BACKGROUND: Many patients requiring a pacemaker have persistent hypertension with systolic blood pressures above recommended levels. We evaluated a pacemaker-based Programmable Hypertension Control (PHC) therapy that uses a sequence of variably timed shorter and longer atrioventricular intervals. METHODS AND RESULTS: Patients indicated for dual-chamber pacing with office systolic blood pressure (oSBP) >150 mm Hg despite stable medical therapy were implanted with a Moderato pulse generator that delivers PHC therapy. Patients were followed for 1 month (Run-In period) with conventional pacing; those with persistent oSBP >140 mm Hg were included in the study and had PHC therapy activated. The co-primary efficacy end points were changes in 24-hour ambulatory systolic blood pressure and oSBP between baseline and 3 months. Safety was assessed by tracking adverse events. Thirty-five patients met the initial inclusion criteria and underwent Moderato implantation. At 1 month, oSBP was <140 mm Hg in 7 patients who were excluded. PHC was activated in the remaining 27 patients with baseline office blood pressure 166+/-11/80+/-10 mm Hg despite an average of 3.2 antihypertensive medications. During the Run-In period, oSBP and 24-hour ambulatory systolic blood pressure decreased by 8+/-13 and 5+/-12 mm Hg (P<0.002), respectively. Compared with pre-PHC activation measurements, oSBP decreased by another 16+/-15 mm Hg and 24-hour ambulatory systolic blood pressure decreased by an additional 10+/-13 mm Hg (both P<0.01) at 3 months. No device-related serious adverse effects were noted. CONCLUSIONS: In pacemaker patients with persistent hypertension despite medical therapy, oSBP and 24-hour ambulatory systolic blood pressure are decreased by PHC therapy. Initial indications are that this therapy is a safe and promising therapy for such patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02282033.
Pacemaker-Mediated Programmable Hypertension Control Therapy
P Neuzil, B Merkely, A Erglis, G Marinskis, JR de Groot, H Schmidinger, M Rodriguez Venegas, M Voskuil, T Sturmberger, J Petru, N Jongejan, J Aichinger, G Kamzola, A Aidietis, L Geller, T Mraz, I Osztheimer, Y Mika, S Evans, D Burkhoff, and KH Kuck
J Am Heart Assoc 2017;6