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August 29, 2012

TAVI Included in 2012 European Joint Guidelines on Valvular Disease

August 25, 2012—At the European Society of Cardiology (ESC) Congress 2012 in Munich, Germany, the ESC announced the new clinical practice guidelines on the management of valvular heart disease from the Joint Task Force of the ESC and European Society of Cardio-Thoracic Surgery (EACTS). The collaborative guidelines were drafted under the direction of Task Force chairmen Alec Vahanian, MD, of Hôpital Bichat in Paris, France, and Ottavio Alfieri, MD, of San Raffaele University Hospital in Milan, Italy. The document is available online in the European Heart Journal

In the ESC press release, the task force chairmen noted that the ESC–EACTS collaboration is critical, particularly in high-risk patients, given the guidelines' emphasis on a team approach. A "heart team" should include cardiologists, cardiac surgeons, imaging specialists, anesthetists, and others if needed in the decision-making process. The task force emphasized the importance of a comprehensive evaluation of the cardiac and extracardiac condition of the patient, constantly checking consistency between the results of diagnostic investigation and clinical findings at each step of the decision-making process. Noting a lack of evidence-based data in the field of valvular disease, the ESC-EACTS Task Force urged an increase in the research efforts in this field.

For the two most frequent native valve diseases, aortic stenosis and mitral regurgitation, the following recommendations have been emphasized.

The ESC stated that for aortic stenosis, the most important new treatment reviewed is transcatheter aortic valve implantation (TAVI). TAVI is recommended only “in hospitals with cardiac surgery on-site” and with a heart team available to assess individual patient risks. The indications for TAVI are based on the results of large European registries and, importantly, on results of the randomized PARTNER trials. TAVI is given a class I B recommendation for use in patients with severe symptomatic aortic stenosis who are judged by the heart team as unsuitable for valve replacement, and a class IIa B recommendation for high-risk patients with severe symptomatic aortic stenosis based on the individual risk profile. The guidelines emphasize that, at present, TAVI should not be performed in patients at intermediate risk for surgery, for which no supporting data are currently available.

In mitral regurgitation, the task force states that mitral valve repair should be the preferred approach when the repair is considered durable. Thus, it is important to increase surgical expertise and the number of reference centers. 
Following results from the EVEREST trials and European registries, edge-to-edge percutaneous mitral valve repair is reported to be relatively safe and generally well tolerated, even by patients in poor clinical condition.

However, the task force noted that the procedure reduces mitral regurgitation less effectively than mitral valve surgery. Thus, the guideline is that percutaneous mitral valve repair using the edge-to-edge technique (MitraClip mitral valve repair system, Abbott Vascular, Santa Clara, CA) may be considered in high-risk or inoperable patients refractory to optimal medical management with the aim of improving symptoms. The guidelines stressed that longer follow-up is needed, as well as randomized clinical trials.

Regarding antithrombotic therapy after valve surgery, the need for a 3-month period of postoperative anticoagulant therapy has been challenged in patients with aortic bioprostheses, with the use of low-dose aspirin now favored as an alternative.

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August 30, 2012

ACCESS-EU 1-Year Data Show Benefits of Abbott Vascular's MitraClip

August 30, 2012

ACCESS-EU 1-Year Data Show Benefits of Abbott Vascular's MitraClip


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