A new treatment available to combat valvular heart disease could be an opportunity to improve the care provided to those who would previously have been too ill for open heart surgery - and cut mortality rates in patients with the disease. Dr Mark De Belder explains.
Transcatheter Aortic Valve Implantation (TAVI) is a new treatment for patients with valvular heart disease and offers benefits to those previously deemed too ill for open heart surgery. There has been a progressive uptake across the country although access to care remains variable.
The benefits on offer to patients will rely on accurate diagnosis, a change in the previously held view that many elderly patients were too high risk for treatment and appropriate referral to the multidisciplinary teams that are evaluating patients and can offer this treatment.
While much debate is ongoing about the quality of care received by the elderly in the UK, new cardiovascular interventions are offering renewed hope for previously inoperable elderly patients.
One such advance relates to symptomatic aortic stenosis, and in particular, the treatment of patients that are old, often frail, and who may have significant comorbidities. In the past, such patients have been deemed at too high risk for conventional open-heart surgery. However, without such intervention, their prognosis is very poor.
A progressive disease, aortic stenosis is characterised by the narrowing of the aortic valve opening, with extra demands being made on the work of the heart required to eject blood past the narrowed valve. Patients can develop angina, breathlessness or even syncope. Patients find themselves living within their symptoms, decreasing their activity level to adapt to the limitations imposed by such symptoms.
Left untreated, fatigue and shortness of breath can progress to pulmonary hypertension, a full blown syndrome of congestive cardiac failure or sudden death. Half of those with untreated severe aortic stenosis will die within an average of two years after the onset of symptoms.
The gold standard treatment for symptomatic aortic stenosis remains surgical aortic valve replacement. However, despite its potential to lead to a full recovery and a near-normal life expectancy after successful surgery, the demands and risks of open heart surgery can prove too much for many elderly patients with multiple comorbidities. Until recently, such patients have instead been treated with the best medical care of their progressive heart failure and have had no option but to suffer a significantly impaired quality of life until their early demise.
However, a new intervention is available that can be offered to many of the patients who are deemed to be too high risk for the conventional operation. Even those who are becoming frail can be considered for this treatment which can improve both their quantity and quality of life. Interventional cardiologists and cardiothoracic surgeons are working together in teams to provide the treatment, known as transcatheter aortic valve implantation (TAVI). Together with cardiothoracic anaesthetists and cardiologists with expertise in cardiovascular imaging, they have come together to form specialised multidisciplinary teams to assess patients and to offer TAVI when it is felt to be the best treatment option.
The PARTNER Trial confirmed that the prognosis of elderly patients who were deemed inoperable was dire. In comparison, patients randomised to receiving TAVI had a much better chance of survival and a significantly improved quality of life. The death rate from any cause at one year was 20 percentage points lower with TAVI than standard therapy. This is one of the largest treatment effects ever seen in a randomized trial in medicine or surgery. The dramatic improvements in quality of life have been estimated as being roughly equivalent to a ten year reduction in age.
In the UK, national professional societies have worked together with the Department of Health and advisors for commissioners to help introduce this treatment across the country. Much progress has been made although there has been a slower uptake in this country compared with others. Aggregated European data presented at the recent PCR London Valves meeting, 2011, shows that the penetration of TAVI in the UK ranks 13th out of 14 European countries.
Understanding such variation is complex but the work of the various multidisciplinary teams around the country is revealing more and more patients who could be offered this treatment.
Although as a country much progress has been made, access to care is not entirely equitable. Despite existing NICE guidance, the frequency of commissioning varies considerably across the country. Some hospitals have been providing the treatment without receiving the necessary funding. In Scotland, none of the heart centres have been given approval to set up a service although some treatments are being commissioned from centres in England.
Although the evidence for providing TAVI to patients deemed inoperable is clear, attention has turned to see whether it should also be considered for patients who are currently eligible for open heart surgery, but who are at the higher end of the acceptable spectrum of surgical risk. Early results are showing that many of these patients may fare better with TAVI.
A UK registry of all patients undergoing this procedure shows results equivalent to those seen in the trials, suggesting that the multidisciplinary teams are making the appropriate judgements to select those best suited to TAVI and those best suited to open heart surgery. The hope now is that NICE will declare this to be a procedure that can be undertaken with normal arrangements for clinical governance, consent and audit. Hopefully, local commissioning will follow. Ensuring regional equity of access across the UK is a matter of priority not only for the current commissioners but also for the new National Commissioning Board.