Adult: Mechanical Circulatory Support: Expert Review
HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations

https://doi.org/10.1016/j.jtcvs.2021.11.085Get rights and content

Abstract

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices.

Graphical abstract

Pump exchange of a HeartWare HVAD to HeartMate 3 LVAD. Exchange of the HVAD device should be performed only “for cause,” for example, pump malfunction. The assessment of the surgical risks of the procedure should determine surgical approach and technique for the exchange procedure. Removal of all HVAD device components including the sewing ring and outflow graft is the optimal technique when feasible and safe. Alternative approaches are available, including minimally invasive techniques.

  1. Download : Download high-res image (220KB)
  2. Download : Download full-size image

Section snippets

Differences in Device Design and Implications for Medical Management

Both pumps are continuous-flow LVADs with centrifugal flow design.15,16 The HVAD uses a hybrid engineering design to levitate the internal impeller with passive magnetic levitation and a hydrodynamic bearing. It incorporates an optional proprietary pump speed management algorithm, termed the “Lavare Cycle,”17 that is designed to reduce pump and ventricular blood stasis and improve washout. The HeartMate 3 is designed with complete magnetic levitation of the internal impeller that permits

Conclusions

This document outlines important differences that exist in both patient management and techniques for surgical exchange of an HVAD-to-HeartMate 3 exchange. Current data support the recommendation that patients supported with a normally functioning HVAD should remain on support and only undergo exchange “for cause” because the risk of death due to device exchange likely exceeds the risk of death remaining on a normally functioning HVAD device. It is likely that future analyses of data from

References (34)

  • J.D. Schmitto et al.

    Long-term support of patients receiving a left ventricular assist device for advanced heart failure: a follow-up analysis of the registry to evaluate the HeartWare left ventricular assist system

    Eur J Cardiothorac Surg

    (2016)
  • J.G. Rogers et al.

    Intrapericardial left ventricular assist device for advanced heart failure

    N Engl J Med

    (2017)
  • S.R. Auerbach et al.

    HVAD usage and outcomes in the current pediatric ventricular assist device field: an advanced cardiac therapies improving outcomes network (ACTION) Analysis

    ASAIO J

    (2021)
  • Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped. U.S. Food and Drug Administration Website

  • F.D. Pagani et al.

    Concordance of treatment effect: an analysis of The Society of Thoracic Surgeons Intermacs database

    Ann Thorac Surg

    (May 31, 2021)
  • E.V. Potapov et al.

    Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis

    Eur J Cardiothorac Surg

    (2021)
  • S.M. Cho et al.

    Cerebrovascular events in patients with centrifugal-flow left ventricular assist devices: propensity score-matched analysis from the INTERMACS registry

    Circulation

    (2021)
  • Cited by (0)

    This article has been copublished in The Journal of Thoracic and Cardiovascular Surgery, The Annals of Thoracic Surgery, and European Journal of Cardio-Thoracic Surgery.

    Members of the HeartWare HVAD System to HeartMate 3 Left Ventricular Assist System Exchange Advisory Group are listed in the Acknowledgments.

    View full text