William Harvey’s treatise detailed the relationship between heart rate and blood pressure, ca. 1628.
4 Centuries Ago
2019 | BaroPace™ is Established
BaroPace™ technology is the key to the next generation of cardiac pacing. Using BaroPace’s revolutionary patent-pending algorithm PressurePace™, all dual chamber pacemakers and dual chamber cardio-defibrillators can be regulated in real-time in response to blood pressure.
Why is this important?
- A more physiologic pacemaker-mediated heart rate response at rest and with exercise for all patients with pacemakers.
- A new treatment option for Drug Resistant Hypertension and the most common form of Heart Failure.
What is Drug Resistant Hypertension (DRH)?
- More than 40% of patients with High Blood Pressure are resistant to treatment (Drug Resistant Hypertension, DRH) an estimated 3.5 million adults in the U.S. and 870 million worldwide, at an annual cost of $17.9 billion in the U.S. beyond the cost associated with nonresistant hypertension. Besides an increased incidence of heart attack, stroke, and death, DRH often results in Heart Failure due to excessive thickening of heart muscle (so-called Diastolic Heart Failure).
- Dramatically increases the risk of heart attack, stroke, kidney failure, and death.
- One half-trillion dollars of annual worldwide healthcare cost.
- No drug or device therapies have been shown to be safe and effective.
What is Diastolic Heart Failure, also known as Heart Failure with Preserved Ejection Fraction (HFpEF)?
HFpEF is the most common type of Heart Failure. It occurs when heart muscle becomes excessively thickened and stiff preventing the heart from adequately filling and pumping blood. DRH is by far the most common cause. There are currently no proven therapies, either pharmacologic or device-based that prevent or improve DHF.
- Six million U.S. cases
- Five hundred thousand new U.S. cases annually
- Twenty-three million cases worldwide
- $30 billion in U.S. healthcare costs in 2017, projected $50 billion by 2030.
BaroPace™ was formed and additional world-class clinicians and scientists joined as scientific advisors, including Kenneth Ellengbogen, MD, author of the definitive book on cardiac pacemakers, and Uri El Kayam MD, an international expert in Heart Failure. The clinical data was presented May 2019 at a prestigious international meeting (Heart Rhythm Society) and published. A few months later, the world’s largest medical device company became an R&D partner assisting in further development and feasibility testing which will lead to human clinical trials.
A fully functioning engineering prototype of the the PressurePace™ system was completed in 2020 wirelessly linking a wearable blood pressure measuring device, the PressurePace™ App in an Android phone and a dual chamber pacemaker. The Chairside I, v1 prospective clinical trial demonstrating the BaroPace effect was completed later in 2020.
Design and programming of more advanced versions of PressurePace™ (PressurePace v2 and PressurePace AI) began in 2021. Two prospective trials received institutional Review Board (IRB) approval in May 2021, including Chairside I, v3, and Treadmill I. Chairside I, v3 expands on the findings of Chairside I, v1 by enrolling patients with Drug Resistant Hypertension and by increasing the treatment options of the PressurePace™ treatment algorithm. Treadmill I is a prospective crossover exercise study with each subject serving as his/her own control in patients with HFpEF and dual chamber pacemakers comparing the effect of a PressurePace™ simulation on exercise tolerance and blood pressure control. Enrollment began June 2021. The retrospective study performed by Nguyen et al was accepted for an oral abstract presentation at HRS, July 2021 in Boston.