Can mechanical circulatory support be an effective treatment for HFpEF patients?

Abstract

Heart failure with preserved ejection fraction (HFpEF) is increasing in prevalence and represents approximately 50% of all heart failure (HF) patients. Patients with this complex clinical scenario, characterized by high filling pressures, and reduced cardiac output (CO) associated with progressive multi-organ involvement, have so far not experienced any significant improvement in quality of life or survival with traditional HF treatment. Left ventricular assist devices (LVAD) have offered a new treatment alternative in terminal heart failure patients with reduced ejection fraction (HFrEF), providing a unique combination of significant pressure and volume unloading together with an increase in CO. The small left ventricular cavity in HFpEF patients challenges left-sided pressure unloading, and new anatomical entry points need to be explored for mechanical pressure and volume unloading. Optimized and pressure/volume-adjusted mechanical circulatory support (MCS) devices for HFrEF patients may conceivably be customized for HFpEF anatomy and hemodynamics. We have developed a long-term MCS device for HFpEF patients with atrial unloading in a pulsed algorithm, leading to a significant reduction of filling pressure, maintenance of pulse pressure, and increase in CO demonstrated in animal testing. In this article, we will discuss HFpEF pathology, hemodynamics, and the principles behind our novel MCS device that may improve symptoms and prognosis in HFpEF patients. Data from mock-loop hemolysis studies, acute, and chronic animal studies will be presented.

A Multi-Domain Simulation Study of a Pulsatile-Flow Pump Device for Heart Failure With Preserved Ejection Fraction

“…To date, however, these studies have focused entirely on HFrEF, whereas investigations of the role that pulsatile-flow support may have on HFpEF patients have been broadly overlooked. This gap in the scientific literature has been emphasized by reports on the development of technologies that go beyond simple continuous-flow support, such as the PulseVAD (NorthernResearch, Oslo, Norway) device—a LA decompression pump with EKG-based adaptive outflow intended to adjust to patient-specific hemodynamics ( Gude and Fiane, 2021 ). Despite the development of these systems for HFpEF patients, no study has yet described the hemodynamic and biomechanical effects that pulsatile support has on the HFpEF physiology.…”

Novel approaches for left atrial pressure relief: Device-based monitoring and management in heart failure

“… Illustrations of each device. (A) Heart POD, quoted from ( 6 ); (B) Sensory implant of V-LAP System (black arrow is the pressure-sensing assembly connected to electronic circuitry), quoted from ( 6 ); (C) Sensor of V-LAP (yellow arrow), quoted from ( 15 ); (D) Corvia Atrial Shunt Device, quoted from ( 19 ); (E) PulseVAD, quoted from ( 30 ), and; (F) Left Atrial Assist Device, quoted from ( 32 ). …”

“…The PulseVAD is a pulsatile heart assist device and pumps blood from the LA to the descending aorta with minimally invasive surgery without cardiopulmonary bypass ( Figure 1E ). Gude and Fiane recently published the results of in vivo studies with the PulseVAD using ovine, and reported survival for 11 days after implantation without any complication ( 30 ).…”

Hemodynamic Evaluation of a Centrifugal Left Atrial Decompression Pump for Heart Failure with Preserved Ejection Fraction

“…The third option is to install a discharge system, such as a magnetic levitation centrifugal pump, which is about the size of a battery or pacemaker [ 17 , 18 ]. This device can discharge a reduced volume of blood, ranging from 0.05 to 0.50 L/min.…”