Will dispense with the bad news first. Biogen has forced me to drop out of the Dex trial to have this FDA approved procedure done. Riluzak ok, Bi-Paps ok, but no DPS. Instead of being on the open label in seven months I have to go to the back of a 36-48 month line when this might be generally available. O well. Guess I am ahead of my time on this one (more on this in a coming blog post).
Good news. Cedars Sinai Medical Center in Los Angeles moved heaven and earth to become only the 2nd or 3rd facility in the country to be able to perform this procedure on ALS patients. The Neurology - ALS Center was extremely responsive to my request to get up and running by year end. My physician and the primary investigator who put it all together was Dr. Evgeny Tsimerinov. Dr. Patrick Lyden, Dr. Abi Muthukumaran, and Nurse Practitioner Hope Gruendler also contributed significantly to the efforts internally. Some additional encouragement by the local ALSA Chapter CEO Fred Fisher probably didn't hurt either. In the end, they expedited the process to just over 10 weeks from start to finish. Beat my 6-8 month prediction by miles!
I am scheduled to be the first patient west of the Rockies to receive the device since it's approval next week. Dr. Onders himself will be assisting Dr. Robert McKenna at Cedars in delivering the device. Will follow up soon with an update about the surgery itself and my personal effectiveness with the procedure.
On a side note, this is an exciting development for pALS and offers some immediate promise in our battle with this disease. However, it is still vital for pALS to level set expectations on what this significant procedure wil and will not do going forward. Dr. Onders has been performing this for almost a decade on paralyzed vent patients with much success. Much of this literature and You Tube videos from the past presents the facts on the patients in the general SCI (Spinal Cord Injury) population and not ALS patients specifically. There are rehab opportunities for the Diaphragm with SCI patients that does not exist for pALS among other things. Make sure you get your medical information from Dr. Onders himself or your ALS Clinic to make certain your expectations match the projected results from this procedure. ALS Specific Link here.
It's important to note there were 50 ALS patients in a clinical trial that ended in 2009. Trail results here. I personally spoke with a few of them that participated at Stanford. This is not a cure, but an FDA approved treatment that enhances quality of life.
- The patients who used the NeuRx DPS® plus non-invasive ventilation (NIV) (such as BiPAP®) survived 16 months longer (on average) than patients who just used NIV. This 16 month time frame is from the time of diagnosis. Survival time was measured until death or the need for a full time ventilator and a tube in the throat (tracheostomy).
- The patients who used the NeuRx DPS® plus NIV survived 9 months longer (on average) than patients who just used NIV. This is from the time they started using NIV.
- Some patients had a feeding tube placed with the NeuRx DPS®. All of these patients survived past 30 days. Normally, 2 to 25 patients out of 100 (up to a fourth of all patients) would not survive this long.
- Some patients had their sleep tested just before their NeuRx DPS® implant and again after using the NeuRx DPS® for 4 months. They had better sleep with DPS, with reduced apneas and hypopneas during REM sleep, than before they received NeuRx DPS®.
Medicare and Private Insurance covers this $55,000 procedure. You can go other places than Cleveland to get it done like LA or Dallas, with more on the way. Make sure you go to an ALS authorized Hospital, not SCI approved. There is a difference. ALS Locations here.
Hope to give you update #3 shortly after New Year's Day.
