Transatlantic Editorial on transcatheter aortic valve replacement

Aortic stenosis (AS) is the most common acquired valve disease in elderly patients, with a prevalence of 2.8% in those 75 years or older [1]. As the general population ages [2], it is reasonable to expect that the number of patients seeking treatment for AS also will increase in the coming years. Surgical aortic valve replacement (SAVR) remains the most effective treatment for AS and can be performed with excellent results [3–7]. However, elderly patients increasingly are presenting with multiple comorbidities, making them either high- or extreme-risk surgical candidates. Transcatheter aortic valve replacement (TAVR) was developed as an alternative to SAVR for patients at high operative risk. Since the introduction of this transformative technology in 2002, TAVR has been found to be superior to standard medical therapy at 5 years in inoperable patients [8]. In addition, mid-term results have revealed that TAVR is equivalent or has superior survival compared with SAVR in high-risk operative patients [9, 10]. These findings, combined with the minimal invasive nature of TAVR, have resulted in an explosion in the number of these procedures performed in North America and Europe [11, 12]. A similar marked experience in the number of TAVR-related clinical studies also has been observed in the last few years, with several recent clinical trials even investigating the use of TAVR in intermediate- and low-risk patients [13, 14]. With such a rapidly developing landscape in the management of patients with severe AS, recommendations that have been published by various medical societies may no longer accurately reflect current clinical practice. For example, valve guidelines produced by the European Society of Cardiology/European Association for Cardio-Thoracic Surgery in 2012 listed bicuspid aortic valve disease and untreated coronary artery disease requiring intervention as relative contraindications for TAVR [15]. However, increasing clinical experience suggest that TAVR can be performed in both of these scenarios (combined with percutaneous coronary intervention for the latter) with good results [16, 17]. As another example, the American Heart Association/American College of Cardiology guidelines from 2014 recommend SAVR as the procedure of choice for intermediate-risk patients with AS (class of recommendation I, level of evidence A) [18]. However, recent data have suggested that transfemoral (TF) balloon-expandable TAVR may be superior to SAVR in intermediate-risk patients [13, 14]. Another randomized, prospective trial using the self-expanding TAVR valve compared with surgery in intermediate-risk patients is forthcoming. In addition to the rapidly changing landscape for patients with AS, significant variations in clinical practice patterns—for a variety of causes—also can be observed between North America and Europe. For example, TAVR was being performed at a much more frequent rate in Germany than in the USA over the last few years. However, TAVR has increased rapidly in the USA and currently is being performed in 44.4% of patients requiring isolated aortic valve procedures, compared with 46.7% in Germany. With this background, the current document aims to evaluate the similarities and differences in the indications and patient populations currently undergoing SAVR and TAVR in Europe and North America. In addition, our multidisciplinary, international writing group aims to present an up-to-date overview of the current state of TAVR to further guide practice patterns and future areas of research within the greater cardiovascular community. The Heart Team has become a central concept in modern cardiovascular disease. Team-based care has been a widely used approach in many medical and surgical fields such as oncology, solid-organ transplants and neurovascular disease. However, it has reached a more integrated level with the inclusion of the Heart Team in the USA as a requirement by the Center for Medicare/Medicaid Services for reimbursement. In addition, in Europe, it is codified in guidelines as a Class I indication for revascularization of patients with chronic stable angina and structural heart disease. The concept of bringing together a multidisciplinary team to reach a consensus in managing complex patients and thereby optimizing outcome is straightforward. Less straightforward is the make-up of and implementation of this multidisciplinary team in daily practice. Equally less straightforward are the metrics that can be used to judge the efficacy in clinical care. With TAVR, the Heart Team seems intuitively obvious, because the care of patients with structural heart disease such as AS crosses the boundaries of cardiac surgery and cardiology, each of which bring different expertise and experience to these complex patients. This is particularly true because both catheter-based as well as surgical skills are needed for patient selection, procedural techniques and periprocedural management of complications should they occur. Both the US and European guidelines are proponents of the Heart Team, with specific performance of TAVR in hospitals with cardiac surgery on-site. Components of the TAVR Heart Team vary. At the present time, the core consists of the partnership between the interventional cardiologist and cardiac surgeon. As mentioned, this relationship has been codified for reimbursement but in actual fact provides merit. Other members of the Heart Team should include imaging specialists experienced with echocardiography and computed tomography (CT), cardiac anaesthesia, non-procedural cardiologists whose role will be to manage the patients pre- and postoperatively and also in terms of longer term care, as well as nursing care specialists and advanced practice providers for these high-risk patients with multiple comorbidities. Occasionally neurologists are required to help determine levels of preoperative dementia. The addition of a patient (or family advocate) may be very valuable in some circumstances to help synergize physician and patient expectations. There are multiple areas and needs for interaction (Fig. 1). Some of these may either occur or be met in structural space, others in the virtual reality of telemedicine. Essential points of contact include: Components of the Heart Team. Cath Lab: Catheter laboratory; OR: operating room; TAVR: transcatheter aortic valve replacement; CT: computed tomography. Evaluation of the patient with AS for the potential need for mechanical intervention. This requires evaluation of clinical patient demographics and the baseline assessment of haemodynamics as well as the degree, severity and extent of comorbidities. After evaluation as a candidate, the surgeon and cardiologist should decide on the risk–benefit ratio of the relative merits for medical therapy or aortic valve replacement via the TAVR or SAVR with the patient and family by both surgeon and cardiologist and the patient the risk–benefit ratio for SAVR TAVR as well as specific and of of the This will include of the of the that is operating or of or of in optimizing of the TAVR stable and care and In this the Heart Team will need to include general as a to the care of the patient which is for The potential can be in These to care, procedural reimbursement and of in the to results in the future as well as to of effective Heart Team of of effective Heart Team of The with the use of the Heart Team has the of management of AS in the have with with the of these complex patients, patient care. 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With recent data this patient the guidelines will have an to evaluate the role of TAVR in this which is of patients undergoing SAVR in the USA it is to that in have to TAVR and that many complications of TAVR, or the need for a may become less common with of of the that needs to be of TAVR in intermediate-risk patients can be is TAVR data on currently are because TAVR was to high-risk patients with survival A recent on TAVR a of but some have the of this longer is required to valve and of valve the TAVR in patients is trials have in the USA that TAVR with SAVR in low-risk patients and in reimbursement may the number of TAVR procedures that are currently particularly in Europe. The current reimbursement for use of TAVR in and are marked in European and the The number of TAVR increase in these the In addition, the number of surgery in Europe is much less than in the USA and Europe The may be the of differences in or a in the of aortic valve disease. 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As and to a of patient selection, the of TAVR has over be that such as disease requiring recent untreated coronary artery severe chronic severe severe and in the clinical Other such as and the assessment in the These patients, a in terms of the most these patients the of patients TAVR in the and trials and These very high and these of outcome (combined of and by and in that of patients in the trial population a outcome by of TAVR is by the in the it to patient outcome and survival TAVR in patients in the population using preoperative by the and observed that those with a a compared with for those with a of is for and to between that are very high and those that are is well that SAVR or TAVR in those with an less than or in and in terms of and should the In these should on need for a aortic or of medical therapy specific or and much of SAVR or TAVR and be by the Heart Team in these that will be in more include advanced disease or and of in those with or on replacement has been with and a of in patients with with severe AS and a in those with However, has been less TAVR in patients with or 5 has been with in TAVR patients in the US and observed a rate of for those on The rate was for those with a but on preoperative for patients with a In the years of the US and observed that TAVR patients with an a rate of a in which procedural have been the TAVR In the between and and observed that an rate increased over a of This was in patients with and 5 and but the of this was and performed a patients undergoing TAVR from studies that that and increased as well as and US patients and on surgical and TAVR in The TAVR patients a rate at compared with for those on they of patients on undergoing or was for for These high that the Heart Team should in these patients and to present the patient and family with expectations. are no recommendations from either on the management of patients with is a common in patients presenting for and at in TAVR patients with to the combined of and of by The patients with a survival rate of compared with for those and also less in those with a greater of the US of TAVR patients by and that was present in of patients. 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