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Emphysema Patients: When Inhalers Are Not Enough

When advanced emphysema patients remain symptomatic – despite maximum inhaler therapy –– Zephyr® Valves may offer the possibility of improved lung function, exercise capacity and quality of life.1-5

Zephyr Valve treatment is a minimally invasive procedure performed in specialised hospitals across Australia.  The valves provide lung volume reduction without surgery and its associated risks, and being removable they preserve future therapy options.1

Severe emphysema can be difficult to manage with limited treatment options – identifying patients who may benefit from Zephyr Vales is a critical management step.6,7

GP recognition of patients experiencing persistent breathlessness despite maximal medical therapy, who are current or ex-smokers and have FEV1<59%, may lead to significantly improved patient outcomes – when referred to Zephyr Valve treatment centres for further assessment.1-5,8

Reduced waitlist assessment times are available at some centres through a fast-tracked ‘rapid referral’ option when referred patients are considered candidates for Zephyr Valves.

The burden of emphysema

Chronic obstructive pulmonary disease (COPD) is a serious long-term condition predominantly affecting older patients and includes conditions such as emphysema and chronic bronchitis.7

Emphysema is characterised by hyperinflation due to the permanent enlargement of distal air spaces (Figure 1), along with the destruction of alveolar walls and loss of elastic recoil. Airflow resistance increases when air is exhaled leading to dynamic hyperinflation. The increased work of breathing leads to progressive breathlessness, reduced exercise capacity and poor quality of life.1

 

Figure 1. Large air spaces are created in emphysematous lungs that stay filled with air even when the patient breathes out.

Severe emphysema can be difficult to manage with patients having significant lung damage, particularly in late disease stages.  Many patients face an agonising level of disability in their daily lives with an estimated 1 in 8 COPD patients experiencing severe or profound disability in their core activities (communication, mobility, self-care).9

While common, COPD still remains under-recognised by doctors and under-reported by patients.10,11  GPs can play an important role in diagnosing and managing COPD patients – and critically, recognising when referral to a specialist respiratory physician is required (Box 1).6

 


Box 1: COPD snapshot

Despite optimal medical management many advanced COPD patients still experience debilitating symptoms

  • COPD affects around 1 in 3 Australians aged over 75 years and 1 in 13 aged over 40 years12
  • Barriers to diagnosis include: multiple clinical features and comorbidities;6 the failure of patients to report symptoms; lack of adequate knowledge/training in COPD diagnosis10
  • COPD-X guidelines indicate persistent airflow obstruction as the most important COPD diagnostic criteria (spirometry: post-bronchodilator FEV1/FVC < 0.7)6
  • COPD is often only identified in the advanced stages when treatment options are limited11
  • Many advanced COPD patients remain very disabled – despite optimal medical therapy13
  • Referral to a respiratory specialist is not always timely – COPD-X guideline referral triggers include diagnostic uncertainty, a rapid decline in functioning or persistent symptoms6
  • Bronchoscopic lung volume reduction with endobronchial valves, such as Zephyr Valves, provides a minimally invasive treatment option for this refractory patient group6

 

Persistent COPD symptoms despite optimal management

COPD medical management requires a stepwise approach to preserve lung function and quality of life which includes bronchodilators, anti-inflammatory agents, supplemental long-term oxygen therapy, pulmonary rehabilitation and non-invasive ventilator options.1,6

However, these options do not address the problem of permeant lung parenchyma destruction and resultant hyperinflation found in severe emphysema.1 Severe emphysema can be the most difficult form to manage and many patients experience further decline despite intensive optimal medical management.

Alternative treatments strategies for this particular group of COPD patients have been sought and include lung volume reduction techniques (e.g., surgery and endobronchial valves).6  These types of procedures reduce the size mismatch between the hyperinflated COPD lungs and the chest cavity.  This helps to restore respiratory muscle efficiency, improve diaphragm mechanics and decrease the work of breathing.14

Lung volume reduction with Zephyr Valves

Surgical lung volume reduction has been shown to improve lung function and exercise tolerance for some patients but is associated with significant short-term mortality and non-fatal complications (such as bronchopleural air leakage known as pneumothorax).1,2 The recent development of minimally-invasive endoscopic procedures, such as endobronchial valves (EBV), has meant lung volume reduction can be achieved without the morbidity and mortality associated with surgery.1

Zephyr Valves are tiny (4-5.5 mm in diameter and 10-13 mm in length), implantable one-way valves that block a hyperinflated lobe while allowing air and mucus to exit the treated area (Figure 2).1,15 The valves are designed to mimic the physiological changes of lung volume reduction surgery, but without the associated risks (Box 2).1,2

Zephyr Valves are placed bronchoscopically via a delivery catheter during a procedure that takes about 60 minutes.15 The insertion can be done with the patient under sedation or general anaesthesia and several valves may be required.  The valves are designed to be permanent, but may be removed (via bronchoscopy) preserving future therapy options.1

 


Box 2: Zephyr Value snapshot

Zephyr Endobronchial Valves

  • Provides a minimally invasive treatment for emphysema patients who remain symptomatic despite optimal medical management1
  • Offers the possibility of improved lung function, exercise capacity and quality of life2-5
  • Designed to be permeant, but are removable – preserving future therapy options1
  • Provides lung volume reduction without surgery and its associated risks1
  • Available publicly and privately in Australia with ‘no gap’
  • Reduced patient assessment waitlist times – when referred to Zephyr Endobronchial Valve Treating Physicians
  • Over a decade of proven clinical experience, with over 15,000 advanced emphysema patients treated worldwide since 200715

Figure 2. Lung volume reduction with Zephyr Endobronchial Valves

The Zephyr Endobronchial Valve Procedure – animation

Zephyr Valves – over a decade of proven clinical experience

The Zephyr Endobronchial Valve is currently the most studied endoscopic lung volume reduction device with six completed randomised controlled clinical trials.2-5,13,16 Zephyr Valves have consistently improved patient outcomes in the areas of lung function, exercise tolerance and quality of life.2-5,13,16

In the recent LIBERATE clinical trial involving 190 patients (with little or no collateral ventilation), almost half of patients treated with Zephyr Valves experienced improved lung function (FEV1 change of ≥15%), compared with just 17% of patients treated with current standard medical approaches.2 The clinical benefits experienced with Zephyr Valves continued for the 12-month post treatment period (Figure 3).

Although there was an increased rate of serious adverse events (SAE) in the short-term with Zephyr therapy (first 45 days post-procedure), the rate reduced over the long-term (46 days to 12 months) compared to standard approaches of care.2

EBV treatment is now included in COPD treatment guidance issued by leading health organisations worldwide, including the Global Initiative for Chronic Obstructive Lung Disease (GOLD), the National Institute for Health and Care Excellence (NICE) and the Australian and New Zealand clinical practice guidelines (COPD-X).6,7,17

 

Figure 3. Zephyr Valve LIBERATE clinical trial findings2

EBV= endobronchial valves (Zephyr Valves); FEV= forced expiratory volume; MCID=minimal clinically important difference; mMRC= modified Medical Research Council scale; RV= residual volume; SGRQ= St. George’s respiratory questionnaire; 6MWD= six-minute walk distance.   Adapted from Criner et al 20182

“In select patients with advanced emphysema, bronchoscopic interventions reduces end-expiratory lung volume and improves exercise tolerance, health status and lung function 6-12 months following treatment” GOLD report7

 

Zephyr Valves: The right therapy for the right patient

With decreased lung function and high levels of comorbidity, treatment of severe COPD patients can be critical. Knowing which COPD patient could potentially benefit from Zephyr Valve treatment is therefore important (Box 3).

Recognising the right patient and referring them to a Zephyr Endobronchial Valve treating Respiratory Physician for assessment may make a significant positive impact to their future quality of life and long-term outcomes.1-5,13,16

 


Box 3: EBV patient snapshot

Zephyr Valve patient selection steps8

☑ History of smoking or confirmed severe COPD/emphysema

☑ Persistent breathlessness despite maximum inhaler therapy

☑ Most recent forced expiratory volume in one second (FEV1) <59%

► Refer patient immediately to a Zephyr Endobronchial Valve treating Respiratory Physician for further assessment

►► Fast-tracked EBV assessment options are available (reduced waitlist time for patient assessment)

↘ Find your closest treating centre and download rapid access referral forms at: www.pulmonx.com.au/HCP

 


 

Complications of the Zephyr Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, haemoptysis, pneumonia, dyspnoea and, in rare cases, death.

 

References

[1]. Herth FJF. The Chartis Pulmonary Assessment System™ and Zephyr® Endobronchial Valve Therapy for the Treatment of Emphysema – A Review. Euro Res Dis. 2012; 8(1):29-33.

  1. 2. Criner et al. A Multicenter RCT of Zephyr® Endobronchial Valve Treatment in Heterogeneous Emphysema (LIBERATE). Am J Resp Crit Care Med. Am J Respir Crit Care Med. 2018;198(9):1151-64.
  2. 3. Kemp S, et al. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Resp Crit Care Med. 2017; 196(12): 1535-43.
  3. 4. Valipour et al. Endobronchial Valve Therapy in Patients with Homogeneous Emphysema. Results from the IMPACT Study. Am J Respir Crit Care Med. Am J Respir Crit Care Med. 2016 Nov 1; 194(9):1073-82.
  4. 5. Klooster K, et al. Endobronchial Valves for Emphysema without Interlobar Collateral Ventilation. N Engl J Med. 2015; 373(24):2325-35, + Supplementary Appendix 2.
  5. Yang IA, et al. COPD-X Australian and New Zealand guidelines for the diagnosis and management of chronic obstructive pulmonary disease: 2017 update. Med J Aust. 2017; 207:436-42.
  6. 7. Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD). Pocket Guide to COPD diagnosis, management, and prevention. A Guide for Health Care Professionals. 2018 edition.
  7. Endobronchial Valves for Endoscopic Lung Volume Reduction – Best Practices. PulmonX, data on file 2016.
  8. Australian Institute of Health and Welfare. Asthma, chronic obstructive pulmonary disease and other respiratory diseases in Australia. 2010. Cat. no. ACM 20. Canberra: AIHW.
  9. Yawn BP, Wollan PC. Int J Chron Obstruct Pulmon Dis. 2008; 3(2): 311-18.

1[1]. Toelle BG, et al. Respiratory symptoms and illness in older Australians: the Burden of Obstructive Lung

Disease (BOLD) study. Med J Aus. 2013; 198:144-8.

  1. 1 Australian Institute of Health and Welfare. COPD (chronic obstructive pulmonary disease) snapshot. Last updated: 24 July 2018. Available at: https://www.aihw.gov.au/reports/chronic-respiratory-conditions/copd/contents/copd Accessed 22/8/18.

[1]3. Davey C, et al. Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial. Lancet. 2015 Sep 12;386(9998):1066-73.

  1. Pizarro C, et al. Effect of Endobronchial Valve Therapy on Pulmonary Perfusion and Ventilation Distribution. PLoS One. 2015; 10(3):e0118976.

[1]5. Pulmonx data on file.

[1]6. Sciurba FC, et al. A Randomized Study of Endobronchial Valves for Advanced Emphysema (VENT). N Engl J Med. 2010 Sep 23;363(13):1233-44.

[1]7. NICE. Endobronchial valve insertion to reduce lung volume in emphysema. Interventional procedures guidance IPG600. 20 December 2017.

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