the impact of mri in changing prognosis of thalassemia major. st. pierre - 15-16 sep... ·...
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The impact of MRI in changing prognosisof ThalassemiaMajor
Tim St Pierre
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Following the Policy of the National Regulation 3.3 , page 17, on CME disclosures, dated 5 November 2009, and on behalf of the Provider , - Collage S.p.A.- n. 309
I (Tim St Pierre) HERE DECLARE
DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS
YES, -over the past two years – I do have a personal financial relationship with a commercial interest and control over educational content related to the products and/or services of the commercial interest(s).
*if yes please provide information below. - Resonance Health Ltd - FerriScan- …………………………………………....-NO, have no relevant personal financial relationship in the medical/health field.
DISCLOSURE OF PROMOTIONAL TALKS
NO, I have not presented any promotional talks for any pharmaceutical companies within the past 12 months
YES, I have presented promotional talks for one or more pharmaceutical companies within the past 12 months
*if yes please provide information below.- …………………………………………….- …………………………………………….
I understand that continuing education accreditation guidelines prohibit me from accepting any reimbursement (financial, gifts or in-kind exchange) for this presentation from any source other than the accredited CME provider ( Collage S.p.A.)
15-16 September, 2017 Tim St Pierre
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How can a diagnostic test improve clinical outcome?
• Diagnostic test does not DO anything to a patient
• Impact of diagnostic test can result from • its influence on decision making regarding interventions
• its influence on patient adherence to treatment regimens
• Clinical decision making relies upon the predictive power of the test
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What evidence do we have that MRI measurements of tissue iron have an impact on outcomes?
• What is the evidence that MRI measurements of tissue iron concentration are predictive of outcome?
• What is the evidence that clinical decisions are determined at least in part by MRI measurements?
• What is the evidence that patient adherence to treatment regimens is improved after MRI measurements?
• What is the evidence that clinical outcomes are improved when MRI measurements are used?
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How can impact of a diagnostic test or monitoring tool be measured?
• Ideally measured in randomised study comparing outcomes for patients with and without the diagnostic test or monitoring tool
• Ethical problems arise for such studies if test is already perceived to be useful
• Retrospective or observational studies can give supporting evidence but are confounded by other factors
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Predictive power of tissue iron measurements
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LIC is a surrogate measure of total body iron stores (TBIS) in patients with thalassaemia major
There is a very strong correlation between LIC and total body iron stores in thalassaemia major patients
Angelucci et al (2000) N Eng J Med 343, 327
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LIC and long-term prognosis
LIC(mg Fe/g dw)
13 year Cardiac Disease Free Survival
Number Patients Group
< 7 93.3% (SE 6.4) 15 (i)
7 – 15 71.4% (SE 17.1) 7 (ii)
> 15 50.0% (SE 15.8) 10 (iii)
Telfer et al (2000) BJH 110: 971-977
32 thalassaemia major patients followed for median period of 13.6 years after single biopsy LIC measurement
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Iron in the heart indicates risk heart disease and heart failure within 12 months
Kirk P, et al. Circulation. 2009;120:1961-8.
T2* < 10 ms, relative risk 159, p < 0.001
T2* < 6 ms, relative risk 268, p < 0.001
Cardiac failure
Pro
po
rtio
n o
f p
ati
en
ts
deve
lop
ing
ca
rdia
c f
ail
ure
Follow-up time (days)
600 120 180 240 300 360
0.3
0.2
0.1
0
0.4
0.5
0.6< 6 ms
6–8 ms
8–10 ms
> 10 ms
Arrhythmia
600 120 180 240 300 360
0.15
0.10
0.05
0
0.20
0.25
0.30
< 10 ms
10–20 ms
> 20 ms
T2* < 20 ms, relative risk 4.6, p < 0.001
T2* < 6 ms, relative risk 8.65, p < 0.001
Follow-up time (days)
Pro
po
rtio
n o
f p
ati
en
ts
wit
h a
rrh
yth
mia
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Studies on the Impact of MRI Tissue Iron Measurements
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Modell, et al. (2008) J Cardiovasc Magn Reson, 10: 42.
• 850 thalassemia major patients in UK
• Retrospective study
• Compare rates of death pre and post 1999
• Post 1999 data includes data up to 2003
• In 1999• Cardiac T2* was introduced
• UK Register information on continuing high mortality circulated to all collaborating doctors
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Modell, et al. (2008) J Cardiovasc Magn Reson, 10: 42.
Number of deaths of patients with thalassaemia major in the UK by intervals
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Modell, et al. (2008) J Cardiovasc Magn Reson, 10: 42.
Investigators identified possible factors for dramatic drop in deaths post 1999
• Introduction of cardiac T2* for identifying patients requiring intensified chelation therapy (considered the most relevant factor)
• Improved application of conventional methods for assessing cardiac function
• Communication of the need for vigilance of heart disease to treating doctors
• The referral of patients to expert centres for assessment
• The promotion of new developments to patients, nurses and doctors by the UK Thalassaemia Society
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Modell, et al. (2008) J Cardiovasc Magn Reson, 10: 42.
Investigators concluded:-
Since 1999, there has been a marked improvement in survival in thalassaemia major in the UK, which has been mainly driven by a reduction in deaths due to cardiac iron overload.
The most likely causes for this include
• the introduction of T2* CMR to identify myocardial siderosis
• appropriate intensification of iron chelation treatment,
• other improvements in clinical care.
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Chouliaras, et al. (2011) JMRI, 34: 56.
• 804 thalassemia major patients
• Retrospective study (period 2003 to 2009)
• Most patients had access to DFO, DFP, or combination therapy during the period of study
• Note that DFX became available in 2006
• Numbers of cardiac deaths recorded for pre-MRI and post-MRI patients
• Risk of cardiac death per 1000 patient years calculated
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Chouliaras, et al. (2011) JMRI, 34: 56.
P = 0.22
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Chouliaras, et al. (2011) JMRI, 34: 56.
The investigators concluded:
MRI has become a vital component of ongoing management and seems to have a beneficial effect on cardiac mortality in thalassemia major.
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Origa, et al. (2013) British J Haematol, 163: 400.
• 313 thalassaemia major patients
• Cardiac T2* measurements between 2002 – 2012
• 157 male & 156 female
• Mean age at first scan 26.7 ± 6.2 y
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Origa, et al. (2013) British J Haematol, 163: 400.
Change in chelator much more likely for patients with low cardiac T2*
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Origa, et al. (2013) British J Haematol, 163: 400.
Frequencies of cardiac T2* values for patients who did and did not develop arrhythmia or cardiac failure within one year of scan
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Origa, et al. (2013) British J Haematol, 163: 400.
The investigators concluded:-
• Abnormal cardiac T2* values determined changes in treatment in most subjects.
• Heart T2* was confirmed to be highly predictive over 1 year for heart failure and arrhythmias.
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• 327 transfusion dependent thalassemia patients
• Followed in period 2002 – 2011
• Mean follow-up 8.0 years (4.4 – 9.0 years)
• DFX > DFO > Combination therapy
• MRI iron measurements increased >5 fold
• 80% increase in number patients receiving LIC measurements
Kwiatkowski, et al. (2012) Blood, 119: 2746.
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• Median LIC dropped• 10.7 => 5.1 mg Fe/g dw
• P < 0.001
• Median Cardiac T2* increased• 23.55 => 34.50 ms
• P = 0.23
• Fraction of patients with ftn>2500 ng/mL or LIC > 15 mg Fe/g dw or cardiac T2* < 10 ms• 33% => 26%
Kwiatkowski, et al. (2012) Blood, 119: 2746.
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• Investigators concluded• Increasing use of magnetic resonance imaging and oral
chelation in thalassemia management has likelycontributed to improved iron burden
Kwiatkowski, et al. (2012) Blood, 119: 2746.
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Evidence of Clinical Decision Making Based on MRI Tissue Iron
Measurements
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• Retrospective study (period 2002 to 2008)
• 40 transfusion dependent patients
• Followed for 1.0 to 6.1 years (median 3.4 years)
• Liver R2-MRI measurement at baseline
• Median number of LIC measurements 5 (range 2-9)
Brown, et al. (2012) Internal Medicine Journal, 42: 990.
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Brown, et al. (2012) Internal Medicine Journal, 42: 990.
Documented clinical decision making based on LIC
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Improvements in iron burden observed
Brown, et al. (2012) Internal Medicine Journal, 42: 990.
Geometric mean LIC decreased
6.8 => 4.8 mg Fe/g dw
(p < 0.008)
LIC >15 mg/g
15 mg/g > LIC > 7 mg/g
LIC < 7 mg/g
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• Investigators concluded• The data are consistent with previous observations that
introduction of non-invasive monitoring of LIC can contribute to a decreased body iron burden through improved clinical decision making and improved feedback to patients and hence improved adherence to chelation therapy.
Brown, et al. (2012) Internal Medicine Journal, 42: 990.
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• 84 SCD patients - chronic transfusion
• Followed from 2006 to 2013
• After introduction of FerriScan R2-MRI in 2006• Proportion of patients obtaining LIC measurements
jumps from 21% to 81%
• Median LIC drops from first R2-MRI to last R2-MRI• 13.2 mg Fe/g dw => 7.9 mg Fe/g dw (p = 0.027)
• Deferasirox also became available in 2006
Stanley, et al. (2016) Pediatric Blood & Cancer, 63: 1414.
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Clinical decisions made following liver iron concentration (LIC) assessment by R2-MRI. Documented decisions were specifically included in provider clinician notes within 6 months of the study.
Documented clinical decision making based on LIC
Stanley, et al. (2016) Pediatric Blood & Cancer, 63: 1414.
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• The investigators concluded
• Increased availability of iron assessment through R2-MRI and of oral chelation paralleled improved management of iron overload in our population with SCD
• Routine liver R2-MRI should be performed in individuals with SCD who receive chronic red cell transfusions
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Nichols‐Vinueza, et al. (2014) Am J Hematol, 89: 684.
• Single center retrospective study
• Study period 2005 – 2012
• LIC by MRI (FerriScan and T2*) and cardiac T2* measurements
• 42 patients (55% male) with at least 2 MRI visits
• Median age at first MRI 17.5 y
• Mean follow-up period 5.2 ± 1.9y
• Median number of MR scan per patient 4.5
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• From baseline to last MRI• 63% of patients remained within target ranges for LIC
and cardiac R2*
• 13% improved from high values into the target range
• Median LIC decreased• 7.3 => 4.5 mg Fe/g dw
• P = 0.0004
• Median cardiac R2* decreased• 33.4 => 28.3 Hz
• p = 0.01
Nichols‐Vinueza, et al. (2014) Am J Hematol, 89: 684.
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• DFO usage decreased from 70% to 10% in 2009
• DFX usage increased• 26% at baseline
• 73% by 2009
Nichols‐Vinueza, et al. (2014) Am J Hematol, 89: 684.
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The investigators concluded:-
Annual MRI iron assessments and availability of oral chelators both facilitate changes in chelation dose and strategies to optimize care.
Nichols‐Vinueza, et al. (2014) Am J Hematol, 89: 684.
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Summary• Cardiac T2* has been shown to be predictive of cardiac
arrhythmia and failure within 12 months
• Liver iron concentration has been shown to be a surrogate measure for total body iron stores and predictive of long term (years) outcomes
• Studies have shown that both liver and heart iron assessments by MRI have led to clinical decision making on interventions
• Associations between the advent of implementation of tissue iron MRI measurements and improvements in body iron burdens have been observed
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Summary
• No single study has been able to “prove” that MRI tissue iron measurement has an impact on prognosis for thalassaemia major
• Randomised trials required for proof would be unethical
• Taken together, multiple studies assessing the impact of MRI tissue iron measurements strongly suggest that they lead to improved iron burden through• Influencing clinical decision making on iron chelation
• Improved feedback to patients to encourage adherence
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