Renal Denervation and Symplicity HTN-3

Papademetriou, Vasilios; Tsioufis, Costas; Doumas, Michael

doi:10.1161/circresaha.115.304099

Cited by 44 publications

(20 citation statements)

References 45 publications

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“…The SYMPLICITY HTN-2 study did not show a placebo effect in the control group, which is typical in pharmacologic trials. The limited ABPM data demonstrated a much smaller effect compared to office measurements than is typically seen in studies of anti-hypertensive medications and this raised questions about the validity of the large reductions seen in office BP [18,19]. Finally, the absence of true control groups in these studies may have masked placebo or Hawthorne effects.…”

Section: Clinical Renal Denervation Trials and Limitationsmentioning

confidence: 92%

Renal Denervation: Back to the Future?

Raman¹,

Chrysostomou²

2015

J Kidney

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Hypertension is a global health epidemic, affecting up to one-third of adults. Despite a plethora of pharmacologic agents that lower blood pressure and mitigate end-organ damage as well as cardiovascular events, a significant percentage of patients fail to achieve target reduction. A subset of these patients is considered to have resistant hypertension with markedly elevated blood pressure despite treatment using at least three agents, including a diuretic. With significant excess risk, additional treatment options for these patients remain an unmet need.

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Section: Clinical Renal Denervation Trials and Limitationsmentioning

confidence: 92%

Renal Denervation: Back to the Future?

Raman¹,

Chrysostomou²

2015

J Kidney

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“…The question is: why did it fail to demonstrate the expected benefit [36]? Although much iteration of reasons has been expressed, most (serious) investigators agree that the main reason was partial or inadequate denervation.…”

Section: Renal Sympathetic Denervation: Past Present and Futurementioning

confidence: 99%

Renal Sympathetic Denervation: Hibernation or Resurrection?

Papademetriou

Doumas²,

Tsioufis³

2016

Cardiology

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The most current versions of renal sympathetic denervation have been invented as minimally invasive approaches for the management of drug-resistant hypertension. The anatomy, physiology and pathophysiology of renal sympathetic innervation provide a strong background supporting an important role of the renal nerves in the regulation of blood pressure (BP) and volume. In addition, historical data with surgical sympathectomy and experimental data with surgical renal denervation indicate a beneficial effect on BP levels. Early clinical studies with transcatheter radiofrequency ablation demonstrated impressive BP reduction, accompanied by beneficial effects in target organ damage and other disease conditions characterized by sympathetic overactivity. However, the failure of the SYMPLICITY 3 trial to meet its primary efficacy end point raised a lot of concerns and put the field of renal denervation into hibernation. This review aims to translate basic research into clinical practice by presenting the anatomical and physiological basis for renal sympathetic denervation, critically discussing the past and present knowledge in this field, where we stand now, and also speculating about the future of the intervention and potential directions for research.

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“…However, neither met efficacy end points when compared with those with sham or device‐off treatment in randomized phase III studies 9, 10. Several major lessons were learned from these trials, such as the Hawthorne effect and unreliability of using office blood pressure measurements alone without 24 hours ambulatory blood pressure monitoring 11. Taking these into account, along with improvements in design of the catheter to deliver more complete renal sympathetic denervation, the SPYRAL HTN OFF‐MED study was conducted as a randomized, sham‐controlled study in patients with mild to moderate hypertension who were taken off all antihypertensive medications.…”

Section: Introductionmentioning

confidence: 99%

“…9,10 Several major lessons were learned from these trials, such as the Hawthorne effect and unreliability of using office blood pressure measurements alone without 24 hours ambulatory blood pressure monitoring. 11 Taking these into account, along with improvements in design of the catheter to deliver more complete renal sympathetic denervation, the SPYRAL HTN OFF-MED study was conducted as a randomized, shamcontrolled study in patients with mild to moderate hypertension who were taken off all antihypertensive medications. The investigators showed a 5 (95% confidence interval 0.2-9.9) mm Hg drop in 24 hours ambulatory systolic blood pressure (SBP) and 4.4 (95% confidence interval 1.6-7.2) mm Hg drop in 24 hours ambulatory diastolic blood pressure (DBP).…”

mentioning

confidence: 99%