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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    • "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.
    Interactive Cardiovascular and Thoracic Surgery 08/2014; 19(5). DOI:10.1093/icvts/ivu236 · 1.16 Impact Factor
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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.
    Transplantation Proceedings 06/2014; 46(5):1469–1475. DOI:10.1016/j.transproceed.2013.12.057 · 0.98 Impact Factor
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    • "Left ventricular assist devices (LVADs) have become efficient treatment for a large number of patients with advanced heart failure either as a bridge to transplant, bridge to recovery, or as destination therapy.1–8 Technological development and increasing clinical implementation have significantly improved the survival in patients supported with continuous-flow (CF) LVADs and are associated with decreased incidence of adverse events and a better quality of life compared to pulsatile devices.5 "
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    ABSTRACT: Left ventricular assist devices (LVADs) are fast becoming standard of care for patients with advanced heart failure. However, despite continuous improvement in VAD technology there remains a significant early post-operative morbidity and mortality in this extreme patient group. The aim of the present study was to explore the short-term outcomes and predictors for 90-day mortality in the patients after implantation of continuous flow LVAD.Peri-operative clinical, echocardiographic, hemodynamic and laboratory data of 90-day survivors and non-survivors were collected and compared retrospectively. Multivariate logistic regression analysis was performed on univariate predictors for 90-days mortality with an entry criterion of p<0.1.Between July, 2006 and May, 2012, 117 patients underwent implantation of a continuous flow LVAD as a bridge to transplantation: 71 (60.7%) HeartMate II (Thoratec Corp) and 46 (39.3%) HVAD (HeartWare International). All cause 90-day mortality was 17.1%. Multivariate analysis revealed higher preoperative CVP (OR 1.18, 95% CI 1.014-1.378; p=0.033) and higher age (OR 1.14, 95% CI 1.01-1.38; p=0.045) as the only independent predictors for 90-day mortality.Optimization of pre-operative volume status, preload and right heart function as well as age based selection of candidates for LVAD support are the critical factors influencing early outcome after continuous flow LVAD implantation.
    ASAIO journal (American Society for Artificial Internal Organs: 1992) 01/2014; 60(2). DOI:10.1097/MAT.0000000000000035 · 1.52 Impact Factor
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