Clinical Effectiveness of the Pneumrx® Coils for the Treatment of Severe Emphysema with Hyperinflation
The Burden of Emphysematous Chronic Obstructive Lung Disease
The Use of Bronchoscope and Coils in Treating Chronic Obstructive Pulmonary Disease
Every Breath You Take – The Lung and Emphysematous Chronic Obstructive Pulmonary Disease
Turn Blue: Living with Chronic Obstructive Lung Disease
THE COIL IS DESIGNED TO:
• Reduce air trapping and hyperinflation
• Increase elastic recoil
• Tether open small airways to prevent airway collapse
• Improve exercise capacity, lung function and quality of life
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Dr Charles Easmon, Editor
Clinical Effectiveness of the Pneumrx® Coils for the 3 Treatment of Severe Emphysema with Hyperinflation
Mark Greener BSc (hons), MRSB (markgreener@virginmedia.com)
The Two Elements of COPD A ‘Shape Memory’ Coil An
Dr
Pulmonary
(COPD) Anton Engler, Medical Correspondent When Lung Function Fails COPD Subtypes The St George’s Respiratory Questionnaire
The spoiled lung saved by coils
Many a General Practitioner has and will continue to experience ‘heartsink ’ patients. A great deal amongst these will be his or her patients with chronic emphysematous lung disease and we might add a new categorisation of ‘lung sink’ patients. Emphysema is the alveolar damage part of chronic obstructive airways (pulmonary) diseases (COPD). The other type of COPD is caused by damage in the bronchi and/ or bronchioles. The following articles focus on COPD emphysema in which air is trapped in the lungs and the lungs have less than normal recoil with an effect of symptomatic breathlessness, tiredness and signs of poor blood oxygenation and carbon dioxide retention. Patients are often desperate for a solution to the misery of their lives. Lives blighted by breathlessness and the vicious cycle of anxiety, which exacerbates it even more. Lives in which the lack of exercise capability frustrates their mental health and makes them dependent on others, and is compounded by poor mobility. An independently mobile person, without thinking about it, can choose when, how and where to associate freely with their friends
and colleagues, but the more severe cases of emphysematous lung disease are denied this social release. The four walls of a room in the house or care environment become a cage.
10 years ago GPs or Clinical Commissioning Groups would secretly throw up their hands as these patients walked or wheeled their way through the door. Medication was not the answer and most surgical options were dangerous, flawed with complications and/or fatal in poorly selected patients . However, science progresses and the use of ‘shape-forming’ coils inserted via a bronchoscopic procedure under sedation or short duration general anaesthetic (30-45 minutes) has now been shown to safely provide a solution for many of the more than 1 million emphysematous lung disease patients in the UK. Now both the GP and the patient have the potential to sigh a ‘breath of fresh air’.
Dr Charles Easmon Editor
Dr Charles Easmon is a medical doctor with 30 years’ experience in the public and private sectors. After qualifying as a physician, he developed his interests in occupational medicine, public health and travel diseases.
References:
1 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080217/ Accessed 23/6/2016
2 http://www.medscape.com/viewarticle/502203_5 Accessed 23/6/2016
3 https://www.nice.org.uk/guidance/ipg517/chapter/4-Efficacy Accessed 23/6/2016
Mark Greener BSc (hons), MRSB (markgreener@virginmedia.com)
ABOUT1.2 million people in the UK have been diagnosed with chronic obstructive pulmonary disease (COPD).1 Although clearly common, this figure probably underestimates the true burden. According to the NHS, three million people in England may have COPD,2 which can cause numerous debilitating symptoms including breathlessness, persistent cough, frequent chest infections, fatigue and weight loss.3 The in-hospital mortality rate for an unplanned COPD-related admission is around 8%.4
Managing this clinical burden costs the NHS more than £800 million a year. Severe COPD costs the NHS almost ten times more to treat than mild disease. In addition, lost productivity due to COPD in Great Britain could exceed £3.8 billion a year.2 This article summarises the evidence showing that PneumRx® Coils improve exercise capacity, lung function and health related quality of life (HRQoL) in patients with severe COPD, characterised by emphysema and hyperinflation.
Essentially, two elements – emphysema and airway obstruction – contribute to COPD, although their relative importance to the clinical picture varies between patients.5 Emphysema, the focus of this feature, follows damage to the alveoli. As a result, the airspace gradually enlarges, thereby increasing the residual volume. The remaining alveoli show reduced elastic recoil. In turn, gas exchange becomes compromised and the lungs trap air (hyperinflation).6, 7
In people with COPD, emphysema is often more debilitating than airway obstruction.5 On average, COPD patients with emphysema have a lower body mass index and fat-free mass, more marked airflow obstruction, increased
dyspnoea (breathlessness) and a poorer health HRQoL than those with predominately airwaysrelated COPD 5
On-going research offers unprecedented insights into the multiple causes of emphysema, implicating numerous genetic and environmental risk factors and pathological mechanisms.5, 6 Currently, however, lung transplantation offers the only prospect of a cure.6 Smoking cessation can slow COPD progression. Nevertheless, in people with emphysema who quit smoking, lung function continues to decline more rapidly than in healthy people.6
Against this background, Lung Volume Reduction Surgery (LVRS) typically removes 20-30% of each lung, targeting the least functional areas. As such, LVRS aims to improve airflow, diaphragm and chest wall mechanics, and gas exchange in the rest of the lung.3 In selected patients (such as those with predominately upper lobe emphysema8), LVRS can improve pulmonary function, walking distance and HRQoL, and, in a subset of patients, reduce mortality. Unfortunately, LVRS is associated with high cost as well as substantial morbidity and proceduralrelated mortality.9
Because of these limitations, researchers are investigating alternatives to LVRS. Endobronchial one-way valves, for example, block the airways that supply the most damaged areas, redirecting the airflow into healthier parts of the lung.9 However, these valves block all the airways supplying the lobe and are only suitable for about a third of people with severe emphysema.10
PneumRx® Coils are made of an alloy of nickel and titanium called nitinol, widely used in medical implants including cardiac stents and bone
Smoking cessation can slow COPD progression. Nevertheless, in people with emphysema who quit smoking, lung function continues to decline more rapidly than in healthy people
More recently, a study of 10 patients with severe airway obstruction suggested that PneumRx® Coils improve hyperinflation, airway resistance, exercise capacity and HRQoL in homogeneous emphysema
anchors. Nitinol is a ‘shape memory alloy’. In other words, a PneumRx® Coil regains its initial coiled shape after being straightened for insertion using a bronchoscope and fluoroscopic guidance. Each procedure takes about 30–45 minutes and is less invasive than LVRS. PneumRx® Coils are available as 100, 125 and 150 mm lengths to accommodate various airway lengths.7,8,11 The manufacturer recommends inserting coils into the contralateral lung within 45-60 days of the first procedure.11
During a typical procedure, a patient receives 10-11 PneumRx® Coils throughout an upper lobe or 11-14 coils in a lower lobe. As they regain their initial shape, the PneumRx® Coils gather up ‘loose’ lung tissue. This creates tension in the airways and, in turn, mechanically increases elastic recoil. Multiple coils implanted throughout a lobe are intended to distribute the increased tension and tether small airways to prevent collapse. PneumRx® Coils are designed to reduce air trapping and hyperinflation, and keep the airways open.7,11
As such, PneumRx® Coils are intended to reduce airway resistance and thus improve lung ventilation. Moreover, inserting PneumRx® Coils shifts preferential filling of the lung from diseased to healthier tissue. Indeed, the authors of the RESET study (see below) described PneumRx® Coils as the “first bronchoscopic intervention for patients with severe emphysema to have clinically meaningful benefits”.12
The first patient received PneumRx® Coil in 2008. 11 Since then several studies have confirmed that PneumRx® Coils improve exercise capacity, lung function and HRQoL in patients with severe emphysema and hyperinflation.8-10,13-15 The benefits seem to persist for at least 3 years.16 Moreover, several studies are currently underway, including:
• A large post-market observational registry (NCT01806636).
• A study assessing the feasibility and safety of re-treatment (NCT02012673).
• A study to identify factors that predict treatment response and explore underlying physiological mechanisms (NCT02179125). These studies should help further define the role of PneumRx® Coils in COPD management.
The CLN0011 study enrolled 60 patients treated in 11 European centres. The patients – aged, on average, 60.9 years with a forced expiratory volume in 1 second (FEV1) of 30.2% of predicted – received a median of 10 coils in each lobe. The authors defined responders as showing minimal
clinically important differences of:
• FEV1 ≥12%
• Residual volume ≥350ml
• Six-minute walking distance (6MWD; ≥26m)
• St George’s respiratory questionnaire (SGRQ): reduction of ≤4 and ≤8 points.
A reduction in the score of this widely used measure suggests an improvement in HRQoL.
Fifty-eight patients were followed for six months and 34 at both six months and a year.10
Lung function improved six months after PneumRx® Coil insertion: 48.0% of patients were responders based on FEV1 and 64.8% based on residual volume. After a year: 40.6% and 57.6% were responders respectively. FEV1 and residual volume showed significant improvements at both times. In the 34 patients followed for a year after insertion, 6MWD improved significantly by means of 42.4 and 51.4 m at six and 12 months respectively, equivalent to responder rates of 52.8% and 60.0% respectively. In line with the respiratory and functional benefits, HRQoL significantly improved at 6 and 12 months (74.1% and 65.6% were responders based on ≥4 points respectively; 61.1% and 53.1% were responders based on ≥8 points respectively).10
The benefits seem to persist for at least 3 years. In the cohort of 22 patients from different studies with similar inclusion criteria followed up after three years:16
• 59% showed at least 4 and 8 point improvements on the SGRQ
• 40% showed a difference in 6MWD ≥26m
• 38% showed a difference in FEV1 ≥10%
• 19% showed a change in residual volume of ≤ 400 ml.
Although the study confirms long-term efficacy, as might be expected with a progressive disease, the benefits of PneumRx ® Coils gradually abate as the underlying condition worsens. 7 The retreatment study will offer important clinical information in this setting.
The RESET study compared 44 PneumRx® Coil procedures in 23 patients, with usual care, again in 23 patients. Ninety days after the procedure, 65% and 57% of the PneumRx® Coil group showed ≥4- and ≥8-point improvements in the SGRQ respectively, the study’s primary end point. These proportions were statistically greater than the 22% and 13% of the usual care group respectively that showed this improvement. In addition:
• 57% and 17% of the PneumRx® Coil and usual care group respectively showed a 0.35 L reduction in residual volume.
• 74% and 17% of the PneumRx® Coil and usual care group respectively showed a 26 m improvement in 6MWD.
• 57% and 26% of the PneumRx® Coil and usual care group respectively showed a 10% improvement in FEV1, although this was not statistically significant.12 Again these benefits were sustained long term. For example, a year after the procedure the SGRQ score had improved by 6.1 points compared to baseline. FEV1 improved by 8.9% and 6MWD by 34.1m.7
The REVOLENS study enrolled 71 men and 29 women (mean age, 62 years). Six months after the procedure, 36% of patients who received PneumRx® Coils showed an improvement of at least 54m in 6MWD. This compared to 18% of those in the usual care group, which is equivalent to an 18% improvement with PneumRx® Coils. The mean between-group differences at 12 months favouring PneumRx® Coils compared to usual care were 0.08 L for FEV1, 21m for 6MWD and 10.6 points improvement on the SGRQ. All these differences were statistically significant.15
Several other investigations, including pilot and preliminary studies, support the benefits of PneumRx® Coils. A meta-analysis encompassed 2,536 PneumRx ® Coils placed during 259 procedures in 140 patients. Six and 12 months after treatment, significant improvements emerged for FEV1 (0.08 L increase at both times), residual volume (–510 and –430 ml respectively), 6MWD (44.1 and 38.1 m respectively) and SGRQ (–9.5 and –7.7 points).13
The distribution of alveolar damage can vary markedly between patients. In some cases, alveolar damage is distributed relatively evenly through the lungs (homogenous emphysema).
In other people, the damage is more localised (heterogeneous emphysema). Partly because LVRS is most effective when surgeons can identify a clear anatomical target,7 most studies assessing treatments for emphysema enrolled people with heterogeneous disease. Against this background, post-hoc analyses of the CLN0011 study showed significant responses for SGRQ, 6MWD and residual volume in homogeneous as well as heterogeneous emphysema.10 In the metaanalysis, no difference in the improvement in FEV1, residual volume, 6MWD or SGRQ emerged between heterogeneous and homogeneous emphysema.13
More recently, a study of 10 patients with severe airway obstruction suggested that PneumRx® Coils improve hyperinflation, airway resistance, exercise capacity and HRQoL in homogeneous emphysema. Patients received a median of 11 coils in each lung. Six months after the procedure:
• 6MWD had improved from 289 to 350 m
• Forced vital capacity had improved from 2.17 to 2.55 L
• Residual volume had improved from 5.04 to 4.44 L
• SGRQ score had improved by 25 points. All these were statistically significant and 70% of patients were responders based on the minimal clinically important differences for residual volume, 6MWD and SGRQ.8
PneumRx® Coils are well tolerated and compare favourably with LVRS.7 In the CLN0011 study, which enrolled 60 patients, no serious adverse events emerged during the procedure. Within 30 days, seven COPD exacerbations, six pneumonias, four pneumothoraces and one haemoptysis occurred that the authors regarded as serious adverse events. About half of patients develop very mild haemoptysis or coloured septum, which does not require treatment. About a third report chest discomfort, which required no treatment or simple analgesia. The authors remark that the rate of post-procedural exacerbations and pneumonia was similar to that following implantation of endobronchial one-way values.10
No coil migrations or unexpected adverse events occurred during the three-year follow up. The prevalence of pneumonia declined from 46% in the first year, to 7% between year 1 and 2, and 5% between years 2 and 3. Hospitalisations due to COPD also declined over the three-year follow up: 51%, 37% and 36% respectively.16
In the meta-analysis of 2,536 coils placed in 140 patients, 37 COPD exacerbations and 27 pneumonias requiring hospitalisation occurred
PneumRx® Coils are made of an alloy of nickel and titanium called nitinol, widely used in medical implants including cardiac stents and bone anchors
Emphysema is a complex disease that can markedly undermine patients’ ability to perform activities that most people with normal lung function take for granted. Unfortunately, a cure remains a distant prospect
in the year after treatment. The incidence of severe COPD exacerbations was 3.1% during the first 30 days after the procedure, 2.9% per month between 30 and 180 days and 2.3% a month between 6 months and a year. The incidence of pneumonia as a serious adverse event was 3.5%, 1.0% and 2.1% respectively. Pneumothorax requiring a chest tube occurred during 3.5% of procedures and in 6.4% of patients.13
Emphysema is a complex disease that can markedly undermine patients’ ability to perform activities that most people with normal lung function take for granted. Unfortunately, a cure remains a distant prospect. However, a growing evidence base shows that in patients with severe emphysema and hyperinflation, PneumRx® Coils improve exercise capacity, lung function and HRQoL for people with this distressing, disabling and often deadly disease.
1 BLF. (British Lung Foundation) Chronic obstructive pulmonary disease (COPD) statistics statistics.blf.org.uk/copd?gclid=COeQ5tD6ycsCFUE_GwodiXYPKw Accessed March 2016.
2 NHS. COPD Commissioning Toolkit: A Resource for Commissioners Publication date: 2 August 2012 Available at: http://tiny.cc/0bxmcy Accessed March 2016.
3 NICE. Lung volume reduction surgery for advanced emphysema www.nice.org.uk/guidance/ipg114 Accessed March 2016.
4 Chalder MJE, Wright CL, Morton KJP, et al. Study protocol for an evaluation of the effectiveness of ‘care bundles’ as a means of improving hospital care and reducing hospital readmission for patients with chronic obstructive pulmonary disease (COPD). BMC Pulmonary Medicine. 2016;16:35.
5 Wan ES, Silverman EK. Genetics of COPD and emphysema. Chest. 2009;136:859-66.
6 Suki B, Sato S, Parameswaran H, et al. Emphysema and mechanical stress-induced lung remodeling. Physiology. 2013;28:404-13.
7 Zoumot Z, Kemp SV, Singh S, et al. Endobronchial Coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS ONE. 2015;10:DOI:10.1371/journal.pone.0122656.
8 Klooster K, ten Hacken NHT, Franz I, et al. Lung volume reduction coil treatment in chronic obstructive pulmonary disease patients with homogeneous emphysema: A prospective feasibility trial. Respiration. 2014;88:116-25.
9 Herth FJ, Eberhard R, Gompelmann D, et al. Bronchoscopic lung volume reduction with a dedicated coil: a clinical pilot study. Therapeutic Advances in Respiratory Disease. 2010;4:225-31.
10 Deslee G, Klooster K, Hetzel M, et al. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014;69:980-6.
11 PneumRx®. Product information supplied by PneumRx®
12 Shah PL, Zoumot Z, Singh S, et al. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. The Lancet Respiratory Medicine. 2013;1:233-40.
13 Slebos DJ, Hartman JE, Klooster K, et al. Bronchoscopic coil treatment for patients with severe emphysema: a meta-analysis. Respiration. 2015;90:136-45.
14 Slebos DJ, Klooster K, Ernst A, et al. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012;142:574-82.
15 Deslée G, Mal H, Dutau H, et al. Lung volume reduction coil treatment vs usual care in patients with severe emphysema: The REVOLENS randomized clinical trial. JAMA. 2016;315:175-84.
16 Hartman JE, Klooster K, Gortzak K, et al. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015;20:319-26.
Dr Charles Easmon, Editor
Cigarettes, pollution, indoor cooking, industrial exposures and some autoimmune diseases have devastated the lungs of millions of people worldwide. In the United Kingdom it is estimated by the British Lung Foundation1 that 3 million people have chronic obstructive lung disease. The World Health Organisation estimates that 6% of global deaths are related to Chronic Obstructive Pulmonary Disease (COPD).
Doctors used to smoke quite happily in the UK and soldiers and other employees were encouraged to do so. The researchers Sir Richard Doll3, Sir Austin Bradford Hill4 and lattery Sir Richard Peto5 did their pioneering studies on the effects of smoking based on doctors who smoked and they first made us realise the effects of, not only mortality, cardiovascular disease and cancer but also chronic lung disease.
In the UK we are fortunate to have a Committee on the Medical Effects of Air Pollution6 (COMEAP). Pollution is a more recent area for research and a current focus is on the damaging effects of particulate matter less than 2.5 microns in size7 (PM2.5). Clear evidence now exists that prolonged exposure to small particles from pollution will cause or contribute to chronic obstructive lung disease. A cyclist in London has to weigh up the health effects of cycling versus the negative effects of pollution exposure8, many mitigate the risk with face masks. The ideal face mask is expensive on a daily basis at over £59 but FP5/P3 or equivalent is likely to reduce PM2.5 exposure to insignificance unlike surgical masks which with respiration moisture become ineffective in a matter of minutes. From a public health point of view controlling fossil fuel fumes and reducing exposure to them are key. The move to hybrid or electric vehicles should decrease future problems with particulate matter exposure. In areas of the world with high pollution such as Beijing or Mexico City residents are in a classic
Catch-22 situation since they are afraid to walk in the pollution so choose to drive which, of course, adds to the problem.
Indoor cooking is a common phenomenon of poorer nations who have no choice and the amount of smoke exposure will have definite effect on the lungs should the individuals live long enough to experience it10. In the UK chefs in poorly ventilated locations cooking barbeque style foods are at risk. In previous times Environmental Health Officers11 would have been expected to find many of these cases and would have issued prohibition notices to the offending employer. Sadly, cuts to council budgets mean less environmental health officers are available to inspect premises. As a General Practitioner, it will always be important to take a comprehensive occupational history of all your patients but especially those with chronic lung diseases.
The autoimmune connection to COPD relates to anti-tissue antibodies12 and is still in the relatively early stages of study.
The quality of life for those with lung disease is severely compromised. The worst cases cannot walk and most use assisted mobilisation, if it is affordable and available. Some find it even hard to talk. The lack of exercise capacity may lead to cachexia or may often lead to obesity and the associated complications which may include diabetes and early heart disease. For many who cannot walk 50 metres on land, flying is not an option at all and for others only if extra oxygen is prearranged with the airline, since at 33,000 feet the cabin altitude is equivalent to being at the top of a mountain of 8,000 feet13 high where the air is thinner, and those with poor starting oxygen saturation fall rapidly down the S-shaped curve.
Chest infections with flu viruses or bacterial pneumonias can be devastating to the health of those with chronic lung diseases and in many cases are fatal. There was a time when
The World Health Organisation estimates that 6% of global deaths are related to Chronic Obstructive Pulmonary Disease (COPD)
The worst cases cannot walk and most use assisted mobilisation, if it is affordable and available
pneumonia was called ‘the old person’s friend’. Lung infection of any kind can be like the last puff of wind that sends a ship over a waterfall in turbulent currents.
COPD costs can be measured at the individual level and at the societal level, in terms of lost productivity, reduced quality of life and costs to the National Health Service (NHS). NHS costs have been estimated as more than £800 million per year and the societal costs in terms of lost productivity due to COPD in Great Britain is estimated as at least £3.8 billion per year14
Medication has offered very little help to COPD patients as medication is not going to change the lung structure and produce the mechanical changes required to improve ventilation. Up to the introduction of ‘shape-memory’ coils surgery held all the therapeutic aces over medication. Removing diseased parts of the emphysematous COPD lung helped some patients for whom it was safe and indicated as did blocking off some airways by endoscopic means. A new set of lungs has in some cases been the ultimate surgical success story but, as we are all aware, replacement lungs
are not readily available as and when needed. The clinician’s mantra is to ‘first do no harm, but sadly, many of the surgical procedures for emphysematous COPD have both high morbidity and mortality.
The introduction of coils placed via a bronchoscope in a 30-40 minute procedure with either sedation or general anaesthetic has been a true game changer in the therapeutic management of emphysematous COPD patients. The coils have been shown in multiple studies to increase quality life, reduce breathlessness, tiredness and six minute walking distance limitation, while showing improvements in signs and symptoms in mixed measures such as that used in the St George’s Respiratory Score.
Relieving the respiratory distress of those with chronic lung disease has been very difficult until the modern technology of coils arrived. With this technology, restoration to normal is clearly not possible but significant symptomatic improvements can be made and major marginal improvements of quality of life obtained.
1 https://www.blf.org.uk/support-for-you/copd Accessed 21/6/2016
2 http://www.who.int/mediacentre/factsheets/fs315/en/ Accessed 21/6/2016
3 https://www.theguardian.com/science/2006/dec/08/cancer.uk Accessed 21/6/2016
4 http://www.ncbi.nlm.nih.gov/pubmed/9246794 Accessed 21/6/2016
5 https://www.ndph.ox.ac.uk/team/richard-peto Accessed 21/6/2016
6 https://www.gov.uk/government/groups/committee-on-the-medical-effects-of-air-pollutants-comeap Accessed 21/6/2016
7 http://tiny.cc/x3wmcy Accessed 21/6/2016
8 http://tiny.cc/b4wmcy Accessed 21/6/2016
9 http://www.screwfix.com/c/safety-workwear/dust-masks-respirators/cat850348 Accessed 21/6/2016
10 http://www.who.int/mediacentre/factsheets/fs292/en/ Accessed 21/6/2016
11 http://www.rehis.com/environmental-health-officer/what-do-ehos-do Accessed 21/6/2016
12 http://www.ersnet.org/chronic-respiratory-disease/item/4211-copd-an-autoimmune-disease.html Accessed 21/6/2016
13 http://www.iata.org/publications/Documents/medical-manual.pdf Accessed 21/6/2016
14 http://tiny.cc/q9wmcy Accessed 22/6/2016
Dr Charles Easmon, Editor
Coil Systems are ‘intended to improve exercise capacity, lung function and quality of life in patients with both heterogeneous and homogeneous emphysema1’.
“The results showed a significant improvement in quality of life in those patients who got the treatment compared to those who did not get the treatment. It also showed an improvement in patient’s exercise capacity in those who got the treatment compared to those who didn’t2.” Dr. Cicenia of the Cleveland Clinic, USA
In athletics, some believe that muscles have memory3 in that, those who used to exercise a lot, find it relatively easy to get back into form after a period where they have lapsed. Manmade and biological materials from plastics to proteins have properties that allow them to regain their original shape even if this is disrupted for a while. The fantastic advance in lung science is the use of coils that can be inserted into the bronchioles to keep them open. These coils rely on their ability to regain a structure suitable for their function after insertion via bronchoscope into the lung of those affected by diseases such as emphysema. The coils then reduce air trapping and allow the lung to regain some of the function of recoiling. The emphysematous COPD lung is full of ‘stale’ air and cannot replace it adequately with ‘fresh’ air to oxygenate the blood and remove the carbon monoxide (the situation is similar to being surrounded on an island with sea water everywhere but not having a drop of water to drink).
The coils are made of a mixture of nickel and titanium and are known as nitinol coils. These ‘shape-memory’ metal coils are commonly used in medical implants like heart stents and bone anchors and so their biological properties and interactions are well known to surgeons and clinicians. Patients have benefited from this significant medical advance since 2008 and they have been approved for use via endobronchial insertion4 by The National Institute for Health and Care Excellence (NICE) in patients with severe emphysema. Ten or more Coils are placed in a single lung in a procedure that typically takes only 30-45 minutes.
Prior to the advent of nitinol coils (which can be given under sedation or general anaesthesia) standard treatment for those with severe emphysema included rehabilitation, medication and oxygen or lung surgery. The surgery options are either Lung Transplantation Surgery or Lung Volume Reduction Surgery (LVRS). Sadly, the shortage of suitable donor lungs makes lung transplant surgery an unrealistic option for many emphysema patients. The heavy anaesthesia required for someone who is already severally impaired in their respiration is a high risk in the major surgery of LVRS and require brave surgeons, anaesthetists and lengthy hospital stays, lengthy post-operative recovery and a high risk of complications such as infection, postoperative bleeding and, of course, death.
Nitinol coils have gradually replaced endoscopic treatment approaches that focus only on reducing lung volume by blocking or collapsing parts of the emphysematous lung5,6 as both a more effective and safer option.
The benefits of ‘shape-memory’ coils over other surgical options can be seen from many different angles. From the patient’s point of view, the symptomatic improvement is greater and obtained at lesser risk. A short anaesthetic or sedation compared to several hours of deep sedation is clearly healthier for someone with already compromised ventilation. The longer sedation and procedural times of lung volume reduction surgery lead to predictable extra complications of infection and the possible need for extended hospitalisation with artificial ventilation in patients who will obviously be hard to wean off ventilation. Another benefit of
The fantastic advance in lung science is the use of coils that can be inserted into the bronchioles to keep them open
A short anaesthetic or sedation compared to several hours of deep sedation is clearly healthier for someone with already compromised ventilation
‘shape-memory’ coils is the sheer number who can be treated amongst the estimated 3 million people in the UK who have COPD7 now that we have an excellent evidence database and supporting NICE guidance on the use of this therapeutic approach8
Although the benefits of ‘shape-memory’ coils from a ’return to work’ or reduced ‘lost productivity’ point of view have yet to be economically calculated for the United Kingdom and Clinical Commissioning Groups, the author argues that anything that can make a dent on the estimated £3.8 billion in costs is not to be ignored, especially if, as has been shown, the risk of complications is not too high and not too severe.
Metal ‘shape-forming’ coils made of nickel and titanium placed permanently in the emphysematous part of the lung can help many millions of people worldwide breathe
easier and undertake more exercise with a resultant improved quality of life. Compared to other surgical options, which require more sedation, longer hospital stays or donors, the risks and practicality are much less and the time required to do and plan the procedure are much reduced. As with all medical or surgical processes there are some risks9. Bleeding is one and caution is required for those on anticoagulants or other blood thinning agents. Some individuals may get a paradoxical worsening of their COPD symptoms. More rarely, a pneumothorax or post-procedure chest infection may occur but fortunately these complications are easily treated and remedied. NICE provides clear guidance on the use of this exciting therapeutic approach in those with severe emphysematous COPD. As the General Practitioner, you may give your ill patient that much needed ‘breath of fresh air’ by recommending, supporting or advocating coil treatment.
References:
1 http://pneumrx.com/prx-uploads/instructions/LBL0139_H_RePneu_Coil_Systems_IFU_EN_REV-English-Final.pdf Accessed 22/6/2016
2 http://www.wjhg.com/news/newschannel7today/headlines/New--366680341.html Accessed 22/6/2016
3 http://jeb.biologists.org/content/219/2/235 Accessed 22/6/2016
4 https://www.nice.org.uk/guidance/ipg517 Accessed 22/6/2016
5 http://tiny.cc/vlxmcy Accessed 22/6/2016
6 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4284519/ Accessed 22/6/2016
7 http://tiny.cc/gmxmcy Accessed 22/6/2016
8 https://www.nice.org.uk/guidance/ipg517/chapter/2-Indications-and-current-treatments Accessed 22/6/2016
9 http://pneumrx.com/en/healthcare-professionals/clinical-evidence/published-studies/ Accessed 22/6/2016
Anton Engler, Medical Correspondent
COPD causes around 23,000 deaths in England each year – that’s one person every 20 minutes1.
THE AVERAGE adult human takes more than 360,000 involuntary breaths in a 24-hour period based on an average breathing rate between 16-18 breaths per minute. These actions depend on an efficient mechanism to exchange air to ensure oxygenation of the arterial blood, but, if this system is inefficient, even faster breathing will not do an adequate job.
Air breathed in by the nostrils or the mouth is taken via the trachea into the branches of the bronchi and bronchioles of the lungs. At the end of the bronchioles, like grapes in a bunch, are the alveoli with their intimate closeness to pulmonary arteries and veins. The less of these there are the less efficient breathing becomes. The surface area of the lung, if it were stretched out, has often been compared to a tennis court2 such that even Wimbledon champion Andy Murray would tire in a day of running back and forth.
The lungs on a mortuary table look like a gelatinous blob of blancmange – pink if healthy, black if affected by smoking. The normal left lung has 2 lobes and the normal right lung has 3. On both sides the upper most lobe is usually the largest. Each lobe is supplied by a major bronchus off the trachea and each bronchus then divides like tree roots into smaller bronchioles until they reach the level of the alveoli. Like a bellows, the lung must expand and collapse to collect and push air out. If a bellows is held open by elastic bands around it, it is obvious that it can no longer puff air out as effectively as when it has flattened out, filled with air and then compressed again and the same is true for the lungs. But this phenomenon in the lungs requires the capacity for ‘recoil’ of lung tissue. If air becomes trapped
in the lungs and the lungs can no longer recoil then less air can be pushed out by the lungs and the exchange of air becomes less efficient. This is the key physiological problem with chronic obstructive pulmonary diseases (COPD).
COPD has 2 main subtypes – damaged bronchi or damaged alveoli. The former is called chronic bronchitis and the latter emphysema. The two are estimated to affect at least 3 million people in the UK3. This series of articles deal with emphysema. Symptomatic enquiry and/or physiological testing as illustrated below can achieve measurement of lung damage symptoms and signs in emphysema.
The St George’s Respiratory Questionnaire4,5 consists of 16 questions in 2 parts and covers symptoms, activity and impacts. In the first part, questions 1-8 address the frequency of respiratory symptoms and aim to assess the patient’s perception of their recent respiratory problems.
In the second part, the questions 9-16 address the patient’s current state with an Activity score that measures disturbances to daily physical activity and an Impacts score that deals with a range of disturbances of psycho-social function. Another more self-explanatory test is the 6-minute walking test6, which focuses on the symptoms elicited rather than the actual distance walked. Dr Roger Bannister7 when he broke the 4-minute mile could, if running easily, cover 4 miles/6.5 Km in 6 minutes and even if walking could probably cover at least 2 miles/ 3.25 km. A patient with moderate emphysema might
New technologies that can both reduce air trapping and improve lung recoil have proven to be beneficial in more than 3000 patients treated world-wide
If air becomes trapped in the lungs and the lungs can no longer recoil then less air can be pushed out by the lungs and the exchange of air becomes less efficient
The Medical Research Council has devised the MRC breathlessness (dyspnea) score8, which can be helpful alongside measures of disturbances of mood (anxiety and depression). For the latter, scores such as the Beck Depression Inventory Score9,10, The General Health Questionnaire11 or the Patient Health Questionnaire12 (PHQ-9) can all be useful and, since mental health issues are likely to be prominent, these should not be forgotten by the General Practitioner caring for emphysematous patients.
Lung or pulmonary function tests in the General Practice surgery are done using spirometry13, but in the respiratory laboratory, more complicated tools such as body plethysmography 14 can be used. We are all well acquainted with using the Peak Flow Meter for our asthmatics. The
References:
basic measurement of the Peak Flow is bound to be reduced in those with emphysema. They will also be able to expel less air in 1 second15 than those with healthier lungs (FEV116). Those with emphysema suffer air trapping and so their Residual Volume (RV17) will be much higher than normal. A restrictive lung defect differs in that the problem there is one of getting air into the lungs in the first place18
Emphysema as a type of Chronic Obstructive Lung/Pulmonary Disease different from bronchitis, which leads to air trapping and a lack of lung recoil. The effect is the ineffective exchange of oxygen and carbon monoxide between the arteries and veins in the arterioles of the alveoli. This leads to lower than expected levels of oxygen in the arterial blood and higher levels of carbon dioxide retention. The nervous system tries to make the inefficient respiration more effective by faster breathing but this is like topping up an oil tank with a large leak at the bottom and may contribute to the sense of anxiety and doom many emphysema sufferers experience. New technologies that can both reduce air trapping and improve lung recoil have proven to be beneficial in more than 3000 patients treated world-wide and this benefit can and should be extended to many more of the many thousands with emphysema. The restrictions are limited to those with active lung infection, known allergies to nickel or titanium and those who cannot tolerate bronchoscopy in the first place19. Most other emphysematous COPD patients without those restrictions could be made to feel better and have an improved quality of life by a relatively simple and safe procedure done through a bronchoscope. As a busy General Practitioner, please remember that better health for those with emphysema is within the sights of a bronchoscope.
1 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/212876/chronic-obstructivepulmonary-disease-COPD-commissioning-toolkit.pdf Accessed 22/6/2016
2 https://www.youtube.com/watch?v=z60odSsJvV8 Accessed 21/6/2016
3 https://www.blf.org.uk/support-for-you/copd Accessed 21/6/2016
4 http://www.healthstatus.sgul.ac.uk/ Accessed 21/6/2016
5 http://www.healthstatus.sgul.ac.uk/SGRQ_download/SGRQ%20Manual%20June%202009.pdf Accessed 21/6/2016
6 https://www.thoracic.org/statements/resources/pfet/sixminute.pdf Accessed 21/6/2016
7 http://news.bbc.co.uk/onthisday/hi/dates/stories/may/6/newsid_2511000/2511575.stm Accessed 21/6/2016
8 https://www.pcrs-uk.org/mrc-dyspnoea-scale Accessed 21/6/2016
9 http://tiny.cc/41xmcy Accessed 21/6/2016
10 http://www.bmc.org/Documents/Beck-Depression-Inventory-BDI.pdf Accessed 21/6/2016
11 http://www.gl-assessment.co.uk/products/general-health-questionnaire-0 Accessed 21/6/2016
12 http://www.cqaimh.org/pdf/tool_phq9.pdf Accessed 21/6/2016
13 http://www.ersnet.org/about-us/healthy-lungs-for-life.html Accessed 21/6/2016
14 https://www.nlm.nih.gov/medlineplus/ency/article/003853.htm Accessed 21/6/2016
15 http://www.spirxpert.com/usefulness.htm Accessed 21/6/2016
16 http://www.spirxpert.com/indices7.htm Accessed 21/6/2016
17 http://www.spirxpert.com/indices13.htm Accessed 21/6/2016
18 http://www.webmd.com/lung/obstructive-and-restrictive-lung-disease Accessed 21/6/2016
19 http://www.pneumrx.com/prx-uploads/instructions/LBL0139-EN.F-english-RePneu-IFU1.pdf Accessed 21/6/2016
Anton Engler, Medical Correspondent
Some 25% of people with COPD are prevented from working due to the disease1
IF YOU were strangled or got a lump of meat stuck in your trachea, within minutes your healthy pink/reddish complexion, if Caucasian, would turn to a bluish colour, which soon reflects the lack of oxygenation in the blood and the build-up of carbon dioxide. Those with a chronic respiratory disease have a more extreme version of this problem. The respiratory mechanism is clearly vital to life and to quality of life.
Many a smoker is unaffected by talk of death or pictures of blackened lungs, but they might be affected by seeing a sufferer of emphysema.
In some cases, the individual may find just talking too much of a problem.
Most will not be able to walk any significant distances and will need the support of motorised transport and, hence, often lack true independence. Work options reduce dramatically because of the decreased breathing capacity but worse for many is the limitation of leisure activities, whether it be going to a concert, football match, taking part in sexual activity or fishing.
The lack of ability to exercise can lead to the additional burden of obesity and all of its complications. Emphysema will also often make the sufferer feel tired2
Feeling breathless is deeply unpleasant and, not surprisingly, many sufferers of emphysema develop or have aggravated mental health issues from anxiety to full blown depression3
Public health doctors and most individuals see the ideal outcome in life as the ‘compression of morbidity’ before we die. In this concept, the final days, weeks or months before the inevitability of death should be as disease free as possible. Those with emphysema have a shortened life expectancy but, sadly, can suffer for months or years with their poor lungs and reduced quality of life.
In your General Practice many of your patients can be expected to have emphysema with a range of severities. Most will be middle aged or elderly. These patients will need to call on you often as they suffer complications from chest infections and secondary heart failure. They will have many hospital admissions and readmissions. They are more vulnerable to ordinary cold viruses such as the adenoviruses. They are more likely to be killed by seasonal flu viruses and they are more prone to bacterial pneumonias and suffer more severely than those without emphysema when infected. Especially in the winter months, they are more likely to need hospitalisation and, once in hospital, the chances of a safe discharge are much reduced, as much has to be done to ensure that they can safely cope in their own home.
Preventative strategies for your emphysema patients include annual seasonal flu vaccination and one-off doses of two available pneumonia vaccines. Ideally, those who smoke will have given up, but many continue to do so (as many as 50%4) often arguing that it is the only pleasure that they have left in life.
Most of your emphysema patients will need social care support, financial support and some form of mobility assistance. Helping them with these issues and pointing them in the right direction can be very time consuming. Many can be directed to the Citizens Advice Bureau5 for financial issues. New rules about Disability Living allowances6 are already having a significant impact and your patient may need to get to an assessment centre to qualify for benefits. Mobility assistance may include a modified car, scooter or a council or charity funded taxi service. Care within the local authority context will effectively be meanstested and, as councils have to cut back on their
Preventative strategies for your emphysema patients include annual seasonal flu vaccination and one-off doses of two available pneumonia vaccines
Those with emphysema have a shortened life expectancy but, sadly, can suffer for months or years with their poor lungs and reduced quality of life
budgets, the poor quality of some of this care is making national news headlines7. Those cared for by family members face new problems if they are in council housing since, when they die, their ‘carer’ may effectively become homeless and so some carers are having to sort their own lives out before that of the person with a condition such as emphysema and some are affected by the ‘bedroom tax8’. Private care options, live-in or part time exist, of course, but these are expensive and a pool of money can soon run out unless a well-planned annuity is agreed with one of the few UK providers9 of such a service. Those who own their own home may have to use a wellstructured and trustworthy equity release scheme to get pre-death cash from their property to invest in their care.
The patient with emphysema faces a steep and steady decline in their quality of life. Often unable to work, they become dependent on the welfare state, which itself is having to ration more and more. Their dependence on social care is also a difficult journey because of financial cuts in this area, also. Life’s simplest pleasures become difficult to enjoy or maintain. All this, whilst being in a constant state of anxiety about feeling breathless and a natural concern around the lack of ability to do basics such as walking and talking. In this sad situation, anything that can improve quality of life is a major advance and, fortunately, the new coil procedure placed via a bronchoscope for those with emphysema is a welcome addition to the therapeutic armoury10
References:
1 http://tiny.cc/p7xmcy Accessed 22/6/2016
2 https://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf Accessed 21/6/2016
3 http://erj.ersjournals.com/content/47/6/1668 Accessed 21/6/2016
4 http://tiny.cc/dcwqcy
5 https://www.citizensadvice.org.uk/ Accessed 22/6/2016
6 https://www.gov.uk/dla-disability-living-allowance-benefit/overview Accessed 22/6/2016
7 http://www.local.gov.uk/documents/10180/5854661/Under+pressure.pdf Accessed 22/6/2016
8 http://tiny.cc/i8xmcyAccessed 22/6/2016
9 http://tiny.cc/08xmcy Accessed 22/6/2016
10 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390222/ Accessed 21/6/2016
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