Specialised Services Policy: CP58. Transcatheter Aortic Valve Implantation (TAVI) for Severe Symptomatic Aortic Stenosis (SSAS)

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1 Specialised Services Policy: CP58 Transcatheter Aortic Valve Implantation (TAVI) for Severe Document Author: Specialised Planner for Cardiothoracic Services Executive Lead: Director of Finance Approved by: Management Group Issue Date: 8 th November 2012 Review Date: July 2014 Document No: CP58 Page 1 of 13

2 Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: /10/12 ICD 10 codes updated 1.1 Date of next revision July 2014 Consultation Name Date of Issue Version Number Criteria developed through cardiac services review in 2011 and first approved by Joint Committee in April April 2011 Approvals Name Date of Issue Version No. Criteria approved by Joint Committee on 26 th June th June 2012 Report to Joint Committee Management Group 8 th November Distribution this document has been distributed to Name By Date of Issue Version No. Page 2 of 13

3 Policy Statement Background Transaortic Valve Implantation (TAVI) is a treatment for severe symptomatic aortic stenosis (SSAS). Aortic stenosis causes impaired outflow of blood from the heart and is usually progressive, leading to heart failure. TAVI aims to provide a less invasive alternative to open cardiac surgery for the treatment of aortic stenosis, avoiding the need for cardiopulmonary bypass (NICE IPG 421). TAVI may be appropriate for patients in whom the risks of surgery are considered to outweigh the benefits. Summary of clinical criteria Patients with severe symptomatic aortic stenosis should be considered for TAVI if all the following are present: TAVI is considered as a substitution for surgery (patients have been referred for surgery in the first instance) the patient has a logistic Euroscore > 20 or a Society of Thoracic Surgeons score > 10 the patient is considered to have a life expectancy of at least 12 months the TAVI MDT considers that the balance of risks and benefits favour TAVI over open surgery A specific exception is the case of patients who are not suitable for surgery for technical reasons (e.g severely calcified or porcelain aorta) who may be considered for TAVI even where their Euroscore is less than 20. Responsibilities All referrals should be considered by the TAVI MDT. The selection of patients for TAVI should be consistent with the criteria set out in this policy. Only patients considered by the TAVI MDT and who meet the criteria for TAVI in this policy will be funded by WHSSC. Details of all patients who undergo a TAVI procedure should be entered into the UK Central Cardiac Audit Database. Page 3 of 13

4 Suitable patients should be considered for entry to the UK TAVI trial. Where patients do not meet these criteria but the MDT believes the balance of risk favours TAVI over surgery, an application for funding on the grounds of exceptionality may be made via the IPFR process. Page 4 of 13

5 Table of Contents 1. Aim Introduction Relationship with other Policy and Service Specifications Scope Definition Codes Access Criteria Clinical Indications Criteria for Treatment Referral Pathway Exclusions Putting Things Right: Raising a Concern 6. Equality Impact and Assessment Annex 1 Referral Pathway Page 5 of 13

6 1. Aim 1.1 Introduction The document has been developed as the policy for the planning of Transaortic Valve Implantation (TAVI) for Welsh patients. The purpose of this document is to: clearly set out the circumstances under which patients will be able to access TAVI; clarify the referral process; and define the criteria that patients must meet in order to be referred. 1.2 Relationship with other Policy and Service Specifications. This document should be read in conjunction with the following documents: All Wales Policy for Making Decisions on Individual Patient Funding Requests Page 6 of 13

7 2. Scope 1. Purpose 2.1 Definition Aortic stenosis causes impaired outflow of blood from the heart and is usually progressive. The increased cardiac workload leads to left ventricular hypertrophy and heart failure. Symptoms of aortic stenosis typically include shortness of breath and chest pain on exertion. TAVI involves the implantation via a catheter of a prosthetic valve within the diseased aortic valve. TAVI may be carried out with the patient under general anaesthesia or using local anaesthesia with sedation. Access to the aortic valve may be transluminal, through a large artery (usually the femoral or subclavian artery; percutaneous or endovascular approach), or surgical, via a minithoracotomy with apical puncture of the left ventricle (transapical approach). (Source: NICE IPG 421). 2.2 Codes ICD-10 Codes Code Code Description Category ICD-10 I35.0 Aortic (valve stenosis) National OPCS codes are yet to be assigned for TAVI. Individual hospitals will use local codes for this activity. Page 7 of 13

8 3. Access Criteria 3.1 Clinical Indications TAVI is a treatment approach for patients with severe symptomatic aortic stenosis (SSAS) who are considered high surgical risks. 3.2 Criteria for Treatment Patients with severe symptomatic aortic stenosis should be considered for TAVI if: TAVI is considered as a substitution for surgery (patients have been referred for surgery in the first instance) the patient has a logistic Euroscore > 20 or a Society of Thoracic Surgeons score > 10 the patient is considered to have a life expectancy of at least 12 months the TAVI MDT considers that the balance of risks and benefits favour TAVI over open surgery A specific exception are patients who cannot be offered surgical AVR for technical reasons (such as patients with porcelain (severely calcified) aorta) who may be considered for TAVI even where their Euroscore is less than 20. Where patients do not meet these criteria but the MDT believes the balance of risk favours TAVI over surgery, an application for funding on the grounds of exceptionality may be made via the IPFR process (see section 3.5). 3.3 Referral Pathway All referrals for TAVI should be considered by an appropriately constituted MDT. South Wales TAVI is provided for South Wales from 2 centres: Morriston Hospital, Abertawe Bro Morgannwg UHB, and the University Hospital of Wales, Cardiff & Vale UHB. All referrals for patients in South Page 8 of 13

9 Wales with severe symptomatic aortic stenosis who are considered high risk for surgical AVR should be made to the joint South Wales TAVI MDT. Patients who meet the criteria in this policy and who are considered by the MDT to be suitable for TAVI, should be referred to the appropriate TAVI centre. North Wales Patients from North Wales who may be appropriate for TAVI should be referred to the TAVI MDT at Liverpool Heart and Chest Hospital. 3.4 Exclusions TAVI should not be considered in circumstances where any of the following are present: the patient is a low or moderate surgical risk the patient has a preference for TAVI but does not meet the criteria in section 3.2 the patient has a life expectancy of less than 12 months 3.5 Exceptions If the patient does not meet the criteria for treatment, but the referring clinician believes that there are exceptional grounds for treatment, an Individual Patient Funding Request (IPFR) can be made to WHSSC under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). If the patient wishes to be referred to a provider out of the agreed pathway and the referring clinician believes that there are exceptional grounds for treatment at an alternative provider, an Individual Patient Funding Request (IPFR) can be made to WHSSC under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). Guidance on the IPFR process is available at Page 9 of 13

10 3.6 Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy Refer via the agreed pathway Clinician considering treatment should: Discuss all the alternative treatment with the patient Advise the patient of any side effect and risks of the potential treatment Inform the patient that treatment is not routinely funded outside of the criteria in the policy. Confirm that there is contractual agreement with WHSSC for the treatment In all other circumstances submit an IPFR request. Page 10 of 13

11 4. Checklist The following checklist should be completed and retained as evidence of policy compliance by the receiving centre. It is expected that this evidence will be provided at the point of invoicing by the receiving centre. Please tick the appropriate boxes: Patient NHS No: Patient is Welsh Resident Patient is English Resident registered with NHS Wales GP Post Code GP Code: Patient meets following access criteria for treatment: Yes No Criteria a TAVI is considered as a substitution for surgery (patients have been referred for surgery in the first instance) AND Criteria b The patient has a logistic Euroscore > 20 or a Society of Thoracic Surgeons score > 10 AND Criteria c The patient is considered to have a life expectancy of at least 12 months AND Criteria d The TAVI MDT considers that the balance of risks and benefits favour TAVI over open surgery AND Criteria e TAVI should not be considered in circumstances where any of the following are present: the patient is a low or moderate surgical risk the patient has a preference for TAVI but does not meet the criteria in section 3.2 the patient has a life expectancy of less than 12 months Patient wishes to be referred to non-contracted provider If the patient wishes to be referred to a non-contracted provider an Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided on the basis of exceptionality. The form can be found at Patient does not meet access criteria but is exceptional An Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided as an exception. The form can be found at Name: Designation: Signature: Date: Page 11 of 13

12 5. Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment provided. The patient or their representative should be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision, of the gatekeeper, that the patient does not meet the criteria for treatment and that the patient is not an exceptional case, the patient and/or their representative has a right to ask for this decision to be reviewed. The review should be undertaken, by the patient's Local Health Board, in line with section 7 of the All Wales Policy: Making Decisions on Individual Patient Funding Requests; When a patient or their representative is unhappy with the care provided during the treatment or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure with a copy of the concern being sent to WHSSC. 6. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). This policy has been subjected to an Equality Impact Assessment. The Assessment has shown that there will be a positive impact on disability equality strand but a negative impact on the human rights equality strand. Page 12 of 13

13 Annex (i) Referral Pathway Cardiology Cardiac surgery (Is the patient suitable for surgery but high risk?) No surgery or medical mgt Yes Joint TAVI MDT (S.Wales) LHCH TAVI MDT (N.Wales) TAVI Surgery Medical mgt Page 13 of 13

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