Durable strong efficacy and favorable long-term renal safety of the anatomically optimized distal renal denervation according to the 3 year follow-up extension of the double-blind randomized controlled trial

Stanislav Pekarskiy,Andrei Baev,Alla Falkovskaya,Valeria Lichikaki,Ekaterina Sitkova,Irina Zubanova,Musheg Manukyan,Mikhail Tarasov,Viktor Mordovin,Sergei Popov

doi:10.1016/j.heliyon.2022.e08747

Stanislav Pekarskiy, Andrei Baev + Show 8 more

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https://doi.org/10.1016/j.heliyon.2022.e08747

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Journal: Heliyon	Publication Date: Jan 1, 2022
Citations: 2	License type: cc-by

Affiliation: Tomsk National Research Medical Center

Abstract

BackgroundHistorical reports on surgical renal denervation consistently describe renal plexus as a triangle or fan-like structure converging at the kidney gate. Following that anatomy, we developed a distal mode of radiofrequency renal denervation (RDN) mainly in segmental branches of the renal artery and confirmed its superior efficacy over the conventional main trunk procedure in a 6-months double-blind randomized controlled trial (NCT02667912). To assess the long-term effects of distal RDN we extended the follow-up of our study to three years. MethodsBP, serum creatinine, eGFR were measured one and three years after randomization; major adverse renal events were assessed over the entire study period. The blinding was maintained over the entire three-year study period. FindingsOf 55 randomized patients, 47 (23/24, distal/main trunk RDN, respectively) were assessed at one year and 39 (21/18) at three years post-procedure. Twenty-four-hour ambulatory systolic BP remained powerfully lowered after distal RDN both at one- and three-years assessments(mean change from baseline: -18.0, 95% CI -27.6 to -8.5; p<0.05 and -16·9, 95% CI -27·3 to -6·5; p<0·05, mmHg, respectively. This was accompanied by a moderate drop in eGFR at one year: -8·9 ml/min/m2, 95% CI -14·8 to -3·1; p<0·05, which, however, subsequently decreased in size at three years: -6·5, 95% CI -13·2 to 0·3; p>0·05. After main trunk RDN, the decrease of 24h systolic BP was quite moderate at one year: -12·1, 95% CI -19·2 to -5·0; p<0·05, and further weakened at three-year assessment: -8·5, 95% CI -19·7 to 2·2; p>0.05. eGFR was almost unchanged at one year: -1·3, 95% CI -6·6 to 4·0; p>0·05, but significantly decreased at three years: -5·0, 95% CI -9·6 to -0·3; p<0·05. InterpretationOur data demonstrate the durable strong BP-lowering efficacy and favorable long-term renal safety of distal RDN.

Highlights

Transcatheter therapies are a completely new treatment paradigm
We developed a distal mode of renal denervation (RDN) in segmental branches of the renal artery (Figure 1) and assessed the efficacy and safety of our distal RDN in comparison with the conventional main trunk RDN in a 6-month double-blind randomized controlled trial
From one to three-year eGFR slightly increased in this group despite the continuing strong blood pressure (BP) lowering signaling some relative improvement in renal function during the late study period

Summary

Introduction

Transcatheter therapies are a completely new treatment paradigm. Instead of reaching the disease sites through traumatic surgical incisions or nonselective dissolution of drugs in the human body, transcatheter interventions deliver treatments through a lumen of the circulatory system, a framework of elastic tubes penetrating every part of the human body. To assess the long-term effects of distal RDN we extended the follow-up of our study to three years. Twenty-four-hour ambulatory systolic BP remained powerfully lowered after distal RDN both at one- and three-years assessments(mean change from baseline: -18.0, 95% CI -27.6 to -8.5; p

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