ethics, technology and health care costs

[Guest guest]

All,This from Medscape...highlighting the dilemma around increasingly expensive technology, the needs and preferences of patients and the responsibility to use healthcare resources wisely.

A. Simpson, DC | Vice President, Medical DirectorThe CHP Group | Smart Solutions. Healthy Results.

Like us on Facebook | Follow us on Twitter | Follow us on LinkedIn | www.chpgroup.com

 csimpson@... O | C6600 SW 105th Ave, Ste 115 | Beaverton, OR 97008

From Journal of the American Geriatrics Society

The Limits of LifeZaldy S. Tan, MD, MPH

Authors and Disclosures

Posted: 05/18/2012; J Am Geriatr Soc. 2012;60(4):786-787. © 2012 Blackwell Publishing

 Print This

 Email this

 

 

Abstract and Introduction

References

Abstract and Introduction

IntroductionIn a hospital conference room in Boston, a packed audience of academic geriatricians gathered on a frigid morning quietly considering a dilemma. In tables and colorful graphs, two cardiologists presented a variety of clinical trials demonstrating the effectiveness of implantable cardioverter defibrillators (ICDs) in thwarting otherwise fatal ventricular arrhythmia. The 3-inch battery-powered electrical impulse generators are true technological marvels, capable of detecting potentially fatal heart rhythms and delivering a jolt of electricity to jump-start a quivering heart back to normality. It is now the standard of care for a patient admitted to the hospital with high-risk cardiac rhythms to walk out with a $25,000 ICD implanted in his/her chest, charged and ready to leap into action. In American medical centers, where lifesaving care is readily available and routinely requested, more than 160,000 of these devices are implanted every year,[1] but that morning, the cardiologists came not to convince the geriatricians of the appropriateness of implanting ICDs in their older patients; they came to question it.

In the United States, the decision to implant an ICD is need based and age blind, with 40% of individuals who receive one being aged 70 and older.[2] As much as the appropriateness of routine implantation of an ICD in the very old and frail can spark a heated debate, the main dilemma being discussed was even more daunting: Is it appropriate to maintain ICDs in the oldest old? With the technological trend toward miniaturization, ICDs have become smaller and battery life correspondingly shorter. On average, the battery of an ICD lasts only approximately 5 years, and to keep it functioning beyond this period, the recipient will need to undergo a hospital procedure that costs approximately $50,000. The questions that the cardiologist presented in a bulleted list were clear and simple, but the answers to them were anything but:

Is it appropriate to replace the battery of an ICD if:It has never needed to fire a shock since it was implanted?The patient is now 5 years older, sicker, and frailer?

There are multiple other medical conditions that limit remaining life expectancy?The discussion took on a special significance because it was being held at the very hospital where the implantable pacemaker and cardiac defibrillators were pioneered and was even more significant because a cardiologist who proclaimed that he was among the city's most prolific in ICD implantation was posing the difficult questions. To find an answer to this question, he and his fellow launched a study attempting to answer the important but controversial question of when, if ever, is it appropriate to disable or at least refuse to change the battery of an ICD. They came in hopes that the geriatricians would guide them on how to proceed the next time an octogenarian came to their office requesting that the battery of her ICD be replaced. The audience fell silent.

Geriatricians, by virtue of training and the population that we serve, are experienced in setting goals of care and facile in end-of-life discussions. When a family member requests intravenous fluids for a patient facing imminent death, we cite the risk of fluid overload and gently nudge them into palliative care; when asked whether tube feeding should be started in an individual with severe dementia, we point out the risk of aspiration and inform them of the advantages of comfort feeding. Although ICDs are, like fluids and tube feeding, potentially life-prolonging, the ICD dilemma is unique in that the risks are low and a heart arrhythmia is not generally considered a terminal illness, that is, of course, until it occurs. There are possible complications to changing the battery of an ICD—bleeding, infection, a punctured lung, the physical and psychological trauma from an inappropriate shock (likened in sensation to a hard kick to the chest), the list goes on—but for the most part, the procedure is straightforward and well tolerated. Unlike fluids and tube feeding, in the dilemma of ICD battery change (or not) the high cost of the device takes center stage. Further adding to the complexity of this dilemma is the fact that the average age of subjects in the ICD clinical trials was more than a decade younger than many individuals who receive ICDs, making extrapolation of safety and efficacy data difficult. A study recently published in this Journal reported that, of 44,805 individuals aged 65 and older in the National Cardiovascular Data ICD registry, almost one-quarter may have received ICDs inappropriately based on risk of death.[3] Another study that examined the subset of participants in ICD trials aged 75 and older found that ICDs did not offer a survival advantage in this age group.[4]Specialty society guidelines are unfortunately of little help in guiding the standard of care, stating only that, before an ICD is inserted, the physician should make certain that the patient has at least 12 months of remaining life expectancy.

For one physician's conviction that the ICD is an invasive, potentially dangerous, expensive intervention lacking in efficacy and safety evidence in elderly adults, another would maintain that to withhold such readily available, potentially lifesaving technology is nothing short of inhumane. Whereas the implantation of an ICD into an octogenarian for the prevention of a fatal arrhythmia may be controversial, in developed countries such as the United States and Germany, it remains standard of practice. The United States leads the rest of Europe in ICD implantation by a wide margin—approximately four ICDs implanted in the United States for every one implanted in Europe, after adjustment for population size.[5] The evidence base, ethics, and economics of implanting and maintaining ICDs in frail elderly adults is increasingly being called into question.

" How about cognitively impaired patients? " asked one geriatrician. " Shouldn't we refrain from inserting and maintaining ICDs on them? "

The cardiologist shook his head. " Average life expectancy for dementia is over 12 months, so not according to the guideline. "

A silver-haired geriatrician standing in the back of the room raised his hand. " Perhaps at the point of implantation, we should be informing patients and families that it will be a time-limited trial which will end with the life of the battery. "

The suggestion was left without resolution. Scarves came out and coats were put on as the geriatricians prepared to confront the blustery morning on their way to clinics, hospital wards, and nursing homes. The cardiologist shouted that a survey assessing their opinions regarding ICDs would be sent electronically. On their way out, the geriatricians could be overheard blaming the perverse financial incentives that prevent ICD manufacturers from making batteries that last longer, proposing policies that would cap the device costs for the life of a patient, and suggesting that the training of primary physicians in discussions regarding goals of care be part of the solution.

Can a physician ever ethically and legally refuse to replace the battery of an ICD in an individual who requests it? At some point, the cost of medical care may rise to a level that the economy can no longer sustain, and health economists and policy-makers will make decisions such as which individuals are eligible for ICD implantation and battery replacement. Until then, more generalists and specialists who question standard practice and specialty society guidelines, especially when such practice is not based on good evidence, are needed. More research is also needed on reliable prognostic tools[6] for the stratification of the risk of mortality of frail elderly adults, which can guide clinicians and policy-makers alike in making decisions regarding who gets what. Considerations of an individual's age, comorbidity, and remaining life expectancy have a vital place not only in decision-making regarding expensive and invasive procedures such as ICD implantation, but also for " routine " health screenings such as for prostate[7] and colorectal cancer.[8]

Does the septuagenarian understand that chemotherapy may not give him the life prolongation observed in clinical trials that did not include people his age? Before the nonagenarian gave consent for the procedure, was she informed that not proceeding with surgery is a reasonable option? Does the older person understand that implantation of an ICD may not prolong his life?

The list of difficult questions goes on. As primary care physicians become increasingly pressed for time, specialists and hospitalists can no longer assume that conversations regarding goals of care have occurred and must be comfortable having these discussions. Only then will informed consent for a treatment or nontreatment decision be truly informed. Finally, as a society, we must learn to accept that, although life is indeed priceless, like the battery life of the ICD, it is by no means limitless.