Device profile of the heartware HVAD system as a bridge-to-transplantation in patients with advanced heart failure: overview of its safety and efficacy

ABSTRACT

Introduction: Heart failure (HF) is one of the rising problems in the contemporary society with growing incidences of end-stage HF. While heart transplantation (HT) is the gold standard treatment for end-stage HF, its availability is limited by the lack of heart donors. As a consequence, left ventricular assist devices (LVADs) are becoming key therapies as bridge to transplant (BTT) strategy to improve survival and outcomes.

Areas covered: A significant advancement for wider applications of LVADs as BTT was facilitated by the introduction of miniaturized pumps such as the HVAD (HeartWare®, Medtronic, MN, USA), allowing intrapericardial implants and less-invasive approaches. In this review article, we describe the technical features of the HVAD and its outcomes in terms of efficacy and safety when implanted as BTT strategy. Moreover, we discuss the postoperative results of HT in HVAD recipients and its application in the pediatric population.

Expert opinion: It has been demonstrated that the HVAD positively influences the survival of end-stage HF patients awaiting HT, with an acceptable rate of adverse events. Due to its reduced size, it is particularly suitable for LVAD implantations through lateral thoracotomy and in patients with small thoracic dimensions.

KEYWORDS:

• Left ventricle assist device
• mechanical circulatory support
• heart transplantation
• bridge to transplant
• HVAD
• HeartWare

Article highlights

• The prevalence of HF is approximately 1–2% of the adult population in developed countries and it will increase 46% from 2012 to 2030.

• Despite HT being the therapy of choice for end-stage HF, there is still a lack of heart donors and mismatch between donors and patients waiting for HT. However, while waiting for HT, many patients experience a rapid deterioration of their clinical situation. As a consequence, strategies such as implantation of left ventricular assist devices (LVADs) as bridge to transplantation (BTT) have been widely applied to improve survival, outcomes and quality of life in patients waiting for HT.

• HVAD (HeartWare®, Medtronic, MN, USA) is a continuous flow centrifugal LVAD characterized by a small pump size, allowing intrapericardial implantation with less invasive surgical approaches.

• HVAD-BTT patients have an excellent postimplant survival of up to 68%, 63%, and 59% at 3, 4, and 5 years with a significant improvement in functional status and quality of life.

• HVAD showed a good safety profile and its adverse event rate tended to decline over time due to better medical management and design improvements.

• HVAD is particularly suitable as BTT in patients with small thoracic dimensions such as women and children.

• Long-term exposure to HVAD artificial surfaces might alter panel reactive antibodies. However, this evidence does not demonstrate any clinical consequence after HT.

Acknowledgments

The authors gratefully acknowledge Mrs. Katharina Homann for her assistance in the preparation of the pictures.

Declaration of interest

JD Schmitto and G Dogan are consultants for Medtronic and Abbott. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One peer reviewer is a surgical proctor and educator for Abbott Inc. One peer reviewer is a consultant to Medtronic. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.