Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States
<i>Background:</i> Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. <i>Methods:</i> For 416 conse...
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MDPI AG
2020-03-01
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| Series: | Medicina |
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| Online Access: | https://www.mdpi.com/1010-660X/56/3/126 |
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| author | Teruhiko Imamura Minoru Ono Koichiro Kinugawa Norihide Fukushima Akira Shiose Yoshiro Matsui Kenji Yamazaki Yoshikatsu Saiki Akihiko Usui Hiroshi Niinami Goro Matsumiya Hirokuni Arai Yoshiki Sawa Nir Uriel |
| author_facet | Teruhiko Imamura Minoru Ono Koichiro Kinugawa Norihide Fukushima Akira Shiose Yoshiro Matsui Kenji Yamazaki Yoshikatsu Saiki Akihiko Usui Hiroshi Niinami Goro Matsumiya Hirokuni Arai Yoshiki Sawa Nir Uriel |
| author_sort | Teruhiko Imamura |
| collection | DOAJ |
| description | <i>Background:</i> Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. <i>Methods:</i> For 416 consecutive LVAD patients who received HeartMate II LVAD implantation and completed a one-year follow-up, age-matched Japanese patients (the Japanese registry for mechanically assisted circulatory support (J-MACS) group) and the US patients were compared for their clinical outcomes. <i>Results:</i> 154 J-MACS patients and 77 US patients were compared. Survival, free from hemocompatibility-related adverse events (HRAEs) in the J-MACS was statistically comparable with the US (75% vs. 63%, <i>p</i> = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, <i>p</i> = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, <i>p</i> = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, <i>p</i> = 0.99). Post-LVAD prothrombin time with international normalized ratio (INR) <1.5 (odds ratio 4.07) was a risk factor for HRAEs in J-MACS, whereas INR >3.0 (odds ratio 5.71) was a risk factor in the US (<i>p</i> < 0.05 for both). <i>Conclusion:</i> In the age-matched cohorts, the J-MACS group experienced more strokes, while the US group had more bleedings. “Tailor-made” therapeutic strategy might be required for each country, given the unique variation of HRAE incidence among each country. |
| first_indexed | 2024-03-12T06:04:51Z |
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| issn | 1010-660X |
| language | English |
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| publishDate | 2020-03-01 |
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| spelling | doaj.art-8234f1fde1d64cd19e904e98c18f149d2023-09-03T03:43:14ZengMDPI AGMedicina1010-660X2020-03-0156312610.3390/medicina56030126medicina56030126Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United StatesTeruhiko Imamura0Minoru Ono1Koichiro Kinugawa2Norihide Fukushima3Akira Shiose4Yoshiro Matsui5Kenji Yamazaki6Yoshikatsu Saiki7Akihiko Usui8Hiroshi Niinami9Goro Matsumiya10Hirokuni Arai11Yoshiki Sawa12Nir Uriel13Second Department of Medicine, University of Toyama, Toyama 930-0194, JapanDepartment of Cardiac Surgery, University of Tokyo Hospital, Tokyo 113-8654, JapanSecond Department of Medicine, University of Toyama, Toyama 930-0194, JapanDepartment of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka 564-8565, JapanDepartment of Cardiovascular Surgery, Kyushu University, Fukuoka 812-8582, JapanDepartment of Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine, Hokkaido 060-0808, JapanDepartment of Cardiovascular Surgery, Tokyo Women’s Medical University, Tokyo 162-0054, JapanDepartment of Cardiovascular Surgery, Tohoku University, Miyagi 980-0812, JapanDepartment of Cardiovascular Surgery, Nagoya University Hospital, Nagoya 464-8601, JapanDepartment of Cardiovascular Surgery, Saitama Kokusai Medical Center, Saitama 350-1298, JapanDepartment of Cardiovascular Surgery, Chiba University, Chiba 260-8677, JapanDepartment of Cardiovascular Surgery, Tokyo Medical and Dental University, Tokyo 113-8510, JapanDepartment of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka 565-0871, JapanDepartment of Medicine, University of Chicago Medical Center, IL 60637, USA<i>Background:</i> Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. <i>Methods:</i> For 416 consecutive LVAD patients who received HeartMate II LVAD implantation and completed a one-year follow-up, age-matched Japanese patients (the Japanese registry for mechanically assisted circulatory support (J-MACS) group) and the US patients were compared for their clinical outcomes. <i>Results:</i> 154 J-MACS patients and 77 US patients were compared. Survival, free from hemocompatibility-related adverse events (HRAEs) in the J-MACS was statistically comparable with the US (75% vs. 63%, <i>p</i> = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, <i>p</i> = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, <i>p</i> = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, <i>p</i> = 0.99). Post-LVAD prothrombin time with international normalized ratio (INR) <1.5 (odds ratio 4.07) was a risk factor for HRAEs in J-MACS, whereas INR >3.0 (odds ratio 5.71) was a risk factor in the US (<i>p</i> < 0.05 for both). <i>Conclusion:</i> In the age-matched cohorts, the J-MACS group experienced more strokes, while the US group had more bleedings. “Tailor-made” therapeutic strategy might be required for each country, given the unique variation of HRAE incidence among each country.https://www.mdpi.com/1010-660X/56/3/126heart failurelvadheartmatebleedingstroke |
| spellingShingle | Teruhiko Imamura Minoru Ono Koichiro Kinugawa Norihide Fukushima Akira Shiose Yoshiro Matsui Kenji Yamazaki Yoshikatsu Saiki Akihiko Usui Hiroshi Niinami Goro Matsumiya Hirokuni Arai Yoshiki Sawa Nir Uriel Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States Medicina heart failure lvad heartmate bleeding stroke |
| title | Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States |
| title_full | Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States |
| title_fullStr | Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States |
| title_full_unstemmed | Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States |
| title_short | Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States |
| title_sort | hemocompatibility related adverse events following heartmate ii left ventricular assist device implantation between japan and united states |
| topic | heart failure lvad heartmate bleeding stroke |
| url | https://www.mdpi.com/1010-660X/56/3/126 |
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