therapy, pulmonary endarterectomy and balloon pulmonary angioplasty) as additional option, that may sufficiently improve outcomes in some patients Funding Acknowledgement Type of funding source: None

Re-do left cardiac sympathetic denervation (LCSD following breakthrough cardiac events in long qt syndrome (LQTS) and catecholaminergic polymorphic ventricular tachycardia (CPVT)

Abstract Background Left cardiac sympathetic denervation (LCSD) is an effective anti-fibrillatory, minimally invasive therapy for patients with either LQTS or CPVT. As a pre-ganglionic fiber resection, re-growth or re-innervation is not possible. However, if a suboptimal CSD was performed, chances for post-LCSD breakthrough cardiac events (BCEs) are increased. Purpose To examine the prevalence and outcomes of patients requiring a re-do LCSD. Methods We performed a retrospective review of the 251 LQTS and CPVT patients who underwent CSD (mostly LCSD) at our institution to identify the subset referred for additional CSD because of recurrent BCEs after their primary LCSD that was performed elsewhere. Clinical data on symptomatic status prior to diagnosis and BCEs after first surgery as well as the surgical reports were reviewed to determine the reasons for the repeat procedure. Results Among the 15 patients (6% overall, 6 female; 13 LQTS, 2 CPVT) referred for additional CSD, 3 patients (20%) had a re-do LCSD performed instead of a sequential RCSD because of incomplete resection with the primary LCSD. Patient 1 is a male with Jervell-and-Lange Nielsen Syndrome (JLNS; KCNQ1-K421fs9X; KCNQ1-N365H), who first experienced syncope with torsades at age 3 after which a primary bilateral CSD was performed elsewhere. He had 2 BCEs and at age 12 underwent re-do LCSD, where his left-sided T2-T4 sympathetic chain with remnants of T1 were found to be intact. Patient 2 is a male who had 3 cardiac events prior to diagnosis (genotype negative LQTS) and LCSD at age 3. Following 3 BCEs, he underwent re-do LCSD at age 5 where scarring of T3 and intact stellate ganglion were found. Patient 3 is an adult female with CPVT (RYR2-deletion exon 3) who had multiple syncopal events, out-of-hospital arrest (leading to ICD) and 2 ICD-storms before primary bilateral CSD. Re-do LCSD was performed after identifying an intact left stellate ganglion and T2. Conclusions Before performing a primary bilateral CSD, proceeding to a RCSD after post-LCSD BCEs, or doing a videoscopic LCSD in the first place, it must be recognized that LCSD's success hinges on fully resecting the lower half of the stellate ganglion and the sympathetic chain through T4. Anything less is a partial denervation and likely ineffective procedure. Funding Acknowledgement Type of funding source: None

Electrical stimulation mapping of the pulmonary artery in swine: impact on pulmonary artery denervation procedure for pulmonary hypertension

Abstract Introduction Pulmonary artery denervation (PAD) has been recently shown to decrease pulmonary artery (PA) pressure. However, there is a lack of data related to target sites for ablation. Purpose To determine the optimal PA ablation sites based on response to high-frequency stimulation mapping and anatomical areas where radiofrequency ablation (RFA) should be avoided due to the risk of severe collateral damage. Methods A total of 17 Landrace swines were included into the study. PA angiography, hemodynamic measurements by right heart-sided catheterization and electrophysiological mapping (EM) using low (cycle length 330 ms) and high-frequency (33Hz) stimulation (HFS). Stimulation was performed at PA bifurcation and proximal parts of the main PA branches with a 5-mm distance between points; catheter manipulation was performed under fluoroscopic guidance in multiple projections. Points with evoked reactions were tagged on a 3-dimentional PA model in each case. In order to confirm reproducibility of reactions, HFS was performed at least twice at each point with a response. PA models obtained from all animals were combined in one for the final analysis. RFA using an open-irrigated catheter (40 Watts; 40 s; irrigation 30 ml/min) were performed at sites with evoked reactions. Repeated HFS was performed at ablation sites. After the procedure all animals were euthanized and underwent an autopsy study. Results Low-frequency stimulation (LFS) allowed to define areas of ventricular capture (VC) where HFS was avoided due to ventricular fibrillation induction risk. During HFS the following evoked responses were documented: sinus bradycardia, sinus rhythm (SR) acceleration, phrenic nerve capture (PNC), and laryngeal recurrent nerve capture. HFS captured left and right phrenic nerves in all animals at PA trunk, and its course was tagged (Figure 1). Laryngeal recurrent nerve capture was found in 4 (23%) of animals. Atrial capture was found in all cases while LFS at the anterior aspects of both PAs even at low output, and this precluded evaluation of neural autonomic reactions in these areas. Evoked bradycardia and SR acceleration were both found during HFS in 10 (59%) of cases each. Following RFA application evoked reactions were non-reproducible in all cases. RFA was applied in areas where no PNC or VC points were observed. An autopsy study confirmed the presence of RF-induced lesions of the PA wall. Conclusions There are two important findings of our study. First, stimulation-guided PA mapping is feasible and reveals several specific responses to HFS. Ablation at points with responses leads to non-reproducibility of the evoked reactions, confirming that transcatheter RFA may be an adequate approach for PA denervation. Second, previously proposed circular PA ablation might be associated with phrenic and laryngeal recurrent nerve damage. Stimulation-guided PA denervation can be proposed as a safer procedure, and should be evaluated in clinical settings. Figure 1. PA schematic representation Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): Russian Foundation for Basic Research

Deep Dive into Denervation: Institutional Experience with Selective Denervation in Nonflaccid Facial Palsy.

Background: Selective denervation of facial nerve branches ("Modified Selective Neurectomy") improves smile dynamics in patients with nonflaccid facial palsy, but functional morbidity such as oral incompetence has been reported. A comprehensive outcomes assessment of selective denervation will help clinicians educate patients regarding risks and benefits, and improve decision making as they incorporate this procedure into treatment algorithms. Methods: Retrospective review identified selective denervation cases performed by the senior author between February 2019 and February 2020. Pre- and postoperative outcomes were assessed using chart review, the facial clinimetric evaluation (FaCE), the electronic clinician-graded facial function tool (eFACE), and an automated computer-aided facial assessment tool (Emotrics). Results: Twenty consecutive selective denervation procedures were performed in 19 patients. Review of patient-reported outcome measures demonstrated mixed results. Favorably, patients reported smile improvement (13/17, 76.5%) and improvements in facial tightness/discomfort (8/17, 47.1%). Seven patients (41.2%) had worse drooling and five patients (29.4%) had increased difficulty chewing after surgery. Clinician-graded evaluation revealed statistically significant improvements in nasolabial fold depth at rest, oral commissure (OC) position at rest, and OC movement with smile. Total, static, and dynamic eFACE scores all demonstrated significant improvements. Computer-aided facial assessment revealed a significant increase in dental display, and an increase in OC excursion that trended toward significance. Conclusions: Selective denervation improves patient-reported, clinician-graded, and automated smile metrics, but some patients experience exacerbations in oral incompetence and articulation difficulties, and must be counseled regarding these possibilities.

Stimulation Mapping of the Pulmonary Artery for Denervation Procedures: an Experimental Study.

Transcatheter pulmonary artery denervation (PADN) has been developed for the correction of pulmonary hypertension. We investigated pulmonary artery stimulation mapping and its role in PADN procedures. Artery stimulation was performed in 17 Landrace pigs. Low-frequency stimulation defined areas of ventricular and atrial capture. High-frequency stimulation evoked the following responses: sinus rhythm slowing and/or atrial rhythm acceleration in 59% of animals, phrenic nerve capture in 100%, and laryngeal recurrent nerve capture in 23%. The sites with evoked heart rate responses were marked by discrete radiofrequency ablations (RFA). An autopsy showed nerves in the adventitia and perivascular fat under the RFA sites, and the lack of muscarinic-1, tyrosine hydroxylase, and dopamine-5 receptors' expression. During PADN, areas adjacent to the course of phrenic and recurrent laryngeal nerves should be avoided. RFA at points with heart rate responses leads to the non-reproducibility of evoked reactions and the disappearance of neural markers' expression. Graphical abstract.

Presacral Neurectomy: Literature Update and Surgical Approach

Study Objective This video will summarize the current literature and guidelines regarding presacral neurectomy (PSN), proper patient selection and surgical approach. We will identify the anatomy in the presacral space, relevant pelvic neuroanatomy and surgical pearls for performing PSN. The viewer will be able to apply key points from this video to clinical practice, allowing for optimization of PSN outcomes. Design N/A Setting Academic teaching hospital. Patients or Participants N/A Interventions PSN is a technically advanced pelvic denervation procedure. PSN has utility in addressing chronic pelvic pain and dysmenorrhea that specifically has a midline component. This video highlights the ongoing importance of effective patient selection, knowledge of anatomy and surgical expertise when performing PSN. Measurements and Main Results N/A Conclusion Presacral neurectomy remains a useful tool for the appropriately trained surgeon in the management of chronic pelvic pain.

Microdissection of the Human Renal Nervous System: Implications for Performing Renal Denervation Procedures.

Despite the use of renal denervation to treat hypertension, the anatomy of the renal nervous system remains poorly understood. We performed a detailed quantitative analysis of the human renal nervous system anatomy with the goal of optimizing renal denervation procedural safety and efficacy. Sixty kidneys from 30 human cadavers were systematically microdissected to quantify anatomic variations in renal nerve patterns. Contrary to current clinical perception, not all renal innervation followed the main renal artery. A significant portion of the renal nerves (late arriving nerves) frequently reached the kidney (73% of the right kidney and 53% of the left kidney) bypassing the main renal artery. The ratio of the main renal artery length/aorta-renal hilar distance proved to be a useful variable to identify the presence/absence of these late arriving nerves (odds ratio, 0.001 (95% CI, 0.00002-0.0692; P: 0.001) with a cutoff of 0.75 (sensitivity: 0.68, specificity: 0.83, area under ROC curve at threshold: 0.76). When present, polar arteries were also highly associated with the presence of late arriving nerve. Finally, the perivascular space around the proximal main renal artery was frequently occupied by fused ganglia from the solar plexus (right kidney: 53%, left kidney: 83%) and/or by the lumbar sympathetic chain (right kidney: 63%, left kidney: 60%). Both carried innervation to the kidneys but importantly also to other abdominal and pelvic organs, which can be accidentally denervated if the proximal renal artery is targeted for ablation. These novel anatomic insights may help guide future procedural treatment recommendations to increase the likelihood of safely reaching and destroying targeted nerves during renal denervation procedures.

Differences in patient and physician perspectives on pharmaceutical therapy and renal denervation for the management of hypertension.

Objective:To study patient and physician attitudes to pharmaceutical therapy and renal denervation for the management of hypertension.Methods:Data were analyzed from 19 market research studies in Western Europe and the United States conducted between 2010 and 2019 to obtain quantitative and qualitative perspectives. The analysis incorporated insights from 2768 patients and the experiences of 1902 physicians either actively performing or interested to perform device procedures, or hypertension specialists who would refer patients for a device-based intervention.Results:Referring cardiologists and proceduralists were more likely to recommend the renal denervation procedure to patients with higher BP levels and a greater number of antihypertensive medications. Physicians perceived patient reluctance towards a procedure as an important obstacle to recommending renal denervation as a treatment option for uncontrolled hypertension. Patient interest in the renal denervation procedure did not correlate with BP severity (P = NS), and the highest preference for the procedure was in patients diagnosed with hypertension but not receiving treatment (P < 0.001). Patients who perceived high BP as a major problem (P = 0.029) and those who experienced side effects attributed to their BP medications (P = 0.006) had a higher preference for renal denervation.Conclusion:Patients with hypertension often regard the choice of renal denervation to lower BP differently from physicians. A considerable proportion of hypertensive patients, especially those not taking medications, may prefer a device-based approach to reduce their BP.

Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy

BackgroundPulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA). ObjectivesThis study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA. MethodsFifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm−5 based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test. ResultsAfter PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm−5 in the PADN group versus 149 ± 73 dyn‧s‧cm−5 in the MED group, mean between-group difference was 109 dyn‧s‧cm−5 (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03). ConclusionsPADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.

MP58-11 A MODIFIED PREOPERATIVE SPERMATIC CORD BLOCK PREDICTS SUCCESS FOLLOWING MICROSCOPIC SPERMATIC CORD DENERVATION SURGERY FOR CHRONIC SCROTAL PAIN

INTRODUCTION AND OBJECTIVE: Chronic scrotal pain is notoriously difficult to treat. After conservative methods have failed, a microscopic spermatic cord denervation (MSCD) procedure has been shown to be effective, but choosing the appropriate candidate is essential. A spermatic cord block has been reported as a predictor for postoperative success. The traditional block includes an injection inferior/medial to the pubic tubercle but may miss contributors to scrotal pain. Here we utilize a modified cord block that targets the 3 primary locations of Wallerian degeneration: cremasteric muscles, vasal sheath and posterior cord fat, and examine its efficacy in predicting postoperative pain. METHODS: All patients presenting with chronic scrotal pain who failed previous treatments were offered the modified block. This was performed by injecting 10mL 0.25% Marcaine circumferentially around the vas deferens and an additional 10mL anterior/medial to the external ring. Pain was assessed using the Numeric Rating Scale (NRS). Patients with 2019 were included in the study. Preoperative, post-block, and 1-month post-surgical pain was assessed. Laterality, age, prior groin surgery, and post-block pain free period were also record. A multivariate linear regression model was used to determine predictors of surgical success. RESULTS: Thirty consecutive patients were tested with the modified block and subsequently underwent MSCD. Mean age was 47 (20-74). Seven patients (23%) had previously undergone vasectomy and 9 (30%) had undergone hernioplasty. Mean post-block pain free period was 5.6hrs (1.5-24). Mean preoperative NRS was 7 (5-9). Following the block, mean pain reduction was 84%, while pain reduction following surgery was 78% (3 <50%; 6 50-69%; 21 clip_image002.png">70%). On multivariate linear regression analysis, reduction in pain following block was an independent predictor of postoperative success (p<0.001). No other factors, including post-block pain free period were statistically significant. CONCLUSIONS: This modified block technique can be utilized as an effective predictor of success following MSCD. Neither prior groin surgery or post-block pain free period were associated with postoperative pain level. A trial comparing this modified approach to traditional spermatic cord block as a method of selecting the optimal surgical candidate is warranted. Source of Funding: none

Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial

Catheter-based renal denervation has significantly reduced blood pressure in previous studies. Following a positive pilot trial, the SPYRAL HTN-OFF MED (SPYRAL Pivotal) trial was designed to assess the efficacy of renal denervation in the absence of antihypertensive medications. In this international, prospective, single-blinded, sham-controlled trial, done at 44 study sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the UK, and the USA, hypertensive patients with office systolic blood pressure of 150 mm Hg to less than 180 mm Hg were randomly assigned 1:1 to either a renal denervation or sham procedure. The primary efficacy endpoint was baseline-adjusted change in 24-h systolic blood pressure and the secondary efficacy endpoint was baseline-adjusted change in office systolic blood pressure from baseline to 3 months after the procedure. We used a Bayesian design with an informative prior, so the primary analysis combines evidence from the pilot and Pivotal trials. The primary efficacy and safety analyses were done in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02439749. From June 25, 2015, to Oct 15, 2019, 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary and secondary efficacy endpoints were met, with posterior probability of superiority more than 0·999 for both. The treatment difference between the two groups for 24-h systolic blood pressure was -3·9 mm Hg (Bayesian 95% credible interval -6·2 to -1·6) and for office systolic blood pressure the difference was -6·5 mm Hg (-9·6 to -3·5). No major device-related or procedural-related safety events occurred up to 3 months. SPYRAL Pivotal showed the superiority of catheter-based renal denervation compared with a sham procedure to safely lower blood pressure in the absence of antihypertensive medications. Medtronic.

Efficacy and safety of renal denervation for the management of arterial hypertension: A systematic review and meta‐analysis of randomized, sham‐controlled, catheter‐based trials

Despite the availability of a numerous antihypertensive agents, hypertension treatment and control rates remain low in many countries. The role of the sympathetic nervous system has long been recognized, but recent sham control renal denervation studies demonstrated conflicting results. In this reviewe paper, the authors performed a systematic review and meta-analysis to examine outcomes of sham-controlled studies utilizing new technologies and procedures. Six published randomized, sham-controlled studies were included in this meta-analysis. Of those, three trials used the first-generation radiofrequency renal denervation device and technique and the other three used second-generation devices and techniques. In total, 981 patients with hypertension were randomized in all 6 trials to undergo renal denervation (n=585) or sham procedure (n=396). Overall, renal denervation resulted in a decrease of 24-hours systolic ambulatory blood pressure (ABP) by 3.62mmHg (95% CI: -5.28--1.96; I2 =0%), compared to sham procedure (GRADE: low). Renal denervation also reduced daytime systolic ABP by 5.51mmHg (95% CI: -7.79--3.23; I2 =0%), compared to sham procedure but not nighttime systolic ABP. Office systolic blood pressure was reduced by 5.47mmHg (95% CI -8.10--2.84; I2 =0%), compared to sham control. Further analysis demonstrated that second-generation devices were effective in reducing blood pressure, whereas the first-generation devices were not. These results indicate that effective renal denervation can result in significant and clinically meaningful blood pressure reduction. The second-generation devices provide better renal nerve ablation.

Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension

Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation. To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy. The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019. Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries. The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months. Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group. Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial. ClinicalTrials.gov Identifier: NCT01873352.

Endoscopic 4-MHz Radiofrequency Treatment of Facet Joint Syndrome Is More Than Just Denervation: One Incision for Three Facets.

Low back pain is well documented as an extremely common health problem. The most frequently used treatment is radiofrequency denervation for chronic low back pain. However, different clinical studies could only show a limited to no improvement regarding the decrease of pain intensity and duration of the effect. The main reasons for these limited effects seem to be due to the size of the lesion and difficulties in locating the exact placement of the cannula near the medial branch as well as or additional pathologies. Using an endoscope, it is possible to coagulate the facet joints and the medial branch under visual control and consider other pathologies such as extraspinal synovial cysts. In this retrospective study, we included 28 patients with low back pain, with a duration > 6 months and a 50% pain reduction on the numeric analog scale (NAS) after a diagnostic block. All patients received endoscopic facet joint denervation of three facets on the left and right side using only one incision on each side with an exploration of the surrounding tissue. Telephone interviews were conducted with all patients. The outcome was determined with Odom's criteria, percentage reduction NAS, subjective assessment of the patient, and duration of the effect. According to Odom's criteria, 68% of the patients showed "acceptable" to "excellent" results and confirmed that denervation helped them manage their daily lives better. The average pain reduction in the responder group was 47% with an average duration of 7.8 months. In this retrospective study, we demonstrated the practicability and effectiveness of the endoscopic facet joint denervation procedure in the treatment of chronic low back pain using only one incision for three facets. Further studies should investigate if this procedure is more effective than percutaneous radiofrequency denervation.

Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome.

Background:Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial.Objective:The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients.Design:Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients.Setting:Regina General Hospital in Regina, Saskatchewan, Canada.Patients:Ten LPHS patients who require opioid therapy.Measurements:The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively.Methods:Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients.Limitations:Single-center study, small sample size.Conclusions:The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients.Trial registration:ClinicalTrials.gov (NCT04332731).

Renal sympathetic denervation for resistant hypertension: where do we stand after more than a decade.

Despite the current availability of safe and efficient drugs for treating hypertension, a substantial number of patients are drug-resistant hypertensives. Aiming this condition, a relatively new approach named catheter-based renal denervation was developed. We have now a clinically relevant time window to review the efficacy of renal denervation for treating this form of hypertension. This short review addresses the physiological contribution of renal sympathetic nerves for blood pressure control and discusses the pros and cons of renal denervation procedure for the treatment of resistant hypertension.

Pulmonary artery denervation in patients with pulmonary hypertension: present state and clinical experience

Despite treatment advances, the prognosis of patients with both primary and secondary pulmonary hypertension (PH) remains unfavorable. The increased activity of the sympathetic nervous system is one of the universal mechanisms involved in the PH pathogenesis. Pulmonary artery denervation is a novel minimally invasive pathogenetic method of PH treatment. The denervation procedure is mainly implemented by using radiofrequency ablation of the pulmonary trunk, where most sympathetic nerve fibers are located. In this article we present an overview and analysis of the present state, results of various experimental and clinical studies, as well as clinical experience. The results of studies demonstrated the safety of endovascular surgery and its beneficial effect on both hemodynamic and clinical parameters.

Pulmonary artery denervation in patients with pulmonary hypertension: present state and clinical experience

Despite treatment advances, the prognosis of patients with both primary and secondary pulmonary hypertension (PH) remains unfavorable. The increased activity of the sympathetic nervous system is one of the universal mechanisms involved in the PH pathogenesis. Pulmonary artery denervation is a novel minimally invasive pathogenetic method of PH treatment. The denervation procedure is mainly implemented by using radiofrequency ablation of the pulmonary trunk, where most sympathetic nerve fibers are located. In this article we present an overview and analysis of the present state, results of various experimental and clinical studies, as well as clinical experience. The results of studies demonstrated the safety of endovascular surgery and its beneficial effect on both hemodynamic and clinical parameters.

P4564Sympathetic renal denervation in patients with refractory arterial hypertension: 2-years follow-up

Abstract Aim To evaluate the efficacy of the sympathetic renal denervation procedure in patients with refractory arterial hypertension and heart failure. Methods The study included 72 patients with refractory arterial hypertension. We used randomization in 2 main groups: the Group I (n=36) included patients, who underwent denervation procedure of the main trunk of the renal artery and the Group 2 (n=36) - included patients who underwent denervation procedure in main trunk and also in second-order renal arteries. Additionally, patients were divided into 2 subgroups: the subgroup A (n=30) included patients, who underwent denervation procedure with a SYMPLICITY catheter, and the subgroup B (n=42) - included patients who underwent denervation procedure with a VESSIX catheter. Also, the renal denervation procedure efficacy, in patients with chronic heart failure (CHF) was analyzed. In all groups, 24-hour blood pressure monitoring, echocardiography and a 6-minute walk test were monitored. Inclusion criteria: refractory hypertension, age of patients 18–85 years, systolic blood pressure (SBP) ≥140/90 mmHg and ≥130/90 mmHg in patients with diabetes mellitus, functioning kidneys, renal arteries ≥40 mm in diameter and the length of the site up to the first bifurcation of at least 20 mm, absence of stenoses in the renal arteries, GFR≥40 ml/min/1.73m2, suitable anatomy of the renal arteries for endovascular procedure. Results 24 months result after the denervation procedure was demonstrated significantly decreased SBP in patients of both groups. In group I, it was, compared with pre-operative data (174.9±1.6 vs. 151.7±2.3 mmHg, respectively; p&lt;0.05), and in group II - 181.9±2.1 vs. 140.4±3.8 mmHg, respectively; p&lt;0.05). However, when comparing SBP values between groups, SBP in group I was significantly higher, than in group II (151.7±2.3 vs. 140.4±3.8 mmHg, respectively; p&lt;0.05). In addition, the average number of drugs in group I was decreased to 2.1±0.8 after 24th month, and in group II - to 1.4±0.6 (p&lt;0.05). When comparing SBP value in subgroup A and subgroup B, the average daily SBP also significantly difference and amounted to 147.8±1.8 vs. 138.4±3.2 mmHg, respectively; p&lt;0.05). Among the all patients included in the study, 38 patients were with CHF. The 6-minute walk test results, compared with pre-operative data, showed a significant improvement and amounted to 321.24±83.22 vs. 212.42±54.72m, respectively; p&lt;0.05. Conclusions The sympathetic renal denervation may be regarded as an effective method of treatment of patients with resistant hypertension, as well as patients with concomitant chronic heart failure. Performing denervation in the arteries of the second order, significantly improves the prognosis of patients, and in patients with concomitant heart failure significantly increases the quality of life and exercise tolerance. Acknowledgement/Funding Russian Academic Excellence Project 5-100