Lotus aortic valve system Source: Sadra Medical

Fueled by mounting data outlining the benefits of transcatheter aortic valve implantation (TAVI), an expert consensus document released Jan. 31 has created a map of proper TAVI use that includes the best practices for proper patient selection and treatment decisions.

The document, put forth by the American College of Cardiology Foundation (ACCF), the American Association for Thoracic Surgery (AATS), the Society of Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS), offers advice about when TAVI is most appropriate for patients.

"This is a new, transformational technology for our patients; we have never had this type of an approach before; it's not like another balloon catheter," David R. Holmes, Jr., MD, president of ACC and chair of the writing committee, said in a statement. "As this technology is introduced into practice, detailed and agreed upon protocols are needed to ensure we achieve optimal clinical results. This consensus document provides the field with clear recommendations and guidance for its use."

TAVI was approved for use by the FDA in November 2011, and already nearly 45,000 patients have undergone TAVI worldwide.

“TAVR [transcatheter aortic valve replacement] is appropriate currently only for a highly select population and the valve team should systematically identify the characteristics that define that population with most benefit and acceptable risk,” according to the statement. However, as technologies improve and operators gain experience, the authors noted that many of these criteria will expand to more patient populations.

TAVI is currently not recommended for patients with:

• An acceptable surgical risk for conventional surgical aortic valve replacement;

• Known bicuspid aortic valve;
• Severe mitral annular calcification or severe mitral regurgitation; and
• Moderate aortic stenosis.

Due to the challenging nature of TAVI, it is recommended that both cardiologists and surgeons be present during procedure. “The most important considerations are team-based care, identification of a specific team leader, close communication and preplanning for outlining management of potential complications,” according to the statement. Additionally, a team-based approach to post-procedural care is important.

The consensus also focused on TAVI screening. In fact, the authors offered that screening should be integrated into each TAVI evaluation, but noted that the specific imaging protocols will vary from hospital to hospital. Some of the information pieces necessary to appropriately screen include: data to calculate STS score, preprocedural imaging for planning, assessing the annular size for device selection and assessment of the arterial anatomy.

The consensus statement also outlined the following:

• Site selection: The guidelines recommend that facilities should have experience with structural heart disease and said that all heart team members should be available on-site. Additionally, centers should providing access to the technology to patients;
• Center and Physician Experience: Performing 50 procedures within the past 12 months is the recommended number;
• Procedural Performance: TAVI should take place in hybrid rooms or cardiac catheterization laboratories. Additionally, imaging and intraprocedural echocardiograms are required for cardiopulmonary bypass to avoid complication;
• Postprocedural Care: While the authors said that postprocedural care depends on the comorbidities present, they also noted that a dedicated recovery room should be set up for patients to receive optimal postprocedural care;
• Registries: Registries should include demographic and mortality outcomes to effectively compare the various strategies to help improve outcomes.

"We have tried to collate the evidence into a coherent road map for judicious use, rational dispersion, and careful postmarketing scrutiny of this promising technology," said Sanjay Kaul, MD, a cardiologist at Cedars-Sinai Heart Institute in Los Angeles and vice chair of the writing committee. “It is now the collective responsibility of all the stakeholders to optimize its full potential for improving the duration as well as the quality of survival in patients with severe symptomatic aortic valvular stenosis."