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).
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
Severe aortic stenosis (valve area ≤ 1 cm2)
Known cardiac amyloidosis
Indication for cardiac resynchronisation therapy
Indication for left bundle branch physiological pacing
Single group
Cardiac amyloidosis screening during CIED implantation
Diagnostic testProcedure 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.
Area under the receiver operating characteristic curve (AUROC) of the right ventricular sensing amplitude for the identification of patients with cardiac amyloidosis
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.
Diagnostic performance of right atrial sensing amplitude for diagnostic of cardiac amyloidosis
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
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
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
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.
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