Hypertension is elevated blood pressure that increases risk of major cardiac events

In November 2017, the American College of Cardiology and American Heart Association published new guidelines changing the classification of various blood pressure (BP) levels. What had been considered “prehypertension” according to the Seventh Joint National Committee (JNC 7) is now split into an “elevated BP” category for patients with systolic 120 to 129 mm Hg and diastolic less than 80 mm Hg and stage 1 hypertension for patients with systolic 130 to 139 mm Hg or diastolic 80 to 89 mm Hg. Stage 2 hypertension now encompasses patients with a systolic BP of at least 140 mm Hg or a diastolic BP of at least 90 mm Hg.

Based on the ACC/AHA reclassification, nearly half of all US adults (45.6% or over 103 million adults) are now deemed to have hypertension, up from 31.9% under prior guidelines. Importantly, 77% of US adults over age 65, the age group most likely to need pacemakers, now have hypertension according to the new guidelines. Further, the guidelines also recommend that a substantial proportion of US adults taking antihypertensive medication undergo a more intensive BP lowering treatment.1

Non-adherence to antihypertensive treatment is a critical contributor to suboptimal blood pressure control and another important risk factor for adverse cardiovascular disease outcomes. An estimated 45% of HTN are non-adherent to medications.2 Thus, many medically responsive patients have high pressure simply because they do not take their medications and medication non-compliance is one of biggest challenges of HTN treatment. In addition, since HTN patients are typically older, they are more likely to be prescribed multiple medications for HTN and other medical conditions: polypharmacy (multiple medications) has been shown to be associated with increased risk of adverse event (fall injury, heart failure, etc.), polypharmacy mismanagement, and drug-drug interactions. Because of the factors mentioned, there is a significant need for alternative therapies to treat hypertension, particularly, device based therapies.

Furthemore, based on the new ACC/AHA guidelines, it is estimated that nearly 80% of the patients that are indicated for the implant of a pacemaker have hypertension. The main reason may be attributed to the average age of the pacemaker patient population being 73 years old and the dramatic increase in the prevalence of hypertension in people over 60 years old. Hypertension is uncontrolled in more than 50% of these people resulting in nearly 40% of all people indicated for a pacemaker having uncontrolled hypertension.

Orchestra BioMed’s BackBeat® Cardiac Neuromodulation Therapy is designed to chronically and substantially lower blood pressure and may offer an important new treatment for the more than 70% of pacemaker patients with high blood pressure and for severe hypertension patients for whom medical therapy has not been effective.

1 “Potential U.S. Population Impact of the 2017 American College of Cardiology/American Heart Association High Blood Pressure Guideline”, Paul Muntner, Robert M. Carey, Samuel Gidding, Daniel W. Jones, Sandra J. Taler, Jackson T. Wright Jr. and Paul K. Whelton, Journal of the American College of Cardiology, November 2017DOI: 10.1016/j.jacc.2017.10.073.
2 Nonadherence to antihypertensive drugs: A systematic review and meta-analysis, Tadesse Melaku Abegaz, MS, Abdulla Shehab, PhD, Eyob Alemayehu Gebreyohannes, MS, Akshaya Srikanth Bhagavathula, PharmD, and Asim Ahmed Elnour, PhD.

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