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Collaboration between the implantation centers, management centers, and regional core hospitals is a key factor in securing long-term implantable ventricular assist device (VAD) management. In Kyushu, a management system for patients with implantable VADs has been established at the prefectural and regional levels. Presently, six implantable VAD implantation centers and seven management centers exists in the eight prefectures of Kyushu and Okinawa, with at least one specialized VAD centers in each prefecture. This collaborative management system allows patients with VADs to receive seamless treatment based on the same management concept wherever they live. In fact, approximately half of the present outpatients treated at our center reside outside the prefecture and are managed in collaboration with management centers and regional core hospitals. Among our patients, there were no significant differences in survival or rehospitalization-free rates between patients with VADs in and out of the prefecture, suggesting that the place of residence did not affect the outcome. With the increase in the number of patients with VADs and the diversification of patients, patient management has become more complex. Mutual collaboration between the implantation centers, management centers, and regional core hospitals, is essential to improve the quality of VAD management. This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2023 (Vol. 52, No. 1, pp. 85-88), with some modifications., (© 2024. The Japanese Society for Artificial Organs.)

In April 2021, destination therapy (DT) was finally approved in Japan. Since DT does not aim at heart transplantation (HT), our goal is to have a patient safely remain on an implantable ventricular assist device (VAD) for the rest of his/her life. To achieve this goal, similarly to bridge-to-transplant (BTT) patients, the authors believe the following six aspects are even more crucial in DT patients: (1) to appropriately assess risks before implantation, (2) to carefully determine the ability to manage the device by multidisciplinary discussions, (3) to prevent complications by improving the quality of care, (4) to expand the number of facilities that can take care of DT patients by improving collaboration among the facilities, (5) to reduce the burden of caregivers by utilizing social resources, and (6) to establish a home palliative care system based on advance care planning. In addition, for elderly DT patients to live happy and long lives, it is essential to help them to find a purpose of life and to keep activities of daily living, such as employment, schooling, and participation in social activities, just like the general elderly population. Our goals are not only to do our best for the patients just in front of us, but also to establish a system to follow up our DT cohort, same as BTT one, by all-Japan manner. In the present review, we discuss the current state of DT in Japan and what we need to focus on to maintain or improve its long-term performance., (© 2024. The Author(s).)

Heart transplantation is considered to be the best treatment for severe heart failure refractory to medical therapy, improving patients' survival and quality of life (QOL). However, the number of donors is smaller than the number of registered applicants for heart transplantation, which increases every year, and the waiting period for heart transplantation has been extended to more than 1700 days by 2022. Since 2011, reimbursement for the implantable left ventricular assist device (iLVAD) was established. The numbers of the iLVAD patients have been increasing year by year. Patients are managed at home with an iLVAD and can live with their families and even return to work, depending on the situation. On the other hand, self-management at home, including caregivers, is important for a safe life. Home management beyond 5 years is becoming more common due to long waiting time for transplant. This article outlines the important aspects of patient management for long-term support. This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2023 (Vol. 52, No. 1, pp. 62-66), with some modifications., (© 2024. The Japanese Society for Artificial Organs.)

Purpose: Bleeding complication is a critical risk factor for outcomes of acute heart failure patients requiring mechanical circulatory support (MCS), including percutaneous catheter-type heart pumps (Impella). The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) is an ongoing, large-scale, real-world registry to characterize Japanese patients requiring Impella. Here we analyzed bleeding complication profiles in patients who received Impella., Methods: All consecutive Japanese patients who received Impella from October 2017 to January 2020 were enrolled. The 30-day survival and bleeding complications were analyzed., Results: A total of 1344 patients were included: 653 patients received Impella alone, 685 patients received a combination of veno-arterial extracorporeal membrane oxygenation and Impella (ECPELLA), and 6 patients had failed Impella delivery. Overall 30-day survival was 67.0%, with Impella alone at 81.9% and ECPELLA at 52.7%. Overall bleeding/hematoma adverse events with a relation or not-excluded relation to Impella was 6.92%. Among them, the rates of hematoma and bleeding from medical device access sites were 1.41% and 4.09%, respectively. There was no difference between etiologies for these events., Conclusion: This study represents the first 3-year survival and the safety profile focused on bleeding adverse events from the J-PVAD registry. The results show that the real-world frequency of bleeding adverse events for patients who received Impella was an expected range from previous reports, and future real-world studies should aim to expand this data set to improve outcomes and adverse events., Competing Interests: Declarations. Conflict of interest: This study was partially funded by the Japanese Abiomed Post-Market Surveillance Program. The authors declare no additional conflicts of interest. IRB information: “Catheter-type ventricular assist device registry study”, Graduate School of Medicine/Faculty of Medicine, Osaka University Ethics Committee, Approval #17232., (© 2024. The Japanese Society for Artificial Organs.)

Background: ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (STEMI-CS) is associated with high mortality rates. Patients admitted during off-hours, specifically on weekends and at night, show higher mortality rates, which is called the "off-hours effect". The off-hours effect in patients with STEMI-CS treated with mechanical circulatory support, especially Impella, has not been fully evaluated., Aims: We aimed to investigate whether off-hours admissions were associated with higher mortality rates in this population., Methods: We used large-scale Japanese registry data for consecutive patients treated with Impella between February 2020 and December 2021 and compared on- and off-hours admissions. On- and off-hours were defined as the time between 8:00 and 19:59 on weekdays and the remaining time, respectively. The Cox proportional hazards model was used to calculate the adjusted hazard ratios (aHRs) for 30-day mortality., Results: Of the 1,207 STEMI patients, 566 (46.9%) patients (mean age: 69 years; 107 females) with STEMI-CS treated with Impella were included. Of these, 300 (53.0%) were admitted during on-hours. During the follow-up period (median 22 days [interquartile range 13-38 days]), 112 (42.1%) and 91 (30.3%) deaths were observed among patients admitted during off- and on-hours, respectively. Off-hours admissions were independently associated with a higher risk of 30-day mortality than on-hours admissions (aHR 1.60, 95% confidence interval: 1.07-2.39; p=0.02)., Conclusions: Our findings indicated the persistence of the "off-hours effect" in STEMI-CS patients treated with Impella. Healthcare professionals should continue to address the disparities in cardiovascular care by improving the timely provision of evidence-based treatments and enhancing off-hours medical services.

Background: Patients with refractory cardiogenic shock (CS) necessitating peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO) often require an intra-aortic balloon pump (IABP) or Impella for unloading; however, comparative effectiveness data are currently lacking., Methods and results: Using Diagnosis Procedure Combination data from approximately 1,200 Japanese acute care hospitals (April 2018-March 2022), we identified 940 patients aged ≥18 years with CS necessitating peripheral VA-ECMO along with IABP (ECMO-IABP; n=801) or Impella (ECPella; n=139) within 48 h of admission. Propensity score matching (126 pairs) indicated comparable in-hospital mortality between the ECPella and ECMO-IABP groups (50.8% vs. 50.0%, respectively; P=1.000). However, the ECPella cohort was on mechanical ventilator support for longer (median [interquartile range] 11.5 [5.0-20.8] vs. 9.0 [4.0-16.8] days; P=0.008) and had a longer hospital stay (median [interquartile range] 32.5 [12.0-59.0] vs. 23.0 [6.3-43.0] days; P=0.017) than the ECMO-IABP cohort. In addition, medical costs were higher for the ECPella than ECMO-IABP group (median [interquartile range] 9.09 [7.20-12.20] vs. 5.23 [3.41-7.00] million Japanese yen; P<0.001)., Conclusions: Our nationwide study could not demonstrate compelling evidence to support the superior efficacy of Impella over IABP in reducing in-hospital mortality among patients with CS necessitating VA-ECMO. Further investigations are imperative to determine the clinical situations in which the potential effect of Impella can be maximized.

Intraaortic balloon pumping(IABP)has been used in more than 20,000 cases annually in Japan and this old device may be used differently by less invasive approach via axillar artery, which enabled the patients to ambulate for rehabilitation. Impella, a newly developed microaxial blood pump, has been used as a less invasive left ventricular assist device in more than 50 case in the last 6 months since its approval in Japan. Our experiences in 11 patients indicated that it improved not only cardiac output, but also cardiac function, which resulted in cardiac recovery in 5 patients. Technical advances in less invasive mechanical circulatory support may play an important role in thoracic surgery as well as cardiology.

Implantable ventricular assist device( VAD) is the only evidence-based option to treat stage D heart failure patients with significant symptoms at rest in spite of maximum medical therapy, other than heart transplant. Implantable VADs available in Japan include Evaheart, DuraHeart both from Japan, Jarvik 2000 and HeartMate II both from United States. In Japanese settings, implantable VAD is indicated and insured only for patients who are supposed to have an indication for receiving heart transplant, which means "bridge to transplantation" use. And in Japan, implantable VAD can be implanted for patients less than 65 years old if it needs to be insured. In the University of Tokyo Hospital, the mid-term outcomes of 41 implantable VAD patients were acceptable with 2 hospital deaths, 2 remote deaths and one year survival rate at 88%.Considering the present Japanese situation with extreme shortage of organ donation, the extended application of implantable VADs as "Destination Therapy" is awaited, but quality of life of care-givers as well as patients themselves and sustainable follow-up system provided by healthcare professionals need to be warranted.

Background: The EVAHEART left ventricular assist device was approved in 2010 by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for bridge to heart transplantation (BTT). However, its effectiveness has not been evaluated since approval. In this study we evaluated the EVAHEART device in a commercial setting in Japan., Methods: Ninety-six consecutive patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed and who received an EVAHEART device, were enrolled from 2011 to 2013 at 14 Japanese centers. Patients' survival rates, adverse events and quality-of-life data were obtained from the J-MACS Registry., Results: Patients' median age was 43 years (85% male). The Interagency Registry for Mechanically Assisted Circulatory Support profiles revealed 12 patients in Level 1, 45 in Level 2, 37 in Level 3 and 1 in Level 4. The mean support duration was 384.7 days, with a cumulative duration of 101.2 years. The Kaplan-Meier survival rate during support was 93.4% at 6 months, 87.4% at 1 year and 87.4% at 2 years. Seventy-seven patients (80.2%) currently remain on support, 7 received a transplant and 10 died during support. Major adverse events included drive-line infection (14.6%) and neurologic events such as ischemic stroke (17.7%), hemorrhage (13.5%), transient ischemic attack (3.1%), pump thrombosis (1%) and hemolysis (1%). There was no gastrointestinal (GI) bleeding or right heart failure requiring right ventricular assist device (RVAD). There was no pump exchange due to mechanical failure., Conclusions: The EVAHEART device provides safe, reliable and long-term circulatory support with improved survival in commercial settings of BTT in Japan, where the transplant waiting period is much longer. Incidences of GI bleeding, hemolysis, right ventricular failure, device thrombosis and mechanical failure were extremely rare in patients on EVAHEART devices., (Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)

Ventricular assist devices (VADs) have long been used as bridge to transplant therapy (BTT). Nipro-Toyobo paracorporeal pulsatile-flow VAD (nt-VAD) was the only device available until April 2011, when implantable continuous-flow VADs (cf-VADs) became available. Although cf-VADs are central to BTT, nt-VAD remains a necessary option. We aimed to clarify the role of nt-VAD in an era of increasing cf-VAD use. We retrospectively reviewed patients who underwent VAD implantation at the National Cerebral and Cardiovascular Center from May 2011 to March 2013. Characteristics were compared between the nt-VAD and cf-VAD groups. Twenty-nine patients (mean age 37.7 ± 11.1 years, 23 males) underwent VAD implantation. Fifteen patients initially received nt-VADs, although 4 were converted to cf-VADs. Of these 15 patients, 3 were too small for cf-VADs and 2 needed bilateral ventricular support. The remaining 10 patients received nt-VADs (7 patients at INTERMACS level 1 and 3 at level 2). The nt-VAD group patients had significantly more preoperative mechanical circulatory support and were in a more critical condition before VAD implantation than the cf-VAD group. The 2-year survival rate was not significantly different. Despite the critical conditions of nt-VAD patients, their overall survival is not statistically inferior to that of cf-VAD patients. nt-VAD is a good option as a BTC for the patient with urgent and critical condition.

Ventricular assist device (VAD) has been applied for treatment of end-stage heart failure. Three major purposes of VAD are a bridge to transplantation, a bridge to recovery and a destination therapy (permanent VAD implantation). In Japan, only paracorporeal ventricular assist device (Toyobo-NCVC type) is approved for coverage by health insurance. Survival after Toyobo VAD implantation has been improving greatly Survivals 1, 3, 5-years after implantation are 75%, 75% and 58% respectively in our experience. Several implantable VADs are under clinical trials in Japan. Implantable VAD has many advantages, such as allowing patients to be discharged and being resistant to infection. Heart transplantation was performed in more than 70,000 cases worldwide. At present, approximately 3,000 transplantations were performed annually. Survivals after 1, 3, 5, 10-years are 86%, 79%, 72% and 51%. Fifty-seven heart transplantations were performed in Japan since 1999. Survivals after 1, 3, 5-years in Japan are 98%, 98% and 94%, which are far superior to world average results.

Japan has a long history of research and development of the artificial heart since Atsumi began studying artificial hearts at the University of Tokyo in 1959. Since that time, the University of Tokyo group has been developing different types of artificial hearts, as well as materials, blood pumps, driving mechanisms, and control methods. Other than the University of Tokyo, there are 12 institutes involved in artificial heart research and development in Japan. As for artificial heart clinical application in Japan, four devices were approved by the government; two are domestic, two are imported. Between 1980 and 2004, 697 cases of clinical application of a ventricular assist device (VAD) have been performed, including in 38 pediatric patients under 18 years. Recently, clinical use of percutaneous cardiopulmonary support has been increasing with 600 to 800 cases being performed every year, including in 40 to 60 patients under age 20 years. Although the requirement for clinical use of pediatric VADs is increasing, there is no device, domestic or imported, currently used in Japan; therefore, there is an urgent need for development of a pediatric VAD.

Background: Two types of ventricular assist systems have been approved for use by the Japanese government., Methods: The two government-approved ventricular assist systems, the Toyobo pump (National Cardiovascular Center type) and the Zeon pump (Tokyo University type), were applied to 219 patients in Japan as of October 20, 1994., Results: Adult-sized were used in 211 patients and pediatric ones in 8 patients. Left ventricular assist systems was performed in most cases (82.6%). The predominant indication was failure to be weaned from cardiopulmonary bypass (65.8%). The duration of ventricular assist system application ranged from 1 hour to 70 days, and the mean was 7.3 days, excluding the patients with cardiomyopathy. The weaning rate was 48.8% and the survival rate was 25.6%. Main causes of death were heart failure including unrecoverable heart failure and multiple organ failure. In 12 cardiomyopathy patients, Toyobo pumps were applied as left ventricular assist systems. Support duration was from 13 days to 192 days (ongoing). One patient was bridged to transplantation successfully and 1 was weaned after 3 months of support., Conclusions: From these data, the Toyobo pump and the Zeon pump are useful for short-term support for acute, profound heart failure. The Toyobo pump also may provide sufficient support as a bridge to transplantation for the medium term.

Hematological changes occurring during use of left ventricular assist devices (LVADs) were evaluated in 3 patients suffering from postcardiotomy cardiogenic shock. LVAD treatment ranged from 6 to 9 days. During the procedure, no anticoagulants were used in the first two cases, while in the third case, a protease-inhibiting agent, nafamostat mesilate (FUT-175), was used. In the first two cases without any anticoagulants, fibrinopeptide A (FPA) and thrombin-antithrombin III complex (TAT) increased markedly over the course of LVAD treatment, suggesting the excessive activation of the coagulatory system. The fibrinolytic system also became activated during LVAD treatment as was indicated by a marked increase in FDP-D-dimer and alpha 2 plasmin inhibitor-plasmin complex (PIC). Continual decreases observed in Factor XII and prekallikrein indicate that the coagulofibrinolytic activation occurring during LVAD treatment is presumably the result of contact activation of these factors due to interaction of blood with the internal surface of the LVAD. In the third case with FUT-175, both coagulation and fibrinolysis were successfully maintained at minimum levels as was demonstrated by the extremely low levels of these molecular markers. There was also no significant consumption of any contact factors. FUT-175 looks promising as an anticoagulant during the use of cardiac assist devices.