The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed Impella CP when both pumps were operated at their maximum speeds.
Second Heart Assist said its study utilized two identical in vitro blood circulatory loops. It compared the hemolytic effects of the devices under identical hemodynamic, temperature and all test conditions. The study adhered to standards defined by the FDA and set by the American Society for Testing and Materials.
According to a news release, the research involved testing five Whisper devices at 10,000 RPM. It compared Impella CP at approximately 44,133 RPM, necessary to match the flow rate of Whisper. Analysis used the tetramethylbenzidine method to measure plasma free hemoglobin, a key indicator of hemolysis.
Findings showed that Whisper had a lower change in plasma-free hemoglobin. Additionally, it “significantly outperformed” Impella CP in both the normalized index of hemolysis and the modified index of hemolysis.
Second Heart Assist said the study goes beyond Impella CP, with findings relative to all micro-axial pump designs.
“These results suggest that the Whisper device could potentially offer a far safer alternative in clinical settings where high rotational speeds are necessary, thereby reducing the risk associated with hemolysis,” Second Heart Assist said. “This may play a critical factor when selecting devices for therapeutic durations exceeding even just one hour before potential acute kidney injury (AKI) caused by high levels of hemolysis.”
More about the Whisper circulatory support device
Whisper, a catheter-based, minimally invasive device, utilizes a stent cage fitted with a motorized impeller. It aids in providing circulatory support throughout a patient’s body.
The system is intended for use in patients hospitalized with acute decompensated heart failure (ADHF) and who develop diuretic resistance with persistent congestion (cardio-renal syndrome (CRS), and/or cardiogenic shock (CS), and those in need of prophylactic hemodynamic support during high-risk percutaneous coronary intervention (HRPCI).
In a recent study, for which the company announced results in December, deployment of Whisper took less than 60 seconds after obtaining arterial access in the study. Removal took less than 30 seconds. Second Heart Assist says this makes it the easiest mechanical circulatory support device in the field to use.
All patients supported by Whisper demonstrated improvement in cardiac output and maintained stable hemodynamic function during support. They experienced minimal levels of hemolysis and successful outcomes with no adverse events.
