著者
Yuki Ikeda Junya Ako Koichi Toda Atsushi Hirayama Koichiro Kinugawa Yoshio Kobayashi Minoru Ono Takashi Nishimura Naoki Sato Takahiro Shindo Morimasa Takayama Satoshi Yasukochi Akira Shiose Yoshiki Sawa J-PVAD Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.87, no.5, pp.588-597, 2023-04-25 (Released:2023-04-25)
参考文献数
30
被引用文献数
16

Background: The Impella®percutaneous left ventricular assist device has been available in Japan since 2017. This is the first large-scale registry study to analyze the efficacy and safety of Impella in Japanese patients with acute myocardial infarction with cardiogenic shock (AMICS).Methods and Results: The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) has registered all consecutive Japanese patients treated with Impella. We extracted data for 593 AMICS patients from J-PVAD and analyzed 30-day survival and safety profiles. Overall 30-day survival was 63.1%. The 30-day survival of the Impella alone and Impella plus venoarterial extracorporeal membrane oxygenation (ECPELLA) groups was 80.9% and 45.7%, respectively. The Impella alone group was older and had a lower rate of cardiac arrest, milder consciousness disturbance, less inotrope use, lower serum lactate concentrations, higher B-type natriuretic peptide concentrations, and higher left ventricular ejection fraction (LVEF) than the ECPELLA group. Cox regression analysis revealed that older age and comorbid renal disturbance were common risk factors affecting 30-day mortality in both groups. Major adverse events were hemolysis (10.8%), hemorrhage/hematoma (7.6%), peripheral ischemia (4.4%), stroke (1.3%), and thrombosis (0.7%). LVEF improved in both groups during support.Conclusions: AMICS treatment with Impella showed favorable 30-day survival and safety profiles. The survival rate of patients treated with Impella alone was particularly high. Further studies are needed to improve outcomes of patients with ECPELLA support.
著者
Yuki Ikeda Junya Ako Koichi Toda Atsushi Hirayama Koichiro Kinugawa Yoshio Kobayashi Minoru Ono Takashi Nishimura Naoki Sato Takahiro Shindo Morimasa Takayama Satoshi Yasukochi Akira Shiose Yoshiki Sawa J-PVAD Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-22-0476, (Released:2023-01-20)
参考文献数
30
被引用文献数
16

Background: The Impella®percutaneous left ventricular assist device has been available in Japan since 2017. This is the first large-scale registry study to analyze the efficacy and safety of Impella in Japanese patients with acute myocardial infarction with cardiogenic shock (AMICS).Methods and Results: The Japanese registry for Percutaneous Ventricular Assist Device (J-PVAD) has registered all consecutive Japanese patients treated with Impella. We extracted data for 593 AMICS patients from J-PVAD and analyzed 30-day survival and safety profiles. Overall 30-day survival was 63.1%. The 30-day survival of the Impella alone and Impella plus venoarterial extracorporeal membrane oxygenation (ECPELLA) groups was 80.9% and 45.7%, respectively. The Impella alone group was older and had a lower rate of cardiac arrest, milder consciousness disturbance, less inotrope use, lower serum lactate concentrations, higher B-type natriuretic peptide concentrations, and higher left ventricular ejection fraction (LVEF) than the ECPELLA group. Cox regression analysis revealed that older age and comorbid renal disturbance were common risk factors affecting 30-day mortality in both groups. Major adverse events were hemolysis (10.8%), hemorrhage/hematoma (7.6%), peripheral ischemia (4.4%), stroke (1.3%), and thrombosis (0.7%). LVEF improved in both groups during support.Conclusions: AMICS treatment with Impella showed favorable 30-day survival and safety profiles. The survival rate of patients treated with Impella alone was particularly high. Further studies are needed to improve outcomes of patients with ECPELLA support.
著者
Koichiro Kinugawa Yasushi Sakata Minoru Ono Shinichi Nunoda Koichi Toda Norihide Fukushima Akira Shiose Shogo Oishi Dai Yumino Teruhiko Imamura Miyoko Endo Yumiko Hori Koichi Kashiwa Kaoruko Aita Hiroyuki Kojin Yutaka Tejima Yoshiki Sawa
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.85, no.10, pp.1906-1917, 2021-09-24 (Released:2021-09-24)
参考文献数
21
被引用文献数
11

Destination therapy (DT) is the indication to implant a left ventricular assist device (LVAD) in a patient with stage D heart failure who is not a candidate for heart transplantation. The implantable LVAD has been utilized in Japan since 2011 under the indication of bridge to transplant (BTT). After almost 10 year lag, DT has finally been approved and reimbursed in May 2021 in Japan. To initiate the DT program in Japan, revision of the LVAD indication from BTT is necessary. Also, in-depth discussion of caregiver issues as well as end-of-life care is indispensable. For that purpose, we assembled a DT committee of multidisciplinary members in August 2020, and started monthly discussions via web-based communication during the COVID-19 pandemic. This is a summary of the consensus reached after 6 months’ discussion, and we have included as many relevant topics as possible. Clinical application of DT has just started, and we are willing to revise this consensus to meet the forthcoming issues raised during real-world clinical experience.
著者
Teruhiko Imamura Koichiro Kinugawa Takashi Nishimura Koichi Toda Yoshikatsu Saiki Hiroshi Niinami Shinichi Nunoda Goro Matsumiya Motonobu Nishimura Hirokuni Arai Masanobu Yanase Norihide Fukushima Takeshi Nakatani Akira Shiose Ikuko Shibasaki Yasushi Sakata Minoru Ono J-MACS Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0264, (Released:2023-06-01)
参考文献数
18
被引用文献数
2

Background: Recently, destination therapy (DT) was approved in Japan, and patients ineligible for heart transplantation may now receive durable left ventricular assist devices (LVADs). Several conventional risk scores are available, but a risk score that is best to select optimal candidates for DT in the Japanese population remains unestablished.Methods and Results: A total of 1,287 patients who underwent durable LVAD implantation and were listed for the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) were eligible for inclusion. Finally, 494 patients were assigned to the derivation cohort and 487 patients were assigned to the validation cohort. According to the time-to-event analyses, J-MACS risk scores were newly constructed to predict 3-year mortality rate, consisting of age, history of cardiac surgery, serum creatinine level, and central venous pressure to pulmonary artery wedge pressure ratio >0.71. The J-MACS risk score had the highest predictability of 3-year death compared with other conventional scores in the validation cohort, including HeartMate II risk score and HeartMate 3 risk score.Conclusions: We constructed the J-MACS risk score to estimate 3-year mortality rate after durable LVAD implantation using large-scale multicenter Japanese data. The clinical utility of this scoring to guide the indication of DT should be validated in the next study.
著者
Kenji Ando Kanki Inoue Tomoo Harada Satoshi Shizuta Yukihiko Yoshida Kengo Kusano Tatsuya Onuki Yuji Watari Akio Fukui Shingo Sasaki Morio Shoda Nobuhiro Nishii Akira Shiose Junya Hosoda Chie Okai Kurt Stromberg Jeffrey Murphy Thomas R Holmes Kyoko Soejima
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0269, (Released:2023-08-02)
参考文献数
15
被引用文献数
2

Background: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61–6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria.Conclusions: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.
著者
Kohei Masaki Toru Hashimoto Masato Katsuki Kisho Ohtani Taiki Higo Tomoki Ushijima Yoshihisa Tanoue Akira Shiose Hiroyuki Tsutsui
出版者
International Heart Journal Association
雑誌
International Heart Journal (ISSN:13492365)
巻号頁・発行日
vol.62, no.5, pp.1182-1185, 2021-09-29 (Released:2021-09-30)
参考文献数
12

A 20-year-old man with arrhythmogenic right ventricular cardiomyopathy (ARVC) was resuscitated from ventricular fibrillation. He was transferred to our hospital because of progressive multiorgan dysfunction despite mechanical circulatory support with peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP). At admission to our hospital, chest X-ray showed bilateral complete lung opacification, and echocardiography revealed a massive thrombus occupying the left atrium (LA) and left ventricle (LV). Conversion to central ECMO with transapical LV venting and thrombectomy were performed. The huge LA thrombus occluded all pulmonary veins (PVs). Despite the surgery and intensive care, complete lung opacity remained, and he died of multiorgan failure associated with sepsis. Autopsy demonstrated bilateral pulmonary multiple red infarctions, and histopathology showed alveolar wall necrosis with extensive hemorrhage, confirming a diagnosis of pulmonary hemorrhagic infarction. Extensive pulmonary infarction was attributable to PV occlusion due to massive LA thrombus. PV thrombosis should be considered when refractory lung opacities are encountered during VA-ECMO and necessitates early intervention.
著者
Teruhiko Imamura Koichiro Kinugawa Minoru Ono Osamu Kinoshita Norihide Fukushima Akira Shiose Yoshiro Matsui Kenji Yamazaki Yoshikatsu Saiki Akihiko Usui Hiroshi Niinami Goro Matsumiya Hirokuni Arai Yoshiki Sawa
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-18-1215, (Released:2019-04-24)
参考文献数
35
被引用文献数
7

Background:Hemocompatibility-related adverse events (HRAEs) are substantial issues in patients with left ventricular assist devices (LVADs). Atrial fibrillation (AF) is associated with worse prognosis in patients with heart failure (HF), but its effect on HRAEs following LVAD implantation remain uncertain.Methods and Results:Data from the Japanese Mechanically Assisted Circulatory Support registry of consecutive patients who received HeartMate II LVADs and were followed for 1 year were retrospectively reviewed. Among 190 patients, 23 had AF and 167 had sinus rhythm. The AF group had comparable baseline characteristics with the non-AF group except for their higher age (53 vs. 42 years, P<0.001). Following LVAD implantation, most cases of AF (73%) persisted. Antiplatelet therapy, anticoagulation therapy, and LVAD speed following LVAD implantation were comparable between groups (P>0.05 for all). The 1-year survival free from HRAEs was comparable between groups (83% vs. 76%, P=0.52). Event rates of the breakdown of HRAEs were comparable between groups except for a relatively higher rate of surgically managed pump thrombosis in the AF group (0.16 vs. 0.04, incidence rate ratio 3.75, 95% confidence interval 0.87–16.1, P=0.075). These trends still remained with propensity score-matched comparison.Conclusions:Existence of AF had no effect on the development of HRAEs following LVAD implantation. The need to aggressively treat AF before or after LVAD implantation needs further investigation.