Muon Do you have any follow up on on the DPS in use today or not.


DPS in ALS: Clinical Trial Under Way at
University Hospitals Case Medical Center
UH physicians involved in the Diaphragm Pacing
Center and the Neuromuscular Center of the
Neurological Institute proposed using the DPS system
in an attempt to maintain respiratory muscle function
in ALS patients. A pilot study conducted between
March 2005 and March 2006 demonstrated the DPS
system can be safely implanted in ALS patients, with
a documented decrease in the decline of respiratory
function leading to increased survival.14
In the pilot study, 16 patients (13 men and 3
women with an average age of 50 years; age range
32-70) received implants and no adverse events were
observed or reported. The mean time between the
onset of symptoms and enrollment in the trial was
45 months. All patients had a 2-month lead-in period
prior to implantation. The median forced vital capacity
(FVC) at implantation was 57%. In all pilot-study
patients, more fluoroscopically observed diaphragm
excursion occurred with diaphragm stimulation than
under maximal voluntary effort. DPS significantly
increased diaphragm muscle thickness when assessed
with ultrasound (P=0.02). After conditioning the
diaphragm with the DPS, preliminary results showed
an average rate of decline in FVC of 1.3% per month
from the pre-implantation decline of 3.1% per
month. This extrapolates to an additional 24 months
of ventilator-free survival

Greetings again, Thelma!

You posted a message from the first pilot study involving the DPS. Several Phase II studies have occurred since and at least one remains open to the best of my knowledge and belief.

There are about fifty sites in the US where one can obtain the implant, provided they meet the qualification criteria. I have found at least five patients who have 'internet disclosed' they obtained the implant this year.

A report from the UK went to press recently, reflecting on a study of 74 patients who were LESS successful than expected . . . about half of these patients underwent the implant. The reports indicates the implant may be harmful to patients but admits some patients might benefit. I have not completed my evaluation of the report but will comment further upon doing so.

". . . the qualification criteria . . ." my previous post this thread probably should read ". . . the HUD/HDE qualification criteria . . . ."

Safety and efficacy of diaphragm pacing in patients with respiratory insufficiency due to amyotrophic lateral sclerosis (DiPALS): a multicentre, open-label, randomised controlled trial

http://www.thelancet.com/journals/la...152-0/fulltext

An issue clearly reflected in the data is asperation pneumonia . . . does the noninvasive ventilation increase risk of asperation pneumonia . . . does the pacer increase the risk of asperation pneumonia?

There may be an increase in asperation pneumonia risk with these technolgies, so be sure to incorporate routine use of pulse oxygen meter with the use of this equipment.

Here is the appendix for the Lancet DPS report:

http://www.thelancet.com/cms/attachm...10528/mmc1.pdf

The French study has resumed, US NIH Clinical Trails database now reports, "This study is ongoing, but not recruiting participants" whereas, previously reported "suspended."

While I continue to review the Lancet report I am convinced the writers ought to have identified gastronomy tube usage among the patients included in the study. Very little data on this issue appears in the report . . . one of the major reasons patients use gastronomy tubes is to decrease the risk of aspiration pneumonia.

The Lancet report also indicates 'no stimulation' is a possible 'sham stimulation,' whereas, in my estimation, 'sham stimulation' means stimulation other than 'no stimulation' or 'intended stimulation.' Its possible the complete absence of stimulation might be harmful in the presence of the implants because the implants may, in effect, cause short-circuits and thus increase the energy neurons must produce to sufficiently activation the synapse. The change in stress neurons may undergo might increase their load and thereby possibly reduce the neuron's longevity. A stimulation offsetting this effect ought to be possible - if it is needed.

The limited amount of French comment on the studies might in fact only be in reference to the Lancet report and thus the remarks implying the French study encountered trouble too is possibly only a rumor.

Possibly the most worrisome issue in the report are the two pulmonary embolisms. Until this report, I was aware of only one case, ending badly. Was this one of those two or are there now three . . . what happened of these two?

My understanding is pulmonary embolisms are always a surgical risk and people who live a sedentary lifestyle have a greater risk. So far no clear connection between the pacer and these embolisms are evident in the documentation I can find on the web. The first occurred within the thirty day surgery period; I can only find they occurred in the report, but not when, as yet.