Notes of EFFORTS members in trials Emphasys's Endobronchial Valve (EBV) or Spiration’s Intra-Bronchial Valve (IBVT)

December 21, 2005

W. Winchell

  I've noticed a flurry of interest and questions pertaining to vents and to the clinical studies being conducted on them and since I've had some experience with this matter I'd like to offer my insights to anyone interested.
  
  In July 2005 I enrolled in the Emphasys Medical study being conducted at Henry Ford Medical Center in Detroit, MI.  I underwent a series of PFT, including FEV-1, FVC, and spirometry, along with two or three others after having abstained from the use of my usual medications for from 12 to 24 hours.  Each PFT was performed a second time after receiving albuterol.  It's my understanding that to be eligible for inclusion participant's FEV-1 had to be between 10% and 40% of the predicted index.  I also had to do a six minute walk, the objective being to finish at whatever speed and distance could be accomplished.  I also had a series of chest x-rays I presume to identify the presence of cancer, which would have been a disqualifying factor.
  
  Finally, I was asked to complete between 13 and 17 sessions of pulmonary rehabilitation.  After completed pulmonary rehab I was re-tested a second time to assure that my PFT's remained within the stated scope of the study.  I was also asked to repeat the six minute walk.
  
    In addition, I had another series of chest x-rays, and also CT scans and a V/Q scan.  The doctors consulting with Emphasys Medical used these test materials to evaluate and grade each lobe of each lung from 0 to 4 with four being the most damaged and least functional.  For the vents to be of benefit a less afflicted lobe must be available for a more damaged lobe to be bypassed in favor of.  For purposes of the study only one lung could be done.
  
    I was also given a stress test (stationary pedaling) presumably to evaluate my heart and related cardio-vascular condition.  This was probably the most difficult of the tests I was required to undergo as it essentially involved pedaling until I could continue no more for whatever reason - SOB or muscular fatigue. 
  
  After all of these test results were evaluated I was "randomized" for inclusion in the vent recipient group and the procedure was scheduled to be performed within two weeks of randomization.  It was my understanding that approximately two thirds of the study participants would be randomized to be vent recipients and one third would be randomized to a control group, which would receive the best currently available treatments and care for comparison to the vent recipients.  My pulmonologist encouraged me by saying that even the control group will receive the best available treatment and care, so I had nothing to lose, and would be first in line for the procedure pending FDA approval.  All costs "related to the study" are paid for by the study sponsor.  Tests, treatments and medications usual to participants are not covered by the sponsor. 
  
  I had six valves implanted by bronchoscope while sedated.  I remember nothing of the procedure and when I awoke in recovery I felt as well as I had before except for a minor sore throat.  I stayed the night in the hospital for observation, as required, and was released the next day to go home.  I did have an inflammatory response to the procedure that was treated by five days of prednisone and by increasing my Advair dosage from 100/50 to 500/50 for two months.  I took about two weeks to get past the inflammatory response and begin to notice improvement.
  
  In most ways the objective of the endobronchial valves is the same a LVRS.  The differences are the valves involve much less surgical risk and they are reversible (removable).  The benefit take more time to be realized, however.
  
  Thirty days after the procedure I returned to Henry Ford Medical Center for my first follow up.  I went through the PFT's, six minute walk, and stress test again.  Chest x-rays were taken to ascertain that the valves had not moved and to determine if the lobe of my lung where they were placed had "collapsed".  I had been told that it may or may not collapse and that benefit can be expected either way.  At this time my FVC had increased by 30% and my FEV-1 by 12% from pre-procedure results.  I covered my distance and desaturated less during my six minute walk, as well.
  
  I also underwent a ninety day follow-up consisting of the same routine.  Both my FVC and my FEV-1 continued to improve from thirty day follow-up test results.  My six minute walk improved, also, as did my stress test results.
  
  My pulmonologist has been very impressed with the results I've experienced.  He's anxious for me to have the other lung done as soon as possible (pending FDA approval) and he's delayed his encouragement for transplant evaluation until my condition becomes more critical.
  
  My experience with the vent trial and the people administering it has been good so far in improving the quality of my life and I hope it will continue to be so when/if the procedure is finally approved.  The damage to my lungs was upper lobe and I was a good candidate for either LVRS or the vents.  My levels of exercise and of endurance have increased post procedurally by 30% by comparison to what I was formerly doing in rehab.
  
  If anyone has any other questions that I can help with, feel free to email me at wwinchell@sbcglobal.net and I will gladly share my experiences.  I believe you will also find a great deal of help is available by contacting study coordinators at the various medical facilities around the country that are conducting trials for Emphasys Medical, as well as other endobronchial valve developers.
 

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June 30,2005
Barbara H.

Just about one year ago, Barbara H was one of the first US patients  in trials of the Emphasys Endobronchial Valves, (the VENT study). A little  bit about the procedure and Barbara's initial response has been reported on  the Internet at sites like
_http://www.atv-ventures.com/news.php?id=150_ http://www.atv-ventures.com/news.php?id=150  . We posted her six month follow-up report earlier, and she has now provided  the following report on her one year checkup.
Frank  B
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Well, how did my 365 check up go??????? Fantastic!!!! I had to bypass  the 6 minute walk and the ergo cycle due to my recent physical problems, but my  PFT's and ABG were great. First, we have to remember, the this valve was  designed by an "healthy" engineer in a lab where all conditions being equal,  that the valve should preform thusly - lobe collapses, FEV1 should rise 10%,  etc. but that is just a projection or an opinion.  
In the real world, we hope that over the course of the year that there  isn't any deterioration in the FEV1, ABG, etc.
 
Now that I've qualified my 365 day check up, let me back up a bit and tell  you that I felt like a failure that my lobe had not collapsed and I was just a disappointment to the trials and to myself by "failing" the hoped for numbers at  the 180 day test. Since then, I have found out that not every bodies lobe  collapses but that does not mean failure. My lobe not collapsing, I believe,  saved me from going to the hospital in December with a severe respiratory infection.
 
Now to get on with the 365 - I have NOT had any deterioration of the FEV1  in a year's time. In the past, it was on a downhill spiral. My ABG is great and I am so full of energy (and unfortunately arthritis) that I am like the Energizer bunny - I just keep going, and going. I said that I would like another valve ASAP but since the FDA has not approved it yet, I will have to wait.
 
With my physical problems, I go to physical therapy in the AM and from  there, I go to Pulmo rehab 3x/week. If someone had suggested this schedule to me  a year ago I would have laughed myself right into the hospital.  
I wish all of you the best of luck and if the valve is offered, I would  jump
at the opportunity again.
 Barbara
 

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Mary Cook

Spent most of the day at Temple Hospital, finding out about the study. I am the last one being accepted there. They had to call the Company to get me in as the cut off date was moved up to this morning & my appointment was not till the afternoon, but they got me in. I will have to start rehab next week and testing in about  two weeks. every thing has to be done by the ,middle of August.  Then I will find if I qualify & if I will get the vent or be in the control group. Going to be a busy 6 weeks, I will have to go in to the city twice a week for rehab, They won't allow me to do it closer to home. Wow the trafic.
Buddy  NJ   s

Jack Meyers
I am in the Pilot Study of Intra-Bronchial Valve System at the University of Washington. This is my schedule. 
                                                              
June 22,2004
    3:00 PM Pulmonary Function Testing - no bronchodilator for 2 hours prior to test
June 23
    10:00 AM ECHO
June 24
    2:00 PM Nuclear Medicine test - QVQ
    3:00 PM Exercise test - wear comfortable clothes and shoes.  You will be exercising on a stationary bicycle.
June 25
    11:00 AM Pre-op History and Physical   followed by Pre-Anesthesia clinic
     1:00 PM 6 Minute Walk Test - don't eat for 2 hours prior and take a quick acting bronchodilator 20 minutes before appointment (an early lunch before the Pre-Op appointment would work)
June 28
    Day of your IBV placement.  Anesthesia will tell you what time to report and where to report.

July 1
Well I'm back home after the valves were implanted on Monday, The week before was testing every day and I think they used every test that has been invented. It is to early to give you a report on the progress, if it works it will take some time for it to show up. I have appointments every week in July for them to check on progress.( I would not like to pay the bill for all of this) The procedure is not hard on you at all I was awake and feeling fine 2 hr, after they finished. I had a little sore throat the next day and sore solar plexus muscles. They done it at about 11:30 am and I was released at 1: pm the next day. I was impressed with the University of Washington Hospital and the staff.  Jack Myers

July 9
  I do not have much to report yet. I got  back from Seattle yesterday, they took x-rays this trip just to make sure the valves were staying put and they were. I go back next week on the 14 th. for 2 days of testing. I may be my imagination but I do believe I can breath a little better than I was. the idea of putting the valves in, is for the air way behind the valve to collapse, so it may take a while and will most likely be different for different people. The other valve study is ahead of this one and I believe they are in clinical trials with that one which would include a lot more people. It is to have the same effect using a different make of valve.

   To answer Franks question as was the criteria the same, as near as I could tell it was. I would think this could be required criteria set up by the FDA.

July 11
      I have been ask by a couple people how I felt the first few days at home. About the worst you can expect is a sore throat, and for me that was not bad, and only lasted a day..  I felt ok as soon as I woke up however it was about a week before I got used to the smaller lung capacity.  I am slowly getting rid of the oxy (I hope) I use 1 liter at night and that may not change. I was using 2 liters at rest when I first got home, and have now today been able to stay at 90-91% at rest without oxy and can walk around with 1 liter and hit 93%.
 I use Foradill twice a day, and Spiriva once a day, they told me to keep using my med. just like I was. I will be doing a PFT at the UW Wed. that will tell some of the rest of the story                                    Jack Myers

July 17
 I just walked to the house from a trip to UW where I done all the test over again. I did not see the Doctor this trip I will see him next wed and then on Thursday, they go back in with the scope, for a look, and make any changes that they think may help. some of the numbers look a little better, but I still desat about the same as before.  Jack Myers

August 3 Update
I went back to Seattle, and done all the test over again, also they went back in for look at the valves, and decided that I needed one more so they put it in. Not much improvement yet. They said it was too early to tell much yet; there is a small improvement in the numbers but not much else. Next appointment Sept. 13,14, &15. Jack Myers

I am Phyllis from Ohio.  I have been a member of Efforts for quite a while, but have not posted until now.  I was being tested at Cleveland Clinic to see if I would qualify for LVRS.  I had heard that they were doing the valve study at the Clinic, so asked if I could get into that and was lucky enough to be the last one of the current group to be included.  I had it done about 2 weeks ago.  The procedure only took about 1/2 hour, but as I was under general anesthetic didn't wake up for about 2 hours.  Then had to spend one night in the hospital.  I had no bad effects from it.

At my one week checkup, they said I could go to 1 or 2 L of oxygen (had been on 3 L) for exercise and could go to room air when at rest.  I could not tell a lot of difference then, but now at almost 3 weeks since the procedure, I find I have a lot more energy to do housework (yuk) and go out to eat and shop.  I have to go back next week for more tests and a repeat of the procedure to see if the valves are still in place.  They put three valves in each of my lungs.  I was able to see them on the x-rays.  I still take Advair and Spiriva and albuterol when needed.  Also take 300 mg. of theophyllin.  Will try to keep you posted as to my progress, but so far, I think it was worth it. 
Phyllis

July 26 2004   I am not exactly sure how the valves work. They showed them to me before I had the procedure done. They are very small, about the size of a thumbtack. They open up like an umbrella once they are inserted. Below is the explanation I copied from the company's explanation.

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"The Intra-Bronchial Valve (IBVT) is a small umbrella-shaped valve placed in the bronchial tree using standard bronchoscopic techniques to seal targeted airways. The one-way valves are designed to prevent air from entering isolated sections of the lung while allowing the normal clearance mechanism of mucus to occur. By limiting ventilation in part of the diseased lungs, the remaining healthier portions of lung may function with better efficiency. The valve's design allows it to be easily delivered and implanted and, if necessary, repositioned or removed using standard bronchoscopic tools."

Jan 10, 2005

Hi everyone - It's been a long time since I posted about my experience with the valves I received on this program. 

 

I received the valves (3 in each lung) on July 7, 2004 and had my six-month checkup last week.  The doctors at Cleveland Clinic agreed with me that the valves were not helping me at all.  Sorry to report that.  I was hoping that maybe it just took longer to show improvement, but I guess not in my case.

 

However, they are going to give me a chance to qualify for a lung transplant, even though I am 66 and they usually cut off at age 65.  I have studied the literature they gave me on transplant surgery, and it seems as though there are a lot of risks of infection and other diseases connected with it.  I would love to hear from any of you who have had this surgery and whether you would recommend it.

Phyllis Dickey - OH

Don Gimeson 

7/30
Here it is 5 p. m. Friday and day has just flew. We got home late Thursday and have not accomplished very much so far, just rest and unwinding, nourishment and coffee.

I received five valves in lowest lobe of right lung and completely eliminated it.  I checked into the crc unit at 8 am and went to operating room at 1130 and was fully awake and going to recovery at 1230.

Everything went exceptionally well, the valves took about five minutes each, and went very smoothly as I am told. I am on antibiotics as a precaution due to a little cloud showing on x-ray of eliminated lobe, but they think that is due to the procedure.

I have not noticed a great deal of improvement yet, except for little things that occur normally due to weather changes etc.  It will normally take a week or two before I will notice any definite improvement, however I am very definitely not any worse. The only trouble I am experiencing is my bowels and this keyboard is not spelling all the words right, so I will quit for now and get this sent. Thanks for all the prayers and support- Don and Allene

8/2
Nothing negative, all positive, sure is nice to eat a meal without having to stop and catch my breath one or two times, also larger without suffering, am eating like a horse,(relax girls, my 123 lbs needs it) am noticing minor improvements such as o2 not dropping as fast, neb treatment only down to 92 when finished. Still on same amount of O2 resting and exercise, but do not get as sob, feel great even with weather like it is today, heat index 102 to 110 with dew point in 70's, barometer was 29.87. Walked outside this am about 1/2 mile but will resort to bicycle and treadmill if weather continues. Don G

2/4/05

Went to iowa city feb 1st for 6 month testing after receiving the valves (non-invasive lung volume reduction surgery).  Did complete blood work, ekg, ergocycle, (sort of bicycle computor controlled stress test) pulmonary function tests, 6 minute walk, c t scan, x-rays, and a v q scan.  Also  got time with two different doctors for questions and answers.  Hindsight is usually 20/20 and they would do the exact same thing again if they had to do over.  I walked farther, stress test improved, pft's showed slight improvement, got to see x-rays briefly and right lung is now a hair shorter then the left.  The valves were placed in low right lung so that is good. I am feeling good except for the normal everyday stresses, and still and will always require supplemental oxygen all the time as I have for several years now. Don G.

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