Renal Artery Denervation Research Articles

OP.4C.04] SAFETY AND PERFORMANCE OF THE ENLIGHTN RENAL DENERVATION SYSTEM IN PATIENTS WITH DRUG-RESISTANT HYPERTENSION

Objective: Catheter-based renal denervation therapy is under evaluation in patients with resistant hypertension. To gain insights from a large dataset, we investigated safety and performance of the EnligHTN™ Renal Denervation System (St. Jude Medical) in patients with drug-resistant hypertension using pooled data from all trials performed to date. This is the first report of pooled data from the EnligHTN I-III trials through 24-months. Design and method: We analysed data from the EnligHTN trials with the following criteria: 18–80 years of age, office systolic BP >/=160 mmHg, >/=3 antihypertensive agents (including a diuretic), and renal artery diameter >/=4 mm, length >/=20 mm. All trials used the same renal artery ablation catheter. Results: 118 patients from these 3 studies (E1 n = 44, E2 n = 39, E3 n = 35), had 24-month follow up data available. Mean age was 61 yrs., mean office systolic BP (OSBP) at baseline of 177.1 mmHg and at 24 months of 151.3 mmHg. Therefore a 24-month reduction in OSBP of 25.8 mmHg was noted (p Results: 103 patients from these 3 studies (E1 n = 43, E2 n = 27, E3 n = 33) had ABPM data available at 24-months. Mean 24-hr systolic ABP at baseline was 152.1 mmHg and at 24-months was 140.5 mmHg. This 11.7 mmHg drop was statistically significant (p Results: 112 patients from these 3 studies (E1 n = 44, E2 n = 35, E3 n = 33) had eGFR data available at 24-months. Baseline was 79.8±19.9 mL/min/1.73 m2; 24-month was 77.1 ± 20.8 mL/min/1.73 m2. The change in eGFR at 24-months was not significant. Conclusions: Pooled data from the complete EnligHTN clinical trial dataset meeting traditional study definitions of resistant hypertension confirm the efficacy and safety of multi-electrode systems for renal artery denervation. Future randomised controlled trials in the patient population with next generation multi-electrode renal denervation systems are warranted. Serious Renal Artery Adverse Events occurred in less than 2% of the population. In addition changes in medication and predictors of blood pressure response will be presented.

Hypertension: Update on renal artery denervation.

Hypertension: Update on renal artery denervation.

Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry.

AimsCatheter-based renal artery denervation (RDN) has been shown to lower blood pressure (BP) in certain patients with uncontrolled hypertension. Isolated systolic hypertension (ISH) (systolic BP [SBP] ≥140 mmHg and diastolic BP <90 mmHg), characterized by increased vascular stiffness, is the predominant hypertensive phenotype in elderly patients. This study compared baseline characteristics and SBP change at 6 months between patients with ISH and combined systolic–diastolic hypertension (CH).Methods and resultsThis study pooled data from 1103 patients from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. A total of 429 patients had ISH, and 674 had CH. Patients with ISH were significantly older than those with CH (66 vs. 55 years), had more type 2 diabetes mellitus (52.9 vs. 34.6%), and a lower estimated glomerular filtration rate (71.8 vs. 78.6 mL/min/1.73 m2); all P < 0.001. At 6 months, the SBP drop for CH patients was −18.7 ± 23.7 mmHg compared with a reduction of −10.9 ± 21.7 mmHg for ISH patients −7.8 mmHg, 95% confidence interval, CI, −10.5, −5.1, P < 0.001). The change in 24-h SBP at 6 months was −8.8 ± 16.2 mmHg in patients with CH vs. −5.8 ± 15.4 mmHg in ISH (−3.0 mmHg, 95% CI −5.4, −0.6, P = 0.015). Presence of ISH at baseline but not age was associated with less pronounced BP changes following the procedure. The strongest predictor of office SBP reduction at 6 months was CH, followed by aldosterone antagonist use and non-use of vasodilators.ConclusionThe reduction in BP among patients with ISH following RDN was less pronounced than the reduction in patients with CH.Clinical.Trials.gov identifiersNCT01534299 and NCT01418261.

Ruminations About Renal Denervation.

Renal artery denervation has captured the imagination of cardiologists as few recent technologies have done.1 The underlying pathophysiological construct seemed persuasive because evidence of sympathetic overactivity in the genesis of hypertension and heart failure has been clearly documented. Moreover, initial nonrandomized studies using different catheter systems in patients with hypertension deemed treatment resistant almost uniformly found large drops in office blood pressure measurements. The initial assessment of those very impressive results was surprisingly noncritical in many parts of the world in which the procedure was adopted into clinical practice. Subsequently, the neutral results of the SYMPLICITY-HTN 3 trial (Renal Denervation in Patients With Uncontrolled Hypertension),2 which was the first to incorporate a “sham procedure” control arm, came as a stunning surprise to some and generated a wide spectrum of responses, including denial, disbelief, abrogation of the entire concept, a critique of several technical and operator-dependent issues, and an increasing awareness of the power of placebo, regression to the mean, and methods of assessing blood pressure control. As is so often the case after the initial furor, it is a time for sober reflection, and a more circumspect view of renal artery denervation has been adopted that in turn has led to the design of more sophisticated ongoing trials. Since the first studies, there is now a much greater understanding of resistant hypertension. Many of these lessons came from the SYMPLICITY HTN-3 trial.2 First, reports of the prevalence of resistant hypertension may have been greatly exaggerated. When studied rigorously, it appears that poor adherence is the root cause of the majority of cases initially felt to be resistant hypertension.3 The salutary role of aldosterone blockade in many instances of resistant hypertension has also now been fully appreciated. Partnership with dedicated hypertension experts based …

Renal Artery Denervation in Patient After Heart and Kidney Transplantation With Refractory Hypertension

We describe the case of a 54-year-old patient after renal and heart transplantation in whom uncontrolled hypertension was diagnosed. Despite combined antihypertensive therapy, no significant therapeutic effect was achieved. Clinical assessment of ambulatory blood pressure monitoring (ABPM) revealed the ineffectiveness of a bisoprolol, nitrendypin, klonidyn, ramipryl, furosemide, and doxasosine combination used at high doses. High blood pressure levels with their effect on a hypertrophic transplanted heart (left ventricular mass 254 g) and poor renal graft function (39 mL/kg/min) posed an extremely high risk of future cardiovascular complications, and were the reason to perform a native renal arteries denervation. The procedure was carried out through the right femoral artery with the use of a 6F guiding catheter. During a 1-year observation, significant decreases in ABPM systolic and diastolic blood pressures were observed after the procedure (168/88 mm Hg vs 154/77 mm Hg, respectively). Moreover a significant regression of left ventricular mass (215 g/m2) and stable renal graft function were noted. The presented case shows that native renal arteries denervation may be successful and safe in kidney and heart transplant recipients. Moreover, during the 1-year follow-up, the reduction in blood pressure was followed by a reduction in transplanted heart hypertrophy, both leading to regression of cardiovascular risk for the patient.

“Won’t Get Fooled Again”

Early trials demonstrated that renal artery denervation (RDN), delivered with a catheter in the renal artery, reduced blood pressure by reducing sympathetic tone in patients with hypertension, as measured by renal norepinephrine spillover and muscular sympathetic nerve activity [(1)][1]. SYMPLICITY

216-07: Pulmonary vein isolation with concomitant renal artery denervation is associated with reduction of both arterial blood pressure and atrial fibrillation burden: data from implantable cardiac monitor

216-07: Pulmonary vein isolation with concomitant renal artery denervation is associated with reduction of both arterial blood pressure and atrial fibrillation burden: data from implantable cardiac monitor

Renal denervation in a patient with unilateral ectopic kidney in the pelvis and refractory hypertension

Ectopic kidney and inherent vascular abnormalities may result in renovascular hypertension. The case we report is peculiar as a left ectopic iliac kidney supplied by a superior and an inferior polar renal arteries was detected in a treatment-resistant hypertensive man. In conclusion, percutaneous renal artery denervation was successfully performed in the right renal artery and in both left accessory renal arteries, obtaining excellent blood pressure decrease at follow-up.

Persistent Increase in Blood Pressure After Renal Nerve Stimulation in Accessory Renal Arteries After Sympathetic Renal Denervation

Blood pressure response to renal denervation is highly variable, and the proportion of responders is disappointing. This may be partly because of accessory renal arteries too small for denervation, causing incomplete ablation. Renal nerve stimulation before and after renal denervation is a promising approach to assess completeness of renal denervation and may predict blood pressure response to renal denervation. The objective of the current study was to assess renal nerve stimulation-induced blood pressure increase before and after renal sympathetic denervation in main and accessory renal arteries of anaesthetized patients with drug-resistant hypertension. The study included 21 patients. Nine patients had at least 1 accessory renal artery in which renal denervation was not feasible. Renal nerve stimulation was performed in the main arteries of all patients and in accessory renal arteries of 6 of 9 patients with accessory arteries, both before and after renal sympathetic denervation. Renal nerve stimulation before renal denervation elicited a substantial increase in systolic blood pressure, both in main (25.6±2.9 mm Hg; P<0.001) and accessory (24.3±7.4 mm Hg; P=0.047) renal arteries. After renal denervation, renal nerve stimulation-induced systolic blood pressure increase was blunted in the main renal arteries (Δ systolic blood pressure, 8.6±3.7 mm Hg; P=0.020), but not in the nondenervated renal accessory renal arteries (Δ systolic blood pressure, 27.1±7.6 mm Hg; P=0.917). This residual source of renal sympathetic tone may result in persistent hypertension after ablation and partly account for the large response variability.

Future prospects for renal artery denervation

Future prospects for renal artery denervation

Similarities between the renal artery and pulmonary vein denervation trials: Do we have to use sham procedures for atrial fibrillation catheter ablation trials?

Similarities between the renal artery and pulmonary vein denervation trials: Do we have to use sham procedures for atrial fibrillation catheter ablation trials?

REFRACTORY ARTERIAL HYPERTENSION AND PROBLEMS OF THERAPY

Resistant arterial hypertension (RAH) occurs with frequency of 10 % to 30 % of cases depending on RAH definition and arterial hypertension (AH) population. To a certain extent, RAH prevalence depends on inclusion into the group of pseudoresistant or real RAH. In the present paper the problems of real RAH are under consideration. Modern definition of RAH is attributed mainly to ambulatory patients, treated by three-or four component program including diuretic. Spironolactone was established to be of great significance in RAH treatment, much more exceeding bisoprolol and doxazosin. Recently, clinical studies regarding the procedure of renal arteries denervation and carotid arteries stimulation were carried out. The uncontrolled studies showed high efficiency of these procedures during three years, whereas the controlled studies are doubtful in respect of their effect.

Optimal Sites for Renal Artery Denervation: Relation to atrial fibrillation ablation

Optimal Sites for Renal Artery Denervation: Relation to atrial fibrillation ablation

Interventional Therapies for Resistant Hypertension: A Brief Update

Resistant hypertension remains a clinical challenge with few management options beyond maximisation of medications. Catheterbased renal artery denervation (RDN) was proposed in 2009 as a possible therapy for resistant hypertension and early feasibility trials caused excitement among cardiologists and antihypertensive specialists, showing remarkable and sustained blood pressure reductions. In 2014, enthusiasm for RDN dampened following the SYMPLICITY 3 trial results, which showed no statistically significant difference in blood pressure between the intervention and control arms. However, hope remains for the improved management of resistant hypertension; procedural understanding, technological advancements and alternative targets – such as baroreceptor activation therapy and arteriovenous shunts – may aid the identification of those patients for whom specific interventional therapies will be effective.

Renal Artery Denervation by Vincristine

Renal Artery Denervation by Vincristine

Interventional Therapies for Resistant Hypertension: A Brief Update

Resistant hypertension remains a clinical challenge with few management options beyond maximisation of medications. Catheter- based renal artery denervation (RDN) was proposed in 2009 as a possible therapy for resistant hypertension and early feasibility trials caused excitement among cardiologists and antihypertensive specialists, showing remarkable and sustained blood pressure reductions. In 2014, enthusiasm for RDN dampened following the SYMPLICITY 3 trial results, which showed no statistically significant difference in blood pressure between the intervention and control arms. However, hope remains for the improved management of resistant hypertension; procedural understanding, technological advancements and alternative targets - such as baroreceptor activation therapy and arteriovenous shunts - may aid the identification of those patients for whom specific interventional therapies will be effective.

Case Report: Renal Sympathetic Denervation + Pulmonary Vein Reisolation in Patients with Long-stand Persistent Atrial Fibrillation and Resistant Hypertension. Does it Work?

Introduction: A recent study reported that renal sympathetic denervation (RSD) reduces systolic and diastolic blood pressure (BP) in patients with drug-resistant hypertension and reduces atrial fibrillation (AF) recurrences when combined with pulmonary vein isolation (PVI), in a prospective randomized study that assessed the impact of renal artery denervation in patients with a history of refractory AF and drug-resistant hypertension who were referred for PVI. Case presentation: In this series of cases of long-standing persistent atrial fibrillation (LSPAF) we report 5 cases refractory to treatment with antiarrhythmic drug that underwent to AF catheter ablation, at least one year. The five patients complained about tachycardic palpitations often, as well as, episodes of dyspnea and pre-syncope, were taking amiodarone 200 mg/day and returned to present LSPAF. Moreover, all of them had resistant hypertension besides to possessing other comorbidities. They had normal renal function, and were using the anti-hypertensive medications for at least 3 months, as well as all of them were using dabigatran 150 mg twice a day. All of them underwent to pulmonary vein re-isolation (PVRI) and RSD. All the patients submitted to RSD showed highly significant reduction in office BP and 24-hour APM, both systolic and diastolic at all times points after the procedure. No changes in the renal function were observed before and after the procedure. Even after prompt successful PVRI + RSD procedures, with the 5 patients recovering sinus rhythm, all of them had recurrence of persistent AF in less than one year. After controlling the BP, even all the individuals being in AF, we observed a reduction in left atrial volume at one year post procedure (P = 0.0008), measured by cardiac magnetic resonance. Due to the maintenance of AF we opted to maintain amiodarone and think a third ablation of this arrhythmia in the future with more aggressive strategies or even opt for the control of heart rate, depending on the symptoms of patients. Conclusions: We can conclude that RSD was effective in controlling BP and associated to PVRI showed a reduction in volume of the left atrium, but in the control of LSPAF, we did not achieve the success.

Modulation of sympathetic nervous system by means of renal denervation for treatment of atrial fibrillation

The autonomous nervous system plays a key role in modulation of cardiac electrophysiology. Despite a great body of data on the presence of anatomic and functional relations between the nervous system and the heart, there remain a number of questions unanswered. Denervation of renal arteries or renal denervation (RDN) has become a crucial interventional technique when treating resistant arterial hypertension (AHT). Since the latter is the most prevailing cardiovascular disease complicating the course of heart rhythm disorders, atrial fibrillations in particular, it would be a good idea to study a potential value of RDN as antiarrhythmic therapy.

TCT-770 Catheter-based renal sympathetic denervation for resistant hypertension: A meta-analysis of randomized trials

Percutaneous renal artery denervation has been shown to decrease blood pressure among patients with resistant arterial hypertension. We present in this review a meta-analysis of all randomized controlled trials evaluating effectiveness and complications of catheter-based RDN for blood pressure

TCT-774 Safety and Performance of the EnligHTN™ Renal Denervation System in Patients with Drug-resistant Hypertension: Pooled analyses from the EnligHTN I, II and III trials

Catheter-based renal artery denervation therapy is under evaluation as a therapeutic option in patients with resistant hypertension. Despite promising data from initial studies, the lack of a clear treatment effect from the SYMPLICITY HTN 3 trial raised concerns around the efficacy of renal