Pacemaker-based cardiac neuromodulation therapy lowers SBP, pulse pressure in patients with ISH

Adding BackBeat cardiac neuromodulation therapy™ (Backbeat CNT), a pacemaker-based treatment for hypertension, on top of medical therapy significantly reduces systolic blood pressure (SBP) and pulse pressure, without reducing diastolic blood pressure (DBP), compared with medical therapy alone in patients with isolated systolic hypertension (ISH), according to a study presented at TCT 2021.

“Ideal management of ISH involves reducing pulse pressure by reducing SBP without an effect on DBP; however, all medications reduce both SBP and DBP … [BackBeat CNT] is a bioelectronic therapy designed to immediately, substantially, and persistently lower BP while simultaneously providing ANS* modulation,” said lead author Dr Daniel Burkhoff from the Cardiovascular Research Foundation in New York, New York, US.

Using data from the MODERATO II** cohort, this study focused on 38 patients with ISH (defined as SBP >140 mm Hg and DBP <90 mm Hg; mean age 74 years) with indication for a pacemaker. The participants were randomized to BackBeat CNT plus continued medical therapy (treatment group; n=23) or continued medical therapy only (control group; n=15) for 6 months. To assess the long-term effects of CNT, the treatment group continued on therapy for 24 months. [TCT 2021, abstract TCT-3]

At 6 months of follow-up, patients who received BackBeat CNT had a significantly greater reduction in 24-hour ambulatory and office SBPs than those who received medical therapy only (mean SBP change, -9.5 vs -2.1 mm Hg; p=0.03 and -10.6 vs +1.4 mm Hg; p=0.04, respectively).

Of note, there was no change in DBP in patients on BackBeat CNT vs those on medical therapy only at 6 months (+0.1 vs -2.1 mm Hg and +0.4 vs -0.9 mm Hg for 24-hour ambulatory and office DBPs, respectively). “This is an important factor when you’re treating patients with ISH, [as] you don’t want the DBP to go down because [it may increase the] risk of hypoperfusion of the coronary arteries,” said Burkhoff said.

A significant reduction in ambulatory and office pulse pressures—the difference between the SBP and DBP—was observed in the Backbeat CNT group vs the medical therapy only group at 6 months (-9.6 vs -0.2 mm Hg; p=0.01 and -11.0 vs +2.3 mm Hg; p<0.01, respectively).

The reductions in office SBP and pulse pressure were sustained at 24 months among patients treated with Backbeat CNT (-15.8 and -13.9 mm Hg, respectively).

“[As we know that] ISH is a more challenging form of hypertension to treat, it is associated with increased risk of cardiovascular disease, stroke, and heart failure, … especially in older patients,” said Burkhoff. This study showed that patients on Backbeat CNT reported no major cardiac events at 6 months, while two events were reported among those on medical therapy only.

“Overall, this exploratory analysis of BackBeat CNT in patients with ISH and an indication for a pacemaker demonstrated improved outcomes, … [with] significant reduction[s] in SBP and DBP [that were sustained up to 24 months], Burkhoff said.

Further definitive studies of BackBeat CNT in patients with ISH are warranted to confirm this finding, Burkhoff added.

*ANS: Autonomic nervous system