Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
- Conditions
- Ventricular TachycardiaPost-extrasystolic Potentiation (PESP)
- Interventions
- Device: Cardiac stimulation through the device leads
- Registration Number
- NCT03631303
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Background: Patients at increased risk for sudden cardiac death (SCD) may receive an implantable cardioverter defibrillator (ICD). The primary criterion for a primary prevention ICD implantation is a left ventricular ejection fraction (LVEF) below 35%, but refinement of ICD criteria is important since only a small proportion of ICD patients receives appropriate device therapy (ATP or a shock) during follow-up. Post-extrasystolic potentiation (PESP) may be a new risk marker for SCD. PESP is defined as a temporary increase in contractility that follows an extrasystolic beat (ESB) and is associated with myocardial calcium handling. In heart failure, changes in calcium homeostasis may lead to afterdepolarisations and thus predispose for SCD. PESP can be measured indirectly and non-invasively as post-extrasystolic blood pressure potentiation (PESP-BP). Abnormal PESP-BP was previously found to be an independent predictor of increased mortality in post-myocardial infarction patients with a reduced LVEF. However, it is unknown if this increased mortality in heart failure patients with abnormal PESP-BP is caused by an increased risk of SCD.
Hypothesis: The investigators hypothesize that PESP-BP might be a new predictor of the occurrence of SCD, and can be used to enhance patient selection for primary prevention ICD therapy.
Design: During scheduled device replacement ESB with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively a continuous electrocardiogram will be recorded. Either before or after the procedure, patients will undergo a 30-minutes assessment of spontaneous ESB, again with blood pressure and ECG recordings.
Study population: 30 patients who are scheduled for device replacement or reposition, are eligible for this study; (1) 10 ICD patients who previously received appropriate device therapy (ADT); (2) 10 ICD patients who are free from ADT and (3) 10 dual-chamber pacemaker patients (control group).
Outcomes: (1) Evoked PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (2) Spontaneous PESP-BP (i.e. blood pressure differences between baseline, ESB and post-ESB); (3) Timing parameters (in ms): the basic cycle length interval; Extra-systolic interval (ESI); Post-extrasystolic interval (PESI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Implanted with a dual-chamber device
- For ICD patients: a LVEF ≤35%, measured recently
- For Pacemaker patients: a LVEF > 50% measured both recently
- A device follow-up of at least one year must be available
- Optimal (stable) medical therapy
- Sinus rhythm
- Age <18 or incapacitated adult
- Unknown left ventricular function prior to device implantation
- Patients unwilling to participate
- Documented atrial fibrillation
- Second or third degree atrioventricular (AV) conduction disorders;
- Patients with a cardiac resynchronization therapy (CRT-D) or one-chamber device
- Hypertrophic cardiomyopathy
- Conditions with insufficient blood flow to the fingers, e.g. M. Raynaud or conditions with extreme vasoconstriction
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICD patients without ATP/Shock Cardiac stimulation through the device leads 10 primary prevention 2-chamber ICD patients (LVEF \<35 percent) who were free from appropriate ICD therapy during follow-up. ICD patients with ATP/shock Cardiac stimulation through the device leads 10 primary prevention 2-chamber ICD patients (LVEF \<35 percent) who received appropriate ICD therapy during follow-up. Pacemaker-patients Cardiac stimulation through the device leads 10 2-chamber pacemaker-patients (LVEF \>50%).
- Primary Outcome Measures
Name Time Method Evoked PESP-BP Measured during stimulation protocol blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
Spontaneous PESP-BP Measured in rest, without cardiac stimulation with spontaneous ESB blood pressure differences between baseline, extrasystolic beat (ESB) and post-ESB
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
VU university medical center
🇳🇱Amsterdam, Netherlands