Authors:

D Haberman¹ , M Jonas¹ , L Zilberman¹ , I Fungenfirov¹ , S Goland¹ , K George¹ , MR Costanzo² , WT Abraham³ , ¹Kaplan Medical Center, Heart Center - Rehovot - Israel , ²Advocate Heart Institute - Naperville - United States of America , ³Ohio State University Hospital, Division of Cardiovascular Medicine - Ohio - United States of America ,

Background:

Fluid overload leading to pulmonary and peripheral edema causes about 90% of all acute decompensated heart failure (ADHF) admissions. This excess in extracellular fluid volume resides in both the intravascular and interstitial spaces. Removal of fluid from the intravascular space is usually accomplished with diuretic therapy, while there is currently no direct means for enhancing fluid removal from the interstitial space, frequently resulting in intravascular volume depletion, hypotension, worsening renal function (WRF), and poor patient outcomes.  We evaluated a novel catheter-based system for the enhancement of lymphatic drainage in a first-in-human proof of concept study.

Methods: 

The White Swell System (White Swell Medical Ltd, Herzliya, Israel) increases the movement of interstitial fluid, via enhanced lymphatic system drainage, to the intravascular space and thus enables total body fluid volume excess to be removed from the body via the kidneys. This prospective, multi-center, single arm study evaluated the safety,  feasibility, and preliminary efficacy of the White Swell System in in ADHF patients. Performance measures of interest included device functioning, volume removal (diuresis), and changes in renal function, during treatment.

Results:

Ten hospitalized ADHF patients with signs of fluid over load were enrolled and 8 underwent the procedure; 2 patients did not complete the procedure due to technical issues. The average age was 73±6.7 years; 75% were men; 62.5% had reduced left ventricle ejection fraction (mean 29.25± 8.1%). On average, procedure duration was 6.4±2.44 hours, reduction in CVP was 6.4±4.3 mmH2O, urine output was 1.76±0.45 liters, and no WRF was observed. In fact, there was a mild post procedure reduction of creatinine levels seen in 7 out of 8 patients. There were no serious adverse events related to the procedure and no readmissions at 30-day follow up.

Conclusion:

In this pilot study, we found the White Swell system to be safe and feasible with initial promising results for the reduction of total body fluid overload in patients with ADHF. The combination of high volume diuresis with preservation or slight improvement in renal function supports additional clinical trials of this approach.