Twenty-Four-Hour Pulsatile Hemodynamics Predict Brachial Blood Pressure Response to Renal Denervation in the SPYRAL HTN-OFF MED Trial

Abstract

Background: Renal denervation (RDN) lowers blood pressure (BP), but BP response is variable in individual patients. We investigated whether measures of pulsatile hemodynamics, obtained during 24-hour ambulatory BP monitoring, predict BP drop following RDN. Methods: From the randomized, sham-controlled SPYRAL HTN-OFF MED Pivotal trial, we performed a post hoc analysis of BP waveforms from 111 RDN patients and 111 sham controls, obtained with a brachial cuff-based sphygmomanometer. Waveforms were acquired during ambulatory BP monitoring at diastolic BP level and processed with validated ARCSolver algorithms to derive hemodynamic parameters (augmentation index; augmentation pressure; backward and forward wave amplitude; estimated aortic pulse wave velocity). We investigated the relationship between averaged 24-hour values at baseline and the change in 24-hour BP at 3 months in RDN patients, corrected for observed trends in the sham group. Results: There was a consistent inverse relationship between baseline augmentation index/augmentation pressure/backward wave amplitude/forward wave amplitude/estimated aortic pulse wave velocity and BP response to RDN: the decrease in 24-hour systolic BP/diastolic BP was 7.8/5.9 (augmentation index), 8.0/6.3 (augmentation pressure), 6.7/5.4 (backward wave amplitude), 5.7/4.7 (forward wave amplitude), and 7.8/5.2 (estimated aortic pulse wave velocity) mm Hg greater for patients below versus above the respective median value ( P <0.001 for all comparisons, respectively). Taking augmentation index/augmentation pressure/backward wave amplitude/forward wave amplitude/estimated aortic pulse wave velocity into account, a favorable BP response following RDN, defined as a drop in 24-hour systolic blood pressure of ≥5 mm Hg, could be predicted with an area under the curve of 0.70/0.74/0.70/0.65/0.62 ( P <0.001 for all, respectively). Conclusions: These results suggest that pulsatile hemodynamics, obtained during 24-hour ambulatory BP monitoring, may predict BP response to RDN.

Predicting Renal Denervation Response in Resistant High Blood Pressure by Arterial Stiffness Assessment: A Systematic Review

“…The majority of included studies had an observational design [ 16 , 23 , 24 , 25 , 26 , 27 , 29 , 30 ], while only two studies were performed as secondary analyses from randomized clinical trials [ 28 , 31 ].…”

“…Definitions of variables and methods used were different across studies. Of the included studies, five measured arterial stiffness exclusively by non-invasive methods: PWV, central pulse pressure, ambulatory arterial stiffness index (AASI), and magnetic resonance-derived parameters [ 23 , 28 , 29 , 30 , 31 ]. Definition of blood pressure response to RDN also varied in clinical studies; some used a 5 mmHg cut-off [ 16 , 24 , 25 , 26 ], while the others used a 10 mmHg cut-off or 5% decrease to delineate between responders and non-responders [ 29 , 30 ].…”

“…Data on non-invasive PWV measurement were available from three studies [ 16 , 28 , 31 ]. Moreover, five reported data on invasive PWV assessment [ 16 , 24 , 25 , 26 ].…”

“…Moreover, five reported data on invasive PWV assessment [ 16 , 24 , 25 , 26 ]. Non-invasive PWV was measured using magnetic resonance imaging only in one study [ 16 ], while the other two investigated classic non-invasive PWV [ 28 , 31 ].…”

“…In one of the two studies investigating classic non-invasive PWV, the authors reported that estimated PWV from ambulatory blood pressure monitoring was independently associated with blood pressure response at multivariate analysis (OR 0.031, 95% CI, 0.006–0.167, p < 0.0001) [ 31 ]. Although estimated PWV was independently associated with RDN response, the proportion of responders stratified according to PWV values was not reported.…”