Barcelona, Spain - Aug. 26, 2017: European Society of Cardiology (ESC) / European Association for Cardio-Thoracic Surgery (EACTS) Guidelines for the management of valvular heart disease are published online today in European Heart Journal1 and on the ESC website.2
"Since the 2012 Guidelines a large amount of new data have accumulated, particularly in the field of catheter interventional treatment of valvular heart disease," said Prof Helmut Baumgartner, ESC Chairperson (Germany). "In aortic stenosis, there have been five randomised clinical trials comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) as well as large-scale registry data."
"There is also new evidence regarding predictors of outcome in asymptomatic patients with valvular heart disease and on antithrombotic therapy in this patient population among other innovations," he continued. "This definitely required an update of management recommendations."
"We have now expanded the indications for transcatheter valves because there is new evidence in the intermediate risk population," said Prof Volkmar Falk, EACTS Chairperson (Germany).
Regarding the decision between SAVR and TAVI for symptomatic aortic stenosis, the guidelines emphasise that it should be made by a heart team of surgeons and cardiologists. A new recommendation is that both procedures should be performed in a heart valve centre which has departments for cardiac surgery and cardiology providing structured collaboration on site, conducts structured training, records data on performance and patient outcomes, and participates in registries.
Broadly speaking, patients at high risk for surgery should receive TAVI and those at low risk (especially younger patients) should undergo SAVR.
But Prof Baumgartner said: "The choice of SAVR or TAVI is not simply based on a risk score or age. The heart team must weigh the risks and benefits of both procedures, particularly in the intermediate risk situation. Discussion should include age, comorbidities, anatomy, and outcomes of the centre for surgery and transcatheter intervention."
"Evidence is based on trials in patients with a mean age of 80 years and the recommendations cannot be applied to those below 70 to 75 years," continued Prof Baumgartner. "Younger patients have more bicuspid valves, which may have worse TAVI results than tricuspid valves, and there is no long-term data on the durability of TAVI valves. Complications such as paravalvular leakage or need for a pacemaker are still more frequent with TAVI compared to surgery which is important in younger patients with a longer life expectancy. In younger patients there must still be a critical risk of surgery before considering TAVI."
In asymptomatic patients with valve disease studies suggested that early surgery may improve outcomes, but deciding when to intervene remains controversial. As examples, pulmonary hypertension has been introduced into the criteria for selecting asymptomatic aortic stenosis patients for surgery following studies showing it was a predictor of poor outcomes. Conflicting studies on the prognostic value of exercise echocardiographic parameters resulted, on the other side, in their removal from the selection criteria for asymptomatic patients with aortic stenosis and mitral regurgitation.
In the area of antithrombotic therapy, there is now sufficient data to recommend non-vitamin K antagonist oral anticoagulants (NOACs) as an alternative to vitamin K antagonists in atrial fibrillation patients with aortic valve disease or mitral regurgitation. NOACs remain, however, contraindicated in patients with mechanical valves and in mitral stenosis.
Prof Falk said: "This is a joint guideline between cardiologists and surgeons. It is absolutely essential that both specialties follow the same recommendations because we are treating the same patients. Decisions in structural valve disease must be taken by a heart team of cardiologists and surgeons."
The document is shorter than conventional guidelines and those wanting more information can consult the updated chapter on valvular heart disease in the ESC Textbook of Cardiology, which was written by the same team. The linkage between these two documents is being piloted and its acceptance by users will be evaluated by the ESC.