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Raffie
Rookie

USA
7 Posts

Posted - Jul 10 2013 :  10:52:56 AM  Show Profile  Reply with Quote
Hi, has anyone had lung volume reduction coil? It's for patients with emphysema. I am looking into it for my mom. This study is being held at Temple in Philadelphia and I just started looking into it. Any info would be helpful. Thanks!

Raffaella Bove

jmrommes
Contributing Member

1610 Posts

Posted - Jul 10 2013 :  11:29:54 AM  Show Profile  Reply with Quote
The coil study is similar to many that have had clinical trials in the US. There have been vents, valves, steam ablation and the current ASPIRE study that uses glue. They're all designed to essentially replicate LVRS results using less invasive measures. To date, none of the devices or techniques have been approved for use in the US by the FDA, though a number of them are in use in Europe, Australia and other countries.

In your shoes, I would look carefully at the NETT study, which outlines the individuals who did best in the LVRS surgery. The best of these clinical trials use those criteria exclusively.

http://www.nhlbi.nih.gov/health/prof/lung/nett/lvrsweb.htm

This will give you an idea of the kinds of questions you and your Mom should be asking.

Jean

Exercise not only lets me live, it enables me to have a life.
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Jul 10 2013 :  1:07:27 PM  Show Profile  Reply with Quote
And those trial methods don't truly replicate the surgical procedure because there is still closed up lung taking up space in the thoracic cavity so the remaining lung really can't expand and do it's job more efficiently.

****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS




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jmrommes
Contributing Member

1610 Posts

Posted - Jul 10 2013 :  5:46:01 PM  Show Profile  Reply with Quote
Good point, Penny; I forgot that.

Jean

Exercise not only lets me live, it enables me to have a life.
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mziegler
Member

USA
97 Posts

Posted - Jul 31 2013 :  5:36:15 PM  Show Profile  Reply with Quote
Raffie, I am currently looking into the RePneu coil study that is being done in San Antonio, TX. I came onto this site to see if I could get some information, but it all seems to be very negative.

PennyPA, I, like a lot of people, do not qualify for LVRS surgery. I was referred to this study by my Transplant Doctor (I am considering a lung transplant). I have just begun researching & would really appreciate any statistical information. It may not provide the same benefits as LVRS, but to me, any relieve is welcome.

Raffie, I will try to post again as I find out more information. Don't lose hope.



Melissa
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gkrenn
Rookie

18 Posts

Posted - Oct 26 2013 :  7:57:28 PM  Show Profile  Reply with Quote
I had the coils, RePneu, Pneum RX Co. placed in my right lung in May, 2013 and my left lung in Sept. 2013. I am in a trial in WI. I did have a pheumothorax in Aug (right lung) They could not say for sure if it was related to the coils but chances are pretty great. I did have the surgery to attach the lung to the chest wall to prevent another pheumothorax. My most recent breathing tests indicated a huge improvement. I am feeling great and back to exercising daily. I am not nearly as short of breath as I was prior to the coil placements. Hoping not to have another collapse, but very glad I did this.
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Oct 26 2013 :  8:41:44 PM  Show Profile  Reply with Quote
We're talking about 2 different coils here...the RePneu "uncoiled" coils and the regular coils. There hasn't been a lot of success with the coils but it appears that RePneu might show some promise. I'm not sure how they can keep that from migrating to other parts the lung but it does sound promising. The several people who have been part of the trials are very happy with it.

****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS




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Diann-NY
Member

USA
58 Posts

Posted - Oct 27 2013 :  9:02:18 PM  Show Profile  Reply with Quote
I really wanted to be part of that clinical trial rather than doing the LVRS, but I am allergic to nickel so I didn't even apply. Why would they use nickel when so many people are allergic to it?

Diann
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fatpuppy
Member

163 Posts

Posted - Oct 27 2013 :  9:36:40 PM  Show Profile  Reply with Quote
quote:
Originally posted by Diann-NY
Why would they use nickel when so many people are allergic to it?


The RePneu coils are made from a material called Nitinol. Nitinol is an alloy of nickle and titanium with the unusual ability to recall it's shape called"shape memory". In the case of the coils, that allows them to be straightened out for insertion in the airways then return to their coiled shape once in the proper position in the lungs. Cardiac stents often use it as well. I have a stent/graft in my aorta to repair an aneurysm and I was asked about nickle allergy because it's made of dacron and Nitinol. The very simple reason they use nickle is because there really is no other substitute at this time.
http://en.wikipedia.org/wiki/Nickel_titanium

ďAs democracy is perfected, the office of president represents, more and more closely, the inner soul of the people. On some great and glorious day the plain folks of the land will reach their heartís desire at last and the White House will be adorned by a downright moron.Ē H.L.Mencken 1920
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Diann-NY
Member

USA
58 Posts

Posted - Oct 28 2013 :  1:47:13 PM  Show Profile  Reply with Quote
Thank you Fatpuppy, that makes sense to me now.

Diann
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barenstam
Rookie

14 Posts

Posted - Dec 11 2013 :  9:37:10 PM  Show Profile  Reply with Quote
I have an appointment early January in Boston to see if I qualify for this trial. It sounds promising.
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Dec 11 2013 :  10:05:17 PM  Show Profile  Reply with Quote
Good luck, barenstam. Let us know how it turns out. My lung function was so low at the time of my LVRS , I didn't want to do a trial.

****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS




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oldky1
Rookie

13 Posts

Posted - Jan 30 2014 :  3:11:30 PM  Show Profile  Reply with Quote
quote:
Originally posted by gkrenn

I had the coils, RePneu, Pneum RX Co. placed in my right lung in May, 2013 and my left lung in Sept. 2013. I am in a trial in WI. I did have a pheumothorax in Aug (right lung) They could not say for sure if it was related to the coils but chances are pretty great. I did have the surgery to attach the lung to the chest wall to prevent another pheumothorax. My most recent breathing tests indicated a huge improvement. I am feeling great and back to exercising daily. I am not nearly as short of breath as I was prior to the coil placements. Hoping not to have another collapse, but very glad I did this.


Would You do this again? I am a newbie here I tried to email but would not let me. What percentage did You improve? Do You feel much better? Besides the collapsed lung what other problems/complications did You have if any? I am scheduled to be screened at the end of Feb. 2014. Do You know if You have heterogeneous or homogeneous emphysema? What were Your FEV1? What are they now? Thank You for Your consideration.

Don

Thanx
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gkrenn
Rookie

18 Posts

Posted - Jan 30 2014 :  4:12:23 PM  Show Profile  Reply with Quote
Don,
Yes I would do the surgery again in a minute. I have heterogeneous COPD. I don't know my prior FEV 1 but I do know that the Drs. cannot believe, and are very impressed by my latest breathing results. I just had a check up in January and all of my breathing tests improved and I increased the number of steps in the six min. walk by 179. I don't know what the total no. of steps were but I exercise daily (consider it part of my job). I do a 7% incline, 3.5 speed for 35 min. on the treadmill with intervals of 4.2 speed. I lift weights too. It's been awesome. I do know that you have to have certain qualifications to have the surgery. As far as I know, only 14 people qualified for the surgery in the hospital that I go to. Let me know how it goes for you. Good Luck, I highly recommend it. But remember, you have to do your part. Keeping a healthy weight, eating good whole foods and, most importantly, keep moving.
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oldky1
Rookie

13 Posts

Posted - Jan 31 2014 :  6:49:14 PM  Show Profile  Reply with Quote
quote:
Originally posted by gkrenn

Don,
Yes I would do the surgery again in a minute. I have heterogeneous COPD. I don't know my prior FEV 1 but I do know that the Drs. cannot believe, and are very impressed by my latest breathing results. I just had a check up in January and all of my breathing tests improved and I increased the number of steps in the six min. walk by 179. I don't know what the total no. of steps were but I exercise daily (consider it part of my job). I do a 7% incline, 3.5 speed for 35 min. on the treadmill with intervals of 4.2 speed. I lift weights too. It's been awesome. I do know that you have to have certain qualifications to have the surgery. As far as I know, only 14 people qualified for the surgery in the hospital that I go to. Let me know how it goes for you. Good Luck, I highly recommend it. But remember, you have to do your part. Keeping a healthy weight, eating good whole foods and, most importantly, keep moving.

Thank You for Your quick response. You mentioned that there were 14 procedures done at Your hospital. Do You know if others have had similar experiences or are Yours unique?

Thanx
Don
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oldky1
Rookie

13 Posts

Posted - Jan 31 2014 :  7:17:32 PM  Show Profile  Reply with Quote
quote:
Originally posted by gkrenn

Don,
Yes I would do the surgery again in a minute. I have heterogeneous COPD. I don't know my prior FEV 1 but I do know that the Drs. cannot believe, and are very impressed by my latest breathing results. I just had a check up in January and all of my breathing tests improved and I increased the number of steps in the six min. walk by 179. I don't know what the total no. of steps were but I exercise daily (consider it part of my job). I do a 7% incline, 3.5 speed for 35 min. on the treadmill with intervals of 4.2 speed. I lift weights too. It's been awesome. I do know that you have to have certain qualifications to have the surgery. As far as I know, only 14 people qualified for the surgery in the hospital that I go to. Let me know how it goes for you. Good Luck, I highly recommend it. But remember, you have to do your part. Keeping a healthy weight, eating good whole foods and, most importantly, keep moving.

Thank You for Your quick response. You mentioned that there were 14 procedures done at Your hospital. Do You know if others have had similar experiences or are Yours unique?

Thanx
Don
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gkrenn
Rookie

18 Posts

Posted - Jan 31 2014 :  7:24:38 PM  Show Profile  Reply with Quote
They can't tell me as it is a trial. I think that once the trial ends they can post the results.
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oldky1
Rookie

13 Posts

Posted - Jan 31 2014 :  7:30:09 PM  Show Profile  Reply with Quote
quote:
Originally posted by gkrenn

They can't tell me as it is a trial. I think that once the trial ends they can post the results.

Thank You. I have just a couple more questions.
You mentioned that You do 3.5 MPH on treadmill with 7% incline. What were You able to do before? Were You able to do steps before? (It's like torture for me) I was on the Lung Transplant list but after rigorous testing I was disqualified until I have elective colon surgery.

Thanx Again

Don
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gkrenn
Rookie

18 Posts

Posted - Jan 31 2014 :  7:42:45 PM  Show Profile  Reply with Quote
I was always exercising, but I too had colon surgery (total colectomy for chronic constipation in 2010) after that surgery ( I came home at 83 lbs and was in the hospital for a month) I was short of breath all the time. I continued to exercise (2.5 MPH on the treadmill, no incline) but was short of breath going up stairs. I've always continued to work. I'm a real estate appraiser, and that was getting hard (measuring houses..) I was just very depressed about how I tried so hard to exercise and was always short of breath. I actually was sent to UW Madison for an evaluation for lung reduction surgery when they asked me if I wanted to be part of a new trial that they were just starting. I tested and qualified and had the coils placed. I maintain 96 lbs. which works great for me. I'm 5'3". I have tons of energy. I actually have to push my exercise to get my heart rate up now where before it went high right away. I'm 59 years old. Both of my parents had COPD and died from it. I did smoke but quit 8 years ago. I actually did not smoke that much but was surrounded by it growing up.
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oldky1
Rookie

13 Posts

Posted - Feb 01 2014 :  08:32:14 AM  Show Profile  Reply with Quote
quote:
Originally posted by gkrenn

I was always exercising, but I too had colon surgery (total colectomy for chronic constipation in 2010) after that surgery ( I came home at 83 lbs and was in the hospital for a month) I was short of breath all the time. I continued to exercise (2.5 MPH on the treadmill, no incline) but was short of breath going up stairs. I've always continued to work. I'm a real estate appraiser, and that was getting hard (measuring houses..) I was just very depressed about how I tried so hard to exercise and was always short of breath. I actually was sent to UW Madison for an evaluation for lung reduction surgery when they asked me if I wanted to be part of a new trial that they were just starting. I tested and qualified and had the coils placed. I maintain 96 lbs. which works great for me. I'm 5'3". I have tons of energy. I actually have to push my exercise to get my heart rate up now where before it went high right away. I'm 59 years old. Both of my parents had COPD and died from it. I did smoke but quit 8 years ago. I actually did not smoke that much but was surrounded by it growing up.

I forgot to ask. Were You on MEDS (inhalers,etc..)? Were You on o2 and what level? Do You still takes MEDS and o2?

Thanx

Don
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gkrenn
Rookie

18 Posts

Posted - Feb 01 2014 :  10:51:07 AM  Show Profile  Reply with Quote
I was, and still use, Advair, Spiriva and Ventolin when I exercise. I've never been on oxygen
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oldky1
Rookie

13 Posts

Posted - Feb 18 2014 :  1:22:59 PM  Show Profile  Reply with Quote
quote:
Originally posted by oldky1

quote:
Originally posted by gkrenn

I was always exercising, but I too had colon surgery (total colectomy for chronic constipation in 2010) after that surgery ( I came home at 83 lbs and was in the hospital for a month) I was short of breath all the time. I continued to exercise (2.5 MPH on the treadmill, no incline) but was short of breath going up stairs. I've always continued to work. I'm a real estate appraiser, and that was getting hard (measuring houses..) I was just very depressed about how I tried so hard to exercise and was always short of breath. I actually was sent to UW Madison for an evaluation for lung reduction surgery when they asked me if I wanted to be part of a new trial that they were just starting. I tested and qualified and had the coils placed. I maintain 96 lbs. which works great for me. I'm 5'3". I have tons of energy. I actually have to push my exercise to get my heart rate up now where before it went high right away. I'm 59 years old. Both of my parents had COPD and died from it. I did smoke but quit 8 years ago. I actually did not smoke that much but was surrounded by it growing up.

I forgot to ask. Were You on MEDS (inhalers,etc..)? Were You on o2 and what level? Do You still takes MEDS and o2?

Thanx

Don



Hello Again
After being screened for qualification, how long was it before You were verified and scheduled for the procedure? I am scheduled 7 days from now.

Thank You

Don
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gkrenn
Rookie

18 Posts

Posted - Feb 18 2014 :  5:00:44 PM  Show Profile  Reply with Quote
I knew right after the screening. After the tests I saw the Dr. and was told I qualified. They had 2 positions that were guaranteed to have the surgery, I was the first. I had the surgery within 3 weeks and the second surgery in 4 months.
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mziegler
Member

USA
97 Posts

Posted - Mar 01 2014 :  4:58:20 PM  Show Profile  Reply with Quote
Just an update on the clinical trail. I was accepted but I am in the Control Group and won't be receiving the coils, at least initally. I just got back from a followup visit. My Hospital, UT in San Antonio, only has 2 patients that have recieved the coils. They are still processing additional patients. I was told that Nation wide there have been 2 deaths of patients in the trial. BOth were from pneumonia and one of those patients was in the control group. I will try to update as I go thru the trial.

Melissa
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SEW4no
Member

127 Posts

Posted - Mar 02 2014 :  09:47:07 AM  Show Profile  Reply with Quote
I checked into the ReNew study at Yale (CT) and the multiple trips to go there was beyond my ability especially during winter months. Initially all that qualified would get the coils, but at some point a control study population would be included.......They were good about sending me all the details but there was no info re if you got sick during the trial, what would happen - would you have to drop out?

Melissa, since you would be a control subject (basically a sham procedure - no coils, but still has risks) did they say how soon afterward they would allow you to have the coils?? Would the coil placement be part of the study and financially covered by them? Would you have to repeat all the testing due to time delay for the next procedure (with the coils?)

I guess I have a hard time understanding why some people would be willing to be a control group when they are in need, and desire, relief from their copd. Would you share your thoughts/reasoning?
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mziegler
Member

USA
97 Posts

Posted - Mar 06 2014 :  1:10:34 PM  Show Profile  Reply with Quote
Sew4no, Per my study info: "After the 12 month visit is complete, those patients assigned to the Control Group may have the opportunity to participate in a separate "follow-on" study to receive the Coil procedure after a medical committee reviews the 12 month study safety data and allows the follow-on study to proceed. If you meet the entry criteria for an approved follow-on study, you will then undergo a bronchoscopy procedure to implant the Coils. The Coils will be provided to the investigator free of charge for this follow-on procedure."

Being in the Control group, there is no procedure done, so no risk. I have to do a 6 min walk, have labs and do a pft each visit. These charges are not covered by the trial and are billed to my insurance. There is some compensation from the trial to offset my costs. I also have to drive about 85 miles to the Facility.

I am willing to partcipate to try to help get new treatments approved.
When I signed up for the study I knew there was a 50% chance I would not be receiving the coils.

I had a small exacerbation and couldn't make one of my appointments, but I was able to reschedule & carry on. In the paperwork they address instances that could end your participation early and illness is one of those, if the treatment is not allowed thru the study, but I don't know what that treatment would be.

I have a wonderful study coordinator. She meets me at the Hospital door with a wheel chair, checks me in and wheels me to all of my appointments, which greatly expidites things.

I hope I have answered some of your questions. I will try to post again further along or if anything changes.

Melissa
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Curtis60
Rookie

USA
1 Posts

Posted - Mar 06 2014 :  5:27:44 PM  Show Profile  Reply with Quote
Do we need to be concerned that the NETT study is already a dozen years old? Somewhere I read that regular LVRS was done at the rate of 4000 per year in the 90s, now only 400 a year because of higher than desired morbidity and quite long hosptalisation in many cases. I have a chance to do LVRS by Dr "magic hands" in a top flight European city, or I personally like the coil procedure alot and could be eligible for it. The peer reviews were top flight and although its young I haven't heard about any dissatisfied customers. I have had regular emphasyma for about 10 years. Had to leave work be disabled and constant oxygen since 2012, which as we know, stinks just as much as those prednisone pills. 10mg daily. I'm new to this wonderful forum. . Btw I have predominant upper lobes damage not sure about exercise tolerance I think I'm good. Any feedback appreciated! I'd sure rather have. Brochioscpoic "procedure" rather than LVRS "surgery" ... Wouldn't you? Curtis
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Mar 06 2014 :  8:26:45 PM  Show Profile  Reply with Quote
Disagree with the quite long hospitalization, Curtis. Average stay is 5 days. Granted, longer than with the coils but the procedure is a bit more proven than the coils.

Why are you on daily prednisone?

And if you're in the U.S., why in the world would you go to Europe to have LVRS? There are several excellent surgeons in the U.S. that are very familiar with this procedure. You can read about my journey to and through LVRS. I had it in 2008 and am still going strong. There are others on my blog that have also had it and are very satisfied with it. However, if you want to wait until the coils are approved, your meds should keep you in decent shape until then. I'm not sure about the pred, though. If you're on daily pred, it sounds like you're in a very serious stage (less than the 20% I had for at least 10 years prior to surgery). Just what is your FEV1, DLCO, TLC, and RV?


****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS




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jmrommes
Contributing Member

1610 Posts

Posted - Mar 06 2014 :  8:50:50 PM  Show Profile  Reply with Quote
As for the NETT study, it is 10 years old, but the results have been followed pretty faithfully. Those LVRS that have been done have been done on the folks who meet the criteria established by the study, and in general they've had a good success rate. Part of the reason for there being fewer of them is that not that many people meet the criteria. As I've followed the various vents, valves, steam and glue trials, I've noticed that they are beginning to mimic the requirements for LVRS, especially the ones that seem to have better results. So that NETT study is useful because to date no one has come up with a better set of criteria for LVRS.

Jean

Exercise not only lets me live, it enables me to have a life.
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Diann-NY
Member

USA
58 Posts

Posted - Mar 15 2014 :  5:56:25 PM  Show Profile  Reply with Quote
The NETT criteria is followed VERY strictly, I found out. After two days of testing at NYPH, some of the tests, qualified me, some of the tests were borderline and ONE test disqualified me by about 5%. So they sent me home without the LVRS. And that is one of the reasons they have such a good success rate - they are very careful about who they allow in the program. However, considering the weather that they had in New York City this winter, I think I am glad that I didn't have to figure out how to brave the storms.

Diann
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Mar 15 2014 :  6:46:47 PM  Show Profile  Reply with Quote
Curtis seems to have disappeared.

****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS




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JeannineR
Rookie

7 Posts

Posted - Mar 24 2014 :  5:30:23 PM  Show Profile  Reply with Quote
I have been invited to participate in the RenEW (coils) at Beth Israel in Boston. I have done some research and have found the results to be quite remarkable. The coils have been approved in Europe since 2012. There are several restrictions on being accepted. Your lungs have to be hyperinflated in order to qualify. Here is the link to the article where I read about the results: http://www.medpagetoday.com/MeetingCoverage/CHEST/35538

I hope these facts encourage others to qualify. What have you got to lose?
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Mar 24 2014 :  7:57:15 PM  Show Profile  Reply with Quote
Here are other criteria:

Criteria

Inclusion Criteria:

Subject is greater than or equal to 35 yrs of age
CT Scan indicates bilateral emphysema
Subject has post-bronchodilator FEV1 less than or equal to 45% predicted
Subject has Total Lung Capacity >100% predicted
Subject has residual volume (RV) greater than or equal to 225%
Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4
Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by a Cotinine test or other appropriate diagnostic test.
Subject has completed a pulmonary rehabilitation program within 6 mos prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 mos prior to baseline testing.
Subject has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy.
Subject (and legal guardian, if applicable) has read, understood, and signed the Informed Consent form.

Exclusion Criteria:

Subject has severe homogeneous emphysema determined by Core Radiology Lab.
Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
Subject has a change in FEV1 of greater than 20% (or, for subjects with pre-bronchodilator FEV1 below 1L, a change of greater than 200mL) post-bronchodilator.
Subject has DLCO of less than 20% of predicted.
Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).
Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
Subject as severe pulmonary hypertension defined by right ventricular systolic pressure of greater than 50mm Hg and/or echocardiogram
Subject has an inability to walk >140m (150 yd) in 6 minutes
Subject has evidence of other severe disease (such as but not limited to lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
Subject has clinically significant bronchiectasis.
Subject has giant bullae >1/3 lung volume
Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices in either lung.
Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.
Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.
Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
Subject has a sensitivity or allergy to Nickel.
Subject has a known sensitivity to drugs required to perform bronchoscopy.
Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).

****************************************************************
Do Not Regret Growing Older. It is a Privilege Denied to Many

You canít change the past but you can ruin the present worrying about the future.

The Bad News: Time flies as you get older.
The Good News: Youíre still the pilot.

Penny's Lung Volume Reduction Surgery

And Our Travel Blog After LVRS





Edited by - PennyPA on Mar 24 2014 7:58:27 PM
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barenstam
Rookie

14 Posts

Posted - Mar 24 2014 :  9:37:09 PM  Show Profile  Reply with Quote
I was evaluated earlier this month for the Renew trials at BI in Boston. I did not met any of the exclusion criteria and I met everyone of the inclusion criteria EXCEPT for the residual volume (RV) of 225%. My score was 221%. My understanding is they've had ten people evaulated and only one person has qualified and had the coils installed. I spoke with that person after they had the first set of coils installed and learned their RV was 226%. I am suppose to go back in four week to take the RV portion of the test again because my RV scores from previous tests have ranged from 225-298%.
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fredtx
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USA
12 Posts

Posted - Jun 07 2014 :  11:30:59 AM  Show Profile  Reply with Quote
I have just looked at the LVRC topic and registered with this Forum. I wanted to let the folks interested in this trial that I am scheduled to have the coils implanted in San Antonio on June 13, 2014.

I took the qualifying tests for this trial on April 24 & 25 and was advised on May 9 that I qualified and chosen by a random computer selection program to receive the coils.

I was Dx'ed with COPD in 2001 and use Spiriva, Perforomist, Albuterol, Azithromycin and oxygen 24/7. Some of the results I had from the LVRC tests were Fev1 21%, RV 256%, TLC 229%, DLCO 28% and walked 200 Meters. Also it was very important that I have been doing pulmonary maintenance rehab for the last 2 years.

I am hoping that I will see an improvement of my QOL and be able to help my wife by doing some of the chores she has had to do due to my condition.


Fred
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fredtx
Rookie

USA
12 Posts

Posted - Jun 16 2014 :  2:07:24 PM  Show Profile  Reply with Quote
Last Friday, the 13th, turned out to be a lucky day for me. I had the LVRC procedure done in San Antonio at the University of Texas Medical Center. It was done on the lower lobe of my left lung and the doctor placed 14 coils in that area. The procedure took 1.5 hours and after getting out of recovery they did a chest x-ray. I then was put in the hospital for observation. In the morning they did another x-ray to be sure everything was ok and once the doctor examined it I was released to go home.

By Saturday evening I was starting to feel pretty good with Sunday being even better. Only issue was discharging of some blood which continues today. This is very normal for Bronchoscopy procedures. It will subside after a few days.

I feel better and only get SOB after exertion but I have noticed that my rebound time has improved. Went to Pulmonary rehab this morning and my exercises seemed to be easier than last week before the procedure.

The healing and recovery will take some time and next month I will return to the hospital to repeat the tests that I took to qualify for this trial so that it may be compared to the initial results. I am very pleased with the procedure and am looking forward to the right lung procedure sometime in the next four months. After just two days my progress has exceeded my expectations.




Fred
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PennyPA
Contributing Member

USA
5767 Posts

Posted - Jun 16 2014 :  4:47:14 PM  Show Profile  Reply with Quote
That does sound encouraging. Let us know if there is any rejection factor although, with the improvements they've made in the last 4 years, you might not have that problem. I know one of the others on one of the boards had the coils and his body eventually said "No thanks, don't want these." I don't remember the time frame though.

What makes this sound neat is that perhaps people that have had LVRS will be able to get the coils as the benefit of their LVRS wears down.

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Edited by - PennyPA on Jun 16 2014 4:48:17 PM
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bjd0316
Rookie

USA
14 Posts

Posted - Jun 16 2014 :  10:17:13 PM  Show Profile  Reply with Quote
Hello, I am new to this forum, but am wondering if the disease keeps progressing, just like it does with lvrs? If so, just like lvrs, can lvrc get more coils? Also, if this procedure becomes available for the public, will it be available in local hospitals, and health insurances pay for these procedures? I am hoping that there will be many available procedures to choose from...so nice, and gives the copd community hope for a better quality of life for once.
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bjd0316
Rookie

USA
14 Posts

Posted - Jun 17 2014 :  04:57:15 AM  Show Profile  Reply with Quote
Hello, I am new to this forum, but am wondering if the disease keeps progressing, just like it does with lvrs? If so, just like lvrs, can lvrc get more coils? Also, if this procedure becomes available for the public, will it be available in local hospitals, and health insurances pay for these procedures? I am hoping that there will be many available procedures to choose from...so nice, and gives the copd community hope for a better quality of life for once.
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fredtx
Rookie

USA
12 Posts

Posted - Jun 17 2014 :  09:31:18 AM  Show Profile  Reply with Quote
In response to your post on LVRC, this procedure does not stop the progressing of emphysema. I do not know what will eventually evolve from this trial. This process is used to determine the answer you seek on the availiability of the use of coils for treating parts of the lung that are no longer funtional and only trap air which is why we emphysema patients get short of breath and increases the residual volume of our lungs which in turn causes our lungs to hyperinflate.

This trial has exclusions for applicants who have had previous LVR surgery, lung transplantation, lobectomy or LVR devices in either lung. That being the case, this trial will not determine whether LVRC can be used on patients who have been excluded fro any of the reasons above and will remain unknown.

I hope someday there will be a method to cure emphysema, until then all we can do is to be hopeful


Fred
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bjd0316
Rookie

USA
14 Posts

Posted - Jun 17 2014 :  11:21:03 AM  Show Profile  Reply with Quote
Thank you so much Fred! I hope they keep coming out with new idea's and medication's, etc. I especially love this support site too, since it is nice to know that we are not alone. Thank uou and everyone else on this site!
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