Quality-of-life and beliefs about medication in relation to a therapy adherence intervention in resistant hypertension: the Resistant HYpertension: MEasure to ReaCh Targets trial.

OBJECTIVE: To assess the impact of personalized feedback on therapy adherence testing results on quality of life and beliefs about medication in patients with resistant hypertension, as well as to identify patient-oriented predictors of therapy adherence. METHODS: This study was a prespecified post hoc analysis of the multicenter randomized controlled trial Resistant HYpertension: MEasure to ReaCh Targets (RHYME-RCT). Patients were randomized to a personalized feedback conversation on measured antihypertensive drug levels additional to standard-of-care, or standard-of-care only. The primary outcomes consisted of EuroQol EQ-5D-5L and Beliefs about Medicine Questionnaire (BMQ) scores at 12 months. RESULTS: A total of 56 patients with median age 61.5 [25th-75th percentile: 55.8-69.3] years (21.4% women) were included. Mean blood pressure ±SD was 149.8/84.1 ±â€Š14.9/13.8 mmHg while being on a median of 5.6 [4.8-7.3] defined daily dosages (DDD) of antihypertensive drugs. At 12 months, no differences were observed in EQ-5D-5L index (0.81 [0.69-0.89] vs. 0.89 [0.73-1.00]; P = 0.18) and visual analogue scale score on general patient-perceived health (70 [60-80] vs. 70 [60-82]; P = 0.53) between the intervention-arm and the standard-of-care only-arm. Likewise, individual EQ-5D-5L domain scores and BMQ scores did not differ between both arms. Irrespective of the intervention, independent positive predictors of the percentage adherence were patient age, EQ-5D-5L index score, BMQ-specific necessity score and concern score, whereas the total number of drugs prescribed was a negative predictor. CONCLUSION: Within this prespecified subanalysis of the randomized RHYME-RCT trial, implementation of a personalized feedback conversation targeting therapy adherence did not improve health-related quality-of-life and beliefs about medication in patients with resistant hypertension.

Long-term safety and efficacy of renal sympathetic denervation in atrial fibrillation: 3-year results of the AFFORD study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained arrhythmia which has been associated with increased sympathetic nervous system activity and hypertension. Recent evidence indicated that renal sympathetic denervation (RDN) could safely contribute to an improvement in AF burden. OBJECTIVE: To investigate the long-term safety and efficacy of radiofrequency RDN in hypertensive patients with symptomatic AF. METHODS: This pilot study included patients with symptomatic paroxysmal or persistent AF (European Hearth Rhythm Association class ≥ II) despite optimal medical therapy, office systolic blood pressure (BP) ≥ 140 mmHg and ≥ 2 antihypertensive drugs. AF burden was measured using an implantable cardiac monitor (ICM), implanted 3 months prior to RDN. ICM interrogation and 24-h ambulatory BP monitoring were performed at baseline and at 3/6/12/24/36 months post RDN. The primary efficacy outcome was daily AF burden. Statistical analyses were performed using Poisson and negative binomial models. RESULTS: A total of 20 patients with a median age [25th-75th percentiles] of 66.2 [61.2-70.8] years (55% female) were included. At baseline, office BP ± standard deviation (SD) was 153.8/87.5 ± 15.2/10.4 mmHg, while mean 24-h ambulatory BP was 129.5/77.3 ± 15.5/9.3 mmHg. Baseline daily AF burden was 1.4 [0.0-10.9] minutes/day and throughout a 3-year follow-up period, no significant change was observed (- 15.4%/year; 95% confidence interval (CI) - 50.2%, + 43.7%; p = 0.54). The number of defined daily doses of antiarrhythmic drugs and antihypertensive drugs remained stable over time, while mean 24-h ambulatory systolic BP decreased with - 2.2 (95% CI - 3.9, - 0.6; p = 0.01) mmHg/year. CONCLUSIONS: In patients with hypertension and symptomatic AF, stand-alone RDN reduced BP but did not significantly reduce AF burden up until 3 years of follow-up.

Unilateral renal atrophy 4 years after renal sympathetic denervation: a case report.

Renal sympathetic denervation (RDN) carries a low risk of renal artery stenosis, and most cases occur within the first year. However, limited data are available on long-term incidence. Here, we present a case of a 68-year-old woman who underwent radiofrequency RDN for resistant hypertension. Ambulatory blood pressure improved following RDN and uptitration of antihypertensive drugs. Between year 3 and 4 after RDN, eGFR reduced from 87 to 50 ml/min per 1.73 m 2 . Ultrasound imaging revealed left renal atrophy, while subsequent magnetic resonance angiography showed a haemodynamically significant stenosis of the left renal artery. The patient remained in good clinical condition with stable blood pressure, while eGFR mildly deteriorated during a 6-year follow-up period. This case of renal artery stenosis occurred in a patient with multiple risk factors. A causal relationship to the RDN procedure cannot be confirmed nor ruled out. Long-term surveillance for adverse events should be considered in all RDN patients.

Association between renal sympathetic denervation and arterial stiffness: the ASORAS study.

OBJECTIVES: Renal sympathetic denervation (RDN) reduces blood pressure (BP). However, one out of three patients does not exhibit a significant BP response to the therapy. This study investigates the association between noninvasive vascular stiffness indices and RDN-mediated BP reduction. METHODS: In this prospective, single-arm pilot study, patients with systolic office BP at least 140 mmHg, mean 24-h systolic ambulatory blood pressure (ABP) at least 130 mmHg and at least three prescribed antihypertensive drugs underwent radiofrequency RDN. The primary efficacy endpoint was temporal evolution of mean 24-h systolic ABP throughout 1-year post RDN (measured at baseline and 3-6-12 months). Effect modification was studied for baseline ultrasound carotid-femoral and magnetic resonance (MR) pulse wave velocity (PWV), MR aortic distensibility, cardiac MR left ventricular parameters and clinical variables. Statistical analyses were performed using linear mixed-effects models, and effect modification was assessed using interaction terms. RESULTS: Thirty patients (mean age 62.5 ±â€Š10.7 years, 50% women) with mean 24-h ABP 146.7/80.8 ±â€Š13.7/12.0 mmHg were enrolled. Following RDN, mean 24-h systolic ABP changed with -8.4 (95% CI: -14.5 to -2.3) mmHg/year ( P  = 0.007). Independent effect modifiers were CF-PWV [+2.7 (0.3 to 5.1) mmHg/year change in outcome for every m/s increase in CF-PWV; P  = 0.03], daytime diastolic ABP [-0.4 (-0.8 to 0.0) mmHg/year per mmHg; P  = 0.03], age [+0.6 (0.2 to 1.0) mmHg/year per year of age; P  = 0.006], female sex [-14.0 (-23.1 to -5.0) mmHg/year as compared with men; P  = 0.003] and BMI [+1.2 (0.1 to 2.2) mmHg/year per kg/m 2 ; P  = 0.04]. CONCLUSION: Higher CF-PWV at baseline was associated with a smaller reduction in systolic ABP following RDN. These findings could contribute to improve identification of RDN responders.

Long-term follow-up of patients undergoing renal sympathetic denervation.

OBJECTIVES: Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. METHODS: In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. RESULTS: Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark's Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. CONCLUSIONS: The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.

Adequacy of blood pressure control in high-risk hypertensive patients: The DEGREE study.

INTRODUCTION: Hypertension is a modifiable risk factor in patients at the highest risk for cardiovascular events. New invasive treatment options are becoming available that might be particularly appealing for high-risk patients. Therefore, the aim of this study was to determine the prevalence of high-risk patients on routine therapy that do not meet guideline recommended ambulatory blood pressure (ABP) targets. METHODS: This single-center, cross-sectional study was conducted at the Erasmus University Medical Center (Rotterdam, The Netherlands). Inclusion criteria were: (1) age 18-80 years, (2) drugs prescribed for hypertension or history of hypertension and (3) high cardiovascular risk as defined according to the European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines. Patients underwent standardized office blood pressure (OBP) and same-day 24-h ABP measurements. Blood pressure (BP) control was defined according to the 2018 ESC/ESH and 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. RESULTS: A total of 100 patients were enrolled (median age 71 years, 35% female). Mean OBP was 142.2/81.9 ± 18.6/12.6 mmHg and mean 24-h ABP was 126.1/70.1 ± 14.3/9.2 mmHg. Patients were on 2.0 [25th-75th percentile: 1.0-3.3] Defined Daily Doses of antihypertensive drugs. ESC/ESH guideline 24-h ABP and OBP targets were not met in 41.8% (95%CI: 31.5-52.6%) and 52.7% (95%CI: 42.0-63.3%), respectively. ACC/AHA guideline 24-h ABP and OBP targets were not met in 59.3% (95%CI: 48.5-69.5%) and 79.1% (95%CI: 69.3-86.9%), respectively. CONCLUSIONS: BP remains uncontrolled in 40-60% of high-risk hypertensive patients despite routine use of guideline-recommended therapy. Our findings support the search towards novel invasive BP lowering treatment options.