Authors' objectives:

VHA’s TAAG asked the Technology Assessment Program (TAP) for a review to support use of ultrafiltration in decompensated heart failure patients in VA patient care.

Authors' recommendations: One ultrafiltration device, the Aquadex FlexFlow system (CHF Solutions, Brooklyn Park MN) has been FDA approved for marketing in the US since December 2006 for temporary (up to eight hours) treatment of patients with fluid overload who have failed diuretic therapy and for extended (longer than eight hours) treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.FDA stipulates that treatment be administered by a health care provider under physician supervision and that both provider and physician have been trained in extracorporeal therapies. FDA’s approval letter does not explicitly reference published studies, but it is reasonable to assume that FDA reviewers identified the same trials included by Colechin (2007; Appendix Table 2), with the exception of Costanzo (UNLOAD trial; 2007 and 2010 also in Appendix Table 2), which was published after the date of the FDA letter and remains the only RCT to address ultrafiltation. Colechin (2007) thus provides the most recent and comprehensive systematic review of ultrafiltration for acute decompensated heart failure and provides the core evidence considered by TAP in the present review.TAP identified no recently published evidence to materially change NHS/CEP conclusions (Colechin, 2007):“CEP finds that ultrafiltration has significant potential to become a routine therapy for excess fluid removal in patients with congestive heart failure. However, further work is needed to establish the patient groups who would benefit most, the optimal rates of fluid removal, the conditions for termination of therapy, and the cost savings associated with long-term quality of life benefits.”These conclusions can be transferred to the US in 2010. Additional shortcomings of the available literature include those elaborated by Colechin and: Lack of blinding, which may be understandably difficult in the case of a bulky bedside device; Lack of explicit power calculations and correspondingly small numbers of patients in clinical trials, which may reflect the relative lack of reliable estimates of clinically significant effects for ultrafiltration in available research on which such calculations would be based; Lack of follow up beyond two to three months; Reliance on intermediate or surrogate outcomes such as fluid volume removed or weight lost, rather than longer term outcomes such as quality of life or heart failure-specific mortality. The device manufacturer is a significant presence in the only published (Costanzo, 2007; 2010) and ongoing trials (Table 3).The systematic reviews and assessments in Table 1 do not report significant adverse events or safety concerns, but studies may not have been adequately powered or followed patients for long enough to detect uncommon adverse events. Post-marketing surveillance for a device only available since late 2006 may also be inadequate for detecting uncommon or late adverse events. Kidney dysfunction with overzealous volume reduction has been observed (Testani, 2010) and is under investigation for ultrafiltration (Appendix Table 3).The related reviews sections of Tables 1 and 2 provide insights into organization of care interventions that may reduce incidence of acute decompensation and the need for ultrafiltration: patient education for self-monitoring, comprehensive discharge planning with post-discharge support, telemonitoring, and multidisciplinary management have been shown to improve CHF outcomes and reduce rehospitalization rates.Finally, TAP’s searches of AHRQ’s database of ongoing trials (www.clinicaltrials.gov; detailed in Appendix Table 3) failed to identify in-progress studies likely to provide definitive answers any time in the near future. Studies listed in Table 3 continue to focus on a research agenda similar to that outlined by Colechin: patient selection and technical refinement rather than large multicenter trials for longer-term outcomes.

Project Status: Completed

URL for project: http://www4.va.gov/VATAP/docs/Ultrafiltration2010.pdf

Year Published: 2010

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: VA Technology Assessment Program

Contact Address: Liz Adams, VA Technology Assessment Program, Office of Patient Care Services (11T), VA Boston Healthcare System Room 4D-142, 150 South Huntington Avenue, Boston, MA 02130 USA Tel: +1 617 278 4469; Fax: +1 617 264 6587;

Contact Name: elizabeth.adams@med.va.gov

Contact Email: elizabeth.adams@med.va.gov

Copyright: VA Technology Assessment Program (VATAP)