Patients' decision making process and expectations of a left ventricular assist device pre and post implantation

Abstract

Objectives

To examine patients' pre-implantation decision-making and pre and post-implantation expectations of left ventricular assist devices (LVADs).

Background

LVADs have been shown to improve both quantity and quality of life of patients living with Stage D heart failure (HF). However, they also pose significant risks.

Methods

15 LVAD participants followed in a longitudinal study of Stage D HF patients were included in this thematic analysis.

Results

Three themes were identified: no choice; I thought I would be doing better; I feel good, but now what. Evidence from pre-implantation to post-implantation suggested that patients' perceived expectations of quality of life improvement were not met.

Conclusions

In light of their declining health, most patients felt their only alternative to implantation was death. In the post-implantation period, patients expected greater improvements in their quality of life. Evidence based guidelines for discussions of goals of care, post-implant expectations, and palliative care are necessary.

Introduction

Heart failure (HF) impacts nearly 6 million Americans with 10% of patients considered to be at an advanced stage of disease.¹ It is anticipated that the prevalence of HF will continue to rise with 8 million expected diagnoses by 2030.² Continued advances in patient management will increase the number of patients surviving to develop advanced Stage D HF. Currently, 5%–10% of all HF patients are classified as Stage D as defined by the presences of progressive, persistent signs and symptoms of HF despite optimal medical, surgical, or device management.³ Heart transplantation is one of the most promising treatment options for Stage D HF patients, however organ scarcity has made heart transplantation an improbable treatment modality.4, 5 Moreover, many Stage D HF patients do not meet the minimum eligibility standards for transplant.⁶ Therefore, alternative strategies have been developed for the treatment of advanced HF including left ventricular assist devices (LVADs).

LVADs were originally developed as a bridge to transplantation (BTT) for patients awaiting heart transplant and are now being used as destination therapy (DT) for patients who are not transplant eligible due to advancing age and comorbidities.⁷ As of 2014, LVAD implantations have reached almost 2500 per year with more than 40% of devices implanted as DT.⁷ The main goals of LVAD implantation are to improve quality of life, improve survival, and help to decrease the number of inpatient hospital days experienced by chronic, advanced HF patients.5, 7, 8, 9 Currently, the one year survival rate after LVAD-DT implantation is 68% and the 2-year survival rate is 58% as compared to 10% (2-year) for those patients who forego implant and are medically managed.⁷ Improvements in quality of life are seen at 3 months after implantation and remain stable through the duration of support for patients implanted for both BTT and DT.¹⁰ Although the increase in quantity and quality of life are positive outcomes with LVADs, they also pose significant risks and burdens to patients. The majority of patients experience a major adverse event within 2 years of implantation including: disabling stroke, replacement of a failed or malfunctioning pump, and death.¹¹ Thrombosis, right ventricular failure, bleeding, life-threatening arrhythmias, infection, and frequent hospital readmissions are also common.¹² Advancing age and existing medical comorbidities are two of the primary reasons patients may be considered for LVADs; however, even after successful LVAD implantations, these patients still have progressive chronic illnesses and advancing age.11, 12, 13, 14, 15 LVAD implantation often occurs during a period of rapid clinical decline and medical instability and in many cases consent is obtained on an emergent basis.

Little is known about the patient's decision-making process prior to LVAD implantation, expectations for the LVAD, and whether these expectations were met post-implantation. Recent studies indicate that most patients feel gratitude for receiving the LVAD as it has improved quality of life; however, they also report little recollection of the decision to implant due to their failing health at the time of the consent.¹⁶ In addition, some patients have reported feeling they had little choice but to consent when facing the alternative of death; whereas others made unrushed, thoughtful decisions to implant.⁸ The literature highlights a need for improved patient/provider conversations, prior to implantation, that ensure patient appreciation of risks, benefits, and burdens of LVAD implantation and outline realistic expectations post-implantation.16, 17, 18 Palliative care involvement from the pre-implantation decision through the post-implantation is recommended and guidelines specific to mechanical circulatory support that provide well defined methods to engage patients in discussions regarding goals of care, values and preferences.¹⁹ The decision to consent to LVAD implantation is complex given the considerable risks and burdens associated with implantation. Therefore, the purpose of this study was to examine the patient's pre-implantation decision-making process and expectations for the device both pre and post-implantation.