Updated EHRA Recommendations on Driving for Patients with Implantable Cardioverter Defibrillators

Linda C. Moulton, RN, MS Owner, Critical Care ED and C.C.E. Consulting Faculty, Order and Disorder Electrophysiology Training Program C.C.E. Consulting New Berlin, Illinois
Linda C. Moulton, RN, MS Owner, Critical Care ED and C.C.E. Consulting Faculty, Order and Disorder Electrophysiology Training Program C.C.E. Consulting New Berlin, Illinois
Recently a new consensus statement was released by the European Heart Rhythm Association (EHRA) updating their recommendations on driving for patients with implantable cardioverter defibrillators (ICDs). Find out more about what changes were made here. Implantable cardioverter defibrillators (ICDs) have saved lives repeatedly since they were made available in the 1980s for sudden cardiac death (SCD) prevention. The implantation of ICDs for primary prevention in patients with low ejection fractions has led to an ever-increasing number of patients with these devices. The safety issues related to patients driving during ICD discharge has been one of concern to patients, families, physicians, governments, and the public. The European Heart Rhythm Association task force on ICDs last produced a guidance document dealing with the subject in 1997.1 Since that time, patients have begun to receive ICDs for primary prevention, representing a different level of risk for SCD; therefore, it was felt that the guidelines needed to be updated. The document that has resulted is the “Consensus statement of the European Heart Rhythm Association: Updated recommendations for driving by patients with implantable cardioverter defibrillators.”2 This article will provide an overview of the consensus document. Task Force Members The task force members who produced this document included clinicians from Belgium, Italy, United Kingdom, Sweden, Germany, France, Poland, Norway, the Netherlands, Switzerland, and Greece. It had been noted by the group that there was much inconsistency among countries regarding driving restrictions, and in many cases, restrictions were the same for all ICD indications. The members hoped this document would assist regulatory agencies in developing driving regulations more appropriate to indication and standardized across the European Union. Psychosocial and Adherence Issues The consensus document relates multiple issues related to driving restrictions for the ICD patient and their family members. Psychological effects abound for both patient and family; in addition, there are lifestyle-related issues, as well as impacts on employment and education. Many families face logistical issues related to loss of a driver. As a result, adherence with restrictions is not always what it should be, and high-risk patients may continue to drive. For patients who have jobs that require driving, the restrictions can be especially devastating financially. However, allowing the ICD patient to drive may pose a major risk to society due to their potential loss of consciousness while behind the wheel. The consensus group recognizes that two principles are involved in this issue: rights of individuals and societal good. An attempt is made to balance these within these recommendations. Patient and family education regarding restrictions is of the utmost importance. The group believed there was a need for improvement in the standardized information available to patients. Risk of Harm Assessment A Canadian document from 19923 included a ‘Risk of Harm’ formula that has subsequently been used for explanation of risk in other documents discussing ICDs and driving. The formula is: RH = TD x V x SCI x Ac RH = risk of harm TD = percentage of time behind the wheel or distance driven in a given period of time V = type of vehicle being driven SCI = risk of sudden cardiac arrest-related incapacitation annually Ac = probability of a fatal or injury-producing accident as a result of an event Ac is 0.02 for all drivers, based on data reported from numerous studies.4-7 Vehicle-related data that is entered into the formula is the following: V = 1 for commercial drivers, and V = 0.28 for private drivers. TD values include: 0.25 for commercial drivers (who spend approximately 25% of their time driving) and 0.04 for private drivers (who spend about 4% of their time driving). This formula was used to help determine level of risk and suitable driving restrictions recommended by the EHRA group. Definitions Definitions for who qualifies as a private driver and professional driver are discussed. The European Union developed guidelines in 1991 that have been adopted in most countries. These guidelines address two groups: Group 1 includes drivers of motorcycles, cars, and other small vehicles with and without a trailer; and Group 2 includes drivers of vehicles weighing greater than 3.5 metric tons, or vehicles exceeding 8 seats that carry passengers.2 An intermediate group would be those driving cabs, ambulances, and other professionally-related vehicles. The consensus report recommends that the intermediate group be included with Group 2 for driving restrictions, due to the number of hours they spend carrying passengers. Driving Recommendations The recommendations developed by the European consensus group are summarized in Tables 1 and 2. It should be noted that the most recent recommendation from the Heart Rhythm Society (HRS)8 restricted private drivers for 1 week post implant in the primary prevention setting, and 6 months post implant for the secondary prevention setting. Commercial drivers are permanently restricted in all categories in the HRS guidelines, which is consistent with the European guidelines in Table 2. Clinical Follow-up and Recommendations The group recommends that the status of the ICD patient be monitored in the follow-up period for worsening of clinical condition and increase in cardiac events. Cardiac rehabilitation is encouraged in patients who are able to participate, as this has been found to lower the incidence of shocks.9-11 In addition, psychological/cognitive interventions are recommended to decrease anxiety and improve quality of life for the ICD recipient. Summary Patients, families, and the public may all be impacted by the patient’s driving privileges post implant. A balance must be struck between individual rights and public safety. These task forces examine the issues related to driving privileges/restrictions, and develop recommendations that they hope are fair for the individual, while promoting the safety of us all. The EHRA consensus statement may be downloaded at: http://europace.oxfordjournals.org/cgi/content/abstract/11/8/1097.