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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
242
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.
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.
Time frame: During CIED implantation
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.
Time frame: During hospitalization for CEID implantation (Day 0)
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.
Time frame: During hospitalization for CEID implantation (Day 0)
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.
Time frame: During hospitalization for CEID implantation (Day 0)
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.
Time frame: During hospitalization for CEID implantation (Day 0)
Diagnostic performance of adipose tissue histology
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.
Time frame: During hospitalization for CEID implantation (Day-0)
Diagnostic performance of right atrial and ventricular sensing amplitudes and pacing thresholds
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.
Time frame: 6 months after CIED implantation (Day 0)
The implantation procedure duration (min) between patients with or without cardiac amyloidosis
Time frame: During CIED implantation
The prevalence of cardiac amyloidosis in the study population
Time frame: Up to 3 months after CIED implantation
The proportion of modifications in the treatment at the 6-month visit.
Time frame: 6 months after CIED implantation
Change in RAND 36-Item Health Survey (SF-36) score
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.
Time frame: Inclusion and 6 months after CIED implantation
Change in New York Heart Association (NYHA) Functional Classification
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.
Time frame: Inclusion and 6 months after CIED implantation
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