Lung Volume Reduction Coils

[helen]

I have been looking for information about the LVRC trial here and did not find it.
So if it's already there and I have overlooked it, please remove this tread.

There is a clinical trial goïng on in the Netherlands, supervised by the US.
Some members of the Dutch COPD forum take part in it, so I could tell a bit more about it if you would like me to do so.......

[Blossom/Jackie W.]

I assume you're talking about the "new trials" ?

By all means yes! Share!

[helen]

Lung Volume Reduction Coils (This is how it's called here)

Interventional Bronchoscopy: Diagnostic and Therapeutic Advances

Tuesday, October 28, 2008
10:30 AM - 12:00 PM



CLINICAL EXPERIENCE USING A NON-VALVE MINIMALLY INVASIVE IMPLANTABLE DEVICE FOR THE TREATMENT OF LATE STAGE HOMOGENEOUS AND HETEROGENEOUS EMPHYSEMA
Armin Ernst, MD* and Felix Herth, MD
Beth Israel Deaconess Medical Center Harvard Medical School, Boston, MA

PURPOSE:Bronchoscopic lung volume reduction devices have been developed to provide a minimally invasive alternative to lung volume reduction surgery. Recent reports have described the use of endobronchial occlusion devices as efficient interventions, but they are limited by collateral ventilation. This study was designed to assess the acute safety and effectiveness of a novel, non-valve implant, delivered via bronchoscope into the airway to compress diseased lung parenchyma.

METHODS:In this single center study, 5 patients were treated unilaterally with the Lung Volume Reduction Device (LVRD) [PneumRx, Inc.; Mountain View, CA], a nitinol self actuating coil, at Heidelberg, Germany by 2 operators (AE, FH). Each patient underwent CT evaluation, Pulmonary Function Tests (PFT’s) and exercise tolerance tests prior to and after treatment. The devices were placed via a specially designed delivery catheter guided by a 6mm therapeutic bronchoscope and fluoroscopic imaging. Placement locations were determined based on CT observations and post processing analysis.

RESULTS:Mean age was 62 years with a male/female ratio of 1:4 and Homogeneous to Heterogeneous ratio was 1:4. and 24 devices were implanted. The average patient treatment time was 38 minutes with each implant requiring less than 3 minutes to place and there were no significant complications. At up to 3 months follow up, patients tolerated the devices well. Pulmonary function, exercise capacity, and quality of life data have showed improvement.

CONCLUSION:Placement of these devices in patients with severe emphysema is safe.

CLINICAL IMPLICATIONS:Placement of these devices is safe and the effects should be independent of collateral ventilation. Efficacy and long term safety data will need to be collected.

DISCLOSURE:Armin Ernst, Consultant fee, speaker bureau, advisory committee, etc. A. Ernst - consultant to PneumRx, F. Herth - consultant to PneumRx; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. PneumRx, Inc. is a private entity developing therapies for pulmonary disease. The PneumRx Lung Volume Reduction Device (LVRD) is an investigational device and it is designed to be a minimally invasive device for the treatment of emphysema.



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Copyright © 2008 by the American College of Chest Physicians.



www.freshpatents.com/Minimally-i ... 221230.php


The first patient of our forum was treated on April 17. 2009 and was home the next day and doïng very well.
This same patient got some coils in the second lung on September 29. 2009, feeling much better than before and life has become much easier for this patient.
Beforehand there was a lot of research, scans etc. done.

Not everyone that wanted to participate was found fit to do so.
But I think these trials can give us all some more hope for the future.
I even heard that this treatment could be done to patients who got Alpha1 (but can't find any data on that).

I have a thorax picture on which the coils can be seen, but it is very large.
So I don't know if I am allowed to put it here.
If I make it smaller the coils won't be visible, I'm afraid.

[John]

Thank You Helen

[Blossom/Jackie W.]

I gotta check this out Helen..... thanks for the post!

[Blossom/Jackie W.]

Hi Helen;
Your link isn't working but I'm sure I can find it. (This does sound familiar for some reason) anyway; as for the picture, if you know how to use Photobucket or the other... Image something or other, just put it up as a clickable thumbnail.... If all else fails you can e mail it to me and I'll put it up for you.

[Deleted]

This may be a path to the neighborhood:

www.freshpatents.com/Minimally-invasive-lung-volume-reduction-device-and-method-dt20070927ptan20070221230.php

[helen]

That's it Deetsk, thank you.

I will try to do it as you say, Blossom.

Edited only to remove the Easter Egg from the hunt.

[helen]

www.plaatjesupload.nl/bekijken/2306902.html

(Yes, I can do it )

It is the 5 white tread like things in the right lung (left in the picture).

[Blossom/Jackie W.]

You're a dear Deetsk!

[susanny]

Thank you, Helen. I'll be interested to see how that patient from your forum continues. Will you keep us up to date?

[helen]

I will, Sue.

It feels weird not to name names, but it’s because of their privacy.


So, patient number 1(A) is doing very well and can do much more than before.

Patient 2(E) also had both lungs treated, was doing well but disappointed because of too high expectations (I think). Does not write much on the forum.

Patient 3(M) one lung done, got pneumonia a few days after getting home.
After that being treated, this person is also doing well and very anxious to go for a walk outside, which can’t be done yet because of the cold air.

Patient 4(I) first lung, two weeks ago and doing fine. Has done a little walk outside already.

Patient 5(R) also first lung, was treated last week. Posted on the forum 2 days later, but not again yet.

[susanny]

It sounds very promising. I've got another question, and I apologize if it's already here but I didn't see it, are these patients having the procedure done under the trial, and, if so, do you have any word about how long the trials are running for?

[helen]

The first two patients were in the first trial, the others in the second.
I don't know how long these trials will take.
Maybe it depends on how many people worldwide are being treated?
Supervision is in the US and all the patients where not treated before the US gave them 'green light'.

[Blossom/Jackie W.]

By George; it took me awhile BUT; I found it! We did talk about this. There was something ringing my little bell about it, I went to our main website; sure enough i had a posting there from October 8th, 2009 ; I then refined my search here and voila!

Here's the original thread that from back then....

philns.proboards.com/index.cgi?board=questions&action=display&thread=3288

Helen for bringing this up again with more recent/updated info becasue although some folks (me included) wanted to mark and follow it, sometimes things get "lost" or "forgotten" on our computers.

[susanny]

Thank you for finding the original post about this, Blossom. Going back and reading the paper that Larry had posted, I would have a concern about the properties of the implant, and maybe it wouldn't matter, but many people have nickel allergies, which is one of the properties. I'm one of those 'lucky' people. I know there's no way anyone here would be able to answer my question about this, but wonder about it. Are people excluded with these sensitivities... That would be such a disappointment.

[helen]

Sue,
I have put a question on the other forum to ask if patients were tested for nickel allergie.
Will post the answer, if and as soon as I get it.

[mary57]

Helen, thank you for the info, this sounds way better than surgery. I'm sure if we can deal with IUDs, stents, pins, and other bits in us we can live with these. Please let us know how these people progress.

[helen]

Sue,
my question was answered by 3 patients (A, M and I), none of them were tested for allergies.

They think only the skin might be allergic to nickel.....?

[susanny]

Thanks, Helen. It was just something I wondered when I read the properties of the coils.

[helen]

Patient R (the last one operated on) is up and around now, doing more things every day.
After treatment doctor advised 24/7 on O2, instead of only nights, so can't tell the diffence to the lungs yet.

[helen]

Patient J who wanted to take part in the trial was rejected, but has a friend (no forum member) who will have the treatment. Febr. 18 first lung, one month later the second lung.

So the trial is not over yet.

[zar]

helen,
Could you find out if the Chartis System was used,and if not why not.Thank You

Chartis System
www.pulmonx.com/clinical-information/chartis-study/index.html

Check videos

[helen]

Zar,
As far as I can see that's a totally different system.
I am not a doctor and have never seen the inside of a university hospital.
So I can't ask people there, why this system and not the other one.
I think it works like this:
The USA wanted the Coils trial done and asked university hospital Groningen to take part in it.
Maybe someone else here knows how these things usually go?

[helen]

Update

A(1) had a lung infection this winter, and is feeling better now. She got 13 coils in total.

E(2) Has had a severe flue as well as a jaw infection this winter, but feels much better now.
When she went for control, the surgeon said there was no one who made more progress than she did.
She exhales 1liter more than she did in may 2009.

M(3) 6 Minutes walking test before she got the coils Nov. 3. 165 meters.
Afterwards Dec. 21. 294 meters, Feb. 8. 345 meters.
Every day she lets her husband or daughter drive her to a nearby hospital and exercises her walks there in the corridors, behind a wheelchair with her O2 in it.
She is the only one with the emphysema spread through the lungs.
Second lung will probably be done in April/May.

I(4) Has had her second lung done. It took only 22 minutes to place 10 coils.
She has got a total of 19 now.
Walking test results:
Jan. 14. six minutes – 236 meters
Feb. 10. six minutes – 320 meters

Is in hospital now with a lung infection, but will be home again soon.

R(5) has had her second lung done, nine new coils which are lower in the lung this time.
Did not feel well immediately afterwards, but is much better now.
Walked 40 meters more at the 6 minutes test and the lung function test showed improvement.

No messages yet from J’s friend R(6), who also became a forum member.
I think she will soon have, or has recently her second lung done.

[susanny]

Thank you for the update, Helen. Is there any possibility that you would/could have the coils done for yourself? I think, by hearing how well these people are doing, that I would if it was available somewhere near me. They seem to be having great results.

[John]

Thank You Hellen

[helen]

Hi Sue,
I'm only stage II and can do a lot more than the people who take part in the trial, but I think it is giving hope for everyone in the future.
I surely think it would be worthwile for everyone, seeing how quickly it's done, how little patients suffer from the treatment and how much the benefit is.
Let's hope the trial stage will be over soon so everyone worldwide can have these coils, but please note that the ones who are in the trial now are probably the ones of which "they" expected the best results beforehand.

[Blossom/Jackie W.]

Sounds promising Helen. TY for the updates. Let's keep our fingers crossed for the patients and the trials!

[susanny]

This is true, Helen. They want the numbers to look good. In the Netherlands, what does Stage 2 relate to the FEV %?