Ethical controversies related to the care of an intravenous drug abuser with endocarditis


Introduction

Infective endocarditis (IE) is a bacterial or fungal infection of the heart valves and lining that Jean François Fernel first mentioned nearly 500 years ago (1554). William Osler described the disease in detail in a series of lectures in 1885 [ ]. The clinical profile of endocarditis has undergone rapid and dramatic change in recent decades. Both microbiology and risk factors related to IE have evolved with new technology and a changing social milieu. An important risk factor is the intravenous (IV) injection of illicit drugs such as heroin and cocaine, and central to the evolution of this disease is the so-called “opioid epidemic” currently affecting the United States and other countries.

Clinical features and outcomes

IE is an uncommon disease, but recently has rapidly increased in incidence. Recent estimates of data from the early 2000s reported an incidence of 3–10 per 100,000 per year worldwide [ ], but rates of IE have been increasing, and, although regional variability is evident, the United States has reported the highest incidence of IE in the world: 15 cases per 100,000 people per year [ ].

The primary causative agent has transitioned from oral streptococcus to staphylococcus owing to many factors such as the development of effective antibiotics, the increased use of prosthetic implants, invasive IV catheters, immunosuppressants, and, central to our discussion, IV drug abuse [ ]. Endocarditis is diagnosed by a combination of history, physical exam, and echocardiography; it is preferentially treated with antibiotics, but, owing to changes in epidemiology and acuity, IE has increasingly become a surgical disease [ ]. Outcomes remain suboptimal: overall in-hospital mortality rates have been reported to be as high as 20% [ ].

Surgical outcomes for IE are heterogeneous and depend heavily on the valve(s) involved, invasiveness of the disease, and comorbidities. Overall perioperative mortality is less than 10% [ ]. Perioperative mortality for isolated native aortic and mitral valve infections confined to the leaflet are similar, at 7% and 6%, respectively, but outcomes for invasive (infection extending beyond the leaflets into adjacent structures) and multivalvular IE are worse. Overall survival is 66% at 5 years, with better survival for noninvasive aortic valve endocarditis and worse survival for mitral valve disease, combined valve disease, and invasive disease. IV drug use is an important comorbidity affecting long-term survival; relapse into drug use and reinfection can lead to worse outcomes long-term [ ].

Opioid epidemic

The use of prescription pain relievers has drastically increased in the United States over the last several decades—an estimated 4.3 million people participate in nonmedical use of prescription pain medications, and these patients are 40 times more likely than the general population to use IV drugs [ ]. About 80% of new heroin users have previously misused prescription pain killers [ ].

The incidence of intravenous drug use-associated infective endocarditis (IVDU-IE) has doubled in the United States in the 15 years between 2002 and 2016 [ ], and just in the 5 years between 2010 and 2015, has doubled from 15.3% to 29.1% of all IE cases [ ]. While IVDU patients with IE have better short-term survival than non-IVDU patients, probably a function of their younger age, their rates of readmission and drug use are higher [ ]. Midterm outcomes are not as promising—at three–four months, the hazard of death or reoperation for IVDU-IE patients are more than 10 times the hazard for IE patients who do not use IV drugs [ ]. In addition, long-term outcomes are worse for patients with IVDU-IE compared with patients who do not use IV drugs: 5 and 10 year survivals are 46.7% and 41.1% versus 71.1% and 52.0%, respectively [ ].

Major ethical issues

Ethical dilemmas are common in the treatment of IVDU-IE, and may substantially affect treatment and outcomes. Common issues often stem from prejudicial attitudes toward drug use, such as the merits of treating patients with apparent self-harming behavior, allocation of scarce resources in the cost-conscious environment of modern care delivery, and doubts about long-term outcomes of treatments owing to possible continued drug use. Less common issues may be seen in some cases, but may nonetheless present serious dilemmas, for example, in the treatment of IVDU-IE in the context of a viable pregnancy.

Caring for the patient who self-harms

Caring for the IV drug user who contracts IE can be challenging on several levels, but many difficulties arise not from questions of “how to treat the problem?” but from questions of “should we treat the problem?” Clinicians find fulfillment in a job well done—knowing that the right patient received the right treatment at the right time, and will consequently do well. Conversely, satisfaction might wane when clinical judgment tells us that a patient will do poorly no matter what we do. Some may feel that whatever treatment they provide to IV drug users, their patients will simply return to IV drug use soon after they are discharged, incurring a high risk of recurrent IE. In addition, IV drug users are commonly denigrated; even though opioid use disorder (OUD) is a recognized diagnosis and disease process, drug addiction is often viewed as a “moral failing” [ ]. Many studies have indicated that negative attitudes and perceptions toward IV drug users are widespread [ ]. The stigma attached to IV drug use has substantial implications for the therapeutic relationship, often causing discontent for both doctor and patient, and possibly damaging treatment outcomes.

Limiting or changing treatment based on patients' lifestyle or behavior

The presence of “self-harming” behavior and its impact on disease affects the attitude of many care providers. Most surgeons will operate for an IV drug user with first-time endocarditis; many may draw the line there, however, with a “one and done” policy toward valve replacement. IV drug use is clearly the independent action of the patient, but addiction is complex and many external influences affect addicts' behavior. A claim that patients have no responsibility for their health would be specious, undermining the principle of autonomy, but other factors may play an important role; for example, opioid addiction often originates from prescribed pain medications, and lack of access to adequate addiction treatment may inhibit or prevent recovery. The presence of social issues or psychological conditions may make stopping the use of drugs more difficult. OUD is highly associated with other mental health disorders that require concurrent treatment in order to optimize results [ ]. To simply refuse to treat recurrent IE due to the presence of drug use that has not been adequately treated would be irresponsible, denying the patient needed care [ ]. OUD is recognized as a medical disease, and the available evidence indicates widespread undertreatment of OUD in association with IE and other IVDU-related infections [ ].

IVDU-IE is not the only disease that stems from apparently self-inflicted harm. It would seem inconsistent for a cardiothoracic surgeon to refuse operating on IV drug users with recurrent endocarditis but to have no hesitation in operating on smokers with recurring lung cancer or obese uncontrolled diabetics with coronary artery disease who have already received stents.

Baldassarri et al. make the interesting comparison of IVDU-IE to other diseases or injuries incurred by more positively viewed risky lifestyles [ ]. They present examples of the avid hiker who presents with recurrent tick-borne illnesses due to outdoor tick exposure and the cyclist or motorcyclist who presents with recurrent fractures owing to accidents while riding. These ailments are incurred from participation in activities that are part of active lifestyles that are viewed positively by society. Even though the patient knows the risk of participating in these activities, and continues to do so despite previous adverse events, no physician would refuse treatment. The authors assert that perhaps the IV drug user, whose neurochemistry is pathologically affected by chemical dependency, is less to blame for developing complications than the hiker or cyclist. One could dispute the relative risks of participating in various activities, but this observation of inconsistencies in how physicians view risky behaviors is thought-provoking.

A specific example of changing treatment based on a patient's lifestyle is the choice of valve type for young patients with IVDU-IE. We know of no formal studies addressing this topic, but anecdotally it is relatively common for young patients with IVDU-IE to receive a bioprosthetic valve. Based on age alone, they might achieve better long-term results with a mechanical valve, but such patients are often assumed to be “unreliable” regarding compliance with anticoagulants. When this assumption is correct, the patient may be spared from valve thrombosis, stroke, and early death, but those who could manage long-term anticoagulation are unfortunately consigned to suffer the sequelae of structural valve degeneration and probable reinterventions in the future.

A single-center study of surgical endocarditis outcomes noted that more than 95% of IVDU-IE patients received a bioprosthetic valve, despite an average age of 43 years in this cohort; by comparison only 73.7% of non-IVDU-IE patients, with an average age of 48 years, received a bioprosthetic valve [ ]. Despite the younger age of the IVDU-IE patients, the median postoperative survival was only 3 years, and there was no increased risk of reoperation in those patients. The authors concluded that a bioprosthetic valve is reasonable for IV drug users with endocarditis, regardless of age. Of note, none of the small number of IV drug users who received mechanical valves had valve-related complications.

Drug use contracts—are they useful?

The Merriam-Webster dictionary defines a contract as “a binding agreement between two or more persons or parties, especially, one legally enforceable” [ ]. Opioid contracts, or pain contracts, are formal, written agreements between prescriber and patient to outline ground rules for appropriate use. They are intended to discourage opioid abuse, but unlike traditional contracts, they are not binding or legally enforceable. For this reason, or owing to discomfort with the word “contract,” some physicians have taken to using the terms opioid or pain “agreement.” Agreements are drafted by a physician with “superior bargaining power,” however, and this power differential abrogates any semblance of collaboration or balanced consensus [ ]. Opioid contracts contain rules and stipulations regulating the prescription, filling, and consumption of opioids, and the consequences of breaking these rules, but little or nothing about goals of care—the execution of an opioid contract speaks to lack of trust or trustworthiness. While lack of trust of the patient by the physician may be warranted, a patient's detection of such a lack may damage the therapeutic relationship.

Success has been reported with opioid contracts. A retrospective study of patients on long-term opioid contracts in an internal medicine practice found that 63% remained adherent to the terms of the contract during the study period. Of 37% who were not adherent, 20% stopped therapeutic medication voluntarily, and in 17%, a physician voided the contract for “breach of contract” [ ]. This study population consisted of patients with chronic pain who were not previously taking opioid pain medications. Drug addiction history is not reported, and it is not reported if any of the study participants were previous IV drug users. Unfortunately, whether this strategy prevents progression from chronic oral opioid to IV opioid use is unclear—random urine drug screens in this population are expected to be positive for opiates. For these reasons, the results of this study are probably not generalizable to the IVDU-IE population.

Opioid-use contracts may be applied to surgical therapies as well. The effectiveness of contracts to prevent recurrent drug use after valve replacement has not been established. In the previously mentioned population of chronic pain patients who had no known history of drug addiction, nearly 20% of patients were found to have breached an opioid contract [ ]. One might expect that the rate of breached contracts in a population of IVDU patients would be substantially higher. As Wurcel et al. editorialize, “Substance use disorders have a complex pathophysiology, influenced heavily by comorbid psychiatric illness and socioeconomic factors … It is unrealistic to expect that a signature on a piece of paper, in a time of medical extremis, will insulate the patient against recurrent drug use” [ ]. A response to that editorial argues that OUD is a fatal disease without treatment, and it is not unreasonable for surgeons to insist that the patient “agree to make a good faith effort to follow the treatment plan after the operation” [ ]. OUD is an important comorbidity to IVDU-IE, and must be treated to ensure the best possible long-term results. If a patient understands, to the best of their capacity, that IV drug use is the reason they have a life-threating valve infection, then it seems logical that they would want to stop using drugs. Arranging for adequate addiction therapy seems more likely to be effective than a contract to stop drug use.

The creation of a written agreement for postoperative addiction treatment does not seem inherently harmful or unethical. If used, the purpose of such a document should be to clarify the patient's and physician's shared goals, and focus on expected pitfalls and available resources. It should not outline punitive measures to be taken in the event of drug use, as this may make the patient less likely to seek help in the event of relapse. In addition, the physician should always acknowledge that any agreement between the patient regarding their drug use or addiction treatment is not legally binding. It is not ethically or legally defensible to deny a patient care based on such a document. As DiMaio et al. remind us, physicians' obligation is to make medical decisions for their patients, not to pass moral judgment on them [ ].

Care of a “second life”—maternal versus fetal rights in cases involving pregnancy

Endocarditis during pregnancy is rare, appearing in only 1 of 8000 pregnancies [ ], but considerably complicates management owing to potential conflicts between maternal and fetal needs. Fetal mortality after cardiac surgery ranges from 16.7 [ ] to 30% [ ] and fetal mortality is much higher earlier in pregnancy [ ]. In comparison, maternal mortality is 2%–3%. Fetal organogenesis occurring in the first trimester suggests that surgery should be deferred until the second trimester [ ]. Waiting until the 28th week has also been suggested [ ], and operating late in the third trimester increases the risk of premature labor [ ].

The development of IE in the presence of IVDU during pregnancy opens the door to substantial conflicts between maternal and fetal interests. Firstly the future mother's use of drugs places the fetus at risk, and vigorous attempts must be made to dissuade the patient from further drug use and to arrange optimal addiction treatment. Secondly what is beneficial to the pregnant woman is not necessarily beneficial to the fetus. If a pregnant woman develops IE during pregnancy, surgery should ideally be delayed until after delivery. Urgently required surgery during pregnancy imposes substantial risk on the fetus. A fetus delivered in the first trimester and early second trimester will not be viable and delaying urgent surgery will most likely result in the death of both woman and fetus, so surgery should be pursued with the understanding that the risk of spontaneous termination of the pregnancy is high in this setting. Surgery in later term pregnancies carry less risk of fetal death, so caesarean delivery of a viable neonate is a reasonable alternative, although preterm birth carries a considerable risk of mortality or long-term neurological problems [ ]. Ultimately a decision to operate must be individualized based on the age of the fetus and the acuity of the pregnant woman's disease.

A pregnant woman may refuse to undergo an indicated procedure such as caesarean section despite the urging of her medical team. Fortunately, future mothers almost always act in the interest of their fetus [ ], but when they do not, they generate a conflict between their own interests and those of their fetus. Unless the patient lacks capacity to make decisions because of mental illness, she has a right to autonomy and to determine what actions may be taken on her body. The rights of the fetus, however, are less clear, and depend on local culture. In the United States, the rights of the woman supersede the rights of the fetus [ ], and consensus indicates it is almost never justifiable to force a procedure on a pregnant woman in the interest of the fetus [ ]. The best way to proceed in cases where maternal and fetal interests appear at odds may be to focus on fetal survival and health as a common goal for all parties involved [ ].

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