Department of Surgery News

<STRONG><BIG>GENERAL SURGERY DIVISION IS FIRST ON LONG ISLAND TO IMPLANT DEVICE TO AID BREATHING, EXTEND LIFE FOR ALS PATIENTS</BIG></STRONG>
<br /><br />
<strong><font color="#990000"><em>"Diaphragm Pacemaker" Implanted for Famed North Fork Chef Gerry Hayden</em></font></strong>

<p>
<div class="photobox2">

<a href="http://medicine.stonybrookmedicine.edu/sdmpubfiles/cckimages/page/TELEM…; title="Gerry Hayden with Dr. Dana A. Telem" class="colorbox colorbox-insert-image" rel="gallery-all"><img typeof="foaf:Image" src="http://medicine.stonybrookmedicine.edu/sdmpubfiles/styles/240/public/cc…; alt="Gerry Hayden with Dr. Dana A. Telem" title="Gerry Hayden with Dr. Dana A. Telem" class="image-240" /></a>
<br /><div class="caption">Gerry Hayden with Dr. Dana A. Telem</div></div>

STONY BROOK, NY, March 20, 2013 — The Department of Surgery's <a href="/surgery/divisions/general-surgery">General Surgery Division</a> has implanted the first diaphragm pacing system for an ALS (<a href="http://stonybrookphysicians.adam.com/content.aspx?productId=117&pid=1&g…; target="_blank">amyotrophic lateral sclerosis</a>) patient on Long Island. Famed chef Gerry Hayden, co-owner of the <a href="http://www.nofoti.com&quot; target="_blank">North Fork Table and Inn</a> of Southold, NY, had the procedure to implant the device in him on March 8 at Stony Brook University Hospital.</p>

<p>Called the NeuRx Diaphgram Pacing System (DPS), the device assists the breathing of individuals who develop chronic hypoventilation from
ALS (also known as Lou Gehrig’s disease), allowing them to breathe for a longer period without the assistance of mechanical ventilators.</p>

<p>
The procedure was performed by <a href="/surgery/people/faculty/dr-dana-a-telem">
Dana A. Telem, MD</a>, assistant professor of surgery, who became among the nation’s first
surgeons to implant the device since it was approved for "humanitarian use" by the U.S. Food and Drug Administration (FDA) in September 2011.</p>

<p>Dr. Telem was
assisted by <a href="/surgery/people/faculty/dr-aurora-d-pryor">Aurora D. Pryor, MD</a>, professor of surgery and chief of general surgery.</p>

<p>Currently the DPS device is offered at only three hospitals in the Tri-State Area (New York, Connecticut, and New Jersey), according to the
device manufacturer, Synapse Biomedical of Oberlin, OH. The other two facilities are SUNY Upstate Medical Center in Syracuse, NY, and Weill Cornell Medical Center in Manhattan, NY.</p>

<p>"This procedure demonstrates that when it comes to cutting-edge surgery, Stony Brook is the leader on Long Island," says <a href="/surgery/people/faculty/dr-alexander-b-dagum">Alexander B. Dagum, MD</a>, professor and interim chairman of surgery.</p>

<p>Candidates for the DPS device have chronic hypoventilation as a result of ALS, and have a diaphragm with partially intact nerves that can be
stimulated, Dr. Telem explains. The nerves are examined by fluoroscopy, ultrasound, or electromyography to determine if a patient is a good
candidate for the procedure.</p>

<div class="callout"><p><strong>
"I am very happy I was a candidate for this device. If we can get the word out <br />about it, it can help more ALS patients
&#133; with their longevity and quality of life."
</strong></p></div>

<p>"Traditionally, we could only assist these types of patients with non-invasive ventilation, which can be cumbersome and not well tolerated by
many patients," says Dr. Telem. The FDA study of the device showed a 16-month improvement in survival for ALS patients from the time they
were diagnosed with chronic hypoventilation.</p>

<p>ALS patients also benefit from improved sleep soon after beginning treatment, says Nurcan Gursoy, MD, PhD, a neurologist with Stony Brook’s <a href="http://stonybrookneurosciences.org/Neuromuscular-Disease-and-ALS-Center…; target="_blank">Christopher Pendergast ALS Center of Excellence</a> in East Setauket, NY. ALS can cause patients to develop sleep apnea and nocturnal ventilation, she explains, which increases carbon dioxide levels and reduces their sleep efficiency.</p>

<p>ALS is a rapidly progressing, incurable, and fatal neuromuscular disease characterized by progressive muscle weakness that results in
paralysis. As the phrenic nerve to the diaphragm muscles fails, patients lose the ability to breathe without ventilator support.</p>

<p>Approximately 30,000 people in the United States live with ALS, and more than 5,600 new cases are diagnosed each year. Approximately
3,300 of those patients have respiratory problems and partially intact phrenic nerves, making them potential candidates for the DPS implant
procedure, according to Synapse Biomedical, maker of the device.</p>

<div class=subhead>About the Procedure</div></p>
<p>The device is implanted through minimally invasive laparoscopic surgery. The surgeon creates four dime-sized holes in the abdominal region
and inserts a laparoscope to view the diaphragm muscle. Electrodes are attached through wires under the skin to a small external
battery-powered pulse generator that stimulates contraction of the diaphragm muscle.</p>

<p>
<div class="alignleft" class="photobox2">
<a href="http://medicine.stonybrookmedicine.edu/sdmpubfiles/cckimages/page/DPS.j…; title="Diagram of Diaphragm Pacer System" class="colorbox colorbox-insert-image" rel="gallery-all"><img typeof="foaf:Image" src="http://medicine.stonybrookmedicine.edu/sdmpubfiles/styles/220/public/cc…; alt="Diagram of Diaphragm Pacer System" title="Diagram of Diaphragm Pacer System" class="image-220" /></a>
<br /><div class="caption">
The pacemaker system uses four implanted<br />
electrodes (A) controlled by the pacing unit<br />
(B) to rhythmically stimulate the diaphragm. </div></div>

After the procedure, the patient gradually conditions the diaphragm muscle through a series of physical therapy sessions. The device
provides electrical stimulation to the muscle and nerves in the diaphragm. When the muscle is stimulated, it contracts, helping to condition the
muscle to improve fatigue resistance during normal exertion.</p>

<p>Mr. Hayden says he hopes the device will extend his ability to use his diaphragm to breathe on his own for at least 4-5 months and perhaps as
much as 18 months. He suffers weakness on the right side of his diaphragm muscle, he says.</p>

<p>Ten days after the procedure, he is already able to use the device for 3-4 hours a day; his goal through conditioning sessions is to be able to
use it around the clock. Currently, his breathing is assisted by a bilateral positive airway pressure device while he sleeps at night.</p>

<p>"I hope that the pacer device will be able to prolong my diaphragm so that it can continue to work on its own," he says. "I can't wake up every morning wondering whether I'm going to die. I have to wake up every morning wondering how I'm going to live with ALS. And that's a big thing I think patients need to know." </p>

<p>"I am very happy I was a candidate for this device. If we can get the word out about it, it can help more ALS patients. The breathing part of the disease is the worst. If it can catch more people early [in their disease process] and help them breathe, it can help patients with their longevity and quality of life."</p>

<p>Prior to his diagnosis, Mr. Hayden served as executive chef at North Fork Table and Inn, which he co-owns with his wife, pastry chef Claudia
Fleming, and Mike and Mary Mraz.</p>

<p>Since being diagnosed with ALS in 2011, his fellow chefs have rallied to his support, conducting a celebrity chef fundraiser in Manhattan last
summer. This year he hopes to organize additional events on Long Island to raise awareness and funding for ALS research.</p>

<p>Mr. Hayden is being treated at the Christopher Pendergast ALS Center of Excellence, the only such center in Suffolk County.</p>

<p><span class="pointer"><strong>For consultations/appointments with Dr. Telem, please call 631-444-4545. Watch this video (2:57 min) to learn more about how diaphragm pacing works to help patients with ALS:</strong></span> </p>

<p><iframe width="420" height="315" src="http://www.youtube.com/embed/hrXLcgyy8jc?rel=0&quot; frameborder="0" allowfullscreen></iframe></p>