Lung Valves

[pollyjj]

What criteria do you have to meet to have lung valves, and how good are they.

polly xx

[Hidden]

I found this on the website.

Lung Valves Have Some Benefits for Emphysema

By Todd Neale, Staff Writer, MedPage Today

Published: September 22, 2010

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner

Action Points

Explain to interested patients that implantation of an endobronchial valve in patients with advanced emphysema resulted in modest improvements in lung function and exercise tolerance.

Also explain that these benefits were accompanied by an increase in pneumonia, chronic obstructive pulmonary disease (COPD) exacerbations, and hemoptysis.

Patients with advanced emphysema received modest improvements in lung function and exercise tolerance after implantation of an endobronchial valve aimed at reducing pulmonary hyperinflation, a randomized trial showed.

Compared with optimal medical therapy alone, patients who also received a valve had a 6.8% relative improvement in forced expiratory volume in 1 second (FEV1) (P=0.005), according to Frank Sciurba, MD, of the University of Pittsburgh, and colleagues.

The valve recipients also extended their six-minute walk distance by 5.8% compared with the controls (P=0.04), the researchers reported in the Sept. 23 issue of the New England Journal of Medicine.

But the benefits were accompanied by an increase in pneumonia, chronic obstructive pulmonary disease (COPD) exacerbations, and hemoptysis.

In an accompanying editorial, Antonio Anzueto, MD, of the University of Texas Health Science Center at San Antonio, noted that the use of medical therapy was not standardized during the study, which hampered interpretation of the findings.

Without such standardization, "it is impossible to fully understand the benefits and potential complications of new treatments," he wrote. "In my opinion, it is premature to recommend the routine use of endobronchial valves in patients with COPD."

Endobronchial valves allow air to escape a pulmonary lobe but not enter it, and they have been shown in uncontrolled trials to reverse hyperinflation related to advanced emphysema and improve lung function.

Sciurba and his colleagues aimed to compare the Zephyr endobronchial valve with standard medical therapy in the Endobronchial Valve for Emphysema Palliation Trial (VENT), which randomized patients with advanced emphysema to valve implantation (220 patients) or the control group (101 patients).

Before randomization, all patients underwent six to eight weeks of pulmonary rehabilitation and optimized medical management.

Endobronchial valves were implanted in the lobe with the highest percentage of emphysema and the greatest degree of heterogeneity (the difference in percentage of emphysema between lobes in the treated lung) using a flexible bronchoscope. The researchers administered prophylactic antibiotics after implantation.

The mean number of valves placed per patient was 3.8.

After six months, there was an absolute increase in FEV1 of 1% of the predicted value in the valve group and an absolute decrease of 0.9% in the control group, yielding a 6.8% relative between-group difference. The findings were similar for the six-minute walk test.

There appeared to be greater benefits from valve implantation in patients with greater heterogeneity of emphysema and intact interlobar fissures.

Anzueto noted in his editorial that lung volumes did not change in either group during the study.

"Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms," he wrote.

There were modest improvements in quality of life, dyspnea, incremental exercise response, and supplemental oxygen use in the valve group.

The composite safety endpoint -- including death, empyema, massive hemoptysis, pneumonia distal to valves, pneumothorax or air leak of more than seven days' duration, or ventilator-dependent respiratory failure lasting more than 24 hours -- occurred at a nonsignificantly higher rate in the valve group at six months (6.1% versus 1.2%, P=0.08).

That numerical difference was primarily driven by an increase in pneumonia, which occurred in 4.2% of patients with endobronchial valves by 12 months.

By six months, there were six deaths, all in the valve group. The between-group difference was not statistically significant (P=0.19).

After one year, valves were removed from 31 patients for various reasons, including valve migration, patient's request for an unspecified reason, pneumonia management, placement in the incorrect lobe, COPD exacerbations, hemoptysis, and other reasons.

The study was supported by Emphasys Medical (now Pulmonx), which makes the valve used in the study, and by a grant from the National Institutes of Health.

Sciurba reported financial relationships with PneumRx and Emphasys.

Anzueto reported being the co-chair of the U.S. COPD Coalition and a member of the executive and scientific committees of the Global Initiative for Chronic Obstructive Lung Disease. He reported financial relationships with GlaxoSmithKline, Bayer-Schering Pharma, Boehringer Ingelheim, AstraZeneca, Dey Pharma, Sepracor, Forest Laboratories, Pfizer, Lilly, Pneuma Lab, Schering-Plough, and the National Heart, Lung, and Blood Institute.

Primary source: New England Journal of Medicine

Source reference:

Sciurba F, et al "A randomized study of endobrachial valves for advanced emphysema" N Engl J Med 2010; 363: 1233-1244.

Additional source: New England Journal of Medicine

Source reference:

Anzueto A "Endobrachial valves to reduce lung hyperinflation" N Engl J Med 2010; 363: 1280-1281.

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Todd Neale

Senior Staff Writer

Todd Neale, MedPage Today Staff Writer, got his start in journalism at Audubon Magazine and made a stop in directory publishing before landing at MedPage Today. He received a B.S. in biology from the University of Massachusetts Amherst and an M.A. in journalism from the Science, Health, and Environmental Reporting program at New York University. He is based at MedPage Today headquarters in Little Falls, N.J.

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[pollyjj in reply to Hidden]

Thanks for this.

[davy1192]

Hi polly, johnwr has had this op and has said on this site before he would answer questions on this, hopefully he will see your question and reply

regards davy

[pollyjj]

Thanks davy will wait and see if he does not I may PM him.

polly xx

[johnwr in reply to pollyjj]

Hi Pollyjj,

First of all,I would say that you should disregard the first answer you got. Things have moved on considerably since that article was published, and I suspect that it was out of date then. That study was carried out in USA, and although various attempts have been made over the last 40 or so years, it is only since the early 2000,s that significant success has been made, when the current plastics were developed. After a number of failures in the early trials, the US administration became reluctant to allow trials, so the centre of activity moved to Europe. Pulmonx set up a manufacturing laboratory in Switzerland, and started working with surgeons in Germany and the UK. With valves made from new materials, and the development of a diagnostic tool to more accurately place the valves, trials proved to be far more successful than previous trials in the US. Germany, which has a different funding system to us allowed the procedure into general practice before us, and I understand now has in excess of 5000 operations. In the UK, the operation only gained NICE approval for general use last year. The NHS has still to add it to its general list. Cases go forward by having to gain approval via funding committees on an individual basis.

So what are the surgeons looking for? Primarily, they want patients with severe lung damage. That damage, they would like to be 'patchy' rather than evenly spread, in other words big holes in fewer locations rather than lots of little holes spread throughout the lungs. Ideally, they also want patients who do not have complications caused by other conditions, eg cardiac or diabetes, although they will be considered if they are in a stable condition and fairly easily managed. Also they are looking for patients who are keen to do the best they can in keeping fit and managing themselves in terms of medication and mobility. Don't be put off from getting a referral to a consultant who is doing the procedure. Even if you are turned down this year, all the results of the tests you take will be recorded, and can be used as a base line for comparison for future reference. Should your condition change after a time, you may be able to get another referral, and be successful. Advances are happening all the time, and these push the boundaries of what is possible.

I have put forward on healthunlocked.com a link to a good video which explains in simple terms what emphysema is, and how the valves are fitted. I have also written a couple of blogs, one is about my experiences of having the valves fitted. The other is about breathing techniques, intended to explain how breathing works, and what works best for us with poor lungs. The links are bellow.

youtube.com/watch?v=7C6CGqX...(Not working as expected?)

blf.healthunlocked.com/blog...

blf.healthunlocked.com/blog...

Hope this gives you a start, when you have more questions, ask either here or by PM.

breathe easy, and best wishes for the New Year

Johnwr

Reply to this

[Hidden]

Hi Polly, if you are in UK, your NHS consultant will be able to advise you if indeed you could qualify and if you would benefit. I believe in UK even paying privately you won't get the op if you don't need it or it would not be of benefit to you.

However I daresay its a different kettle of fish in other countries.

[caroleoctober]

Hi Polly, I have an appointment with my consultant on Monday to discuss the possibility of having pulmonary valves inserted, will let you know how I get one.

Carole x

[pollyjj in reply to caroleoctober]

Thank you Carole, best of luck for monday.

polly xx

[caroleoctober in reply to pollyjj]

Ooops meant on not one!!