Download Transcatheter Aortic Valve Implantation Workshop Report

DLA Piper Australia
140 William Street
Melbourne VIC 3000
PO Box 4301
Melbourne VIC 3000
Australia
DX147 Melbourne
T +61 3 9274 5000
F +61 3 9274 5111
W www.dlapiper.com
Health Policy Advisory Committee on Technology Transcatheter Aortic Valve Implantation Workshop Workshop Report June 2013 DLA Piper Australia is part of DLA
Piper, a global law firm, operating
through various separate and distinct
legal entities.
A list of offices and regulatory
information can be found at
www.dlapiper.com
HEALTHPACT ADVISORY The Health Policy Advisory Committee on Technology (HealthPACT) is the national committee for the horizon scanning of new and emerging technologies. HealthPACT provides jurisdictions with evidence‐based advice on emerging technologies. This information is used to inform jurisdictional financing decisions and to assist in the managed introduction of new medical technologies. HealthPACT is a sub‐committee of the Australian Health Ministers’ Advisory Council, reporting through its Hospitals Principal Committee. HealthPACT comprises representatives from all Australian State and Territory health departments, the Australian Department of Health and Ageing, the Medical Services Advisory Committee, the Therapeutic Goods Administration (TGA), the Department of Veterans’ Affairs (DVA) and the New Zealand National Health Committee. In terms of burden of disease in Australia, cardio‐vascular disease is second only to cancer; however, cardiac treatments make it the most costly. To address the concerns of jurisdictions, including New Zealand, in regard to how best to manage the burgeoning costs associated with the treatment of cardio‐vascular disease, HealthPACT commissioned an evidence‐based report on new and emerging cardiac devices in 2012. In addition, on 14 February 2013, HealthPACT convened a workshop with clinicians, health service managers, industry bodies, academics and policymakers to discuss the national and international experience and outcomes on transcatheter aortic valve implantation (TAVI). To date, a TAVI device has yet to be included on the Australian Register of Therapeutic Goods (ARTG). As a result, use of these devices in Australia is currently confined to specific avenues that allow lawful supply of these devices in specific circumstances, such as a clinical trial. Data to support safety and performance of these devices for their intended purpose vary in quality and extent for each specific TAVI device, but there are both clinical trial and registry data for some. In Australia, in view of the lack of TGA approval, this high‐cost technology ($25‐30,000 for the device alone) is only available through three avenues: 
the Commonwealth’s Special Access Scheme, where the importation of an unapproved therapeutic good is assessed on a case‐by‐case basis for 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment'; 
via importation for personal use; or 
under the auspices of a clinical trial. Despite the absence of TGA approval, TAVI devices have rapidly diffused throughout the health care sector, becoming established clinical practice at some sites. It should be noted that the optimal target population for this technology has not been established. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013 i Widespread, uncontrolled use of a high‐cost and novel technology such as TAVI raises significant concerns for the jurisdictions in respect to the safety and effectiveness of the device, in addition to the budgetary impact and affordability of the technology. In addition, there appears to be a disconnect in the governance surrounding Human Research Ethics Committee (HREC) decisions regarding the implantation of TAVI, with a need for a coordinated approach to the governance, and implementation of, HREC decisions. HealthPACT noted that the majority of patients with aortic stenosis are suitable candidates for cardiac surgery, which remains the gold standard of care for these patients and is of the order of half the cost of TAVI. The cost‐effectiveness of TAVI in Australasian health care settings is yet to be evaluated. Current available international literature suggests that TAVI is potentially a cost‐effective treatment for patients with severe aortic stenosis who are inoperable, but may not be cost‐
effective for patients with severe aortic stenosis who are high surgical risk, although it appears to be safe and effective in this cohort. However, doubt remains about the durability of effect. Caution is advised regarding the interpretation of international literature reporting the cost‐
effectiveness of TAVI until such time as an independent clinical expert committee, such as the Medical Services Advisory Committee in Australia and the National Health Committee in New Zealand, have evaluated cost‐effectiveness of TAVI within the context of specific patient cohorts and the Australian and New Zealand health care systems. HealthPACT has collated information from the jurisdictions, including New Zealand, on the number of TAVI procedures performed in recent years. This reveals considerable variation in the usage of these devices between the jurisdictions. Some centres perform only a low volume of procedures, which has implications for the maintenance of quality and safety, and also training. There does appear to be a ‘learning curve’ for operators and the data indicates a reduction in complication rates (such as pacemaker insertion) with greater experience. HealthPACT noted the presentations given by attendees during the workshop and appreciated the time participants gave in attending the forum. HealthPACT acknowledged that further consultation with clinicians involved in all aspects of the clinical care pathway of patients with aortic stenosis would benefit the decision‐making processes for the future. The formation of multi‐disciplinary heart teams would include clinicians involved in all aspects of the care pathway and these teams would be responsible for the selection of suitable candidates for TAVI. HealthPACT does not support the use of TAVI in the Australian or the New Zealand setting outside of properly conducted clinical trials until such devices are included on the ARTG. However, HealthPACT recognises that implementation of TAVI is of significance to the Australian community, in terms of patient care and cost, that consideration should be given to the managed introduction on the basis of an Australian/New Zealand coordinated clinical trial at selected sites. In the interim all outcomes must be carefully monitored using an appropriate data registry. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013 ii
HealthPACT recommends, given the current available clinical and cost effectiveness evidence for TAVI, the fact that TAVI devices are not registered on the ARTG and that the role of TAVI in various cardiac cohorts remains to be proven, and indeed the lack of testing to the longevity of the device, that jurisdictions: i) put in place measures to prevent uncontrolled dissemination; and ii) review this position following the outcome of any respective regulatory consideration of TAVI. HealthPACT notes the actions proposed by workshop attendees, including: 
joint development, by the Cardiac Society of Australia and New Zealand and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons, of patient referral and selection criteria, including articulation of criteria for patients deemed suitable for TAVI and to be cared for by a multi‐disciplinary heart team; and 
development of an Australian/New Zealand TAVI Registry (ANZTAVIR) as a means of tracking procedure numbers and, more importantly, short and long‐term outcomes. This report will be provided to the Hospitals Principal Committee and the Australian Health Ministers Advisory Council as part of HealthPACT’s reporting responsibilities and advice in regard to these matters. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013 iii
CONTENTS EXECUTIVE SUMMARY ............................................................................................................................ 1 BACKGROUND ......................................................................................................................................... 3 The purpose of this report ......................................................................................................... 3 The pre‐workshop background paper ....................................................................................... 3 WELCOME BY THE CHAIR OF HEALTHPACT ............................................................................................ 4 WORKSHOP PRESENTATIONS ................................................................................................................. 4 Industry perspectives on TAVI ................................................................................................... 4 TAVI experience in Australia ...................................................................................................... 5 TAVI funding and regulation ...................................................................................................... 6 What do policy makers and funders need to know about TAVI ................................................ 8 TAVI program establishment ..................................................................................................... 8 GROUP DISCUSSIONS .............................................................................................................................. 9 TAVI program components ...................................................................................................... 10 Clinical governance .................................................................................................................. 11 Patient and referral criteria ..................................................................................................... 12 An Australian/ New Zealand TAVI registry............................................................................... 13 Bi‐national training program.................................................................................................... 14 PRIORITY ACTIONS ARISING FROM THE WORKSHOP ........................................................................... 14 WORKSHOP CONCLUSION .................................................................................................................... 15 APPENDIX 1: WORKSHOP AGENDA....................................................................................................... 16 APPENDIX 2: DISCUSSION PAPER EXTRACT .......................................................................................... 18 HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013 iv
EXECUTIVE SUMMARY Transcatheter aortic valve implantation (TAVI) is a cardiac technology with significant potential to influence the management of patients with both inoperable and operable aortic valve disease and to impact significantly on health budgets. TAVI devices have not received regulatory approval for marketing in Australia and New Zealand but may receive approval in the future. This workshop is one of a number of strategies used to gather information to assist HealthPACT and the jurisdictions in determining a position on the diffusion and utilisation of TAVI technology for the overall care of patients with aortic stenosis in Australia and New Zealand into the future. Workshop participants, many of whom are currently engaged in providing TAVI services, represented a cross‐section of clinicians with a specific interest in TAVI models of care. Participants did not, however, represent the broad spectrum of clinicians who provide care for patients with aortic stenosis. Feedback into TAVI policy development from this latter clinician group has been sought by HealthPACT members through alternative sources. The current health policy and practice environment is characterised by increasing resource constraints. The implications of this for the introduction of TAVI into the clinical services system in Australia and New Zealand were not considered in detail at the workshop. Further, funders of health services were not broadly represented at the workshop. Policy makers will consider the introduction of TAVI from an individual clinical perspective and also from a population perspective that facilitates the judicious use of finite health resources across patient groups. Notwithstanding these limitations, stakeholders who participated in the workshop discussed the evidence for the use of TAVI in the treatment of aortic stenosis in different patient groups and identified a number of features of a safe, high quality TAVI service system. The evidence regarding the effectiveness of TAVI in different patient groups continues to evolve. As a result, there is currently no international consensus regarding the specific patient groups for whom TAVI is appropriate, nor have patient selection criteria been agreed. Further, the current limited data on the long term durability and cost effectiveness of the device necessitate ongoing evaluation of the technology. There was a shared view amongst workshop participants that criteria need to be developed to guide patient referral and selection for TAVI in Australia and New Zealand before the technology is introduced more broadly. Criteria should be based on the best available evidence regarding TAVI safety and effectiveness, reflect patient groups that are likely to receive the most benefit from the device and guide the selection of alternative and more affordable treatment strategies of equal or greater effectiveness for appropriate patients. TAVI service providers should work with referring providers to maximise the delivery of routine pre‐ and post‐procedure care in the patient's usual cardiology service. According to participants TAVI services should ideally be provided by a heart team that determines the suitability of the patient for TAVI and provides the peri‐procedural and HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
1 immediate pre‐ and post‐procedural care to the patient. Relevant medical, nursing and allied health expertise in the provision of complex interventional cardiology, cardiac surgery, cardiac imaging and cardiac anaesthetic care is required to deliver high quality care. To achieve high quality patient outcomes, TAVI services at present and in the immediate future should be delivered in a limited number of hospitals with the ability to provide the highest complexity cardiac services, high annual cardiology and cardiac surgery case volumes and sufficient annual TAVI case volumes. The challenge will be to achieve an appropriate balance between service concentration for quality purposes, and access. There was consensus that even if TAVI services are introduced more broadly not all interventional cardiology units should provide them. Instead, services should be maximally concentrated to improve efficiency and maximise outcomes nationally. Stakeholders anticipated, as a guide for service development, that a defined number of centres per million population may be required initially to deliver TAVI services until knowledge and expertise builds and the technology is at a stage of readiness that supports safe and efficient diffusion to cardiology units more widely, when appropriate approvals from the Commonwealth and jurisdictions is also achieved. Participants agreed that the education and training needs of clinicians involved in the care of patients undergoing TAVI need to be addressed before wider introduction of the technology. Standards should be established that describe the requirements for best practice education and training in TAVI procedures, pre‐procedural care and after‐care across medical, nursing and allied health professional groups. Participants suggested that a system of accreditation of TAVI services and operators would be a key element of good clinical governance. Accreditation is a preferred mechanism for ensuring TAVI services provide safe, high quality care. There was support for an Australian/ New Zealand TAVI registry for local data collection to address limitations in the currently available data regarding safety and effectiveness of TAVI. A registry that facilitates the collection of data relating to all forms of aortic valve replacement and that will enable comparative assessments of effectiveness and safety of TAVI is preferred by stakeholders. The strong preference of stakeholders who participated in the workshop is that the Cardiac Society of Australia and New Zealand (CSANZ) and the Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) lead the development, and provide strategic leadership and oversight of, a model of care for TAVI services for consideration by policy‐
makers and funders, including development of a program of monitoring and review of accredited TAVI services to ensure high standards of care and high quality patient outcomes, if and when TAVI receives regulatory approval. In addition, introduction of technologies such as TAVI cannot be considered in isolation, but need to take into account other competing clinical and financial priorities.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
2 BACKGROUND The purpose of this report DLA Piper was engaged by Queensland Health on behalf of the HealthPACT to facilitate a workshop on 14 February 2013. The purpose of the workshop was to discuss national and international TAVI experiences and outcomes, to assist in informing decision‐making as to policy and service planning for these technologies. TAVI is a cardiac technology with significant potential to contribute to the care of patients with aortic valve disease and to impact significantly on health budgets. The workshop is one of a number of sources of information that is contributing to policy development on the potential role of TAVI in the overall care of patients with aortic stenosis in Australia and New Zealand into the future. TAVI devices have not received regulatory approval for marketing in Australia and New Zealand but may be approved in the future. Workshop participants, many of whom are currently engaged in providing TAVI services, represented a cross‐section of clinicians with a specific interest in TAVI models of care. The feedback and input of other groups of clinicians who provide care for patients with aortic stenosis has been sought by HealthPACT members through alternative consultation processes. Dr Heather Wellington, DLA Piper, facilitated the workshop that brought together clinicians, health service managers, industry bodies, academics and policymakers. This is the report of the workshop. The pre‐workshop background paper A discussion paper was prepared by DLA Piper with input from HealthPACT members. The paper was informed by a targeted review of the peer‐reviewed and “grey” literature and by interviews with workshop invitees nominated by HealthPACT and was circulated to participants prior to the workshop. An extract of the discussion paper is included at Appendix 2. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
3 Welcome by the Chair of HealthPACT Professor Brendon Kearney, Chair of HealthPACT, welcomed participants to the workshop. Professor Kearney noted that health technology contributes approximately 30% to the increased costs of running the health system each year. TAVI is a costly technology that has not yet been approved by the TGA for introduction into Australian clinical practice and has been introduced in a controlled manner into New Zealand clinical practice. There is variation in application of the technology in clinical practice internationally. Different health systems have introduced the technology in different patient groups and with variations in the governance, workforce and data requirements. Professor Kearney noted that the stimulus for convening the workshop was to explore clinical services, workforce, data and policy requirements for the safe, systematic and appropriate introduction of TAVI into cardiology practice in Australia and New Zealand. WORKSHOP PRESENTATIONS A series of presentations was delivered at the commencement of the workshop by clinical, academic and industry stakeholders. A summary of each presentation is described below. Industry perspectives on TAVI Representatives from manufacturers of TAVI devices provided an overview of international experience with TAVI including device type, clinical trials and outcomes of particular relevance to their TAVI products. A representative from Edwards Life Sciences described international experience with the Sapien and Sapien XT devices. It was noted that the first TAVI procedure was performed in 2002 and that over 50,000 TAVI procedures have been performed since this date. At present 50 countries worldwide have approved the first generation of the device and 46 countries have approved the third generation of the device. It was noted that the devices have been approved for research but not clinical use or marketing in Australia and New Zealand. TAVI device use in the USA is also approved for research applications where the procedure is performed for clinical indications other than those approved by the FDA. The international experience with Sapien devices has involved 9,000 patients across 14 clinical studies. At three years follow‐up a 26.8% reduction in mortality (PARTNER trial) has been observed. The delivery systems for implanting transcatheter aortic valves were noted to have improved substantially over time, with better guidance systems and catheter size decreasing to 14 French with newer devices. Representatives from Medtronic presented on the CoreValve devices. The economic justification for TAVI was the focus of this presentation. According to the presenters available data demonstrate cost effectiveness of TAVI. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
4 The presenters proposed that future local data collection should address uncertainty and limitations in data that are currently evident, including the need for further data collection to determine cost‐effectiveness of the devices. This was viewed by the presenters as necessary as it is difficult to perform economic evaluations for technologies such as TAVI due to the rapidly shifting evidence base. A representative from Boston Scientific described current experience with the Lotus valve which is currently in clinical trial phase. The Lotus valve enables controlled deployment, is a preloaded device, has dimensions of 18 French or less, facilitates a traumatic repositioning and decreased leakage and has an adaptive seal. The REPRISE trials (1, 2 and 3) were described. Australia is a trial site for REPRISE 1 to 3. A discussion followed the presentations in which it was identified that increasing competition by industry to develop TAVI devices should result in reductions to the costs of the devices. Clinicians noted that TAVI devices cost approximately $25,000 to $30,000 (AUD) per device, which is substantially more than the cost of surgical valves. Clinicians with experience of TAVI in Australia estimated that approximately 50% of the cost of the procedure is due to the cost of the device. These participants predict that the total costs of the procedure are therefore likely to reduce as device costs decrease. TAVI experience in Australia Clinicians with experience in providing TAVI services in Australia provided an overview of their experiences with the technology to date. A cardiologist from The Alfred Hospital, Victoria, provided an overview of the Australia‐
New Zealand CoreValve TAVI study. Patients in this study were generally in their early 80s and had EuroSCOREs of approximately 17. The study applied a Society of Thoracic Surgeons (STS) score to determine the patient's risk of dying within 30 days of surgery in order to guide patient selection for the study. Results demonstrated procedural success of approximately 98% and procedure time of approximately 2½ hours. However, significant reductions in procedure time were reported as the operator deploying the device became more experienced. For the most recent cohort of patients the procedure time was less than one hour. Hospital length of stay (LOS) is estimated at 7.5 days and has decreased over time as a result of increasing operator and clinical team experience. Overall, one‐year survival is approximately 77.9%, which was noted to be a significant improvement compared with the expected survival of patients with symptomatic and inoperable aortic stenosis. It was noted that major vascular complications had occurred in 4% of patients and minor vascular complications had occurred in 8.4% of patients. Stroke occurred in 3.5% of patients within 30 days and in 9% of patients within 2 years. Between 15% and 20% of patients experienced moderate to severe aortic regurgitation after the TAVI procedure. Leakage occurs predominantly due to poor positioning of the HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
5 valve or the valve not being sized properly. It was noted that with the use of CT to size the valve prosthesis, the rate of successful sizing has improved. It was noted that in Australia and New Zealand 40% of patients with CoreValve also required pacemaker implantation. Over time, the pacemaker insertion rate has decreased to 15.9%, which has been attributed to better positioning and sizing of the prosthesis. Approximately 7% to 8% of patients have bundle branch block at 12‐24 months after the procedure. Conduction problems are thought to have decreased over time. It is currently not clear whether bundle branch block influences mortality risk. A cardiac specialist with significant experience of TAVI procedures from Queensland provided an overview of Australian experience with TAVI, including clinical programs in Australia. In Australia in 2012, there were approximately 370 TAVI procedures performed. There were a corresponding 4,800 surgical aortic valve replacements performed, indicating an estimated 7% of the aortic valve replacement caseload in Australia last year was by TAVI. It was noted that the SOLACE AU trial has begun in Australia and that Edwards Life Sciences has an Australian TAVI registry that is mapped to the SOURCE EU registry. The presentation described the inclusion criteria used in studies internationally for indicating which patients should receive TAVI. These are generally based on the presence of symptoms, valvular dimensions and EuroSCORE / STS scores. However, a range of additional clinical factors must be taken into account in determining the patient's suitability for TAVI, including the presence of cachexia / frailty, pulmonary insufficiency and vascular calcification. A clinical determination should be made by the treating clinical team regarding whether the patient was likely to receive a few years of good quality life in order to guide patient selection. Data were presented that reflect higher complication rates and poorer outcomes in patients who receive TAVI by the transapical compared with the transfemoral route. However, these patient groups were not directly comparable as sicker patients generally required the transapical procedure. A number of issues remain to be resolved. It is not certain whether the improved aortic valve function is durable over the long‐term. Further, it is likely that different valves (made by different companies at present) will most likely have different applications in different patient groups. This needs to be defined over time. Other niche applications for TAVI (e.g. treating patients with failed bioprosthetic valves) are likely to emerge over time. It was noted that US requirements for delivering TAVI services include the presence of an on‐site heart team, on‐site heart valve program, intensive care services, minimum centre case volumes of 20 or more cases a year and, ideally, access to hybrid operating theatres. TAVI funding and regulation A senior medical adviser with the TGA described the TGA approval process for supply of therapeutic goods in Australia. A number of avenues whereby legal access to TAVI can occur were described, including via the Special Access Scheme and via personal HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
6 importation, as well as by participation in clinical trials. Workshop participants were aware that the TGA had assessed TAVI devices for inclusion on the Australian Register of Therapeutic Goods (ARTG). There are few available data on the durability of the device and its long‐term impact on therapeutic outcomes in comparison to standard aortic valve replacement (AVR). The threshold of 'non‐inferiority' between TAVI and open repair was discussed as the point at which TAVI surpasses open repair is not easily defined at the individual patient level. TAVI devices may be listed on the ARTG in the future. Discussion between workshop participants ensued regarding the use of a heart 'team' and/or cardiac scoring systems (e.g. EuroSCORE) to judge whether patients should receive TAVI. Some participants suggested that scores / objective measures are necessary; both to facilitate data collection regarding patient outcomes after TAVI and to enable monitoring of clinical practice against TGA requirements once the products are listed. A combined process that includes the use of objective measures and interdisciplinary clinical assessment was proposed by participants to guide optimal patient selection. Stakeholders reported that the ANZSCTS is developing a coronary risk score and valve score to define patients for TAVI. Participants discussed accreditation arrangements for clinical centres providing TAVI as a mechanism for ensuring delivery of high quality, safe TAVI services. Some participants proposed that registration of individual heart teams (i.e. accreditation of heart teams) could be considered to monitor access. However, others preferred a system of accreditation of the facility where TAVI services were provided. A senior medical advisor with the DVA described the DVA experience with TAVI to date. The veteran population is an ageing cohort and the majority of people receiving DVA‐
funded treatments are 85 years and older. The DVA provides prior approval for access to health services not listed on the MBS. The Veterans' Entitlement Act 1986 prohibits experimental treatment on veterans. The DVA requires veterans to be fully informed and that the procedure will be performed in circumstances where there is a reasonable expectation that the veteran will have a good life expectancy and good quality of life after TAVI. The DVA also expects the procedure to be performed by a clinician who is appropriately experienced and working in an adequately equipped facility. The DVA has the capacity to identify the majority of costs associated with providing care to veterans. TAVI is estimated to cost between $50,000 and $60,000 per procedure for veterans. These costs relate to the average of cost of care to Veterans in the 14 months following TAVI and do not include the device and operating costs, including the costs of a pacemaker where required. The DVA has noted that the average annual cost of providing care to veterans decreases by approximately 20% (including allied health, community nursing, medical, pharmacy, hospital, rehabilitation, veterans home care and "other" medical costs) for the period commencing 3 months after a TAVI procedure. The greatest reductions are in hospital HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
7 expenses (32%). Approximately 23% of veteran patients who have undergone a TAVI procedure to date have received pacemakers post TAVI. What do policy makers and funders need to know about TAVI A Health Economist from Griffith University spoke about the Belgian health technology assessment of TAVI. It was noted that Belgium did not fund TAVI procedures in 2008 due to safety concerns and because the population in whom the device was indicated was not well defined at that stage. This decision was revised in 2011 and TAVI procedures were subsequently funded for patients contraindicated for surgery who have a logistic EuroSCORE > 20% and STS score>10%. A brief report of a detailed analysis of the Belgian health technology assessment on TAVI was presented. It was noted that the assessment appeared to have a number of flaws that limited the ability to generalise the findings of the assessment to the Australian and New Zealand setting. In particular, the assessment overemphasised stroke risk in TAVI recipients, had a small sample size for "anatomically inoperable" patients and modelled quality of life outcomes poorly. A cardiologist from Western Australia described the results of the Western Australian (WA) TAVI cost‐effectiveness study. WA offers TAVI in a single centre (Royal Perth Hospital) for a population of 2 million people. At the time of the workshop, there had been 127 TAVI procedures performed to date for limited clinical indications i.e. a specific subgroup of patients with aortic stenosis. Analysis of WA data found that the costs of index admissions and re‐admissions to 30 days (2010/2011 dollar values) was $16,000 less for TAVI compared with surgical AVR in 'high risk' patients. These data have not yet been subject to peer review and demonstrate a trend that is opposite to that expected (i.e. a higher cost associated with TAVI compared with AVR). The lower cost of TAVI, however, was attributed to shorter intensive care unit LOS and shorter total LOS compared with 'high risk' surgical AVR. In WA, deaths in patients were more common during the first year of the program, attributed to an operator and team “learning curve”. After the learning phase, 30‐day mortality decreased from 14.3% to 4.8% and 12‐month mortality decreased from 28.6% to 4.8%. Costs of delivering care during the procedural phase of treatment also decreased over time as experience improved. This was attributed to reduced medical and critical care costs and to better patient selection. It was noted that introduction of TAVI in WA was associated with a decrease in the mean EuroSCORE of patients receiving surgical AVRs, presumably because high risk patients received TAVI instead of surgery. TAVI program establishment Cardiologists from MonashHeart provided an overview of program issues that need to be addressed in order to establish a TAVI service within an acute setting. In this setting it was thought that the presence of a clinical academic milieu within the facility, clinical research infrastructure, track record and experience of the cardiac service (including high annual HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
8 volumes of patients receiving cardiac services) and a culture accepting of change are necessary prerequisites to the introduction of a TAVI service. Infrastructure requirements include: 
cardiac imaging (including trans‐thoracic and trans‐oesophageal echocardiography and a highly skilled echocardiography team); 
access to multi‐detector CT scanning with experienced radiographers, a well‐
trained cardiac surgical team able to interpret the images and radiologists with specialist cardiac expertise; 
a catheterisation laboratory with adequate imaging quality and adequate size to accommodate sufficient staff (routinely 11+ staff in a teaching facility); 
hybrid operating theatres (an ideal compromise is a purpose built structural heart disease catheter laboratory with large floor size); 
a high volume cardiothoracic surgery unit experienced in high risk valve and coronary artery bypass surgery, rapid availability of surgeon and theatre, adaptable nursing staff and perfusionist; 
a dedicated coronary care unit with intensive care unit back‐up; and 
a dedicated cardiac research unit with exposure to new technologies, data monitoring, contribution to the global pool of evidence and potential cost reduction by involvement in clinical trials. The facility ideally needs to be sufficiently large to support all required infrastructure and workforce and have a large referral base with high clinical case volumes to enable operators to become rapidly proficient in the techniques of TAVI. Not all referred patients proceed to TAVI, therefore the facility needs to be able to offer alternative treatment options including balloon aortic valvuloplasty, heart failure clinics and palliative care services. The need for a heart team within the facility was described, that comprises, at a minimum, interventional cardiologists, imaging cardiologists, cardiothoracic surgeons, cardiac anaesthetists and a TAVI coordinator. GROUP DISCUSSIONS Workshop participants then contributed to a group discussion regarding the optimal configuration of TAVI services across jurisdictions. Discussion topics included governance, training and data collection requirements. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
9 TAVI program components Participants discussed workforce and infrastructure requirements necessary to provide safe and high quality TAVI services and factors that should influence site selection for services. Participants identified that TAVI services should ideally be provided by a heart team who determine the suitability of the patient for TAVI and who provide the peri‐procedural and immediate pre‐ and post‐procedural care to the patient. As there is no national or international consensus regarding the membership of the heart team, participants proposed that the CSANZ and the ANZSCTS provide advice on heart team membership, including team composition across the domains of interventional cardiology, cardiac surgery, cardiac imaging, cardiac anaesthetics and gerontology in medical, nursing and allied health domains. According to participants, TAVI services should be delivered in hospitals with high annual cardiology and cardiac surgery case volumes. Not all cardiology units should provide TAVI services. Instead, services should be delivered by units with high interventional cardiology caseloads and established skills in dealing with patients with complex cardiology care needs. Participants identified that the annual TAVI case volume is an important factor that influences the optimal number of sites for delivery of TAVI services. Services should be maximally concentrated to improve efficiency and maximise outcomes nationally. Participants expressed a preference for determining a number of centres per million population to deliver TAVI services until knowledge and expertise builds and the technology is at a stage of readiness where diffusion to cardiology units more widely is desirable. Participants discussed at length whether an ideal TAVI centre procedural volume could be specified. It was recognised that standards for minimum annual centre volumes vary internationally from greater than 20 procedures a year in the US to between 25 and 50 a year in Canada and the United Kingdom. Although participants supported maximal service concentration and the nomination of a minimum procedure volume, participants preferred to refer this matter to the CSANZ and the ANZSCTS to provide advice on the threshold procedural volume for centres. Current evidence does not guide whether the centre's procedural volume is only important during the “learning curve” phase of the technology's introduction or whether centre volumes needed to be maintained over time. Participants suggested that in the absence of evidence to the contrary, maintenance of centre volumes over time is the preferred approach. There was no consensus regarding whether an individual operator needs to achieve specific annual procedural volumes in order to maintain their competence. It was suggested that this matter should also be referred to the CSANZ and the ANZSCTS for advice. Clinicians experienced in the delivery of TAVI services reinforced the need for providers to be proficient in the use of all of the TAVI devices available at present rather than just one HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
10 device because different patients are likely to benefit from different types of valve prostheses. This needs to be taken into account when determining minimum case volumes for TAVI centres. Participants discussed the need for some form of formal accreditation of centres providing TAVI services. Participants supported the referral of this issue to the CSANZ and the ANZSCTS in order to provide advice on minimum standards and accreditation requirements for the safe, high quality delivery of TAVI services. It was proposed that the accreditation process should include monitoring and review of patient outcomes and complication rates of patients to ensure providers are meeting acceptable thresholds as advised by the Cardiac Societies. Clinical governance Participants discussed the clinical governance requirements for ensuring the delivery of safe and high quality TAVI services to patients in whom the procedure is indicated. The CSANZ and the ANZSCTS were viewed by clinicians as having an important clinical governance role in providing professional oversight of the TAVI service system and supporting health service executives who have primary governance responsibility for the services their organisation provides. Specific roles for the cardiac societies into the future may include: 
providing advice on thresholds for minimum annual TAVI case volumes for services and clinicians; 
advising on a process for accreditation of TAVI services, including setting minimum standards for services; and 
advising on audit and review processes that should be used to ensure high standards of care by centres. The accreditation processes discussed above were identified as a key element of good clinical governance. Participants agreed that accreditation processes should be transparent and afford procedural fairness for stakeholders. There was discussion about whether accreditation alone would be adequate to determine whether a centre should be approved to provide TAVI services, or whether a complementary licensing and/or purchasing approach would be necessary to ensure services do not proliferate inappropriately, particularly in the developmental phase. Several participants suggested that it may not be appropriate for all services that meet accreditation standards to provide TAVI services, as there are likely to be significant population benefits from greater service concentration. It was suggested that in the public sector it is easier to regulate the number of funded services, but it may be more difficult to control inappropriate service proliferation in the private sector. Government stakeholders noted their requirement for involvement in decisions regarding TAVI service establishment and operation in the public sector as the TAVI is an expensive HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
11 intervention with significant complications associated with its use. Policy makers raised the affordability of TAVI services as a concern, particularly if the services are introduced in an uncontrolled manner. Most jurisdictions have a separate procurement program and TAVI is currently funded from discretionary funds. There is significant variability in how TAVI is currently funded across Australian and New Zealand. For example, given the lack of TGA approval of devices, one jurisdiction has directed that public monies should not support device procurement, while another has allocated a budget for TAVI activity, including devices, for both high‐risk and inoperable patients. Assuming that TAVI devices are eventually approved for use in Australia and New Zealand, it was proposed that state procurement committees should work together to achieve the best device price as device costs are a major factor influencing the affordability of the procedure. The potential for uncontrolled private sector growth was discussed. Some participants expressed concern that this may have a detrimental impact on the safety of the procedure, particularly if low procedural numbers occur in some private settings and patient selection is not rigorous. It was suggested that in order to ensure appropriate private sector growth policymakers could work with the health insurance industry or licensing approaches could be applied. Ideally, the same accreditation process would be used across the public and private sectors for site selection for TAVI services and the same criteria for number of centres per million population would be applied. Audit and review are important clinical governance tasks required to monitor and assure the quality of TAVI services, particularly their safety and their efficacy. This is the responsibility of the health services that provide TAVI services. However, clinicians felt the input of the CSANZ and the ANZSCTS would be beneficial and cited the Australian Cardiac Procedures Registry, the ANZSCTS audit program and the CSANZ accreditation program for pacemaker lead removal as a parallel model where this had occurred successfully. Patient and referral criteria Participants agreed that criteria should be used to guide patient referral and selection for TAVI in Australia and New Zealand. The criteria that should be used, however, are a significant issue of debate nationally and internationally. Participants agreed it was outside the scope of the workshop to determine this. Instead, participants suggested the advice of the CSANZ and the ANZSCTS could be sought. A number of principles were agreed by participants for guiding TAVI services in their patient selection: 
criteria for patient selection should be based on the best available evidence regarding the effectiveness and safety of TAVI; 
non‐futility of treatment, with advice from the CSANZ and the ANZSCTS, should be used to determine which patient groups are likely to receive the most benefit from TAVI; HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
12 
decisions regarding which patient groups should be selected for TAVI need to take into account the number of patients in whom the procedure may be indicated and the associated costs to the health system of implementing the technology in these patient groups; and 
criteria should be developed with due consideration to minimising a "shift to the left" i.e. the use of TAVI in patients in whom alternative and more affordable treatment strategies of equal or greater effectiveness could be used. Internationally, criteria have distinguished between patients with symptomatic aortic stenosis that is surgically inoperable versus those with surgically operable disease but in whom surgery poses a high risk. Clinicians felt that this distinction was arbitrary and not particularly helpful in guiding patient selection in clinical practice. Clinicians expressed concern that health facilities providing TAVI services will experience disproportionate increases in their interventional cardiology caseload. This was attributed to: 
TAVI services continuing to manage patients in the after‐care phase of their procedure rather than referring patients back to their referring cardiology centre; 
patients preferring to receive after‐care at the TAVI service; and 
clinicians providing TAVI services managing patients with complex cardiology needs who are referred for TAVI but in whom an alternative treatment is provided. To manage this risk, participants proposed the CSANZ and the ANZSCTS lead development of criteria for: 
an entry pathway for patients that describes to referring clinicians which patients should be referred to a TAVI service for assessment and the assessment that referring centres should perform prior to referral; and 
an exit pathway that guides TAVI centres in when to refer patients back to their usual cardiology providers, that describe a standardised approach to after‐care of patients with a TAVI intervention and that indicate when re‐referral to the TAVI centre is required. An Australian/ New Zealand TAVI registry Workshop presenters highlighted a number of limitations in the data that are currently available regarding the safety and effectiveness of TAVI. Participants proposed the development of a national registry for local data collection. The development of a separate module for cardiac devices in the Australian Cardiac Procedures Registry was proposed as a possible mechanism providing resources could be made available to support this. Advantages of engagement of the CSANZ and the ANZSCTS in this work include their expert knowledge, their experience in developing and operating cardiac registries, their HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
13 experience with the Australian Cardiac Procedures Registry and their independence from policymakers and funders. Participants preferred development of an integrated registry that facilitates the collection of data relating to all forms of aortic valve replacement, enabling comparative assessments of effectiveness and safety of TAVI to be performed locally. A preference for mandatory registry contribution of patient data by clinicians was expressed by some participants in order to facilitate complete data collection and minimise reporting bias within the registry dataset. Data collection is problematic at present because there is no TAVI‐specific DRG or ICD procedure code. Participants felt that both should be developed as a priority. It was acknowledged that there is a high degree of expertise bi‐nationally in designing and operating cardiac devices registries and that the creation of a TAVI module in the national cardiac devices registries would be feasible. Industry was proposed as a possible source of funds to pay for the development and maintenance of the registry. Bi‐national training program The “learning curve” associated with developing skills in TAVI procedures was highlighted by presenters and discussed throughout the workshop. There are multiple education and training needs associated with the introduction and ongoing provision of safe, high quality TAVI services in Australia and New Zealand. It was agreed that training standards need to be established by the CSANZ and the ANZSCTS that describe the requirements for best practice education and training in TAVI procedures, pre‐procedural care and after‐care. Standards need to be specific to each of the disciplines and craft groups involved in the heart team and should encompass the needs of medical practitioners, nurses and allied health providers delivering care along the clinical pathway. Standards for education and training should also incorporate minimum numbers of procedures that are required to be performed under supervision as part of training. Participants proposed that the accredited TAVI centres provide on‐site training for new practitioners. The training standards developed by the CSANZ and the ANZSCTS should include standards for trainers to ensure their competence in delivering supervision and training to new practitioners. The role of industry in supporting the delivery of training was discussed briefly. Some participants suggested that industry has a role in facilitating the delivery of training to device operators. Other participants expressed a view that industry should not be involved in training. PRIORITY ACTIONS ARISING FROM THE WORKSHOP Whilst acknowledging that, if approved by the TGA, specific clinical and patient criteria will be put in place restricting the use of TAVI, workshop participants agreed that the following actions were a priority before TAVI use becomes widespread: HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
14 Criteria for patient referral and selection for TAVI should be developed that incorporate the following: 
the best available evidence regarding effectiveness and safety; 
non‐futility of treatment should be defined to guide which patient groups are likely to receive the most benefit from TAVI; and 
decisions regarding patient groups in whom TAVI is indicated should take into account the number of patients in whom the procedure may be indicated and potential costs to the health system. A TAVI clinical pathway should be defined that describes the entry pathway for patients into TAVI services for assessment, including the assessment that referring centres should perform prior to referral; and the exit pathway that guides TAVI centres in when to refer patients back to their usual cardiology providers. A clinical governance framework should be developed that describes: 
the criteria that should be used to determine the suitability of a clinical service to provide TAVI service; 
the membership and roles of a 'heart team' within a TAVI service; 
acceptable minimum and optimal caseloads for TAVI service; 
an accreditation system for the selection and ongoing quality assurance and improvement of TAVI service; and 
a system of monitoring and review of the safety and quality outcomes of TAVI service. Training standards should be established that describe the requirements for best practice education and training in TAVI procedures, pre‐procedural care and after‐care across medical, nursing and allied health professional groups. Given current data limitations, a TAVI registry should be developed that is broadly inclusive of relevant cardiac patient groups, not just patients receiving TAVI. The strong preference of stakeholders is that the CSANZ and the ANZSCTS should develop and provide strategic leadership and oversight of the model of care for TAVI services, including development of a program of monitoring and review of accredited TAVI services to ensure high standards of care and high quality patient outcomes. WORKSHOP CONCLUSION In closing, Professor Kearney thanked participants for their constructive participation and their contribution of ideas. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
15 APPENDIX 1: WORKSHOP AGENDA Agenda ‐ Transcatheter Aortic Valve Implantation (TAVI) Workshop Time: 11.45am – 5.00pm (Working lunch available from 11.30am) Venue: DLA Piper Boardroom, Level 21, 140 William Street, Melbourne Date: Thursday, 14 February 2013 Facilitators: Dr Heather Wellington and Dr Kelly Shaw, DLA Piper Australia Time Topic Who 11:45 1. Welcome & introduction 11:50 2. Purpose and background to workshop, including:  Objectives of the workshop  Overview of the discussion and background papers 12.00 3. TAVI experience ‐ International  Devices, clinical trials & outcomes (clinical and cost effectiveness) Industry Representatives (Edwards Lifesciences, Medtronic Australasia, Boston Scientific)
12.40 4. TAVI experience – Australia  Clinical programs in Australia  Presentation of TAVI registry data Leading cadiologists from Victoria and Queensland
1.40 5. Therapeutic Goods Administration & Department of Veteran's Affairs experiences – a snapshot of policy & outcomes 2.00 6. What do policy makers and funders need to know about TAVI  Critique of the Belgian HTA on TAVI (Edwards valve)  WA TAVI cost‐effectiveness study 2.30 7. TAVI program issues  Patient cohort  Infrastructure (e.g. room type, imaging requirements)  Workforce (e.g. medical, surgical, nursing, training)  Other ‐ incl. governance, accreditation, funding 3.00 Prof Brendon Kearney, Chair, HealthPACT
Facilitator
Senior medical advisors from the TGA and DVA
Health economist from Griffith University Cardiologist from Western Australia Cardiologists from MonashHeart
Working Afternoon Tea HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
16 Time Topic 3:10 8. Group discussion on following topics:  TAVI program components  Clinical governance  Patient and referral criteria  National approach to using TAVI – data collection  National training program 4:10 9. Summary of discussion topics, outlining key actions and recommendations 4:45 10. Workshop Close a. Summing up b. Identification of priority recommendations 5:00 Who All
Facilitator/All Facilitator
Informal networking (drinks and light food provided) HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
17 APPENDIX 2: DISCUSSION PAPER EXTRACT Background Aortic stenosis ("AS") is the most common valvular heart disease1. AS is present in between 2% and 7% of patients aged 65 years and over, and prevalence increases with increasing age. AS is generally characterised by years to decades of slow disease progression, followed by rapid clinical deterioration and high mortality after symptoms develop2. The onset of symptoms confers a poor prognosis with an average mortality of 75% at three years without surgery3. Surgical aortic valve replacement ("SAVR") is the mainstay of treatment of symptomatic AS and offers substantial improvements in symptoms and life expectancy4. The onset of symptoms and left ventricular function determine timing of surgery. As studies report that between 8% and 34% of symptomatic patients die suddenly, prompt referral of symptomatic patients for surgical assessment is desirable5. Improvements in valve technology, surgical and anaesthetic practice have improved patient outcomes associated with SAVR. 
The 30‐day mortality associated with aortic valve replacement surgery is currently approximately 2.6%6; 
Patients who survive surgery (at mean age of 58‐60 years) enjoy near‐normal life expectancy with relative survival at 5, 10 and 15 years of 99%, 85% and 82%, respectively7; 
In patient aged > 80 years pooled survival rates at 1, 3, 5, and 10 years after SAVR are estimated at 88%, 79%, 65%, and 30%, respectively8; SAVR for symptomatic severe AS is recommended current US and European guidelines910. 1
2
3
Lung B et al. A prospective survey of patients with valvular heart disease in Europe. European Heart Journal 2003; 24: 1231-43.
Sawaya F et al. Aortic stenosis: a contemporary review. The American Journal of the Medical Sciences 2012; 343: 490-6.
Schwarz F et al. The effect of aortic valve replacement on survival. Circulation 1982;66:1105–10.
4
Kelly T et al. Comparison of outcome of asymptomatic to symptomatic patients older than 20 years of age with valvular aortic stenosis.
American Journal of Cardiology 1988;16:123-130.
5
Sawaya F et al. Aortic stenosis: a contemporary review. The American Journal of the Medical Sciences 2012; 343: 490-6.
6
Brown J et al.. Isolated aortic valve replacement in North America comprising 108,687 patients in 10 years. Journal of Thoracic and
Cardiovascular Surgery 2009;137:82–90.
7
Kvidal P et al. Long-term follow-up of morbidity and mortality after aortic valve replacement with a mechanical valve prosthesis.
European Heart Journal 2000;21:1099–111.
8
Vasques F et al. Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: a
systematic review and meta-analysis of 48 studies. Am Heart J 2012;163:477–85.
9
Bonow R et al. Update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease.
Circulation 2008; 118:e523.
10
VahanianA et al. Guidelines on the management of valvular heart disease (version 2012): (EACTS). European Journal of Cardiothoracic
Surgery 2012;42:S1-44.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
18 Newer minimally invasive access modalities are emerging that reduce the length of incision in order to minimise the effects of surgery. Sutureless prostheses are being used in some patients to provide a faster, less invasive procedure than SAVR11. Surgical aortic valve replacement in Australia and New Zealand Hospitalisations for aortic valve disease have increased in Australia and New Zealand over time (Table 1)1213. Demand for aortic valve replacement is expected to continue to increase with the increasing median age of the population. The Australian and New Zealand Society of Cardiac and Thoracic Surgeons ("ANZSCTS") is currently developing a policy on percutaneous valve insertion in association with the Cardiac Society of Australia and New Zealand ("CSANZ")14. Table 1: Aortic valve procedures over time, Australia and New Zealand1516 New Zealand
Australia
Transcatheter Aortic Valve Implantation Although SAVR is the established treatment for symptomatic AS, approximately one third of patients are not suitable for the treatment because of age and co‐morbidities17. To date, there is no medical treatment proven to improve survival in patients with AS and palliative balloon valvuloplasty, an alternative surgical procedure for management of inoperable aortic stenosis, provides only temporary symptom improvement in some patients, lasting an average of six to 12 months but associated with significant risk of complications1819. 11
12
13
14
15
16
Walther T et al. Contemporary management of aortic stenosis. Heart 2012; 98: Siv23-9.
AIHW. Hospitalisations data cubes. Accessed December 2012.
New Zealand Cardiology Clinical Network.
http://www.anzscts.org/policies-and-clinical-practice-guidelines/ .
Sutureless aortic valve replacement: a technology note prepared by the National Health Committee, May 2012.
AIHW. Hospitalisations data cubes. Accessed December 2012.
17
Lung B et al.. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J
2005;26:2714–20.
18
Radford D and Waters D.Balloon aortic valvotomy in pregnancy. Australian and New Zealand Journal of Obstetrics and Gynaecology
2004; 44: 577-9.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
19 Transcatheter aortic valve implantation ("TAVI") is an emerging alternative to SAVR for patients in whom surgery is either not possible or carries high risk of death or serious morbidity following surgery. TAVI provides a less invasive treatment option than SAVR and lower anaesthetic risks20. However, suggestions that TAVI leads to shorter recovery times compared to SAVR have not been realised, at least in Australia21. Currently more than 50,000 patients worldwide have received TAVI, although most procedures to date have been performed in Europe. Multiple systematic reviews of the literature assessing the evidence for effectiveness of TAVI have been performed2223242526272829. Readers are referred to these reviews for a comprehensive analysis of the literature regarding TAVI. In summary, reviews consider TAVI use in two patient groups: those in whom SAVR is contraindicated and those at high risk from SAVR30. 
In patients in whom surgery is contraindicated, TAVI is associated with significantly fewer deaths compared with standard (non‐surgical) therapy. However, patients who receive a TAVI experience higher rates of strokes and transient ischaemic attacks, major bleeding and vascular complications compared with standard therapy31. There are no consistent differences across studies in rates of renal replacement therapy or pacemaker insertion between patients who receive TAVI and patients who receive standard therapy. 19
Cribier A et al. Advances in percutaneous techniques for the treatment of aortic and mitral stenosis. In: Topol E (ed) Textbook of
Interventional Cardiology, 4th edn. Philadelphia: Saunders; 2003; 941–953.
20
Piazza N et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr)
CoreValve:revalving system.EuroIntervention 2008;4:242–9.
21
Personal communication from WA, QLD & VIC cardiologists to HealthPACT.
22
Takagi H et al. Less invasiveness may not always result in less mortality: a meta-analysis of transcatheter versus surgical aortic valve
replacement for aortic stenosis. International Journal of Cardiology 2011;153(2):207-8.
23
Eggebrecht H et al. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients.
Euro Intervention 2012;8(1):129-38.
24
Jilaihawi H et al. Meta-analysis of complications in aortic valve replacement: comparison of Medtronic-Corevalve, Edwards-Sapien and
surgical aortic valve replacement in 8,536 patients. Catheterization & Cardiovascular Interventions 2012;80(1):128-38.
25
Genereux P et al. Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a
weighted meta-analysis of 3,519 patients from 16 studies. Journal of the American College of Cardiology 2012;59(25):2317-26.
26
Erkapic D et al. Risk for permanent pacemaker after transcatheter aortic valve implantation: a comprehensive analysis of the literature. J
CardiovascElectrophysiol 2012;23(4):391-7. doi: 10.1111/j.540-8167.2011.02211.x. Epub 2011 Nov 3.
27
Bates M et al. Postoperative permanent pacemaker implantation in patients undergoing trans-catheter aortic valve implantation: what is
the incidence and are there any predicting factors? Interactive Cardiovascular & Thoracic Surgery 2011;12(2):243-53.
28
Figulla L et al. Transcatheter aortic valve implantation: evidence on safety and efficacy compared with medical therapy. A systematic
review of current literature. Clinical Research in Cardiology 2011;100(4):265-76.
29
Messori et al. Early and intermediate survival after transcatheter aortic valve implantation: systematic review and meta-analysis of 14
studies. BMJ Open 2013; 3: Print 2013.
30
Defined by a Society of Thoracic Surgeons risk score of 10% or higher, or by the presence of coexisting conditions that would be
associated with a predicted risk of death by 30 days after surgery of 15% or higher.
31
Vascular complications defined as thoracic aortic dissection, access-site or access-related vascular injury leading to death, the need for
substantial blood transfusion (>3 units), or percutaneous or surgical intervention and distal embolisation (non-cerebral) from a vascular
source requiring surgery or amputation or resulting in irreversible end-organ damage;
Major bleeding defined as any episode of major internal or external bleeding that caused death, hospitalisation, or permanent injury or that
necessitated the transfusion of at least 3 units of packed red cells or a pericardiocentesis procedure.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
20 
In high‐risk patients, there are no statistically significant differences in rates of mortality, rates of pacemaker insertion, or rates of renal replacement therapy between patients who receive TAVI and those who receive SAVR. However, the risk of vascular complications is significantly higher in patients receiving TAVI than those receiving SAVR. Moderate or severe paravalvular regurgitation is also significantly more frequent. The risk of neurological events with TAVI compared with SAVR in this patient group is still unclear. These systematic reviews and meta‐analyses are based on a small number of included studies, most of which have significant quality limitations. In all cases, significant heterogeneity is demonstrated across studies. Few RCTs have been performed; instead single arm studies and registry data are the main information sources upon which safety and effectiveness is assessed. Further, a major limitation of the published evidence is the paucity of follow‐up data beyond 2 years; the patients who reach this follow‐up length are approximately 10% of the population initially enrolled according to the most recent analysis32. While newer generation TAVI devices improve upon their predecessors, both structurally and from an efficacy perspective, the currently limited outcomes data, for any TAVI device, makes it difficult for policy makers and funders to assess their long‐term clinical effectiveness, let alone cost effectiveness. That TAVI will likely reduce the multiple admissions of those with inoperable AS is anticipated, but the lack of robust comparable data and analysis also makes it difficult for hospital executives and policy makers to consider the long‐term impacts and benefits of TAVI. This is important since many consider that, even if TAVI is not approved by regulators, there will be demand for access by those who are eligible for SAVR but would prefer a minimally invasive procedure compared with open heart surgery. Regulatory approval status of available transcatheter aortic valves The CoreValve, Sapien, Sapien XT, JenaValve and Acurate TA valve devices all have the Conformité Européenne (CE ‐ European Conformity) mark of approval. There is also separate CE marking for the different catheter delivery approaches. The Sapien device is approved in Europe for implantation via the transfemoral and transapical approaches, whereas the CoreValve device can also be implanted via a subclavian approach or by direct puncture of the aorta. The Sapien device was given FDA approval in November 2011 for a transfemoral approach in non‐surgical patients; in October 2012 FDA approval was expanded to high‐risk surgical candidates and to transapical device delivery. The CoreValve device is still investigational in the US. Enrolment of "extreme risk" patients is currently ongoing as part of the Continued Access Policy of the FDA. The device also has conditional FDA approval for study in patients at intermediate risk from SAVR. 32
Messori et al. Early and intermediate survival after transcatheter aortic valve implantation: systematic review and meta-analysis of 14
studies. BMJ Open 2013; 3: Print 2013.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
21 At least a dozen other transcatheter aortic valves are currently under development33. It is unknown what, if any, impact the recent announcement by the FDA (Strengthening our national system for medical device post market surveillance34) will have on TAVI provision in the USA. In New Zealand ministerial approval of public funding for TAVI was provided in April 2011 with approval granted for high‐risk surgical candidates, subject to nationally consistent criteria and patient prioritisation, including regional multi‐disciplinary patient review committees. There are at least three different devices currently used in New Zealand, CoreValve (the majority), Sapien and Sapien XT. No TAVI devices have yet received TGA approval for use in Australia. However, TAVI use is conducted under trial conditions according to TGA's Special Access Scheme (refer to Attachment 1). International recommendations for use of TAVI Internationally several guidelines and consensus documents have been published that make recommendations regarding the use of TAVI. Table 2 details the organisations and the recommendations made. Recommendations are not specific to a particular TAVI device type or manufacturer. Table 2: International recommendations for use of TAVI Institution Recommendation in high risk patients Recommendation in inoperable patients NICE Interventional Procedure35 For patients with aortic stenosis for whom SAVR is considered suitable but to pose a high risk, evidence of efficacy of TAVI is inadequate. In these patients TAVI should only be used with special arrangements for clinical governance, consent and data collection or research. NICE encourages clinicians to enter suitable patients into the UK TAVI trial. Details of all patients should be entered into the UK Central Cardiac Audit. For patients with aortic stenosis who are considered to be unsuitable for SAVR the evidence on the efficacy of TAVI is adequate. In these patients TAVI may be provided according to normal arrangements for clinical governance, consent and audit. Details of all patients should be entered into the UK Central Cardiac Audit. Belgian Health Care Knowledge Centre36 Patients with symptomatic severe aortic stenosis and severe Patients with symptomatic severe aortic stenosis in whom 33
Heartwire.Docs debate valve choice as number of TAVI devices set to mushroom. October 5, 2012. Available at:
http://www.theheart.org/article/1456317.do (accessed January 2013).
34
Available at
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf
35
National Institute for Health and Clinical Excellence (NICE).Transcatheter aortic valve implantation for aortic stenosis: NICE
interventional procedure guidance 421. London, March 2012.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
22 Institution Recommendation in high risk patients Recommendation in inoperable patients medical comorbidities, in whom correction of the aortic stenosis is considered as possibly beneficial, should preferably be treated surgically and are not eligible for reimbursement for TAVI (even if the estimated mortality risk of the operation is high or very high). correction of the aortic stenosis is considered as possibly beneficial but who are considered to be inoperable due to anatomical factors (by a heart surgeon who is independent of the heart team treating the patient) are eligible for treatment with, and reimbursement of, TAVI. Patients with symptomatic severe aortic valve stenosis and severe comorbidities who are considered inoperable due to medical factors are not eligible for reimbursement of TAVI. American College of TAVI is a reasonable alternative Cardiology Foundation, the to surgical AVR in patients at high American Association for surgical risk. Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons (ACCF/AATS/SCAI/STS) expert consensus document 201237 The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio‐Thoracic Surgery (EACTS)38 TAVI should be considered in high‐risk patients with severe symptomatic AS who may still be suitable for surgery, but in whom TAVI is favoured by a "heart team" based on the individual risk profile and anatomic suitability. TAVR is recommended in patients with severe, symptomatic, calcific stenosis of a tri‐leaflet aortic valve who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. TAVI is indicated in patients with severe symptomatic AS who are not suitable for AVR as assessed by a "heart team" and who are likely to gain improvement in their quality of life and to have a life expectancy of more than 1 year after consideration of their comorbidities. 36
Neyt M et al. Transcatheter Aortic Valve Implantation (TAVI): a Health Technology Assessment Update. Brussels: Belgian Health Care
Knowledge Centre (KCE), 2011.
37
Holmes D et al. ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. Journal of the American
College of Cardiology 2012; In press.
38
VahanianA et al. Guidelines on the management of valvular heart disease (version 2012): (EACTS). Eur J CardiothoracSurg
2012;42:S1-44.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
23 Institution Recommendation in high risk patients Canadian Agency for Drugs No recommendation and Technologies in Heath39 Recommendation in inoperable patients TAVI represents a viable alternative for patients with severe aortic valve stenosis who are not eligible to standard surgery treatment, with statistically significant clinical benefits. Developing the TAVI service system in Australia and New Zealand Up‐to‐date numbers of TAVIs being performed in Australia are not available. Up to January 2010, an estimated 180 or more TAVI procedures had been performed in public hospitals in at least four states (QLD, NSW, VIC and WA). Some of Australia's leading cardiologists are chief investigators for national and international clinical trials for a range of TAVI devices. Most State or Territory health departments allocate specific funding for TAVI devices, with providers required to source device funding through existing funding mechanisms. VIC, for example, has established a policy that, due to the lack of TGA approval and long‐term outcomes data, health services should not use case‐mix funding to support device procurement, but should use other revenue sources instead. Due to the current lack of TGA approval for TAVI devices in Australia, it is understood that health service providers must first seek TGA approval for their use through its Special Access Scheme, which allows for import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. On this basis, it is expected that all TAVI activity in Australian hospitals should also be approved by relevant Human Research Ethics Committees prior to each case. In New Zealand the first TAVIs were performed in 2008. Waikato District Health Board ("DHB") put forward a proposal to the National Service and Technology Review Advisory Committee ("NSTR") for a publicly funded programme for high‐risk surgical candidates. NSTR found TAVI to be an emerging technology with low levels of evidence and did not recommend the development of a full business case for public funding. NSTR did, however, acknowledge the need for "funding with evidence" so that DHBs could implement such technologies as part of formal clinical trials that include utility analysis. The Ministry of Health then supported a TAVI pilot at Waikato DHB, from which results were provided in September 2010. Ministerial approval of public funding for TAVI was received in March 2011. TAVIs were approved for high‐risk surgical candidates, subject to nationally consistent criteria and patient prioritisation, including regional multi‐disciplinary patient review committees. In the 2011/12 financial year, TAVIs were performed by the Waikato, Auckland and 39
Canadian Agency for Drugs and Technologies in Heath.Transcatheter Aortic Valve Implantation for Aortic Stenosis: A Review of the
Clinical Effectiveness and Guidelines. Rapid Response Report: Summary with Critical Appraisal, 2011.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
24 Canterbury DHB cardiac units. The three units have evolved slightly different pathways (in terms of where surgical input enters) and work continues on a protocol for prioritisation criteria. There has been discussion about the potential for New Zealand Cardiac Network ("NZCN") oversight and the development of a national registry. TAVI in clinical practice Evaluation of the patient for TAVI is performed by a multidisciplinary team. Workup involves the confirmation of AS and assessment for other valvular lesions, left ventricular function and aortic annulus size. Aortography or computed tomography angiography is performed to assess aortic size and evaluate the diameter, degree of calcification, tortuosity and stenosis of the major vascular accesses especially the femoral and iliac arteries. According to NICE guidance patient selection should be carried out by a multidisciplinary team including interventional cardiologists, cardiac surgeons, a cardiac anaesthetist and an expert in cardiac imaging. The multidisciplinary team should determine the risk level for each patient40. In the US the FDA has granted approval for the use of the Edwards transcatheter valve in patients with inoperable and, more recently, very high‐risk patients with aortic stenosis. The FDA has included a requirement for a "heart team" in the selection of candidates for TAVI to ensure appropriate use of this technique. Discussion What should the criteria be for patient referral and selection for TAVI in Australia and New Zealand? Given current data limitations, what should the Australian and New Zealand approaches be regarding data collection? What are the data collection priorities and options?
It takes time for cardiology providers and multidisciplinary teams to become skilled in providing TAVI. Operator proficiency concerning TAVI has been shown to improve rapidly, particularly over the first 30 cases performed. Procedural success has been observed to increase from approximately 80% in the initial experience to more than 95% over time. Average procedure duration, median contrast volumes, fluoroscopy time, average elapsed time between valvuloplasty of the malfunctioning valve to deployment of the new valve and decreases in radiation doses improve as procedural experience increases414243. Each member of the multidisciplinary team has specific learning needs and different skills to acquire. 40
NICE. Transcatheter aortic valve implantation for aortic stenosis.IPG 421. March 2012.
41
Clavel M et al. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe
aortic stenosis. Journal of the American College of Cardiology 2009;53:1883–91.
42
Alli O et al. Transcatheter aortic valve implantation.Assessing the learning curve.JACC Cardiovascular Interventions 2011;
DOI:10.1016/j.jcin.2011.09.014.
43
Block P. Lessons from the learning curve JACC Cardiovascular Interventions 2011; DOI:10.1016.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
25 Discussion What are the education and training needs, and accreditation requirements, associated with the introduction and on‐going provision of safe, high quality TAVI in Australia and New Zealand?
According to current NICE guidance TAVI is a technically challenging procedure that should be performed only by clinicians and teams with special training and experience in complex endovascular cardiac interventions. Units undertaking this procedure should have both cardiac and vascular surgical support for emergency treatment of complications44. Internationally, cardiovascular specialty societies compare implementation of a TAVI programs to implementation of an organ transplant program, with comparable needs for multidisciplinary teams of clinicians and specialised facilities and equipment. TAVI provision, therefore, has significant implications for workforce, capital planning, service planning, funding and performance. "Oversaturation" of TAVI programs presents a potential issue. The workforce, eligible patient demand and funding is limited. Assuming TAVI is supported by all stakeholders, its provision at capable health services is unlikely to be sustainable or supported. Discussion What are the clinical governance requirements for ensuring the delivery of safe and high quality TAVI services to patients in whom the procedure is indicated? What are the workforce and infrastructure requirements necessary to provide a safe and high quality TAVI program in Australia and New Zealand? What factors should influence site selection for safe and appropriate delivery of TAVI in Australia and New Zealand?
44
NICE. Transcatheter aortic valve implantation for aortic stenosis. IPG 421. March 2012.
HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
26 Summary Aortic stenosis is the most common valvular disease in Australia and New Zealand and affects mainly individuals older than 60 years. Medical therapies for AS remain ineffective with SAVR remaining the only proven effective long‐term treatment. TAVI has revolutionised the treatment of inoperable severe AS and holds promise for future widespread use as more long‐term experience is established. The forthcoming HealthPACT workshop provides an opportunity for clinicians, industry, health managers and policymakers to consider and identify options for a suitable service model and access criteria before TAVI is approved for marketing in Australia and New Zealand and before its use becomes widespread without due consideration of associated policy, funding and workforce implications. HealthPACT: Transcatheter Aortic Valve Implantation Workshop Report: June 2013
27