Experts call on NICE to review TAVI guidelines for aortic stenosis

Leading experts have urged the National Institute for Health and Care Excellence (NICE) to review its guidelines on the use of transcatheter aortic valve implantation (TAVI) for aortic stenosis to include intermediate-risk patients.

Speaking at a plenary session of the PCR–London Valves conference, experts delivered a focused summary of the new European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on valvular heart disease (Baumgartner et al, 2017). This included details of how the guidelines have been updated to lower the threshold for intervention with TAVI to patients at intermediate-risk of surgery. Previous guidance stipulated that TAVI should only be considered for those patients with symptomatic aortic stenosis at high risk of surgery (Vahanian et al, 2017).

Dr Helmut Baumgartner, chair of the taskforce for the European Guidelines, has said the new recommendations mark a profound change to the 2012 guidelines. This is largely owing to the number of randomised controlled trials comparing surgical and transcatheter treatments in the last 5 years. These have looked at intermediate- and low-risk patients treat-ed, not just elderly high-risk patients (Leon et al, 2016). He said:

‘There is much controversy right now over who should undergo surgery and who should undergo per-cutaneous valve implantation, and this is an area in which we have profound changes in what we recommend and have consequently dedicated a large part of the guide-lines to the choice of intervention in symptomatic aortic stenosis.

‘We are now recommending that surgical valve replacement remains the first line of therapy in low-risk patients, and low risk should not only be defined by risk scores, because these have several limitations, but by the lack of frailty and other specific risks for surgery not included in risk scores such as porcelain aorta or sequelae of chest radiation. There are numerous issues that need to be considered before we speak of low-risk patients.’

How NICE guidelines differ

An updated version of NICE’s Interventional Procedures Guidelines (IPG), which considers whether procedures are safe and work well enough for wider use in the NHS, was published a month before the ESC/EACTS guidelines (NICE, 2017). At first glance, it appears not to have revised the indication for TAVI beyond the high-risk patient population, unlike the European guidelines. According to a press advisory from Edwards Lifesciences (2017), NICE said additional trials are needed before TAVI could be considered in patients at inter-mediate risk for surgery:

‘Based on current data, TAVI is recommended in patients with severe symptomatic aortic stenosis who are, according to the heart team considered unsuitable for conventional surgery because of severe comorbidities.

Should NICE guidelines change?

Approximately 1.5 million people in the UK over 65 years suffer from heart valve disease with aortic stenosis (d’Arcy et al, 2016). This represents 2–7% of those over 65 years (Spaccarotella et al, 2011) and 13% of those over 75 years (Nkomo et al, 2006). For many cardiologists, it is believed that expanding the use of TAVI would enable more patients in the UK to have access to the minimally-invasive therapy, rather than have to undergo open-heart surgery.

According to Dr Bernard Prendergast, Consultant Cardiologist at Guy’s and St Thomas Hospital and Course Director/Board Member of PCR London Valves, recent evidence increasingly supports the use of TAVI for intermediate-risk patients. Speaking at the PCR–London Valves conference, he said:

‘There is growing evidence in favour of the use of TAVI for the treatment of intermediate-risk patients with severe symptomatic aortic stenosis. This expanded indication in the ESC/EACTS guidelines paves the way for more patients to receive a true alter-native to open-heart surgery.’

As a result, Prendergast emphasised why NICE should update their guidelines to be in line with the rest of Europe:

‘We are calling for NICE to review their recent IPG in light of these new ESC guidelines in order to address current inequalities in treatment across the UK, and between the UK and most of Europe.’

There is concern that the NICE guidelines leave UK patients at a disadvantage in the treatment of aortic stenosis com-pared with the rest of Europe. Currently, the UK performs far fewer aortic valve implantations than Germany, France, Norway and Sweden.

Clearing up misconceptions

It was hoped in light of the new ESC/EACTS guidelines that this disadvantage would change. However, when NICE was asked if they will be looking into revising their guidelines to recommend TAVI for aortic stenosis for intermediate-risk patients for the writing of this article, they clarified that their guidelines have actually already been extended beyond the high-risk population.

In response to the expert calls for revision and the critical comments quoted in this article, a spokesperson from NICE requested a correction, stating:

‘The new guidance gives standard arrangements for TAVI and does not any longer differentiate between different risk groups. The decision as to which patients are suitable is left to risk assessment by clinicians and the MDT [multidisciplinary team].’

References

Baumgartner H, Falk V, Bax JJ et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017;38(36):2739–2791.

d’Arcy JL, Coffey S, Loudon MA et al. Large-scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: The OxVALVE Population Cohort Study. Eur Heart J. 2016;37(47):3515-3522.

Edwards Lifesciences Ltd. Leading Experts Call for Adoption of New ESC/EACTS Guidelines on the Management of Valvular Heart Disease to include Intermediate-Risk Patients in National Protocols [Press Advisory]. Berkshire: Edwards Lifesciences Ltd.

Leon MB, Smith CR, Mack MJ et al. Transcatheter or surgical aortic-valve replacement in intermediate risk patients. N Engl J Med. 2016;374(17):1609-20.

National Institute for Health and Care Excellence. Transcatheter aortic valve implantation for aortic stenosis. Interventional procedures guidance [IPG586]. London: NICE; 2017.

Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart disease: a population-based study. Lancet. 2006;368:1005-11.

Spaccarotella C, Mongiardo A, Indolfi C. Pathophysiology of aortic stenosis and approach to treatment with percutaneous valve implantation. Circ J. 2011;75(1):11-19.

Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. 2012;33(19):2451-96.

Taken from British Journal of Cardiac Nursing, published October 2017.