Year: 2017
Type: article
Study design: Clinical Trial
Abstract: 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.
Authors: Petr Neuzil, Béla Merkely, Andrejs Erglis, Germanas Marinskis, Joris R. de Groot, Herwig Schmidinger, Manuel Rodriguez Venegas, Michiel Voskuil, Thomas Sturmberger, Jan Petru, Niels Jongejan, Josef Aichinger, Ginta Kamzola, Audrius Aidietis, Laszlo Gellér, Tomas Mraz, Istvan Osztheimer, Yuval Mika, Steven Evans, Daniel Burkhoff, Karl‐Heinz Kuck, Jaroslav Simon, Libor Dujka, Libor Machalek, Ákos Király, Levente Molnár, Attila Kovács, Marianna Szabó, Kaspars Kupics, Ieva Ansaberga, Janis Ansabergs, Nikolajs Nesterovics, Jurate Barysiene, Marc van Cruijsen, Mindel M. Schellevis, Thomas Pezawas, Emilio Flores, Demian Fullerton, Martine M.A. Beeftink, Matthias Meine, Deborah D. Ascheim, Jose Dizon, Samuel Hanon, Harold Hastings
Institutions: Na Homolce Hospital, Semmelweis University, Pauls Stradiņš Clinical University Hospital, Vilnius University Hospital Santariskiu Klinikos, Amsterdam UMC Location University of Amsterdam, Sigmund Freud Privatuniversität Wien, University of Vienna, Medical University of Vienna, Complejo Asistencial Sótero del Río, University Medical Center Utrecht, Krankenhaus der Elisabethinen, BackBeat Medical Inc. (United States), Cardiovascular Research Foundation, Asklepios Klinik St. Georg
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,810
OpenAlex ID: W2775950094