Risk Factors Affecting the Outcomes of CT-Guided Radiofrequency Thermocoagulation of Thoracic Sympathetic Nerve in the Treatment of Primary Palm Hyperhidrosis.

BACKGROUND: Primary palm hyperhidrosis (PPH) is a chronic disease characterized by uncontrolled palm-sweating exceeding physiological needs. It negatively impacts the quality of life of the patients and can lead to different degrees of psychological problems. Currently, there are a variety of treatment options for PPH, of which thoracotomy is a first-line treatment that has shown good efficacy. However, since it is an invasive procedure requiring general anesthesia and is often associated with high costs and serious complications, better alternatives should be explored. Computed tomography (CT)-guided percutaneous puncture of radiofrequency thermocoagulation (RF-TC) of the thoracic sympathetic nerve is a promising alternative treatment. It is a minimally invasive procedure that can be performed under local anesthesia and is associated with rapid recovery. However, the factors affecting the duration of the surgery-related benefits and outcomes of CT-guided percutaneous RF-TC of the thoracic sympathetic nerve are unclear. OBJECTIVES: To investigate the factors influencing the outcomes of CT-guided percutaneous RF-TC of the thoracic sympathetic nerve in patients with PPH. STUDY DESIGN: A retrospective study. SETTING: This study was conducted at the Pain Department of Jiaxing University Affiliated Hospital (Jiaxing, China). METHODS: After approval by the Ethics Committee of the Affiliated Hospital of Jiaxing College, the data of 232 corresponding patients were assessed. The Kaplan-Meier method was used for survival analysis. Univariate and multivariate analyses were performed to identify factors associated with PPH and to construct a nomogram for predicting postoperative recurrence. Time-independent receiver operating characteristic (ROC) curve analyses were performed to assess the nomogram's predictive capacity. RESULTS: In the one-year survival analysis model, gender (HR = 1.573, 95%CI: 0.844 to 2.934), age (HR = 0.965, 95%CI: 0.915 to 1.018), disease course (HR = 0.960, 95%CI: 0.908 to 1.015), palm temperature difference (HR = 0.377, 95%CI: 0.287 to 0.495), perfusion index difference (HR = 0.590, 95%CI: 0.513 to 0.680) and hyperhidrosis disease severity scale (HR = 1.963, 95%CI: 0.769 to 5.011) were identified as statistically significant factors in univariate analysis, while palm temperature difference (HR = 0.589, 95%CI: 0.369 to 0.941) and perfusion index difference (HR = 0.357, 95%CI: 0.588 to 0.968) were the independent factors in the multivariate Cox proportional hazards risk model. In the 2-year survival analysis model, palm temperature difference (HR = 0.353, 95%CI: 0.261 to 0.478), perfusion index difference (HR = 0.589, 95%CI: 0.510 to 0.680) and hyperhidrosis disease severity scale (HR = 1.964, 95%CI: 0.771 to 5.006) were the statistically significant factors while palm temperature difference (HR = 0.507, 95%CI: 0.321 to 0.799) and perfusion index difference (HR = 0.789, 95%CI: 0.625 to 0.995) were the independent factors. LIMITATIONS: This single-center retrospective study was limited by its small sample size, short follow-up time, and the possibility of bias resulting from the non-random patient selection. CONCLUSION: Palm temperature difference and perfusion index difference were independent risk factors associated with prolonging the surgical benefits and reducing postoperative recurrence of CT-guided RF-TC of the sympathetic nerves in patients with PPH.

La sudoración compensatoria como efecto secundario en la cirugía de la hiperhidrosis palmar primaria / Compensatory Sweating as a Side Effect of Surgical Treatment of Primary Palmar Hyperhidrosis

Introducción: La sudoración compensatoria es un efecto secundario de la simpaticotomía videotoracoscópica, que tiene una alta incidencia y puede provocar insatisfacción en los pacientes operados. Objetivo: Determinar el comportamiento de la sudoración compensatoria en los pacientes en que se les realizó una simpaticotomía videotoracoscópica por hiperhidrosis palmar. Métodos: Se realizó un estudio retrospectivo, transversal y descriptivo de 42 pacientes que tras la cirugía por hiperhidrosis palmar presentaron sudor compensatorio. Se analizó la incidencia, localización, severidad, afectación de la calidad de vida y nivel de satisfacción. Resultados: Predominó la sudoración compensatoria ligera, la localización en la espalda y el abdomen. Hubo un alto nivel de tolerancia, con solo un paciente insatisfecho y un 100 por ciento de mejoría de la calidad de vida. Conclusiones: La sudoración compensatoria no influyó negativamente en la calidad de vida de los pacientes(AU)

Introduction: Compensatory sweating is a side effect of videothoracoscopic sympathectomy. It presents high incidence and may cause dissatisfaction to operated patients. Objective: To determine the characteristics of compensatory sweating in patients who underwent videothoracoscopic sympathectomy for palmar hyperhidrosis. Methods: A retrospective, cross-sectional and descriptive study was carried out with 42 patients who presented compensatory sweating after surgery for palmar hyperhidrosis. Incidence, location, severity, change in quality of life and level of satisfaction were analyzed. Results: Light compensatory sweating predominated, with location on back and abdomen. There was a high level of tolerance, with only one dissatisfied patient and 100 percent of improvement in quality of life. Conclusions: Compensatory sweating did not influence negatively the patients' quality of life(AU)

[Renal denervation : Really an alternative to reducing blood pressure?] / Renale Denervation : Wirklich eine Alternative zu Blutdrucksenkern?

Since the current guidelines were published in 2018, a total of 5 sham-controlled high-quality studies evaluating renal denervation have been conducted and the results were published. These five studies clearly confirmed the efficacy and safety of renal denervation, which correspond to the knowledge of the Clinical Consensus Conference. Thus, an update of the guidelines for the treatment of arterial hypertension regarding the clinical significance of renal denervation is urgently necessary. For this reason, the position paper of the working group of the European Society of Hypertension on the current state of renal denervation was reviewed. An approval of this procedure can soon be expected. In Germany there is a diagnosis-related group (DRG) for the reimbursement of renal denervation, which was suspended due to the erroneous Symplicity 3 study. This DRG should be revived in practice by a structured process of the implementation of renal denervation. It will then be a joint task of treating physicians and specialists in certified centers to identify eligible patients. In the future, antihypertensive treatment will consist of three pillars: lifestyle measures, pharmacotherapy and interventional treatment. These three treatment options should not be regarded as competitive (which is better) but alternative (patient preference) and additive (the aim is blood pressure control). It is the task of the treating physician to provide the patient with the ideal treatment concept. Clearly, renal denervation will not replace antihypertensive pharmacotherapy; however, it can lead to a reduction of the drug burden and increase of patient adherence to medication. It represents an option of modern antihypertensive treatment and will also become increasingly more important in special patient groups.

Bilateral one-stage single-port sympathicotomy in primary focal hyperhidrosis, a prospective cohort study: treat earlier?

BACKGROUND: Primary Focal Hyperhidrosis (PFH) has a detrimental effect on Quality of Life. Repetitive, non-curative symptomatic strategies dominate current treatment of PFH, in spite of the availability of an effective and permanent curative treatment like Endoscopic Thoracic Sympathectomy (ETS). Current surgical optimization may allow for a re-established position of sympathetic modulation in this treatment algorithm. We sought to evaluate the safety, effectiveness, and long-term results of a Bilateral One-stage Single-port Sympathicotomy (BOSS) procedure in PFH patients and to identify subgroups benefitting most. METHODS: Prospective analysis of 163 patients, 35 (21.5%) underwent Rib-3 (R3) BOSS for palmar PFH, 58 (35.6%) R3-R5 BOSS for axillary PFH and 70 (42.9%) R3-R5 BOSS for combined palmar/axillary PFH. Effectiveness was measured using Skindex-29 and the Hyperhidrosis Disease Severity Scale (HDSS). RESULTS: Overall Skindex-29-rating (46.5 ± 14.8 preoperatively vs 20.1 ± 20.6 postoperatively, p < 0.001), and HDSS score (3.71 ± 0.45 preoperatively vs 1.82 ± 0.86 postoperatively, p < 0.001) indicated a significant improvement in health-related quality of life after BOSS. R3 BOSS was superior to R3-R5 BOSS in terms of HDSS score (1.49 vs 1.91 respectively, p = 0.004) and in terms of severe compensatory hyperhidrosis, a frequently reported side-effect (17.1% vs 32.8% respectively, p < 0.001). No major complications occurred. CONCLUSIONS: BOSS is safe, effective, and offers a long-term curative solution in the treatment of PFH. Especially in the palmar PFH subgroup, R3 BOSS treatment results compare favorably to the treatment results of non-curative alternatives published in the current literature. Therefore, R3 BOSS should be offered to all patients with severe PFH, reporting insufficient benefit of treatment options such as oral and/or local agents.

Arrhythmic Risk Profile and Outcomes of Patients Undergoing Cardiac Sympathetic Denervation for Recurrent Monomorphic Ventricular Tachycardia After Ablation.

Background Cardiac sympathetic denervation (CSD) has been used as a bailout strategy for refractory ventricular tachycardia (VT). Risk of VT recurrence in patients with scar-related monomorphic VT referred for CSD and the extent to which CSD can modify this risk is unknown. We aimed to quantify arrhythmia recurrence risk and impact of CSD in this population. Methods and Results Adjusted competing risk time to event models were developed to adjust for risk of VT recurrence and sustained VT/implantable cardioverter-defibrillator shocks after VT ablation based on patient comorbidities at the time of VT ablation. Adjusted VT and implantable cardioverter-defibrillator shock recurrence rates were estimated for the subgroup who subsequently required CSD after ablation. The expected adjusted recurrence rates were then compared with the observed rates after CSD. Data from 381 patients with scar-mediated monomorphic VT who underwent VT ablation were analyzed, excluding patients with polymorphic VT. Sixty eight patients underwent CSD for recurrent VT. CSD reduced the expected adjusted VT recurrence rate by 36% (expected rate of 5.61 versus observed rate of 3.58 per 100 person-months, P=0.01) and the sustained VT/implantable cardioverter-defibrillator shock rates by 34% (expected rate of 4.34 versus observed 2.85 per 100 person-months, P=0.03). The median number of sustained VT/implantable cardioverter-defibrillator shocks in the year before versus the year after CSD was reduced by 90% (10 versus 1, P<0.0001). Conclusions Patients referred for CSD for refractory scar-mediated monomorphic VT are at a higher risk of VT recurrence after ablation as compared with those not requiring CSD, mostly because of their cardiac comorbidities. CSD significantly reduced both the expected risk of recurrences and VT burden.

Video-assisted thoracoscopic sympathectomy versus modified Wittmoser method in surgical management of primary hyperhidrosis.

PURPOSES: We compared two different surgical methods evaluating the effectiveness of procedures and the quality of life (QoL) of patients. METHODS: From January 2010 to November 2017 we carried out 476 biportal video-assisted thoracoscopic surgery (VATS) approaches of sympathetic chain in 238 patients. One hundred and twenty-nine (54%) patients underwent conventional sympathectomy (CS) while 109 (46%) patients underwent sympathicotomy associated with the division of the rami communicantes (MWT). Quality of Life (QoL) was classified as follows: from 20 to 35 excellent; from 36 to 51 very good; from 52 to 68 good; from 69 to 84 poor; and > 84 very poor. RESULTS: We noticed statistical significant reduction of complications comparing CS with MWT approaches (chest pain from 36.4 to 4.5%; paresthesias from 8.5 to 3.6%; bradycardia from 28.6 to 10%, respectively). The preoperative and postoperative QoL index evaluation revealed a statistically significant improvement after surgery (CS: 86 ± 2 versus 35 ± 1, p = 0.00001; MWT: 85 ± 1 versus 33 ± 2, p = 0.00001), with general satisfaction of the two techniques. CONCLUSION: Modified Wittmoser method seems to be a valid alternative to conventional sympathectomy, minimizing the percentage rate of complications and showing significant effectiveness in the quality of life improvement.

Device-based therapies for arterial hypertension.

Arterial hypertension is the most prevalent modifiable risk factor associated with cardiovascular morbidity and mortality. Although antihypertensive drugs are widely available, in many patients blood pressure control to guideline-recommended target values is not achieved. Several device-based approaches have been introduced to lower blood pressure; most of these strategies aim to modulate autonomic nervous system activity. Clinical trials have moved from including patients with resistant hypertension receiving intensive pharmacological treatment to including patients with mild-to-moderate hypertension in the presence or absence of antihypertensive medications. Renal sympathetic denervation is the most extensively investigated device-based therapy for hypertension, and randomized, sham-controlled trials have provided proof-of-principle data for its blood pressure-lowering efficacy. Unilateral electrical baroreflex activation, endovascular baroreflex amplification and pacemaker-mediated cardiac neuromodulation therapy have yielded promising results in observational trials, which need to be confirmed in larger, adequately powered, sham-controlled trials. Until further evidence becomes available, device-based therapy for hypertension should not be considered for routine treatment. However, when considering a device-based treatment for hypertension, the underlying pathophysiology in each patient has to be taken into consideration, and the procedural risks weighed against the cardiovascular risk attributable to the elevated blood pressure. This Review summarizes the pathophysiological rationale and the latest clinical evidence for device-based therapies for hypertension.

Attenuation of Splanchnic Autotransfusion Following Noninvasive Ultrasound Renal Denervation: A Novel Marker of Procedural Success.

BACKGROUND: Renal denervation has no validated marker of procedural success. We hypothesized that successful renal denervation would reduce renal sympathetic nerve signaling demonstrated by attenuation of α-1-adrenoceptor-mediated autotransfusion during the Valsalva maneuver. METHODS AND RESULTS: In this substudy of the Wave IV Study: Phase II Randomized Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension, we enrolled 23 subjects with resistant hypertension. They were randomized either to bilateral renal denervation using therapeutic levels of ultrasound energy (n=12) or sham application of diagnostic ultrasound (n=11). Within-group changes in autonomic parameters, office and ambulatory blood pressure were compared between baseline and 6 months in a double-blind manner. There was significant office blood pressure reduction in both treatment (16.1±27.3 mm Hg, P<0.05) and sham groups (27.9±15.0 mm Hg, P<0.01) because of which the study was discontinued prematurely. However, during the late phase II (Iii) of Valsalva maneuver, renal denervation resulted in substantial and significant reduction in mean arterial pressure (21.8±25.2 mm Hg, P<0.05) with no significant changes in the sham group. Moreover, there were significant reductions in heart rate in the actively treated group at rest (6.0±11.5 beats per minute, P<0.05) and during postural changes (supine 7.2±8.4 beats per minute, P<0.05, sit up 12.7±16.7 beats per minute, P<0.05), which were not observed in the sham group. CONCLUSIONS: Blood pressure reduction per se is not necessarily a marker of successful renal nerve ablation. Reduction in splanchnic autotransfusion following renal denervation has not been previously demonstrated and denotes attenuation of (renal) sympathetic efferent activity and could serve as a marker of procedural success. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02029885.

Bezold-Jarisch reflex in a patient undergoing endoscopic sympathectomy for management of refractory angina pectoris: a case report / Reflexo de Bezold-Jarisch em paciente submetida à simpatectomia endoscópica para tratamento de angina pectoris refratária: relato de caso

Abstract Background and objectives Ischemic cardiomyopathy is characterized by imbalance between supply and demand of myocardial oxygen. Endoscopic transthoracic sympathectomy is a therapeutic option indicated in refractory cases. However, the patient's position on the operating table may favor ischemic coronary events triggering the Bezold-Jarisch reflex. Case report A female patient, 47 years old, with refractory ischemic cardiomyopathy, admitted to the operating room for endoscopic transthoracic sympathectomy, developed the Bezold- Jarisch reflex with severe bradycardia and hypotension after placement in semi-sitting position to the procedure. Conclusion Bradyarrhythmia, hypotension, and asystole are complications potentially associated with patient placement in a semi-sitting position, particularly in cases with previous ischemic heart disease.

Resumo Justificativa e objetivos A cardiomiopatia isquêmica caracteriza-se pelo desbalanço entre a oferta e o consumo de oxigênio pelo miocárdio. A simpatectomia transtorácica endoscópica é uma opção terapêutica indicada nos casos refratários. Contudo, a posição do paciente na mesa cirúrgica pode favorecer eventos coronarianos isquêmicos e deflagrar o reflexo de Bezold-Jarisch. Relato de caso Paciente do sexo feminino, 47 anos, portadora de cardiomiopatia isquêmica refratária, admitida na sala de cirurgia para simpatectomia transtorácica endoscópica, deflagrou o reflexo de Bezold-Jarisch e desenvolveu bradicardia e hipotensão graves logo após colocação em posição semissentada para o procedimento. Conclusão Bradiarritmia, hipotensão e assistolia são complicações potencialmente associadas à colocação do paciente em posição semissentada, especialmente nos casos em que há prévio comprometimento isquêmico do coração.

[Bezold-Jarisch reflex in a patient undergoing endoscopic sympathectomy for management of refractory angina pectoris: a case report]. / Reflexo de Bezold­Jarisch em paciente submetida à simpatectomia endoscópica para tratamento de angina pectoris refratária: relato de caso.

BACKGROUND AND OBJECTIVES: Ischemic cardiomyopathy is characterized by imbalance between supply and demand of myocardial oxygen. Endoscopic transthoracic sympathectomy is a therapeutic option indicated in refractory cases. However, the patient's position on the operating table may favor ischemic coronary events triggering the Bezold-Jarisch reflex. CASE REPORT: A female patient, 47 years old, with refractory ischemic cardiomyopathy, admitted to the operating room for endoscopic transthoracic sympathectomy, developed the Bezold-Jarisch reflex with severe bradycardia and hypotension after placement in semi-sitting position to the procedure. CONCLUSION: Bradyarrhythmia, hypotension, and asystole are complications potentially associated with patient placement in a semi-sitting position, particularly in cases with previous ischemic heart disease.

Device-Directed Therapy for Resistant Hypertension.

Hypertension remains a significant risk factor for an array of diseases despite advancements in pharmacotherapy. Patients with resistant hypertension who do not respond to conventional medical treatments and lifestyle modifications are especially at risk for poor health outcomes. With the increasing awareness of resistant hypertension, ever-evolving research efforts continue to focus on innovative interventions, including renal denervation, median nerve stimulation, and baroreceptor activation therapy. This article reviews the current evidence and summarizes previous clinical trials for each of these interventions.

Interventional procedures and future drug therapy for hypertension.

Hypertension management poses a major challenge to clinicians globally once non-drug (lifestyle) measures have failed to control blood pressure (BP). Although drug treatment strategies to lower BP are well described, poor control rates of hypertension, even in the first world, suggest that more needs to be done to surmount the problem. A major issue is non-adherence to antihypertensive drugs, which is caused in part by drug intolerance due to side effects. More effective antihypertensive drugs are therefore required which have excellent tolerability and safety profiles in addition to being efficacious. For those patients who either do not tolerate or wish to take medication for hypertension or in whom BP control is not attained despite multiple antihypertensives, a novel class of interventional procedures to manage hypertension has emerged. While most of these target various aspects of the sympathetic nervous system regulation of BP, an additional procedure is now available, which addresses mechanical aspects of the circulation. Most of these new devices are supported by early and encouraging evidence for both safety and efficacy, although it is clear that more rigorous randomized controlled trial data will be essential before any of the technologies can be adopted as a standard of care.

[Invasive treatment of hypertension : Update 2016]. / Interventionelle Hypertonietherapie : Update 2016.

Invasive treatment methods-more specifically renal denervation and baroreceptor activator therapy-have been used for the treatment of therapy-resistant hypertension for several years now. In particular, renal denervation has aroused great interest because it was easy to perform and the first studies provided very promising results. Meanwhile, however, three randomized, blinded studies have been published, and none showed a significant benefit of renal denervation compared to a sham procedure. In addition, in several studies it was demonstrated that intensification of drug therapy, particularly with spironolactone, is at least comparable. Carotid sinus node baroreceptor activator therapy tends to be superior to renal denervation, but the probe currently used is not optimal. The first results by inserting an arteriovenous shunt between the iliac artery and vein are promising, but lack long-term safety data. Currently, all invasive treatment procedures should be performed within the framework of studies or accurate register surveys.

CT-Guided, Ethanol Sympatholysis for Primary Axillary-Palmar Hyperhidrosis.

PURPOSE: Primary hyperhidrosis is an excessive sweating due to an overactive sympathetic system. Our objective was to test the feasibility and provide early data on the safety/efficacy of CT-guided sympatholysis, for primary hyperhidrosis. MATERIALS AND METHODS: Nine consecutive patients with axillary-palmar hyperhidrosis were treated between 2013 and 2015. CT-guided sympathetic block was performed in the outpatients at T-2, T-3, and T-4, bilaterally using alcohol under local anesthesia. Immediate postprocedure CT was obtained to assess the complications as per Common Terminology Criteria for Adverse Events, version 4. Technical success and clinical success were recorded. Primary and secondary efficacy were assessed by phone and clinical visits; mean follow-up was 12 months (6-26 months). Descriptive statistics was used to report the outcomes. RESULTS: One procedure was aborted due to eyelid ptosis after lidocaine injection. All other eight patients (5:3, F:M) (median age 32) had immediate cessation of sweating. Two major complications (pneumothorax, one requiring a chest tube) occurred. Two patients recurred with unilateral and one with bilateral symptoms. One of the unilateral recurrence and the bilateral recurrence patients was retreated successfully. Median follow-up was 1 year. No cases of Horner's or compensatory hyperhidrosis were observed. CONCLUSIONS: CT-guided EtOH sympatholysis for axillary/palmar primary hyperhidrosis is feasible. Technical failure rate was 11 %. Primary and secondary efficacy are 75 and 94 %, respectively, to a median follow-up of 1 year. Risk profile appears favorable. Despite a small sample size, results confirm feasibility and encourage a larger study.

Emerging concepts for patients with treatment-resistant hypertension.

Treatment-resistant hypertension (TRH) is defined as elevated blood pressure despite treatment with three properly dosed antihypertensive drugs, and is associated with adverse cardiovascular and renal outcomes and increased mortality. Treatment of patients with TRH focuses on maximizing the doses of antihypertensive drugs and adding drugs with complementary mechanisms of action, including a combination of angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, calcium channel blockers, and thiazide-like diuretics. Randomized clinical trials have demonstrated the efficacy of the mineralocorticoid receptor antagonist spironolactone as a fourth-line therapy for patients with TRH. Other pharmacologic considerations include adding α-blockers, combined α-ß-blockers, centrally acting α-agonists, or direct vasodilators. However, a small, but important subset of patients remain hypertensive despite combination regimens with multiple antihypertensive drugs, underscoring the need for novel blood pressure-lowering therapies. Over recent years, alternative approaches for treating TRH have emerged, including agonists of natriuretic peptides, endothelin-receptor antagonists, and additional vasoactive drugs. Lastly, device-based interventions, such as renal denervation or carotid baroreflex activation, may supplement drug therapy for these patients. This review summarizes current knowledge on the management of TRH, with focus on novel therapeutic strategies designed to achieve optimal blood pressure control.

[Sedated non-intubated bilateral thoracoscopic sympathectomy R3-R4]. / Simpatectomía torácica bilateral R3-R4 en un paciente sedado no intubado.

Non-intubated thoracic surgery entails procedures performed through regional anesthesia method in awake or mildly sedated, spontaneously ventilating patients. This method represents advantages for the cardiovascular system, and reduces the orotracheal trauma, postoperative atelectasis, and pneumonia. It also possibly reduces costs. Other theoretical advantages are: easier acceptance of surgery, attenuated stress hormone and immune response, and possibly a better survival in oncological surgery. We show a 34-year-old woman with sever palmar-axillary hyperhidrosis. We performed the procedure with local anesthesia (ropivacaine 2 mg/ml) 5 ml in each wound trocar; 20 ml inside the thoracic cavity. The patient was mildly sedated with fentanyl and dexmedetomidine. The procedure was very simple, the patient was included in an outpatient program 90 minutes after the surgery. We conclude that sympathectomy with a non-intubated patient is safe and could be the beginning of other kinds of more complex procedures.

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

BACKGROUND: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. METHOD: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). RESULTS: We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ±â€Š12 mmHg (RDN) and 159 ±â€Š14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ±â€Š18.8 mmHg (RDN) vs. -6.0 ±â€Š13.5 mmHg (SHAM)] and at 6 months [-6.1 ±â€Š18.9 mmHg (RDN) vs. -4.3 ±â€Š15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ±â€Š2.7 (RDN) vs. 7.0 ±â€Š2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. CONCLUSION: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.