Japanese Multicenter Outcomes With the HeartMate II Left Ventricular Assist Device in Patients With Small Body Surface Area

Ōno, Minoru; Sawa, Yoshiki; Nakatani, Takeshi; Tominaga, Ryuji; Matsui, Yoshiro; Yamazaki, Kenji; Saiki, Yoshikatsu; Niinami, Hiroshi; Matsumiya, Goro; Arai, Hirokuni

doi:10.1253/circj.cj-16-0203

Cited by 35 publications

(23 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Finally, the clinical implications of ramp tests should be compared and validated between Japan and the USA, as there are many differences in the populations, such as genetics, body habits, and dietary habits that may affect study results [68]. …”

Section: Future Perspectivesmentioning

confidence: 99%

Clinical implications of hemodynamic assessment during left ventricular assist device therapy

Imamura

Chung

Nguyen

et al. 2018

Journal of Cardiology

View full text Add to dashboard Cite

Left ventricular assist devices (LVADs) significantly improve outcomes of advanced heart failure patients. However, patients continue to have high readmission rates due to complications ranging from bleeding, thrombosis, heart failure, and infection. Considering that the hallmark benefit of LVAD therapy is improvement in hemodynamics (cardiac unloading and increased cardiac output), hemodynamic assessment on LVAD support is key to better understand these difficult complications and may serve as a tool to resolving them. In this review, we will discuss the hemodynamic changes following LVAD implantation, and the implications and prognostic impact of hemodynamic optimization on outcomes and complications.

show abstract

Section: Future Perspectivesmentioning

confidence: 99%

Clinical implications of hemodynamic assessment during left ventricular assist device therapy

Imamura

Chung

Nguyen

et al. 2018

Journal of Cardiology

View full text Add to dashboard Cite

show abstract

“…All J-MACS patients received LVAD implantation as BTT (destination therapy is not approved in Japan) [4]. Patients in the J-MACS registry had smaller BSA, and probably, as a result, LVAD speed was lower, although there is no study demonstrating the association between the body size and optimal device speed [8].…”

Section: Differences In Background Characteristics Between Countriesmentioning

confidence: 99%

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

Imamura¹,

Ōno²,

Kinugawa³

et al. 2020

Medicina

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…Subsequent innovations (axial to centrifugal flow) have not resulted in a reduction in infectious complications [7,8] with an actual increase in sepsis with the Heartware HVAD device compared to HeartMate II control [7]. Studies have looked at factors including age [22], gender [23], body habitus including both small patients [24] and obesity [25], trauma [26], duration of LVAD support [27] as well as presence of comorbid conditions such as diabetes [28][29][30], depression and chronic kidney disease (CKD) [31], alcoholism and immunosuppression [29], and malnutrition ( [32,33] and references therein). In a Japanese multicenter trial looking at 300 patients receiving HeartMate II between April 2013 and December 2016, patients older than 60 had similar overall survival and risk of driveline and pocket infections [22].…”

Section: Epidemiology and Risk Factors For Lvad Infectionsmentioning

confidence: 99%

“…Women receiving LVADs were often sicker (Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS) cohorts 1 or 2) and had significantly higher bleeding complications, arrhythmias and right heart failure, but not infectious complications [23]. Driveline infections were slightly more common in smaller (body surface area (BSA) < 1.5 m 2 ) patients (13 vs. 12 patients, p = 0.003) but mediastinal infections occurred in 2 patient with BSA > 1.5 m 2 with no cases among smaller patients [24]. Clerkin et al examined data from a BTT cohort of 3856 patients between 2004 and 2014, and found that patients with a body mass index (BMI) >35 kg/m 2 had a trend towards increased infection risk (hazard ratio 1.59, 95% confidence interval 0.99-1.94, p = 0.058) [25].…”

Section: Epidemiology and Risk Factors For Lvad Infectionsmentioning

confidence: 99%

Left Ventricular Assist Device Infections

Skalweit¹

2018

Advanced Concepts in Endocarditis

View full text Add to dashboard Cite

Left ventricular assist device (LVAD) infections are important causes of morbidity and mortality in patients who receive these mechanical circulatory supports as a bridge to transplantation (BTT) or as destination therapy (DT) (for individuals who are not candidates for cardiac transplant). Infections are more common among persons who received pulsatile flow LVADs as opposed to newer continuous flow (CF) devices. Other risk factors for infection include obesity, renal failure, depression and immunosuppression. An LVAD infection increases the risk of infections in persons who undergo cardiac transplantation. Infections include percutaneous site, driveline, pump pocket and pump/cannula infections; sepsis, bacteremia, mediastinitis and endocarditis. Diagnosis is achieved by monitoring LVAD flow parameters and observing typical clinical and laboratory manifestations of infection. Imaging such as PET-CT or SPECT-CT imaging can be helpful to establish a diagnosis of pump pocket infection. Echocardiography may aid in detecting native valve endocarditis and thrombus associated with the LVAD. The most common pathogens include Staphylococcus, Corynebacterium, Enterococcus, Pseudomonas and Candida spp. Treatment requires targeted antimicrobials plus surgical debridement of infected tissue and device components. In cases of pump/cannula/LVAD endocarditis, especially if fungal pathogens or Mycobacterium chimaera are involved, LVAD removal/reimplantation vs. transplant is necessary, combined with extended antimicrobial therapy.

show abstract

Japanese Multicenter Outcomes With the HeartMate II Left Ventricular Assist Device in Patients With Small Body Surface Area

Cited by 35 publications

References 18 publications

Clinical implications of hemodynamic assessment during left ventricular assist device therapy

Clinical implications of hemodynamic assessment during left ventricular assist device therapy

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

Left Ventricular Assist Device Infections

Contact Info

Product

Resources

About