Aggiornamenti sull’uso dell’ecografia in · ease of learning for non-expert musculoskeletal...

Aggiornamenti sull’uso

dell’ecografia in

emofilia in Italia

CONVEGNO ANNUALE AICE “ASSISTENZA DELL’EMOFILIA E DELLE MEC IN ITALIA: SCENARI IN EVOLUZIONE ”

Napoli, 30 Settembre – 2 Ottobre, 2015

Radiologia – DISSAL Università di Genova, Italy [email protected]

Carlo Martinoli, MD

Matteo Nicola Dario Di Minno, MD

Dept of Clinical and Experimental Medicine Federico II University, Naples, Italy

Gianluigi Pasta, MD

Dept of Orthopaedics. IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy

Why Ultrasound?

Excellent spatial resolution

Dynamic capabilities (joint motion, muscle contraction)

Clinical examination Availability, portability (US performed at the bedside), low cost

First Line Imaging Modality Point-of-Care Imaging

quick screen system as part of the normal physical exam (not to be billed separately) extends the doctors’ vision beyond their fingertips

advent of simple to use, cheap portable machines with adequate technology to examine the MSK system with high-res



Why Clinicians?

May radiologists have a role in the first line?

Multi-joint disease with early

changes expected to occur in joints

that are nearly asymptomatic

US performed/interpreted by the clinician

focused, decision-making strategy to answer specific clinical questions, or identify relevant biomarkers, without the need for detailed, radiological assessment

not comparable with a comprehensive MSK US examination performed by imaging specialists, but rather supporting a more time-efficient, straightforward, real-time approach to critical clinical issues that may affect patient management



Second Opinion Need for Additional Imaging Assessment Help with Ultrasound Training

target joint

mild deficit

bleeding episodes in the past

Imaging

Department

Waiting List

no time-efficient feedback for

treatment decisions

delayed

information

Readers often unaware of haemophilia issues inadequate reporting

How many joints to

ask for imaging?

Imaging basically

underutilized

probably negative

Why Clinicians ... Workflow



DISEASE ACTIVITY

Joint Effusion

Chronic Synovial Proliferation

OSTEOCHONDRAL DAMAGE

Chondral Abnormalities

Subchondral Bone Damage

*

4mm

Why Ultrasound in Haemophilia?

TWO MAIN DOMAINS

Often Undetected at Phys Ex Hyperlax Joints in Children

Very early, aggressive damage Symptoms appear later than expected



Assumption #1 - synovium

HAEMOPHILIC ARTHROPATHY

excellent biomarker of previous

(recent) joint bleeds

haemosiderin - synovium

basically hypovascular at CD/PD

RHEUMATOID ARTHRITIS

excellent biomarker of inflammation

active vs. inactive disease

active disease basically hypervascular at CD/PD

Indicator of Disease

Activity



IRON

the diffuse osteochondral damage in HA may warrant the policy of considering one surface representative of the overall status of the joint without significantly reducing the sensitivity of the method

Assumption #2 – osteochondral surfaces



ease of learning for non-expert musculoskeletal sonologists

ease of use with conventional US machines, including portable machines

reasonably informative to assess the status of the joints in terms of disease activity and disease damage in HA

reliable and repeatable enough for being used as a marker to monitor the efficacy of treatment and the evolution of damage in longitudinal studies

time efficient to be implemented in the daily activity

AD-HOC SCANNING PROTOCOLS

ELBOW

KNEE

ANKLE

Haemophilia Early Arthropathy Detection with UltraSound



Systematic evaluation of the joint recesses Selection of a target osteochondral surface (one per joint) DAMAGE

ACTIVITY ✔

Job for Imaging Specialists

Ligaments

Muscles

Tendons

Nerves

Vessels

✗ Is the HEAD-US system equivalent to a MSK Ultrasound Exam?




Will HEAD-US be best utilised as an adjunct to physical examination assessment tools?

Will it compete by virtue of its shorter learning curve and more objective assessment?

Physical (complex) US (simple, confirmatory) US (first) Physical (simplified)


Physical assessment of joint status often falls below the standards of due care

The short learning curve of HEAD-US combined with "simplified" physical tests tailored to specific aspects that are “blind” at US, would offer the best potential

small/peripheral centers, where local expertise may fall short, due

to a lack of training and dedicated personnel



US vs Clinical Examination (Gilbert & HJHS)

US vs X-ray

(Pettersson)

US vs MRI (Compatible scale)

CENTER Investigators

MILANO Elena Santagostino,

Gianluigi Pasta

PARMA Annarita Tagliaferri

Franca Rivolta

GENOVA Carlo Martinoli

Claudio Molinari

FIRENZE Massimo Morfini

NAPOLI Giovanni Di Minno

Dario Di Minno

Participating Centers

Procedure Totali = 646

Characteristics of the study population

Hemophilia A Hemophilia B

Number of patients 49 12

Severe hemophilia 36(73.5%) 9 (75%)

Mild/moderate 13(26.5%) 3 (25%)

Age 30 31

History of inhibitory antibodies 12 (24.5%) 0

High-titer inhibitors (>5BU) 8 (16.3%) 0

Treatment

Prophylaxis 37 (75.5%) 8 (66.7%)

On-demand 12 (24.5%) 4 (33.3%)

Number of joints studied

Hemophilia A

Overall 145

Ankles 68

Knees 39

Elbows 38

WFH 136

HJHS 2.0 91

HJHS 2.1 81

HEAD-US 145

Pettersson 131

MRI 62

Results of the examinations

Mean Median IQR

Gilbert 2.14 1 0-3

HJHS 2.0 5.18 3 0-8

HJHS 2.1 5.41 4 0-9

X-ray 3.18 1 0-6

US 3.3 3 1-6

Assessment of early arthropathic changes

Gilbert HJHS 2.0 HJHS 2.1 X-ray US

0 44.8% 29.7% 27.2% 45% 22.1%

1 16.2% 13.2% 14.8% 9.9% 9%

2 7.35% 5.5% 4.9% 4.6% 10.3%

3 7.35% 3.3% 2.5% 3.8% 10. 3%

4 3.7% 4.4% 6.2% 4.6% 9%

5 4.4% 4.4% 7.4% 3.8% 13.1%

6 3.7% 7.7% 4.9% 4.6% 17.2%

7 4.4% 6.6% 3.7% 3.0% 8.3%

8 2.9% 2.2% 2.5% 7% 0.7%

9 3.7% 2.2% 2.5% 3% -

10 1.5% 2.2% 2.5% 3.8% -

>10 - 18.6% 20.9% 6.9% -

Results of the examinations

Gilbert vs HEAD-US Total joints Ankles Knees Elbows

ICC 0.725

(0.614-0.804)

0.647

(0.423-0.784)

0.812

(0.629-0.905)

0.801

(0.606-0.900)

r 0.574,

P < 0.001

0.478,

P < 0.001

0.767,

P < 0.001

0.670,

P < 0.001

Gilbert = 0 61 joints

US = 0 23 joints (37.7%)

US ≥ 1 38 joints

Synovium: 15 joints (8 grade 1 and 7 grade 2), Cartilage: 34 joints (9 grade 1; 8 grade 2; 11 grade 3 and 6 grade 4) Bone: 8 joints (5 grade 1 and 3 grade 2).

HJHS 2.0 vs HEAD-US Total joints Ankles Knees Elbows

ICC 0.714

(0.566-0.811)

0.701

(0.469-0.831)

0.805

(0.508-0.923)

0.677

(0.223-0.866)

r 0.744,

P < 0.001

0.713,

P < 0.001

0.972,

P < 0.001

0.642,

P = 0.001

HJHS 2.0 = 0 27 joints

US = 0 18 joints (66.7%)

US ≥ 1 9 joints

Synovium: 3 joints (2 grade 1 and 1 grade 2), Cartilage: 7 joints (3 grade 1; 3 grade 2; 1 grade 3) Bone: 1 joints (grade 1).

HJHS 2.1 vs HEAD-US Total joints Ankles Knees Elbows

ICC 0.700

(0.534-0.807)

0.702

(0.464-0.834)

0.813

(0.465-0.935)

0.641

(0.009-0.870)

r 0.720,

P < 0.001

0.695,

P < 0.001

0.980,

P < 0.001

0.632,

P = 0.007

HJHS 2.1 = 0 22 joints

US = 0 16 joints (72.7%)

US ≥ 1 6 joints

Synovium: 3 joints (2 grade 1 and 1 grade 2), Cartilage: 5 joints (2 grade 1; 1 grade 2; 2 grade 3) Bone: 1 joints (grade 1).

Pettersson (X-ray) vs HEAD-US Total joints Ankles Knees Elbows

ICC 0.805

(0.725-0.862)

0.802

(0.666-0.883)

0.778

(0.569-0.886)

0.822

(0.652-0.909)

r 0.759,

P < 0.001

0.759,

P < 0.001

0.724,

P < 0.001

0.773,

P < 0.001

X-ray = 0 59 joints

US = 0 21 joints (35.5%)

US ≥ 1 38 joints

Synovium: 13 joints (8 grade 1 and 5 grade 2), Cartilage: 33 joints (9 grade 1; 11 grade 2; 12 grade 3, 1 grade 4) Bone: 4 joints (grade 1).

… ongoing …

- Stratification for age (pediatric patients)

- Assessment of joints with HEAD-US = 0

- Identification of cut-off points for disease

- Comparison with MRI

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