EP-4735091-A1 - A SYSTEM TO TREAT HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF)

Abstract

A system to treat heart failure with preserved ejection fraction (HFpEF) is described. The system comprises a blood pumping device (120) configured for implantation in a left ventricle (31) of a heart of a subject, in which the blood pumping device is configured to draw blood from a left atrium (30) into the left ventricle (31) of the heart through a mitral valve (34) upon activation, an anchoring assembly (122) for anchoring the blood pumping device to the heart, and a connector (125) rigidly connecting the anchoring assembly (122) to the blood pumping device (120) in a spaced-apart relationship to allow the blood pumping device to be positioned in the left ventricle and the anchoring assembly to be anchored at an anatomical location in or adjacent to the heart and distant to the left ventricle, wherein the system is configured for percutaneous delivery to the heart.

Inventors

• Hameed, Aamir
• Malone, Andrew
• COLGAN, DARRAGH
• HICKEY, Donald

Assignees

• Royal College of Surgeons in Ireland

Dates

Publication Date

20260506

Application Date

20240628

Claims (17)

1. 1. A system to treat heart failure with preserved ejection fraction (HFpEF), the system comprising: a blood pumping device (120) configured for implantation in a left ventricle (31) of a heart of a subject, in which the blood pumping device is configured to draw blood from a left atrium (30) into the left ventricle (31) of the heart through a mitral valve (34) upon activation; an anchoring assembly (122) for anchoring the blood pumping device to the heart; and a connector (125) connecting the anchoring assembly (122) to the blood pumping device (120) in a spaced-apart relationship to allow the blood pumping device to be positioned in the left ventricle and the anchoring assembly to be anchored at an anatomical location in or adjacent to the heart and distant to the left ventricle. wherein the system is configured for percutaneous delivery to the heart.
2. 2. A system according to Claim 1 , in which the connector is configured to locate the anchoring assembly in the pulmonary vein or left atrium when the blood pumping device is located in the left ventricle.
3. 3. A system according to Claim 2, in which the connector is configured to locate the anchoring assembly in the left atrium when the blood pumping device is positioned in the left ventricle.
4. 4. A system according to any preceding Claim, in which the blood pumping device has a blood inlet end, in which the connector has a proximal end coupled to the anchoring assembly and a distal end coupled to the blood inlet end of the pumping device.
5. 5. A system according to any preceding Claim, in which the anchoring assembly is or comprises an expandable frame adjustable between a contracted delivery configuration and an expanded anchoring configuration dimensioned to anchor the expanded anchoring assembly in a chamber of the heart other than the left ventricle by exerting a radial or outward pressure against the walls of the chamber.
6. 6. A system according to Claim 5, in which the expandable frame is selfexpandable.
7. 7. A system according to Claim 5 or 6, in which the expandable frame is configured to expand to a shape that abuts the wall of the left atrium and anchors the frame in the left atrium.
8. 8. A system according to any of Claims 5 to 7, in which the expandable frame comprises a distal annular hub (122A), a proximal annular hub (122B), and a plurality of elongate struts (1213) extending between the distal annular hub and the proximal annular hub, in which the elongate struts are configured for adjustment from a relaxed outwardly curved configuration to a tensioned straight configuration.
9. 9. A system according to any preceding Claim, including an elongated delivery catheter having a lumen configured to receive the blood pumping device and the anchoring assembly in a contracted delivery configuration, and an elongated delivery shaft having a distal end configured for detachable coupling to the blood pumping device.
10. 10. A system according to any preceding Claim, in which the blood pumping device comprises: a housing comprising a fluid inlet, a fluid outlet, and a lumen extending through the housing from the fluid inlet to the fluid outlet; a rotor disposed in the housing; an impeller disposed on the rotor; and a motor operably coupled to the rotor for rotation thereof upon activation, in which the blood pumping device is configured to draw fluid through the housing from the inlet to the outlet upon activation.
11. 11. A system according to any preceding Claim, in which the blood pumping device comprises two or more impellers disposed on the rotor.
12. 12. A system according to Claim 11 , in which vanes of a first impeller are disposed out of phase to vanes of a second impeller.
13. 13. A system according to any preceding Claim, comprising a controller configured to modify the output parameters of the blood pumping device so as to activate and deactivate the blood pumping device in a pattern synergistic with a cardiac cycle of the subject comprising activation during ventricular diastole and deactivation during ventricular systole.
14. 14. A system according to Claim 13, comprising at least one sensor in communication with the controller for detecting one or more parameters associated with the heart, wherein the controller is configured to modify the output parameters of the blood pumping device based on the one or more detected parameters received from the sensor.
15. 15. A system according to any preceding Claim, comprising an implantable power unit and a power lead configured to percutaneously electrically couple the implantable power unit and the blood pumping device.
16. 16. A system to treat heart failure with preserved ejection fraction (HFpEF), the system comprising: a blood pumping device (120) configured for implantation in a left ventricle (31) of a heart of a subject, in which the blood pumping device is configured to draw blood from a left atrium (30) into the left ventricle (31) of the heart through a mitral valve (34) upon activation; an anchoring assembly (122) for anchoring the blood pumping device to the heart; and a connector (125) connecting the anchoring assembly (122) to the blood pumping device (120) in a spaced-apart relationship to allow the blood pumping device to be positioned in the left ventricle and the anchoring assembly to be anchored at an anatomical location in or adjacent to the heart and distant to the left ventricle, wherein the system is configured for percutaneous delivery to the heart, in which the blood pumping device is dimensioned for percutaneous delivery to the left ventricle of the heart inside a delivery catheter of up to 32 Fr along a guidewire.
17. 17. A system to treat heart failure with preserved ejection fraction (HFpEF), the system comprising: a blood pumping device (120) configured for implantation in a left ventricle (31) of a heart of a subject, in which the blood pumping device is configured to draw blood from a left atrium (30) into the left ventricle (31) of the heart through a mitral valve (34) upon activation; an anchoring assembly (122) for anchoring the blood pumping device to the heart; and a connector (125) connecting the anchoring assembly (122) to the blood pumping device (120) in a spaced-apart relationship to allow the blood pumping device to be positioned in the left ventricle and the anchoring assembly to be anchored at an anatomical location in or adjacent to the heart and distant to the left ventricle, wherein the system is configured for percutaneous delivery to the heart, in which the anchoring assembly comprises a self-expanding frame that is adjustable between a contracted delivery configuration and an expanded anchoring configuration dimensioned to anchor the expanded frame in the left atrium by exerting an outwards force against a wall of the left atrium.

Description

TITLE A system to treat heart failure with preserved ejection fraction (HFpEF) Field of the Invention The present invention relates to a system to treat heart failure with preserved ejection fraction (HFpEF). The invention also relates to a method of treating heart failure with preserved ejection fraction (HFpEF), and a method of relieving or preventing secondary pulmonary hypertension. Background to the Invention Heart failure is defined as the inability of the heart to supply adequate blood to the body. As the demographics suggest, with an increasing ageing population, prevalence of heart failure is also increasing. The cardinal manifestations of HF are dyspnea and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary and/ or splanchnic congestion and/or peripheral oedema. Heart cycle has two phases; a contraction phase when heart pumps the blood to the whole body and the relaxation phase when heart is filled with blood. Heart failure associated with the contraction phase (systole) includes HF with reduced ejection fraction (HFrEF), a condition commonly caused by ischemic heart disease that leads to decrease in stroke volume and cardiac output which results in the activation of neurohormonal response in order to restore the normal cardiac output. Left ventricular assist devices have been developed to assist the heart during the contraction phase, including pump devices designed to assist the pumping of blood into the aorta during diastole (contraction), and contractile devices designed to be implanted between two walls of the left ventricle that reciprocate in a pattern synergistic with the heart rhythm to assist the contraction of the left ventricle during systole. Pump devices for treatment of HFrEF are described in US2016/000983 and US7942804. Heart disease associated with the relaxation phase of the heart cycle (diastole) includes Heart failure with preserved ejection fraction (HFpEF). HFpEF is a clinical syndrome in which patients have symptoms and signs of HF with normal or near normal left ventricular ejection fraction (LVEF >50 percent). During early diastole phase of the cardiac cycle, the healthy LV acts as a ‘vacuum cleaner’ that enhances the suction particularly during exercise. In HFpEF, cardiomyocyte stiffness results in the loss of this relaxation enhancement, hence normal LV filling is dependent on high left atrial (LA) pressure to push blood into the LV. This pressure elevation can further cause atrial remodeling and secondary pulmonary hypertension, predisposing patients to develop atrial fibrillation and right ventricular (RV) dysfunction. Each 10 mm Hg increment in pulmonary artery pressure in patients with HFpEF was found to be associated with a 28% increase in 3-year mortality 3. Hence, there is a need to effectively control the death rate from HFpEF. To date, no pharmacological treatment has yet been shown to reduce morbidity and mortality in patients with HFpEF in randomised clinical trials, mainly due to the pathophysiological heterogeneity of the disease. Current treatment strategies as per the American Heart Association (AHA) and European Society of Cardiology (ESC) focus on treating the comorbidities and use of diuretics to relieve congestion. Transcatheter left to right interatrial shunt devices (REDUCE LAP-HF-I) have been proposed as a possible treatment for HFpEF, although right ventricular (RV) volume overloading and subsequent RV failure and worsening of secondary pulmonary hypertension may be an issue with these shunt devices. A left ventricular implantable device that applies direct internal expansion forces to increase the LV volume (CORolla) has also been proposed as a possible treatment for HFpEF. In theory, expansive elements in the CORolla device could be used for the treatment of all forms of HFpEF, however performance of such a device would likely be heavily dependent on the degree of cardiac remodeling, which varies significantly over HFpEF phenotypes. W02020/081481 describes an implantable device to treat HFpEF comprising a pump that is attached to the mitral valve and is controlled to pump blood from the left atrium to the left ventricle during the cardiac cycle where the pump operates continuously between a low pumping speed (first current) during myocardial perfusion during diastole and a high pumping speed (second current) during the rest of the cardiac cycle. The constant operation of the pump is required as it is attached to the mitral valve and therefore prevents the mitral valve ever fully closing. Thus, during ventricular systole, when the mitral valve is normally fully closed, it is necessary to actuate the pump at high speed to prevent backflow of blood from the left ventricle into the left atrium. The low pumping speed during diastole is required to prevent compression of the left ventricle during diastole. Attaching the pump via a sewing cuff to the mitral valve is a complicated procedure. In addition, the