Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Who Cannot Undergo Surgery

Recommendations of Others

Blue Cross Blue Shield Association (BCBSA)

No reports on this technology were found at the BCBSA Technology Evaluation Center website.

Canadian Agency for Drugs and Technologies in Health (CADTH)

CADTH has been tracking and publishing reports on transcatheter aortic valve replacement since 2005; these reports can be found at https://www.cadth.ca/en/search?q=sapien+valve. These reports display the evolving TAVR research and findings between June 2005 and October 2011. Of relevance to this assessment are the Rapid Response Reports from October 2011:

1. Report: Rapid Response: Transcatheter Aortic Valve replacement for Aortic Stenosis: Competency: 20 October 2011. The report stated that there is no evidence-based literature available to help determine the annual number of TAVR procedures required to maintain competency and/or expertise in performing the procedure.

2. Report: Rapid Response: Transcatheter Aortic Valve Implantation for Aortic Stenosis: A Review of the Clinical Effectiveness and Guidelines, 28 October 2011. The report conclusion states that:

TAVR represents a viable alternative for patients with severe aortic valve stenosis who are not eligible to standard surgery treatment, with statistically significant clinical benefits. However, long-term success and complication rates of the procedure are uncertain at the present time. No evidence that met the study inclusion criteria regarding procedural access points was identified. Existing guidelines and reviews suggested that strict patient selection and procedural considerations following consultation with a multidisciplinary team are vital to the success of TAVR."

National Institute for Health and Clinical Excellence (NICE)

NICE issued full guidance for TAVI/TAVR for aortic stenosis in June 2008. NICE is reassessing the guidance and underwent a consultation period which closed on August 22, 2011. The 2008 guidance as well as all consultation comments can be found at https://guidance.nice.org.uk/IPG266. The Interventional Procedures Advisory Committee (IPAC) is reviewing the guidance and the consultation comments to determine the safety and efficacy of the procedure. The date of publication for the reassessment including outcomes of the consultation period and any changes to the current guidance document is unknown.

Centers for Medicare and Medicaid Services (CMS)

On September 22, 2011, the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC) submitted a formal request to CMS to develop a National Coverage Determination (NCD) for TAVR. The proposed decision memo will be released on 3/28/2012 and the expected National Coverage Analysis (NCA) completion date is 6/26/2012. The National Coverage Analysis Tracking Sheet for TAVR can be found at https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=257&ver=1&NcaName=Transcatheter%20Aortic%20Valve%20Replacement%20(TAVR)&bc=AiAAAAAAIAAA&.

American Association for Thoracic Surgery (AATS)

AATS was invited to provide an opinion on the technology and to send a representative to participate at the meeting. AATS provided a written opinion on this technology and sent a representative to participate at the meeting.

Society of Thoracic Surgeons (STS)

STR was invited to provide an opinion on the technology and to send a representative to participate at the meeting. STS provided a written opinion on this technology and sent a representative to participate at the meeting.

American College of Cardiology (ACC), CA Chapter

The California Chapter of the ACC was invited to provide an opinion on the technology and to send a representative to participate at the meeting. ACC provided a written opinion on this technology and sent a representative to participate at the meeting.

The Society for Cardiac Angiography and Interventions (SCAI)

SCAI was invited to provide an opinion on the technology and to send a representative to participate at the meeting. SCAI provided a written opinion on this technology and sent a representative to participate at the meeting.

Advanced Medical Technology Association (ADVAMED)

ADVAMED was invited to provide an opinion on the technology and to send a representative to participate at the meeting. ADVAMED did not provide an opinion on this technology and did not send a representative to participate at the meeting.

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