• Media type: E-Article
  • Title: Pacemaker‐Mediated Programmable Hypertension Control Therapy
  • Contributor: Neuzil, Petr; Merkely, Béla; Erglis, Andrejs; Marinskis, Germanas; de Groot, Joris R.; Schmidinger, Herwig; Rodriguez Venegas, Manuel; Voskuil, Michiel; Sturmberger, Thomas; Petru, Jan; Jongejan, Niels; Aichinger, Josef; Kamzola, Ginta; Aidietis, Audrius; Gellér, Laszlo; Mraz, Tomas; Osztheimer, Istvan; Mika, Yuval; Evans, Steven; Burkhoff, Daniel; Kuck, Karl‐Heinz; Simon, Jaroslav; Dujka, Libor; Machalek, Libor; [...]
  • imprint: Ovid Technologies (Wolters Kluwer Health), 2017
  • Published in: Journal of the American Heart Association, 6 (2017) 12
  • Language: English
  • DOI: 10.1161/jaha.117.006974
  • ISSN: 2047-9980
  • Keywords: Cardiology and Cardiovascular Medicine
  • Origination:
  • Footnote:
  • Description: <jats:sec xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en"> Many patients requiring a pacemaker have persistent hypertension with systolic blood pressures above recommended levels. We evaluated a pacemaker‐based Programmable Hypertension Control ( <jats:styled-content style="fixed-case">PHC</jats:styled-content> ) therapy that uses a sequence of variably timed shorter and longer atrioventricular intervals. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> Patients indicated for dual‐chamber pacing with office systolic blood pressure ( <jats:styled-content style="fixed-case">oSBP</jats:styled-content> ) &gt;150 mm Hg despite stable medical therapy were implanted with a Moderato™ pulse generator that delivers <jats:styled-content style="fixed-case">PHC</jats:styled-content> therapy. Patients were followed for 1 month (Run‐In period) with conventional pacing; those with persistent <jats:styled-content style="fixed-case">oSBP</jats:styled-content> &gt;140 mm Hg were included in the study and had <jats:styled-content style="fixed-case">PHC</jats:styled-content> therapy activated. The co‐primary efficacy end points were changes in 24‐hour ambulatory systolic blood pressure and <jats:styled-content style="fixed-case">oSBP</jats:styled-content> 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, <jats:styled-content style="fixed-case">oSBP</jats:styled-content> was &lt;140 mm Hg in 7 patients who were excluded. <jats:styled-content style="fixed-case">PHC</jats:styled-content> 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, <jats:styled-content style="fixed-case">oSBP</jats:styled-content> and 24‐hour ambulatory systolic blood pressure decreased by 8±13 and 5±12 mm Hg ( <jats:italic>P</jats:italic> &lt;0.002), respectively. Compared with pre‐ <jats:styled-content style="fixed-case">PHC</jats:styled-content> activation measurements, <jats:styled-content style="fixed-case">oSBP</jats:styled-content> decreased by another 16±15 mm Hg and 24‐hour ambulatory systolic blood pressure decreased by an additional 10±13 mm Hg (both <jats:italic>P</jats:italic> &lt;0.01) at 3 months. No device‐related serious adverse effects were noted. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en"> In pacemaker patients with persistent hypertension despite medical therapy, <jats:styled-content style="fixed-case">oSBP</jats:styled-content> and 24‐hour ambulatory systolic blood pressure are decreased by <jats:styled-content style="fixed-case">PHC</jats:styled-content> therapy. Initial indications are that this therapy is a safe and promising therapy for such patients. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Clinical Trial Registration</jats:title> <jats:p xml:lang="en"> <jats:styled-content style="fixed-case">URL</jats:styled-content> : <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: <jats:styled-content style="fixed-case">NCT</jats:styled-content> 02282033. </jats:p> </jats:sec>
  • Access State: Open Access