The present disclosure relates generally to ejection fraction, and in particular to measuring ejection fraction in a patient and triaging a patient for treatment.
Ejection fraction is a measurement of the amount of blood pumped out of a chamber of a heart with each contraction. Ejection fraction essentially compares the amount of blood in the chamber of the heart to the amount of blood pumped out of the chamber of the heart. Left ventricular ejection fraction is the ejection fraction of the left heart and indicates how effectively blood is being pumped by the heart into the systemic circulatory system. Traditionally, ejection fraction of a patient is measured through image tests, such an echocardiogram, a multigated acquisition (MUGA) scan, or a computerized tomography (CT) scan. Other tests used to determine ejection fraction include cardiac catheterization and nuclear stress testing. Each of these tests requires a highly-trained specialist to perform the test and interpret the results of the test. Thus, patients must travel to a cardiologist or other cardiovascular specialist to get an initial heart screening. These tests can be expensive and can possibly take days or weeks to inform the patient of their ejection fraction. A solution is needed that will provide greater access to ejection fraction screening for patients with less travel. Preferably, the solution will also reduce the amount of time patients must wait to get results from their ejection fraction screenings so patients can seek further testing and/or treatment with less delay.
In one example, a hemodynamic monitor is disclosed for detecting heart failure. The hemodynamic monitor includes a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller. The hemodynamic monitor also includes an integrated hardware unit with a system processor, a system memory, and a display with a user interface. The system memory includes instructions that, when executed by the system processor, are configured to: adjust, by the pressure controller, a pressure within the inflatable blood pressure bladder to maintain a constant volume of an artery of a patient for a period of time based on a feedback signal generated by the optical transmitter and the optical receiver; generate an arterial pressure waveform data of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time; extract a plurality of signal measures from the arterial pressure waveform data of the patient; extract input features from the plurality of signal measures that are indicative of an ejection fraction score of the patient; determine the ejection fraction score of the patient based on the extracted input features; generate a first sensory alarm signal configured to generate a first sensory alert that indicates that the patient has low ejection fraction when the ejection fraction score exceeds a threshold score, or generate a second sensory alarm signal configured to generate a second sensory alert that indicates that the patient does not have low ejection fraction when the ejection fraction score is below the threshold score; transmit the first sensory alarm signal or the second sensory alarm signal to the user interface; and output the first sensory alert or the second sensory alert through the user interface.
In another example, a hemodynamic monitor is disclosed for detecting heart failure. The hemodynamic monitor includes an arterial blood pressure sensor with a housing, a fluid input port connected via tubing to a fluid source, a catheter-side fluid port connected to a catheter inserted within an arterial system of a patient, a pressure transducer in communication with the fluid source through the fluid port, and an I/O cable in electrical communication with the pressure transducer. The hemodynamic monitor also includes an integrated hardware unit with a system processor, a system memory, a display comprising a user interface, and an analog-to-digital (ADC) converter. The system memory includes instructions that, when executed by the system processor, are configured to: receive an electrical signal from the pressure transducer over a period of time, the electrical signal based on a pressure of the arterial system of the patient transmitted through the fluid source; convert the electrical signal to a digital signal; generate an arterial pressure waveform data of the patient based on the digital signal; extract a plurality of signal measures from the arterial pressure waveform data; extract input features from the plurality of signal measures that are indicative of an ejection fraction score of the patient; determine the ejection fraction score of the patient based on the extracted input features; generate a first sensory alarm signal configured to generate a first sensory alert that indicates that the patient has low ejection fraction when the ejection fraction score exceeds a threshold score, or generate a second sensory alarm signal configured to generate a second sensory alert that indicates that the patient does not have low ejection fraction when the ejection fraction score is below the threshold score; transmit the first sensory alarm signal or the second sensory alarm signal to the user interface; and output the first sensory alert or the second sensory alert through the user interface.
In a further example, a method for triaging a patient for risk of heart failure is disclosed. The method includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. The hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data and extracts input features from the plurality of signal measures that are indicative of an ejection fraction of the patient. The hemodynamic monitor further determines the ejection fraction of the patient based on the input features and outputs the ejection fraction of the patient to a display. The hemodynamic monitor alerts and the patient or medical personnel that the ejection fraction is low when the ejection fraction is less than or equal to forty percent.
As described herein, a hemodynamic monitoring system uses an arterial waveform of a patient to detect an ejection fraction of a patient. The hemodynamic monitoring system uses machine learning to extract sets of input features from the arterial pressure of the patient. The sets of input features are used by the hemodynamic monitoring system to determine the ejection fraction of the patient while visiting an office of a primary care physician, while in an emergency care setting, or any other patient care environment.
Depending on the ejection fraction measured by the hemodynamic monitoring system, the hemodynamic monitoring system can raise a signal or an alarm to medical workers and/or the patient to alert the medical workers and/or the patient that the ejection fraction of the patient is low and the patient is at high risk for heart failure. The hemodynamic monitoring system is described in detail below with reference to
As further described below, hemodynamic monitor 10 includes one or more processors and computer-readable memory that stores ejection fraction software code which is executable to determine an ejection fraction measurement of the patient based on sensed hemodynamic data of the patient. Hemodynamic monitor 10 can receive the sensed hemodynamic data representative of an arterial pressure waveform of the patient, such as via one or more hemodynamic sensors connected to hemodynamic monitor 10 via I/O connectors 14. Hemodynamic monitor 10 executes the ejection fraction software code to obtain, using the sensed hemodynamic data, multiple ejection fraction profiling parameters (e.g., input features), which can include one or more vital sign parameters characterizing vital sign data of the patient, as well as differential and combinatorial parameters derived from the one or more vital sign parameters, as is further described below.
As illustrated in
As illustrated in
In operation, a column of fluid (e.g., saline solution) is introduced from a fluid source (e.g., a saline bag) through hemodynamic sensor 16 via fluid input port 20 to catheter-side fluid port 22 toward the catheter inserted into the patient. Arterial pressure is communicated through the fluid column to pressure sensors located within housing 16 which sense the pressure of the fluid column. Hemodynamic sensor 16 translates the sensed pressure of the fluid column to an electrical signal via the pressure transducers and outputs the corresponding electrical signal to hemodynamic monitor 10 (
In operation, the pressure controller continually adjusts pressure within the finger cuff to maintain a constant volume of the arteries in the finger (i.e., the unloaded volume of the arteries) as measured via the optical transmitter and optical receiver of inflatable finger cuff 28. The pressure applied by the pressure controller to continuously maintain the unloaded volume is representative of the blood pressure in the finger and is communicated by the pressure controller to hemodynamic monitor 10 shown in
As illustrated in
Hemodynamic monitor 10, as described above with respect to
As illustrated in
Hemodynamic sensor 34 can be attached to patient 36 to sense hemodynamic data representative of the arterial pressure waveform of patient 36. Hemodynamic sensor 34 is operatively connected to hemodynamic monitor 10 (e.g., electrically and/or communicatively connected via wired or wireless connection, or both) to provide the sensed hemodynamic data to hemodynamic monitor 10. In some examples, hemodynamic sensor 34 provides the hemodynamic data representative of the arterial pressure waveform of patient 36 to hemodynamic monitor 10 as an analog signal, which is converted by ADC 44 to digital hemodynamic data representative of the arterial pressure waveform. In other examples, hemodynamic sensor 34 can provide the sensed hemodynamic data to hemodynamic monitor 10 in digital form, in which case hemodynamic monitor 10 may not include or utilize ADC 44. In yet other examples, hemodynamic sensor 34 can provide the hemodynamic data representative of the arterial pressure waveform of patient 36 to hemodynamic monitor 10 as an analog signal, which is analyzed in its analog form by hemodynamic monitor 10.
Hemodynamic sensor 34 can be a non-invasive or minimally invasive sensor attached to patient 36. For instance, hemodynamic sensor 34 can take the form of minimally invasive hemodynamic sensor 16 (
In certain examples, hemodynamic sensor 34 can be configured to sense an arterial pressure of patient 36 in a minimally invasive manner. For instance, hemodynamic sensor 34 can be attached to patient 36 via a radial arterial catheter inserted into an arm of patient 36. In other examples, hemodynamic sensor 34 can be attached to patient 36 via a femoral arterial catheter inserted into a leg of patient 36. Such minimally invasive techniques can similarly enable hemodynamic sensor 34 to provide substantially continuous beat-to-beat monitoring of the arterial pressure of patient 36 over an extended period of time, such as minutes or hours. While hemodynamic sensor 34 can monitor the arterial pressure of patient 36 over an extended period of time, hemodynamic sensor 34 will only need to monitor the arterial pressure of patient 36 for few minutes (such as 5 minutes) to provide enough data to hemodynamic monitor 10 to determine ejection fraction measurement of patient 36.
System processor 40 is a hardware processor configured to execute ejection fraction software code 48, which implements first module 50, second module 51, and third module 52 to generate the ejection fraction measurement for patient 36. Examples of system processor 40 can include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or other equivalent discrete or integrated logic circuitry.
System memory 42 can be configured to store information within hemodynamic monitor 10 during operation. System memory 42, in some examples, is described as computer-readable storage media. In some examples, a computer-readable storage medium can include a non-transitory medium. The term “non-transitory” can indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium can store data that can, over time, change (e.g., in RAM or cache). System memory 42 can include volatile and non-volatile computer-readable memories. Examples of volatile memories can include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories. Examples of non-volatile memories can include, e.g., magnetic hard discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories.
Display 12 can be a liquid crystal display (LCD), a light-emitting diode (LED) display, an organic light-emitting diode (OLED) display, or other display device suitable for providing information to users in graphical form. User interface 54 can include graphical and/or physical control elements that enable user input to interact with hemodynamic monitor 10 and/or other components of hemodynamic monitoring system 32. In some examples, user interface 54 can take the form of a graphical user interface (GUI) that presents graphical control elements presented at, e.g., a touch-sensitive and/or presence sensitive display screen of display 12. In such examples, user input can be received in the form of gesture input, such as touch gestures, scroll gestures, zoom gestures, or other gesture input. In certain examples, user interface 54 can take the form of and/or include physical control elements, such as a physical buttons, keys, knobs, or other physical control elements configured to receive user input to interact with components of hemodynamic monitoring system 32.
In operation, hemodynamic sensor 34 senses hemodynamic data representative of an arterial pressure waveform of patient 36. Hemodynamic sensor 34 provides the hemodynamic data (e.g., as analog sensor data), to hemodynamic monitor 10. ADC 44 converts the analog hemodynamic data to digital hemodynamic data representative of the arterial pressure waveform of the patient.
System processor 40 executes ejection fraction software code 48 to determine, using the received hemodynamic data, the ejection fraction measurement for patient 36. For instance, system processor 40 can execute first module 50 to perform waveform analysis of the hemodynamic data to determine a plurality of signal measures. The plurality of signal measures includes waveform features and hemodynamic effects that characterize individual cardiac cycles of the arterial pressure waveform of the patient. The plurality of signal measures is discussed in greater detail below in the discussion of
If the ejection fraction measurement of patient 36 is equal to or less than forty percent, system processor 40 invokes sensory alarm 58 of user interface 54 to send a first sensory signal to alert medical worker 38 that patient 36 has a low ejection fraction measurement and patient 36 is at high risk of heart failure. Medical worker 38 can respond to the low ejection measurement of patient 36 by recommending patient 36 undergo further tests and examinations to verify the heart health of patient 36. In this manner, hemodynamic monitor 10 functions as a screening tool that can be used in the office of a primary care physician for detecting and discovering heart failure in patient 36 during routine physical examinations. Similarly, hemodynamic monitor 10 can be used at home by patient 36 for self-screening to self-determine whether patient 36 needs to see a doctor or specialist.
If system processor 40 and third module 52 determine that the ejection fraction measurement of patient 36 is within forty-one percent and forty-nine percent, system processor 40 invokes sensory alarm 58 of user interface 54 to send a second sensory signal to alert medical worker 38 that patient 36 has a borderline ejection fraction measurement and patient 36 may be at risk of heart failure in the near future. Medical worker 38 can respond to the borderline ejection measurement of patient 36 by recommending patient 36 undergo further tests and examinations to verify the heart health of patient 36. In this manner, hemodynamic monitor 10 functions as a screening tool that can be used in the office of a primary care physician for detecting a future potential of heart failure, or early onset of heart failure, in patient 36 during routine physical examinations. Similarly, hemodynamic monitor 10 can be used at home by patient 36 for self-screening to self-determine whether patient 36 needs to see a doctor or specialist.
If system processor 40 and third module 52 determine that the ejection fraction measurement of patient 36 is above fifty percent, system processor 40 invokes sensory alarm 58 of user interface 54 to send a third sensory signal to alert medical worker 38 that patient 36 has a normal ejection fraction measurement and that patient 36 has a low risk of heart failure in the near future. Additional screening or examination of patient 36 for ejection fraction is unlikely when hemodynamic monitor 10 determines patient 36 has a normal ejection fraction measurement. As a healthy heart pumps out no more than half to two-thirds the volume of blood in a chamber in one heartbeat, the ejection fraction measurement of patient 36 should not exceed seventy percent.
In some embodiments, system processor 40 can determine multiple subsets of the input features, with each subset of the input features being related to a different level or range of ejection fraction measurement. For example, system processor 40 can execute first module 50 to perform waveform analysis of the hemodynamic data to determine a plurality of signal measures. System processor 40 executes second module 51 to extract a first subset, a second subset, and a third subset of the input features from the plurality of signal measures of patient 36. The first subset of the input features are those input features that third module 52 will use to determine whether patient 36 has a normal ejection fraction measurement. The second subset of the input features are those input features that third module 52 will use to determine whether patient 36 has a low ejection fraction measurement. The third subset of the input features are those input features that third module 52 will use to determine whether patient 36 has a borderline ejection fraction measurement. System processor 40 can execute first module 50 to extract a single batch of the plurality of signal measures for a given unit of time, and that single batch of signal measures can be used by second module 51 to extract all of the first subset, the second subset, and the third subset of the input features for that unit of time. Second module 51 can extract all of the first subset, the second subset, and the third subset of the input features concurrently from the plurality of signal measures. System processor 40 can execute third module 52 to concurrently calculate probabilities of a normal ejection fraction score, a low ejection fraction score, and a borderline ejection fraction score for patient 36.
Ejection fraction software code 48 of hemodynamic monitor 10 can utilize, in some examples, a multi-classification-type machine learning model with three labels: normal ejection fraction verses low ejection fraction versus borderline ejection fraction. For example, processor 40 can output to display 12 (and/or a display of a mobile device of patient 36) the normal ejection fraction score of patient 36 with both the low ejection fraction score and the borderline ejection fraction score of patient 36, so that all subset of probabilities are compared together: the probability patient 36 has a normal ejection fraction measurement, the probability that patient 36 has a low ejection fraction measurement, and the probability that patient 36 has a borderline ejection fraction measurement. With the normal ejection fraction score, the low ejection fraction score, and the borderline ejection fraction score of patient 36 together on display 12 of hemodynamic monitor 10, medical worker 38 can better understand and cross-check whether patient 36 has a normal ejection fraction measurement versus a low ejection fraction measurement or borderline ejection fraction measurement. As discussed below with reference to
Hemodynamic monitor 10 can color-code and/or score the ejection fraction measurement of patient 36 in display 12 depending on whether the ejection fraction measurement is normal, borderline, or low. As noted above with reference to
Medical worker 38 (shown in
First clinical dataset 61 contains a collection of arterial pressure waveforms recorded from a first group of individuals who each have a confirmed normal ejection fraction measurement above fifty percent. First clinical dataset 61 can be collected from the first group of individuals by invasive hemodynamic sensors, such as hemodynamic sensor 16 shown in
After the arterial pressure waveforms of first clinical dataset 61 have been collected and labeled with first label, the arterial pressure waveforms of first clinical dataset 61 are ready for use for data mining and machine training of hemodynamic monitor 10. The arterial pressure waveforms of first clinical dataset 61 are data mined and used to machine train hemodynamic monitor 10 to determine the first subset of the input features. As discussed above with reference to
Second clinical dataset 62 contains a collection of arterial pressure waveforms recorded from a second group of individuals who each have a confirmed low ejection fraction measurement that is less than or equal to forty percent. Second clinical dataset 62 can be collected from the second group of individuals by invasive hemodynamic sensors, such as hemodynamic sensor 16 shown in
After the arterial pressure waveforms of second clinical dataset 62 have been collected and labeled with second label, the arterial pressure waveforms of second clinical dataset 62 are ready for use for data mining and machine training of hemodynamic monitor 10. The arterial pressure waveforms of second clinical dataset 62 are data mined and used to machine train hemodynamic monitor 10 to determine the second subset of the input features. As discussed above with reference to
Third clinical dataset 63 contains a collection of arterial pressure waveforms recorded from a third group of individuals who each have a confirmed borderline ejection fraction measurement within forty-one percent and forty-nine percent. Third clinical dataset 63 can be collected from the third group of individuals by invasive hemodynamic sensors, such as hemodynamic sensor 16 shown in
After the arterial pressure waveforms of third clinical dataset 63 have been collected and labeled with third label, the arterial pressure waveforms of third clinical dataset 62 are ready for use for data mining and machine training of hemodynamic monitor 10. The arterial pressure waveforms of Third clinical dataset 63 are data mined and used to machine train hemodynamic monitor 10 to determine the third subset of the input features. As discussed above with reference to
To machine train hemodynamic monitor 10 to identify the first subset of the input features described in
Signal measures are extracted from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles of each of the arterial pressure waveforms of first clinical dataset 61. The signal measures can correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles. Those hemodynamic effects can include contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle. The signal measures calculated or extracted by the waveform analysis of first step 72 of method 70 includes a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles. The signal measures can also include heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles of each of the arterial pressure waveforms of first clinical dataset 61.
After the signal measures are determined for first clinical dataset 61, step 74 of method 70 is performed on the signal measures of first clinical dataset 61. Step 74 of method 70 computes combinatorial measures between the signal measures of first clinical dataset 61. Computing the combinatorial measures between the signal measures of first clinical dataset 61 can include performing steps 76, 78, 80, and 82 shown in
Similar to how method 70 was applied to the arterial pressure waveforms of first clinical dataset 61 to determine the first subset of the input features, method 70 is applied to second clinical dataset 62 to determine the second subset of the input features. Method 70 is also applied to third clinical dataset 63 to determine the third subset of the input features.
The following are non-exclusive descriptions of possible embodiments of the present invention.
In one example, a method for triaging a patient for risk of heart failure includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. The hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data. The hemodynamic monitor extracts input features from the plurality of signal measures that are indicative of an ejection fraction of the patient. The hemodynamic monitor determines the ejection fraction of the patient based on the input features and outputs the ejection fraction of the patient to a display. The hemodynamic monitor alerts the patient that the ejection fraction is low when the ejection fraction is less than or equal to forty percent. The hemodynamic monitor alerts the patient that the ejection fraction is borderline when the ejection fraction is within forty-one percent and forty-nine percent. The hemodynamic monitor alerts the patient that the ejection fraction is normal when the ejection fraction is above fifty percent.
The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing method, further comprising: training the hemodynamic monitor for determining the ejection fraction of the patient, wherein training the hemodynamic monitor comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above; collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement that is less than or equal to forty percent; collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate a plurality of waveform signal measures; and determining the input features by computing combinatorial measures between the plurality of waveform signal measures and selecting top signal measures from the plurality of waveform signal measures with most predictive combinatorial measures and labeling the top signal measures as the input features.
In another example, a system for triaging a patient for risk of heart failure includes a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform of the patient. The system also includes a user interface with a display to show an ejection fraction measurement of the patient to medical personnel. Ejection fraction software code is stored on a system memory of the system. The system includes a processor that is configured to execute the ejection fraction software code to perform: waveform analysis of the hemodynamic data to determine a plurality of signal measures; extract input features from the plurality of signal measures that are indicative of the ejection fraction measurement of the patient; determine, based on the input features, the ejection fraction measurement of the patient; and output the ejection fraction measurement to the display of the user interface.
The system of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing system, wherein the input features of the ejection fraction software code are determined by machine training, and wherein the machine training comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent; collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent; collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate a plurality of waveform signal measures; and determining the input features by computing combinatorial measures between the plurality of waveform signal measures and selecting top signal measures from the plurality of waveform signal measures with most predictive combinatorial measures and labeling the top signal measures as the input features.
A further embodiment of the foregoing system, wherein performing waveform analysis of the labeled arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate the plurality of waveform signal measures comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles; and extracting the plurality of waveform signal measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles.
A further embodiment of the foregoing system, wherein the plurality of waveform signal measures correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing system, wherein the plurality of waveform signal measures comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles.
A further embodiment of the foregoing system, wherein the plurality of waveform signal measures comprise heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles.
A further embodiment of the foregoing system, wherein computing the combinatorial measures between the plurality of waveform signal measures of the first clinical dataset, the second clinical dataset, and the third clinical dataset comprises: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures; performing step two by calculating different orders of power for each of the subset of signal measures to generate powers of the subset of signal measures; performing step three by multiplying the powers of the subset of signal measures together to generate the product of the powers of the subset of signal measures; performing step four by performing receiver operating characteristic (ROC) analysis of the product to arrive at a combinatorial measure for the subset of signal measures; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures.
A further embodiment of the foregoing system, wherein the hemodynamic sensor is a noninvasive hemodynamic sensor that is attachable to an extremity of the patient.
A further embodiment of the foregoing system, wherein the hemodynamic sensor is a minimally invasive arterial catheter based hemodynamic sensor.
A further embodiment of the foregoing system, wherein the hemodynamic sensor produces the hemodynamic data as an analog hemodynamic sensor signal representative of the arterial pressure waveform of the patient.
A further embodiment of the foregoing system, further comprising: an analog-to-digital converter that converts the analog hemodynamic sensor signal to digital hemodynamic data representative of the arterial pressure waveform of the patient.
In another example, a method is disclosed for triaging a patient for risk of heart failure. The method includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. The hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data. The hemodynamic monitor extracts input features from the plurality of signal measures that are indicative of an ejection fraction of the patient. The hemodynamic monitor determines the ejection fraction of the patient based on the input features and outputs the ejection fraction of the patient to a display and/or mobile device. The hemodynamic monitor alerts the patient or medical personnel that the ejection fraction is low when the ejection fraction is less than or equal to forty percent.
The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing method, further comprising: alerting the patient or the medical personnel that the ejection fraction is borderline when the ejection fraction is within forty-one percent and forty-nine percent.
A further embodiment of the foregoing method, further comprising: alerting the patient or the medical personnel that the ejection fraction is normal when the ejection fraction is above fifty percent.
A further embodiment of the foregoing method, further comprising: training the hemodynamic monitor for determining the ejection fraction of the patient, wherein training the hemodynamic monitor comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent; labeling each of the arterial pressure waveforms of the first clinical dataset with a first label; performing waveform analysis of the labeled arterial pressure waveforms of the first clinical dataset to calculate a plurality of waveform signal measures of the first clinical dataset; and determining a first subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the first clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the first clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the first clinical data set as the first subset of the input features.
A further embodiment of the foregoing method, wherein training the hemodynamic monitor for determining the ejection fraction of the patient further comprises: collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent; labeling each of the arterial pressure waveforms of the second clinical dataset with a second label; performing waveform analysis of the labeled arterial pressure waveforms of the second clinical dataset to calculate a plurality of waveform signal measures of the second clinical dataset; and determining a second subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the second clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the second clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the second clinical data set as the second subset of the input features.
A further embodiment of the foregoing method, wherein training the hemodynamic monitor for determining the ejection fraction of the patient further comprises: collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; labeling each of the arterial pressure waveforms of the third clinical dataset with a third label; performing waveform analysis of the labeled arterial pressure waveforms of the third clinical dataset to calculate a plurality of waveform signal measures of the third clinical dataset; and determining a third subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the third clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the third clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the third clinical data set as the third subset of the input features.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the first clinical dataset to calculate the plurality of waveform signal measures of the first clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; and extracting the plurality of waveform signal measures of the first clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the first clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the first clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the first clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset.
A further embodiment of the foregoing method, wherein computing the combinatorial measures between the plurality of waveform signal measures of the first clinical dataset: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step two by calculating different orders of power for each of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset to arrive at a combinatorial measure for the subset of signal measures product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the first clinical dataset.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the second clinical dataset to calculate the plurality of waveform signal measures of the second clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; and extracting the plurality of waveform signal measures of the second clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the second clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the second clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the second clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset.
A further embodiment of the foregoing method, wherein computing the combinatorial measures between the plurality of waveform signal measures of the second clinical dataset: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step two by calculating different orders of power for each of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset to arrive at a combinatorial measure for the subset of signal measures product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the second clinical dataset.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the third clinical dataset to calculate the plurality of waveform signal measures of the third clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; and extracting the plurality of waveform signal measures of the third clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the third clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the third clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein the plurality of waveform signal measures of the third clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein computing the combinatorial measures between the plurality of waveform signal measures of the third clinical dataset: performing step one by arbitrarily selecting a subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step two by calculating different orders of power for each of the signal measures from the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset to arrive at a combinatorial measure for the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the third clinical dataset.
In another example, a method for training a hemodynamic monitor to determine an ejection fraction of a patient is disclosed. The method of training the hemodynamic monitor includes collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent. A second clinical dataset is collected containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent. The method further includes collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent. Waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset is performed to calculate a plurality of waveform signal measures. Input features are determined by computing combinatorial measures between the plurality of waveform signal measures and selecting top signal measures from the plurality of waveform signal measures with most predictive combinatorial measures and labeling the top signal measures as the input features. The input features are saved to a memory of the hemodynamic monitor.
The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing method, further comprising: connecting a hemodynamic sensor to the hemodynamic monitor and to the patient to input a sensed arterial pressure waveform of the patient into the hemodynamic monitor; extracting by a processor of the hemodynamic monitor values for the input features of the sensed arterial pressure waveform of the patient; determining, by the processor of the hemodynamic monitor based on the values of the input features of the sensed arterial pressure waveform, the ejection fraction of the patient; and outputting the ejection fraction of the patient to a display and/or mobile device.
A further embodiment of the foregoing method, further comprising: alerting the patient and/or medical personnel that the ejection fraction is low when the ejection fraction is less than or equal to forty percent.
A further embodiment of the foregoing method, further comprising: alerting the patient and/or the medical personnel that the ejection fraction is borderline when the ejection fraction is within forty-one percent and forty-nine percent.
A further embodiment of the foregoing method, further comprising: alerting the patient and/or the medical personnel that the ejection fraction is normal when the ejection fraction is above fifty percent.
In another example, a hemodynamic monitor is disclosed for detecting heart failure. The hemodynamic monitor includes a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller. The hemodynamic monitor also includes an integrated hardware unit with a system processor, a system memory, and a display with a user interface. The system memory includes instructions that, when executed by the system processor, are configured to: adjust, by the pressure controller, a pressure within the inflatable blood pressure bladder to maintain a constant volume of an artery of a patient for a period of time based on a feedback signal generated by the optical transmitter and the optical receiver; generate an arterial pressure waveform data of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time; extract a plurality of signal measures from the arterial pressure waveform data of the patient; extract input features from the plurality of signal measures that are indicative of an ejection fraction score of the patient; determine the ejection fraction score of the patient based on the extracted input features; generate a first sensory alarm signal configured to generate a first sensory alert that indicates that the patient has low ejection fraction when the ejection fraction score exceeds a threshold score, or generate a second sensory alarm signal configured to generate a second sensory alert that indicates that the patient does not have low ejection fraction when the ejection fraction score is below the threshold score; transmit the first sensory alarm signal or the second sensory alarm signal to the user interface; and output the first sensory alert or the second sensory alert through the user interface.
The hemodynamic monitor of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features are determined by machine training, wherein the machine training comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent; collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent; collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate a plurality of waveform signal measures; and determining the input features by computing combinatorial measures between the plurality of waveform signal measures and selecting top signal measures from the plurality of waveform signal measures with most predictive combinatorial measures and labeling the top signal measures as the input features.
A further embodiment of the foregoing hemodynamic monitor, wherein performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate the plurality of waveform signal measures comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles; and extracting the plurality of waveform signal measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles.
A further embodiment of the foregoing hemodynamic monitor, wherein the plurality of waveform signal measures correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing hemodynamic monitor, wherein: the plurality of waveform signal measures comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles; and/or the plurality of waveform signal measures comprise heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles.
A further embodiment of the foregoing hemodynamic monitor, wherein computing the combinatorial measures between the plurality of waveform signal measures of the first clinical dataset, the second clinical dataset, and the third clinical dataset comprises: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures; performing step two by calculating different orders of power for each of the subset of signal measures to generate powers of the subset of signal measures; performing step three by multiplying the powers of the subset of signal measures together to generate the product of the powers of the subset of signal measures; performing step four by performing receiver operating characteristic (ROC) analysis of the product to arrive at a combinatorial measure for the subset of signal measures; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features comprise a first subset and a second subset, and wherein the instructions, when executed by the system processor, are further configured to: extract the first subset and the second subset of the input features concurrently from the plurality of signal measures; concurrently determine a normal ejection fraction score of the patient from the first subset of the input features and a low ejection fraction score of the patient from the second subset of the input features; output the normal ejection fraction score of the patient and the low ejection fraction score of the patient to the display of the user interface.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features comprise a third subset, and wherein the instructions, when executed by the system processor, are further configured to: extract the first subset, the second subset, and the third subset of the input features concurrently from the plurality of signal measures; concurrently determine the normal ejection fraction score of the patient from the first subset of the input features, the low ejection fraction score of the patient from the second subset of the input features, and a borderline ejection fraction score of the patient from the third subset of the input features; output the normal ejection fraction score of the patient, the low ejection fraction score of the patient, and the borderline ejection fraction score of the patient to the display of the user interface.
In another example, a hemodynamic monitor is disclosed for detecting heart failure. The hemodynamic monitor includes an arterial blood pressure sensor with a housing, a fluid input port connected via tubing to a fluid source, a catheter-side fluid port connected to a catheter inserted within an arterial system of a patient, a pressure transducer in communication with the fluid source through the fluid port, and an I/O cable in electrical communication with the pressure transducer. The hemodynamic monitor also includes an integrated hardware unit with a system processor, a system memory, a display comprising a user interface, and an analog-to-digital (ADC) converter. The system memory includes instructions that, when executed by the system processor, are configured to: receive an electrical signal from the pressure transducer over a period of time, the electrical signal based on a pressure of the arterial system of the patient transmitted through the fluid source; convert the electrical signal to a digital signal; generate an arterial pressure waveform data of the patient based on the digital signal; extract a plurality of signal measures from the arterial pressure waveform data; extract input features from the plurality of signal measures that are indicative of an ejection fraction score of the patient; determine the ejection fraction score of the patient based on the extracted input features; generate a first sensory alarm signal configured to generate a first sensory alert that indicates that the patient has low ejection fraction when the ejection fraction score exceeds a threshold score, or generate a second sensory alarm signal configured to generate a second sensory alert that indicates that the patient does not have low ejection fraction when the ejection fraction score is below the threshold score; transmit the first sensory alarm signal or the second sensory alarm signal to the user interface; and output the first sensory alert or the second sensory alert through the user interface.
The hemodynamic monitor of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features are determined by machine training, wherein the machine training comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent; collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent; collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate a plurality of waveform signal measures; and determining the input features by computing combinatorial measures between the plurality of waveform signal measures and selecting top signal measures from the plurality of waveform signal measures with most predictive combinatorial measures and labeling the top signal measures as the input features.
A further embodiment of the foregoing hemodynamic monitor, wherein performing waveform analysis of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset to calculate the plurality of waveform signal measures comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset, the second clinical dataset, and the third clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles; and extracting the plurality of waveform signal measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles.
A further embodiment of the foregoing hemodynamic monitor, wherein the plurality of waveform signal measures correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing hemodynamic monitor, wherein: the plurality of waveform signal measures comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles; and/or the plurality of waveform signal measures comprise heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles.
A further embodiment of the foregoing hemodynamic monitor, wherein computing the combinatorial measures between the plurality of waveform signal measures of the first clinical dataset, the second clinical dataset, and the third clinical dataset comprises: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures; performing step two by calculating different orders of power for each of the subset of signal measures to generate powers of the subset of signal measures; performing step three by multiplying the powers of the subset of signal measures together to generate the product of the powers of the subset of signal measures; performing step four by performing receiver operating characteristic (ROC) analysis of the product to arrive at a combinatorial measure for the subset of signal measures; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features comprise a first subset and a second subset, and wherein the instructions, when executed by the system processor, are further configured to: extract the first subset and the second subset of the input features concurrently from the plurality of signal measures; concurrently determine a normal ejection fraction score of the patient from the first subset of the input features and a low ejection fraction score of the patient from the second subset of the input features; determine the ejection fraction measurement of the patient based on the normal ejection fraction score of the patient and the low ejection fraction score of the patient; and output the ejection fraction measurement to the display of the user interface.
A further embodiment of the foregoing hemodynamic monitor, wherein the input features comprise a third subset, and wherein the instructions, when executed by the system processor, are further configured to: extract the first subset, the second subset, and the third subset of the input features concurrently from the plurality of signal measures; concurrently determine the normal ejection fraction score of the patient from the first subset of the input features, the low ejection fraction score of the patient from the second subset of the input features, and a borderline ejection fraction score of the patient from the third subset of the input features; output the normal ejection fraction score of the patient, the low ejection fraction score of the patient, and the borderline ejection fraction score of the patient to the display of the user interface.
In another example, a method is disclosed for triaging a patient for risk of heart failure. The method includes receiving, by a hemodynamic monitor, sensed hemodynamic data representative of an arterial pressure waveform of the patient. The hemodynamic monitor performs waveform analysis of the sensed hemodynamic data to calculate a plurality of signal measures of the sensed hemodynamic data. The method further includes extracting, by the hemodynamic monitor, input features from the plurality of signal measures that are indicative of an ejection fraction of the patient. Extracting the input features includes extracting a first subset of the input features and extracting a second subset of the input features concurrently with the first subset of the input features. The method further includes concurrently determining, by the hemodynamic monitor, a normal ejection fraction score of the patient from the first subset of the input features and a low ejection fraction score of the patient from the second subset of the input features. The hemodynamic monitor outputs the normal ejection fraction score and the low ejection fraction score of the patient to a display and/or mobile device.
The method of the preceding paragraph can optionally include, additionally and/or alternatively, any one or more of the following features, configurations, and/or additional components listed below.
A further embodiment of the foregoing method, wherein extracting the input features further comprises: extracting a third subset of the input features concurrently with the first subset and the second subset of the input features; and wherein the hemodynamic monitor concurrently determines the normal ejection fraction score of the patient from the first subset of the input features, the low ejection fraction score of the patient from the second subset of the input features, and a borderline ejection fraction score of the patient from the third subset of the input features; and wherein the hemodynamic monitor outputs the normal ejection fraction score of the patient, the low ejection fraction score of the patient, and the borderline ejection fraction score of the patient to the display and/or the mobile device.
A further embodiment of the foregoing method, further comprising: training the hemodynamic monitor for determining the ejection fraction of the patient, wherein training the hemodynamic monitor comprises: collecting a first clinical dataset containing arterial pressure waveforms from a first group of individuals with a normal ejection fraction measurement above fifty percent; labeling each of the arterial pressure waveforms of the first clinical dataset with a first label; performing waveform analysis of the labeled arterial pressure waveforms of the first clinical dataset to calculate a plurality of waveform signal measures of the first clinical dataset; determining a first subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the first clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the first clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the first clinical data set as the first subset of the input features; collecting a second clinical dataset containing arterial pressure waveforms from a second group of individuals with a low ejection fraction measurement less than or equal to forty percent; labeling each of the arterial pressure waveforms of the second clinical dataset with a second label; performing waveform analysis of the labeled arterial pressure waveforms of the second clinical dataset to calculate a plurality of waveform signal measures of the second clinical dataset; determining a second subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the second clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the second clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the second clinical data set as the second subset of the input features; collecting a third clinical dataset containing arterial pressure waveforms from a third group of individuals with a borderline ejection fraction measurement within forty-one percent and forty-nine percent; labeling each of the arterial pressure waveforms of the third clinical dataset with a third label; performing waveform analysis of the labeled arterial pressure waveforms of the third clinical dataset to calculate a plurality of waveform signal measures of the third clinical dataset; and determining a third subset of the input features by computing combinatorial measures between the plurality of waveform signal measures of the third clinical dataset and selecting top signal measures from the plurality of waveform signal measures of the third clinical dataset with most predictive combinatorial measures and labeling the top signal measures of the third clinical data set as the third subset of the input features.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the first clinical dataset to calculate the plurality of waveform signal measures of the first clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; and extracting the plurality of waveform signal measures of the first clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the second clinical dataset to calculate the plurality of waveform signal measures of the second clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; and extracting the plurality of waveform signal measures of the second clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset.
A further embodiment of the foregoing method, wherein performing waveform analysis of the labeled arterial pressure waveforms of the third clinical dataset to calculate the plurality of waveform signal measures of the third clinical dataset comprises: identifying individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; identifying a dicrotic notch in each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; identifying a systolic rise phase, a systolic decay phase, and a diastolic phase in each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset; and extracting the plurality of waveform signal measures of the third clinical dataset from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein: the plurality of waveform signal measures of the first clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle; the plurality of waveform signal measures of the second clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle; and the plurality of waveform signal measures of the third clinical dataset correspond to hemodynamic effects from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset, and wherein the hemodynamic effects comprise contractility, aortic compliance, stroke volume, vascular tone, afterload, and full cardiac cycle.
A further embodiment of the foregoing method, wherein: the plurality of waveform signal measures of the first clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; the plurality of waveform signal measures of the second clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; and the plurality of waveform signal measures of the third clinical dataset comprises a mean, a maximum, a minimum, a duration, an area, a standard deviation, derivatives, and/or morphological measures from each of the systolic rise phase, the systolic decay phase, and the diastolic phase from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein: the plurality of waveform signal measures of the first clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the first clinical dataset; the plurality of waveform signal measures of the second clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the second clinical dataset; and wherein the plurality of waveform signal measures of the third clinical dataset comprises heart rate, respiratory rate, stroke volume, pulse pressure, pulse pressure variation, stroke volume variation, mean arterial pressure (MAP), systolic pressure (SYS), diastolic pressure (DIA), heart rate variability, cardiac output, peripheral resistance, vascular compliance, and/or left-ventricular contractility extracted from each of the individual cardiac cycles in each of the arterial pressure waveforms of the third clinical dataset.
A further embodiment of the foregoing method, wherein computing the combinatorial measures between the plurality of waveform signal measures of the first clinical dataset comprises: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step two by calculating different orders of power for each of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset to arrive at a combinatorial measure for the subset of signal measures product of the powers of the subset of signal measures from the plurality of waveform signal measures of the first clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the first clinical dataset.
A further embodiment of the foregoing method, wherein computing the combinatorial measures between the plurality of waveform signal measures of the second clinical dataset comprises: performing step one by arbitrarily selecting subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step two by calculating different orders of power for each of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset to arrive at a combinatorial measure for the subset of signal measures product of the powers of the subset of signal measures from the plurality of waveform signal measures of the second clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the second clinical dataset; wherein computing the combinatorial measures between the plurality of waveform signal measures of the third clinical dataset comprises: performing step one by arbitrarily selecting a subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step two by calculating different orders of power for each of the signal measures from the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset to generate powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step three by multiplying the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset together to generate a product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; performing step four by performing receiver operating characteristic (ROC) analysis of the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset to arrive at a combinatorial measure for the product of the powers of the subset of signal measures from the plurality of waveform signal measures of the third clinical dataset; and repeating steps one, two, three, and four until all of the combinatorial measures have been computed between all of the plurality of waveform signal measures of the third clinical dataset.
While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.
This application is a continuation of PCT Application No. PCT/US2023/032950, filed Sep. 15, 2023, and entitled “HEMODYNAMIC MONITOR FOR TRIAGING PATIENTS WITH LOW EJECTION FRACTION,” which claims the benefit of U.S. Provisional Application No. 63/375,843, filed Sep. 15, 2022, and entitled “HEMODYNAMIC MONITOR FOR TRIAGING PATIENTS WITH LOW EJECTION FRACTION OR AORTIC STENOSIS,” the disclosures of which are hereby incorporated by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 63375843 | Sep 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/032950 | Sep 2023 | WO |
| Child | 19080437 | US |