EDEN PRAIRIE, Minn., Oct. 07, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (NASDAQ:CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, today announced data from a retrospective study and a case study supporting the benefit of Aquadex™ therapy in the treatment of heart failure. These data were presented at the 24th Annual Scientific Meeting of Heart Failure Society of America.
The real-world retrospective study of 335 patients treated with the Aquadex FlexFlow® System, “10 years of real world data with UF for ADHF patients,”1 compared previous RCT trials with ultrafiltration (UF) and demonstrated that UF compares favorably in reducing heart failure (HF) rehospitalizations, renal function response, and weight/volume loss. Specific results included:
- Substantial mean fluid removal (14.58 liters) and weight loss (15.63 lbs), which was sustained at 1-2 weeks post follow-up.
- Improvement in reduced HF rehospitalization rates at 30, 90 days, and 1 year of 12.4%, 14.9%, 27.3% respectively.
- Mean serum creatinine (sCr) increase of +0.07-0.11 mg/dl recorded at time of stopping therapy, discharge, and follow up.
- On average, patients had 1.74 fewer hospitalizations for HF in the year following UF when compared to the year preceding UF.
- Major bleeding, defined as requiring discontinuation of anticoagulation, was 3.6 %
In comparison to previous randomized control trials focused on UF (AVOID2, CARRESS3, DOSE4, and UNLOAD5), patients in this study were older with worse renal function and greater HF hospitalizations in the year preceding UF therapy. The ability to adjust the rate of fluid removal with the Aquadex system is believed to be a major contributor to favorable outcomes. The study was conducted by Abington Hospital – Jefferson Health in Abington, Pennsylvania and funded by CHF Solutions.
The case study, “Outpatient Ultrafiltration to Prevent Hospital Readmissions During COVID-19 Pandemic in Diuretic Intolerant Patient: Case Study,”6 involved the successful outpatient treatment of a 70-year-old female with heart failure with preserved ejection fraction and pre- and post-capillary pulmonary hypertension. This patient did not respond to outpatient therapies and diuretics and experienced multiple hospitalizations due to recurrent congestion. Given the patient’s co-morbidities and high-risk status, the patient received UF treatment with the Aquadex SmartFlow™ system in an outpatient setting to avoid exposure to COVID-19. Over the course of 4 days, a total of 4950 ml of isotonic fluid was removed. The patient showed immediate improvement in clinical symptoms and was effectively stabilized in the outpatient setting at Advocate Good Samaritan Hospital in Downers Grove, Illinois.
“We are pleased with the results of these two studies confirming the benefits of Aquadex therapy in the treatment of heart failure patients, as demonstrated in previous studies and clinical observations, and the effectiveness of use in the outpatient setting to limit exposure to COVID-19,” said John Erb, Chairman and CEO of CHF Solutions. “We thank the teams at Abington Hospital – Jefferson Health and Advocate Good Samaritan Hospital for furthering data on the benefits of ultrafiltration.”