Clinical Results, Adverse Events, and Change in End-Organ Function in Elderly Patients With HeartMateII Left Ventricular Assist Device　― Japanese Multicenter Study ―

Abstract

plantation rule, patients aged >60 years at the time of wait list entry are been being treated nominally with bridge-totransplantation therapy (BTT) but practically with DT. To achieve better clinical results at introduction of DT in Japan, the clinical results and adverse events in these DT patients should be evaluated.In the present study, we compared the clinical results of patients aged >60 years at LVAD implantation with younger patients, and analyzed the adverse events and change of end-organ function on long-term follow-up using a national database. Use of a left ventricular assist device (LVAD) has become standard therapy for end-stage congestive heart failure. 1-6 Age has been shown to have an adverse impact on long-term clinical results for continuousflow LVAD, 2,7,8 but the age at which the risk of an LVAD becomes unacceptable is undefined. Furthermore, studies on the risk factors for mortality after LVAD implantation specifically in elderly patients, are very limited. 8 In Japan, destination therapy (DT) will be approved by the Ministry of Health, Labor and Welfare in the near future but, because of donor shortage and national trans- Yoshiki Sawa, MD, PhD on behalf of the Japanese HeartMateII Investigators Background: Advanced age has an adverse impact on clinical results in left ventricular assist device (LVAD) patients. We compared the clinical results of patients aged >60 years with younger patients using a national Japanese database. Methods and Results:Between April 2013 and December 2016, 300 patients underwent HeartMateII implantation. Of these, 37 patients were ≥60 years at LVAD implantation, and the clinical results of these patients were compared with the other younger 263 patients. At 1 and 3 years the on-device survival was 95%, 91% in younger patients, and 85%, 75% in older patients, respectively (P=0.016), although age was not a risk factor on the multivariate analysis. There was no significant difference between the groups in incidence of various adverse events except stroke. In the propensity-matching cohort, the incidence of stroke was significantly higher in patients aged >60 years (P=0.047). In patients aged >60 years, improvement of renal function was transient and there was no improvement later than 3 months, and recovery of serum albumin level to preoperative value was delayed.Conclusions: There were significant differences in the stroke incidence and recovery of end-organ functions after LVAD implantation. This may have important implications for patient selection in future destination therapy in Japan, where quality of life is an important issue in LVAD support.

Palliative and end-of-life care for heart failure patients in an aging society

“…The 48-month survival rate of patients with a VAD is 49% in the United States, while it is especially high (88.7%) in Japan [ 63 , 64 ]. However, VAD implantation involves invasive thoracotomy and hospitalization, which are associated with a high risk of complications such as stroke and infection [ 65 , 66 ], especially in older patients [ 67 ]. Furthermore, although a VAD can relieve HF symptoms, such as shortness of breath and dyspnea, and improve exercise capacity, patients may continue to experience other symptoms such as physical pain, depression, and anxiety [ 68 ].…”

Left Ventricular Assist Device Infections

“…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].…”

“…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]. An older study found that age and the presence of diabetes were associated with increased risk of LVAD endocarditis [34] with a median age of 59 among patients with endocarditis compared with a median age of 53 in those without (p = 0.02).…”

Left Ventricular Assist Device (LVAD) Implantation and Renal Dysfunction

“…Использование механических устройств кровообращения приводит к улучшению функции почек у пациентов после имплантации, однако почечные исходы после трансплантации сердца, по-видимому, в большей степени зависят от уровня почечной функции, достигнутого во время имплантации LVAD, чем от базового уровня функции почек [36] [38]. При этом в случае тщательного подбора пациентов, лица старше 65 лет, получавших терапию LVAD с постоянным потоком, демонстрировали хороший уровень выживаемости [39]. В японском национальном исследовании, при сравнении группы лиц молодого возраста, с лицами старше 60 лет, через 1 и 3 года выживаемость после имплантации LVAD составляла 95%, 91% у более молодых пациентов и 85%, у 75% пожилых пациентов соответственно (Р = 0,016), хотя возраст не был фактором риска для многомерного анализа, однако, улучшение функции почек после 60 лет было временным, и улучшение длилось не более, чем 3 месяца [40].…”