Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension.

BACKGROUND: Sham-controlled trials demonstrated safety and efficacy of renal denervation (RDN) to lower blood pressure (BP). Association of baseline heart rate with BP reduction after RDN is incompletely understood. OBJECTIVES: The purpose of this analysis was to evaluate the impact of baseline heart rate on BP reduction without antihypertensive medications in the SPYRAL HTN-OFF 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) Pivotal trial. METHODS: Patients removed from any antihypertensive medications were enrolled with office systolic blood pressure (SBP) ≥150 and <180 mm Hg and randomized 1:1 to RDN or sham control. Patients were separated according to baseline office heart rate <70 or ≥70 beats/min. BP changes from baseline to 3 months between treatment arms were adjusted for baseline SBP using analysis of covariance. RESULTS: Scatter plots of 3-month changes in 24-hour and office SBP illustrate a wide range of changes in SBP for different baseline heart rates. Treatment difference at 3 months between RDN and sham control with baseline office heart rate ≥70 beats/min for 24-hour SBP was -6.2 mm Hg (95% CI: -9.0 to -3.5 mm Hg) (P < 0.001) and for baseline office heart rate <70 beats/min it was -0.1 mm Hg (-3.8 to 3.6 mm Hg) (P = 0.97) with an interaction P value of 0.008. Results were similar for changes in office, daytime, and nighttime SBP at 3 months, with a greater reduction in SBP with baseline office heart rate ≥70 beats/min. CONCLUSIONS: Reduction in mean office, 24-hour, daytime, and nighttime SBP for RDN at 3 months was greater with baseline office heart rate ≥70 than <70 beats/min, suggesting an association between baseline heart rate and BP reduction after RDN. (SPYRAL PIVOTAL-SPYRAL HTN-OFF MED Study; NCT02439749).

Outcome following neurectomy of the deep branch lateral plantar nerve and plantar fasciotomy for hindlimb proximal suspensory desmopathy in western performance horses: 21 cases.

OBJECTIVE: To report the outcome of horses used in western performance disciplines after deep branch lateral plantar neurectomy/fasciotomy surgery for hind limb proximal suspensory desmopathy (PSD). STUDY DESIGN: Retrospective analysis. SAMPLE POPULATION: Twenty-one client-owned horses. METHODS: Medical records were reviewed (2009-2019) for horses involved in western performance disciplines that had been treated with deep branch lateral plantar neurectomy and plantar fasciotomy for lameness due to hind limb PSD. Follow-up was obtained by reexamination and/or verbal interviews with owners >2 years postoperatively. RESULTS: Sixteen quarter horses and five paints were used for western pleasure (14/21), barrel racing (2/21), cutting (1/21), steer wrestling (1/21), working cow horse (1/21), team roping (1/21) and reining (1/21). A median duration of 8 months was required before horses were able to resume training or athletic work. Nine horses were able to return to a similar or higher level of athletic use, nine horses returned to a lower level of athletic performance, and three horses could not return to intended function. Owner satisfaction with outcome after the procedure was high (16/21), average (3/21), and low (2/21). CONCLUSION: Deep branch lateral plantar neurectomy and plantar fasciotomy allowed most horses to resume some athletic function as western performance horses. CLINICAL SIGNIFICANCE: These results provide evidence of potential outcomes when considering surgical treatment of hind limb PSD in western performance horses.

Patient satisfaction and outcomes of partial wrist denervation in inflammatory arthritis.

INTRODUCTION: Inflammatory arthritis frequently affects the wrist, resulting in pain and disability. This study aims to investigate the long-term outcome of patients who underwent posterior interosseous nerve (PIN) denervation for inflammatory arthritis of the wrist. METHOD: xForty consecutive wrists (36 patients) treated with PIN denervation were identified (mean follow-up 47 months; mean age 62.6 years, 77.5% female). Pain and function scores were objectively measured using the patient-rated wrist-evaluation (PRWE) questionnaires. Data was compared for pre-operation and post-operation (early and long term). The Student's t test was used to compare differences between groups for continuous data, whilst the sign test was utilised for pairwise comparisons. The p value was set at 0.05 for all comparisons. RESULTS: Three patients died during the course of this study from causes unrelated to wrist surgery, resulting in 93% follow-up. PRWE questionnaires demonstrated a significant improvement following PIN denervation (median pain pre-op 42 vs post-op 16 (p < 0.001); median function pre-op 82 vs post-op 41 (p < 0.001), respectively). There were no differences identified between early and long-term post-operative scores. Four cases (10%) had persistent, ulnar-based pain and required secondary salvage wrist arthrodesis. However, 95% of patients remained "very satisfied" or "satisfied" after surgery. CONCLUSIONS: This study highlights the effectiveness of PIN denervation as a simple alternative to wrist arthrodesis due to long-term improvement in pain and preservation of function. We recommend this procedure in the presence of a positive diagnostic PIN infiltration test to avoid wrist arthrodesis for as long as possible. In patients with predominantly ulnar-based wrist pain, the outcome is less predictable and this subgroup of patients should be counselled about the possibility of subsequent salvage wrist fusion. Key Points • One of the largest study cohorts which report on the outcome of the wrist PIN denervation procedure with over 2-year follow-up • Clinical outcomes of success are enhanced with the use of validated, objective patient-reported outcome measures relating to overall satisfaction, pain relief and function. • Long-term outcomes are compared to pre-operative and immediate post-operative outcome scores, demonstrating the benefits of PIN denervation and the longevity it provides.

Blood pressure changes after renal denervation are more pronounced in women and nondiabetic patients: findings from the Austrian Transcatheter Renal Denervation Registry.

OBJECTIVES: Three recently published sham-controlled studies proved the efficacy of renal denervation (RDN) in hypertensive patients. The study presented here analyzed a nationwide multicentre registry database to clarify which patient subgroups benefit most from radiofrequency RDN. METHODS: This is a post hoc analysis from the multicentre Austrian Transcatheter Renal Denervation Registry hosted by the Austrian Society of Hypertension. We correlated change of SBP after RDN to sex and presence/absence of comorbidities. Univariable correlation and multiple linear regression analyses were performed. RESULTS: Two hundred and ninety-one patients (43% women, median age 64 years) undergoing RDN between April 2011 and September 2014 were included in this analysis. Mean baseline ambulatory 24 h BP (systolic/diastolic) was 150 ±â€Š18/89 ±â€Š14 mmHg and mean baseline office BP was 170 ±â€Š16/94 ±â€Š14 mmHg.After RDN, mean ambulatory 24 h BP reduction was 9 ±â€Š19/6 ±â€Š16 mmHg. The following features were associated with a good response to RDN: high baseline systolic ambulatory BP, high baseline diastolic office BP, female sex, absence of diabetes mellitus, and absence of peripheral artery disease. Multivariable analysis identified female sex and absence of diabetes mellitus as strongest predictors for ambulatory BP reduction, although those groups had the lowest baseline ambulatory BP. DISCUSSION: Ambulatory BP reductions after RDN were substantially more pronounced in female and in nondiabetic patients despite lower baseline BP. It is concluded that in terms of efficacy female patients and nondiabetic patients might benefit more from RDN.

Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 12-month results from the ACHIEVE study.

OBJECTIVES: First-generation radiofrequency renal denervation devices may have had limited efficacy due to incomplete circumferential ablation and dependence on individual operator technique. This study evaluated a next-generation catheter-based technology using ultrasound designed to maximize nerve coverage using circumferential ultrasound energy. METHODS: This was a prospective, multicenter, nonrandomized, postmarket study evaluating the safety and efficacy of an endovascular ultrasound renal denervation system (Paradise) in patients who met the European Society of Hypertension/European Society of Cardiology definition of resistant hypertension. Major exclusion criteria included renal artery stenosis and renal insufficiency. Patients were followed for 12 months. Safety and efficacy endpoints included procedural safety and renal artery patency, as well as changes in systolic office and 24-h ambulatory bllod pressure (BP) measurement. RESULTS: A total of 96 patients from eight European sites were included. Mean age was 63.9 years and 41% of patients were female. At baseline, mean 24-h ambulatory BP was 156.2/88.4 ±â€Š15.4/12.7 mmHg, and mean office BP was 176.2/95.0 ±â€Š20.6/16.0 mmHg. Patients were on average on 5.1 ±â€Š2.5 antihypertensive agents. At 12 months, the average 24-h ambulatory BP change was -7.5/-3.8 ±â€Š18.3/10.6 mmHg (P = 0.0007; P = 0.0024) with an average office BP change of -15.0/-7.0 ±â€Š27.0/12.3 mmHg (P < 0.0001 for both). At 12 months, there was a single patient death unrelated to the device or procedure. CONCLUSION: This single-arm study represents the largest cohort of patients treated with endovascular ultrasound renal denervation to date. Within this trial, the therapy appeared safe and resulted in sustained reductions in both office BP and 24-h ambulatory BP through 12 months.

Buying Time: Long-Term Results of Wrist Denervation and Time to Repeat Surgery.

Background: This study reviews long-term outcomes of partial wrist denervation focusing on need for and time to revision procedure. Methods: A retrospective study was conducted of all patients undergoing partial wrist denervation between 1994 and 2014. At average latest follow-up of 6.75 years (range, 1-21 years), clinical and radiographic data and need for revision surgery were recorded. Results: There were 100 wrists in 89 patients (61 male, 28 female) with average age at surgery of 54 years (range, 26-80). Principal diagnoses were arthritis (58%), inflammatory (19%), and posttraumatic arthritis (7%). Average flexion-extension arc was 83% and grip strength 75% of unaffected extremity. Average Mayo Wrist Scores improved from 48 preoperatively to 77 postoperatively. Sixty-nine percent of patients did not undergo other procedures during the time interval studied. Thirty-one percent underwent revision at an average of 26 months following denervation (range, 2-165). Conclusions: Partial wrist denervation is a motion-preserving procedure for patients with refractory wrist pain with 69% in this series requiring no further procedures. The remaining 31% experienced average symptom relief for 2 years prior to ultimately undergoing revision operation.

Corticosteroid Injections Into Lumbar Facet Joints: A Prospective, Randomized, Double-Blind Placebo-Controlled Trial.

BACKGROUND: Corticosteroid injections into the intra-articular zygapophysial (z-joints) are frequently used to treat this cause of low back pain. No studies have been done on the efficacy of intra-articular corticosteroids in those with z-joint pain confirmed by dual comparative medial branch blocks. OBJECTIVE: The aim of the study was to determine whether an injection of a corticosteroid into lumbar z-joints is effective in reducing pain and the need for radiofrequency neurotomy. METHODS: This is a double-blind, prospective, randomized, placebo-controlled trial. The study was conducted in Academic Medical Center. Twenty-eight subjects with z-joint pain confirmed by medial branch blocks were included in the study. Subjects with confirmed z-joint pain via dual comparative medial branch block were randomized to receive either intra-articular corticosteroid (triamcinolone 20 mg) or saline via fluoroscopic guided injection. RESULTS: No statistically significant difference in the need for radiofrequency neurotomy (radiofrequency neurotomy) between the groups, with 75% (95% confidence interval = 50.5%-99.5%) of the saline group vs. 91% (95% confidence interval = 62.3%-100%) of the corticosteroid group receiving radiofrequency neurotomy. There is no difference in mean time to radiofrequency neurotomy between saline (6.1 wks) and corticosteroid (6.5 wks) groups. There is a need for radiofrequency neurotomy. CONCLUSIONS: Corticosteroid injections into the lumbar z-joints were not effective in reducing the need for radiofrequency neurotomy of the medial branches in those with z-joint pain confirmed by dual comparative medial branch blocks.

Renal denervation for treatment of uncontrolled hypertension in an Asian population: results from the Global SYMPLICITY Registry in South Korea (GSR Korea).

Reports detailing the response of hypertensive patients to renal denervation (RDN) in Asian patients are limited. We evaluated 6- and 12-month outcomes after RDN in an Asian population and compared outcomes to a primarily Caucasian population. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, worldwide registry that evaluates the safety and effectiveness of RDN and includes the Korean registry substudy (GSR Korea) and a Caucasian subset (GSR Caucasian). Given differences in baseline characteristics among GSR Korea (n=93) as compared with GSR Caucasian (n=169) patients, including lower baseline office systolic blood pressure (SBP), lower body mass index and differences in medications, propensity score adjustment was performed when comparing the change in SBP between subsets. The 6- and 12-month change in SBP in GSR Korea was -19.4±17.2 and -27.2±18.1 mm Hg, respectively (P<0.001 for both vs baseline). GSR Caucasian had a SBP change similar to GSR Korea at 6 months (-20.9±21.4 mm Hg, unadjusted P=0.547, adjusted P=0.998), whereas at 12 months the change was significantly less pronounced (-20.1±23.9 mm Hg, unadjusted P=0.004, adjusted P=0.002). There were no protocol-defined procedure-related adverse events and no chronic adverse events associated with the device in an Asian population. RDN provided a significant reduction in 6- and 12-month office SBP among Asian patients, with a favorable safety profile. The 12-month SBP reduction was larger than that observed in Caucasian patients.

[Economic efficiency of renal denervation in patients with resistant hypertension: results of Markov modeling].

Aim of this study was to evaluate the cost-effectiveness of renal denervation (RD) in resistant arterial hypertension (AH) in Russia. Modeling of Markov conducted economic impact of RD on the Russian population of patients with resistant hypertension in combination with optimal medical therapy (OMT) compared with OMT using a model developed by American researchers based on the results of international research. The model contains data on Russian mortality, and costs of major complications of hypertension. The simulation results showed a significant reduction in relative risk reduction of adverse outcomes in patients with resistant hypertension for 10 years (risk of stroke is reduced by 30%, myocardial infarction - 32%). RD saves 0.9 years of quality-adjusted life (QALY) by an average of 1 patient with resistant hypertension. Costs for 1 year stored in the application of quality of life amounted to RD 203 791.6 rubles. Which is below the 1 gross domestic product and therefore indicates the feasibility of this method in Russia.

[Renal denervation: new treatment for refractory hypertension?]. / Dénervation rénale: nouveau traitement de l'hypertension artérielle résistante?

Sympathetic renal hyperactivity is involved hypertension and in its progression towards organ damages. Using femoral access, a dedicated ablation catheter can be inserted into the renal vessels to deliver high frequency energy in the arterial wall. This therapy leads to a focal heating, which ablates the renal nerve fibers running in the adventitia. First clinical results (Simplicity HTN 1 and HTN 2 trials) have demonstrated a significant and sustained decrease in office blood pressure. The response rate to this therapy was about 85 to 90%. This procedure did not cause serious adverse event and seems to have also positive impact on glucose metabolism and exercise capacity. Based on these first results, renal denervation appears as a new interesting therapy, which requires further studies to better define its place in the antihypertensive therapeutic arsenal. Actually, it should not be considered as an alternative to pharmacological therapy and renal denervation should be only proposed to patients with resistant hypertension. Prior to renal denervation, an upstream work has to be done to ensure an adequate patient selection. The mandatory point is to ensure that patient scheduled for this therapy respond to the definition of arterial resistant hypertension. Because of the narrowed limit between the very common situation of "uncontrolled" hypertension and the "true resistant" group, we proposed a 3 steps algorithm that can help for patient selection.

[Renal denervation in resistant hypertension: proposal for a common multidisciplinary attitude]. / Dénervation rénale pour le traitement de l'hypertension artérielle résistante: proposition pour une attitude multidisciplinaire commune.

The prevalence of resistant hypertension ranges between 5-30%. Patients with resistant hypertension are at increased risk of cardiovascular events. Radiofrequency renal denervation is a recent and promising technique that can be used in the setting of resistant hypertension. However, long-term safety and efficacy data are lacking and evidence to use this procedure outside the strict setting of resistant hypertension is missing. The aim of the article is to propose a common work-up for nephrologists, hypertensiologists, cardiologists and interventional radiologists in order to avoid inappropriate selection of patients and a possible misuse of this procedure.

Effectiveness of repeated radiofrequency neurotomy for lumbar facet pain.

STUDY DESIGN: Retrospective chart review. OBJECTIVES: To determine the success rate and duration of relief of repeat radiofrequency neurotomy for lumbar facet joint pain. SUMMARY OF BACKGROUND DATA: Radiofrequency neurotomy is an effective but temporary management of lumbar facet pain. When pain recurs, radiofrequency neurotomy is usually repeated, but the outcome and duration of relief for repeat radiofrequency neurotomies are unknown. METHODS: Record review of consecutive patients who had an initial successful radiofrequency neurotomy, subsequent recurrence of pain, and then repeat radiofrequency neurotomy. Responses of repeat radiofrequency neurotomies were compared with initial radiofrequency neurotomy for success rates and duration of relief. RESULTS: There were 16 women and 4 men. Mean age was 48 years (range, 26-63). Radiofrequency neurotomy denervated one segment in two patients, two segments in 16 patients, and three or more in two patients. There were 10 bilateral and 10 unilateral radiofrequency neurotomies. Mean duration of relief after initial radiofrequency neurotomy was 10.5 months (range, 4-19). To date, two patients had a series of two radiofrequency neurotomies performed, six had three, five had four, three had five, and four had seven or more. Twenty patients had a second radiofrequency neurotomy, which was successful in 17 (85%) but unsuccessful in two. The mean duration of relief in 16 of these 17 patients was 11.6 months (range, 6-19), and relief is continuing in one. Sixteen patients had a third radiofrequency neurotomy, of which 15 were successful and one was unsuccessful. The mean duration of relief in nine of the 15 was 11.2 months (range, 5-23), and relief is continuing in the other six. Eight patients had a fourth radiofrequency neurotomy, which was successful in seven but unsuccessful in one. The mean duration of relief was 9 months (range, 5-14) in three patients, and relief is continuing in the other four. None of these differences is significant. The frequency of success and durations of relief remained consistent after each subsequent radiofrequency neurotomy. CONCLUSIONS: Repeated radiofrequency neurotomies are an effective long-term palliative management of lumbar facet pain. Each radiofrequency neurotomy had a mean duration of relief of 10.5 months and was successful more than 85% of the time.

Persistence of attacks of cluster headache after trigeminal nerve root section.

Cluster headache is a strictly unilateral headache that occurs in association with cranial autonomic features. We report a patient with a trigeminal nerve section who continued to have attacks. A 59-year-old man described a 14-year history of left-sided episodes of excruciating pain centred on the retro-orbital and orbital regions. These episodes lasted 1-4 h, recurring 2-3 times daily. The attacks were associated with ipsilateral ptosis, conjunctival injection, lacrimation, rhinorrhoea and facial flushing. From 1986 to 1988, he had trials of medications without any benefit. In February 1988, he had complete surgical section of the left trigeminal sensory root that shortened the attacks in length for 1 month without change in their frequency or character. In April 1988, he had further surgical exploration and the root was found to be completely excised; post-operatively, there was no change in the symptoms. From 1988 to 1999, he had a number of medications, including verapamil and indomethacin, all of which were ineffective. Prednisolone 30 mg orally daily rendered the patient completely pain free. Sumatriptan 100 mg orally and 6 mg subcutaneously aborted the attack after approximately 45 and 15 min, respectively. He was completely anaesthetic over the entire left trigeminal distribution. Left corneal reflex was absent. Motor function of the left trigeminal nerve was preserved. Neurological and physical examination was otherwise normal. MRI scan showed a marked reduction in the calibre of the left trigeminal nerve from the nerve root exit zone in the pons to Meckel's cave. An ECG-gated three-dimensional multislab MRI inflow angiogram was performed. No dilatation was observed in the left internal carotid artery during the cluster attack. Blink reflexes were elicited with a standard electrode and stimulus. Stimulation of the left supraorbital nerve produced neither ipsilateral nor contralateral blink reflex response. Stimulation of the right supraorbital nerve produced an ipsilateral response with a mean R2 onset latency of 36 ms and a contralateral response with a mean R2 onset latency of 32 ms. Lack of ipsilateral vessel dilatation makes the role of vascular factors in the initiation of cluster attacks questionable. With complete section of the left trigeminal sensory root the brain would perceive neither vasodilatation nor a peripheral neural inflammatory process; however, the patient continued to have an excellent response to sumatriptan. The case illustrates that cluster headache may be generated primarily from within the brain, and that triptans may have anti-headache effects through an entirely central mechanism.

[Leprosy surgery in a bush hospital in Africa: experience in Madagascar]. / La chirurgie de la lèpre dans un hôpital de brousse en Afrique: expérience à Madagascar.

We report our experience of leprosy surgery in terms of feasibility and efficacy in a small hospital of bush in Madagascar during the period of September 1989 to January 1993. Operations of neurolysis, corrections of claw hands by the techniques of Lasso-Zancolli or Van Droogenbroeck, arthrodesis, resections and amputations have been performed. Our results suggest that at least a part of these surgical procedures may be performed by a non specialized medical team, taught on the premises. Thus, the cost of treatment will be low and accessible to more leprosy patients.

[Leprosy surgery: retrospective study in Madagascar]. / La chirurgie de la lèpre: étude rétrospective à Madagascar.

Leprosy is endemic in Madagascar and the diagnosis of leprosy is still done lately. Thus, many patients suffer from multiple and/or severe disabilities. Since a long time, many leprologists argue that surgery is necessary and useful in the treatment of these disabilities. We report the results of a retrospective study done in 25 patients reevaluated 2 to 7 years after surgery. Of these patients: 17 patients (68%) have success, 7 patients (28%) have a partial improvement and only 1 case (4%) had no benefit. These results are encouraging and suggest that surgery must be proposed more often to treat in leprosy disabilities.