Abstract-We aimed to investigate for the first time the blood pressure (BP)-lowering effect of renal sympathetic denervation (RDN) versus clinically adjusted drug treatment in true treatment-resistant hypertension (TRH) after excluding patients with confounding poor drug adherence. Patients with apparent TRH (n=65) were referred for RDN, and those with secondary and spurious hypertension (n=26) were excluded. TRH was defined as office systolic BP (SBP) >140 mm Hg, despite maximally tolerated doses of ≥3 antihypertensive drugs including a diuretic. In addition, ambulatory daytime SBP >135 mm Hg after witnessed intake of antihypertensive drugs was required, after which 20 patients had normalized BP and were excluded. Patients with true TRH were randomized and underwent RDN (n=9) performed with Symplicity Catheter System versus clinically adjusted drug treatment (n=10
A pproximately 10% of patients treated for hypertension remain with uncontrolled high blood pressure (BP), despite prescription of antihypertensive drugs.1 Renal sympathetic denervation has been introduced as a new treatment of hypertension apparently resistant to drug treatment.2 However, it has been known for decades that poor drug adherence is a major problem among these patients. 3,4 It is unknown to what degree the decline in BP after renal denervation (RDN) 2 is caused by denervation itself or concomitantly improved drug adherence. We aimed to investigate for the first time the BP lowering effect of RDN in treatment-resistant hypertension after witnessed intake of medication just before qualifying ambulatory BP. Methods Study Design and PatientsPatients referred specifically for RDN from hospitals and specialist practices in the southern part of Norway (n=18) after publication of the Symplicity HTN-2 study 2 were worked up in the nephrology outpatient clinic at Oslo University Hospital, Ullevål in the time period from December 2011 through June 2012. Treatment-resistant hypertension was defined as uncontrolled hypertension (office systolic BP >140 mm Hg), despite regular intake of maximally tolerated doses of ≥3 antihypertensive drugs, including a diuretic. In addition, patients had to qualify by having mean ambulatory daytime systolic BP >135 mm Hg immediately after investigator witnessed intake of their antihypertensive morning drugs. Patients were asked to bring their prescribed medication to the clinical visit with one of the investigators (one of the authors of the article). Medication was documented and administered by the investigator and swallowed by the patient under continuous observation, to secure the intake of prescribed medication in prescribed doses. Patients were then continuously under the observation by the investigator to prohibit throwing up again of the pills until 24-hour ambulatory BP device had been mounted and tested out in a somewhat more lengthy procedure than usually to prolong the period of observation. Patients stayed in the hospital for 2 hours to capture those with potential symptomatic hypotension caused by full intake of medication. Visits with subsequent ambulatory BP measurements were done in the morning, and further observation of patients in the hospital was done during working hours.Plasma and urine metabolites of drugs were not measured because these tests would not have contributed in the present situation. Such tests could have identified the nondrug compliant patients but not secured their intake of medication. See Editorial Commentary, pp 450-452Abstract-It is unknown whether the decline in blood pressure (BP) after renal denervation (RDN) is caused by denervation itself or concomitantly improved drug adherence. We aimed to investigate the BP lowering effect of RDN in true treatmentresistant hypertension by excluding patients with poor drug adherence. Patients with resistant hypertension (n=18) were referred for a thorough clinical and laboratory work-up. Treat...
Poor drug adherence is one of the main reasons for the failure to achieve treatment targets in hypertensive patients. In patients who receive pharmacological treatment, assessment of drug adherence is of the utmost importance. The aim of this review is to present an update of the methods available to reveal and monitor non-adherence in patients with apparent treatment-resistant hypertension. Methods for monitoring adherence are divided into indirect and direct methods. The indirect methods are mainly based on self-reported adherence and can easily be manipulated by the patient. Directly observed therapy and therapeutic drug monitoring are examples of direct methods. There are limitations and advantages to all of the methods, and because of the patient's ability to manipulate the outcome of indirect methods, direct methods should be preferred. Therapeutic drug monitoring and directly observed therapy with subsequent ambulatory blood pressure measurement are considered to be reliable methods and should be used more in the routine assessment of patients with apparent treatment-resistant hypertension.
Objective . The blood pressure (BP)-lowering effect of renal sympathetic nervous denervation (RDN) in resistant hypertension (rHT) shows large variation among studies. Methods. We meta-analyzed summary statistics of randomized clinical trials on RDN in rHT. For continuous outcomes, we assessed heterogeneity by Cochran ' s Q test and used random-effect models weighted for the inverse of the variance. We assessed safety by assessing the risk of major adverse events from stratifi ed contingency tables. Results. Of 5652 patients screened in seven trials, 985 (17.4%) qualifi ed and were randomized to control ( n ϭ 397) or RDN with SYMPLICITY ™ catheters ( n ϭ 588). Follow-up was 6 months. In both control and RDN patients, antihypertensive treatment was continued or optimized. At enrolment, age averaged 58.1 years, systolic/ diastolic offi ce and 24 h BP 168.5/93.3 mmHg and 151.8/86.1 mmHg, respectively, and estimated glomerular fi ltration rate (eGFR) 79.3 ml/min/1.73 m ² . For BP outcomes, there was heterogeneity among trials. Pooled effects (control minus RDN) were Ϫ 4.9/ Ϫ 3.5 mmHg (95% confi dence interval, Ϫ 20.9 to 11.1/ Ϫ 8.9 to 1.9) for offi ce BP, Ϫ 2.8/ Ϫ 1.5 mmHg ( Ϫ 6.5 to 0.8/ Ϫ 3.3 to 0.4) for 24 h BP and 0.81 ml/min/1.73 m ² ( Ϫ 1.69 to 3.30) for eGFR. Removing one trial at a time produced confi rmatory results. Adverse events occurred in 7.4% and 9.9% of control and RDN patients, respectively ( p ϭ 0.24). Conclusion. In selected rHT patients maintained on antihypertensive drugs, RDN with the SYMPLICITY systems does not signifi cantly decrease BP but is safe. Future trials with next-generation catheters should aim at identifying responders in patients with evidence of sympathetic nervous overactivity.
Depending on populations studied and applied methods and definitions, the prevalence of treatment-resistant hypertension varies from 3% to 30%. 1,2 The SYMPLICITY studies [3][4][5] demonstrated that in this indication catheter-based endovascular sympathetic renal denervation (RDN) by means of low-frequency energy is feasible. It entails a 25-to 30-mm Hg decrease in office systolic blood pressure, 84% of patients achieving a decrease in office systolic blood pressure of ≥10 mm Hg with a rate of procedural adverse events <5% assessed 6 months after RDN. 4 However, as reviewedAbstract-Based on the SYMPLICITY studies and CE (Conformité Européenne) certification, renal denervation is currently applied as a novel treatment of resistant hypertension in Europe. However, information on the proportion of patients with resistant hypertension qualifying for renal denervation after a thorough work-up and treatment adjustment remains scarce. The aim of this study was to investigate the proportion of patients eligible for renal denervation and the reasons for noneligibility at 11 expert centers participating in the European Network COordinating Research on renal Denervation in treatment-resistant hypertension (ENCOReD). The analysis included 731 patients. Age averaged 61.6 years, office blood pressure at screening was 177/96 mm Hg, and the number of blood pressure-lowering drugs taken was 4.1. Specialists referred 75.6% of patients. The proportion of patients eligible for renal denervation according to the SYMPLICITY HTN-2 criteria and each center's criteria was 42.5% (95% confidence interval, 38.0%-47.0%) and 39.7% (36.2%-43.2%), respectively. The main reasons of noneligibility were normalization of blood pressure after treatment adjustment (46.9%), unsuitable renal arterial anatomy (17.0%), and previously undetected secondary causes of hypertension (11.1%). In conclusion, after careful screening and treatment adjustment at hypertension expert centers, only ≈40% of patients referred for renal denervation, mostly by specialists, were eligible for the procedure. The most frequent cause of ineligibility (approximately half of cases) was blood pressure normalization after treatment adjustment by a hypertension specialist. Accordingly, several national and international consensus papers 16,17 have proposed guidelines for evaluation and management of patients with resistant hypertension before considering RDN. The proportion of patients with truly resistant hypertension eligible for RDN and the reasons of noneligibility after thorough screening and optimization of drug treatment in expert centers remain elusive. In this study, we reviewed the reasons for noneligibility at 11 hypertension expert centers performing RDN for treatment-resistant hypertension and collaborating within the European Network COordinating research on Renal Denervation (ENCOReD). 8 Methods PatientsWe performed systematic reviews of the literature published elsewhere 6,7 and identified ENCOReD centers engaging in RDN. At the fourth ENCOReD network meeting, held...
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