Can This Pacemaker Overcome Stubborn Hypertension?
Atrioventricular interval modulation (AVIM) therapy, a pacing algorithm incorporated into dual-chamber pacemakers, is being tested in patients with uncontrolled hypertension and a need for a pacemaker. Ongoing research could lead to a widened indication in patients who have uncontrolled blood pressure but do not need cardiac pacing, according to the developers of the technology.
In April, the US FDA granted a Breakthrough Device Designation to Orchestra BioMed for its AVIM device, called BackBeat. According to the company, more than 7.7 million Americans meet the agency's criteria for this designation, having uncontrolled hypertension, preserved left ventricular systolic function, and a 10-year risk for atherosclerotic cardiovascular disease.
David Hochman, the CEO of Orchestra BioMed, the company that created AVIM therapy, said a benefit of the technology is that it doesn't require patient adherence to medication. 'With hypertension, patients don't really necessarily feel symptoms, but they need to take medication to reduce the risk of high blood pressure, and they do feel side effects from the medicine.'
Orchestra BioMed is collaborating with Medtronic on the BACKBEAT study, a randomized, double-blinded trial aiming to enroll approximately 500 patients.
The MODERATO II study, on which the FDA designation was based, found patients who used the device experienced an 11.1 mm Hg ( P < .001) reduction in mean 24-hour ambulatory systolic blood pressure at 6 months, a 8.1 mm Hg greater than those managed only with antihypertensive medications.
Older patients with isolated systolic hypertension are particularly challenging to manage. They 'are at higher risk of heart failure because of higher pulse pressure against a stiffer ventricle and stiffer blood vessels,' and they also are more challenging to treat,' Hochman said. 'It's a population with more unmet need and less dedicated research,' he added.
Christopher DeSimone, MD, a cardiologist and electrophysiologist at Mayo Clinic in Rochester, Minnesota, said a nonpharmacologic option for uncontrolled hypertension is appealing because 'patients may have issues with compliance issues, polypharmacy and drug-drug interactions and face rising drug costs and fixed incomes.'
However, he said he would like to see data showing this benefit is sustained in longer follow-up of 6-12 months. The 11 mg Hg reduction in systolic blood pressure seen in the MODERATO II trial is 'significant, and would play a big role for a lot of our patients.' A 2016 meta-analysis found every 10 mm Hg reduction in systolic blood pressure reduced the risk for major cardiovascular disease events by 20% and led to a 13% reduction in all-cause mortality.
In those with pacemakers already, DeSimone said, 'the added risk of running the algorithm is essentially nothing. The patient would only stand to benefit and if not — the algorithm can be turned off.'
But the implantation of a new pacing device for treating hypertension alone, he added, 'there are risks associated with the procedure, as well as infection risks given these reside in the bloodstream and can serve as a nidus for infection.'
James Brian Byrd, MD, assistant professor at the University of Michigan, Ann Arbor, Michigan, and a cardiologist who researches and treats hypertension, said reducing blood pressure is 'really, really important from the perspective of public health and avoiding strokes and early deaths from heart attacks.'
But he questioned whether the financial incentives of implanting a device could outweigh the incentives of adding on inexpensive medications. 'We have really well established and effective treatments that are inexpensive, that aren't used enough, and don't have champions necessarily for them,' Byrd said, referencing later-line hypertension therapies like spironolactone, amiloride, guanfacine, and eplerenone.
Spironolactone, for example, is a generic drug that does not receive industry promotion, and while it can be effective in treating isolated systolic hypertension in particular, use of the m edication is associated with hyperkalemia. He worried that physicians could be financially incentivized to implant a device that does not require long-term follow-up 'as opposed to giving people medication where you have to check periodically to see whether their potassium is too high.'
DeSimone agreed hypertension therapy falls short in many patients. 'It is quite difficult for the patient's family doctor to add on yet another therapy that takes time and resources to monitor in a situation that is already overwhelmed,' he said. As a result, the overwhelming majority of hypertension patients 'are not optimized, so they're not taking all of the therapies they could take or they've not been prescribed the right doses.'
Hochman said that concerns that pacemakers would be overused for blood pressure are premature. Orchestra Med would need to 'produce very compelling data that satisfies regulators and ultimately satisfies the clinical community' before the pacemakers could be used to treat blood pressure alone, he explained.
He added that pacemakers have become safer, with the advent of conduction system pacing. Pacemakers are also becoming easier to implant with the move toward leadless devices which are implanted fully in the heart and have a small footprint.
DeSimone said the two other approved medical devices to treat blood pressure, baroreflex activation therapy and renal denervation, have had limited effectiveness and uptake. With AVIM technology 'by altering the physiology of the heart and the autonomic nervous system together, this device would fill a need that is currently lacking.'
Hochman is the CEO of Orchestra BioMed, the company that created the AVIM pacemaker technology. Byrd has served on advisory boards for companies developing medications for hypertension. DeSimone reported having no relevant financial conflicts of interest.
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