Pacemaker-based Long-term Monitoring of Sleep Apnea

Study Overview
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Brief Summary
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This is a prospective, non-interventional cohort study. It tests the hypothesis that Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of AHRE in SR patients implanted with a DDDR pacemaker.

Detailed Description
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All forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.

Official Title
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Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring

Conditions
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Bradycardia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: implanted Microport TEO SR/DR or BOREA SR/DR pacemaker device signed informed consent Exclusion Criteria: any contraindication to perform a cardiac CT examination eGFR < 30 ml/min/1.73 m2 allergy against CT contrast medium hyperthyreoism inability of the patient to understand the study purpose and plan inability of the patient to perform baseline examinations pregnancy or breast-feeding; women with childbearing potential estimated life expectancy below one year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with severe sleep apnea<br>defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment | |
| patients with autonomic imbalance<br>defined by PRD ≥ 5.75deg2 assessed within the first 12 months of enrollment | |
| patients with a sedentary lifestyle<br>defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3P-MACE | death, myocardial infarction and/or stroke | after 3 years | 
| 3P-MACE | death, myocardial infarction and/or stroke | after 5 years | 
| 3P-MACE | death, myocardial infarction and/or stroke | after 10 years | 
| Atrial high rate episodes | in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration | after 3 years | 
| Atrial high rate episodes | in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration | after 5 years | 
| Atrial high rate episodes | in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration | after 10 years | 
| Ventricular tachyarrhythmia | cycle length < 320 ms; ≥ 40 beats | after 3 years | 
| Ventricular tachyarrhythmia | cycle length < 320 ms; ≥ 40 beats | after 5 years | 
| Ventricular tachyarrhythmia | cycle length < 320 ms; ≥ 40 beats | after 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of subclinical coronary atherosclerosis assessed by CTA | Agatston-Score stratified to 0, 1-10, 11-100, 101-400, >400. Coronary lesions will be graded according to the CADSRAD classification (minimal < 10%, mild < 50%, moderate 50-70%, severe > 70%). Coronary plaques will be classified as T1 = calcified, T2 = mixed, T3 = mixed, primarily calcified, T4 = non-calcified). High risk plaque-criteria will include: low attenuation plaque, napkin-ring, spotty calcification < 3mm, remodelling index. | after 5 years | 
| Deterioration of lung function | conventional lung function testing | after 5 years | 
| Progression of subclinical peripheral artery disease | sonography | after 5 years | 
| Progression of subclinical peripheral artery disease | ABI | after 5 years | 
| QoL assessment | EQ-5D-5L | after 5 years |