New Guidelines for Driving After an ICD event

[Guest guest]

www.medscape.com

NOTE: To view the article with Web enhancements, go

to:

http://www.medscape.com/viewarticle/554202

Driving Restrictions for Patients With ICDs for

Primary Prevention: New Recommendations

Medscape Family Medicine. 2007; ©2007 Medscape

Posted 04/04/2007

Editor's Note

In February, the American Heart Association and Heart

Rhythm Society jointly released new guidelines that

update previous recommendations on safe driving

practices for patients with implantable cardioverter

defibrillators (ICDs).[1] In an earlier driving

guideline, issued in 1996,[2] the focus of ICD

recommendations was almost solely on patients with

ICDs implanted for secondary prevention, that is,

patients who had survived a life-threatening

arrhythmia, such as ventricular tachycardia or

ventricular fibrillation. However, over the past

several years, there has been a shift in practice

toward implantation of these devices for primary

prevention in patients who have not yet experienced a

life-threatening arrhythmia but are at high risk for

such an event. The new guidelines focus specifically

on the primary prevention patient population, which

now represents the majority of patients implanted with

ICDs in the United States.

The recommendations are intended to address the

potential public safety risks that occur when ICD

patients experience an arrhythmia and receive a shock

or other appropriate ICD therapy while driving. Such

an event may produce sudden mental and physical

impairment or even loss of consciousness that could

result in a serious motor vehicle accident. The

guidelines were developed to minimize the risk for

repeat events occurring while patients are behind the

wheel.

Medscape recently spoke with E. Epstein, MD,

FAHA, FACC, Professor of Medicine at the University of

Alabama at Birmingham and the lead author of the new

guidelines, about the current recommendations and

implications of driving restrictions in the ICD

patient population. In the following interview, Dr.

Epstein provides an overview of the guidelines as well

as unique insight into the medical and ethical

considerations that go into managing these patients.

Driving Recommendations: Primary vs Secondary

Prevention

Medscape: Why update the guidelines at this time?

Dr. Epstein: At the time when the initial guidelines

were written in 1996, the vast majority of ICDs were

implanted for secondary prevention in people who had

been resuscitated from a cardiac arrest or had

ventricular tachycardia. Now, however, 80% of the

devices implanted across the country are for primary

prevention -- to prevent sudden cardiac death in

people who have never had a life-threatening

arrhythmia, but are at high risk for such an event.

Although the 1996 document included a discussion that

anticipated the primary prevention strategies that we

have today, this was not the focus of the

recommendations. Furthermore, there was no clear

guidance about whether driving restrictions should be

imposed on patients with ICDs implanted for primary

prevention who experienced appropriate ICD therapy. As

a result, the previous guidelines were often

misinterpreted with respect to their application to

patients with ICDs implanted for primary or secondary

prevention, and how they should be handled.

Thus, because the complexity of the landscape has

changed in terms of the indications for getting a

device, this update was as much a clarification as

anything else. The guidelines really haven't changed

since 1996, but the current document offers a more

concise summary that focuses on the use of

defibrillators for primary prevention to make it

easier for physicians to address that patient

population.

Medscape: What do the guidelines say about when

driving should be restricted for primary prevention

patients, and does this differ from the

recommendations for secondary prevention patients?

Dr. Epstein: For individuals getting a primary

prevention device who have never had an arrhythmia

event, the current guidelines recommend that driving

be restricted only for as long as is necessary to

allow the implantation wound to heal -- which is

usually 1 week. Other than that, there are no

restrictions recommended as long as the patient does

not experience an arrhythmia event with ICD

intervention.

However, if a primary prevention patient experiences

an event, they transition to the same guidelines as

those for secondary prevention patients -- and those

recommendations are straightforward. If a patient

experiences an appropriate ICD therapy for ventricular

tachycardia or ventricular fibrillation, that patient

should not drive for 6 months thereafter. If the

patient goes for the full 6 months without

experiencing another appropriate therapy, then driving

can be resumed. However, if another appropriate ICD

intervention is experienced, even after 5.9 months,

the clock starts again and the patient should continue

to be restricted from driving for another 6 months.

The rationale for that recommendation is based on the

fact that the risk for event recurrence is a

descending exponential curve -- with the greatest

chance for a recurrent arrhythmia in the period

immediately following an event. By 3 months, the curve

flattens considerably and it is then flat at 6 months.

It's also important to note that these rules apply

only to private driving and that commercial driving

licensed under the US Department of Transportation is

a separate entity that is governed by national law.

Nationwide Laws

Medscape: Do some physicians or patients believe that

these recommendations are too restrictive?

Dr. Epstein: Some people complain that 6 months is too

long to restrict driving for these patients, but in

fact, it is much less restrictive than virtually all

of the state laws that govern driving due to medical

conditions. Laws that govern epilepsy, for example,

require patients to be seizure-free for 1 year prior

to resuming driving. Very few states have laws that

directly address defibrillators and loss of

consciousness from an arrhythmia. However, a few

states have syncope laws, and these also require

patients to go for 1 year without an event before they

can drive again, unless there is a reversible cause

for the syncope that has been treated. Therefore, a

recommendation of 6 months event-free is actually very

liberal compared with what some state laws require for

certain medical conditions.

Medscape: Do you think that there should be a

nationwide law that governs driving for ICD patients?

Dr. Epstein: Ideally, yes, but I think functionally

we've got bigger fish to fry. If we really want to

have an impact on driver safety, we should go after

drunk drivers. The number of accidents related to

somebody passing out with an arrhythmia is dwarfed by

other problems, such as alcoholism and individuals

with functional limitations who continue to drive long

after they should.

Doctor-Patient Relationship

Medscape: Should patients who have experienced an ICD

therapy be monitored more closely than usual before

they are allowed to drive again?

Dr. Epstein: No; it's really black or white -- either

they've had an event or not. If physicians follow

manufacturer recommendations for ICDs, these patients

should be evaluated every 3 months anyway to

interrogate the device, and that should be sufficient

for follow-up unless there is another reason to call

the patient in. Also, we tell patients that for a

single shock, you don't need to come to the office --

that's why you have the device. It's when you have

multiple shocks or new symptoms that you need to be

seen sooner. So no intensification of follow-up is

needed unless patients are experiencing multiple

shocks or new symptoms or there is some other reason

to call them in -- and, there's really nothing else

you can look for that might predict an event.

Medscape: What about the patient who has experienced

an event but is noncompliant with his/her doctor's

advice not to drive? How should physicians handle this

problem?

Dr. Epstein: Taking care of patients is a partnership.

We, as physicians, tell them what they should do; we

write it down for them; and if the patient doesn't

follow our instructions and drives anyway, there is

not much that we can do about it. If they get into an

accident and the physician is called to testify in

court and is asked whether they told the patient not

to drive, the physician can say, " Yes; I sure did. " We

cannot control what patients do; they have a choice.

We can't make them take their medicines, and we can't

make them comply with driving recommendations, but we

can and should offer them our best advice.

Medscape: Do you find in your practice that the

majority of patients who experience an event follow

your instructions on driving restrictions?

Dr. Epstein: Yes, because I'm very clear about it and

I talk about it before implantation, not after.

Unfortunately, for many patients who get ICDs in this

country, the subject is never brought up, but

physicians should be discussing this issue before they

even implant the device.

Medscape: The guidelines include a substantial section

on ethics and social responsibility that talks about

the physician's societal responsibility in relation to

ICD patients. Why is ethics given so much

consideration?

Dr. Epstein: That section was written by Blair Grubb,

MD (Medical College of Ohio, Toledo), who is known for

his writings on ethics in the electrophysiology and

cardiology communities, and I am extremely happy that

we included that section in the guidelines. All of

these decisions require a balance between patient

autonomy and societal responsibility. We don't live in

a vacuum: We have to consider our neighbors, and these

guidelines are really an attempt to make life safer

both for the individual and the population as a whole.

Supported by an independent educational grant from St.

Jude Medical

References

Epstein AE, Baessler CA, Curtis AB, et al; American

Heart Association; Heart Rhythm Society. 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. Circulation. 2007;115:1170-1176. Abstract

Epstein AE, Miles WM, Benditt DG, et al. 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.

Abstract

E. Epstein, MD, FAHA, FACC, FHRS, Professor of

Medicine, Department of Medicine, Division of

Cardiovascular Disease, The University of Alabama,

Birmingham

Disclosure: has disclosed no relevant

financial relationships.

Disclosure for interviewee: E. Epstein, MD,

FAHA, FACC, FHRS, has disclosed that he has served as

an advisor to Reliant and sanofi-aventis.

________________________________________________________________________________\

____Luggage? GPS? Comic books?

Check out fitting gifts for grads at Search

http://search./search?fr=oni_on_mail & p=graduation+gifts & cs=bz