Inappropriate restrictions on life saving technology in the UK

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Stephen Westaby and David Taggart, Department of Cardiothoracic Surgery, John Radcliffe Hospital, Oxford, UK, published an editorial in Heart (Heart 2012;98:1117-1119) criticising the fact that the National Health Service (NHS) does not fund circulatory support equipment to treat cardiogenic shock in the majority of cardiac tertiary centres.

 

According to the paper, this affects 2% of 40,000 cardiac surgical patients who fail to separate from cardiopulmonary bypass and around 5% of 25,000 myocardial infarction patients who progress to cardiogenic shock.

“These disparate groups suffer ischaemia followed by reperfusion injury, then lethal but potentially recoverable myocardial stunning. Young patients with myocarditis or postpartum cardiomyopathy may experience a similar fate through an inflammatory process. Chronic heart failure patients suffer bouts of decompensation from which they can be rescued. At a conservative estimate these categories account for between 2,000 and 3,000 patients per annum in the UK,” the authors wrote.

In the editorial, Westaby and Taggart noted that, though supported by American and European guidelines, an intra-aortic balloon pump does not significantly increase cardiac output and that several studies have failed to show reduction in infarct size or survival benefit in established cardiogenic shock.

“In virtually, all European countries and the USA have a range of circulatory support devices that are utilised routinely for shock patients in cardiac centres. These range from short-term pumps deployed in the catheter laboratory to the surgically implanted permanent artificial hearts whose price tag exceeds that of a Porsche car,” the authors said. “The less expensive temporary devices are used for rescue from cardiogenic shock and the implantable pumps to gain years of life after organ dysfunction resolves. New extracorporeal membrane oxygenator [ECMO] systems can be inserted percutaneously during cardiopulmonary resuscitation in any part of the hospital and used to stabilise the patient during transportation to a tertiary care cardiac facility. The goal of ‘bridge to decision’ circulatory support is to provide rapid resuscitation for shock patients who have reasonable potential for full recovery. A blood pump then sustains the patient pending functional recovery, cardiac transplantation or implantation of a long-term LVAD [left ventricular assist device]. Recent information shows that even the over 70s have satisfactory quality of life and survival benefit with the implantable rotary blood pumps.”

The authors report that in 2006 the National Institute for Health and Clinical Excellence (NICE) published guidance on temporary circulatory support, concluding: “Limited evidence on the safety and efficacy of short-term circulatory support with LVADs 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”. The authors stated that, if LVADs had been made available in UK cardiac surgical centres since the NICE guidelines, at least 5,000 lives could have been saved in five years.

“While transplantation is in decline, new evidence supports the use of circulatory support pending functional recovery or as a bridge to a long-term LVAD. Nevertheless the National Specialist Commissioning Group fund devices only in a few centres, intentionally constraining their use to transplant candidates or respiratory extra corporeal membrane oxygenation patients. […] We believe that provision of this simple intervention remains inadequate and that the Commissioning Group’s standpoint that only specialised centres can manage extra corporeal membrane oxygenation is inaccurate and inappropriate.”

Westaby and Taggart noted that the NHS continues to withhold circulatory support equipment from most tertiary cardiac centres, even those who perform surgery on infants and children. “This is incomprehensible when more than half of patients who die after cardiac surgery or post-infarction shock could survive with appropriate treatment. Furthermore, it is potentially punitive to individual surgeons in a system which publishes their mortality rates,” they wrote.

Intra-aortic balloon pump must no longer be regarded as the ‘ceiling’ for shock treatment in contemporary UK practice, Westaby and Taggart said.

“If the UK is to meet the aspirations of ‘world class healthcare outcomes’ proposed in the recent White Paper, ‘Equity and excellence: liberating the NHS’, then systems of care must keep pace with advances in technology. All tertiary cardiac centres must have the capacity to deal with cardiogenic shock and have access to the necessary equipment. Towards this goal, a UK bioengineering group is working to develop more affordable circulatory support devices. Meanwhile the nationwide project to provide primary percutaneous angioplasty networks for myocardial infarction should now establish appropriate ‘hub and spoke’ shock centres in cardiac surgical units. In 2008, the cost to the NHS of providing terminal care to cancer patients (27% of the 470,000 annual UK deaths) was £1.8 billion. A tiny fraction of this outgoing could restore normal life to many of the patients who die annually from acute heart failure,” they wrote.

Westaby told Cardiovascular News: “Busy tertiary cardiac centres, particularly those in hospitals with a regional trauma centre, see numerous patients who could benefit from rescue ECMO. These range from out of hospital cardiac arrest patients who develop acute heart failure, those who undergo primary angioplasty for myocardial infarction, drownings and patients with acute lung injury. Many are young and too unstable for transfer, and the UK does not have a comprehensive system for this. The European Societies of Cardiology and Cardiothoracic Surgery guidelines advocate ECMO for patients with myocardial infarction or myocarditis who develop cardiogenic shock. The equipment is simple to use and outcomes continue to improve. There can be no logical clinical reason to limit this relatively inexpensive lifesaving resource.”

Within a week of publishing the editorial in Heart the Oxford team were faced with a 20-year-old student with an ion channelopathy and idiopathic ventricular fibrillation who was resuscitated by paramedics. After 70 DC shocks and substantial beta blockade the patient developed acute biventricular failure and required ECMO. There was no option for safe inter-hospital transfer nor time to arrange this. Because her pupils remained briskly reactive at this stage, an ECMO system was requested but took six hours to arrive. Despite very effective ECMO support and recovery of hepato-renal function the patient suffered cerebral hypoxia and oedema before the system arrived and did not survive. As a result of ECMO organs apart from the heart were preserved and used for transplantation. Westaby said, “This is a recurrent problem. Without funding, team training and equipment in the hospital we are not in a position to save these patients. Whilst surgeons and hospitals are judged on their outcomes, it is a moral and ethical dilemma to withhold this equipment”. 

Westaby’s team are not beginners with circulatory support. They achieved the longest surviving LVAD patient (7.5 years) using a Jarvik 2000 Heart. They performed the UK’s first bridge to recovery in viral myocarditis and first bridge to transplant in a child using the Berlin Heart both in 1998. These patients are both alive and well 14 years later. 

 

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