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Open AccessArticle

Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States

1
Second Department of Medicine, University of Toyama, Toyama 930-0194, Japan
2
Department of Medicine, University of Chicago Medical Center, IL 60637, USA
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Department of Cardiac Surgery, University of Tokyo Hospital, Tokyo 113-8654, Japan
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Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka 564-8565, Japan
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Department of Cardiovascular Surgery, Kyushu University, Fukuoka 812-8582, Japan
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Department of Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine, Hokkaido 060-0808, Japan
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Department of Cardiovascular Surgery, Tokyo Women’s Medical University, Tokyo 162-0054, Japan
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Department of Cardiovascular Surgery, Tohoku University, Miyagi 980-0812, Japan
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Department of Cardiovascular Surgery, Nagoya University Hospital, Nagoya 464-8601, Japan
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Department of Cardiovascular Surgery, Saitama Kokusai Medical Center, Saitama 350-1298, Japan
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Department of Cardiovascular Surgery, Chiba University, Chiba 260-8677, Japan
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Department of Cardiovascular Surgery, Tokyo Medical and Dental University, Tokyo 113-8510, Japan
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Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan
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Division of Cardiology, Columbia University Medical Center, New York, NY 10019, USA
*
Author to whom correspondence should be addressed.
Medicina 2020, 56(3), 126; https://doi.org/10.3390/medicina56030126 (registering DOI)
Received: 17 February 2020 / Revised: 4 March 2020 / Accepted: 12 March 2020 / Published: 13 March 2020
(This article belongs to the Special Issue Ventricular Assist Device Therapy in Heart Failure)
Background: 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. Methods: 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. Results: 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%, p = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, p = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, p = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, p = 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 (p < 0.05 for both). Conclusion: 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. View Full-Text
Keywords: heart failure; LVAD; HeartMate; bleeding; stroke heart failure; LVAD; HeartMate; bleeding; stroke
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Imamura, T.; Ono, M.; Kinugawa, K.; Fukushima, N.; Shiose, A.; Matsui, Y.; Yamazaki, K.; Saiki, Y.; Usui, A.; Niinami, H.; Matsumiya, G.; Arai, H.; Sawa, Y.; Uriel, N. Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States. Medicina 2020, 56, 126.

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