European Societies Issue New Valvular Heart Disease Guidelines, With Important Shifts

BARCELONA, Spain—Major developments in the field of valvular heart disease and, in particular, transcatheter aortic valve implantation have made their way into new clinical guidelines released here at the European Society of Cardiology (ESC) Congress 2017.

The document, led by Helmut Baumgartner, MD (University of Muenster, Germany), stems from a joint collaboration of the ESC and the European Association of Cardiothoracic Surgery (EACTS). It is the first new guidance in this field since 2012.

“If you consider that we cover the whole range of valve heart disease, it is a pretty condensed document, much shorter than the American ones,” Baumgartner told TCTMD. Major changes, he summarized, pertain to the heart team and dedicated heart valve centers, new recommendations for TAVR, the role of non-vitamin K antagonists in the setting of valvular disease, when to intervene in asymptomatic valve disease, and how to handle concomitant coronary disease.

The importance of the heart team was included in the previous guidelines and in a separate document, he noted, but in this year’s update it has become a much more central part of the document.

“The treatment of heart valve disease has become more complex over the years, we have more and more treatment options interventionally and surgically,” Baumgartner said, “so this requires very high expertise and therefore high volume, high expertise centers with very close collaboration between cardiac surgeons and cardiologists.”

The 2017 valve guidelines therefore offer specific recommendations as to the types of specialists that should be on-site full time for centers wishing to be heart valve centers, he said. The team should include cardiologists, cardiac surgeons, imaging specialists, anesthesiologists, and, “if needed, general practitioners, geriatricians, and heart failure (HF), electrophysiology, or intensive care specialists,” the document notes.

Transcatheter Aortic Valve Interventions

Recommended treatment options for aortic valve stenosis get an overhaul in the new guidance—five randomized trials and a range of registry studies led to a number of new recommendations. Unlike the recent update to American guidelines, the European guidelines include the SURTAVI intermediate-risk trial presented earlier this year, along PARTNER A (high-risk), PARTNER B (inoperable), PARTNER 2 (intermediate risk), CoreValve (high risk), and NOTION (intermediate/low risk).

On the basis of this evidence, the new guidelines give a clear indication for surgical valve replacement for symptomatic aortic stenosis (AS) in low-risk patients (class I, level of evidence B), while TAVR is recommended for patients deemed not suitable for surgery, as assessed by the heart team (class I, level of evidence B). In patients at increased surgical risk (STS or EuroSCORE II ≥ 4%—a cut point which includes intermediate risk patients ) the decision between SAVR and TAVR should be made by the heart team, with TAVR “being favored” in elderly patients suitable for transfemoral access (class I, level of evidence B).

This represents an expansion of eligible patients as well as a recommendation upgrade from the 2012 guidelines, which singled out  “high-risk patients” only, stating that TAVR “should be considered” in high-risk patients who may still be “suitable” for surgery, but in whom the heart team believes a percutaneous approach would be better—an approach given a class IIa, level of evidence B.

Surgical aortic valve replacement remains the only procedure recommended for asymptomatic AS patients and only gets a class I indication for patients with severe AS.

Other Highlights

To TCTMD, Baumgartner also pointed to tweaked guidance on whether or not to intervene in asymptomatic valvular disease as well as recommendations regarding the use of anticoagulation, including the non-vitamin K antagonist oral anticoagulants (NOACs) in the setting of valve disease.

In a section on atrial fibrillation and anticoagulation, for example, the guideline committee notes that despite the lack of data, NOACs “should be considered” as an alternative to vitamin K antagonists in patients with aortic stenosis, aortic regurgitation, and mitral regurgitation presenting with A-fib (class IIa, level of evidence B). NOACs “may be used” in patients who have A-fib associated with a bioprosthesis after the third postoperative month, but are strictly contraindicated in the setting of mechanical bioprostheses (class IIa, level of evidence C).

Around the question of whether to perform PCI in the context of percutaneous valve interventions, the new guidelines state that PCI “should be considered” in patients with a primary indication to undergo TAVR, or a primary indication to undergo transcatheter mitral valve interventions, if they have stenoses > 70% in proximal segments (class IIa, level of evidence C for both).

In mitral regurgitation (MR), the guidelines include a role for percutaneous edge-to-edge repair, a field first pioneered by the MitraClip (Abbott Vascular). Percutaneous edge-to-edge repair is given a class IIb, level of evidence C for both primary MR in inoperable or high surgical risk patients, as well as in secondary MR patients who remain symptomatic despite optimal medical management.

For surgeons and cardiologists already familiar with the recommendations in the 2012 guidelines, this year’s document includes a handy table summarizing specific changes that were made, Baumgartner noted.