Friday, February 09, 2007

Defibrillators and Driving

New policy recommendations were released this week by the Heart Rhythm Society and American Heart Association regarding driving restrictions in patients with implantable cardiac defibrillators (ICDs). These newer guidelines were basically a supplement to earlier guidelines published in 1996 when most ICDs were placed after individuals already had a documented arrhythmia or episode of aborted sudden death ("secondary prevention"). These newer guidelines extend the former guidelines to also include patients who have never had an index arrhythmia, but instead have been implanted with an ICD to avoid their first arrhythmia ("primary prevention").

There is probably no more contentious issue that I struggle with as a cardiac electrophysiology physician than the question "When can I drive?" after implanting an ICD. People need their cars for a whole host of reasons. Our society is wedded to cars. So to tell someone who has been independent all of their life that they can no longer drive, becomes a personal affront to their independence - some would even claim to the extent that we are intruding on their personal rights. The guidelines admit to this dilemma:
In American society, there is a constant conflict between the rights of the individual and the good of society. The individual is given the right to act in whatever manner he or she chooses as long as that act does not impinge on the rights of others. The latter requirement demands that limits be placed on the rights of the individual just as limits are placed on the rights of society to restrict individual action. Ethics tries to address the delicate balance between these two conflicting principles. In American society, individual mobility and access to education, employment, health maintenance, and personal enrichment opportunities are highly dependent on the automobile. Being unable to drive puts limitations on the individual, which results in both emotional stress and loss of economic status. At the same time, the citizens of a society have the right to protect themselves against the harm caused by individuals who are unable to operate a motor vehicle in a safe and prudent manner. In a just and open society, all individuals are treated equally. Therefore, restrictions on the driving ability of patients with arrhythmias must be clearly elaborated and applied uniformly to all.
Okay, okay, but I have a bit of a problem with the last sentence of this paragraph. Is there no line to be drawn for the evaluating physician? But even harder to swallow was this paragraph:
The physician and other healthcare professionals are bound to uphold the confidentiality of information regarding a patient’s medical condition, and such information is shared with others only when consent is given by the patient. If a patient requests that medical information be withheld from his or her employer, the ethical physician will not comply with the patient’s request if doing so would pose a risk to others. In such instances, the patient should be asked to release this information. If, however, the patient does not agree, the physician is bound to breach confidentiality. Although breaking the principle of confidentiality may result in legal action by the patient against the physician, the ethical responsibilities of beneficence (“do good and avoid evil”) and nonmaleficence (“do no harm”) take precedence over the principle of confidentiality in this setting. In such situations, the ethical course is for the physician to release the required information to the proper authorities, such as the state or national departments of transportation, while providing full disclosure to the patient.
In effect, we get to be tattle tales in the interest of public safety. So much for your confidentiality. And this will be in spite of this tidbit of data:
Patients randomized in the AVID Trial reported resuming driving early regardless of medical advice to the contrary (80% were driving within 6 months), reported driving frequently (57% reported driving every day), and reported driving significant distances (25% were driving 100 miles/wk). However, these patients, who had survived a near-fatal episode of ventricular arrhythmia, had a very low rate of automobile accidents. Indeed, the frequency of automobile accidents (3.4% of patients per year) was less than that of the general driving population of the United States (7.1% patients per year). Nevertheless, the relatively high event rate soon after the index episode of ventricular tachyarrhythmias led to a suggestion that driving be restricted for all patients for 1 month and for most patients up to 8 months after such an event.
I agree with the task force's opinion that driving in primary prevention patients be restricted from driving for a week after a new implant, but asking patients to avoid driving for 6 months after they've had a significant arrhythmia in all cases seems excessive, specially if a precipitating cause (ischemia, heart failure, drug effect or device programming error) is identified.

Patients with these devices and their managing physicians need to beware of the implications of these recommendations. While these guidelines help standardize US practices regarding ICDs and driving, much of these are developed with very minimal data but have now been carved in stone - at least until new guidelines are published.


(1) Addendum to “Personal and Public Safety Issues Related to Arrhythmias That May Affect Consciousness: Implications for Regulation and Physician Recommendations: A Medical/Scientific Statement From the American Heart Association and the North American Society of Pacing and Electrophysiology” Public Safety Issues in Patients With Implantable Defibrillators A Scientific Statement From the American Heart Association and the Heart Rhythm Society*
Andrew E. Epstein, MD, FAHA, FHRS; Christina A. Baessler, RN, MSN; Anne B. Curtis, MD, FAHA, FHRS; N.A. Mark Estes III, MD, FAHA, FHRS; Bernard J. Gersh, MB, ChB, DPhil, FAHA; Blair Grubb, MD, FAHA; L. Brent Mitchell, MD, FHRS
Circulation published online Feb 7, 2007; DOI: 10.1161/CIRCULATIONAHA.106.180203

(2) Epstein AE, Miles WM, Benditt DG, Camm AJ, Darling EJ, Friedman PL, Garson A Jr, Harvey JC, Kidwell GA, Klein GJ, Levine PA, Marchlinski FE, Prystowsky EN, Wilkoff BL. Personal and public safety issues related to arrhythmias that may affect consciousness: implications for regulation and physician recommendations: a medical/scientific statement from the
American Heart Association and the North American Society of Pacing and Electrophysiology. Circulation. 1996;94:1147–1166.

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1 comment:

Margaret Polaneczky, MD (aka TBTAM) said...

Seems Medtronics needs to amend their add..

"10,000 less car rides..."