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Pacemaker-Mediated Programmable Hypertension Control Therapy.

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: NCT02282033.

SUBMITTER: Neuzil P

PROVIDER: S-EPMC5779015 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Pacemaker-Mediated Programmable Hypertension Control Therapy.

Neuzil Petr P Merkely Béla B Erglis Andrejs A Marinskis Germanas G de Groot Joris R JR Schmidinger Herwig H Rodriguez Venegas Manuel M Voskuil Michiel M Sturmberger Thomas T Petru Jan J Jongejan Niels N Aichinger Josef J Kamzola Ginta G Aidietis Audrius A Gellér Laszlo L Mraz Tomas T Osztheimer Istvan I Mika Yuval Y Evans Steven S Burkhoff Daniel D Kuck Karl-Heinz KH

Journal of the American Heart Association 20171223 12

<h4>Background</h4>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.<h4>Methods and results</h4>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 ge ...[more]

PMID: 29275370

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Project description:Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (P=0.012). There were no Moderato device- or CNT-related adverse events. Conclusions CNT significantly reduced 24-hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02837445.

Project description:RATIONALE:Cardiac pacing is a critical technology for the treatment of arrhythmia and heart failure. The impact of specific pacing strategies on myocardial function is an area of intense research and high clinical significance. Mouse models have proven extremely useful for probing mechanisms of heart disease, but there is currently no reliable technology for long-term pacing in the mouse. OBJECTIVE:We sought to develop a device for long-term pacing studies in mice. We evaluated the device for (1) treating third-degree atrioventricular block after macrophage depletion, (2) ventricular pacing-induced cardiomyopathy, and (3) high-rate atrial pacing. METHODS AND RESULTS:We developed a mouse pacemaker by refashioning a 26 mm×6.7 mm clinical device powered by a miniaturized, highly efficient battery. The electrode was fitted with a single flexible lead, and custom software extended the pacing rate to up to 1200 bpm. The wirelessly programmable device was implanted in the dorsal subcutaneous space of 39 mice. The tunneled lead was passed through a left thoracotomy incision and attached to the epicardial surface of the apex (for ventricular pacing) or the left atrium (for atrial pacing). Mice tolerated the implantation and both long-term atrial and ventricular pacing over weeks. We then validated the pacemaker's suitability for the treatment of atrioventricular block after macrophage depletion in Cd11b DTR mice. Ventricular pacing increased the heart rate from 313±59 to 550 bpm ( P<0.05). In addition, we characterized tachypacing-induced cardiomyopathy in mice. Four weeks of ventricular pacing resulted in reduced left ventricular function, fibrosis, and an increased number of cardiac leukocytes and endothelial activation. Finally, we demonstrated the feasibility of chronic atrial pacing at 1200 bpm. CONCLUSIONS:Long-term pacing with a fully implantable, programmable, and battery-powered device enables previously impossible investigations of arrhythmia and heart failure in the mouse.

Project description:PURPOSE OF REVIEW:To give an overview on recent developments in permanent implant-based therapy of resistant hypertension. RECENT FINDINGS:The American Heart Association (AHA) recently updated their guidelines to treat high blood pressure (BP). As elevated BP now is defined as a systolic BP above 120 mmHg, the prevalence of hypertension in the USA has increased from 32% (old definition of hypertension) to 46%. In the past years, device- and implant-mediated therapies have evolved and extensively studied in various patient populations. Despite an initial drawback in a randomized controlled trial (RCT) of bilateral carotid sinus stimulation (CSS), new and less invasive and unilateral systems for baroreflex activation therapy (BAT) with the BAROSTIM NEO® have been developed which show promising results in small non-randomized controlled (RCT) studies. Selective vagal nerve stimulation (VNS) has been successfully evaluated in rodents, but has not yet been tested in humans. A new endovascular approach to reshape the carotid sinus to lower BP (MobiusHD™) has been introduced (baroreflex amplification therapy) with favorable results in non-RCT trials. However, long-term results are not yet available for this treatment option. A specific subgroup of patients, those with indication for a 2-chamber cardiac pacemaker, may benefit from a new stimulation paradigm which reduces the AV latency and therefore limits the filling time of the left ventricle. The most invasive approach for resistant hypertension still is the neuromodulation by deep brain stimulation (DBS), which has been shown to significantly lower BP in single cases. Implant-mediated therapy remains a promising approach for the treatment of resistant hypertension. Due to their invasiveness, such treatment options must prove superiority over conventional therapies with regard to safety and efficacy before they can be generally offered to a wider patient population. Overall, BAROSTIM NEO® and MobiusHD™, for which large RCTs will soon be available, are likely to meet those criteria and may represent the first implant-mediated therapeutical options for hypertension, while the use of DBS probably will be reserved for individual cases. The utility of VNS awaits appropriate assessment.

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Pacemaker-Mediated Programmable Hypertension Control Therapy.

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Pacemaker-Mediated Programmable Hypertension Control Therapy.

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