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Time course of appropriate implantable cardioverter-defibrillator therapy and implications for guideline-based
Michael H Kim1, Yan Zhang2, Scott Sakaguchi3
1Alpert Medical School of Brown University and the Cardiovascular Institute, Rhode Island, Miriam, and Newport Hospitals, Providence, Rhode Island.
Insights
Patients with implantable cardioverter-defibrillators (ICDs) receiving appropriate therapy for ventricular arrhythmias (VA) face a higher risk of subsequent events sooner than current driving restrictions suggest. This highlights the need for updated driving guidelines for ICD patients.
Area of Science:
- Cardiology
- Electrophysiology
- Medical Device Technology
Background:
- Current guidelines restrict driving for 6 months post-implantable cardioverter-defibrillator (ICD) implantation for ventricular arrhythmias (VA) based on prevention type and therapy received.
- These recommendations aim to mitigate risks associated with sudden cardiac events while driving.
Purpose of the Study:
- To analyze ICD therapy data to inform guideline recommendations regarding driving restrictions for patients.
- To evaluate the time course and risk of subsequent appropriate therapies in ICD patients.
Main Methods:
- The OMNI Registry was queried for data on ventricular arrhythmias (VA) and appropriate ICD therapies.
- Kaplan-Meier method estimated event rates, with a 7-day blanking period applied.
- A blinded committee adjudicated all events.
Main Results:
- 2262 patients (74% primary prevention) were analyzed; 28% received at least one appropriate therapy.
- The likelihood of subsequent appropriate therapy increased with each prior event and occurred at shorter intervals.
- At 6 months, the risk of shock was 3 times higher if the first VA was treated with shock versus antitachycardia pacing (30.0% vs 9.9%).
Conclusions:
- Each appropriate VA therapy increases the risk of a subsequent event occurring sooner than current driving restrictions allow.
- A notable difference in shock risk exists between antitachycardia pacing and shock for the initial VA event.
- Findings support re-evaluation of clinical guidelines and practices for driving restrictions in ICD patients.
Background:
American Heart Association/Heart Rhythm Society recommendations restrict driving in implantable cardioverter-defibrillator patients for 6 months after implant for secondary prevention or primary prevention with an appropriate therapy (antitachycardia pacing or shock) for ventricular arrhythmias (VA).
Objective:
The purpose of this study was to analyze implantable cardioverter-defibrillator therapy data to inform guideline recommendations on driving.
Methods:
The OMNI Registry was queried for VA and assessed for the time course of appropriate therapies. A blind events committee adjudicated events. The Kaplan-Meier method was used to estimate event rates. A 7-day blanking period was used for each event of interest.
Results:
A total of 2262 patients (mean age 67 ± 12 years; mean left ventricular ejection fraction 28%) were enrolled; 1659 (73%) were men, and 1666 (74%) were implanted for primary prevention. Overall, 628 of 2255 patients (28%) received ≥1 appropriate therapy. The probability of receiving a subsequent appropriate therapy increased and occurred in a shorter time interval with each appropriate therapy. At 6 months, the likelihood of receiving a shock when the first VA was terminated by shock (30.0%) was 3 times the risk when the first VA was terminated by antitachycardia pacing (9.9%).
Conclusion:
Each appropriate VA therapy is associated with an increased risk of a subsequent event that occurs, on average, in a time frame shorter than current guideline-based restrictions. A differential risk of shock is noted in those receiving antitachycardia pacing vs shock for the first appropriate VA. These findings may help to inform future clinical guideline and practice decisions related to driving.
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