The National Institute for Health and Clinical Excellence is examining short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the preliminary recommendations
• the identification of factual inaccuracies
• additional relevant evidence.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.

The Advisory Committee will then prepare draft guidance which will be the basis for the Institute’s guidance on the use of the procedure in the NHS in England, Wales and Scotland.

• For further details, see the Interventional Procedures Programme manual, which is available from the Institute’s website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 28 March 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Limited evidence on the safety and efficacy of short-term circulatory support with left ventricular assist devices as a bridge to cardiac transplantation or recovery appears adequate to support the use of this procedure provided that the normal arrangements are in place for audit and clinical governance.

Publication of further research will be useful, especially on the use of this procedure in patients who are suffering from cardiogenic shock after acute myocardial infarction.

Short-term circulatory support with left ventricular assist devices (LVADs) may be indicated for patients with end-stage heart failure (of any aetiology) who are awaiting a donor for heart transplantation, and for patients with a severe acute heart failure syndrome from which myocardial recovery is anticipated (such as acute myocarditis). LVADs are sometimes used for patients who fail to wean from cardio-pulmonary bypass after cardiac surgery .

The management of patients with end-stage heart failure or acute heart failure from naturally reversible causes is challenging, and may include combination medical therapy (including inotropic support), intra-aortic balloon pumping and heart transplantation.

A number of LVADs are available which increase cardiac output by providing mechanical support to the failing left ventricle. The choice of device may depend on the patient’s body size, the length of support time required, the degree of support needed and the type of blood flow desired.

Implantation of an LVAD is done under general anaesthesia through a chest incision in an operation that usually lasts for several hours. The inflow pipe of the LVAD is inserted into the left side of the heart, usually the left ventricle, and its outflow pipe is inserted into the systemic arterial system, usually the aorta. The LVAD pumps oxygenated blood from the failing left ventricle to the systemic arterial system under pressure.

Results from case series included within a systematic review showed that between 60% (12/20) and 83% (5/6) of patients survived to transplant or were still alive awaiting transplant on LVAD support. In the active arm of a non-randomised controlled study 78% (32/41) of patients survived for a mean length of 215 days with LVAD support. In another comparative study 81% (13/16) of patients survived to transplant (duration of support not stated). One case series demonstrated that at 30 days of bridging to transplant with an LVAD, survival was 83%, falling to 19% after 24 months of support.

In a non-randomised controlled trial post-transplant survival of patients bridged on LVAD support was 66% (21/32) at 41 months, compared with 67% (98/146) of patients at 36 months who had a transplant without circulatory support. However, patients in the latter group were significantly older. One case series of 243 patients bridged to transplant with an LVAD found actuarial post-transplant survival of 91% at 1 year, 70% at 5 years and 40% at 10 years.

Of the total cases of bridge to recovery reported, 58% (7/12) of patients survived to final follow-up, and 58% (7/12) had the device successfully explanted or were weaned from support. For more details, refer to the sources of evidence (see Appendix).

The Specialist Advisors commented that LVADs may improve quality of life and survival rates in patients with an otherwise fatal condition .

Definitions of infection varied among the studies identified, and rates of infection between 0% (0/10) and 100% (5/5) during LVAD support were reported in series documented in a systematic review. A non-randomised controlled trial noted infection in 8% (1/13) of patients during LVAD bridging, and one case series reported an infection rate of 18% (43/243) of patients.

Cerebral infarction causing stroke was found to have occurred in 21% (55/264) of cases in one series. In a second case series a cerebrovascular accident occurred in 5% (13/243) of patients, and stroke occurred in 5% of patients during support time (mean of 78 days). In a third series a neurological event (not defined) occurred in 8% (1/13) of patients.

Significant haemorrhage occurred in between 10% (1/10) to 30% (6/20) of patients reported in a systematic review, and re-operation because of bleeding was required in 31% (4/13) of patients in one series.

The Specialist Advisors noted adverse events relating to the procedure including bleeding, infection, device malfunction, haemolysis, peripheral ischaemia, and perforation of a ventricle or the aorta. In addition, they noted theoretical complications including device-related thrombosis and device-related strokes.

This guidance refers to patients for whom other treatments including intra-aortic balloon pumping would be ineffective, who are considered eligible for heart transplantation, or who suffer from acute severe heart failure that is likely to be reversible (such as acute myocarditis). It was noted that there are others who might potentially benefit from this procedure, such as patients who cannot be weaned off cardiopulmonary bypass after cardiac surgery, and patients with cardiogenic shock complicating acute myocardial infarction.

It was noted that a number of different devices are available for this procedure and that the technology is evolving rapidly. Some devices include a right-ventricular assist device (biventricular assist devices).The Institute may review this guidance upon publication of further evidence.

It was also noted that implantation of an LVAD may unmask previously subclinical right ventricular dysfunction.

These recommendations exclude short-term circulatory support with left ventricular devices as destination therapy.

NICE has issued a clinical guideline Chronic heart failure: management of chronic heart failure in adults in primary and secondary care (www.nice.org.uk/CG005).

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

• Interventional procedure overviewof left ventricular assist devices for short term circulatory support as a bridge to transplantation or recovery, December 2005

  Available from: www.nice.org.uk/ip059overview