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

Abstract

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.

Mechanical circulatory support for adults in Japan: A 10‐year perspective

“…A review of J-MACS data demonstrated a higher stroke rate in a Japanese cohort as compared with an agematched USA LVAD cohort treated at a single center (0.221 vs. 0.052/patient-year, p = 0.005), though the cohort in the single center may not necessarily represent the overall USA cohort. 34 This difference between the countries could be explained by differences in multiplefactors including genetics, salt sensitivity, body size, and heart failure etiology. Samura and colleagues investigated risk factors for stroke after CF-LVAD implantation in 158 Japanese patients and found that LVAD patients with an early stroke (within 90 days) had a significantly lower pump output within 24 h after LVAD implantation (3.4 vs. 4.0 L/min) and significantly higher LDH level within 2 weeks.…”

“…A review of J‐MACS data demonstrated a higher stroke rate in a Japanese cohort as compared with an age‐matched USA LVAD cohort treated at a single center (0.221 vs. 0.052/patient‐year, p = 0.005), though the cohort in the single center may not necessarily represent the overall USA cohort 34 . This difference between the countries could be explained by differences in multiple‐factors including genetics, salt sensitivity, body size, and heart failure etiology.…”

Implication of Hemodynamic Assessment during Durable Left Ventricular Assist Device Support

“…Recently, therapies including omega-3 fatty acid and digoxin administration were found to be associated with fewer gastrointestinal bleeding events, possibly due to suppression of these maladaptive cascades [30][31][32]. Genetic and dietary factors might also have a considerable impact on angiogenesis activity, given a considerably lower observed incidence of gastrointestinal bleeding in Japanese cohorts [33]. Further molecular biological analyses are warranted to clarify the relationship between hemodynamics, the angiogenesis cascade, and gastrointestinal bleeding.…”

What is the optimal therapeutic protocol for using a durable left ventricular assist device in the near future of a developing country?

“…Bleeding complications in organs, including the gastrointestinal system and the brain, are major concerns in our center. We also suspect that there may be genetic or racial differences between the Asian and Western population (3)(4)(5). We hope that HeartMate3 may reduce the incidence of bleeding complications.…”