Cardiovascular Implantable Electronic Devices -> Bradycardia Devices: -> Clinical Trials D-AB04 - Innovations, Nuances and Critical Questions in CIED Management Therapies (ID 33) Abstract

D-AB04-02 - Safety And Effectiveness Of Cardiac Neuromodulation Therapy (Backbeat-CNT) In Patients With Hypertension And An Indication For A Pacemaker: Results Of A Double-blind Randomized Trial (ID 1407)

Abstract

Background: More than 70% of patients implanted with a pacemaker have hypertension (HTN) and many remain uncontrolled despite medical therapy. Pacemaker-based cardiac neuromodulation therapy (Backbeat-CNT) involves AV pacing with a sequence of alternating short and long AV delays that immediately lower systolic blood pressure (SBP) by reducing ventricular filling (preload) and modulating baroceptor responses to reduced pressure, preventing sympathetic activation and resulting in sustained reductions of SBP. In unblinded studies, Backbeat-CNT delivered by the Moderato device (Orchestra Biomed) reduced 24-hour ambulatory SBP (aSBP) by >10 mmHg at 3-month and office SBP (oSBP) by >15 mmHg at 2-years.
Objective: Evaluate safety and efficacy of CNT in a randomized blinded study.
Methods: Patients were eligible if indicated for a pacemaker, if daytime aSBP was ≥130 mmHg and oSBP was ≥140 mmHg despite ≥1 anti-HTN medication for >6 weeks. Major exclusion criteria included permanent atrial fibrillation, LVEF <50%, NYHA ≥II symptoms. Eligible patients underwent Moderato implant. The device was programed as a standard pacemaker for a 1 month “run-in” period. Patients with daytime aSBP >125 mmHg at the end of this period continued to the randomized study phase. Patients were randomized to treatment (CNT-ON) or control (CNT-OFF); both groups continued on medical therapy. Patients and caregivers were blinded to group. The primary endpoint was the between group difference aSBP at 6 months.
Results: Of 68 enrolled patients, 47 met the criteria at the end of the run-in period and were randomized, 26 to treatment and 21 to control. Mean age was 74.0±8.7 years, 30 [64%] were male, LVEF was 59.2±5.7%, oSBP was 163.1±14.6, aSBP was 143.5±10.9 mmHg, on 3.3±1.5 anti-HTN medications; 81% had Isolated systolic hypertension (ISH). At 6 months, aSBP decreased in CNT-ON from 136.3 to 125.2 mmHg and in the CNT-OFF from 136.3 to 132.0 mmHg, a between groups difference of 8.1±3.0 mmHg (p=0.01). oSBP decreased by 12.3±5.4 mmHg more in CNT-ON than in CNT-OFF (p=0.02).
Conclusion: Patients treated with pacemaker-based CNT demonstrated a significant reduction in SBP compared to a control group after 6 months of therapy (including in ISH) in a double-blind randomized trial.

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