Heart Failure
Evidence
EVIDENCE FOR HEART FAILURE PATIENTS
The Aquadex® System has been studied in more patients than any other ultrafiltration system.
CLINICAL STUDIES
Highest level of evidence: Level 1 (randomized controlled clinical trials)7
| Study Name | Study Design | Patients | Rationale | Results Summary | Pub. Date |
|---|---|---|---|---|---|
| SAFE1 | Multi-center, prospective, single arm | 21 | IDE for 501k | Safety: Removal of intravascular excess fluid can be safely achieved via peripherally inserted intravenous catheters |
2003 JF |
| EUPHORIA2 | Single-center, prospective, single-arm | 20 | Early Ultrafiltration (UF) in diuretic resistant patients |
Efficacy: UF before IV diuretics effectively and safely decreases length of stay and readmissions |
2004 JACC |
| RAPID-HF3 | Multi-center, prospective, RCT | 40 | Early UF vs Diuretics | Early application of UF for patients with chronic HF was feasible, well-tolerated, and resulted in significant weight loss and fluid removal |
2005 JACC |
| UNLOAD4 | Multi-center, prospective, RCT | 200 | UF vs SC |
|
2007 JACC |
| CARRESS-HF5 | Multi-center, prospective, RCT | 188 | UF vs SC in patients with cardiorenal syndrome |
|
2012 NEJM |
| AVOID-HF6 | Multi-center, prospective, RCT | 224 | UF vs SC to evaluate readmissions |
|
2016 JACC:HF |
Sources:
1. Jaski BE et al. J Card Fail. 2003; 9(3): 227-32.
2 Costanzo MR et al. JACC. 2005; 46(11): 2047-52.
3. Bart BA et al. JACC. 2005; 46(11): 2043-47.
4. Costanzo MR et al. JACC. 2007; 49(6): 675-83.
5. Bart BA et al. NEJM. 2012; 367: 2296-304.
6. Costanzo MR et al. JACC. 2012; 4(2): 95-105.
7. Level of Evidence Grading Scale as Adapted from the Oxford Centre for Evidence-based Medicine (2009)
THE CARRESS-HF STUDY
A reflection on the original findings and what has been learned since 2012.
KEY TAKEAWAYS
Ultrafiltration vs. pharmacological therapy was associated with more fluid removal but also rise in serum creatinine and neurohormonal activation. Additionally, loop diuretic use vs. UF was associated with an increase in serum bicarbonate despite less decongestion, data which question the commonly held conception of a ‘contraction alkalosis’.
Ten years of real-world data with ultrafiltration (UF) for the management of ADHF patients
Retrospective, single-center analysis of 335 consecutive acutely decompensated heart failure patients treated with adjustable-rate ultrafiltration using the Aquadex FlexFlow® System from 7/28/2009 to 6/30/2019.
Source: 1. Watson R, et al. J Card Fail. 2020; 26(10): S56. 2. Costanzo MR, et al. JACC. 2017; 69(19):2428-2445.
KEY TAKEAWAYS
- All patients had a stable renal function at follow-up
- Compared with previous UF trials (UNLOAD, CARRESS & AVOID), real-world experience demonstrates
that UF compares favorably for HF re-hospitalizations, renal function response, and weight/volume loss - Real-world experience allowed for the adjustment of UF rate during therapy, which contributed to favorable outcomes
- UF is a safe and effective strategy for decongestion
- Hospitalizations per patient per year decreased, on average, by 81% from twice a year to once every
two and a half years - Rehospitalizations for patients after receiving ultrafiltration with Aquadex was 48% less than the
National Average at 30 days
AQUADEX IN AN OUTPATIENT SETTING
BREAKING THE CYCLE OF HF REHOSPITALIZATIONS
Your Nuwellis Territory Manager and Clinical Education Specialist can work with you to develop a tailored Outpatient Aquadex Program.
Sources:
1. Gheorghiade M, et al. Eur Heart J Suppl. 2005;7:B13-9.
2. Premier Applied Sciences Database
3. Costanzo MR, et al. J Am Coll Cardiol. 2017 May 16;69(19):2428-2445.
4. Emani S, et al. Poster from The 16th Annual Scientific Meeting of HFSA. 2012.
5. Chung ES, O’Brien TM et al. Korean Circ J. 2014; 44(3): 151-61.
META-ANALYSES OF ULTRAFILTRATION
PEER REVIEWS
AQUADEX IN HEALTHCARE ECONOMICS
PROFESSIONAL SOCIETY GUIDELINES
Professional societies provide valuable support to the medical community. Their focus on ethics and advancing clinical standards are essential to improving the quality of care. Ultrafiltration is supported in the following clinical guidelines:
