Dataset Information

Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.

ABSTRACT: Renal denervation has been shown to reduce blood pressure in patients with uncontrolled hypertension, but less is known about its impact on quality of life. This analysis evaluated 12-month blood pressure and quality of life outcomes in 934 patients from the Global SYMPLICITY Registry who completed the EuroQoL five-dimensions three-level questionnaire (EQ-5D-3L). At baseline, 32% of patients reported anxiety/depression and 48% reported pain/discomfort. At 12 months (n=496), office and 24-hour ambulatory systolic blood pressure were reduced by 13.9±26.6 and 7.7±19.3 mm Hg, respectively, and 8% (P<.001) more patients reported no problems in anxiety/depression. Furthermore, numerically more patients reported no problems in pain/discomfort (4%, P=.08). Perceived health-related quality of life (visual analog scale) improved from baseline to 12 months (68±18 vs 73±17, P<.001), and the improvement was largest among patients with severe anxiety/depression at baseline (50±24 vs 64±22, P=.005 [n=32]). In this analysis, renal denervation was associated with a significant improvement in health-related quality of life, particularly anxiety/depression.

SUBMITTER: Kindermann I

PROVIDER: S-EPMC8031037 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.

Kindermann Ingrid I Wedegärtner Sonja Maria SM Mahfoud Felix F Weil Joachim J Brilakis Nicole N Ukena Julia J Ewen Sebastian S Linz Dominik D Fahy Martin M Mancia Giuseppe G Böhm Michael M

Journal of clinical hypertension (Greenwich, Conn.) 20170507 9

Renal denervation has been shown to reduce blood pressure in patients with uncontrolled hypertension, but less is known about its impact on quality of life. This analysis evaluated 12-month blood pressure and quality of life outcomes in 934 patients from the Global SYMPLICITY Registry who completed the EuroQoL five-dimensions three-level questionnaire (EQ-5D-3L). At baseline, 32% of patients reported anxiety/depression and 48% reported pain/discomfort. At 12 months (n=496), office and 24-hour am ...[more]

PMID: 28480523

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Project description:BackgroundThe Global SYMPLICITY Registry DEFINE (Denervation Findings in Real World) investigates radiofrequency renal denervation (RDN) in a broad range of patients with hypertension. We evaluated whether the number or type of antihypertensive medications were associated with increased long-term blood pressure (BP) reductions and cardiovascular outcomes following radiofrequency RDN.MethodsPatients underwent radiofrequency RDN and were categorized by baseline number (0-3 and ≥4) and different combinations of medication classes. BP changes were compared between groups through 36 months. Individual and composite major adverse cardiovascular events were analyzed.ResultsOf 2746 evaluable patients, 18% were prescribed 0 to 3 and 82% prescribed ≥4 classes. At 36 months, office systolic BP significantly decreased (P<0.0001) by -19.0±28.3 and -16.2±28.6 mm Hg in the 0 to 3 and ≥4 class groups, respectively. Twenty-four-hour mean systolic BP significantly decreased (P<0.0001) by -10.7±19.7 and -8.9±20.5 mm Hg, respectively. BP reduction was similar between the medication subgroups. Antihypertensive medication classes decreased from 4.6±1.4 to 4.3±1.5 (P<0.0001). Most decreased (31%) or had no changes (47%) to the number of medications, while 22% increased. The number of baseline antihypertensive medication classes was inversely related to the change in prescribed classes at 36 months (P<0.001). Cardiovascular event rates were generally low. More patients in the ≥4 compared with 0 to 3 medication classes had myocardial infarction at 36 months (2.8% versus 0.3%; P=0.009).ConclusionsRadiofrequency RDN reduced BP safely through 36 months, independent of the number and type of baseline antihypertensive medication classes. More patients decreased than increased their number of medications. Radiofrequency RDN is a safe and effective adjunctive therapy regardless of antihypertensive medication regimen.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT01534299.

Project description:ObjectivesRenal denervation (RDN) has been proven to be effective in lowering blood pressure (BP) in patients, but previous studies have had short follow-ups and have not examined the effects of RDN on major cardiovascular outcomes. This study aimed to demonstrate the effectiveness and safety of RDN in the long-term treatment of hypertension and to determine if it has an effect on cardiovascular outcomes.MethodsAll patients with resistant hypertension who underwent RDN between 2011 and 2015 at Tianjin First Central Hospital were included in the study. Patients were followed up at 1,5 and 10 years and the longest follow-up was 12 years. Data were collected on office BP, home BP, ambulatory BP monitoring (ABPM), renal function, antihypertensive drug regimen, major adverse events (including acute myocardial infarction, stroke, cardiovascular death and all cause death) and safety events.ResultsA total of 60 participants with mean age 50.37 ± 15.19 years (43.33% female individuals) completed long-term follow-up investigations with a mean of 10.02 ± 1.72 years post-RDN. Baseline office SBP and DBP were 179.08 ± 22.05 and 101.17 ± 16.57 mmHg under a mean number of 4.22 ± 1.09 defined daily doses (DDD), with a reduction of -35.93/-14.76 mmHg as compared with baseline estimates ( P < 0.0001). Compared with baseline, ambulatory SBP and DBP after 10-years follow-up were reduced by 14.31 ± 10.18 ( P < 0.001) and 9 ± 4.35 ( P < 0.001) mmHg, respectively. In comparison to baseline, participants were taking fewer antihypertensive medications ( P < 0.001), and their mean heart rate had decreased ( P < 0.001). Changes in renal function, as assessed by estimated glomerular filtration rate (eGFR) and creatinine, were within the expected rate of age-related decline. No major adverse events related to the RDN procedure were observed in long-term consequences. All-cause mortality and cardiovascular mortality rates were 10 and 8.34%, respectively, for the 10-year period.ConclusionThe BP-lowering effect of RDN was safely sustained for at least 10 years post-procedure. More importantly, to the best of my knowledge, this is the first study to explore cardiovascular and all-cause mortality at 10 years after RDN.

Project description:BackgroundIt is unclear whether renal denervation (RDN) can safely result in blood pressure (BP) reductions in Asian hypertensive patients and whether such reductions would be sustainable. The study is to assess the safety and efficacy of RDN achieved by either main renal artery ablation using the Symplicity FlexTM catheter or main plus branch renal artery ablations using the Symplicity SpyralTM catheter in Taiwanese uncontrolled hypertensive patients enrolled in the Global SYMPLICITY Registry (GSR) with 3 years of follow-up.MethodsThe GSR is a prospective, open-label, and all-comer registry to evaluate the safety and effectiveness of RDN in patients with uncontrolled hypertension worldwide.ResultsAmong 26 patients enrolled (mean age, 59.1 ± 13.8 years), 8 were treated with the Symplicity FlexTM catheter, and 18 were treated with the Symplicity SpyralTM catheter. Baseline office systolic BP was 168.2 ± 19.8 mmHg and diastolic BP was 89.0 ± 14.3 mmHg. Office BP reductions following RDN were sustained throughout the follow-up periods of up to 3 years in the Symplicity FlexTM group and 2 years in the Symplicity SpyralTM group. In the Symplicity FlexTM group, the office systolic BP reductions were 14.9 ± 14.7 mmHg and 29.7 ± 25.9 mmHg at 3 months and 3 years, respectively (both p < 0.05 from baseline). In the Symplicity SpyralTM group, the office systolic BP reductions were 21.2 ± 28.7 mmHg and 42.4 ± 10.7 mmHg at 3 months and 2 years, respectively (both p < 0.05 from baseline). There were no significant changes in heart rate or antihypertensive medication classes. Three protocol-defined adverse events occurred in 2 patients, including new-onset end-stage renal disease, stroke, and hospitalization for new-onset heart failure.ConclusionsGiven the susceptibility of Asian populations to hypertension, RDN, as a safe antihypertensive procedure with long-lasting BP-lowering effects, could reliably serve as an alternative or complementary BP-lowering strategy for patients with uncontrolled hypertension in Taiwan and other Asian countries.

Dataset Information

Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.

Publications

Improvement in health-related quality of life after renal sympathetic denervation in real-world hypertensive patients: 12-month outcomes in the Global SYMPLICITY Registry.

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