Risk prediction in inherited conditions Laminopathies
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1 Risk prediction in inherited conditions Laminopathies Karim Wahbi Cochin hospital, Paris
2 Risk prediction in laminopathies Current approach for risk stratification A new score to predict malignant VTA Perspectives for risk stratification for sudden death in dilated cardiomyopathy
3 Laminopathies: the first descriptions Gene - LMNA Proteins Lamins A/C LMNA Lamin A Lamin C Bonne et al. Nature Genet Idiopathic dilated cardiomyopathy: LMNA mutations in 5% of cases
4 Laminopathies: arrhythmogenic cardiomyopathies with a high risk of sudden death Meta-analysis (233 patients) Sudden death = 35 (11.7%, 46% of all deaths) Pacemaker recipients = 84 SD=16 (19%) Arrhythmias Pacemaker 19 patients with an indication for permanent pacing (age=41.7±13.4 years) LVEF>45% ICD implantation Follow-up duration = 33.9 ± 1.0 months malignant VTA in 8 patients 30 years Heart Failure Implantable cardiac defibrillators (rather than pacemakers) Meune C, et al. N Engl J Med ;354: van Berlo JH et al. J Mol Med. 2005;83:79-83.
![[27-45]) Follow up = 43 months [17-101] Malignant ventricular](/docs-images/95/122789620/images/5-2.jpg "arrhythmia in 48 patients (4.")
5 Risk stratification for sudden death: the current strategy European registry (Cardiology tertiary centers) N = 269 patients (Age=36 years [27-45]) Follow up = 43 months [17-101] Malignant ventricular arrhythmia in 48 patients (4.7%/year) Multivariate analysis: 4 risk factors (1) Male (2) Non missense mutation (3) NSVT (4) LVEF<45% van Rijsingen IA, Arbustini E, Elliott PM, et al. J Am Coll Cardiol. 2012;59:
6 Why developing a score to predict VTA in laminopathies? 1. Risk score calculation is the best approach to assess patient prognosis (consider number of prognostic factors & provide an estimate of patients absolute risk of an event) 2. Questions raised by the current score: Conduction system disease is absent from risk predictors Some specific situations Male + truncating mutation + no NSVT + LVEF=65%? Female + AVB1 + AF + LVEF=50%?
7 Patient selection Derivation cohort France OPALE: Nationwide Registry on Laminopathies 660 Patients diagnosed with pathogenic LMNA mutations between January 2000 and Nov 2016 Validation cohort UK - Barts Heart centre US - Brigham and Women s Hospital, Boston Tertiary cardiology referral centers 179 Patients diagnosed with pathogenic LMNA mutations between 2000 and June Excluded 23 With first visit to cardiologist before January Malignant VTA prior to baseline 39 Age <16 years 38 Neuromuscular and systemic disease with onset before 16 years 3 With other cardiomyopathy mutations 92 Absence of any clinical data 34 Excluded 4 First visit to cardiologist before January Malignant VTA prior to baseline 2 Absence of any clinical data 3 Transplant prior to baseline Study population of 444 patients with adult-onset laminopathies Study population of 145 patients with adult-onset laminopathies
8 Baseline characteristics Derivation sample (n=444) Validation sample (n=145) Original data Imputed data Original data Imputed data Parameter Value Missing (n) Value Value Missing (n) Value Age,y 40.6± ± ± ±15.4 Men 194 (43.7) (43.7) 75 (51.7) 0 75 (51.7) Non-missense mutation 127 (28.6) (28.6) 67 (46.2) 0 67 (46.2) AVB (34.2) (34.2) 41 (32.3) (33.1) AVB 3 67 (18.1) (18.2) 19 (15.0) (16.6) Atrial fibrillation 141 (31.8) (31.8) 55 (37.9) 0 55 (37.9) NSVT 60 (17.4) (16.9) 30 (20.7) 0 30 (20.7) LVEF, % 56.3± ± ± ±12.2
9 Patient outcome Derivation cohort (n = 444) Validation cohort (n = 145) Survival probability Survival probability Dotted lines delimit the 95% CI 0.1 Dotted lines delimit the 95% CI Time (in years) Follow-up duration = 3.6 years [ ] Malignant VTA = 86 (19.3%) Time (in years) Follow-up duration = 5.1 [ ] Malignant VTA = 34 (23.4%)
10 Model development Full variable model HR [95% CI] P- value Coefficients Final model HR [95% CI] Age 0.99 [ ] P- value Male gender 1.7 [ ] [ ] AVB [ ] [ ] AVB [ ] [ ] <0.001 Atrial fibrillation 1.17 [ ] NSVT [ ] < [ ] <0.001 Non-missense mutation [ ] [ ] LVEF (%) 0.96 [ ] < [ ] <
11 Score validation Internal (derivation cohort) C-index [95%IC] [ ] Calibration slope External (validation cohort) C-index [95%IC] [ ] Calibration slope [95% IC] [ ] Guidelines-based indications for ICD ( 2 risk factors) C-index [95%IC] [ ] Calibration slope [95% IC] [ ]
12 Clinical implications Effect of using different thresholds of 5-year VTA risk to implant an ICD in 225 LMNA patients (Pooled cohort) Strategy to select patients for ICD implantation Type Number of events = 52 (23.1%) Threshold values Clinical consequences Patients implanted with an ICD, n (%) VTA during follow-up predicted at baseline, n (%) Guidelines-based strategy 2RF 86 (38.2) 35 (67.3) 35 (40.7) 5-year risk score strategy 1% 225 (100) 52 (100) 52 (23.1) 2% 222 (98.7) 52 (100) 52 (23.4) 3% 203 (90,2) 51 (98.1) 51 (25.1) 4% 186 (82,7) 51 (98.1) 51 (27.4) 5% 171 (76) 50 (96.1) 50 (29.2) 6% 158 (70,2) 50 (96.1) 50 (31.6) 7% 150 (66,7) 50 (96.1) 50 (33.3) 8% 137 (60.9) 47 (90.4) 47 (34.3) 9% 128 (56,9) 44 (84.6) 44 (34.4) 10% 120 (53,3) 44 (84.6) 44 (36.7) 15% 99 (44) 41 (78.8) 41 (41.4) 20% 69 (30.7) 36 (69.2) 36 (52.2) 25% 52 (23.1) 31 (59.6) 31 (59.6) Patients with an ICD developing VTA during follow-up. n (%)
13 Comparison of the 2 models (risk factors vs prediction score) Risk Reclassification Analysis Number of events = 52 (23.1%) Threshold of 5- year SCD risk used to implant ICD VTA No VTA reclassification reclassification correct incorrect net correct incorrect net 1% % % % % % % % % % % % %
14 New score to predict malignant VTA in patients with LMNA mutations 1. Good discrimination 2. Good calibration 3. Correct reclassification of patients with VTA compared to the guidelines-recommended approach
15 Perspectives sudden death prevention Dilated cardiomyopathy Inflammatory LVEF <35% CAT, AMIO-VIRT, DEFINITE, SCD-HeFT, COMPANION, Personalised medicine DANISH Genetic 1- Diagnosis 2- Specific prediction models 3- Innovative tools for risk stratification 4- Innovative therapies Arrhythmogenic conditions LMNA DES FLNC EMD RF Score Disease-specific risk stratification (registries, cohorts)
16
17 2: cardiolaminopathies: more severe than other familial cardiomyopathies Cardiac death Cardiac death HF, transplantation Taylor et al. J Am Coll Cardiol 2003;41:
18 Clinical implications Effect of using different thresholds of 5-year VTA risk to implant an ICD in 225 LMNA patients (Pooled cohort) Threshold of 5-year VTA risk used to implant ICD Total number of ICD implanted ICD implanted VTA No ICD implanted No ICD implanted No VTA ICD implanted 4% 180 (80,0%) 51 (23%) 1 (0,4%) 44 (20%) 129 (57%) 6% 152 (67,6%) 50 (22%) 2 (0,8%) 71 (32%) 102 (45%) 8% 135 (60,0%) 47 (21%) 5 (2,2%) 85 (38%) 88 (39%) 10% 118 (52,4%) 44 (20%) 8 (4%) 99 (44%) 74 (33%) 15% 98 (43,6%) 41 (18%) 11 (5%) 116 (52%) 57 (25%) 20% 68 (30,2%) 36 (16%) 16 (7%) 141 (63%) 32 (14%) 25% 52 (23,1%) 31 (14%) 21 (9%) 152 (68%) 21 (9%)
19 Clinical implications Comparison of the 5-year VTA risk prediction strategy to implant an ICD to guidelines-based indication ( 2 risk factors) Guidelines-based indications for ICD ( 2 risk factors) (validation cohort) C-index [95%IC] [ ] Calibration slope [95% IC] [ ] Threshold of 5-year VTA risk used to implant ICD Compared to the guidelines-based strategy Additional VTA predicted Additional ICD implanted in patients without VTA 4% 16 (7%) 78 (35%) 6% 15 (7%) 51 (23%) 8% 12 (5%) 37 (16%) 10% 9 (4%) 23 (10%) 15% 6 (3%) 6 (3%) 20% 1 (0%) -19 (8%) 25% -4 (2%) -30 (13%) Pooled cohort (225 patients)
20 Clinical implications Comparison of the 5-year VTA risk prediction strategy to implant an ICD to guidelines-based indication ( 2 risk factors) A. Total population B. Patients with 2RF C. Patients with <2RF Guidelines -based Guidelines -based Guidelines -based
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