Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: A mechanical circulatory support system for a heart having a cooling element and a method for using the system to treat the effects of a cardiac episode. The support system has a pump comprising a rotor, the rotor having at least one blade. The system also has a catheter having an inner surface and an outer surface, the catheter extending proximally relative to the pump housing. The outer surface of the catheter is configured to contact blood when disposed within patient vasculature. The outer surface of the catheter comprises a heat transfer surface configured for cooling blood that comes in contact with the outer surface. The support system is operated to provide a temperature selected to cool the circulating blood in contact with the outer surface of the catheter to a temperature selected to reduce or prevent an effect of a cardiac episode.

Abstract: We provide herein a method of preventing or limiting the effects of heart failure in a human patient that has sustained myocardial infarction by reducing maladaptive cardiac remodeling in the patient. The method comprises percutaneously inserting a transvalvular blood pump, comprising a rotor and a cannula, into the patient's vasculature and positioning the cannula across the aortic valve of the patient's heart, with a distal end of the cannula located in the left ventricle of the heart and a proximal end of the pump located in the aorta. The method then comprises, prior to reperfusing the heart, operating the positioned pump to unload the left ventricle at a pumping rate of at least 2.5 L/min of blood flow for a support period between at least 30 minutes and less than 60 minutes. Then, after the support period, the method comprises applying coronary reperfusion therapy to the heart.

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: The systems and methods described herein determine metrics of cardiac or vascular performance, such as cardiac output, and can use the metrics to determine appropriate levels of mechanical circulatory support to be provided to the patient. The systems and methods described determine cardiac performance by determining aortic pressure measurements (or other physiologic measurements) within a single heartbeat or across multiple heartbeats and using such measurements in conjunction with flow estimations or flow measurements made during the single heartbeat or multiple heartbeats to determine the cardiac performance, including determining the cardiac output. By utilizing a mechanical circulatory support system placed within the vasculature, the need to place a separate measurement device within a patient is reduced or eliminated. The system and methods described herein may characterize cardiac performance without altering the operation of the heart pump (e.g., without increasing or decreasing pump speed).

Abstract: The systems and methods described herein determine metrics of cardiac or vascular performance, such as cardiac output, and can use the metrics to determine appropriate levels of mechanical circulatory support to be provided to the patient. The systems and methods described determine cardiac performance by determining aortic pressure measurements (or other physiologic measurements) within a single heartbeat or across multiple heartbeats and using such measurements in conjunction with flow estimations or flow measurements made during the single heartbeat or multiple heartbeats to determine the cardiac performance, including determining the cardiac output. By utilizing a mechanical circulatory support system placed within the vasculature, the need to place a separate measurement device within a patient is reduced or eliminated. The system and methods described herein may characterize cardiac performance without altering the operation of the heart pump (e.g., without increasing or decreasing pump speed).

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: The systems, devices, and methods presented herein use a heart pump to obtain measurements of cardiovascular function. The heart pumps described herein can operate in parallel with and unload the heart. The system can quantify the functioning of the native heart by measuring certain parameters/signals such as pressure or motor current, then calculate and display one or more metrics of cardiovascular function. These metrics, such as left ventricular end diastolic pressure (LVEDP), left ventricular pressure, and contractility, provide valuable information to a user regarding a patient's state of heart function and recovery.

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: A mechanical circulatory support system for a heart having a cooling element and a method for using the system to treat the effects of a cardiac episode. The support system has a pump having a distal end and a proximal end, the pump comprising a rotor, the rotor having at least one blade. The system also has a catheter having a distal end, a proximal end, and inner surface, and an outer surface, the catheter extending proximally of relative to the pump housing. The outer surface of the catheter is configured to contact blood when disposed within patient vasculature. The outer surface of the catheter comprises a heat transfer surface configured for cooling blood that comes in contact with the outer surface. The cooling element can be either a helix or double helix extending along a catheter surface or a Peltier element on the surface.

Abstract: Methods and systems for using mechanical circulatory support concurrently with a biologic therapy (e.g. a gene therapy vector). Particular adaptations include a cardiac therapy method in which a blood vessel such as a coronary artery or blood vessel is occluded, followed by injecting a gene therapy vector or biologic distal to the occlusion site and waiting a certain amount of time, while using the mechanical circulatory support system to provide circulatory support to the patient.

Abstract: Systems and methods for improving kidney function. A first mechanical circulatory support system (MCS) is introduced in a patient's heart, and a second mechanical circulatory support system is introduced in a patient's inferior vena cava or renal vein. The second mechanical circulatory support system is operated while the first mechanical circulatory support system is operating. A renal parameter is monitored during. Combined operation of the two mechanical circulatory support systems results in a change in renal parameter, e.g. pressure drop in the renal vein, indicating an improvement in kidney function. Once the renal parameter is determined to be below a target threshold, operation of the second mechanical circulatory support device is stopped.

Abstract: The systems and methods described herein determine metrics of cardiac or vascular performance, such as cardiac output, and can use the metrics to determine appropriate levels of mechanical circulatory support to be provided to the patient. The systems and methods described determine cardiac performance by determining aortic pressure measurements (or other physiologic measurements) within a single heartbeat or across multiple heartbeats and using such measurements in conjunction with flow estimations or flow measurements made during the single heartbeat or multiple heartbeats to determine the cardiac performance, including determining the cardiac output. By utilizing a mechanical circulatory support system placed within the vasculature, the need to place a separate measurement device within a patient is reduced or eliminated. The system and methods described herein may characterize cardiac performance without altering the operation of the heart pump (e.g., without increasing or decreasing pump speed).

Abstract: The systems and methods described herein determine metrics of cardiac performance via a mechanical circulatory support device and use the cardiac performance to calibrate, control and deliver mechanical circulatory support for the heart. The systems include a controller configured to operate the device, receive inputs indicative of device operating conditions and hemodynamic parameters, and determine vascular performance, including vascular resistance and compliance, and native cardiac output. The systems and methods operate by using the mechanical circulatory support device (e.g., a heart pump) to introduce controlled perturbations of the vascular system and, in response, determine heart parameters such as stroke volume, vascular resistance and compliance, left ventricular end diastolic pressure, and ultimately determine native cardiac output.

Abstract: Small diameter tools are provided, and methods of use described, to facilitate less invasive surgical procedures employing laser beams. Such tools include distal tips that enhance the precise placement of optical waveguides, as well as enable cutting and dissecting procedures. A rotary coupler allows precise control of flexible conduits in which waveguides may be disposed. Waveguide tips with conical features protect waveguide ends and allow unobstructed propagation of the laser beam out of the waveguide. A preferentially bending jacket for waveguides may be used to control an orientation of a waveguide disposed therein. Surgical waveguide assemblies may include various combinations of these components.

Abstract: We provide herein a method of preventing or limiting the effects of heart failure in a human patient that has sustained myocardial infarction by reducing maladaptive cardiac remodeling in the patient. The method comprises percutaneously inserting a transvalvular blood pump, comprising a rotor and a cannula, into the patient's vasculature and positioning the cannula across the aortic valve of the patient's heart, with a distal end of the cannula located in the left ventricle of the heart and a proximal end of the pump located in the aorta. The method then comprises, prior to reperfusing the heart, operating the positioned pump to unload the left ventricle at a pumping rate of at least 2.5 L/min of blood flow for a support period between at least 30 minutes and less than 60 minutes. Then, after the support period, the method comprises applying coronary reperfusion therapy to the heart.

Abstract: Small diameter tools are provided, and methods of use described, to facilitate less invasive surgical procedures employing laser beams. Such tools include distal tips that enhance the precise placement of optical waveguides, as well as enable cutting and dissecting procedures. A rotary coupler allows precise control of flexible conduits in which waveguides may be disposed. Waveguide tips with conical features protect waveguide ends and allow unobstructed propagation of the laser beam out of the waveguide. A preferentially bending jacket for waveguides may be used to control an orientation of a waveguide disposed therein. Surgical waveguide assemblies may include various combinations of these components.