Re: FDA....

GINI (gini_intl(AT)email.msn.com)
Fri, 20 Mar 1998 13:57:52 -0800

About two and a half years ago, someone asked IVUN about the breathing
pacemaker. The information on the mailing list earlier this week referred
to a FDA approval of the new Mark IV breathing pacemaker. The following may
shed some more light on the information. Joan

Would a breathing pacemaker (diaphragm pacing or phrenic nerve pacer) be a
good option for the survivors of polio who are now using portable volume
ventilators to breathe?
Information regarding diaphragm pacing was presented at the ventilator
users' session at the Sixth International Post-Polio and Independent Living
Conference in June of 1994. The proceedings from that meeting were
published in I.V.U.N. News, Vol. 8, No. 4, in the Fall of 1994. In her
comments, Joan Lamb, RN, from the Dobelle Institute, did describe who are
the best candidates for diaphragm pacing: "Traditionally, diaphragm pacing
has been successful primarily in people with obstructive sleep apnea or with
high spinal cord injury, but there have been more inquiries about whether
the newer types of diaphragm pacemakers would be of use in people with
neuromuscular disease. The key is the amount of residual function left in
the phrenic nerve and diaphragm. If the phrenic nerve is not working or the
diaphragm cannot contract, then the point of pacing the nerve is useless."
She continues "If, however, some residual fibers in the nerve have been
saved, and the diaphragm does contract to some extent, there is a
possibility with some of the newer equipment, that diaphragm pacers can be
more finely adjusted."
Ms. Lamb continues "The pacemaker costs in the vicinity of $40,000, but the
tradeoff is that one no longer needs ventilatory equipment and other
disposables."
A few points:
1. The estimated cost of $40,000 is a conservative estimate based on
$20,000 per unit. Total cost for bilateral phrenic pacing may be over
$200,000 because surgery and hospitalization is required to install the
pacer and frequently (up to 90%) a tracheostomy is needed as well for
suctioning and to avoid obstructive sleep apnea.
2. In addition to the need for a functioning diaphragm and intact phrenic
nerve, airway resistances, and chest wall and lung compliances, all need to
be close to normal.
3. Many polio survivors do not have an appropriately functioning diaphragm

and/or phrenic nerve. It cannot be said that diaphragm pacing is a good
option for people who are polio survivors. Non-invasive IPPV would be the
first choice, and tracheostomy IPPV would be the second choice. Diaphragm
pacing is an option for patients with central hypoventilation and high
spinal cord lesions but not without risk.

Gazette International Networking Institute
(GINI)
coordinator of International Ventilator Users Network (IVUN)
4207 Lindell Boulevard #110
Saint Louis, MO (Missouri) 63108-2915 USA
314/534-0475 314/534-5070 fax
gini_intl(AT)msn.com

www.post-polio.org