Abstracts e45

ORAL SECTION

2Department of Health Sciences, University of Leicester, Leicester, UNITED

Oral Presentations
KINGDOM, 3Department of Chemical Pathology and Metabolic Disease, Uni-
INTERVENTIONAL THERAPY AND versity Hospitals of Leicester NHS Trust, Leicester, UNITED KINGDOM, 4De-
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partment of Cardiovascular Sciences, University of Leicester, Leicester, UNITED

DEVICES KINGDOM, 5Leicester Diabetes Centre, Leicester General Hospital, Leicester,
hCywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/16/2024

UNITED KINGDOM, 6Department of Neuroscience, Psychology and Behaviour,

University of Leicester, Leicester, UNITED KINGDOM, 7Cardiovascular Diseases
Health Psychology Service, University Hospitals of Leicester NHS Trust, Leices-
ter, UNITED KINGDOM
CATHETER-BASED RENAL DENERVATION – LONG TERM
SAFETY AND BLOOD PRESSURE REDUCTION IN PATIENTS WITH Objective: Biofeedback is a mind-body intervention that uses a device to provide
RESISTANT HYPERTENSION feedback on physiological responses, such as heart rate variability. Through train-
ing and practice, participants can learn to exert an element of control over auto-
Markus Schlaich1, Jonathon Sesa-Ashton2, Rebecca Lee2, Elisabeth Lambert3, nomic responses. There is a wealth of research on biofeedback in a range of health
Gavin Lambert3, Janis Nolde1, Antony Walton2, Murray Esler2. 1Dobney Chair conditions, this review focuses on hypertension and diabetes.
in Clinical Research, Perth, AUSTRALIA, 2Baker Heart and Diabetes Institute,
Melbourne, AUSTRALIA, 3Swinburn University, Melbourne, AUSTRALIA Methods: The systematic review aimed to evaluate the effectiveness of bio-
feedback on systolic and diastolic blood pressure and psychological wellbeing
Objective: Recent sham-controlled andomised clinical trials have confirmed the
in patients with hypertension and/or diabetes. The review was preregistered on
safety and efficacy of catheter-based renal denervation (RDN) with clinically mean-
PROSPERO and followed the PICO search strategy. The following databases were
ingful blood pressure (BP) reductions in hypertensive patients on or off antihyperten-
searched: MEDLINE, PsycINFO, CINHAL, PubMed, Embase and Cochrane
sive medication. Longer-term safety and efficacy data have so far only been docu-
Central Register of Controlled Trials. Selection criteria included randomised con-
mented out to 3 years. Here we provide a first report on safety and efficacy outcomes
trol trials, diagnosis of hypertension/diabetes, inclusion of pre and post interven-
in a cohort of patients with resistant hypertension beyond 5 years of follow up.
tion measurements and recordings of blood pressure, Hba1c or blood glucose.
Design and method: We recruited patients with resistant hypertension who were
Results: A total of 1189 papers were retrieved, 32 papers met the inclusion cri-
previously enrolled in various RDN trials applying radiofrequency energy to ab-
teria. Sample sizes ranged from 10 to 301 with a total of 1425 participants, 48%
late the renal nerves using the Symplicity Flex system. All participants had base-
female and mean age 50.16 (±8.16) and 48.71 (±9.19) in experimental and control
line assessments prior to RDN and repeat assessment at current long term follow
group respectively. Of the 32 papers, 28 investigated hypertension and 4 papers
up including medical history, automated office and ambulatory BP measurement,
looked at diabetes. Of the 28 hypertension studies, 13 showed significant find-
and routine blood and urine tests.
ings in favour of biofeedback. The analysis excluded 11 papers due to incomplete
Results: A total of 60 participants (age: 70.0 ± 10.3 years (mean ± SD), 76.3% data. Biofeedback was significantly associated with reduced systolic blood pres-
male) have completed long-term follow up investigations with an average of 6.8 sure (-3.62 mmHg, [-6.33, -0.90], p value < 0.0001; Figure 1) and diastolic blood
(range 6–10) years post-procedure. Ambulatory systolic BP was reduced by 12.0 ± pressure (-4.15 mmHg, [-6.04, -2.26], p value < 0.0001). Biofeedback modalities
21.6mmHg (from 145.7mmHg to 132.8mmHg; p < 0.001) and diastolic BP by 8.3 ± included galvanic skin response, heart rate variability, thermal, electromyogra-
12.8mmHg (from 81.6 mmHg to 72.0 mmHg; p < 0.001). This BP reduction occurred phy, blood pressure and heart rate. Intervention length ranged from 10 days to
despite participants being on less antihypertensive medication with a reduction in the 4 months, and follow up ranged from 1 week to 12 months. Of the 4 diabetes
average defined daily dose, the assumed average maintenance dose per day for a drug papers, 2 showed significant findings in favour of biofeedback. A total of 7 papers
used for its main indication in adults, from 4.91 ± 0.37 to 4.02 ± 0.27 (p < 0.01). eGFR recorded psychological wellbeing measurements (i.e. depression and anxiety).
remained stable at long-term follow up with no statistically significant difference in However, only two reported incorporation of psychological/wellbeing targeted
participants with pre-existing CKD from baseline. intervention components.
Conclusions: Our investigation indicates a significant and robust reduction in Conclusions: The preliminary findings highlight the high heterogeneity between
ambulatory systolic and diastolic blood pressure, despite reduction in antihyper- existing trials in biofeedback modality, intervention length, follow up and details
tensive medications, in the long-term following catheter-based renal denervation reported. The results show biofeedback had a significant effect on systolic and
without evidence of adverse consequences on renal function. diastolic blood pressure. There is limited research on biofeedback and diabetes.
This systematic review will inform the protocol development of a biofeedback
THE EFFECT OF BIOFEEDBACK ON HYPERTENSION AND feasibility trial in patients with hypertension and anxiety. A key finding is the
DIABETES: PRELIMINARY RESULTS FROM A SYSTEMATIC REVIEW limited use of psychological wellbeing based intervention components, despite
study measurements and correlating hypotheses. This is an important element we
S. Jenkins1,2, P. Gupta3,4, K. Khunti1,5, A. Cross6,7. 1Diabetes Research Centre, Uni- will integrate within our biofeedback intervention.
versity of Leicester, Leicester General Hospital, Leicester, UNITED KINGDOM,

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