Symposia Highlights Variances Between Guideline-Based, ‘Real-World’ Indications for TAVR

Guidelines in the United States and Europe for the management of valvular heart disease are in close agreement regarding indications for transcatheter aortic valve replacement (TAVR). However, results from real-world clinical practice suggest the potential for benefit outside of guideline recommendations in an intermediate- or even low-risk patient population, according to presentations Sunday at TCT 2015.

Alec S. Vahanian, MD, of Hospital Bichat, University Paris VII, in Paris, France, reported “full agreement” between the 2012 guidelines for management of valvular heart disease released by the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery and those released by the American Heart Association and the American College of Cardiology in 2014. 

Both documents indicate the need for a multidisciplinary team involving surgeons, anesthesiologists and imaging specialists to evaluate patients for potential TAVR candidacy and that surgery is the preferred treatment for patients at low or intermediate risk. But they also say that TAVR is an alternative to surgical aortic valve replacement (SAVR) in patients at high surgical risk, Vahanian reported. Both documents recommended against performing TAVR in patients not likely to benefit due to the presence of comorbidities. “At every step of the recommendations, [the two documents] agree,” Vahanian concluded. 

However, in a presentation on the use of TAVR according to real-world practice, Axel Linke, MD, of University of Leipzig Heart Center in Leipzig, Germany, specified that in addition to indication for inoperable and high-risk patients, other candidates are those at intermediate risk and those aged over 80 years who are at low risk. Only patients aged below 80 years are “maybe” not indicated for the procedure, Linke said.

He cited results from the PARTNER trial and the CoreValve US Pivotal Trial demonstrating improved survival among high- or intermediate-risk patients treated with TAVR compared with SAVR. Linke also noted results from the PARTNER II S3 trial, which indicated better-than-expected mortality rates among TAVR patients, and from the NOTION trial, which showed no difference in survival for up to 2 years among low-risk patients treated with TAVR compared with SAVR.

During a third presentation, which focused on determining which patients are definitively not TAVR candidates, Thomas Walther, MD, PhD, of Kerckhoff HeartCenter, in Bad Nauheim, Germany, stressed the importance of an individualized approach. “I believe we need to look at individual patients,” he said. “There are good ones and bad ones; you need to think about individual risk and outcome options.” 

Factors that could influence TAVR candidacy include the presence of abnormal cardiac conditions such as aortic aneurysm or CAD, anatomical or morphological factors such as excessive calcification, endocarditis or the need for aortic root surgery or AV reconstruction, he said. Walther also noted that SAVR produces “excellent” outcomes in low-risk patients and that the long-term results and durability of TAVR have yet to be fully established. 

In the low-risk population, Walther said, certain “straightforward” patients, such as those with moderate calcification and symmetric distribution, are viable candidates for TAVR. However, younger, intermediate-risk patients or those with heavy, excentric calcification have “hostile” anatomy for TAVR, he added. 

Stressing the need for an experienced heart team, Walther said the lack of such a team “is a contraindication for TAVR. … Expertise is very important.”

Disclosures:

• Linke reports relationships with multiple device companies.
• Vahanian reports receiving consultant/honoraria from Edwards Lifesciences and Medtronic.
• Walther reports no relevant conflicts of interest.