setting up a newfill clinic for Web [Compatibility Mode]

“Setting up a New-fill® clinic”
Sharron Brown, Gillian Dean, Odile
Brennan, Louise Kerr
Objectives
• To know / understand:
– background of facial lipoatrophy in context HIV
– what products are available / mode of action / adverse events
– the practicalities of setting up a Newfill® clinic
– overview of current services
– if you can’t set up a Newfill® clinic….
– how service requirements have changed over last 8 years
– understand the patients’ experience
– Q & A session
1
Pathogenesis & incidence of lipoatrophy
•
Multi-factorial
•
Host, viral & therapeutic elements
•
Lipoatrophy exists in HIV infection &
45
40
35
30
increases with HAART
•
30-40% of cohorts with clinically
% 25
20
15
significant changes
•
10
HAART selection strategy to minimise
5
0
risk of lipoatrophy
HIV neg
HIV + (no
HAART)
arms
legs
HIV + (HAART)
face
Palella FJ et al. Clin Infect Dis. 2004;38:903–907
Lipoatrophy in HIV
•
No standard definition
•
Subcutaneous fat loss
– limbs, face, buttocks
•
40-50% fat loss by the time
clinically apparent (limbs)
•
Facial area maybe more sensitive
•
Difficult to diagnose – often
triggered by patient concerns
•
Once present – difficult to reverse
© elementshiv.org
2
Pathophysiologic mechanisms
•
Mitochondrial dysfunction
Control x 400
↑ no. of smaller
adipocytes x 200
– inhibition of mitochondrial DNA
polymerase → mitochondrial injury
•
Pro-inflammatory mediators
– increased IL-6 / TNF-α expression
– macrophage infiltration
•
Compromised adipocyte life cycle
X 400
Increased number of
macrophages
– adipocytes replaced by fibrous
tissue
– ↓ adipocyte size, ↑ apoptosis
© elementshiv.org
Implications of lipoatrophy
• Psychological effects / quality of life1
– ↓ self-confidence, self-esteem
– anxiety / depression2
• Social effects3,4
– social alienation
– difficulty finding clothing
– impaired quality social relationships (OR 0.38)
• Sexual dysfunction5
• Decreased adherence6-7
• Physical effects (e.g. discomfort while sitting)
1. Rajagopalan R et al, Antiviral Therapy 2007;12Suppl 2:L32
2. Marin A et al. Qual Life Res. 2006;15:767–775
3
Implications of lipoatrophy
• Psychological effects / quality of life1
– ↓ self-confidence, self-esteem
– anxiety / depression2
• Social effects3,4
– social alienation
– difficulty finding clothing
– impaired quality social relationships (OR 0.38)
• Sexual dysfunction5
• Decreased adherence6-7
• Physical effects (e.g. discomfort while sitting)
3. Santos CP et al. AIDS. 2005;19(suppl 4):S14–S21
4. Collins E et al. AIDS Read. 2000;10:546–551
Implications of lipoatrophy
• Psychological effects / quality of life1
– ↓ self-confidence, self-esteem
– anxiety / depression2
• Social effects3,4
– social alienation
– difficulty finding clothing
– impaired quality social relationships (OR 0.38)
• Sexual dysfunction5
• Decreased adherence6-7
• Physical effects (e.g. discomfort while sitting)
5. Guaraldi G et al. Antivir Ther. 2007;12:1059–1065
4
Implications of lipoatrophy
• Psychological effects / quality of life1
– ↓ self-confidence, self-esteem
– anxiety / depression2
• Social effects3,4
– social alienation
– difficulty finding clothing
– impaired quality social relationships (OR 0.38)
• Sexual dysfunction5
• Decreased adherence6-7
• Physical effects (e.g. discomfort while sitting)
6. Duran S et al. AIDS. 2001;15:2441–2444
7. Ammassari A et al. J Acquir Immune Defic Syndr. 2002;31(suppl 3):S140–S144
Treatment options for facial lipoatrophy
5
Treatment options for facial lipoatrophy
•
Bioabsorbable fillers - effective, temporary intervention
– Collagen – bovine – 3-6 months
– Poly-L-lactic acid injections1-5 (New-Fill)
– Hyaluronic acid filler6 (Restylane, Hylaform, Juvederm)
– Calcium hydroxylapatite (Radiesse)
•
Permanent fillers
– Used with caution in HIV/AIDS patients due to continuing body changes
– Risk of migration, foreign body reactions, late stage infections
– Bio-Alcamid7
•
Autologous fat transplant
3,8-10
– Surgical procedure, temporary, costly, low availability fat for harvest,
lipohypertrophy
1. Barton SE et al. Int J STD AIDS. 2006;17:429–435
2. Cattelan AM et al. Arch Dermatol. 2006;142:329–334
3. Guaraldi G et al. Antivir Ther. 2005;10:753–759
4. Kates LC et al. Aesthet Surg J 2008;28:397-403
5. Moyle GJ et al. HIV Med 2006;7:181-5
6. Skeie L et al. HIV Med 2010;11: 170-77
Treatment options for facial lipoatrophy
•
Bioabsorbable fillers - effective, temporary intervention
– Collagen – bovine – 3-6 months
– Poly-L-lactic acid injections1-5 (New-Fill)
– Hyaluronic acid filler6 (Restylane, Hylaform, Juvederm)
– Calcium hydroxylapatite (Radiesse)
•
Permanent fillers
– Used with caution in HIV/AIDS patients due to continuing body changes
– Risk of migration, foreign body reactions, late stageinfections
– Bio-Alcamid7
•
Autologous fat transplant
3,8-10
– Surgical procedure, temporary, costly, low availability fat for harvest,
lipohypertrophy
7. Loutfy MR et al. AIDS. 2007;21:1147–1155
6
Treatment options for facial lipoatrophy
•
Bioabsorbable fillers - effective, temporary intervention
– Collagen – bovine – 3-6 months
– Poly-L-lactic acid injections1-5 (New-Fill)
– Hyaluronic acid filler6 (Restylane, Hylaform, Juvederm)
– Calcium hydroxylapatite (Radiesse)
•
Permanent fillers
– Used with caution in HIV/AIDS patients due to continuing body changes
– Risk of migration, foreign body reactions, late stage infections
– Bio-Alcamid7
•
Autologous fat transplant
3,8-10
– Surgical procedure, temporary, costly, low availability fat for harvest,
lipohypertrophy
3. Guaraldi G et al. Antivir Ther. 2005;10:753–759
8. Guaraldi G et al Ann Intern Med. 2009 ;150:61-3.
9. Levan P et al. AIDS. 2002; 16:1985-87
10. Cohen et al. J Drugs Dermatol. 2009; 8:486-9
Ideal injectable
•
Safe & effective
•
Approved (CE mark, FDA)
•
Biodegradable/ bioresorbable
•
Longer-lasting result
•
Non animal origin
•
No skin test required
•
Cost effective
•
Easy to use / store
•
Widely available
7
New-fill®
•
Class III medical device (PLA)
•
Highly bio-compatible
•
Safety profile well documented
•
Used for ∼30 years in medicine
– skull & facial reconstructive surgery
– tissue regeneration
– resorbable implants, screws - orthopaedics
– resorbable sutures - ophthalmics, neurosurgery
– carrier for slow release medication (prostate cancer)
– encapsulation of vaccines
Mechanisms of action
Dual Mechanism:
–
immediate mechanical action - related to volume
–
delayed reaction - formation of new collagen, persists despite
resorption of P.L.A. particles
–
micro particles (diameter 40µ-63µ), held in gel suspension
–
<10µ phagocytosis, <30µ dispersed into capillaries, >100µ
difficult to inject
Duration of Stimulus
–
biodegradation (approx. 24 months, based on clinical response)
8
Complications of New-fill® - rare
Early
Late
•
Swelling, erythema, bruising
•
•
Blanching / vasoconstriction
– incorrect technique
– less common with more dilute
suspension
– initially 3mls; now up to 8mls
– 31% cases in early studies,
now <1%
– related to lignocaine?
– generally transient, painless
•
Infection
– no cases infection identified by
C&W, Brighton, St Thomas’s &
Harley Street practices
Nodules
•
Late stage granulomas
– non-allergic immunological
phenomenon
– intra-lesional steroid injection
9
Practicalities of setting up a
New-fill® Clinic
What’s involved?
Lou Kerr
10
Approximate size of required cohort
Estimated incidence of facial lipoatrophy – 30-40% with
>50% fat loss i.e. clinically significant
How many likely to need New-fill®? 10% looking at bigger cohorts
Estimated need to do 6 treatments / month to maintain competencies
(average number treatments per patient = 4)
Equivalent of ~ 20 individual
patient referrals each year
Individual cohort
Part of network
Royal College of Nursing Competencies
•
An integrated career and
competence framework for
nurses working with HIVassociated facial lipoatrophy in
adults
•
Minimum number of patients to
be treated per month to
maintain skills = 6
http://www.rcn.org.uk/__data/assets/pdf_file/0019/255322/003537.pdf
11
Approximate size of required cohort
Estimated incidence of facial lipoatrophy – 30-40% with
>50% fat loss i.e. clinically significant
How many likely to need New-fill®? 10% looking at bigger cohorts
Estimated need to do 6 treatments / month to maintain competencies
(average number treatments per patient = 4)
Equivalent of ~ 20 individual
patient referrals each year
Individual cohort
Part of network
Approximate size of required cohort
Incidence lipodystrophy 30-40%
1,000 patients
300 patients
5-10% take up New-fill® for facial lipoatrophy
15-30 patients
Average 4 treatments each
60-120 treatments per year
5-10 per month
12
Clinic referrals
• Important to have clear referral pathway
• Patients registered at clinic for >6
months – prevent clinic hopping to
access treatment
• Be on or has been on HAART
• Referred by clinic doctors / clinician
• Importance of having ‘gate keepers’
Patient referral criteria
• Moderate to severe atrophy – physical / psychological
13
Patient referral criteria
• Very few contra-indications
– pregnancy, lidocaine allergy
• Cautions
– haemophilia – ensure good control (extra factor VIII), more dilute
product (less traumatic / less viscous)
– individuals prone to keloid scarring
– on high dose steroids / other medical immunosuppression
– acute skin conditions
• Agree to photos
Who’s going to deliver the service
• Some degree of dexterity /
good aesthetic eye
• Aesthetics practitioner / HIV /
dermatology / plastic surgeon
• Need for an assistant?
• Doctor vs registered nurse
14
Registered Nurses
• Lidocaine - prescription only medn
– prescribers course for nurses
– formatted prescription
– Patient Group Directions (PGDs)
• Band 6 or above
– extended scope of practice
– Trust policy & role definition
– vicarious liability / private insurance
– 5hs/fortnight - £3220 (incl. on-costs)
• Sanofi–Aventis approval
• Assistant – HCA?
Doctors
• All can prescribe
• No differences in adverse events
vs nurses4
• Insurance – need to inform
defence union but covered by
Trust indemnity for NHS work
• Sanofi – Aventis approval
• Work with an assistant – HCA/RN?
4. Enrique Castro Sanchez, 2007, Mortimer Market Centre, London
15
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
16
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
17
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
Training process
Advance practitioner
/ trainer status
Peer & network support
Independent practice
Skills maintenance (6
treatments / month)
Observation of practice of
advanced practitioner &
theoretical training
Supervised practice – 4-6
sessions, mixture of new
patients / top-ups
Competency based
practice assessment by
advanced practitioner -endorsed
by Sanofi-Aventis
18
Competency documents for nurses
Sanofi-Aventis support
• Comprehensive training manual
• DVD
• Patient information leaflets & after
care
• Support from local representatives
• Theoretical training
• Updates (but often aimed at
aesthetic nurses)
19
Administrative issues
• Secretarial
– system for sending
appointments
• Finance
– invoicing
– chasing up unpaid bills
• Database
– often maintained by clinician
Audit
• Total referral – new vs top-up
• Adverse events
– asymmetry
– bruising
– nodules / granulomas,
– infection
• Pre & post photos
• Waiting times
• Patient satisfaction survey – provides evidence of
service value
20
Odile Brennan
• Where existing NewFill services are-map
• Models for service delivery – e-questionnaire
• Changing patient profile - how service requirements
have changed over last 8 yrs
• Funding of service - capping/rationing
• Standard costs
• Contact details and USB sticks
Map of existing UK services
21
Models for service delivery
• E- questionnaire – (75%) return.
•
•
•
•
•
•
25 existing services
All services 4-5 yrs old
Average clinic No – 1 x wk
2-4 patient appointments per week
Practitioners – doing 8-16 treatments per month
Ratio of new to top-up patient – 1:3
Changing patient profile
• New patients are decreasing and are mild to moderate in
severity
• Increasing numbers of repeats or top-ups
• Extreme variation in the duration of patient perceived
result (12-36 months!) – some don’t need it ever again...
• Some patients have had treatment privately before with
a variable or unknown protocol or had other types of
facial fillers or permanent implants
22
Funding of services
• Own in-house service
• Regional Networks - feeding to main trust clinics,
• Individual case funding - reimbursement from PCT
• Private treatment – paid for by patient (more expensive!)
• Capping/rationing – for sustainability
Approximate cost of standard 4
treatments within NHS
• Newfill - £282 per box inc VAT
• £1128
• Equipment £4
• Staff cost £50
• Admin. Charge
• £16
• £200
• £50
• TOTAL
• £1394
23
Sharron Brown
Treatment Challenges
• Nodules and their management
• Presence of permanent implants
• Presence of facial hypertrophy
• Lipoatrophy and ageing
• Female sex
24
Management of nodules
• Best way to avoid nodules
• Dilution 7-8mls
• Reconstitution 24-72hrs
• Injection Technique
• Time between treatment sessions
1. Fitzgerald R. Advanced Techniques for Sculptra J Drugs Dermatol. 2009;8(4);S17-S20
2. Vleggaar D. Facial Volumetric Correction with poly-L-lactic Acid. Dermatol Surg. 2005;31(11Pt 2 ) 1511-1517
3. Sculptra poly-L-lactic acid. Physician Introductory Training Workbook UK 7/2008
Management of nodules
• Most nodules are non- visible
& may resolve spontaneously
1,2
• Published advise from Dr D
Veglaar states if nodule is
visible to subcise the nodule
using a 26G needle then inject
with sterile saline to break it
down then massage area 2
• ASDS Guidelines of care for
Injectable Fillers recommends
if nodules or less commonly,
foreign body granulomas, are
present these may be broken
down injecting sterile saline
with a 26G needle and
intralesional steroids 3
1. Fitzgerald R. Advanced Techniques for Sculptra J Drugs Dermatol. 2009;8(4);S17-S20
2. Vleggaar D. Facial Volumetric Correction with poly-L-lactic Acid. Dermatol Surg. 2005;31(11Pt 2 ) 1511-1517
3. Sculptra poly-L-lactic acid. Physician Introductory Training Workbook UK 7/2008
25
MORE COMPLICATIONS
26
Autologus Fat Transfer
Facial lipohypertrophy
• Body disfigurement
• Limited range of upper
extremity and neck motion
• Neck & back discomfort
• Difficulty with sleep
including sleep-study-
• Excess subcutaneous
and / or visceral fat,
lipomas
• Dorsocervical (buffalo
hump)
• Submental, lateral and
confirmed obstructive sleep
anterior neck, pre
apnoea
parotid
27
Lipohypertrophy: remove extra volume!
• Ultrasonic assisted liposelection with Vaser
• Lipectomy
• Facelift, necklift
Lipoatrophy prevalence increases with age
HIV-positive patients with moderate to severe lipoatrophy
(N=337) at a median of 20 months of follow-up
20
18.8
% of patients
16
12
8
13.3
10.1
4
0
<40 yr
(N=138)
40–49 yr
>50 yr
(N=135)
(N=64)
Age
Lichtenstein KA et al. J Acquir Immune Defic Syndr. 2003;32:48–56
28
LIPOATROHPY
• Multiple facial shadows sometimes with accentuated facial folds
• Sunken temples and cheeks
• Protruding facial musculature and bony landmarks
Brown T. Approach to the Human Immunodeficiency Virus-Infected Patient with Lipodystrophy.. The
Journal of Clinical Endocrinology and Metabolism,Aug 200893 (8):2937=2945
Pre
During
Post
3D Surface Imaging
29
Question & answer session
Question & answer session
30
Learning points
•
↓ incidence drug-induced facial lipoatrophy
•
↑ incidence age related changes
•
Following thorough training - Newfill® excellent treatment for facial
lipoatrophy
•
Maintenance of competence essential
•
Most cases straight forward – minority are complex
•
3 models of service - need to decide which suits your cohort
– set-up own clinic
– work as part of regional HIV network
– feed into national expertise with PCT approval (NHS / private sector)
31