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This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.

Epidemiological studies have shown that chronically elevated resting heart rate (HR) is significantly associated with organ damage, morbidity and mortality in a wide range of patients including hypertensive patients. Evidence is also available that an increased HR reflects sympathetic nervous system overdrive which is also known to adversely affect organ structure and function and to increase the risk of unfavourable outcomes in several diseases. The causal relationship between elevated HR, organ damage, and cardiovascular outcomes can thus be explained by its relationship with sympathetic cardiovascular influences although evidence of sympathetically-independent adverse effect of HR increases per se makes it more complex. Interventions that target HR by modulating the sympathetic nervous system have therefore a strong pathophysiological and clinical rationale. As most clinical guidelines now recommend the use of combination therapies in patients with hypertension, it might be desirable to consider as combination components drugs which lower HR, if HR is elevated such as, according to guideliines, when it is above 80 b/min.

BACKGROUND: Use of drug combinations is recommended by hypertension guidelines for most patients because of the greater blood pressure (BP)-lowering effect compared with monotherapy. However, no evidence is available on outcome benefits of treatment strategies based on drug combinations vs. simpler treatment regimens, using data from randomized clinical trials (RCTs). We evaluated drug combination therapies of different complexity.METHODS: Electronic databases were searched for BP-lowering RCTs that compared combination treatment or monotherapy vs. placebo, no-treatment or less-complex treatment. Combination treatment was considered as follows: background treatment continued during follow-up on top of the trial drug(s) of interest and drug(s) were added to the initial drug(s) of interest in the majority of the patients. Monotherapy was considered whenever pre-randomization treatment was withdrawn or absent and a single drug was administered at randomization. Complexity of treatment indicates the higher averaged number of daily medications used in the eligible RCTs.RESULTS: We selected 93 trials (290 304 patients; follow-up, 3.9 years). The on-treatment mean number of drugs was 2.10 and 0.99 in the more and less actively treated patients, respectively. Compared with placebo, no-treatment or less-complex treatment, combination treatments of any complexity (mean number of drugs, 1.40 vs. 0.41, 2.32 vs. 0.48, 2.56 vs. 1.62 and 3.14 vs. 2.19) were associated with reduction of all or most fatal and nonfatal outcomes. There was also an increased rate of side effects leading to treatment discontinuation, although in absolute numbers the benefit usually prevailed.CONCLUSION: These data provide randomized-based trial evidence that antihypertensive combination treatment up to three or more drugs is protective. The net benefit, however, may be attenuated when side effects are considered.

Hypertension is a major risk of cardiovascular diseases. This study's aim was to examine associations between hypertension and a priori known lifestyle risk factors, including weight status and Mediterranean diet adherence. The study included a representative sample of the adult population (N = 3775 (40.8% males)), from the Hellenic National Nutrition and Health Survey (HNNHS), which took place from September 2013 to May 2015. Demographic and anthropometric data were collected using validated questionnaires, and blood pressure (BP) measurements were performed for the two main metropolitan areas (N = 1040; 41.1%). Hypertension diagnosis was according to the International Classification of Diseases (ICD-10) guidelines. Weighted proportions, extended Mantel-Haenszel (M-H) analyses, and multiple logistic regressions (for the survey data) were performed. Mean systolic BP (SBP) and diastolic BP (DBP) were 118.6 mmHg and 72.2 mmHg respectively, with both values being higher in males compared to females in all age groups (p < 0.001). Study participants with hyperlipidemia or diabetes, and those overweight, were almost twice as likely to be hypertensives, with the odds increasing to 4 for those obese (p for all, < 0.05). Stricter Mediterranean diet adherence significantly decreased the likelihood of hypertension by 36% (OR: 0.64; 95% CI: 0.439, 0.943), and a significant interaction was found between Mediterranean diet adherence and weight status on hypertension. The presence of hypertension is clustered with comorbidities, but is significantly associated with modifiable risk factors, including Mediterranean diet and weight status, underlining the need for personalized medical nutritional treatment.

Background/purpose: Catheter-based renal sympathetic denervation (RDN) has been introduced to lower blood pressure (BP) and sympathetic activity in patients with uncontrolled hypertension with at best equivocal results. It has been postulated that anatomic and procedural elements introduce unaccounted variability and yet little is known of the impact of renal anatomy and procedural parameters on BP response to RDN. Methods/materials: Anatomical parameters such as length and diameter were analyzed by quantitative vascular analysis and the prevalence of accessory renal arteries and renal artery disease were documented in 150 patients with resistant hypertension undergoing bilateral RDN using a mono-electrode radiofrequency catheter (Symplicity Flex, Medtronic). Results: Accessory renal arteries and renal artery disease were present in 56 (37%) and 14 patients (9%), respectively. At 6-months, 24 h-ambulatory BP was reduced by 11/6 mm Hg (p < 0.001 for both). Change of systolic blood pressure (SBP) was not related to the presence of accessory renal arteries (p = 0.543) or renal artery disease (p = 0.598). Patients with at least one main renal artery diameter ≤ 4 mm had a more pronounced reduction of 24 h-ambulatory SBP compared to patients where both arteries were >4 mm (−19 vs. −10 mmHg; p = 0.038). Neither the length of the renal artery nor the number of RF ablations influenced 24 h-ambulatory BP reduction at 6 months. Conclusions: 24 h-ambulatory BP lowering was most pronounced in patients with smaller renal artery diameter but not related to renal artery length, accessory arteries or renal artery disease. Further, there was no dose-response relationship observed with increasing number of ablations. Condensed abstract: Because little is known of the impact of renal anatomy and procedural parameters on blood pressure (BP) response to renal denervation (RDN), anatomical and procedural data were analyzed in 150 patients undergoing bilateral RDN. BP lowering was most pro, National Institutes of Health (Grant R01-GM49039)