In the present study, it was revealed that almost 10% of the patients consulted at the Osaka University Hospital Heart Center for advanced heart failure treatment had to abandon heart transplantation or LVAD due to the lack of caregivers. The primary reason for not advancing to discussions at the institutional review committee for heart transplantation or LVAD indication was the improvement of conditions through medical or surgical treatment. The second leading cause was patient death before deliberation. For many patients who died before the deliberation, the consultation appeared to have been too late. Earlier consultations might have led to higher survival rates. The absence of caregivers was the third most common reason for not proceeding to discussions at the institutional review committee. This is the first study to examine the availability of caregivers for patients with severe heart failure in Japan.

Although the importance of caregiver support for end-stage heart failure treatment is well known [4,5,6], previous studies focusing on caregivers of patients who underwent heart transplantation or LVAD implantation in Japan are rare [10, 11]. Suzuki et al. studied changes in the quality of life (QOL) in 32 LVAD patients and 24 caregivers before and after LVAD implantation. In LVAD patients, the QOL improved significantly post-implantation if there were no significant LVAD-related complications. However, for caregivers, while their anxiety reduced, their QOL remained unchanged before and after LVAD. Their study suggested that social QOL and activity levels did not improve post-implantation, indicating that the social participation and activities of LVAD patients and their caregivers are limited. They discussed that the requirement for caregivers to always accompany the patient prevents both LVAD patients and caregivers from fulfilling their normal social roles [10].

Kato et al. also examined the impact of LVAD implantation on caregivers’ QOL in a longitudinally quantitative study. They showed that the mental QOL of caregivers improved after LVAD implantation, but it remained lower than that of the general Japanese population. The caregiving burden increased post-discharge compared to pre-implantation, and this burden was an independent predictor of lower mental QOL for caregivers. They reported that caregivers felt their relationships with friends and other family members suffered due to the caregiving responsibilities. In addition, the study revealed that the lower QOL of caregivers was associated with their unemployed status [11]. It is often the case that caregivers must quit their jobs because of the rule that they must accompany LVAD patients at all times. Kato et al.’s study shows that the QOL of caregivers who quit their jobs for caregiving is significantly impaired. Conversely, many situations arise where both the patient and the caregiver cannot financially sustain themselves if the caregiver quits their job, forcing patients to abandon the LVAD option. These patients are included in the 10% who abandoned LVAD treatment due to the lack of caregivers in the present study.

The present study revealed that a significant percentage of severe heart failure patients are forced to abandon LVAD or heart transplant treatment due to the requirement that caregivers must attend to LVAD patients 24 h a day, 365 days a year. This situation undermines patients’ rights to equal access to the best possible care. Figure 3 presents the results of an international survey conducted by the International Consortium of Circulatory Assist Clinicians (ICCAC) in December 2020, which asked, “Does the center implant LVAD in a patient without a designated caregiver?” (permission to publish obtained from ICCAC). In the United States, 17% of LVAD centers replied that they would implant LVAD in a patient without a caregiver, and in Australia, 100% (4/4) of centers replied that they would do so. Japan is among the minority of countries that completely prohibit the placement of implantable LVADs in patients without caregivers [12] and is the only country that requires the caregiver to be physically present with the LVAD patient at all times.

Results of an international survey conducted by the International Consortium of Circulatory Assist Clinicians (ICCAC) in December 2020, which asked, “Does the center implant LVAD in a patient without a designated caregiver?” (permission to publish obtained from ICCAC)

Given that the HeartMate 3 has become the mainstream implantable LVAD and has significantly reduced events such as sudden pump stoppages and severe strokes [13, 14], it is imperative to reconsider the necessity of this stringent caregiver requirement. To repeal this rule, it is essential to understand how strictly current LVAD patients and their caregivers adhere to this requirement and how much their quality of life (QOL) is impaired by it. Furthermore, it is necessary to provide clear data on the incidence of serious LVAD-related accidents and the extent to which the presence of a caregiver prevents these incidents. Future research should focus on several key areas:

1. Adherence to caregiver requirements: studies should investigate the actual adherence levels of current LVAD patients and their caregivers to the 24/7 rule and assess the impact on their QOL.

2. Quality of life assessment: further research should evaluate the QOL of both patients and caregivers under the current caregiving requirements, using robust and validated tools.

3. Safety and incident data: collect and analyze data on serious LVAD-related incidents to determine how often caregiver intervention prevents accidents and whether the stringent caregiver presence requirement is justified.

4. Policy and practice comparison: comparative studies with countries that have more relaxed caregiver requirements can provide insights into the impact of different policies on patient outcomes and safety.

By addressing these areas, we can develop evidence-based guidelines that balance patient safety with quality of life, potentially leading to policy changes that improve access to LVAD and heart transplant treatments for patients in Japan.

There are several limitations to this study, including its retrospective nature and the relatively small number of patients included. The patients included in this study were limited to those who were referred from other hospitals to Osaka University, and the hospital visits were conducted by the heart failure team for the treatment of severe heart failure. These patients do not necessarily reflect the overall situation of patients with severe heart failure in Japan. The detailed reasons for the inability to secure caregivers were unavailable because they were not documented in the heart failure consultation database, although most of reasons were the physical absence of a caregiver and economic factors. The outcomes of patients who were not transferred to Osaka University Hospital were unavailable. It is highly likely that the prognosis of patients who required a heart transplant or LVAD but were forced to abandon these options due to the lack of a caregiver would have been significantly poor. Caregiver requirements for home LVAD treatment were somewhat relaxed from April 2024. This study was conducted before that rule change, and the situation may change slightly in future. These limitations underscores the need for a more comprehensive, multicenter prospective study to capture a broader range of patient outcomes and provide a more definitive assessment of the impact of caregiver requirements on access to advanced heart failure treatments.