ECMO: A Clinical and Ethical Challenge for Our Time

The New Yorker has posted an excellent essay ("How ECMO is Redefining Death") on the history, current status, and ethical challenges of extracorporeal membrane oxygenation (a/k/a ECMO), an out-of-body device that bypasses the heart and lungs by taking carbon dioxide out of a patient's blood, oxygenating it, and returning the blood to the patient's circulatory system. Issues abound -- Under what circumstances should this procedure be started (i.e., for what medical purpose)? If it's started to keep a patient alive until a transplant organ becomes available, what happens if the patient's condition deteriorates until she is no longer a candidate for an organ? Who decides whether to stop ECMO? What are the standards for stopping? What if the patient wants to be kept alive on ECMO? (If you're not a subscriber, you can brush up on the ethical analysis of ECMO by reading an article on PubMed,) Or . . .

The piece is written by Clayton Dalton, identified as an ER physician in New Mexico. His personal website has links to other published essays, including a bunch of New Yorker articles. If you're not a subscriber to the magazine, he might have the ECMO piece posted on his website sometime soon.

What Is a Hospital to Do When a Patient Refuses a Discharge?

Here's the scenario: A patient is admitted to the hospital for treatment. Treatment goes well, and the patient can safely be discharged to home. But the patient refuses to leave the hospital. If the patient lacks decision-making ability, the surrogate decision-maker may be refusing on the patient's behalf. Either way, a patient who no longer needs hospital-level care continues to consume hospital resources -- a bed, nursing time and attention, housekeeping, dietary, etc. -- without a discernible medical advantage.

There are lots of ways to respond to the refusal to leave, mostly involving a sensitive exploration of the social, familial, financial, emotional or other reasons for the refusal. Sometimes it is possible to make arrangements that can address the patient's (or surrogate's) concerns.

As reported in the Los Angeles Times (and reprinted by KFF News (Nov. 15)), San Francisco-based Dignity Health, a tax-exempt organization Catholic hospital system with $9.5 billion in revenue, is trying another approach: sue the patients for trespass. In three cases, Dignity Health has invoked a California law intended to prevent anti-abortion demonstrators from obstructing entry to healthcare facilities, accusing the patients of "commercial blockage" for "unreasonably and unlawfully" refusing to be discharged once they were deemed medically and legally eligible. Dignity claims the actions hindered its ability to care for other patients during COVID-19 surges. 

Unsurprisingly, the patients claim a right to be discharged to a facility that offered appropriate care and that they could afford, not simply sent home without the ability to take care of themselves. As described by California Disability Rights, state and federal law (Medicare's Conditions of Participation) provide significant protections against hospital discharges that aren't safe, so the outcome in these cases is likely to turn on very fact-specific considerations.

One of the cases is scheduled to go to trial on November 15. More later . . . .

Nonconsensual Pelvic Exams

Over the years (decades, actually), I've heard reports from med students who were disturbed by what they witnessed during their ob-gyn clinical rotation: pelvic exams performed on sedated women who had not consented to the exam. Following up, I've been told repeatedly that this doesn't happen, that consent was obtained from all women who experienced pelvic exams, but the med students didn't know about the consent. That sounds kind of sketchy. Why wouldn't the consent process be included as an essential part of the med students' training? 

That's certainly not the story by way of NBC News (courtesy of the Hastings Center):

NBC TV Nightly News featured a Hastings Center Report study estimating that more than 3.5 million patients in the U.S. may have been given pelvic exams without consent, often while sedated for surgery. Doctors interviewed by NBC called the practice a “violation of medical ethics” and of “patient autonomy.” Watch the NBC segment. 

"Futility" Policy at Mass General Hospital

Thad Pope has alerted us to the publication of a report from within Massachusetts General Hospital, "Declining to Provide or Continue Requested Life-Sustaining Treatment: Experience With a Hospital Resolving Conflict Policy." It's apparently "open access" and is available in HTML as PDF. The report is well worth reading, for a number of reasons:

• Texas has had a statutory policy for 23 years. It is, like the MGH policy, an example of a "due process" approach to resolving disputes over life-sustaining treatment (LST). A hospital policy without statutory protections for participants in the process leaves the hospital legally exposed, which is bound to have an effect on how the process plays out in real time, but it is still possible to learn some valuable lessons from a stand-alone hospital's experience.
• The report covers 20 years' worth of cases that were handled under the MGH policy.
• It demonstrates a pattern that I have experienced in Texas hospitals: The futility policy gets invoked in an almost vanishingly small percentage of cases in which it could be useful.

There are many aspects to futility disputes that are outcome-determinative in terms of the utility of invoking the policy. In other words, details concerning the family dynamics, patient characteristics, and the treatment team's history with patients and surrogates (or lack thereof) may be more important to achieving a satisfactory than the policy itself. The policy, however, does provide some degree of rigor and consistency from patient to patient. Whether the results justify the existence of a policy is very much in the eye of the beholder. The MGH report is a good place to start.

Reducing mortality rates in hospitals: Good. Tying reductions to executive comp: Bad

Becker's Healthcare reports (June 21, 2023) that clinicians at various HCA facilities are pressured to refer patients to palliative care and hospice in order to move those patients' deaths off the hospital's books, thus lowering the mortality rate reported for that hospital. More on that below, where I analyze the ethics of the reported practice. But I don't want to bury the lede, so it's important to understand that executive compensation within the ranks of HCA, from the corporate CEO on down to hospital execs, is based in part upon lowering mortality rates. It is hard for me to see this linkage as anything but an invitation to distort and corrupt end-of-life care in these hospitals. HCA denies every aspect of the story.

[The story in Becker's is based upon an NBC News report. Having read both, I can say that the version in Becker's is a faithful rendition of the NBC News report. I've linked to both in this post because hyperlinks to stories don't last forever.]

Reducing hospital mortality rates

1. Reducing hospital mortality rates is an admirable goal. For decades hospitals have been enjoined to fight hospital-acquired infections, reduce rapid readmissions, and address various systemic weaknesses in the delivery of quality health care to reduce avoidable morbidity and mortality.
2. Palliative care is a valuable service. Study after study shows greater patient satisfaction with interactions with palliative staff than with with members of the treatment team. In my experience, a hospital's introduction of a palliative care service usually leads to an almost immediate and quite dramatic decrease in requests for consultations with the hospital's ethics committees. This "ethics prophylaxis" -- engaged listening and honest communication that addresses confusion, disagreements, and distress before there is a breakdown in patients' and families' trust in their treatment team -- contributes to the quality of care provided by the team. It's like dealing with small flare-ups before they turn into a conflagration. Ethics committees are often brought into the conversation too late to accomplish a break-through. (It's one reason among many that the model for ethics consultations is mediation, which seeks compromises that are limited in duration and scope.) Also, palliative care consultants are in a position to build a relationship with the patient and family over time. By contrast, ethics committee members walk into a consultation room without the benefit of that healthy relationship. (They also don't walk in with the burden of a bad relationship. Being a neutral has its advantages, though not all patients and families see the ethics team as neutral.) One final point: Palliative care isn't just about end-of-life care. It's appropriate anytime that a seriously ill patient might benefit from expert interactions that address the physical, psychological, or spiritual suffering the patient is experiencing. And with a common but often lethal diagnosis like metastatic cancer, on average it's been found to result in longer lives of higher quality. All of this is to say that a hospital or health care system that encourages appropriate referrals to the palliative care service is doing a good thing, not a bad thing.
3. Much the same can be said for hospice care. It's a valuable multidisciplinary service that addresses a similar set of needs as palliative care. It is also underutilized. Medicare covers 6 months (180 days) of hospice care based upon the reasonable judgment of a physician that the patient is likely to die within those 6 months. (This can be extended if the patient is still alive at the end of 6 months as long as the physician can reasonably determine that the patient is likely to die within the next 6 months.) The reality is that the average lifetime lengths of stay is about 3 months and for a single hospice stay about 50% of patients die or are discharged in less than 2.5 months (source). Encouraging earlier use of hospice is a good thing (as long as the referrals are appropriate) because of the integration of hospice and palliative care for the benefit of the dying patient.

Tying palliative care and hospice referrals to executive compensation is a really bad idea.

1. HCA's policy creates the impression that referrals to what is generally regarded as high quality end-of-life care are made for third-party financial gain and not the needs of the patient. Well, it's actually more than an impression, isn't it? That's exactly the situation that HCA's compensation scheme creates. 
2. Stories like this give the false impression that palliative care physicians and their staffs are inclined for their own reasons to push patients into end-of-life treatments prematurely. If the result is patient or family refusals to accept the referral, the result is often suboptimal care for the patient: the loss of an opportunity for higher quality care whether death is imminent or not.
3. The article illustrates how the pressure from above creates moral distress on the part of attending physicians and other clinical staff. Practicing medicine is hard enough in this day and age without creating yet another conflict of interest (or its appearance) to be negotiated or finessed.
4. Not to be petty, but the base pay of HCA's corporate CEO is already $35.3 million for the two years this incentive has been in place, of which the compensation incentive in question accounted for $305,400. And why? Because $17.8 million a year just isn't enough?

New study endorses harvesting hearts after declaration of cardiopulmonary death

There's an Associated Press article in this morning's Dallas Morning News describing a multicenter study involving the transplantation of hearts taken out of donors who were not brain dead but had been declared dead after irreversible cessation of cardiac and circulatory function (DCD/DCCD).

Certain solid organs have been transplanted after DCD for decades. The protocol for harvesting involves the following steps:

• moving the patient to the operating room (usually from an ICU);
• stopping all life-supporting measures;
• waiting for a fixed period of time for the heart to stop beating (usually 60-90 minutes);
• if the heart stops, waiting another period of time (usually 5 minutes) to see if the heart will autoresuscitate;
• if autoresuscitation doesn't occur, death is declared and organ harvesting (usually kidneys, liver, and pancreas).

The DCD procedure was designed to shorten the warm ischemic time from when cardiopulmonary function ceases and the harvested organ can be restored to function in the recipient's body. Even with that innovation, though, hearts were not considered for transplantation because of their extreme fragility.

As described by the AP, however, the results of a multicenter study over a number of years establishes that the six-month survival rate after DCD (94%) was slightly better that the survival rate for heart transplants after brain death (90%). So what has changed? As reported by the AP:

Now doctors can remove those hearts and put them in a machine [a "heart-in-a-box" device invented by TransMedics, the sponsor of the study] that “reanimates” them, pumping through blood and nutrients as they’re transported –- and demonstrating if they work OK before the planned transplant.

I am all for increasing the supply of donor hearts, and this is a very interesting development.  I am wondering, however, how to square the transplantation of a viable heart with the cardiopulmonary criterion of death. The statutory standard of "irreversible cessation of all cardiopulmonary function" will  now need to be understood as “irreversible in the donor’s body but not necessarily in the body of the recipient of the heart.” That begs the question, which has applied to DCD from the beginning, why has cardiopulmonary ceased (because we took away the donor’s life support) and why is the cessation irreversible (because we didn’t try to reverse it). Once we actually try to restore cardiac function (“reanimating” the heart in a “heart-in-a-box” device), some hearts are restored and do at least as well in the recipient’s body as a heart from a brain-dead patient. 

Are we comfortable with this slightly altered version of "irreversible cessation"? Should we be? The so-called "dead donor rule" (DDR) forbids killing a patient for organs or removing organs needed to sustain life from a living patient. So far, we have avoided the slippery slope of removing organs from patients who are almost dead or "as good as dead." How certain are we that this new approach to DCD heart transplantation satisfies the DDR? 

The High Costs of Non-Beneficial Treatments in the ICU

Thad Pope has a useful post on this subject. There are direct medical costs (estimated at $2,700/day (Ottawa study) to $4,000/day (UCLA study)), but equally if not more concerning "may be (a) the opportunity cost when other patients are denied ICU care, (b) moral distress of the nursing staff, and (c) suffering inflicted on the patient." 

None of this seems to matter to the legislators in Texas who try, every legislative session, to gut the provisions of the Texas Advance Directives Act that were added in 1999 to deal with disputes over medically inappropriate treatment. The provisions are at Tex. Health & Safety Code § 166.046. The purpose of the law was to provide a nonjudicial mechanism for resolving these disputes. The key provision is in subsection (d), which -- after reasonable efforts over a 10-day period to find a provider willing to provide the treatment requested by the surrogate decision-maker fail to identify a provider willing to accept transfer of the patient -- permits the disputed treatment to be withheld or withdrawn.

The objectors in the legislature want to replace that 10-day process with a provision that requires the health care providers to "treat until transfer." This benign-sounding idea would mean that, in the vast majority of cases in which no transferee provider can be found, medically inappropriate treatment must be provided until death occurs, which may be months or even years later. A current example is the Tinslee Lewis case in Fort Worth, which has been in litigation for over two years. According to a motion filed by defendant Cook Children's Hospital, 

a review of Tinslee’s case was initiated by third-party administrator Aetna’s Special Investigative Unit, which has requested all of Tinslee’s records. The Special Investigative Unit’s mandate under Medicaid regulations is to investigate “waste, abuse, and fraud,” the motion says.

“In Cook Children’s experience, such reviews are often precursors to efforts to deny payment or even claw back funds previously paid,” the motion said.

COVID-19 Vaccination and Ethics: Stanford/AJOB Webinar

The American Journal of Bioethics and Stanford's Center for Biomedical Ethics (David Magnus & Bela Fishbeyn) on Feb. 16 put on an excellent panel discussion of the ethics of COVID-19 vaccination policies. It was a far-ranging discussion with knowledgeable participants and well worth watching.