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SPECIAL FOCUS ON LVADS
Brave new world
Dr Steven Tsui asks for a wider understanding of options open to end-stage heart failure patients and weights the risks and benefits of using ventricular assist devices

Monday 1 pm. VAD and heart failure conference. I interrupt my operating list to join the weekly multi-disciplinary team discussion of patients on our mechanical circulatory support programme.
 The first patient is Janet, a 34-year-old mother of two, who has been suffering from heart failure for over a year. She has been waiting for a heart transplant, but was brought into hospital because she was struggling at home with lung congestion. Initially, she responded well to treatment, but after five days in hospital, her circulation deteriorated and her organs began to shut down. Janet was dying. She was in desperate need of a new heart, but none was immediately available. She was taken to the operating room that night and emerged six hours later with a left ventricular assist device (LVAD) surgically attached to her failing heart. That was three weeks ago and Janet has made a good recovery from the operation. With the LVAD pumping more blood around her body than her failing heart was, she is now feeling better than she has done for months. Her LVAD can probably last a year or more, long enough for us to find her a suitable donor heart. Tomorrow she will be able to go home to her family and wait for her heart transplant.

The next patient is Ronald, a 69-year-old retired lecturer. His heart was very badly damaged by three successive heart attacks over the last five years. He has been told that he cannot have a heart transplant because his kidneys are not very good. During this year alone, he has been admitted to hospital four times with worsening heart failure. Ronald has a limited quality of life and knows that unless something can be done, he will die soon. He has heard that we are considering using LVADs as a definitive treatment for people like him and he is desperate to try anything. Unfortunately, we have to tell him that there is no funding for using LVADs as long-term treatment at present, but will keep him in mind should it become available.

End-stage heart failure is characterised by debilitating symptoms on minimal exertion despite optimal medical therapy. Recurrent exacerbations require hospital admissions, but decline is inevitable in most cases and life expectancy is limited. Heart failure is currently one of the commonest killers in the United Kingdom, second only to coronary heart disease. Its incidence is increasing exponentially across all Western countries. The economic and public health burdens of end-stage heart failure are well described.

Heart transplantation was successfully introduced to the UK in 1979. It remains the gold standard for treating end-stage heart failure that is refractory to medical therapy, affording quality life extensions. However, the shortage of donor hearts has restricted this effective treatment to selected patients only. Furthermore, many patients deteriorate and die before a suitable donor heart becomes available.

Bridging to transplantation with VADs has been available in the UK for the last 10 years. Approximately 150 patients have undergone this treatment with variable success. In experienced hands, survival rates can be as high as 70 to 75 per cent. However, it became clear that deploying VADs successfully in very sick patients is a demanding business. It is labour-intensive for the doctors involved and resource-intensive for the National Health Service. Serious adverse events associated with the use of these devices are not uncommon and are at times fatal. As a result, most experts reserve the use of VADs as a last resort for patients when all other options have been exhausted.

In order to achieve the best possible results from this highly complex, high-cost treatment, it seemed appropriate to concentrate the expertise in a small number of specialist centres. In 2002, the National Specialist Commissioning Advisory Group (NSCAG) formally commissioned a programme of bridge-to-transplant in the UK at three designated centres: the Freeman Hospital, Newcastle Upon Tyne; Harefield Hospital, London and Papworth Hospital, Cambridge. Altogether, approximately 25 patients per year receive VAD treatment at these three centres. At the same time, a prospective audit was initiated by the Health Technology Assessment (HTA) division of the NHS to evaluate this bridge-to-transplant programme. Data is being collected on survival, quality of life, adverse events and resource use. This evaluation is on-going and a report is expected by mid-2005.

As waiting times for heart transplant increases, many patients being bridged to transplant are living with their VADs for progressively longer periods. Most report a reasonably good quality of life during VAD support and a few patients have even been able to return to work. This longer-term experience has opened up the possibility of using VADs as a definitive treatment for heart failure patients who are not heart transplant candidates. Based on the results of a clinical trial that confirmed a modest extension to life expectancy, reimbursement agencies in the USA approved funding for this treatment in July 2003. Discussions are now underway in the UK to consider the evidence and cost-effectiveness of using VADs as long-term treatment for end-stage heart failure.

So, is the NHS doing everything that should be done for patients with severe heart failure? Regrettably, no. The truth is that there is a serious lack of awareness within the medical profession about what can be done for these patients. Readers of this article already know more about this subject than the majority of doctors in the UK. Sadly, many patients like Janet simply languish in their local hospital until it is far too late. Some die before they can be transferred for treatment, whilst many more are probably not even referred. As a result, the VAD bridge-to-transplant service in the UK is presently under-utilised.

There is an urgent need to set up a clinical heart failure network across the UK, in order for patients with severe heart failure to be able to access these advanced treatments in a more consistent and timely manner. Doctors working in general practice and at local hospitals need to appreciate that patients with advanced heart failure can often benefit from the expertise of specialist regional heart failure centres, which should be equipped to assess and optimise most of these patients. Those patients who are too far down the road should be immediately referred to one of the tertiary centres that are designated for heart transplant and/or VAD therapy.

If VADs can save lives, why not let more hospitals have access to this type of technology to help more patients?

It is apparent that there is a steep learning curve for doctors as well as institutions in the application of VADs. Unsuccessful VAD therapy results in death from multi-organ failure and is costly for the NHS. For a team to acquire and maintain the skills necessary to apply this technology successfully, and for a hospital to sustain the infrastructure that is essential for providing such a service, a minimum volume of activity is required. Formal training must become mandatory, standards must be defined and outcomes must be monitored and audited before wider dissemination of this technology is considered.

What about putting VADs in non-transplant candidates like Ronald? A research study in the USA has shown that a VAD could double his chances of being alive at one year from 25 per cent to 50 per cent. Some critics of this report have argued that the high treatment cost of VADs cannot be justified for such a modest gain in life expectancy. This may be so when we look at a population at large. However, for an individual patient like Ronald whose time is running out, this is plenty good enough for him.


Steven Tsui is a consultant cardiac surgeon and clinical lead for mechanical circulatory support at Papworth Hospital, Cambridge
 
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