MUNICH – Transcatheter aortic valve implantation should not be performed in patients at intermediate risk for surgery, according to new European guidelines on the management of valvular heart disease.
"We strongly stress that today, TAVI should not be performed in patients at intermediate risk," said task force chair Dr. Alec Vahanian of the department of cardiology at Bichat Hospital, Paris.
This is the first time that TAVI has been addressed in the guidelines, a joint collaboration between the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery.
Patrice Wendling/IMNG Medical Media
Dr. Alec Vahanian
The use of TAVI has mushroomed in recent years among high-risk patients with severe aortic stenosis and in those who are not candidates for surgery, but also has been performed in patients at lower risk.
The new guidelines update those issued in 2010, and were prompted by new evidence on risk stratification, diagnostic methods, therapeutic options, and the importance of the collaborative approach between cardiologists and cardiac surgeons, Dr. Vahanian said at the annual congress of the European Society of Cardiology.
"The key message – the core of the document – is to stress teamwork," he said.
The guidelines state that TAVI should be undertaken only with a multidisciplinary "heart team" including cardiologists, cardiac surgeons, and other specialists, if necessary, and only in hospitals with cardiac surgery on-site.
The indications for TAVI, based on results of the randomized PARTNER trial and large European registries, include patients with severe, symptomatic aortic stenosis (AS) who are not suitable for aortic valve replacement (AVR) as assessed by a heart team, and who are likely to gain improvement in their quality of life and are expected to live more than 1 year.
TAVI also should be considered in high-risk patients with severe symptomatic AS who may still be suitable for surgery, but in whom TAVI is favored by a heart team based on the individual risk profile and anatomic suitability, Dr. Vahanian said.
He reported a virtual laundry list of absolute and relative contraindications to TAVI, including an inadequate annulus size, defined as less than 10 mm or greater than 29 mm; thrombus in the left ventricle; active endocarditis; plaques with mobile thrombi in the ascending aorta or arch; inadequate vascular access for a transfemoral/subclavian approach; and a very low left ventricular ejection fraction of less than 20%.
Dr. Vahanian said AVR remains suitable for patients with severe symptomatic AS, including those undergoing coronary artery bypass surgery or surgery of the ascending aorta or another valve, as well as those who are suitable for TAVI, but in whom surgery is favored by a heart team. He observed that there was a great deal of debate among the task force members regarding surgery in symptomatic patients with low flow, low- gradient (defined as less than 40 mm Hg) aortic stenosis, and a normal ejection fraction.
"We have to be extremely cautious and treat only the patient while symptomatic and we are absolutely sure, if we can be sure, that the aortic disease is severe," he remarked.
Disclosures were not provided. The Organizing Committee assumed responsibility for ensuring that all potential conflicts of interest relevant to the program are declared to the participants.