Pacemaker-Mediated Programmable Hypertension Control Therapy.

Area of Science:

• Cardiology
• Medical Devices
• Hypertension Management

Background:

• Persistent hypertension is common in patients requiring pacemakers.
• Existing medical therapies may not adequately control blood pressure in these individuals.

Purpose of the Study:

• To evaluate the efficacy and safety of a pacemaker-based Programmable Hypertension Control (PHC) therapy.
• To assess the impact of PHC therapy on office systolic blood pressure (oSBP) and 24-hour ambulatory systolic blood pressure.

Main Methods:

• Patients with hypertension indicated for dual-chamber pacing received a Moderato™ pulse generator delivering PHC therapy.
• A 1-month run-in period with conventional pacing was followed by PHC therapy activation for eligible patients.
• Co-primary endpoints included changes in oSBP and 24-hour ambulatory systolic blood pressure at 3 months post-activation.

Main Results:

• PHC therapy was activated in 27 patients with baseline oSBP of 166±11/80±10 mmHg, 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 mmHg and 5±12 mmHg, respectively (P<0.002).
• Following PHC activation, oSBP decreased by an additional 16±15 mmHg and 24-hour ambulatory systolic blood pressure by 10±13 mmHg at 3 months (P<0.01).

Conclusions:

• Pacemaker-based PHC therapy significantly reduces both office and ambulatory systolic blood pressure in hypertensive patients.
• The therapy demonstrated a favorable safety profile with no device-related serious adverse events.
• PHC therapy represents a promising new treatment option for pacemaker patients with persistent hypertension.