Cardiac Amyloidosis, Conduction Abnormality, Left Ventricular Hypertrophy
Conditions
Keywords
Cardiac Amyloidosis, Pacemaker, Scintigraphy
Brief summary
This multicenter prospective study aims to evaluate the diagnostic performance of right ventricular sensing amplitude measured during cardiac implantable electronic device (CIED) implantation (pacemaker or defibrillator) to identify cardiac amyloidosis in patients with left ventricular hypertrophy and conduction abnormalities. Patients aged 65 years or older referred for CIED implantation will be included. During the procedure, electrophysiological parameters will be recorded. Additional assessments will be performed, including cardiac scintigraphy, biological analyses, and subcutaneous adipose tissue biopsy. The results of these investigations will be used to confirm or rule out cardiac amyloidosis. Diagnostic performance will be assessed using the area under the receiver operating characteristic curve (AUROC).
Interventions
DIAGNOSTIC_TESTCardiac amyloidosis screening during CIED implantation
Procedure of CIED implantation will not be modified by inclusion in the study. However, several exams will be performed to confirm or ruled out the diagnosis of cardiac amyloidosis: During the procedure: Subcutaneous adipose tissue sampling Collection of a subcutaneous adipose tissue sample during device implantation for histological analysis to detect amyloid deposits. Blood sampling for serum free light chain assay, serum and urine electrophoresis with immunofixation (baseline visit) Diagnostic Test: 99mTc-DPD or HMDP Scintigraphy Cardiac scintigraphy performed within 3 months after implantation to assess myocardial tracer uptake and detect cardiac amyloidosis.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient referred for CIED implantation (pacemaker or Implantable Cardioverter Defibrillator with a pacemaker feature) due to at least one conduction abnormality (Atrioventricular block, Sinoatrial block or Atrial fibrillation with slow ventricular rate). Patients referred for implantation of an Implantable Cardioverter Defibrillator with a pacemaker feature can be included if they present one of these conduction abnormalities. * Left ventricular hypertrophy definite as maximal end-diastolic interventricular septum thickness ≥ 12mm * Patients aged ≥ 65 years * Written consent * Patient affiliated to a social security
Exclusion criteria
* Severe aortic stenosis (valve area ≤ 1 cm2) * Known cardiac amyloidosis * Indication for cardiac resynchronisation therapy * Indication for left bundle branch physiological pacing * Ejection fraction \< 45% on echocardiography. * Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants. * Patient on AME (state medical aid) * Adults subject to a legal protection measure (guardianship, curatorship, or safeguard of justice). * Patients deprived of their liberty by a judicial or administrative decision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis | During CIED implantation | The area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude, measured during CIED implantation in patients with conduction abnormalities, for the identification of patients with cardiac amyloidosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis | During hospitalization for CEID implantation (Day 0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis. |
| Diagnostic performance of atrial pacing thresholds for diagnostic of cardiac amyloidosis | During hospitalization for CEID implantation (Day 0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis. |
| Diagnostic performance of ventricular pacing thresholds for diagnostic of cardiac amyloidosis | During hospitalization for CEID implantation (Day 0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of right atrial sensing amplitude, atrial and ventricular pacing thresholds estimated during CIED implantation for identifying patients with cardiac amyloidosis. |
| Diagnostic performance of maximal end-diastolic interventricular septal thickness | During hospitalization for CEID implantation (Day 0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of maximal end-diastolic interventricular septum thickness at echocardiography for identifying patients with cardiac amyloidosis. |
| Diagnostic performance of adipose tissue histology | During hospitalization for CEID implantation (Day-0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of histological analysis of adipose tissue for identifying patients with cardiac amyloidosis. |
| Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds | 6 months after CIED implantation (Day 0) | The area under the receiver operating characteristic curve (AUROC) and sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios of 12-lead electrocardiogram data (low voltage in limb leads) for identifying patients with cardiac amyloidosis. |
| The implantation procedure duration (min) between patients with or without cardiac amyloidosis | During CIED implantation | — |
| The prevalence of cardiac amyloidosis in the study population | Up to 3 months after CIED implantation | — |
| The proportion of modifications in the treatment at the 6-month visit. | 6 months after CIED implantation | — |
| Change in RAND 36-Item Health Survey (SF-36) score | Inclusion and 6 months after CIED implantation | Change in health-related quality of life between inclusion and the 6-month visit, assessed using the RAND 36-Item Health Survey, Version 1.0 (SF-36). The questionnaire comprises 36 items grouped into 8 domains. Each domain score ranges from 0 to 100, with higher scores indicating better health-related quality of life. |
| Change in New York Heart Association (NYHA) Functional Classification | Inclusion and 6 months after CIED implantation | Change in New York Heart Association (NYHA) Functional Classification between baseline and the 6-month visit in patients with and without cardiac amyloidosis. The NYHA Functional Classification ranges from Class I to Class IV, with higher class indicating worse functional status. |
Contacts
CONTACTSamia BALOUL
CONTACTPhilippe Le Corvoisier, MD, PhD
STUDY_CHAIRPhilippe Le Corvoisier, MD, PhD
Assistance public Hôpitaux de Paris
Outcome results
None listed