Article

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: 5.61). 11/2010; 29(11):1218-25. DOI: 10.1016/j.healun.2010.05.016
Source: PubMed

ABSTRACT 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.

0 Followers
 · 
73 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Einleitung Miniaturisierte Herzunterstützungspumpen, sog. Kunstherzsysteme oder „ventricular assist devices“ (VADs) bieten die Möglichkeit, diese Systeme im Kindesalter anzuwenden. Durch die lange Wartezeit auf ein geeignetes Spenderorgan sollte bei Kindern, unterstützt mit einem intrakorporealen VAD, die Entlassung nach Hause angestrebt werden. Schwerpunkte vor einem Spitalaustritt sind neben der adäquaten Schulung und Aufklärung des Patienten und deren Familie auch ein Ausbildungs- und Schulungskonzept für die lokalen Rettungskräfte und die Betreuungspersonen vor Ort. Methoden Es wird ein auf die präklinische Versorgung abgestimmter Notfallalgorithmus für die Erstversorgung von VAD-Patienten vorgestellt sowie das gemeinsam erarbeitete Ausbildungskonzept der lokalen Rettungskräfte und des Kinderspitals Zürich. Schwerpunkte des Schulungsprogramms sind neben der theoretischen Einführung praktische Workshops, „cardiac arrest simulation training“ (CAST) sowie die Erstellung eines genau definierten Alarmierungsplans unter Einbezug der lokalen ärztlichen Organisationsstrukturen und der Spezialisten des Kinderspitals. Schlussfolgerung Die Besonderheiten bei der Versorgung von Kindern am VAD werden vorgestellt und diskutiert.
    Notfall 10/2013; 16(6):469-476. DOI:10.1007/s10049-013-1744-4 · 0.32 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: In the last 2 decades, there have been significant advances in medical treatment of heart failure. However, there is a group of patients who are refractory to the available medical therapy and progress inevitably to a state of end-stage heart failure, whose only therapeutic alternative is cardiac transplantation. But this is an option limited by the scarce availability of donors. Therefore many patients die waiting for an organ. Recently, extra or intracorporeal left ventricular devices have emerged as a viable alternative for patients with end-stage heart failure waiting for a heart transplant. These devices discharge the left ventricle, increasing cardiac output and improving systemic perfusion. This year, in our hospital we began a left ventricular device implantation program for the most severely ill patients on the waiting list for cardiac transplantation. We report two males aged 30 and 53 years, in whom a left ventricular device was successfully implanted, using a minimally invasive surgical technique developed at the University of Hannover in Germany.
    Revista medica de Chile 04/2014; 142(7):914-918. · 0.37 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Little is known about the outcomes of children supported on intracorporeal left ventricular assist device (HVAD), and the feasibility of outpatient management. All centers with pediatric patients discharged from the hospital on the device were identified using company database. A total of 14 centers were contacted, with 9 centers, contributing data retrospectively. From 2011 to 2013, 12 pediatric patients (7 females), mean aged 11.9 ± 2.3 years (range 8-15), mean weight 43 ± 19 kg (range 18-81), mean body surface area 1.3 ± 0.3 m(2) (range 0.76-1.96) were identified. Diagnosis included: dilated cardiomyopathy (CMP) (n = 5), noncompaction CMP (n = 4), toxic CMP (n = 2) and viral CMP (n = 1). Indications for support were permanent support (n = 1), bridge to recovery (n = 1) and bridge to transplantation (n = 10). Prior to HVAD implantation, all patients received intravenous inotropes and two patients were on temporary mechanical support. Overall mortality was 0%. Mean duration of inpatient and outpatient support were 56 (range: 19-95 days) and 290 days (range: 42-790), respectively. Mean readmission rate was 0.02 per patient month (2.1 per patient). No adverse events involving emergency department occurred. Eight children resumed local schooling. Home discharge of children supported on HVAD is feasible and safe. School integration can be achieved. There is wide center variability to discharge practice for children. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.
    American Journal of Transplantation 02/2015; 15(2):453-60. DOI:10.1111/ajt.13003 · 6.19 Impact Factor