Article
作者: van Cruijsen, Marc ; Dizon, Jose ; Fullerton, Demian ; Molnár, Levente ; Schmidinger, Herwig ; Dujka, Libor ; Király, Ákos ; Beeftink, Martine M.A. ; Kamzola, Ginta ; Schellevis, Mindel M. ; Neuzil, Petr ; Barysiene, Jurate ; Marinskis, Germanas ; Rodriguez Venegas, Manuel ; Kovács, Attila ; Flores, Emilio ; Ascheim, Deborah D. ; Simon, Jaroslav ; Hanon, Samuel ; Ansabergs, Janis ; de Groot, Joris R. ; Aichinger, Josef ; Hastings, Harold ; Ansaberga, Ieva ; Nesterovics, Nikolajs ; Mraz, Tomas ; Gellér, Laszlo ; Szabó, Marianna ; Machalek, Libor ; Aidietis, Audrius ; Mika, Yuval ; Meine, Matthias ; Evans, Steven ; Erglis, Andrejs ; Osztheimer, Istvan ; Kuck, Karl‐Heinz ; Petru, Jan ; Pezawas, Thomas ; Sturmberger, Thomas ; Voskuil, Michiel ; Merkely, Béla ; Burkhoff, Daniel ; Jongejan, Niels ; Kupics, Kaspars
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:
NCT
02282033.