“Setting up a New-fill clinic” · 1 “Setting up a New-fill® clinic” Sharron Brown, Gillian...

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“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

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Pathogenesis & incidence of lipoatrophy

• Multi-factorial

• Host, viral & therapeutic elements

• Lipoatrophy exists in HIV infection &

increases with HAART

• 30-40% of cohorts with clinically

significantchanges

• HAART selection strategy to minimise

risk of lipoatrophy0

5

10

15

20

25

30

35

40

45

HIV neg HIV + (noHAART)

HIV + (HAART)

arms legs 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

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Pathophysiologic mechanisms

X 400Increased number ofmacrophages

Control x 400↑↑↑↑ no. of smalleradipocytes x 200

• Mitochondrial dysfunction

– inhibition of mitochondrial DNA polymerase → mitochondrial injury

• Pro-inflammatory mediators

– increased IL-6 / TNF-α expression

– macrophage infiltration

• Compromised adipocyte life cycle

– 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:L322. Marin A et al. Qual Life Res. 2006;15:767–775

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3. Santos CP et al. AIDS. 2005;19(suppl 4):S14–S214. Collins E et al. AIDS Read. 2000;10:546–551












5. Guaraldi G et al. Antivir Ther. 2007;12:1059–1065

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6. Duran S et al. AIDS. 2001;15:2441–24447. Ammassari A et al. J Acquir Immune Defic Syndr. 2002;31(suppl 3):S140–S144

Treatment options for facial lipoatrophy

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• 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;17:429–4352. Cattelan AM et al. Arch Dermatol. 2006;142:329–3343. Guaraldi G et al. Antivir Ther. 2005;10:753–7594. Kates LC et al. Aesthet Surg J 2008;28:397-403 5. Moyle GJ et al. HIV Med 2006;7:181-56. Skeie L et al. HIV Med 2010;11: 170-77







– Risk of migration, foreign body reactions, late stageinfections

– Bio-Alcamid7



7. Loutfy MR et al. AIDS. 2007;21:1147–1155

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– Risk of migration, foreign body reactions, late stage infections

– Bio-Alcamid7



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; 16:1985-8710. 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

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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)

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Complications of New-fill ® - rare

Early• Swelling, erythema, bruising

• Blanching / vasoconstriction

– related to lignocaine?

– generally transient, painless

• Infection

– no cases infection identified by

C&W, Brighton, St Thomas’s &

Harley Street practices

Late• Nodules

– incorrect technique– less common with more dilute

suspension– initially 3mls; now up to 8mls– 31% cases in early studies,

now <1%

• Late stage granulomas– non-allergic immunological

phenomenon– intra-lesional steroid injection

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Practicalities of setting up a New-fill® Clinic

What’s involved?

Lou Kerr

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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 HIV-

associated 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

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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


Incidence lipodystrophy 30-40% 1,000 patients

5-10% take up New-fill® for facial lipoatrophy15-30 patients

300 patients

Average 4 treatments each60-120 treatments per year

5-10 per month

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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

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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

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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

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Training process

Advance practitioner/ trainer status

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

Independent practiceSkills maintenance (6 treatments / month)

Peer & network support

Training process







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Training process







Training process







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Training process







Training process







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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)

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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

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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

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• 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

Models for service delivery

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

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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

• Equipment £4• Staff cost £50• Admin. Charge

• TOTAL

• £1128

• £16• £200• £50

• £1394

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Sharron Brown

Treatment Challenges

• Nodules and their management

• Presence of permanent implants

• Presence of facial hypertrophy

• Lipoatrophy and ageing

• Female sex

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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-S202. Vleggaar D. Facial Volumetric Correction with poly-L-lactic Acid. Dermatol Surg. 2005;31(11Pt 2 ) 1511-15173. 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-S202. Vleggaar D. Facial Volumetric Correction with poly-L-lactic Acid. Dermatol Surg. 2005;31(11Pt 2 ) 1511-15173. Sculptra poly-L-lactic acid. Physician Introductory Training Workbook UK 7/2008

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MORE COMPLICATIONS

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Autologus Fat Transfer

Facial lipohypertrophy

• Body disfigurement

• Limited range of upper

extremity and neck motion

• Neck & back discomfort

• Difficulty with sleep

including sleep-study-

confirmed obstructive sleep

apnoea

• Excess subcutaneous

and / or visceral fat,

lipomas

• Dorsocervical (buffalo

hump)

• Submental, lateral and

anterior neck, pre

parotid

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Lipohypertrophy: remove extra volume!

• Ultrasonic assisted liposelection with Vaser• Lipectomy• Facelift, necklift

(N=135) (N=64)(N=138)

% o

f pat

ient

s

0

4

8

12

16

20

<40 yr 40–49 yr >50 yr

HIV-positive patients with moderate to severe lipoa trophy (N=337) at a median of 20 months of follow-up

Lichtenstein KA et al. J Acquir Immune Defic Syndr. 2003;32:48–56

Age

Lipoatrophy prevalence increases with age

10.1

13.3

18.8

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Brown T. Approach to the Human Immunodeficiency Virus-Infected Patient with Lipodystrophy.. The Journal of Clinical Endocrinology and Metabolism,Aug 200893 (8):2937=2945

LIPOATROHPY• Multiple facial shadows sometimes with accentuated facial folds• Sunken temples and cheeks• Protruding facial musculature and bony landmarks

PreDuring Post

3D Surface Imaging

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Question & answer session

Question & answer session

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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)

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