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Percutaneous Heart Valve Replacement
Comparative Effectiveness Technical Briefs, No. 2
Investigators: John W Williams, Jr, MD, MHS, Remy Coeytaux, MD, PhD, Andrew Wang, MD, and Donald D Glower, MD.
Author Information and AffiliationsAbstract
Objectives:
To describe the types of prosthetic heart valves now in use and in development, summarize clinical studies completed or under way, and discuss factors that may impact clinical outcomes for percutaneous heart valve (PHV) replacement.
Data Sources:
MEDLINE®, EMBASE®, and gray literature sources.
Review Methods:
We searched the English-language literature to identify systematic reviews and comparative clinical studies of conventional heart valves and studies of PHVs in adults. We define PHV replacement as the delivery of a prosthetic heart valve via a catheter inserted either through a vein or artery (femoral vein; femoral, subclavian, or axillary arteries; or the ascending aorta) or through the apex of the heart via an incision in the chest wall (transapical approach).
Results:
We identified numerous mechanical and bioprosthetic heart valves. Six systematic reviews compared various conventional valves; the single high-quality review found better short-term hemodynamic performance but longer operating times with stentless compared to stented bioprosthetic valves. A large primary literature (57 randomized controlled trials [RCTs], 40 observational studies) compares various conventional heart valves.
Seven manufacturers of PHVs were identified in 62 fully published case reports or non-comparative case series that studied 856 unique patients. All but 19 of these patients received valves produced by one of two PHV manufacturers. The route of access was via the femoral artery in 580 patients (68 percent). The transapical approach was used in 223 patients (26 percent). The route of access for the remaining 53 patients (6 percent) was via the femoral vein, subclavian artery, axillary artery, or ascending aorta. All but two of the prosthetic valves were implanted in the aortic valve position in patients with symptomatic aortic stenosis at high operative risk. Successful implantation was achieved in 92 percent of patients; 30-day survival was 86 percent. The lack of comparative studies limits the ability to determine which variables associated with PHV replacement are causally related to outcomes. A multicenter RCT comparing PHV to conventional heart valve replacement or medical management is currently underway in the United States.
Conclusions:
A large number of heart valve prostheses are in use, but there are limited data to inform the selection of one valve over another. There is sufficient existing primary literature to support systematic reviews or meta-analyses to help inform several important clinical questions pertaining to conventional heart valve replacement. PHV replacement is a rapidly emerging technology that has been proven feasible and is a promising therapeutic option for patients with severe, symptomatic aortic stenosis who have a higher risk of poor outcome with surgical aortic valve replacement. Well-designed observational studies and decision modeling could help inform clinical and health policy in the absence of RCTs.
Contents
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-02-0025. Prepared by: Duke Evidence-based Practice Center.
Suggested citation:
Williams JW, Coeytaux R, Wang A, Glower DD. Percutaneous Heart Valve Replacement. Technical Brief No. 2. (Prepared by Duke Evidence-based Practice Center under Contract No. 290-02-0025.) Rockville, MD: Agency for Healthcare Research and Quality. August 2010. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0025). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850. www
.ahrq.gov
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- Percutaneous Heart Valve ReplacementPercutaneous Heart Valve Replacement
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