Diaphragm Pacemakers – Breathing New Life into Quadriplegics

By Nicole Ficarra, Communications Coordinator, Avery Biomedical Devices (Commack, NY, www.averybiomedical.com), the global leader in high reliability diaphragm pacemakers.

A Diaphragm Pacemaker from Avery Biomedical

I would not have predicted the path my life has taken. Car accidents, of course, are unpredictable, and I was in one at age four. I suffered a spinal cord injury; a stretched spine, which left me a quadriplegic, unable to walk or breathe without ventilator support.

At age 11, though accustomed to my life in a wheelchair and using a mechanical ventilator, my life changed due to a diaphragm pacemaker. The device is used to support breathing in individuals who require breathing assistance due to a spinal cord injury or other medical conditions such as Congenital Central Hypoventilation Syndrome, Central Sleep Apnea, central neurological disorders or autoimmune diseases like Multiple Sclerosis, serious bacterial infections, Lyme Disease and Acute Flaccid Myelitis.

At age 11, on a trip to the emergency room with pneumonia, I learned about diaphragm pacers. I resisted having the surgery to implant the diaphragm pacemaker components. My parents, however, having learned its benefits, scheduled the surgery; the best decision they ever made for me. That’s why I believe all individuals with spinal cord injuries should explore whether they would be a good candidate for this device.

How a Diaphragm Pacemaker Works

Avery Spirit Transmitter; full system with plastic case.

To understand how a diaphragm pacemaker works, you must understand the phrenic nerve and its role in breathing. This nerve originates in the neck at the cervical nerves C3 through C5 and continues down between the lung and heart to the diaphragm. It serves as the neurological pathway between the brain and the diaphragm.

It is composed of motor, sensory and sympathetic nerve fibers, enabling it to send motor information to the diaphragm and receive sensory information back. A diaphragm pacemaker system consists of surgically-implanted components, an external transmitter, and antennas worn on the skin. A battery-powered transmitter sends a series of electrical pulses to the antennas.

These pulses are converted into radio waves and transmitted through intact skin to an implanted receiver. Pulses inside the body are sent to the phrenic nerve via a small electrode implanted close to the nerve, causing the diaphragm to contract. This contraction increases the space around the lung resulting in inhalation. Exhalation occurs when the pulses stop and cause the diaphragm to relax. This repetitive process produces a normal breathing pattern.

Are You a Candidate for a Diaphragm Pacemaker?

Not everyone is a candidate, nor needs ventilator assistance. For instance, patients with an injury or disease at C1, C2, and higher cervical nerve, may have little or no movement of their head and neck, and may be entirely dependent on ventilator assistance for breathing. Those with C3 level injuries, typically do have control of their head and neck, and can sometimes be weaned from ventilator assistance. Those with C4 level injuries are often weaned from ventilator assistance, and those with C5 and lower injuries generally don’t need ventilator assistance.

The key criteria are: the individual must have functional lungs and diaphragm muscle, and an intact or repaired phrenic nerve(s). To qualify a patient, a neurologist performs a phrenic nerve conduction study. In the study, the phrenic nerve is stimulated, just as it would be by a diaphragm pacemaker, and the diaphragm muscle’s response to the stimulation is recorded. The surgical procedure lasts two to four hours. To confirm the proper stimulation of the phrenic nerve and diaphragm functioning, an interoperative evaluation is conducted to observe the chest wall and palpitation, and measure CO2 changes. For some patients, a fluoroscopy test is performed to observe the diaphragm’s motion in greater detail. There is usually a one or two day hospital stay. Some individuals can undergo the minimally invasive procedure on an outpatient basis.

The Benefits of Diaphragm Pacemakers over Mechanical Ventilators

As awareness of the device’s benefits over mechanical ventilators continues to grow, more physicians are recommending it to their patients. Individuals with diaphragm pacemakers also are communicating the benefits these devices have provident them, such as:

  • Greater mobility and freedom to pursue different activities;
  • Easier time performing daily activities;
  • Elimination of routine maintenance and disposable supplies ventilators require;
  • Less risk of the infections, pneumonia, collapsed lungs, airway injuries and diaphragm atrophy associated with ventilators;
  • No stress associated with locating power sources or power outages;
  • Improved breathing, speech, eating, drinking and hearing;
  • Better sleep quality; and
  • Reduced hospital re-admissions.

A study published in the peer-reviewed journal, Spinal Cord, also found that diaphragm pacing costs an estimated 90% less than ventilator-related expenses, yielding savings of up to $20,000 annually.

Diaphragm Pacemakers Are Having a Huge Impact

The first commercially distributed diaphragm pacemaker was developed in 1971 by Avery Laboratories, now known as Avery Biomedical Devices (Commack, NY). Today, Avery is recognized as the global leader in diaphragm pacing with its device implanted in over 2,000 people in 40 countries. The Avery device has a consistent record of safety and reliability spanning almost five decades, and full market approval from the U.S. Food and Drug Administration (FDA) and CE Marking privileges under the European Active Implantable Medical Device Directive for adult and pediatric use. Its high reliability and economic value has Medicare and most private and government insurance providers offering reimbursement for the Avery diaphragm pacemaker.

Once implanted with a diaphragm pacemaker, I gained renewed confidence. I earned my Bachelor’s Degree in Advertising, internships with a local legislator and area hospital, and a job as social media coordinator for Avery (whose device I have). Additionally, I serve as a patient ambassador for Avery, encouraging others to learn how a diaphragm pacemaker could help them and attend medical conferences to raise awareness. It’s not all work for me either. I enjoy the same activities as my peers. I recently had an incredible experience at Disney’s D23 Expo and regularly attend concerts featuring artists like Pink, Justin Timberlake, Pink and the Jonas Brothers.

Nicole Ficarra at Disney World.

Other quadriplegics also have regained their lives following a spinal cord injury. Arlyne M. said, “I do more things than ‘normal’ people do, and even go golfing and dancing. The pacer has changed my life tremendously from being on a ventilator 24/7, and always worrying about power outages or running out of time on the battery life, it is fabulous. It is very liberating.”

Dalen J. has seen his health improve greatly. He’s had no infections since getting a diaphragm pacemaker and his speech and hearing have improved, improving his social interactions. For former professional cricket player, Jamie H., the device has him back in the sport he loves as a coach. Former diver and gymnast, Keith S., who suffered a spinal cord injury from a trampoline accident, now feels like he is breathing on his own. The diaphragm pacemaker improved his mobility, enabling him to return to work and take overnight trips. Annapolis Naval Academy graduate and Top Gun Instructor, William M., said, “Before my surgery, there was a real sense of having two minutes to live should my ventilator become disconnected. Now, I can relax a little bit knowing that I am able to breathe without having a tube connected and breathe off the vent in my wheelchair.”

Many physicians recognize the value of diaphragm pacemakers for carefully selected patients. Don B. Headley, MD (Phoenix, Arizona), an ENT Surgeon/ Otolaryngologist, currently retired from Dignity Health (San Francisco, California), the fifth largest health system in the nation, noted, “Freedom from being tethered to a mechanical ventilator is the single most important benefit patients with diaphragm paralysis note after being implanted with a diaphragm pacer. It is very humbling to be able to make such a profound change in people’s lives through the implantation of this Avery device. Working with the dedicated members of this organization that enables these patients to have more freedom, and live longer, more fulfilling lives with this device is most satisfying.”

George V. Letsou, M.D., FACS, Professor of Adult Cardiac, Thoracic, and Vascular Surgery at Baylor College of Medicine, The Texas Heart Institute and TIRR (the Institute for Rehabilitation and Research) in Houston, Texas commented that, “Diaphragm pacing can dramatically improve the lives of people dependent on mechanical ventilation. Usually the relatively small operation involves only an overnight hospital stay. As outlined by Ms. Ficarra (in this article), the procedure can free appropriate patients from mechanical ventilation, allowing them to lead fuller and markedly more complete lives.”

In summary, the diaphragm pacemaker can help individuals with spinal cord injuries regain their freedom and pursue the life they wanted. To borrow a quote from Dr. Seuss, “Oh, the places you’ll go!”L

Learn more about the Avery Diaphragm Pacing System

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