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NHS England position statement
January 2023 Version 1.2
1. NHS England (NHSE) has a published policy for TAVI, for eligible patients defined as high surgical risk. TAVI may provide an alternative to standard surgical aortic valve replacement (SAVR) for eligible patients at intermediate and low surgical (SAVR) risk who meet the inclusion criteria outlined in this position statement. This interim position and inclusion of intermediate and low surgical risk patients aims to alleviate the pressures on local systems in supporting elective performance and is dependent on the ability and capacity of systems to deliver either option.
2. TAVI is known to have resource benefits. It can be performed in a catheterisation laboratory without general anaesthesia, rather than in an operating theatre. It is also associated with lower requirements for Intensive Care Unit (ICU) support and a reduced mean length of hospital stay (around 3 days) compared with surgery (around 7 days).
3. In the context of elective performance, TAVI may offer an appropriate alternative to cardiac surgery in selected patients. Decision-making by the aortic valve multi-disciplinary meeting (MDM) should govern patient selection, valve and device type and associated complication profiles. The Blueteq prior approval form for TAVI has been amended and simplified, and providers are reminded of the need to complete this form prior to intervention.
4. Local systems should review their capacity and ability to implement TAVI against cardiovascular waiting times and authorise the use of this position statement as part of the elective care recovery response. Patients who should have surgery (as decided by the aortic valve multi-disciplinary meeting (MDM)) could be offered surgery at another centre if it cannot be performed locally in a timely fashion (dependent on mutual aid discussions and patient choice).
5. The clinical eligibility and exclusion criteria for the use of TAVI can be found in annex A.
6. This position statement will take effect from the date of publication and will be reviewed annually, as a minimum, taking into account the extent to which system capacity has recovered to pre-pandemic activity levels. It is anticipated that at the appropriate point, this interim commissioning statement will be revoked, and the clinical commissioning published policy for TAVI will be reinstated.
7. The National Institute for Health and Care Excellence (NICE) has published guidance on the investigation and management of heart valve disease in adults (NG208). The implementation strategy for TAVI, highlights that TAVI is clinically effective but not currently cost effective for patients defined as intermediate or low risk for cardiac surgery for aortic valve disease.
8. The heart has four valves which, when they work correctly, ensure the one-way flow of blood between the different chambers of the heart and from the heart to the arteries. The aortic valve maintains the flow of blood from the left ventricle (the muscular lower pumping chamber of the heart) into the aorta (the main blood vessel that supplies blood to the rest of the body).
9. Aortic stenosis is the narrowing and hardening of the aortic valve which restricts its ability to open and close. Most commonly, this is due to age-related changes of the valve and the narrowing of the aortic valve usually gets worse over time. Aortic stenosis causes the left ventricle to work harder to pump blood through the narrowed valve and into the aorta. As with any muscle, this increased workload may cause the left ventricular muscle to thicken. It may also cause the muscle to work less effectively and this can result in heart failure.
10. People with aortic stenosis initially have no symptoms. As the stenosis becomes more severe, they may still have no symptoms or they may develop symptoms of breathlessness, chest pain, or fainting on exertion. Once symptoms develop, the condition has a high mortality rate without treatment.
Shared decision-making responsibilities
11. Joint decision-making by the aortic valve MDM should govern patient selection, valve and device type and associated complication profiles. The core members of the aortic valve MDM should include a cardiac surgeon with aortic valve expertise, an imaging cardiologist with structural intervention echocardiography skills, a trans-catheter heart valve/structural heart interventionist and allied health professionals such as specialist nurses (Archbold 2022). Access to cardiac anaesthetists, elderly care input and comprehensive geriatric assessment should be available to support decision making and patient selection by the aortic valve MDM.
12. All patients being considered for TAVI should have documented evidence of formal shared decision making with the patient.
13. Every centre undertaking cardiac surgery and each individual cardiac surgeon must be registered with, and submit data to, the Society of Cardiothoracic Surgeons National Adult Cardiac Surgery Database to support quality improvement and quality assurance in addition to the public reporting of patient outcomes.
14. Every centre performing TAVI must be registered for the purposes of provision of procedural data with NICOR (National Institute for Cardiovascular Outcomes Research), providing details of a clinical lead and data manager contact at that centre. Every case of TAVI should be submitted to the NICOR UK TAVI Registry in line with data set requirements.
15. There are no medicines that can treat aortic stenosis, although some medicines can help to alleviate symptoms. If a patient develops symptoms the only effective option to relieve the stenosis is to replace the aortic valve. There are currently two main options for treatment: either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). Both procedures are available in England and are conducted in cardiac surgery centres.
16. SAVR is a major operation that is performed under a general anaesthetic. An incision is made into the chest wall, usually through the breastbone, to gain access to the heart, aorta and aortic valve. A heart and lung bypass machine is used, so that the blood pumping function of the heart is taken over by the machine while the valve is replaced. TAVI is a less invasive method that can be performed under a local anaesthetic and uses a tube that is inserted into a large blood vessel in the groin to deliver the valve to the heart. The new valve is carried up through the tube and installed in place of the old valve.
17. Promoting equality and addressing health inequalities are at the heart of NHS England’s values. Throughout the development of the policies and processes cited in this document, we have:
- Given due regard to the need to eliminate discrimination, harassment and victimisation, to advance equality of opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited under the Equality Act 2010) and those who do not share it; and
- Given regard to the need to reduce inequalities between patients in access to, and outcomes from, healthcare services and to ensure services are provided in an integrated way where this might reduce health inequalities.
Recommendations for data collection
18. A minimal clinical dataset will be collected at baseline and at 12 months using the prior approval form that accompanies this position statement.
Clinical outcome reporting
19. As outlined in the safety reporting, clinical outcomes will be aligned to the outcome measures recorded from the Society of Cardiothoracic Surgeons National Adult Cardiac Surgery Database and the NICOR UK TAVI Registry.
Annex A: Patient eligibility and exclusion criteria
20. It is important to note that the eligibility criteria within this position statement differs from that included within the published policy for TAVI to include provision for low and medium surgical risk patients. The published policy states that:
- TAVI should be reserved for patients who have been considered by a multidisciplinary team (including 2 surgeons and 2 interventional cardiologists) who consider the risk/benefit ratio of open heart surgery and TAVI to favour TAVI.
- The usual “high risk” patient will have a logistic Euroscore of >20 or an STS score of >10.
- In general TAVI should be performed for symptomatic severe degenerative aortic stenosis. Under exceptional circumstances and after full discussion within a multidisciplinary team, other forms of aortic valve disease such as a failing aortic bio-prosthesis may be treated.
21. Patients must meet all the following inclusion criteria to be eligible for TAVI:
21.1 Patients with severe aortic valve stenosis confirmed by transthoracic echocardiography meeting the following criteria:
- Aortic valve area ≤1.0cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR
- Mean gradient ≥40mmHg, OR
- Maximal aortic valve velocity ≥4.0ms-1.
i) Patients must be symptomatic (breathlessness with New York Heart Association (NYHA) Functional Class ≥2, or exertional chest pain, or pre-syncope or syncope) from the aortic valve stenosis.
ii) The patient has been discussed at, and a formal documented decision made by an appropriately constituted, quorate, aortic valve MDM (defined above), guided by the clinical and anatomical features of the patient in conjunction with estimated surgical risk of in-hospital patient mortality.
ii) Risk scores such as Society of Thoracic Surgery Predictor of Mortality (STS-PROM) or European System for Cardiac Operative Risk Evaluation (EuroSCORE II) should be used but account also needs to be taken of factors that may not be captured in the risk scores:
- Extreme or high risk for SAVR is defined as an estimated surgical risk of in-hospital mortality ≥8%, this includes patients considered inoperable
- Intermediate risk for SAVR is defined as an estimated surgical risk of in-hospital mortality of 4-8%
- Low risk for SAVR is defined as an estimated surgical risk of in-hospital mortality of ≤4%. Patients in this group could be considered for TAVI where patient anatomy is favourable, and the patient is:
- Age ≥ 80 years
- Age ≥ 70 years with comorbidities which could influence recovery
22. The exclusion criteria are outlined below:
- Where comorbidity, frailty or life expectancy from non-cardiovascular causes makes intervention inappropriate (futility or life expectancy is less than one year)
- Individuals determined not to be suitable for TAVI approach determined by MDM assessment.