Implementing NICE guidance

1
The PleurX peritoneal catheter drainage system
for vacuum-assisted drainage of
treatment-resistant, recurrent malignant ascites
Implementing NICE guidance
March 2012
NICE medical technology guidance 9
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What this presentation covers

• Background and definitions
• Guidance
• Discussion
• Accessing the guidance and implementation tools
• Case studies

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Background medical technologies guidance

• NICE medical technology guidance addresses
  specific technologies notified to NICE by
  manufacturers.
• If the case for adopting the technology is
  supported, then the technology has been found to
  offer advantages to patients and the NHS.
• The specific recommendations on individual
  technologies are not intended to limit use of
  other relevant technologies that may offer
  similar advantages.

4
Definitions

• Malignant ascites an abnormal accumulation of
  fluid in the peritoneal cavity, caused by cancer.
  Symptoms include breathlessness, nausea,
  bloating, acid reflux, abdominal pain, reduced
  appetite, reduced mobility and psychological
  distress related to negative perception of body
  image
• Treatment-resistant there is a low likelihood
  of further medical or oncological interventions,
  in particular chemotherapy, being successful in
  preventing or reducing re-accumulation of ascites

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Background current clinical practice

• Conventional management involves repeated
  large-volume paracentesis (inserting a catheter
  into the pertioneal cavity to drain ascitic
  fluid)
• Most commonly done as an inpatient procedure.
  Some centres offer it as a day case procedure
• In large volume paracentesis the catheter stays
  in placeuntil most of the ascites has drained.
  Some patients may need to stay in hospital for
  one or more nights for repeated drainage
  procedures.

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Background The PleurX peritoneal catheter
drainage system for vacuum-assisted drainage

• Allows palliative management of
  treatment-resistant, recurrent malignant ascites
  in the community setting
• Comprises a silicone catheter and a drainage
  system containing a vacuum bottle and drainage
  line
• The catheter can remain in place indefinitely
• Patients and carers are trained to perform
  drainage
• To drain, the vacuum bottle is attached to the
  catheter. A fresh valve cap and dressing are
  applied once the drainage is completed

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Guidance (1)

• The case for adopting the PleurX peritoneal
  catheter drainage system in the NHS is supported
  by the evidence.
• Evidence and cost modelling suggests that the
  PleurX peritoneal catheter drainage system
• is clinically effective
• has a low complication rate
• has the potential to improve quality of life
• enables early treatment of symptoms in the
  community
• is cost saving compared with inpatient
  large-volume paracentesis

Reproduced with permission from UK Medical Ltd
8
Guidance (2)

• The PleurX peritoneal catheter drainage system
  should be considered for use in patients with
  treatment-resistant, recurrent malignant ascites

Reproduced with permission from CareFusion
Corporation
9
Management in the community

• The device is not likely to increase the need for
  community nursing support because most patients
  in the terminal stages of cancer will receive
  healthcare in the community
• The need for community nursing may be reduced
  slightly, as the nursing wound management
  associated with large volume paracentesis will
  not be needed
• Training is required for community nurses,
  patients and carers to perform community drainage

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Discussion

• How can we prepare a case for the organisation to
  invest in this technology?
• Where can we access further training resources to
  support the implementation of this guidance in
  practice?
• Where a healthcare professional identifies a
  patient that may benefit from this device do we
  have systems in place for referral and further
  consideration of suitability? If not, how can we
  develop these?
• How can we encourage local commissioners to
  support the use of this device?

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Accessing the guidance and implementation tools
online

• Visit www.nice.org.uk/guidance/MTG9 for
• Guidance
• Costing tools
• Audit support
• Podcast
• Clinical case scenarios (PDF)

Reproduced with permission from UK Medical Ltd
12
Case studies

• The decision to start treatment with the PleurX
  peritoneal catheter drainage system should be
  shared between clinicians and patients
• These case studies have been have been put
  together to improve your ability to identify
  people who would potentially benefit from using
  the PleurX peritoneal catheter drainage system
  for vacuum-assisted drainage. They are aimed at
  oncologists and oncology clinical nurse
  specialists but could be used to support learning
  in a variety of healthcare professionals
  responsible for caring for people with cancer.
• These cases are also available in PDF format for
  individual learning

Disclaimer these case studies, their content and
suggested actions are not NICE guidance. They
have been developed in collaboration with experts
in the field to support learning but they are
beyond the scope of the guidance
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Case scenario 1 Stephen

• Presentation
• Stephen is a 68-year-old man with advanced colon
  cancer. You are Stephens community palliative
  nurse specialist. Stephen is complaining of
  bloating, nausea, acid reflux and reduced
  appetite which you believe to be caused by
  ascites. He underwent large volume paracentesis
  20 days ago, and 5 litres of ascites were
  drained. Prior to this he has never had
  paracentesis. Stephen's oncologist considers him
  to have 'treatment-resistant' cancer with
  malignant ascites.
• Question 1.1
• Should the PleurX peritoneal catheter drainage
  system
• be considered for Stephen?

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Case scenario 1 Stephen

• Answer 1.1
• Yes, the PleurX peritoneal catheter should be
  considered for Stephen as his cancer is
  considered to be 'treatment-resistant' with
  'malignant ascites' and it is possible that his
  ascites has re-accumulated. However, the
  Committee recognised the uncertainty about the
  point in the care pathway at which it would be
  clinically appropriate to treat patients with
  treatment-resistant, recurrent malignant ascites
  with the PleurX peritoneal catheter drainage
  system. Tapping et al. (2011) considered that
  patients who had at least three previous
  large-volume paracentesis procedures would be
  suitable for treatment with the PleurX peritoneal
  catheter drainage system, whereas Courtney et al.
  (2008) inserted the PleurX peritoneal catheter in
  patients who had had at least two large-volume
  paracentesis procedures in the previous 30 days.
• The Committee did not recommend a minimum number
  of re-occurrences of ascites before it would be
  clinically appropriate to treat with the PleurX
  peritoneal catheter drainage system. They
  considered that the decision to start treatment
  with the PleurX peritoneal catheter drainage
  system should be shared between clinicians and
  patients.

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Case scenario 1 Stephen

• Question 1.2
• What are the options for Stephen?

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Case scenario 1 Stephen

• Answer 1.2
• There are two options here. Stephen could undergo
  repeat large volume paracentesis with further
  monitoring of symptoms and re-accumulation of
  ascites, leaving open the option for treatment
  with the PleurX peritoneal catheter drainage
  system when this happens. Alternatively, if
  Stephen's multidisciplinary team believes it is
  clinically appropriate to use the PleurX
  peritoneal catheter drainage system at this stage
  and Stephen is in agreement, Stephen could begin
  treatment with the PleurX peritoneal catheter
  drainage system immediately.
• As Stephens community palliative care nurse it
  is important that you discuss these options with
  Stephen and the relevant members of his
  multidisciplinary team.
• Questions 1.3
• If a decision is made between Stephen and his
  multidisciplinary team to use the PleurX
  peritoneal catheter drainage system how could you
  help with this process?

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Case scenario 1 Stephen

• Answer 1.3
• It could be suggested that prior to insertion of
  the device the appropriate healthcare
  professionals in Stephen's multidisciplinary team
  should contact the relevant GP and community
  healthcare team to ensure they have the skills
  and resources to support Stephen.
• The NICE costing tools can help you to calculate
  the anticipated local costs and savings
  associated with implementing this guidance.
• The manufacturer provides training and learning
  resources to support use of this device including
  patient leaflets, instruction booklets and
  videos. These resources are available from
  www.ukmedical.com/pleurx. Note that this webpage
  also provides details of other uses of PleurX
  devices. This guidance only covers the use of
  the PleurX peritoneal catheter drainage system
  for vacuum-assisted drainage of
  treatment-resistant, recurrent malignant ascites.

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Case scenario 2 Julie

• Presentation
• Julie is a 58-year-old woman who has been
  diagnosed with stage 4 ovarian cancer and has
  been offered primary chemotherapy. She has been
  found to have moderate volume ascites as well as
  pleural effusion on a CT (computed tomography)
  scan but is currently asymptomatic. She will
  commence carboplatin and paclitaxel chemotherapy
  next week
• Question 2.1
• Should the PleurX peritoneal catheter drainage
  system be considered for Julie?

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Case scenario 2 Julie

• Answer 2.1
• No, because although ascites has been found on
  Julie's CT scan she is asymptomatic. The purpose
  of the PleurX peritoneal catheter drainage system
  is symptom relief. If she does not need symptom
  relief then treatment with the PleurX peritoneal
  catheter drainage system is not suitable for her.
  Additionally, she is scheduled to start
  chemotherapy, which is expected to prevent
  further accumulation of ascites. Her condition is
  therefore not yet considered to be
  'treatment-resistant. Although her ascites is
  likely to be malignant the PleurX peritoneal
  catheter drainage system would not be considered
  suitable for her at this stage.
• see notes

20
Case scenario 3 Suzanne

• Presentation
• Suzanne is a 68-year-old woman who is attending
  an oncology clinic after discovery of a pelvic
  mass and ascites by her gynaecology team. Tissue
  biopsy has confirmed incurable metastatic lobular
  breast carcinoma. She has been offered endocrine
  therapy. She has marked shortness of breath and
  nausea which are considered to be associated with
  the ascites. Her ascites was drained 10 days ago
  and clinically has now recurred.
• Question 3.1
• Should the PleurX peritoneal catheter drainage
  system be considered for Suzanne?

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Case scenario 3 Suzanne

• Answer 3.1
• Suzanne has been offered treatment with endocrine
  therapy. It is anticipated that the endocrine
  therapy may relieve the ascites. Therefore,
  although Suzanne's ascites could be considered
  malignant her condition is not yet considered
  treatment-resistant. The PleurX peritoneal
  catheter drainage system is therefore not
  considered suitable for her at this stage. For
  symptom relief large-volume paracentesis should
  be suggested.
• If the endocrine therapy does not treat the
  ascites then the PleurX peritoneal catheter
  drainage system should be considered.

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Case scenario 4 John

• Presentation
• John is a 54-year-old man with pancreatic cancer.
  The multidisciplinary team considers that his
  cancer is incurable and is not suitable for
  surgical resection or radical radiotherapy.
  Palliative chemotherapy did not prevent disease
  progression. His notes indicate that there is a
  low likelihood of further medical or oncological
  interventions, in particular chemotherapy, being
  successful in preventing or reducing
  re-accumulation of ascites. You are the oncology
  nurse specialist working in the oncology ward
  where John has been admitted as an unplanned
  inpatient for large volume paracentesis. During
  the ward round you note that this is Johns third
  admission for large volume paracentesis in 35
  days. The need for repeated paracentesis is the
  main barrier to John receiving care at home.
• Question 4.1
• Should the PleurX peritoneal catheter drainage
  system be considered for John?

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Case scenario 4 John

• Answer 4.1
• Yes, the PleurX peritoneal catheter should be
  considered for John. NICE recommends that the
  PleurX peritoneal catheter drainage system should
  be considered for use in patients with
  treatment-resistant, recurrent malignant ascites.
  The Committee concluded from the available
  clinical evidence that the PleurX peritoneal
  catheter drainage system is effective in the
  palliative management of treatment-resistant,
  recurrent malignant ascites. It has a high
  procedural success rate, a low complication rate
  and the potential to improve patient quality of
  life
• There is no definition in the guidance as to what
  recurrent is and the Committee recognised the
  uncertainty about the point in the care pathway
  at which it would be clinically appropriate to
  treat suitable patients with the PleurX
  peritoneal catheter drainage system. Tapping et
  al. (2011) considered that patients who had at
  least three previous large-volume paracentesis
  procedures would be suitable for treatment with
  the PleurX peritoneal catheter drainage system,
  whereas Courtney et al. (2008) inserted the
  PleurX peritoneal catheter in patients who had
  had at least two large-volume paracentesis
  procedures in the previous 30 days. Answer
  continued on next slide

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Case scenario 4 John

• Answer 4.1 continued
• The Committee did not recommend a minimum number
  of re-occurrences of ascites before it would be
  clinically appropriate to treat with the PleurX
  peritoneal catheter drainage system. They
  considered that the decision to start treatment
  with the PleurX peritoneal catheter drainage
  system should be shared between clinicians and
  patients. In light of this information you and
  the multidisciplinary team should consider the
  PleurX peritoneal catheter drainage system for
  John.
• Question 4.2
• What would you do next?

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Case scenario 4 John

• Answer 4.2
• You should first discuss this treatment option
  with the relevant members of John's
  multidisciplinary team.
• When developing the guidance the Committee
  considered that the decision to start treatment
  with the PleurX peritoneal catheter drainage
  system should be shared between clinicians and
  patients. You should discuss this option with
  John and his carers so that he and the
  multidisciplinary team can make a joint decision.
  
• It could also be suggested that prior to
  insertion of the device the appropriate
  healthcare professionals in Johns
  multidisciplinary team should contact the
  relevant GP and community healthcare team to
  ensure they have the skills and resources to
  support John.
• Answer continued on next slide

26
Case scenario 4 John

• Answer 4.2 continued
• The NICE costing tools can help you to calculate
  the anticipated local costs and savings
  associated with implementing this guidance.
• The manufacturer provides training and learning
  resources to support the use of the device
  including patient leaflets, instruction booklets
  and videos. These resources are available from
  www.ukmedical.com/pleurx. Note that this webpage
  also provides details of other uses of PleurX
  devices. This guidance only covers the use of
  the PleurX peritoneal catheter drainage system
  for vacuum-assisted drainage of
  treatment-resistant, recurrent malignant ascites.
  

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Case scenario 5 Doris

• Presentation
• Doris is a 75-year-old woman. You are her
  oncologist. She was diagnosed with stage IV
  ovarian cancer 3 years ago. She has had surgery
  and multiple types of chemotherapy. Doris is
  attending your clinic today and you need to
  report on her latest CA125 levels. The result
  indicates her cancer has progressed again. There
  are no further treatment options available to
  Doris which would reduce the ascites. She has
  been admitted for inpatient large volume
  paracentesis twice in the past 25 days, and on
  each occasion 56 litres of ascites were drained.
  
• On presentation Doris is complaining of shortness
  of breath and nausea.
• Question 5.1
• If these symptoms were confirmed as ascites would
  you consider the PleurX peritoneal catheter
  drainage system for Doris?

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Case scenario 5 Doris

• Answer 5.1
• Yes, the PleurX peritoneal catheter drainage
  system should be considered for Doris. NICE
  recommends that the PleurX peritoneal catheter
  drainage system should be considered for use in
  patients with treatment-resistant, recurrent
  malignant ascites. However, the Committee
  recognised the uncertainty about the point in the
  care pathway at which it would be clinically
  appropriate to treat patients with
  treatment-resistant, recurrent malignant ascites
  with the PleurX peritoneal catheter drainage
  system. Tapping et al. (2011) considered that
  patients who had at least three previous
  large-volume paracentesis procedures would be
  suitable for treatment with the PleurX peritoneal
  catheter drainage system, whereas Courtney et al.
  (2008) inserted the PleurX peritoneal catheter in
  patients who had had at least two large-volume
  paracentesis procedures in the previous 30 days.
• Answer continued on next slide

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Case scenario 5 Doris

• Answer 5.1 continued
• In current practice some clinicians would not
  offer it as a treatment option until the ascites
  has re-occurred three times. However, the
  Committee did not recommend a minimum number of
  re-occurrences of ascites before it would be
  clinically appropriate to treat with the PleurX
  peritoneal catheter drainage system. They
  considered that the decision to start treatment
  with the PleurX peritoneal catheter drainage
  system should be shared between clinicians and
  patients. In light of this information you and
  the multidisciplinary team should consider the
  PleurX peritoneal catheter drainage system for
  Doris.
• Question 5.2
• What would you do next?

30
Case scenario 5 Doris

• Answer 5.2
• The most appropriate course of action depends on
  how short of breath she is. If the ascites is
  leading to significant respiratory compromise
  then it may be appropriate to admit her to
  hospital acutely and perform urgent paracentesis
  to relieve her shortness of breath.
• If her shortness of breath is not severe then
  sufficient time should be taken to discuss both
  the PleurX peritoneal catheter drainage system
  and repeated large-volume paracentesis and allow
  Doris to make an informed choice between the two.
  A joint decision on treatment should be made by
  Doris and her multidisciplinary team.
• If the decision is made to use the PleurX
  peritoneal catheter drainage system it could be
  suggested that prior to insertion of the device,
  the appropriate healthcare professionals in
  Doris's multidisciplinary team should contact the
  relevant GP and community healthcare team to
  ensure they have the skills and resources to
  support Doris.
• Answer continued on next slide

31
Case scenario 5 Doris

• Answer 5.2 continued
• The NICE costing tools can help you to calculate
  the anticipated local costs and savings
  associated with implementing this guidance.
• The manufacturer provides training and learning
  resources to support the use of the device
  including patient leaflets, instruction booklets
  and videos. These resources are available from
  www.ukmedical.com/pleurx. Note that this webpage
  also provides details of other uses of PleurX
  devices. This guidance only covers the use of
  the PleurX peritoneal catheter drainage system
  for vacuum-assisted drainage of
  treatment-resistant, recurrent malignant ascites.

32
Case scenario 6 Jane

• Presentation
• Jane is a 58-year-old woman diagnosed with stage
  III ovarian cancer. She is experiencing bloating,
  acid reflux and reduced appetite, which is
  thought to be caused by ascitic fluid. You are a
  gynaecology oncology clinical nurse specialist
  and Jane is attending your preoperative clinic.
  She is booked for surgery in two weeks time with
  the objective of surgical staging and complete
  resection of all macroscopic disease, followed by
  chemotherapy.
• Question 6.1
• Should the PleurX peritoneal catheter drainage
  system be considered for Jane?

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Case scenario 6 Jane

• Answer 6.1
• No, the symptoms listed above are not necessarily
  caused by large volume ascites there could be
  peritoneal disease or bowel involvement.
• If it were to be established that these symptoms
  were caused by ascites the PleurX peritoneal
  catheter drainage system should still not be
  considered at this stage because it is
  recommended by NICE for consideration in people
  with treatment-resistant, recurrent malignant
  ascites. Jane's condition is not yet considered
  'treatment-resistant as it is anticipated that
  the planned surgery and chemotherapy will treat
  the ascites and prevent further accumulation.
• In this case if Jane had had a tense abdomen with
  confirmed ascites she would have received
  paracentesis in advance of surgery.

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Clinical case scenarios references and
acknowledgements

• References
• Becker G, Galandi D, Blum H E (2006) Malignant
  ascites systematic review and guideline for
  treatment. European Journal of Cancer 42 (5)
  58997
• Courtney A, Nemcek A A Jr, Rosenberg S et al.
  (2008) Prospective evaluation of the PleurX
  catheter when used to treat recurrent ascites
  associated with malignancy. Journal of Vascular
  Interventional Radiology 19 (12) 172331
• Tapping C R, Ling L, Razack A (2011) PleurX
  drain use in the management of malignant ascites
  safety, complications, long-term patency and
  factors predictive of success. British Journal of
  Radiology 2011 Mar 22. Epub ahead of print
• Acknowledgements
• NICE would like to thank the members of the
  Medical Technologies Advisory Committee, in
  particular Dr Alex Faulkner.
• We would also like to thank the following people
  
• Dr. Hans-Ulrich Laasch, Consultant Radiologist
  Interventional Lead, The Christie NHS Foundation
  Trust
• Alison Keen, Interim Head of Cancer Nursing,
  University Hospital Southampton NHS Foundation
  Trust
• Dr Peter Hall, Specialist Registrar/Clinical
  Research Fellow, Leeds Teaching Hospitals NHS
  Trust/University of Leeds

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36
Clinical case scenarios definitions

• Malignant ascites is defined as abnormal
  accumulation of fluid in the peritoneal cavity,
  caused by cancer. It is most commonly associated
  with breast, lung, ovary, stomach, pancreas and
  colon cancer (Becker et al. 2006). The
  accumulation of a large volume of ascitic fluid
  increases abdominal pressure and can cause
  symptoms such as breathlessness, nausea,
  bloating, acid reflux, reduced appetite, reduced
  mobility and psychological distress related to
  negative perception of body image (Becker et al.
  2006). Patients with malignant ascites have a
  mean survival of 14 months, depending on the
  nature and extent of the underlying tumour
  (Courtney et al. 2008). Patients having
  palliative treatment may survive significantly
  longer.
• Treatment-resistant The Committee was advised
  that the term treatment-resistant is normally
  understood by clinicians to mean that there is a
  low likelihood of further medical or oncological
  interventions, in particular chemotherapy, being
  successful in preventing or reducing
  re-accumulation of ascites

Return to case 1 - presentation
Return to answer 1.1
Return to answer 2.1
Return to answer 3.1
Return to answer 6.1