Use of intracardiac blood pumps as a bridge to high-risk medical procedures

Abstract

A method of using an intracardiac blood pump in connection with a medical procedure. In some cases, a patient may be turned away from a medical procedure based on the risk that the procedure itself may cause the patient to experience a cardiac event during and / or after the procedure. In some instances, an intracardiac blood pump may be used to support the heart before, during, and / or after the medical procedure to minimize such risks and thus allow the patient to receive critical treatment that might otherwise be denied.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 234,568, filed August 18, 2021, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Intracardiac blood pumps are traditionally used to temporarily assist the pumping function of a patient's heart during emergency cardiac procedures, such as stent placement, performed after suffering a heart attack, cardiac arrest, and / or cardiogenic shock. Intracardiac blood pumps may also be used to unload a patient's heart and allow it to recover from such cardiac procedures, or from a heart attack, cardiac arrest, cardiogenic shock, or heart damage (e.g., caused by a viral infection). In that regard, intracardiac blood pumps may be introduced into the heart, either surgically or percutaneously, and used to deliver blood from one location within the heart or circulatory system to another location within the heart or circulatory system. For example, when placed in the left heart, an intracardiac blood pump may pump blood from the left ventricle of the heart to the aorta. Similarly, when placed in the right heart, an intracardiac blood pump may pump blood from the inferior vena cava to the pulmonary artery. An intracardiac pump may be powered by a motor located outside the patient's body via an elongated drive shaft (or drive cable) or by an on-board motor located within the patient's body. Examples of such systems include the IMPELLA® family of devices (Abiomed, Inc., Danvers Mass.). Summary of the Invention

[0003] The present technology relates to a method of using an intracardiac blood pump as a bridge to high-risk medical procedures. For example, in some instances, a patient may require a medical procedure (e.g., a surgical procedure) but may be declined for the procedure based on the risk that the patient may experience an adverse outcome (e.g., the procedure itself may cause the patient to experience hemodynamic instability during and / or after the procedure and / or may result in the patient's death). In other words, the medical procedure may be considered a high-risk procedure for the patient. As described herein, high-risk medical procedures may include cardiac procedures and non-cardiac procedures. For example, high-risk procedures may include gastrointestinal surgery (e.g., cholecystectomy), laparoscopic surgery (e.g., laparoscopic bariatric surgery), tumor resection, atrial fibrillation catheter ablation, mitral valve repair, etc. In such cases, an intracardiac blood pump may be used to support the heart before, during, and / or after the procedure to minimize such risks, thus allowing the patient to receive critical care that would otherwise be denied.

[0004] In one aspect, the disclosure describes a method of administering a medical procedure, comprising: identifying a patient in need of the medical procedure; making a first assessment of the patient's likelihood of experiencing one or more of a set of adverse outcomes if the medical procedure is performed without the patient receiving support from an intracardiac blood pump before, during, or after the medical procedure; determining the patient's suitability for the medical procedure based on the first assessment; making a second assessment of the patient's likelihood of experiencing one or more of a set of adverse outcomes if the medical procedure is performed with the patient receiving support from an intracardiac blood pump at least before, during, or after the medical procedure; determining the patient's suitability for the medical procedure based on the second assessment; and inserting an intracardiac blood pump into the patient to provide cardiac support at least before, based on, during, or after the medical procedure. In some aspects, the method further comprises determining a period during which the patient would benefit from receiving support from an intracardiac blood pump, the determined period comprising one or more of before, during, or after the medical procedure. In some aspects, inserting the intracardiac blood pump into the patient to provide cardiac support is performed for the determined period. In some embodiments, the method further includes performing a medical procedure on the patient. In some embodiments, inserting the intracardiac blood pump into the patient is performed prior to, simultaneously with, or after performing the medical procedure. In some embodiments, the medical procedure includes a non-cardiac medical procedure. In some embodiments, the intracardiac blood pump is configured to provide left heart support. In some embodiments, the intracardiac blood pump is configured to provide right heart support. In some embodiments, the medical procedure requires the patient to be anesthetized. In some embodiments, the medical procedure includes one or more of laparoscopic surgery, tumor resection, or gastrointestinal surgery. In some embodiments, the medical procedure includes one or more of mitral valve repair, mitral valve replacement, ventricular tachycardia ablation, or atrial fibrillation catheter ablation. In some embodiments, the medical procedure includes knee arthroplasty or hip arthroplasty.In some embodiments, the set of adverse outcomes includes one or more of hypotension, pulmonary edema, ventricular fibrillation, ischemic deterioration, myocardial ischemia, hemodynamic collapse, cardiac arrest, stroke, heart attack, acute kidney injury, neurological decline, or death. In some embodiments, the first assessment or the second assessment is based on one or more of the patient's age, height, weight, body mass index, blood pressure, cholesterol level, liver function, kidney function, pre-existing medical conditions, personal medical history, or family medical history. In some embodiments, the first assessment or the second assessment is based on whether the patient has one or more of diabetes, autoimmune disorder, or heart disease. In some embodiments, the first assessment or the second assessment is based on statistics regarding how prevalent each adverse outcome in the set of adverse outcomes is in a given population. In some embodiments, the given population includes a group of people who share one or more characteristics with the patient. In some embodiments, the second assessment is based on the likelihood that the patient will experience one or more of the adverse outcomes in the set of adverse outcomes as a result of implantation of the intracardiac blood pump in the patient. [Brief description of the drawings]

[0005] [Figure 1] 1 depicts an exemplary intracardiac blood pump assembly configured for left heart support, according to aspects of the present disclosure. [Diagram 2] 1 depicts an exemplary intracardiac blood pump assembly configured for right heart support, according to aspects of the present disclosure. [Diagram 3] 1 depicts an exemplary method for assessing whether a patient may benefit from therapy with an intracardiac blood pump in connection with a medical procedure. [Figure 4] 1 depicts an exemplary method for treating a patient using an intracardiac blood pump in connection with a medical procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0006] The embodiments of the present disclosure will be described in detail with reference to the drawings in which like reference numbers identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, the details of the specific structure and function disclosed herein should not be interpreted as limitations, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to employ the present disclosure in other suitable structures.

[0007] To provide a general understanding of the systems, methods, and devices described herein, certain illustrative examples are described. Although the examples may describe specific medical procedures and / or uses of intracardiac blood pumps, it will be understood that the present technology may be employed in any suitable context.

[0008] 1 depicts an exemplary intracardiac blood pump assembly 100 adapted for left heart support, according to an embodiment of the present disclosure. As shown in FIG. 1, the intracardiac blood pump assembly adapted for left heart support may include an elongate catheter 102, a motor 104, a cannula 110, a blood inflow cage 114 disposed at or near a distal end 112 of the cannula 110, a blood outflow cage 106 disposed at or near a proximal end 108 of the cannula 110, and an optional atraumatic extension 116 disposed at a distal end of the blood inflow cage 114.

[0009] In some aspects of the present technology, the motor 104 may be configured to rotatably drive an impeller (not shown), thereby generating sufficient suction to draw blood into the cannula 110 through the blood inflow cage 114 and expel blood from the cannula 110 through the blood outflow cage 106. In that regard, the impeller may be positioned distal to the blood outflow cage 106, for example, within the proximal end 108 of the cannula 110, or within a pump housing 107 coupled to the proximal end 108 of the cannula 110. In some aspects of the present technology, rather than the impeller being driven by the on-board motor 104, the impeller may instead be coupled to an elongated drive shaft (or drive cable) that is driven by a motor located external to the patient.

[0010] The catheter 102 may house electrical wires coupling the motor 104 to one or more electrical controllers and / or sensors. Alternatively, if the impeller is driven by an external motor, an elongated drive shaft may pass through the catheter 102. The catheter 102 may also include purge fluid conduits, lumens configured to receive a guidewire, and the like.

[0011] The blood inflow cage 114 may include one or more apertures or openings configured to allow blood to be drawn into the cannula 110 when the motor 104 is running. Similarly, the blood outflow cage 106 may include one or more apertures or openings configured to allow blood to flow from the cannula 110 out of the intracardiac blood pump assembly 100. The blood inflow cage 114 and the blood outflow cage 106 may be constructed of any suitable biocompatible material. For example, the blood inflow cage 114 and / or the blood outflow cage 106 may be formed from a biocompatible metal, such as stainless steel, titanium, or a biocompatible polymer, such as polyurethane. Additionally, the surfaces of the blood inflow cage 114 and / or the blood outflow cage 106 may be treated in various manners, including, but not limited to, etching, texturing, or coating or plating with another material. For example, the surfaces of the blood inflow cage 114 and / or the blood outflow cage 106 may be laser textured.

[0012] Cannula 110 may include a flexible hose portion. For example, cannula 110 may be constructed, at least in part, from a polyurethane material. In addition, cannula 110 may include a shape memory material. For example, cannula 110 may include a combination of a polyurethane material and one or more strands or coils of a shape memory material, such as Nitinol. Cannula 110 may be formed to include one or more bends or curves in its relaxed state, or may be configured to be straight in its relaxed state. In that regard, as shown in the exemplary configuration of FIG. 1, cannula 110 may have a single preformed anatomical bend 118 based on the portion of the left heart in which it is intended to operate. Despite this bend 118, cannula 110 may also nevertheless be flexible and thus be capable of straightening (e.g., during insertion over a guidewire) or bending further (e.g., in patients whose anatomy has narrower dimensions). Further in that regard, cannula 110 may include a shape memory material configured to allow cannula 110 to be a different shape (e.g., straight or nearly straight) at room temperature and to form bend 118 when the shape memory material is exposed to the heat of the patient's body.

[0013] The atraumatic extension 116 may aid in stabilizing and positioning the intracardiac blood pump assembly 100 in the correct position within the patient's heart. The atraumatic extension 116 may be solid or tubular. If tubular, the atraumatic extension 116 may be configured to allow a guidewire to pass therethrough to further aid in positioning the intracardiac blood pump assembly 100. The atraumatic extension 116 may be of any suitable size. For example, the atraumatic extension 116 may have an outer diameter in the range of 4-8 Fr. The atraumatic extension 116 may be constructed, at least in part, from a flexible material and may be of any suitable shape or configuration, such as a straight configuration, a partially curved configuration, a pigtail-shaped configuration as shown in the example of FIG. 1, etc. The atraumatic extension 116 may also have sections with different stiffnesses. For example, the atraumatic extension 116 may include a proximal section that is sufficiently stiff to prevent buckling and thereby keep the blood inflow cage 114 in a desired location, and a distal section that is softer and has a lower stiffness, thereby providing an atraumatic tip for contacting the wall of the patient's heart and allowing for guidewire loading. In such cases, the proximal and distal sections of the atraumatic extension 116 may be constructed from different materials or may be constructed from the same material, with the proximal and distal sections treated to provide different stiffnesses.

[0014] Notwithstanding the above, as noted above, the atraumatic extension 116 is an optional structure. In that regard, the present technology may also be used with intracardiac blood pump assemblies and other intracardiac devices that include extensions of different types, shapes, materials, and qualities. Similarly, the present technology may be used with intracardiac blood pump assemblies and other intracardiac devices that do not have distal extensions of any kind.

[0015] As described herein, the intracardiac blood pump assembly 100 may be inserted percutaneously. For example, when used for left heart support, the intracardiac blood pump assembly 100 may be inserted via catheterization through the femoral or axillary artery, into the aorta, across the aortic valve, and into the left ventricle. So positioned, the intracardiac blood pump assembly 100 may deliver blood from a blood inflow cage 114 located inside the left ventricle through the cannula 110 to a blood outflow cage 106 located inside the ascending aorta. In some aspects of the present technology, the intracardiac blood pump assembly 100 may be configured such that the bend 118 rests against a predetermined portion of the patient's heart when the intracardiac blood pump assembly 100 is in a desired location. Similarly, the atraumatic extension 116 may be configured to rest against a different predetermined portion of the patient's heart when the intracardiac blood pump assembly 100 is in a desired location.

[0016] 2 depicts an exemplary intracardiac blood pump assembly 200 adapted for right heart support, according to an embodiment of the present disclosure. As shown in FIG. 2, the intracardiac blood pump assembly adapted for right heart support may include an elongate catheter 202, a motor 204, a cannula 210, a blood inflow cage 214 disposed at or near a proximal end 208 of the cannula 210, a blood outflow cage 206 disposed at or near a proximal end 212 of the cannula 210, and an optional atraumatic extension 216 disposed at a distal end of the blood outflow cage 206.

[0017] 1, the motor 204 may be configured to rotatably drive an impeller (not shown) to generate sufficient suction to draw blood into the cannula 210 through the blood inflow cage 214 and expel blood from the cannula 210 through the blood outflow cage 206. In that regard, the impeller may be positioned distal to the blood inflow cage 214, for example, within the proximal end 208 of the cannula 210, or within a pump housing 207 coupled to the proximal end 208 of the cannula 210. Again, in some aspects of the present technology, rather than the impeller being driven by the on-board motor 204, the impeller may instead be coupled to an elongated drive shaft (or drive cable) that is driven by a motor located external to the patient.

[0018] Cannula 210 of FIG. 2 may serve the same purpose and may have the same properties and characteristics described above with respect to cannula 110 of FIG. 1. However, as shown in the exemplary configuration of FIG. 2, cannula 210 may have two preformed anatomical bends 218 and 220 based on the portion of the right heart in which it is intended to operate. Here again, despite the presence of bends 218 and 220, cannula 210 may still be flexible and thus may be able to straighten (e.g., during insertion over a guidewire) or bend further (e.g., in patients whose anatomy has narrower dimensions). Further in that regard, cannula 210 may include a shape memory material configured to allow cannula 210 to be a different shape (e.g., straight or nearly straight) at room temperature and form bends 218 and / or 220 when the shape memory material is exposed to the heat of the patient's body.

[0019] The catheter 202 and atraumatic extension 216 of Figure 2 may serve the same purpose and may have the same properties and characteristics described above with respect to the catheter 102 and atraumatic extension 116 of Figure 1. Similarly, the blood inflow cage 214 and blood outflow cage 206 of Figure 2 may be similar to the blood inflow cage 114 and blood outflow cage 106 of Figure 1, except that they are located on the opposite side of the cannula from those of Figure 1, and therefore may have the same properties and characteristics described above.

[0020] Similar to the exemplary assembly of Fig. 1, the intracardiac blood pump assembly 200 of Fig. 2 may also be inserted percutaneously. For example, when used for right heart support, the intracardiac blood pump assembly 200 may be inserted via catheterization through the femoral vein, into the inferior vena cava, through the right atrium, across the tricuspid valve, into the right ventricle, through the pulmonary valve, and into the pulmonary artery. Thus positioned, the intracardiac blood pump assembly 200 may deliver blood from a blood inflow cage 214 located inside the inferior vena cava, through the cannula 210, to a blood outflow cage 206 located inside the pulmonary artery.

[0021] FIG. 3 depicts an exemplary method 300 for assessing whether a patient could benefit from treatment with an intra-cardiac blood pump (eg, intra-cardiac blood pump assembly 100 or 200) in connection with a high-risk medical procedure.

[0022] In this regard, in step 302, the patient is identified as needing a medical procedure. As described herein, this medical procedure may include a cardiac procedure such as mitral valve repair, mitral valve replacement, ventricular tachycardia ablation, or atrial fibrillation ablation. In some instances, such a cardiac procedure may be performed after an emergency cardiac procedure has been performed (e.g., after the patient has been treated for an emergency cardiac event). The medical procedure may also be any type of surgery or other procedure that targets an area of ​​the body other than the heart or the "great vessels" that deliver blood to and from the heart. For example, the procedure may include a laparoscopic procedure, such as laparoscopic bariatric surgery.

[0023] An evaluation may then be performed to determine the patient's risk of undergoing such a medical procedure. For example, as shown in step 304, a first evaluation may be performed to determine the likelihood of the patient experiencing one or more of a set of adverse outcomes if the medical procedure is performed without the patient receiving support from an intracardiac blood pump before, during, or after the medical procedure. In some aspects of the present technology, the set of adverse outcomes may include any potential adverse outcomes known to be correlated with a medical procedure, such as hypotension (e.g., as may be caused by anesthesia), pulmonary edema, ventricular fibrillation, worsening ischemia, myocardial ischemia, hemodynamic instability and / or collapse, cardiac arrest, death, etc. Similarly, in some embodiments of the present technology, the likelihood of a patient experiencing one or more adverse outcomes of a set of adverse outcomes may be based on any suitable criteria, including, but not limited to, relevant information about the patient, such as the patient's age, height, weight, body mass index, blood pressure, cholesterol levels, liver function, kidney function, pre-existing medical conditions (e.g., diabetes, autoimmune disorders, heart disease), personal medical history, family medical history, etc.; statistics regarding the rate of each adverse outcome in a population in general; and statistics regarding the rate of each adverse outcome in patients who share one or more characteristics with the patient.

[0024] In step 306, the suitability of the patient for the medical procedure is determined based on the first evaluation. In some examples, the suitability of the patient for the medical procedure may be determined based solely on the risks identified in the first evaluation. Suitability may also be based on balancing those risks with one or more other risks, such as the patient's likelihood of experiencing one or more adverse outcomes if the medical procedure is not provided. For example, a patient assessed as having a high risk of heart failure during elective cosmetic surgery may be deemed unsuitable for the medical procedure. On the other hand, a patient assessed as having a high risk of heart failure during surgery to remove a cancerous tumor may be deemed suitable for the medical procedure if assessed as having an even higher risk of imminent death from cancer if the tumor is not removed.

[0025] As described herein, a patient who is deemed unsuitable for a given medical procedure based on the risk of experiencing one or more of a set of adverse outcomes (as discussed with respect to steps 304 and 306) may still be eligible to receive the procedure if the identified risk can be mitigated by the use of an intracardiac blood pump before, during, and / or after the procedure. In such a case, the patient's risk profile may be evaluated a second time using the assumption that such support will be provided, after which the patient's suitability for the medical procedure may be reconsidered. In the example of FIG. 3, it is assumed that such a second evaluation is performed.

[0026] Thus, in step 308, if the intracardiac blood pump is used to support the patient's heart before, during, and / or after the medical procedure, a second assessment may be made of the patient's likelihood of experiencing one or more of the set of adverse outcomes as a result of the medical procedure. Again, the set of adverse outcomes may include any adverse outcomes on which the first assessment was based. Further in that regard, the set of adverse outcomes may also include any adverse outcomes known to be correlated with the use of the intracardiac heart pump. Similarly, the patient's likelihood of experiencing one or more of the set of adverse outcomes may be based on the same criteria on which the first assessment was based, and may further reflect how the use of the intracardiac blood pump may change the patient's likelihood of experiencing each of the set of adverse outcomes.

[0027] Thus, for example, if a patient is deemed to be at risk for severe hypotension while under anesthesia in a first assessment based on one or more criteria (e.g., age and / or previous medical conditions), a second assessment of that patient may reflect a lower risk of hypotension based on the use of an intracardiac blood pump while the patient is under anesthesia and / or while the patient is recovering from a procedure. Similarly, if a patient is deemed to be at risk for hemodynamic collapse in a first assessment based on one or more criteria (e.g., inability to tolerate the stress of a medical procedure due to obesity, diabetes, heart disease, etc.), a second assessment of that patient may reflect a lower risk of hemodynamic collapse based on the use of an intracardiac blood pump to reduce the load on the patient's heart before, during, and / or after the procedure.

[0028] Finally, in step 310, the suitability of the patient for the medical treatment may be determined based on the second assessment. Again, the suitability of the patient for the medical treatment may be determined based solely on the risks identified in the second assessment. Similarly, in some embodiments of the present technology, the suitability of the patient may also be based on balancing those risks with one or more other risks, such as the likelihood of the patient experiencing one or more adverse outcomes if the medical treatment is not provided.

[0029] As will be appreciated, in some instances, a patient may be deemed unsuitable for a given medical procedure based on a first assessment, but the patient may be deemed suitable for that procedure based on a second assessment, so long as an intracardiac blood pump is used to support the patient's heart before, during, and / or after the procedure.

[0030] 4 depicts an exemplary method 400 for treating a patient using an intracardiac blood pump (e.g., intracardiac blood pump assembly 100 or 200) in connection with a medical procedure. In that regard, method 400 may be employed when it has been determined that a patient would benefit from the use of an intracardiac blood pump assembly during a medical procedure that would be considered high risk to the patient without the use of an intracardiac blood pump assembly in accordance with method 300 and / or when the patient is not suitable for the medical procedure without support from an intracardiac blood pump assembly (see steps 306 and 310 of FIG. 3).

[0031] At step 402, a determination may be made regarding a period of time during which the patient would benefit from receiving support from an intracardiac blood pump. This period may be one or more of before, during, and after a medical procedure. In that regard, the intracardiac blood pump may be used in various ways to reduce and / or eliminate the risk of the patient experiencing a cardiac event during or after the medical procedure. For example, the intracardiac blood pump may be used prior to a medical procedure to rest the heart prior to the medical procedure, thus potentially reducing the risk of the heart subsequently overcoming the trauma of the medical procedure. Similarly, the intracardiac blood pump may be used during a medical procedure to reduce the load on the heart and maintain blood flow through the body, thus potentially reducing the risk of ventricular fibrillation, worsening ischemia, myocardial ischemia, pulmonary edema, hemodynamic collapse, cardiac arrest, death, and the like, that may occur during the medical procedure. Additionally, intracardiac blood pumps may be used after a medical procedure to allow the heart to recover, thus reducing the risk of post-operative cardiac events such as heart attack, ventricular fibrillation, worsening ischemia, myocardial ischemia, pulmonary edema, hemodynamic collapse, cardiac arrest, death, etc. Thus, depending on the situation, intracardiac blood pumps may be used: (a) only before the procedure, (b) before and during the procedure, (c) before, during, and after the procedure, (d) only before and after the procedure but not during the procedure, (e) only during the procedure, (f) only during and after the procedure, or (g) only after the procedure.

[0032] In step 404, the intracardiac blood pump may be inserted into the patient to provide cardiac support for the period of time determined in step 402. In this regard, any suitable manner of inserting, positioning, and providing cardiac support using the intracardiac blood pump may be used, including the methods of providing left cardiac support and right cardiac support described above with respect to Figures 1 and 2, respectively.

[0033] In step 406, a medical procedure may be performed. In some aspects of the present technology, steps 404 and 406 may be performed simultaneously or their order may be reversed from that shown in the exemplary method 400. For example, if it is determined in step 402 that the intracardiac blood pump is to be used only after the medical procedure, the medical procedure (step 406) may be performed before the insertion of the intracardiac blood pump (step 404). Similarly, if the intracardiac blood pump is to be used during the medical procedure, the intracardiac blood pump may nevertheless be inserted into the patient (step 404) at some point after the medical procedure (step 406) has begun. In some aspects of the present technology, performing the medical procedure may include or begin with placing the patient under anesthesia.

[0034] As will be appreciated, the exemplary methods 300 and 400 may be used to identify and treat patients who do not have an identified cardiac condition, but who may nevertheless be at risk for a cardiac event during a medical procedure, and therefore benefit from receiving support from an intracardiac blood pump before, during, and / or after the procedure. For example, an elderly patient may be healthy and have a healthy heart. However, based on age, required medications, medical history, or other factors, the patient may be deemed unsuitable for a medical procedure (e.g., an arthroplasty procedure such as a knee or hip replacement) based on the risk that the patient may experience an adverse outcome, such as hypotension during anesthesia, which may subsequently cause a stroke, heart attack, acute kidney injury, postoperative neurological decline, and / or increased postoperative mortality. Similarly, the same patient may be deemed unsuitable for a medical procedure, even though they have a healthy heart under normal circumstances, based on the risk that the stress of the procedure may result in hemodynamic collapse. If the risks posed by the medical procedure outweigh the potential benefits of the procedure (e.g., the patient has a repaired knee or hip), the patient may be denied treatment. However, if these risks could be reduced or eliminated by supporting a patient's heart with an intracardiac blood pump, patients may be able to safely undergo medical procedures that significantly prolong and / or improve their quality of life.

[0035] The exemplary methods 300 and 400 may also be used to identify and treat patients with one or more cardiac conditions that create a risk of a cardiac event during a medical procedure (cardiac or non-cardiac), and thus would benefit from receiving support from an intracardiac blood pump before, during, and / or after the procedure. For example, the patient may be obese and may suffer from a variety of related medical diseases, such as diabetes, hypertension, dyslipidemia, high C-reactive protein levels, fatty liver, etc. In addition, the patient may also have one or more cardiac conditions (e.g., coronary heart disease, NYHA class I, II, III, or IV heart failure, etc.) that may complicate the medical procedure, but are nevertheless not addressed with an immediate cardiac procedure (e.g., angioplasty or stent placement) to address these cardiac conditions. For example, the patient's cardiac condition may not yet be severe enough to warrant such a cardiac procedure, may not be of a type that can be addressed with a cardiac procedure, or may be severe enough to warrant an eventual cardiac procedure but not severe enough to take precedence over the current medical procedure. Such patients may, for example, benefit from weight loss and therefore may be prime candidates for bariatric surgery under normal circumstances. However, they may nevertheless be turned down for such procedures because their cardiac condition and / or other medical issues place them at an unacceptably high risk of experiencing a cardiac event during bariatric surgery. Again, an intracardiac blood pump may be used to reduce and / or eliminate some or all of the above risks by supporting the heart before the procedure (e.g., to allow the heart to rest before the trauma of surgery), during the procedure (e.g., to reduce the load on the heart and maintain blood flow, thus reducing the risk during the procedure of ventricular fibrillation, worsening ischemia, myocardial ischemia, pulmonary edema, hemodynamic collapse, cardiac arrest, etc.), and / or after the procedure (e.g., to allow the heart to recover, thus reducing the risk of post-operative cardiac events). In this way, an intracardiac heart pump may enable patients to receive life-saving medical procedures that may not be available otherwise.

[0036] From the above and with reference to the various figures, those skilled in the art will understand that certain modifications can be made to the present disclosure without departing from the scope of the present disclosure. Although several aspects of the present disclosure are shown in the drawings, the present disclosure is not intended to be limited to these embodiments, as it is intended that the present disclosure should be as broad as the art will permit, and that the specification should be read in the same manner. Thus, the above description should not be interpreted as limiting, but merely as an illustration of certain aspects of the present technology.

Claims

1. 1. A method for determining whether a patient is amenable to a medical procedure, comprising: conducting a first assessment of the likelihood of the patient experiencing one or more adverse outcomes of a set of adverse outcomes if the medical procedure is performed without the patient receiving support from an intracardiac blood pump before, during, or after the medical procedure; determining the patient's suitability for the medical procedure based on the first assessment; and conducting a second assessment of the likelihood of the patient experiencing one or more adverse outcomes of the set of adverse outcomes if the medical procedure is performed with the patient receiving support from an intracardiac blood pump at least before, during, or after the medical procedure; determining the patient's suitability for the medical procedure based on the second evaluation; and providing an intracardiac blood pump for use to provide cardiac support at least before, during, or after said medical procedure.

2. 10. The method of claim 1, further comprising determining a period of time during which the patient would benefit from receiving support from the intra-cardiac blood pump, the determined period of time comprising one or more of before, during, or after the medical procedure.

3. The method of claim 2 , wherein the intracardiac blood pump is provided for the determined period of time.

4. 4. The method of claim 3, wherein the intracardiac blood pump is provided prior to, simultaneously with, or after performing the medical procedure.

5. The method of claim 1 , wherein the medical procedure comprises a non-cardiac medical procedure.

6. The method of claim 1 , wherein the intracardiac blood pump is configured to provide left heart support.

7. The method of claim 1 , wherein the intracardiac blood pump is configured to provide right heart support.

8. 10. The method of claim 1, wherein the medical procedure requires the patient to be anesthetized.

9. The method of claim 1 , wherein the medical procedure comprises one or more of laparoscopic surgery, tumor resection, or gastrointestinal surgery.

10. 10. The method of claim 1, wherein the medical procedure comprises one or more of mitral valve repair, mitral valve replacement, ventricular tachycardia ablation, or atrial fibrillation ablation.

11. The method of claim 1 , wherein the medical procedure comprises knee or hip arthroplasty.

12. 10. The method of claim 1, wherein the set of adverse outcomes comprises one or more of hypotension, pulmonary edema, ventricular fibrillation, worsening ischemia, myocardial ischemia, hemodynamic collapse, cardiac arrest, stroke, heart attack, acute kidney injury, neurological decline, or death.

13. 10. The method of claim 1, wherein the first assessment or the second assessment is based on one or more of the patient's age, height, weight, body mass index, blood pressure, cholesterol level, liver function, kidney function, pre-existing medical conditions, personal medical history, or family medical history.

14. 10. The method of claim 1, wherein the first assessment or the second assessment is based on whether the patient has one or more of diabetes, an autoimmune disorder, or heart disease.

15. 10. The method of claim 1, wherein the first assessment or the second assessment is based on statistics regarding how prevalent each adverse outcome in the set of adverse outcomes is in a given population.

16. 16. The method of claim 15, wherein the given population comprises a group of people who share one or more characteristics with the patient.

17. 10. The method of claim 1, wherein the second assessment is based on the likelihood that the patient will experience one or more adverse outcomes of the set of adverse outcomes as a result of implantation of the intracardiac blood pump in the patient.

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