Abstract
Abstract
Background:
Heart failure (HF) in its chronic form is an irreversible and progressive disease. Palliative care (PC) interventions have traditionally been focused on patients with advanced cancer. We performed a pilot study to assess the feasibility of implementing the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for early PC intervention in patients with advanced HF who were seeking or received potentially curative therapies.
Methods:
Twenty consecutive patients with advanced HF referred to PC from the heart transplant service with stage D, New York Heart Association (NYHA) class III–IV symptoms were analyzed retrospectively in a tertiary care setting. Data were reviewed to assess the clinical impact of PC intervention. Feedback was obtained to assess satisfaction of the patients, their families, and the health care professionals. An independent assessment of the impact of the PC service in the care of each patient was performed by a cardiologist and PC physician by use of a scoring system.
Results:
Twenty consecutive patients with HF were analyzed. PC consult was obtained for a variety of reasons. All patients complained of a high symptom burden. PC consultation resulted in a decrease in the use of opioids and increased patient satisfaction. Patients and their family members generally reported improved holistic care, continuity of care, more focused goals of care, and improved planning of treatment courses. The nonstandardized scoring system used to determine the impact of the PC service showed an average of moderate to significant impact when assessed by both a cardiologist and a PC physician.
Conclusion:
PC consultation appears to be beneficial in the treatment and quality of life of advanced HF patients, independent of their prognosis. This pilot study demonstrated feasibility and sufficient evidence of clinical benefit to warrant a larger randomized clinical trial assessing the benefit of standard involvement by PC in patients with advanced HF, independent of the patient's prognosis or treatment goals.
Introduction
With advances in diagnosis and therapy, patients with HF have access to a variety of treatments. These treatments have been broadly divided into four categories: 1) medical therapy, 2) electrical therapy, 3) surgical therapy, and 4) combination therapy. 3 As the disease advances, patients become more symptomatic and require additional supportive care. In advanced stages (stage D according to the current American College of Cardiology/American Heart Association [ACC/AHA] staging system) of HF, 4 patients present with more generalized symptoms that are in part independent of left ventricular dysfunction. Despite maximal medical therapy, these patients often require advanced treatments such as inotropic therapy, evaluation for placement of mechanical circulatory support devices such as ventricular assist devices (VADs), and/or cardiac transplantation. The implantation of devices such as VADs can either serve as a “bridge to cardiac transplantation” or as “destination therapy” if the patient is not considered a candidate for transplantation, mainly based on comorbidities and advanced age. If the patient is not a candidate for the aforementioned interventions, not many other options remain. Unfortunately, HF patients are rarely referred to palliative care (PC) or hospice services early in the disease process.
In 2009, 2212 patients underwent heart transplantation in the United States. 5 Ten-year survival of heart transplant patients is approximately 55%. 6 Not all patients potentially eligible for cardiac transplantation are fortunate enough to undergo transplant surgery, partly due to a shortage of donor organs, among other limitations. With advancements in the treatment of HF and improved survival after transplantation, patients are now frequently referred to centers that specialize in the care of advanced HF by offering VAD therapy as well as other options such as multi-organ transplantations in highly selected patients. In 2010, our HF group at Cedars-Sinai Medical Center (CSMC) evaluated more than 200 patients for advanced surgical therapies; 76 patients received heart transplantation and 27 patients received a surgically implanted VAD. All patients are evaluated by the entire advanced HF/Transplant team at CSMC, which is composed of nine cardiologists, four surgeons specialized in transplantation and VAD surgery, five nurse practitioners, one transplant pharmacist, several nurses, three designated social workers, one dietitian, and a financial coordinator. We were interested in piloting the inclusion of specialist PC in this team as involvement of PC in patients with advanced (stage D) HF is now a class I recommendation outlined in the “ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult.” 7
We share our initial experience of involvement of PC services in the routine management of this patient population.
Methods
The study received institutional review board approval at CSMC. The data of the first 20 patients who received a PC consult by the HF/Transplant team are summarized. The following methodology was undertaken to analyze the data:
1. Data were collected retrospectively by chart review after patient discharge. Data were studied to determine: 1) reason for PC consult, 2) symptom(s) at consult, and 3) symptom improvement after involvement of PC. 2. Open-ended questions were asked to assess the impact of the PC service on a) patients and their families, and b) the health care professionals within the care provider teams. 3. A nonstandardized tool was used independently by two physicians, one from the HF service and one from the PC service, to assess the impact of PC intervention on patients with advanced HF. A numerical score was used that included a range from 1 to 4; a score of “1” reflected no impact from the service, “2” meant minimal impact, “3” showed moderate impact, and “4” indicated significant impact that potentially changed treatment and outcomes.
Results
PC consultation was obtained in a total of 20 HF patients from November 2009 to March 2010. Consults were initiated by health care professionals from the HF service, including physicians, nurse practitioners, and social workers. A summary of patient characteristics is given in Table 1. All patients were in New York Heart Association (NYHA) class IV, stage D HF, and patients were on maximal medical therapy including beta-blockers, ACE inhibitors, and diuretics.
Either intravenous infusions of dobutamine or milrinone.
One patient had received three heart transplantations and one patient had received a second heart transplantation along with simultaneous kidney transplantation.
VAD, ventricular assist device.
Palliative care consultation
The reasons for obtaining a PC consult are listed in Table 2. In several cases, the PC role transitioned to a purpose different than the initial intended one as the patient's clinical status changed.
The following symptoms were assessed at the time of the initial PC consultation: 1) generalized or localized pain (n=20), 2) dyspnea at rest (n=15), and 3) insomnia (n=20). Throughout the course of the PC team's involvement, the patients reported improvement in their symptoms, which was also noted by family members and the physicians on the primary HF service.
With PC, pain complaints were appropriately addressed, and patients demonstrated a surprising decrease in the use of opioids after involvement of PC. Several patients with pain syndromes were placed on a steady dose of long-acting opioids to prevent crises, consequently causing a reduction in the high amount of “as needed” pain medication required after the onset of pain. This reduced the total amount of medication needed as well as the patients' complaints regarding poorly controlled pain. There was also an improvement in pain control by the selection of more appropriate opioids. For example, the common side effect of peripheral neuropathy due to immunosuppressant medications, such as tacrolimus, was more effectively managed with methadone.
Furthermore, involvement of PC in the overall medical management of the HF patients resulted in a more holistic approach. Patients also were screened for the need for other consultative services such as psychiatry, spiritual counseling through hospital chaplaincy, and social work services. Most patients expressed increased clarity about the treatment plans and realignment of goals of care, especially as their clinical condition changed. The topics of advance directives and goals of care were addressed with all patients by the PC team, and six patients (30%) completed advance care directives following PC involvement. Several patients were also appreciative of the improved continuity of care as they were transferred among different levels of care (intensive care to telemetry units).
Analysis of a HF physician's and a PC physician's scoring of the impact of PC consultation on patients demonstrated a perception of a moderate to significant impact (Table 3). There was no significant difference between the evaluations by the two teams.
Discussion
Heart disease is a leading cause of death in the United States
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with about one in five patients dying within one year of diagnosis.
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Regardless of prognosis and treatment plan, this patient population is quite ill, with a long and arduous disease course that can benefit from the care provided by PC. The involvement of PC in patients with advanced HF is now a class I recommendation. Our pilot study integrating early PC consult in the care of patients being treated by the HF/Transplant team revealed the following in patients pursuing aggressive HF treatment options (i.e., cardiac transplant, VAD insertion):
1. PC integration resulted in improved management of patient's pain and other symptoms, including dyspnea, insomnia, and anxiety. Interestingly, an overall decrease in opioid use was observed. 2. PC was well received by the patients and their families. 3. HF/Transplant team physicians, who requested assistance with symptom management, clarification of goals of care, advance care planning, and end-of-life care, viewed PC integration as beneficial to the patient. Improved efficiency of the HF/Transplant team was reported. 4. PC integration assisted with a holistic approach to management of patients and their needs. This included assisting with addressing spiritual and psychosocial needs, recommending involvement of appropriate consult services, and improving continuity of care. It is noteworthy that the median time to heart transplant in 2008 was 168 days.
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We found that this period, which we term “the wait,” can invoke great distress for patients as they are caught in between the potential for cure or death. Effective management of the distress often required intense pharmacologic (for anxiety and depression) and nonpharmacologic interventions. Referral to psychiatry and the chaplaincy program was crucial in providing patients with support.
This was a pilot study with a number of limitations. It was a retrospective, nonrandomized chart review without a control group. Patients receiving PC were chosen based upon perceived need by the HF/Transplant team, which could have biased the results. Feedback regarding benefit of PC service was received verbally, which is open to bias. A nonstandardized questionnaire was used to assess the perceptions of the PC and HF physicians, introducing further possible bias. Additionally, there was no long-term follow-up to assess whether there was any persistent benefit of PC service.
We believe that the clinical benefits and absence of negative impact observed would justify a larger, more comprehensive prospective clinical trial that randomized patients being evaluated by the heart transplant service to receiving PC consult plus usual standard care versus usual standard care alone. Patients would be able to cross over to the treatment arm if the patient or the treating team perceived a need. Such a study would address the limitations of this study, and provide definitive support for the putative benefits of PC in this population.
Footnotes
Author Disclosure Statement
No competing financial interests exist.