title: Impact of pump replacement on outcome in advanced heart failure patients with left ventricular assist system.
abstract: Pump thrombosis is one of the major adverse events associated with the use of a left ventricular assist system (LVAS) in patients with advanced heart failure. We investigated the clinical implication of pump replacement because of thrombus formation. This study included 87 patients who underwent implantation of a Nipro (Toyobo) pulsatile extracorporeal LVAS intended as a bridge to transplantation and were alive more than 3 months after implantation. The pump of this device is translucent, and daily evaluation for signs of thrombus formation was performed. Pump replacement was performed for significant thrombus formation that became visible. Data collection including demographics as well as hematologic values were performed 1 day before (baseline) and 3 months after implantation, and all patients were followed for 2 years or until death. At 3 months after LVAS implantation, 41 patients (47.1%) had undergone pump replacement because of pump thrombus. Baseline body surface area <1.63 m(2) was a significant predictor of pump replacement (hazard ratio [HR] 2.15, P = 0.04). At 3 months after implantation, there was a significantly higher incidence of stroke (P < 0.05) as well as a significantly greater decrease in body weight (F = 4.92, P = 0.03) in patients who underwent pump replacement as compared to those without. The 2-year mortality after implantation was 26.4%. Multivariate Cox regression analysis showed that pump replacement within 3 months after implantation was an independent predictor of mortality (HR 2.50, P = 0.03). In conclusion, pump replacement for thrombus formation may have a strong association with worse outcome. Our results reconfirm the clinical importance of device thrombus in the management of LVAS.
authors.affiliation: Division of Hypertension and Nephrology, National Cerebral and Cardiovascular Center, Suita City, Osaka, Japan. iwashima@hsp.ncvc.go.jp
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Iwashima
authors.forename: Masanobu
authors.initials: M
authors.lastname: Yanase
authors.forename: Takeshi
authors.initials: T
authors.lastname: Horio
authors.forename: Osamu
authors.initials: O
authors.lastname: Seguchi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Murata
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Fujita
authors.forename: Koichi
authors.initials: K
authors.lastname: Toda
authors.forename: Yuhei
authors.initials: Y
authors.lastname: Kawano
authors.forename: Takeshi
authors.initials: T
authors.lastname: Nakatani
mesh_terms: D000328:Adult; D001830:Body Surface Area; D016009:Chi-Square Distribution; D020878:Device Removal; D018572:Disease-Free Survival; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006439:Hemodynamics; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000295:instrumentation*; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013927:Thrombosis / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D015431:Weight Loss; D055815:Young Adult
keywords: Device thrombus; Heart assist device; Heart failure; Left ventricular assist system; Pump replacement; Risk factor