Initial clinical experience with a novel left ventricular assist device with a magnetically levitated rotor in a multi-institutional trial

Department of Cardiothoracic Surgery, Medical University of Vienna, Vienna General Hospital, Waehringer Guertel 18-20, Vienna, Austria.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation (Impact Factor: 6.65). 11/2010; 29(11):1218-25. DOI: 10.1016/j.healun.2010.05.016
Source: PubMed


Third-generation rotary blood pumps have magnetically levitated rotors that eliminate mechanical wear over the years. Together with their potential for miniaturization, these pumps seem suitable for long-term support of patients with a wide range of body surface areas (BSA). Recently, the novel HVAD pump (HeartWare Inc, Framingham, MA), a miniaturized centrifugal pump with a hydrodynamic, magnetically levitated rotor, became ready for clinical application.
In a multi-institutional trial in Europe and Australia, 23 patients (mean age, 47.9 ± 12 years) in end-stage heart failure were enrolled in 5 centers. The primary end point of the bridge-to-transplant study was survival to heart transplant or survival to 180 days on the device, whichever occurred first. Follow-up data at 1 year are presented. The small size of the device allows for intrapericardial placement of the pump.
Implant procedures were generally fast and uneventful. Mean duration of support was 167 ± 143 days (range, 13-425 days), and mean blood flow provided by the pump was 6.1 ± 1.1 liters/min. At the 180-day end point, 2 patients had undergone successful transplant at 157 and 175 days, 2 patients died while on the device, and 19 patients continued pump support for more than 180 days. Actuarial survival after 6 months was 91% and was 86% at the 1-year follow-up.
The design of the HVAD pump enables a quick and less invasive implantation. The results to date demonstrate satisfactory long-term survival with excellent quality of life in this cohort of 23 patients of the initial multi-institutional Conformité Européene (CE) mark trial.

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    • "Many types of implantable LVADs have been developed since the early 1960s, which have been widely used in heart failure patients as a bridge to recovery, transplantation , or destination therapy [2] [3] [4] [5]. Compared with other types of pumps, the third-generation implantable LVADs suspend the impeller with magnetic or hydrodynamic suspension systems [6] [7] [8] [9]. Because of simpler design (no mechanical bearings, no mechanical or biological valves), these devices show a potential of longer durability. "
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    ABSTRACT: The aim of the study was to use the ovine model to evaluate the hemocompatibility and end-organ effects of a newly developed magnetic suspension centrifugal left ventricular assist device (LVAD) by CH Biomedical Inc., Jiangsu, China. The LVADs were implanted in 6 healthy sheep, where inflow was inserted into the left ventricular apex and outflow was anastomosed to the descending aorta. All sheep received anticoagulation and antiaggregation therapy during the study. Hematologic and biochemical tests were performed to evaluate anemia, hepatorenal function, and the extent of hemolysis. The experiments lasted for up to 30 days on the beating hearts. All sheep were humanely killed at the termination of the experiments, and the end-organs were examined macroscopically and histopathologically. Autopsy was performed in all animals and there was no thrombus formation observed inside the pump. The pump’s inflow and outflow conduits were also free of thrombus. Hematologic and biochemical test results were within normal limits during the study period. Postmortem examination of the explanted organs revealed no evidence of ischemia or infarction. Based on the in vivo study, this LVAD is suitable for implantation and can provide efficient support with good biocompatibility. The encouraging results in this study suggest that it is feasible to evaluate the device’s long-term durability and stability.
    Full-text · Article · Oct 2015
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    • "The results of a subsequent retrospective analysis of the explanted pump impellers and the pump manufacturing techniques led to a change in the impeller manufacturing process and tighter specifications for the thrust-bearing dimensions. These technological changes significantly improved outcomes with significantly less device failures because of thrombosis [10] [11]. "
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    ABSTRACT: OBJECTIVES The Synergy® CircuLite® micropump is a novel partial-support miniature left ventricular assist device that propels 2–3 l/min blood from the left atrium into the right subclavian artery. The ability of currently available investigative modalities to confirm Synergy pump malfunction is limited. The Synergy speed fluctuates periodically (at 10-s intervals) from the baseline to a transient decrease followed by a transient increase (alternating speed algorithm, ASA) with the purpose of changing the blood flow behaviour, thereby reducing thrombogenicity. The aim of this study was to develop a simple non-invasive monitoring technique to assess pump function based on the detection of the ASA in the peripheral microcirculation.
    Full-text · Article · Aug 2014 · Interactive Cardiovascular and Thoracic Surgery
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    • ", did not statistically differ between the groups. Earlier studies show different results regarding PSIs, ranging from 7% to 39% [16] [24] in patients supported with HM II and from 12.1% to 26.1% in HW patients [1] [9] [17] [22]. "
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    ABSTRACT: Objective Ventricular assist devices have become a standard treatment for patients with advanced heart failure. We present data comparing results after implantation of HeartMate II (HM II) versus HVAD (HW) left ventricular assist devices (LVADs) for the past 7 years at our institution. Methods From July 2006 to August 2012, 121 consecutive patients underwent LVAD implantation: 70 (57.9%) received HM II and 51 (42.1%) HW. Patient demographics, perioperative characteristics, and laboratory parameters as well as postoperative outcome were compared retrospectively. Results Patients in the HM II group were significantly younger (P < .01), with more deranged liver function (higher bilirubin [P = .02] and alanine aminotransferase [P = .01] levels), and had a significantly higher rate of preoperative infections requiring antibiotic treatment (P = .02) and a higher body core temperature (P < .01). Other demographic and preoperative parameters did not show statistical differences. Most postoperative characteristics were also similar between the two groups. HM II patients had a significantly higher transfusion rate, but there were no differences in incidence of resternotomy (P = .156). Recovery and VAD explantation were more likely in the HM II group (P = .02). Although there was no significant difference in survival (log rank test: P = .986; Breslow test: P = .827), HM II patients were more likely to develop a percutaneous site infection (P = .01). Conclusions Both HM II and HW provide similar early postoperative outcome and good long-term survival. The differences observed between the groups may be related to demographic and preoperative factors rather than the type of the device used.
    Full-text · Article · Jun 2014 · Transplantation Proceedings
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