Standards defining a ‘Heart Valve Centre’: ESC Working Group on Valvular Heart Disease and European Association for Cardiothoracic Surgery Viewpoint

The increasing number of patients with heart valve disease and the wider range of therapeutic options now available, demands the standardization of organizational structures.1 , 2 The ‘heart valve clinic’ is already established as a specialist outpatient clinic3 , 4 linked with multidisciplinary inpatient care as well as education and training. Recent international guidelines extend this specialist concept to a ‘Heart Valve Centre of Excellence’1 or ‘Heart Valve Centre’.2 These centres were proposed in order that durable mitral valve repair could be virtually guaranteed at close to zero risk in patients with asymptomatic severe mitral regurgitation caused by prolapse. The intention was that invasive valve interventions should not occur outside Heart Valve Centres. The standards defining such a centre have not previously been described and this is the purpose of this document. A Heart Valve Centre includes a heart valve clinic, but also multidisciplinary heart teams for the care of patients with mitral valve disease, tricuspid valve disease, diseases of the aorta and aortic valve and infective endocarditis (Table 1). Requirements of a comprehensive heart valve centre Echocardiography: 2D/3D, stress, transoesophageal, intraoperative5 , 6 CMR, cardiac CT, CT-PET7 Departments and individual imagers accredited by recognized national or international systems8 Surgical: Replacement of all valves, mitral valve repair, tricuspid valve repair, surgery for aortic root and ascending aorta, atrial fibrillation ablation Percutaneous: TAVI, Mitral edge to edge procedures (e.g., MitraClip) Links with hospitals offering superspecialist techniques Surgical: Ross procedure, aortic valve repair, robotic mitral valve repair, heart transplant Percutaneous: Balloon mitral valvotomy, closure of paraprosthetic regurgitation, developing mitral and tricuspid valve interventions Other specialist cardiac services including heart failure, and electrophysiology Intensive care (dedicated beds, ExtraCorporeal Membrane Oxygenation) Extracardiac specialties: vascular surgery, general surgery, neurology, renal, stroke and elderly care medicine, psychology, genetics and dental surgery Organization into multidisciplinary teams including endocarditis 24 h, 7 day cover allowing for annual leave and sickness Culture of safety (e.g. World Health Organisation checklist, review of complications) Training Job-planning to include valve related sessions including continuing education Internal audit processes including rates of repair and haemodynamic results, complications, durability of repair and rates of reoperation assessed annually and summarized at 5 and 10 years Involvement in national databases with mandatory external review Echocardiography: 2D/3D, stress, transoesophageal, intraoperative5 , 6 CMR, cardiac CT, CT-PET7 Departments and individual imagers accredited by recognized national or international systems8 Surgical: Replacement of all valves, mitral valve repair, tricuspid valve repair, surgery for aortic root and ascending aorta, atrial fibrillation ablation Percutaneous: TAVI, Mitral edge to edge procedures (e.g., MitraClip) Links with hospitals offering superspecialist techniques Surgical: Ross procedure, aortic valve repair, robotic mitral valve repair, heart transplant Percutaneous: Balloon mitral valvotomy, closure of paraprosthetic regurgitation, developing mitral and tricuspid valve interventions Other specialist cardiac services including heart failure, and electrophysiology Intensive care (dedicated beds, ExtraCorporeal Membrane Oxygenation) Extracardiac specialties: vascular surgery, general surgery, neurology, renal, stroke and elderly care medicine, psychology, genetics and dental surgery Organization into multidisciplinary teams including endocarditis 24 h, 7 day cover allowing for annual leave and sickness Culture of safety (e.g. World Health Organisation checklist, review of complications) Training Job-planning to include valve related sessions including continuing education Internal audit processes including rates of repair and haemodynamic results, complications, durability of repair and rates of reoperation assessed annually and summarized at 5 and 10 years Involvement in national databases with mandatory external review CMR, cardiac magnetic resonance; CT, computed tomography; PET, positron emission tomography; TAVI, transcatheter aortic valve implantation. Requirements of a comprehensive heart valve centre Echocardiography: 2D/3D, stress, transoesophageal, intraoperative5 , 6 CMR, cardiac CT, CT-PET7 Departments and individual imagers accredited by recognized national or international systems8 Surgical: Replacement of all valves, mitral valve repair, tricuspid valve repair, surgery for aortic root and ascending aorta, atrial fibrillation ablation Percutaneous: TAVI, Mitral edge to edge procedures (e.g., MitraClip) Links with hospitals offering superspecialist techniques Surgical: Ross procedure, aortic valve repair, robotic mitral valve repair, heart transplant Percutaneous: Balloon mitral valvotomy, closure of paraprosthetic regurgitation, developing mitral and tricuspid valve interventions Other specialist cardiac services including heart failure, and electrophysiology Intensive care (dedicated beds, ExtraCorporeal Membrane Oxygenation) Extracardiac specialties: vascular surgery, general surgery, neurology, renal, stroke and elderly care medicine, psychology, genetics and dental surgery Organization into multidisciplinary teams including endocarditis 24 h, 7 day cover allowing for annual leave and sickness Culture of safety (e.g. World Health Organisation checklist, review of complications) Training Job-planning to include valve related sessions including continuing education Internal audit processes including rates of repair and haemodynamic results, complications, durability of repair and rates of reoperation assessed annually and summarized at 5 and 10 years Involvement in national databases with mandatory external review Echocardiography: 2D/3D, stress, transoesophageal, intraoperative5 , 6 CMR, cardiac CT, CT-PET7 Departments and individual imagers accredited by recognized national or international systems8 Surgical: Replacement of all valves, mitral valve repair, tricuspid valve repair, surgery for aortic root and ascending aorta, atrial fibrillation ablation Percutaneous: TAVI, Mitral edge to edge procedures (e.g., MitraClip) Links with hospitals offering superspecialist techniques Surgical: Ross procedure, aortic valve repair, robotic mitral valve repair, heart transplant Percutaneous: Balloon mitral valvotomy, closure of paraprosthetic regurgitation, developing mitral and tricuspid valve interventions Other specialist cardiac services including heart failure, and electrophysiology Intensive care (dedicated beds, ExtraCorporeal Membrane Oxygenation) Extracardiac specialties: vascular surgery, general surgery, neurology, renal, stroke and elderly care medicine, psychology, genetics and dental surgery Organization into multidisciplinary teams including endocarditis 24 h, 7 day cover allowing for annual leave and sickness Culture of safety (e.g. World Health Organisation checklist, review of complications) Training Job-planning to include valve related sessions including continuing education Internal audit processes including rates of repair and haemodynamic results, complications, durability of repair and rates of reoperation assessed annually and summarized at 5 and 10 years Involvement in national databases with mandatory external review CMR, cardiac magnetic resonance; CT, computed tomography; PET, positron emission tomography; TAVI, transcatheter aortic valve implantation. A heart valve clinic is a dedicated and structured outpatient clinic.3 , 4 The cardiologist(s) running the clinic should have competencies in treating patients with heart valve disease (ideally including imaging). Some heart valve clinics may include interventional cardiologists or surgeons allowing immediate case-discussions in patients suitable for intervention. According to local structures and regulations some roles can be delegated to clinical scientists or specialist nurses within a multidisciplinary service,9 , 10 which is safe and cost-effective.11 , 12 In the UK, follow-up of patients with native valve disease or biological replacement valves requiring echocardiography is increasingly performed by clinical scientists.9 Patients after valve replacement who do not require echocardiography may be followed up by a senior cardiac nurse,9 allowing the cardiologist to focus on new or complex cases. Echocardiographic and clinical protocols with thresholds for alerting the supervising cardiologist must be established and approximately 10–15% of cases seen by the scientist or nurse need cross-referral to the cardiologist. The main functions of the heart valve clinic are to confirm and refine the diagnosis of heart valve disease, follow patients and determine the correct timing of referral to the appropriate Heart Team. The activities of the heart valve clinic extend to inpatient care, and to training doctors and educating patients.3 , 4 Education of patients is vital for the early identification of symptoms and to allow fully informed decision-making about the type of intervention and its timing. Active patient involvement is essential when requested by the patient and has been shown to improve quality of life after surgery.13 , 14 It is also important for the early recognition of infective endocarditis. A heart valve specialist can be characterized15 by: (1) a record of training within a Heart Valve Centre; (2) valve-related programmed activity, e.g. valve clinics, inpatient care, involvement with Heart Team meetings, specialization in imaging of valve disease, research; (3) continuous medical education (CME) in valve disease by attendance at scientific meetings of professional societies (e.g. the European Society of Cardiology Working Group on Valvular Heart Disease, ESC, EACVI or EAPCI, European Association for Cardiothoracic Surgery or National Society Working Groups on Valve Disease). Echocardiography is the cornerstone for the detection and assessment of valve disease. However, other modalities such as cardiac magnetic resonance (CMR) and computed tomography (CT) provide additional information and help in risk assessment in some patients.16–18 Echocardiographic operators need to be certified nationally and preferably accredited by an international organization.8 Echocardiography skills can only be maintained by continued education and practical involvement. 3D transthoracic and transoesophageal echocardiography and stress echocardiography are mandatory. Surgeons performing valve repair and interventional cardiologists performing transcatheter procedures are likely to develop the ability to interpret echocardiograms and CT scans. However, they will require continued collaboration with cardiologists or clinical scientists who have relevant imaging expertise. Echocardiography should be available 24/7. Cardiac CT and CMR need to be performed by cardiologists or by radiologists with expertise in cardiovascular disease. CT should be available 24/7. Software to analyse images and plan structural valve interventions must be available. Positron emission tomography (PET) should also be available since the 2015 European Society of Cardiology modified criteria include PET evidence as a major criterion in the diagnosis of prosthetic valve endocarditis.19 A multidisciplinary approach is recommended for all types of valve disease and infective endocarditis.19–23 Individuals with areas of expertise (e.g. mitral valve repair, TAVI) should be named. The expertise required for mitral, aortic valve and tricuspid valve disease and endocarditis differs but also overlaps. It is therefore likely that individuals may be members of more than one team, for example a surgeon with expertise in mitral valve repair is likely also to be a member of the endocarditis team. Nurses and case-managers depending on local arrangements are also involved in the multidisciplinary team. Assessment by relevant non-cardiac specialists (elderly care physician, pulmonologist etc.) should be available for patients with significant comorbidities. There should be regular Heart Team meetings to discuss the indications for and timing of intervention together with necessary procedural details. In most high volume centres it will be logistically easiest for separate multidisciplinary meetings to occur for mitral, aortic and endocarditis cases. However it is reasonable to have combined meetings at smaller centres depending on patient volumes and the individuals constituting the teams. This meeting can also be used for case debriefing. Meetings should take place weekly or at a frequency depending on annual hospital volumes. For emergent treatment, ad hoc multidisciplinary consultation should be possible. The wishes of the patient will inform the discussion of treatment options at multidisciplinary meetings. The consensus of the meeting will be communicated to the patient and if desired will inform further discussion about the timing and nature of surgery. It may on occasion be appropriate to invite a patient to a discussion about his or her case. The details of multidisciplinary teams are discussed in ‘Mitral valve multidisciplinary heart teams’, ‘Aortic valve multidisciplinary heart teams’, and ‘Endocarditis multidisciplinary team approach’ sections. In a comprehensive valve service it should be possible to consult cardiologists with complementary expertise, including adult congenital disease, inherited cardiac diseases, heart failure and electrophysiology. Collaboration with members of a heart failure service and electrophysiology specialists is needed in patients with secondary mitral regurgitation to ensure that medical therapy (and cardiac resynchronization if indicated) has been optimized before considering surgical or transcatheter intervention. Patients with heart failure and valve disease may be better cared for in a heart failure clinic (rather than a heart valve clinic) if no invasive intervention is planned. Collaboration with heart transplant centres is also necessary for these patients. The Heart Valve Centre must have a dedicated cardiac surgical department including cardiac anesthesia,24 intensive care and step-down unit. The option to use devices such as intra-aortic balloon pump and extracorporeal membrane oxygenation should be available. The following services should also be available: vascular surgery, general surgery, neurology, nephrology, microbiology and infection, stroke and elderly care medicine, and care of psychiatric illness. The procedures available at a Heart Valve Centre must be: replacement of valves in all four positions; mitral and tricuspid valve repair; atrial fibrillation ablation; transcatheter aortic valve implantation; and surgery for the aortic root and ascending aorta. Transcatheter mitral and tricuspid procedures including mitral edge-to-edge repair should rarely be performed outside a Heart Valve Centre. Aortic valve repair and percutaneous repair of paravalvular regurgitation are infrequently performed and technically challenging and not available at all Heart Valve Centres. Valve disease as part of complex congenital heart disease should be managed by a centre specializing in paediatric and adult congenital disease and relevant expertise will not be available at every Heart Valve Centre. In some countries, percutaneous balloon mitral valvotomy may also not be available at every Heart Valve Centre. Therefore there should be service level agreements in place to allow transfer to centres, which perform highly specialized procedures so that these are not restricted by geography if required for an individual patient. Knowledge of which centres offer these highly specialized procedures should be easily available. Coverage of the service by an appropriate number of physicians should be organized in order to allow for leave and sickness. There should be sufficient beds to allow uninterrupted transfer of patients from peripheral hospitals and sufficient intensive therapy unit capacity to allow urgent surgery when clinically indicated. Operating schedules should allow urgent or emergent operations. There should be a safety checklist at the start of all procedures and a debriefing at the end.24 The team must include at minimum a surgeon with special expertise in mitral and tricuspid valve repair, a cardiologist with specialist expertise in valve disease, a specialist in echocardiography (who may also be the cardiologist), a specialist in other imaging modalities (CT, cardiac MR). An interventional cardiologist is also essential. The imaging and clinical data of each patient should be reviewed by the expert Heart Team to determine whether the mitral valve is amenable to repair. Repairable primary disease should be operated on by surgeons with special expertise in valve repair22 , 25 and results according to basic data collection (Table 2) at least as good as the targets in Table 3. Multidisciplinary Heart Team discussions must also take place for patients being considered for transcatheter mitral edge-to-edge repair.21 Data for collection in repair and replacement for primary mitral or aortic valve disease Data for collection in repair and replacement for primary mitral or aortic valve disease Example targets for surgical outcomes in repair of mitral valve prolapse Example targets for surgical outcomes in repair of mitral valve prolapse The relationship between case volume and outcomes of surgery and transcatheter interventions is complex although volume recommendations already exist (or are being discussed) for percutaneous coronary intervention,32 vascular surgery,33 and percutaneous valve techniques.20 , 21 What constitutes sufficiently high individual surgeon or hospital volumes to maintain good results for repair of mitral valve prolapse is controversial. For this reason, the ability to demonstrate good results is more important than mandating volume targets. It is also likely that external audit of results will encourage good outcomes. Retrospective analyses show that higher annual surgeon volume and institutional experience are associated with higher rates of mitral repair and lower mortality.34 , 35 However, a high hospital volume partly reflects high individual surgeon volumes17 and may also be a surrogate for excellent facilities and processes. Annual thresholds of >20–40 mitral valve repair procedures for individual surgeons28 , 34–37 have been suggested by expert consensus28 or retrospective analyses.34–37 Hospital mitral surgery volumes of >50 procedures/year have been suggested by expert consensus,28 although retrospective analyses suggest higher thresholds.35 , 37 An analysis37 of 13 614 operations for mitral regurgitation at 577 US centres showed a surgical of in centres performing mitral procedures/year with for performing procedures and for performing rates were in the and in the high volume centres performing A further retrospective of patients surgery for mitral regurgitation an of procedures/year for hospital volume and procedures for individual For mitral valve no individual surgeon thresholds have been However lower rates are in higher volume centres, as aortic and mitral valve replacement procedures or for mitral repair and replacement This in high volume centres is shown for and patient For mitral surgery a of operations has been with an of at least one to maintain results although higher volumes are associated with better The is challenging for the surgeon and the team, and is not part of minimum These are retrospective and for the expertise of individual surgeons and valve and patient is since repair rates were not with the of repair. Some surgeons high repair rates and some high volume surgeons repair , 37 these not record such as stroke and rates of mitral regurgitation or need for surgery. In of these the ability to demonstrate good results (Table is a more important than volume targets. However, it is likely these will not be high individual surgeon and centre volumes. Multidisciplinary meetings are needed the of intervention and its the type of intervention required or biological valve may not be For the of intervention in aortic may to symptoms and risk so that the of intervention is about surgery for mitral regurgitation or the of an aortic valve with or at the of coronary may also be Surgery of the aortic root and ascending aorta including replacement and techniques are within the of of all aortic valve However there should be with vascular surgeons to patients with more aortic There should also be close with adult congenital heart disease specialists and clinical of the in patients with aortic The to surgery is complex and on the but also risk including or and by the and of the associated valve disease. about the timing of surgery should be discussed in a multidisciplinary Heart Team aortic valve replacement is a cardiac surgical However, as for the mitral new of valves requiring techniques should be with the help of a to the The Ross is example of a complex that must be at a centre with techniques are in or aortic valves but data are for complex of aortic valves may be at a specialist referral , and aortic root may be a of these repair and expertise is needed for the team since assessment and imaging are early rates for aortic valve replacement have been for surgeons who or high volume hospitals have lower rates than volume with a suggested of For aortic or combined aortic valve and root one that in hospitals performing than procedures For TAVI, better results early and rates of have been shown for hospitals that , However, as for mitral surgery all these are data suggest that this may be in and annual centre volumes >50 are recommended in and the (and in discussed for mitral repair and individual surgeon and hospital volumes are to be for data and the ability to demonstrate good results is more important than to volume targets. However, from Heart Valve are to inform on minimum volumes for and complex procedures well as for new percutaneous A multidisciplinary team approach is essential for treatment of patients with , , and has been shown to from to The team should include cardiologists with specialist competencies in valve disease, cardiac surgeons with expertise in complex valve surgery, and specialists in medical microbiology on the local of service Other must be available: a specialist in surgeon or depending on national an specialized in of a and to on the of and a surgery is performed in at least of and its timing Heart Team a of should be established between the Heart Valve Centre and all hospitals cardiac surgery so that all cases of possible endocarditis can be discussed and depending on clinical need and national arrangements for the Heart Valve Centre there must be between the endocarditis team and the microbiology and echocardiography cases will be cases should be discussed on identification or transfer by the specialist the specialist and cardiac surgery the cardiac surgeon must be involved to discuss timing and of the There should be regular Heart Team meetings to follow the of and However, the need for a discussion should surgery and schedules should allow for urgent or emergent surgery in patients with endocarditis aortic and mitral valve endocarditis surgery should be within the of an However, additional expertise is necessary in such as aortic root or when valve repair is possible. The of immediate surgery a lower of as surgery with a higher of but also of heart failure and by surgeons should be considered for challenging cases. There must be audit or and meetings are mandatory and of as a of should be of repair, results including regurgitation or hospital and , 21 , , must be and The centre should at least and and 5 rates and the information in Table Echocardiographic and clinical results must be available for and external It is recommended that these results, by national are on the Heart Valve Centre and available to patients and of all valve procedures in an international or national is essential these , 21 used risk (e.g. or including for transcatheter valve procedures should be available to interpret data at the level of individual patient risk Data collection is a to early failure of new of replacement valve or repair techniques as well as at an individual Training is an essential of a Heart Valve Centre and should be and by national cardiovascular professional societies with for and other professional training should be for to specialized experience to the of the on , 35 , increasingly require procedures and have that training and this is necessary to procedural The for transcatheter to a structured training for the and who will be involved in the care of the This should be the than the training can occur training within to other or by external members of the multidisciplinary Heart Team including and nurses need to be involved in continuing education appropriate to National societies should valve-related training and There is an of involvement in clinical and The standards described are on expert consensus and retrospective all important to valve and surgical risk are These will help recommendations for and minimum centre and individual volume for surgery and percutaneous and that there is in and services related to heart valve disease, this is to provide on to develop specialized Heart Valve for the to the of the the of heart disease will to surgical and transcatheter valve interventions will an increasing at the standards in diagnosis and treatment are and These can be in multidisciplinary care teams established within a of care for a It be to the standards discussed However that and will centres who with these standards and are to demonstrate excellent of

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