Authors' objectives:

This Assessment evaluates the available evidence to determine the effect on health outcomes of using microvolt T-wave alternans (MTWA) testing to risk stratify patients who might be considered for implantable cardioverter defibrillator (ICD) therapy for primary prevention of sudden death.

Authors' recommendations: Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether microvolt T-wave alternans testing for risk stratifying patients being considered for ICD therapy for primary prevention of sudden death meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria. 1. The technology must have final approval from the appropriate governmental bodies. Microvolt T-wave alternans (MTWA) testing may be performed using a commercially available system called the Heartwave Alternans Processing System marketed by Cambridge Heart, Inc. This system received 510(k) clearances on November 17, 2002 (K03564) and July 16, 2002 (K022152). 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes. The available evidence on MTWA is insufficient to permit conclusions regarding the effect on health outcomes. 3. The technology must improve the net health outcome, and 4. The technology must be as beneficial as any established alternatives. The evidence is insufficient to determine whether the use of MTWA improves net health outcome or whether it is as beneficial as any established alternatives. 5. The improvement must be attainable outside the investigational settings. Whether the use of MTWA improves health outcomes is not established in the investigational settings. Therefore, the use of microvolt T-wave alternans testing for risk stratifying patients being considered for implantable cardioverter defibrillator therapy for primary prevention of sudden death does not meet the TEC criteria.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.bcbs.com/blueresources/tec/contact-tec.html

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: BlueCross BlueShield Association

Contact Address: BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321

Contact Name: tec@bcbsa.com

Contact Email: tec@bcbsa.com

Copyright: BlueCross BlueShield Association (BCBS)