Baroreflex activation therapy

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Baroreflex activation therapy
Baroreflex activation.svg
Mechanism of baroreflex activation therapy
Specialty Cardiology

Baroreflex activation therapy is an approach to treating high blood pressure and the symptoms of heart failure. It uses an implanted device to electrically stimulate baroreceptors in the carotid sinus region. This elicits a reflex response through the sympathetic and vagal nervous systems that reduces blood pressure.

Contents

Medical uses

Baroreflex activation therapy is used to reduce the symptoms of heart failure in patients who do not qualify for cardiac resynchronization therapy. [1]

Adverse effects

In common with pacemakers, implantation of baroreflex activation therapy devices carries risks of bleeding, bruising and infection. [2]

The location of the electrode, on the carotid artery, carries a theoretical risk of disturbing plaque inside the carotid artery that in principle could cause a stroke, although protocols typically include scanning the artery for plaques beforehand, and such events appear not to have occurred in the systematic trials.[ citation needed ]

High stimulation voltages can cause an appreciable sensation which can be unpleasant. In typical use the device output voltage is adjusted to below the level that causes unpleasant sensations. [3]

Devices

Device development benefited from the related technology of pacemakers which have markedly reduced in size and increased in efficiency since their introduction in 1958. The falling cost of the fundamental technology that combines a long-lasting battery, stimulating electrode and a microcontroller in a single device, made it possible to create specialized devices to activate baroreceptors. Examples are the Rheos and the Barostim Neo systems. [4] In 2019, the FDA awarded the BAROSTIM NEO® a Breakthrough Device Designation [5] and approved the device for the treatment of heart failure. [6] It is currently available in Europe and the United States.

Procedure

The device is implanted into upper chest with the electrodes placed in the neck. [7] First, an incision is made in the neck to visualize the carotid bifurcation. The electrode is placed over the carotid artery and positioned where stimulating through it elicits a blood pressure reduction. The electrode is then sutured in place. The main part of the device (also called the pulse generator) is then placed in a pocket underneath the skin.

Adjustments of the stimulation pattern (size and frequency of pulses) are made using a device programmer which communicates with the implanted device through short-range radio signals. Stimulation is set at a level that reduces blood pressure but does not cause discomfort.

Mechanism

Baroreflex activation is distinct from vagal stimulation. [8] [9] Electrical stimulation of the external surfaces of the carotid sinus activates baroreceptors believed to be in the adventitia of the artery. This stimulates an afferent limb which activates central nervous system pathways that in turn exert two different but synergistic autonomic effects on the body. First, global sympathetic outflow is reduced and, second, vagal outflow is increased.

These two autonomic effector pathways reduce heart rate and vasomotor tone, leading to a reduction in blood pressure. Effects can be seen within a few seconds of initiation of stimulation, a feature which is used in the initial implant procedure to aid positioning of the electrode.

History

Despite modern medications against high blood pressure, only around half of people with hypertension in England, USA and Canada have blood pressure at or below target levels. [10]

In many cases the situation can be resolved with increases in antihypertensive medication. However in about 10% of patients, blood pressure is still above target (140/90mm Hg) despite at least 3 anti-hypertensives, a status known as resistant hypertension. [11]

Some patients prefer not to be prescribed progressively greater number of medications, because of side effects or the difficulty managing a complex medication regime. Despite the greater invasiveness, they may prefer the option of a device that can contribute to blood pressure control. Electrical stimulation of the carotid baroreceptor region is one such option to lower blood pressure. [12]

Related Research Articles

A transient ischemic attack (TIA), commonly known as a mini-stroke, is a minor stroke whose noticeable symptoms usually end in less than an hour. TIA causes the same symptoms associated with strokes, such as weakness or numbness on one side of the body, sudden dimming or loss of vision, difficulty speaking or understanding language, slurred speech, or confusion.

<span class="mw-page-title-main">Vagus nerve</span> Cranial nerve X, for visceral innervation

The vagus nerve, also known as the tenth cranial nerve, cranial nerve X, or simply CN X, is a cranial nerve that carries sensory fibers that create a pathway that interfaces with the parasympathetic control of the heart, lungs, and digestive tract. It comprises two nerves—the left and right vagus nerves—but they are typically referred to collectively as a single subsystem. The vagus is the longest nerve of the autonomic nervous system in the human body and comprises both sensory and motor fibers. The sensory fibers originate from neurons of the nodose ganglion, whereas the motor fibers come from neurons of the dorsal motor nucleus of the vagus and the nucleus ambiguus. The vagus was also historically called the pneumogastric nerve.

Baroreceptors are sensors located in the carotid sinus and in the aortic arch. They sense the blood pressure and relay the information to the brain, so that a proper blood pressure can be maintained.

Antihypertensives are a class of drugs that are used to treat hypertension. Antihypertensive therapy seeks to prevent the complications of high blood pressure, such as stroke, heart failure, kidney failure and myocardial infarction. Evidence suggests that reduction of the blood pressure by 5 mmHg can decrease the risk of stroke by 34% and of ischaemic heart disease by 21%, and can reduce the likelihood of dementia, heart failure, and mortality from cardiovascular disease. There are many classes of antihypertensives, which lower blood pressure by different means. Among the most important and most widely used medications are thiazide diuretics, calcium channel blockers, ACE inhibitors, angiotensin II receptor antagonists (ARBs), and beta blockers.

<span class="mw-page-title-main">Reflex syncope</span> Brief loss of consciousness due to a neurologically induced drop in blood pressure

Reflex syncope is a brief loss of consciousness due to a neurologically induced drop in blood pressure and/or a decrease in heart rate. Before an affected person passes out, there may be sweating, a decreased ability to see, or ringing in the ears. Occasionally, the person may twitch while unconscious. Complications of reflex syncope include injury due to a fall.

<span class="mw-page-title-main">Baroreflex</span> Homeostatic mechanism in the body

The baroreflex orbaroreceptor reflex is one of the body's homeostatic mechanisms that helps to maintain blood pressure at nearly constant levels. The baroreflex provides a rapid negative feedback loop in which an elevated blood pressure causes the heart rate to decrease. Decreased blood pressure decreases baroreflex activation and causes heart rate to increase and to restore blood pressure levels. Their function is to sense pressure changes by responding to change in the tension of the arterial wall The baroreflex can begin to act in less than the duration of a cardiac cycle and thus baroreflex adjustments are key factors in dealing with postural hypotension, the tendency for blood pressure to decrease on standing due to gravity.

<span class="mw-page-title-main">Cardiac catheterization</span> Insertion of a catheter into a chamber or vessel of the heart

Cardiac catheterization is the insertion of a catheter into a chamber or vessel of the heart. This is done both for diagnostic and interventional purposes.

<span class="mw-page-title-main">Carotid sinus</span> Dilated area near internal carotid artery above bifurcation

In human anatomy, the carotid sinus is a dilated area at the base of the internal carotid artery just superior to the bifurcation of the internal carotid and external carotid at the level of the superior border of thyroid cartilage. The carotid sinus extends from the bifurcation to the "true" internal carotid artery. The carotid sinus is sensitive to pressure changes in the arterial blood at this level. It is the major baroreception site in humans and most mammals.

<span class="mw-page-title-main">Renal artery stenosis</span> Medical condition

Renal artery stenosis (RAS) is the narrowing of one or both of the renal arteries, most often caused by atherosclerosis or fibromuscular dysplasia. This narrowing of the renal artery can impede blood flow to the target kidney, resulting in renovascular hypertension – a secondary type of high blood pressure. Possible complications of renal artery stenosis are chronic kidney disease and coronary artery disease.

<span class="mw-page-title-main">Vagus nerve stimulation</span> Medical treatment that involves delivering electrical impulses to the vagus nerve.

Vagus nerve stimulation (VNS) is a medical treatment that involves delivering electrical impulses to the vagus nerve. It is used as an add-on treatment for certain types of intractable epilepsy and treatment-resistant depression.

<span class="mw-page-title-main">Ventricular assist device</span> Medical device to assist or replace a heart

A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artificial cardiac pacemaker in that a VAD pumps blood, whereas a pacemaker delivers electrical impulses to the heart muscle. Some VADs are for short-term use, typically for patients recovering from myocardial infarction (heart attack) and for patients recovering from cardiac surgery; some are for long-term use (months to years to perpetuity), typically for patients with advanced heart failure.

The Bezold–Jarisch reflex involves a variety of cardiovascular and neurological processes which cause hypopnea, hypotension and bradycardia in response to noxious stimuli detected in the cardiac ventricles. The reflex is named after Albert von Bezold and Adolf Jarisch Junior. The significance of the discovery is that it was the first recognition of a chemical (non-mechanical) reflex.

The Nicoladoni–Branham sign is named after Carl Nicoladoni, who first noticed the phenomenon of the pulse slowing in a patient with right arm phlebarteriectasia when the brachialis artery proximal to it was compressed. In modern medicine, the sign is elicited when pressure is applied to an artery proximal to an arteriovenous fistula and said to be positive if the following occurs:

A vagal maneuver is an action used to stimulate the parasympathetic nervous system by activating the vagus nerve. The vagus nerve is the longest nerve of the autonomic nervous system and helps regulate many critical aspects of human physiology, including heart rate, blood pressure, sweating, and digestion through the release of acetylcholine. Common maneuvers that activate the vagus nerve include the Valsalva maneuver and carotid sinus massage, which can serve diagnostic or therapeutic functions.

<span class="mw-page-title-main">Pathophysiology of hypertension</span>

Pathophysiology is a study which explains the function of the body as it relates to diseases and conditions. The pathophysiology of hypertension is an area which attempts to explain mechanistically the causes of hypertension, which is a chronic disease characterized by elevation of blood pressure. Hypertension can be classified by cause as either essential or secondary. About 90–95% of hypertension is essential hypertension. Some authorities define essential hypertension as that which has no known explanation, while others define its cause as being due to overconsumption of sodium and underconsumption of potassium. Secondary hypertension indicates that the hypertension is a result of a specific underlying condition with a well-known mechanism, such as chronic kidney disease, narrowing of the aorta or kidney arteries, or endocrine disorders such as excess aldosterone, cortisol, or catecholamines. Persistent hypertension is a major risk factor for hypertensive heart disease, coronary artery disease, stroke, aortic aneurysm, peripheral artery disease, and chronic kidney disease.

Low pressure baroreceptors are baroreceptors that relay information derived from blood pressure within the autonomic nervous system. They are stimulated by stretching of the vessel wall. They are located in large systemic veins and in the walls of the atria of the heart, and pulmonary vasculature. Low pressure baroreceptors are also referred to as volume receptors and cardiopulmonary baroreceptors.

A choke-out is a hand-to-hand combat tactic involving the use of a chokehold to cause syncope, or temporary loss of consciousness, at which point the choke is released. Common chokeholds in grappling used to accomplish a choke-out include the rear naked choke, arm triangle, triangle choke, and the guillotine.

Renal sympathetic denervation (RSDN) is a minimally invasive, endovascular catheter based procedure using radiofrequency ablation or ultrasound ablation aimed at treating resistant hypertension. Nerves in the wall of the renal artery are ablated by applying radiofrequency pulses or ultrasound to the renal arteries. This causes reduction of sympathetic afferent and efferent activity to the kidney and blood pressure can be decreased. Early data from international clinical trials without sham controls was promising - demonstrating large blood pressure reductions in patients with treatment-resistant hypertension. However, in 2014 a prospective, single-blind, randomized, sham-controlled clinical trial failed to confirm a beneficial effect on blood pressure. A 2014 consensus statement from The Joint UK Societies did not recommend the use of renal denervation for treatment of resistant hypertension on current evidence. More recent sham-controlled trials suggest renal denervation can lead to lower systolic blood pressure.

Hypertension is managed using lifestyle modification and antihypertensive medications. Hypertension is usually treated to achieve a blood pressure of below 140/90 mmHg to 160/100 mmHg. According to one 2003 review, reduction of the blood pressure by 5 mmHg can decrease the risk of stroke by 34% and of ischaemic heart disease by 21% and reduce the likelihood of dementia, heart failure, and mortality from cardiovascular disease.

<span class="mw-page-title-main">Labile hypertension</span> Medical condition

Labile hypertension occurs when there are unexpected changes in blood pressure. The term can be used to describe when people have blood pressure measurements that abruptly fluctuates from being abnormally high, approximately 140/90mm Hg or over and returns to its normal range.

References

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  2. Wallbach, M; Böhning, E; Lehnig, LY; Schroer, C; Müller, GA; Wachter, R; Lüders, S; Zenker, D; Koziolek, MJ (August 2018). "Safety profile of baroreflex activation therapy (NEO) in patients with resistant hypertension". Journal of Hypertension. 36 (8): 1762–1769. doi:10.1097/HJH.0000000000001753. PMID   29677053. S2CID   5014715.
  3. CVRx. "SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)" (PDF). FDA. Retrieved 22 January 2022.
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  5. Commissioner, Office of the (2020-03-24). "FDA approves new device to improve symptoms in patients with advanced heart failure". FDA. Retrieved 2021-06-18.
  6. Health, Center for Devices and Radiological (2019-12-20). "BAROSTIM NEO System - P180050". FDA.
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