Systems, methods, and devices for ambulatory cardiac pacing

Abstract

Systems and methods for ambulatory cardiac pacing are provided. A method may include providing an implantable medical device and a medical lead and inserting the medical lead into a vein of a patient; and securing the holder adjacent the insertion site of the medical lead. The method may include selecting, for execution by an implantable medical device, a pacing algorithm from a first pacing algorithm configured to provide intermittent pacing support and a second pacing algorithm configured to provide continuous pacing support.

Description

Cross Reference to Related Applications

[0001] This application is related to U.S. Patent Application No. 18 / 486,930, filed October 13, 2023, which is a continuation of U.S. Patent Application No. 18 / 058,137, filed November 22, 2022, which is a continuation of U.S. Patent Application No. 17 / 739,893, filed May 9, 2022, which claims priority to U.S. Provisional Patent Application No. 63 / 268,498, filed February 25, 2022, and U.S. Provisional Patent Application No. 63 / 230,064, filed August 6, 2021, the entire contents of each of these patent applications are incorporated herein by reference. This application is also related to PCT Application No. PCT / US2022 / 038192, filed July 25, 2022, which claims priority to U.S. Patent Application No. 17 / 739,893, filed May 9, 2022, U.S. Provisional Patent Application No. 63 / 268,498, filed February 25, 2022, and U.S. Provisional Patent Application No. 63 / 230,064, filed August 6, 2021, and to Australian Patent Application No. AU2022323058A, European Patent Application No. EP22754998.7A, and Canadian Patent Application No. CA3227916A, all filed July 25, 2022, the entire contents of each of these patent applications are incorporated herein by reference. In addition, this application claims priority to U.S. Patent Application No. 63 / 516,941, filed August 1, 2023, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates generally to temporary cardiac pacing devices and methods. BACKGROUND

[0003] U.S. Patent Publication 2022 / 0273958 Al by Garai et al. describes a temporary pacing lead that can be used after a cardiac procedure, such as transcatheter aortic valve replacement (TAVR). Garai et al. further describe that instead of implanting a permanent pacemaker after a cardiac procedure, a temporary pacing lead and a micro-signal generator (also known as an external or temporary pacemaker or pulse generator) can be used to allow the patient to leave the hospital until the patient’s cardiac cycle has recovered, and then return to the hospital for lead removal. However, Garai et al. do not describe essential aspects necessary for successful clinical application. SUMMARY

[0004] The present disclosure describes systems and methods for a physician to select an appropriate temporary pacing algorithm for a given patient based on electrophysiological metrics, monitor such electrophysiological metrics over time, and manage temporary pacing parameters accordingly during a recovery period after hospital discharge, and determine when the patient can be weaned off temporary pacing and / or should be implanted with a permanent pacemaker based on the monitored electrophysiological metrics. The goal of these systems and methods can be to avoid unnecessary permanent pacemaker implantation if permanent pacemaker implantation becomes unnecessary after the recovery period.

[0005] In some aspects, the technology described herein relates to a method for operating an ambulatory pacing device, the method comprising: receiving a patient physiological condition indicator; selecting a pacing algorithm from a first pacing algorithm or a second pacing algorithm based on the physiological condition indicator, wherein the first pacing algorithm provides first pacing parameters based on the patient physiological condition indicator and the second pacing algorithm provides second pacing parameters independent of the physiological condition indicator; and operating the ambulatory pacing device based on the first pacing parameters or the second pacing parameters.

[0006] In some aspects, the technology described herein relates to an apparatus for cardiac pacing, the apparatus comprising: an implantable medical device; a medical lead configured to be inserted into a vein of a patient; a processor; and a memory storing instructions that, when executed by the processor, cause the apparatus to: select a pacing algorithm from a first pacing algorithm configured to provide intermittent pacing support and a second pacing algorithm configured to provide continuous pacing support; execute the selected pacing algorithm to deliver pacing therapy to the patient via the medical lead; perform periodic capture checks to determine whether a pacing signal effectively paces the patient’s heart; and determine a measure of pacing dependence by comparing pacing suppression per unit time to a threshold.

[0007] In some aspects, the technology described herein relates to an apparatus for cardiac pacing, the apparatus comprising: a processor; and a memory storing instructions that, when executed by the processor, cause the apparatus to perform operations comprising: receiving a pacing method used during a cardiac surgery, the pacing method used during the cardiac surgery based on an input signal indicative of a pre-operative electrocardiogram (ECG) assessment of a patient and a determination of a pre-operative risk level of the patient derived from the pre-operative ECG assessment; receiving a post-operative pacing method, the post-operative pacing method based on an input signal indicative of a post-operative ECG assessment of the patient and a determination of a post-operative risk level of the patient derived from the post-operative ECG assessment, wherein the post-operative pacing method is selected from a first algorithm configured to provide intermittent pacing support, a second algorithm configured to provide continuous pacing support, and no pacing support; and updating one or more pacing parameters based on the received pacing method and the received post-operative pacing method.

[0008] The above summary is not intended to describe each embodiment or every implementation of the disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various example embodiments and together with the description, explain the principles of the disclosed embodiments. The drawings illustrate different aspects of the disclosure, and, where appropriate, like structures, components, materials and / or elements in different drawings are labeled like. It should be understood that various combinations of the structures, components, and / or elements, other than those specifically shown, are contemplated and are within the scope of the present disclosure.

[0010] Numerous inventions are described and illustrated herein. The described inventions are not limited to any single aspect or embodiment, nor to any combination and / or arrangement of the same. Furthermore, the described inventions and / or embodiments thereof can be used alone or in combination with one another. For the sake of brevity, some combinations and permutations of the described inventions and / or embodiments will not be discussed again. It is noted that the embodiments described herein are intended to be illustrative, and that the scope of the disclosure is limited only by the claims. For example, an embodiment described as “exemplary” is not necessarily to be preferred or advantageous over other embodiments; rather, it is intended to indicate one example embodiment.

[0011] The accompanying drawings illustrate the exemplary embodiments of the disclosure and, together with the description, explain the principles of the disclosure. The drawings merely illustrate certain embodiments and are not, therefore, limiting of the disclosure or the invention.

[0012] Figure 1 is a schematic of an extracorporeal system of an ambulatory pulse generator (APG) and a temporary pacing lead (TPL) connected to a patient by a fixation member.

[0013] Figure 2 is a schematic of an intracorporeal system of a TPL placed in the right ventricle (RV) of a patient.

[0014] Figure 3 is a system block diagram of an APG, a TPL, and associated user controls.

[0015] Figure 4 is a flowchart of a pre-operative method.

[0016] Figure 5 is a flowchart of a post-operative method.

[0017] Figure 6This is a flowchart of the Pacer Dependent – ​​Multi-Day pacing algorithm.

[0018] Figure 7 This is a table of example parameters and ranges used in pacemaker-dependent multi-pacing algorithms.

[0019] Figure 8 This is a flowchart of the Pacer Dependent – ​​Short Block (PDB) pacing algorithm.

[0020] Figure 9 This is a table of example parameters and ranges used in the pacemaker-dependent – ​​short block pacing algorithm.

[0021] Figure 10 This is a flowchart of an at-risk pacing algorithm.

[0022] Figure 11 This is a table of example parameters and ranges used in pacing algorithms that are at risk.

[0023] Figure 12 This is a flowchart of the procedures after discharge from the hospital.

[0024] Figure 13A This is a schematic diagram illustrating an example of a capture detection method during pacing, showing capture.

[0025] Figure 13B This is a schematic diagram illustrating an example of a capture detection method during pacing, showing a case of non-capture.

[0026] Figure 14 This is a block diagram of an alternative system used in a hospital setting, in which the APG is used as a surgical pulse generator and is controlled by a resident master pulse generator (MPG).

[0027] Figure 15 This is a schematic diagram of the external system consisting of APG, retainer, insert patch, and TPL.

[0028] Figure 16 yes Figure 15 The diagram shows a system of APG, retainer, insert patch, and TPL, wherein the TPL is inserted into the subclavian vein and the system is covered by a covering patch.

[0029] While the embodiments of this disclosure are applicable to various modifications and alternatives, details of this disclosure have been illustrated by example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Implementation

[0030] As used herein, the terms “comprises,” “includes,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may also include other elements not expressly listed or inherent to such a process, method, article, or apparatus. The term “exemplary” is used in the sense of “example” rather than “ideal.” Furthermore, the terms “first,” “second,” etc., do not indicate any order, quantity, or importance herein, but are used to distinguish an element or structure from another element or structure. Additionally, the terms “a” and “an” as used herein do not indicate a limitation of quantity but rather indicate the presence of one or more of the referenced items.

[0031] The term "distal end" or any variation thereof refers to the portion of the device furthest from the operator during surgery. Conversely, the term "proximal end" or any variation thereof refers to the portion of the device closest to the operator. Furthermore, any use of the terms "about," "approximately," "substantially," and "roughly" generally means + / - 10% of the indicated value.

[0032] Schematic diagram of in vitro and in vivo systems

[0033] In some embodiments, reference Figure 1 A schematic diagram of an extracorporeal system 100 is shown, comprising a walking pulse generator (APG) 110 and a temporary pacing lead (TPL) 120 connected to a patient via a fixation member 130. The APG 110 is configured to generate pacing pulses and monitor heartbeats. The fixation member 130 may include an elastic cuff or other suitable member known in the art, configured to hold the APG 110 in place during patient movement. The TPL 120 (which may be similar to the examples described in U.S. Patent Application Publication No. 2002 / 0273958 by Garai et al. and U.S. Patent Application Publication No. 2018 / 0353751 by Pedersen et al., the entire disclosures of which are incorporated herein by reference) is configured to be inserted into the patient's vascular system. The TPL 120 may be inserted into the heart via various access points such as the femoral vein, femoral artery, carotid artery, jugular vein, basilic vein, cephalic vein, axillary vein, subclavian vein, brachiocephalic vein, or brachial vein, as shown in the figure. TPL 120 is configured to deliver pacing pulses from APG 110 to the heart and sense the heartbeat, thereby providing feedback to APG 110 for adjusting pacing parameters.

[0034] In some embodiments, such as Figure 2 (As shown in the schematic diagram of the in vivo system), the distal end of the TPL 120 is positioned in the right ventricle (RV) of the heart. The TPL 120 may include an anchoring mechanism 122, such as a canine, configured to secure the distal end of the TPL 120 to the cardiac tissue. A biasing mechanism 124 (such as a balloon) may push the anchoring mechanism 122 against the interventricular septum, thereby deploying the anchoring mechanism 122 into the cardiac tissue. The TPL 120 may further include one or more electrodes 126 configured to contact and facilitate pacing and sensing of heartbeats in the cardiac tissue. An APG 110 communicating with the TPL 120 can process the sensed cardiac signals to dynamically adjust pacing parameters, thereby ensuring appropriate cardiac support based on the patient's condition. The system 100 is configured to provide temporary cardiac pacing postoperatively, allowing patient mobility and remote monitoring by a healthcare provider.

[0035] System block diagram

[0036] In some embodiments, reference Figure 3 A system block diagram of a walking pulse generator (APG) 110, a temporary pacing lead (TPL) 120, and an associated user control 310 is shown. The APG 110 (which may resemble a conventional external pulse generator but has a smaller form factor) is configured to generate pacing pulses and monitor heartbeats based on pre-programmed pacing algorithms, which can be selected by one or more entities, programs, etc. (such as a treating physician). The APG 110 and TPL 120 can be connected via one or more data connections (such as lead connection 119) to transmit pacing signals. The system may include the user control 310, which is configured to receive data from the APG 110 and transmit or present data to various users, including patients and telehealth personnel, at different levels of restriction. For example, the user control 310 may provide patients with limited access to and control over the APG 110 when they are away from supervised medical care (such as at home after discharge).

[0037] In some embodiments, APG 110 may include system control 111, which includes a microcontroller configured to host control software and provide hardware connectivity to all subsystem components. APG 110 may further include a pacemaker 118 configured to generate pulse waveforms controlled by system control 111. Pacemaker 118 may provide VVI pacing, which in some embodiments is a cardiac pacing mode in which the pacemaker paces the ventricle only when intrinsic ventricular activity is not detected, thereby suppressing the pacing pulse when intrinsic heartbeat is sensed. In some embodiments, pacemaker 118 may output a voltage in a step size of approximately 0.1 mV or finer in the range of approximately 0 V to approximately 8 V, or a current output in a step size of approximately 1 mA or finer in the range of approximately 0 mA to approximately 25 mA. Pacemaker 118 may also generate pulse widths of approximately 0.2 ms to approximately 2 ms in steps of approximately 0.1 ms, with the pulse width nominally set to approximately 1.5 ms.

[0038] In some embodiments, the APG 110 may include a sensing circuit 115 configured to receive and process sensed electrical cardiac signals. The sensing circuit 115 can tolerate polarization potentials up to about 0.5 V while remaining within its linear operating range and can have a low noise floor of less than about 0.2 mV to effectively distinguish physiological signals from noise.

[0039] In some embodiments, APG 110 may include communication circuitry 116 that provides a low-power local data link to a local repeater device, such as user control 310. Communication circuitry 116 may also provide a remote data link to a call center, independent diagnostic testing facility (IDTF) 320, electronic health record (EHR) system, or other healthcare communication infrastructure. This bidirectional communication enables data transmission from APG 110 and command reception from remote sites. APG 110 may further include a main power supply 113 and / or one or more auxiliary power supplies, which may be removable for refurbishment or recycling of APG 110.

[0040] In some embodiments, user control 310 (which may be a separate unit from APG 110) is configured for wired or wireless communication. User control 310 may be configured to provide different levels of control over APG 110 and access to its data based on user type. For example, a patient may have limited control and access, a treating physician may have full control and access, and other healthcare providers may have intermediate levels of access. User control 310 may feature a user interface device control 314 (e.g., a graphical user interface) configured to present APG 110 data (including status, statistics, and records) and facilitate control and settings of APG 110. This interface can range from minimal, such as an LED indicator, to richer, such as a smartphone app or a dedicated device with similar capabilities but controlled update access. User control 310 may also include a communication module 312 for short-range wireless communication with APG 110 or long-range (e.g., cellular) communication with call centers, IDTF, etc. User control 310 may further include its own power supply 316 to ensure independent operation.

[0041] In some embodiments, the APG 110 may include one or more components (such as a speaker) for generating an audible tone 117, which is configured to alert a patient to a specific condition. The audible tone 117 may be configured to be loud enough and operate at multiple frequencies for the hearing-impaired patient to hear. Additionally, the APG 110 may include a patient button 114 that the patient can press to initiate a data recording session or send a communication notification to a healthcare provider via a long-distance link.

[0042] In some embodiments, APG 110 may include external heartbeat detector circuitry 112 configured to prevent false alarms of lost capture (LOC) conditions. The heartbeat detector may include a lead-independent ECG channel, a photoplethysmography (PPG) sensor, or a pressure cuff. These features may be alternatively or additionally incorporated into user control 310 to ensure accurate monitoring and decision-making based on the patient's heartbeat.

[0043] Preoperative methods

[0044] In some embodiments, reference Figure 4The diagram illustrates a flowchart of an example method for preoperative application. Prior to a patient undergoing cardiac surgery (such as transcatheter aortic valve replacement (TAVR) 410), a preoperative conduction assessment 402 using a multi-lead ECG (e.g., a 12-lead ECG, but it should be understood that the ECG can have any number of applicable leads) can be performed to assess the patient's cardiac health and determine whether postoperative temporary pacing can be indicated. For example, if the patient's heart is determined to be relatively healthy, as indicated by a QRS interval of less than approximately 120 ms 404, the patient can be flagged as relatively low risk, and rapid left ventricular (LV) unipolar pacing using a pacing guidewire and grounding pad can be performed to facilitate valve deployment, as described in U.S. Patent Application Publication No. 2023 / 0042385 by David Daniels, the entire disclosure of which is incorporated herein by reference.

[0045] In some embodiments, if a patient's heart is determined to be relatively unhealthy, as indicated by a cardiac conduction block condition (such as pre-existing right bundle branch block (RBBB) 406), the patient can be flagged as high-risk for the need for postoperative temporary pacing. In this case, a TPL 120 can be placed in the right ventricle (RV) for rapid RV pacing during valve deployment, with the intention of using the TPL 120 in conjunction with an APG 110 after surgery and continuing this use for a period after the patient's discharge. Additionally, for high-risk patients, brachial vein access using a temporary lead 408 can be considered to ensure effective pacing support.

[0046] Postoperative methods

[0047] In some embodiments, reference Figure 5 The diagram illustrates a flowchart of an example method 500 for postoperative application. Following cardiac surgery, immediate postoperative conduction assessment 502 can be performed using a multi-lead ECG (e.g., a 12-lead ECG; however, it should be understood that an ECG can have any number of applicable leads) to assess the patient's cardiac condition and determine whether temporary pacing is indicated. If the patient's heart is determined to be relatively healthy, as indicated by a QRS interval of less than 120 ms, and no cardiac conduction block occurred during cardiac surgery, the patient can be categorized as relatively low-risk, and postoperative temporary pacing can be indicated as optional. In this case, a narrow QRS TAVR postoperative condition without surgical cardiac conduction block 504 indicates that the patient does not require immediate temporary pacing.

[0048] In some embodiments, if and / or when a patient's heart is determined to be relatively unhealthy, as indicated by a QRS interval exceeding approximately 120 ms, the patient can be flagged as having increased risk. This increased risk may be associated with conditions such as right bundle branch block (RBBB) or left bundle branch block (LBBB). In such cases, methods such as reference [reference missing] can be used. Figure 6 and Figure 7 The described risky pacing algorithm 508 is used to instruct the patient to undergo temporary pacing.

[0049] In some embodiments, a patient may be labeled as pacemaker dependent if and / or when the patient has cardiac conduction block. In this case, methods such as those described in the reference... Figure 8 , Figure 9 , Figure 10 and Figure 11 The described pacemaker relies on algorithm 510 to instruct the patient to perform temporary pacing. These algorithms are configured to provide the necessary pacing support based on the patient's specific condition.

[0050] In either of these latter scenarios, the patient can be discharged home 512, where the distal end of the TPL 120 is in the right ventricle (RV), the proximal end of the TPL 120 is connected to the APG 110, and the APG 110 is connected to the patient via a fixation component 130 (e.g., a strip). An appropriate pacing algorithm can be programmed into the APG 110, as described in the reference. Figure 6 to Figure 11 As described, this ensures continuous monitoring and support as needed.

[0051] Pacemakers rely on pacing algorithms

[0052] In some embodiments, the pacemaker-dependent algorithm provides VVI pacing with an adjustable pacing rate, wherein the pacing pulse can be suppressed by detecting the intrinsic heartbeat (after the refractory period) before the start of the next pacing pulse. The pacemaker-dependent algorithm also provides periodic capture checks, controlled pacing rate reduction, and other features as further described herein.

[0053] refer to Figure 6 The diagram illustrates a flowchart of a multi-day algorithm 600. This algorithm provides VVI pacing 606 with full support 602 and includes status recording of statistics and rhythm bars 604. The algorithm performs periodic capture checks 608 to determine if the pacing signal has reached the cardiac tissue and is effectively pacing the heart. A lack of capture can indicate a loss of capture (LOC), in which case an alert is issued to the user 610.

[0054] The algorithm includes controlled pacing rate reduction methods 612, such as gradual reduction of conduction block, a scheme defined as a function of heart rate, or a scheme defined as a function of time. These reductions can be linear, exponential, continuous, parametric, or step functions. The algorithm determines pacemaker dependence by comparing pacing suppression at each sampling time with a threshold 614. If the pacing rate is below the minimum rate for more than the minimum rate time 616, a controlled pacing rate increase 618 can occur. Similarly, the algorithm checks if the pacing rate is below the low rate for more than the low rate time 620. Data is transmitted to the user 622 to aid in patient management. The cycle continues with pacing, capture checks, controlled rate reduction, pacemaker dependence testing, adjustment of pacing parameters as needed, and recording / transmission.

[0055] refer to Figure 7 A table illustrating the parameters and ranges of the multi-day algorithm 700 is shown. Parameter 702 includes full support rate, periodic capture check interval, capture check pacing pulse, pacing suppression sampling time, pacing suppression threshold, minimum rate, minimum rate sampling time, rate increase, low rate, and low rate sampling time. These ranges are provided by way of example and are not necessarily limiting, and include very low values ​​704, lower values ​​706, nominal values ​​708, higher values ​​710, and very high values ​​712.

[0056] refer to Figure 8 A flowchart illustrating a short-block pacemaker-dependent algorithm 800 is shown. This algorithm provides VVI pacing 806 with full support 802 and includes status recording of statistics and rhythm bars 804. The algorithm performs periodic capture checks 808 to determine if the pacing signal has reached cardiac tissue and is effectively pacing the heart. An alarm is issued to the user 810 in the event of capture failure. The alarm may be a visual, auditory, tactile (e.g., vibration) notification or a combination thereof to inform the user of the capture failure.

[0057] The algorithm may include periodic controlled pacing rate reduction 812. If the pacing rate remains below the minimum rate for more than the minimum rate time 818, the algorithm may stop rate reduction and set to full support rate 816. The algorithm determines pacemaker dependence by comparing pacing suppression during each indwelling interval to a threshold 814. Data is transmitted to the user 820 to aid in patient management. The cycle continues through pacing, capture checks, controlled rate reduction, pacemaker dependence testing, adjusting pacing parameters as needed, and performing / transmitting recordings.

[0058] refer to Figure 9A table illustrating the parameters and ranges of the short-block algorithm 900 is shown. Parameter 902 includes full support rate, periodic capture check interval, capture check pacing pulse, pacing rate reduction step-down, step-down indwelling pacing pulse, periodic pacing rate reduction test interval, pacing suppression threshold, minimum rate, and minimum rate sampling time. These ranges are provided by way of example and are not necessarily limiting, and include very low values ​​904, lower values ​​906, preferred values ​​908, higher values ​​910, and very high values ​​912.

[0059] Pacing algorithms at risk

[0060] In some embodiments, Figure 10 and Figure 11 Example pacing algorithm 1000 under risk is illustrated with flowcharts and parameter tables. Parameters and ranges are provided illustratively and are not necessarily restrictive, and correspond to the flowcharts. Pacing algorithm 1000 under risk can operate as a standalone algorithm or as a subroutine, and can be collaboratively linked to the pacemaker-dependent algorithms described herein.

[0061] In some embodiments, the pacing algorithm 1000 under risk can be configured to test physiological conditions and adjust pacing accordingly. Algorithm 1000 can initially set the pacemaker to a slow rate, such as approximately 20 BPM, to provide rescue pacing. It should be understood that one or more other values ​​may be set for the slow rate, depending on one or more specific characteristics of the patient and / or one or more clinical goals. Algorithm 1000 can cycle on each pacing or sensing event, monitoring for certain physiological conditions, such as bradycardia fast enough that pacing support is not required. If a prolonged period of bradycardia exists, such as at a rate less than approximately 40 BPM for more than approximately 30 seconds, algorithm 1000 can switch to a pacemaker-dependent algorithm as described above (e.g., full pacemaker support 1010). It should be understood that one or more other values ​​may be set for timing periods and / or rates, depending on one or more specific characteristics of the patient and / or one or more clinical goals. For example, if the pacing rate increases (e.g., 4 BPM) due to cardiac arrest, Algorithm 1000 can similarly transition to a pacemaker-dependent algorithm as described herein (e.g., Full Pacemaker Support 1010). After transitioning to Full Pacemaker Support 1010, a status record can be made. Other aspects of the pacing algorithm 1000 at risk may be the same as or similar to the pacemaker-dependent algorithms described herein, which are incorporated herein by reference in this section of the specification.

[0062] In some embodiments, multi-day algorithm 600 ( Figure 6This provides a slower, controlled rate reduction (e.g., approximately 0.25 BPM per hour) to test pacemaker independence over multiple days, while the short block algorithm 800 ( Figure 8 This provides frequent, rapid pacing rate reductions (e.g., a gradual reduction of approximately 10 BPM per minute per day). After the test is complete, the pacing rate can be restored to its pre-test state. The pacing rate reduction can be a linear, exponential, continuous, parametric, or step function.

[0063] refer to Figure 10 The risk-based pacing algorithm 1000 involves several steps. Pacemaker dependence determination 1002 assesses the patient's condition to determine pacing requirements. If the VVI rate is set to the risk-based (AR) minimum 1004, the algorithm checks whether the intrinsic rate is less than or equal to the AR bradycardia rate sustained for more than the AR bradycardia time 1006. The AR bradycardia rate can refer to a predefined threshold heart rate below which the patient is considered to be experiencing bradycardia (characterized by an abnormally slow heart rate), and the AR bradycardia time can refer to a predefined duration during which the patient's intrinsic heart rate must remain below the AR bradycardia rate to trigger a specific response from the pacing algorithm. If the intrinsic rate condition is met, the VVI rate is set to full pacemaker support 1010. Additionally, the algorithm checks the number of pacing cycles per AR pause sampling interval against the AR pause event limit 1008. If the number of pacing cycles exceeds the event limit, the VVI rate is set to full pacing support 1010.

[0064] refer to Figure 11 This section illustrates the parameters and ranges of the pacing algorithm 1100 under risk. Parameters 1102 that can be used as indicators of a patient's physiological condition may include the minimum VVI rate under risk, the rate of bradykinesia under risk, the duration of bradykinesia under risk, the limit of pause events under risk, and the pause sampling interval under risk. These ranges are provided by way of example and are not necessarily restrictive, and include very low values ​​1104, lower values ​​1106, nominal values ​​1108, higher values ​​1110, and very high values ​​1112. It should be understood that this list of parameters is not exclusive, and one or more additional parameters may be considered. Furthermore, one or more of these parameters may be combined to assess a patient's physiological condition.

[0065] As used herein, the term "patient physiological condition indicator" can refer to any measurable parameter or set of parameters that provides information about a patient's physiological state or health. These indicators may include, but are not limited to, heart rate, blood pressure, respiratory rate, blood oxygen level, electrocardiogram (ECG) readings, body temperature, and biochemical markers. Indicators may also encompass derived indicators, such as variability in heart rate, trends over time, and responses to medical interventions. This definition aims to include any parameters that can help assess a patient's health status or physiological condition.

[0066] Post-discharge methods

[0067] In some embodiments, once an appropriate algorithm has been selected or programmed as described above, the patient can be discharged, and a post-discharge protocol or algorithm 1200 can be employed, such as... Figure 12 As shown. Typically, post-discharge approaches aim to enable physicians to make clinical decisions regarding the suitability of a permanent pacemaker. They also aim to ensure capture during the recovery period (i.e., the temporary pacing lead (TPL) remains in the desired position) and, in the event of loss of capture (LOC), to alert the patient and, optionally, the healthcare provider, to seek medical care for corrective surgery (e.g., adjustment or replacement of the TPL) or permanent pacemaker implantation. Further, they aim to wean the patient off the walking pulse generator (APG) and TPL within a timeframe (e.g., 30 days) to reduce the risk of infection from the indwelling device, such as the TPL.

[0068] In some embodiments, the post-discharge method or algorithm 1200 may include determining pacemaker dependence by comparing a pacemaker dependence metric to a lower limit pacemaker dependence threshold, a moderate pacemaker dependence threshold, and an upper limit pacemaker dependence threshold. If the lower limit threshold is met, the patient may be flagged for removal of the TPL and APG based on the treating physician's clinical judgment 1210. Similarly, if the upper limit threshold is met, the patient may be flagged for implantation of a permanent pacemaker 1212 based on the treating physician's clinical judgment. To enable clinical judgment, data, events, bar graphs, statistical analyses, etc., may be monitored, recorded, and transmitted to the healthcare provider as previously mentioned.

[0069] In some embodiments, by way of example and not necessarily limitation, the lower limit pacemaker dependence threshold may include one or more parameters (such as the time or heart rate requiring pacing support) of approximately less than 5%, the intermediate pacemaker dependence threshold may include one or more parameters (such as the time or heart rate requiring pacing support) of approximately 5% to approximately 20%, and the upper limit pacemaker dependence threshold may include one or more parameters (such as the time or heart rate requiring pacing support) of approximately greater than 20%. The thresholds may be selected and modified by one or more entities (such as physicians) and programmed into the APG. The range of thresholds may be exclusive or overlapping. Alternatively, thresholds may not be used, and clinical judgment may be relied upon alone. The percentage of pacemaker dependence may be reported on a continuum or at different grading levels (e.g., low, intermediate, high).

[0070] In some embodiments, an example metric for pacemaker dependence is the percentage of time the previously described pacing algorithm is in pacing or non-pacing mode, or the number of heartbeats. For example, it may be the inherent percentage of pacing (or the number of beats) over a given period of time. The sampling period may include, for example, an hour, a day, or a week, and previous and subsequent sampling percentages may be compared to obtain a trend.

[0071] In some embodiments, the first sampling period may include one week immediately following discharge (i.e., at home), during which a pre-programmed pacing algorithm is executed to progressively reduce the pacing rate. Subsequent sampling periods 1206 may include another week. Throughout these periods, pacemaker dependence data may be measured, monitored, recorded, and optionally transmitted for review by a physician (e.g., an electrophysiologist (EP)) to enable clinical judgment regarding pacemaker dependence.

[0072] In some embodiments, if a patient has low pacemaker dependence and no cardiac conduction block, the patient can be marked as recovered and TPL / APG removal can be instructed 1210. If a patient has moderate pacemaker dependence and no cardiac conduction block, or if a patient has low pacemaker dependence and intermittent cardiac conduction block, an additional sampling period (e.g., another week) can be specified. However, if a patient has moderate pacemaker dependence and intermittent cardiac conduction block or high pacemaker dependence, the patient can be marked as suitable for a permanent pacemaker 1212. This process can be repeated as prescribed or programmed, with multiple follow-up and sampling periods, and such periods can be adjusted as needed.

[0073] In some embodiments, after an additional sampling period, the physician (e.g., EP) can review the data again. If the additional sampling period reveals low pacemaker dependence and no cardiac conduction block, the patient can be marked as recovered and TPL / APG removal can be instructed 1210. If the additional sampling period reveals low pacemaker dependence with intermittent cardiac conduction block, or moderate to high pacemaker dependence, the patient can be marked as suitable for a permanent pacemaker 1212. This process can be repeated as prescribed or programmed, with multiple follow-up and sampling periods, and such periods can be adjusted as needed.

[0074] like Figure 12 As shown, the post-discharge method or algorithm 1200 may include one or more steps and / or assessments. The method may begin with the patient being discharged with a walking pulse generator (APG) and a temporary pacing lead (TPL) 1202. The patient may experience an initial period 1204, which may last approximately the first week post-discharge, or may last one or more other periods, as required by one or more specific characteristics of the patient and / or one or more desired clinical outcomes. During this initial period, the patient's pacemaker dependence and cardiac conduction block status may be monitored. After the initial period 1204, the patient may enter a subsequent period 1206, such as the second week post-discharge. During this subsequent period, a post-discharge electrophysiological (EP) appointment 1208 may be scheduled to review the patient's rhythm strips and pacing percentage. Based on the review, the patient's pacemaker dependence and cardiac conduction block status may be assessed, leading to different possible outcomes. If and / or when it is determined that the patient has low pacemaker dependence and no cardiac conduction block, 1210 the APG and TPL may be removed, indicating that the patient has adequately recovered. If and / or if a patient is found to have low pacemaker dependence but with intermittent cardiac conduction block, or moderate pacemaker dependence without cardiac conduction block, an additional period 1206 (e.g., another week) can be designated for further monitoring and evaluation. After the additional period 1206, if the patient continues to show low pacemaker dependence and without cardiac conduction block, 1210 APG and TPL can be removed. However, if the patient shows low pacemaker dependence with intermittent cardiac conduction block, or moderate to high pacemaker dependence, the patient can be marked for admission with a permanent pacemaker 1212. It should be understood that, depending on the specific implementation, one or more additional periods 1206 may be employed. During subsequent monitoring periods, background capture tests 1214 can be performed periodically to ensure that the TPL remains in the desired position and capture is maintained. If the capture test passes, periodic capture tests can continue. If the capture test fails, the patient can be directed to the emergency room (ER) for admission and immediate correction, possibly including permanent pacemaker implantation.

[0075] Seize the inspection method

[0076] In some embodiments, each of the algorithms described above may provide a periodic capture check routine, which may run in parallel with the algorithm or as a background process. Various capture check methods (or their derivatives, lost capture (LOC) check methods) may be employed, examples of which are described below.

[0077] exist Figure 13A and Figure 13B The examples shown illustrate different scenarios used for capture detection. Figure 13A The diagram 1300 shows a patient without pacing prior to capture testing (i.e., pacing rate lower than inherent), where the inherent beat 1312 can be measured, and test pacing 1315 can be delivered at a rate greater than the inherent rate (e.g., +30 BPM). Capture 1310 can be indicated by detecting the inherent beat 1312 of the heartbeat 1311 during the test pacing period. If inhibition is detected during test pacing, the pacing rate can be increased until no inhibition is detected. Test pacing can then be skipped, indicated by the absence of test pacing 1316, and the pre-test pacing rate can be resumed after a brief pause (e.g., 3 seconds or 20 BPM). Capture can be further indicated by detecting the inherent beat 1312 during the pause. Pacing capture (not sensed, in the process of fading) 1314 can indicate one or more periods during which the pacing signal is not sensed due to the fading period. The blanking period can be the time period following the pacing pulse during which one or more sensing circuits are temporarily disabled, configuring them to enter a non-sensing state. This prevents the sensing circuits from detecting one or more electrical artifacts generated from the pacing pulse and erroneously responding to them. During this period, the sensing circuits can be configured to ignore one or more or all electrical signals.

[0078] In some embodiments, if the patient is pacing prior to the capture test (i.e., the pacing rate is higher than inherent), capture 1310 can be indicated by the absence of suppression at pacing 1315 (e.g., suppression rate < 1 per 20 pacings), followed by inherent pacing 1312 during the pause period. Loss of capture 1320 can be indicated by frequent suppression at pacing 1325 (e.g., suppression rate > 1 every one or more pacings, such as 20 pacings) or by a sudden onset of frequent suppression (e.g., loss of suppression rate > 1 per 20 pacings). Figure 13B(As shown in Figure 1300). The term "not sensed, during blanking" 1324 refers to the time periods during which the intrinsic beat is not sensed due to the blanking period, potentially leading to a misinterpretation of the capture state. Additionally, "sensed suppression" 1326 indicates the point where the pacing signal is suppressed due to the detection of the intrinsic beat, and "delayed pacing" 1328 shows the interval during which pacing is delayed.

[0079] In some embodiments, another example of a capture detection method involves rapid overdrive pacing. Rapid overdrive pacing (e.g., 90 BPM to 180 BPM), followed by a brief pause (e.g., 3 seconds or 20 BPM) or a no-pacing period, can generate a period without an intrinsic beat 1322, followed by a gradual recovery of the baseline heart rate of beat 1321. The presence of an intrinsic beat 1322 immediately following overdrive pacing (i.e., no suppression period) can indicate a loss of capture 1320, while the absence of an intrinsic beat immediately following overdrive pacing can indicate capture 1310. Intrinsic detection following overdrive pacing at two or more pacing rates can provide greater confidence in capture. At high overdrive pacing rates that may result in prolonged suppression of the intrinsic beat 1322, a rescue pacing rate can be used during the suppression period to restore a normal heart rate more quickly, such as adjusting the pacing rate to VVI 20 BPM during testing.

[0080] In some embodiments, another example of capture detection involves progressively increasing the pacing rate and measuring the return cycle length. Capture 1310 can be indicated by a cycle length that increases proportionally with the pacing rate, while loss of capture 1320 can be indicated by a cycle length that does not change or changes disproportionately with the pacing rate.

[0081] Alternative system block diagram

[0082] In some embodiments, Figure 14A block diagram 1400 of an alternative system for use in hospital settings (e.g., catheterization lab, ED, OR, etc.) is shown, in which an APG 1410 provides surgical pacing and is controlled by a resident master pulse generator (MPG) 1420. For example, the APG 1410 and TPL 120 can be used for surgical pacing during cardiac surgery (e.g., transcatheter aortic valve replacement (TAVR)), where the APG pacemaker 1418 is controlled by the MPG 1420, and the pacing signal is delivered to the patient's heart via the TPL 120. The APG 1410 and TPL 120 can be connected via one or more data connections (e.g., leaded connection 1419) to enable the transmission of the pacing signal. The MPG 1420 can be wirelessly connected to a remote control module (RCM) 1440 and includes a surgical pacing algorithm as described in U.S. Patent Application Publication No. 2023 / 0042385 by David Daniels, the entire disclosure of which is incorporated herein by reference. In this context, the resident MPG 1420 is the master device from the APG 1410. The MPG 1420 may optionally include its own pacemaker 1426 and sensing circuitry 1430 for use in the absence of the APG 1410. Thus, the APG 1410 is used both as a surgical pacemaker and as a walking pacemaker.

[0083] In some embodiments, the APG 1410 includes several components. A system control 1411, configured to manage and coordinate the functions of the APG, is connected to a pulse detector 1412, a main battery power supply 1413, and a patient button 1414. A pacemaker 1418 is configured to generate pacing signals that are delivered to the heart via a TPL 120. The APG 1410 also includes a sensing circuit 1415 configured to detect heartbeats, and one or more components 1417 for generating audible tones, which are configured to alert the patient to specific conditions. A communication module 1416 enables data exchange between the APG 1410 and other devices, such as the MPG 1420 and RCM 1440.

[0084] In some embodiments, MPG 1420 is configured to function as a control unit in the system. MPG 1420 includes a controller 1424 configured to manage the operation of MPG 1420 and control APG 1410 via an APG control link. MPG 1420 also includes its own pacemaker 1426 and sensing circuitry 1430, which can be used independently of APG 1410 to generate and monitor pacing signals. A user interface 1428 is provided for one or more entities (such as one or more systems, one or more healthcare professionals, etc.) to interact with and control MPG 1420, and a communication module 1422 enables wireless data exchange with RCM 1440 and other hospital systems. A power supply 1432 and a rechargeable battery 1434 ensure continuous and / or intermittent operation of MPG 1420.

[0085] In some embodiments, the RCM 1440 is configured to facilitate remote control and monitoring of the MPG 1420 and APG 1410. The RCM 1440 includes a main battery power supply 1442, UI buttons and indicators 1444 for user interaction, a controller 1446 configured to manage the functions of the RCM 1440, and a communication module 1448 for wireless communication with the MPG 1420.

[0086] The integration of APG 1410, MPG 1420, and RCM 1440 in the Alternative System Block Diagram 1400 enables a flexible and robust pacing system suitable for various clinical environments. The APG 1410 can be used as a walking pacemaker during patient movement and as a surgical pacemaker during cardiac surgery when controlled by the MPG 1420. The RCM 1440 allows for remote control and monitoring, ensuring that healthcare providers can manage the pacing system efficiently and effectively.

[0087] Alternative system configuration and insertion site

[0088] In some embodiments, reference Figure 15 and Figure 16 A schematic diagram of an alternative system configuration 1500 is shown, which includes an APG 1510, a retainer 1540, an adhesive-backed insert patch 1550, and a TPL 1520. See details. Figure 15APG 1510 and TPL 1520 can be configured as described above. The retainer 1540 may have a posterior surface (not visible) and a shaped recess 1542 conforming to the shape of the APG 1510. This posterior surface may be flat or otherwise shaped to conform to the skin surface of the patient's adjacent insertion site (e.g., the area below the clavicle when the TPL 1520 is inserted into the subclavian vein). The posterior surface may optionally include an adhesive layer. The retainer 1540 may further include a retainer 1544 configured to releasably secure the TPL 1520. Therefore, the retainer 1540 can stabilize the relative position of the APG 1510 and TPL 1520 to avoid strain therebetween, and securing the retainer to the skin can prevent the transmission of force to the TPL 1520, which could otherwise lead to migration. In addition, the adhesive-backed insertion patch 1550 can be placed on or around the TPL 1520 to fix the TPL 1520 relative to the patient's skin at the insertion site, thereby preventing the TPL 1520 from migrating relative to the intracardiac pacing site.

[0089] In some embodiments, reference Figure 16 The above references are shown schematically. Figure 15 The described system, in which the TPL 1520 is inserted into the patient's body, for example, through the subclavian vein, and the system is covered by an adhesive-backed waterproof cover patch 1560. The APG 1510, held in place by a retainer 1540, and the TPL 1520, secured by the adhesive-backed insertion patch 1550, are positioned to ensure stability and reduce the risk of migration. The cover patch 1560 provides additional security and protection, thereby maintaining the position of the components and protecting the insertion site from moisture and external contaminants.

[0090] In some embodiments, one or more of the algorithms described herein can be executed by a machine learning model trained on input data to develop associations between patient parameters and desired outcomes, such as selection of pacing modes, algorithms, etc. The machine learning model can be configured to receive various types of input data, including but not limited to patient-specific physiological parameters (e.g., heart rate, heart rhythm, historical pacing data), surgical data (e.g., type and duration of cardiac surgery), and environmental factors (e.g., activity level, posture). Input data can be collected from sensors and monitoring devices integrated with the APG, MPG, TPL, and RCM systems described herein. During training, the machine learning model can analyze large datasets to identify patterns and correlations indicating optimal pacing strategies for different patient conditions and scenarios.

[0091] Once trained, the model can be implemented within the system controls of an APG or MPG, where it continuously analyzes real-time data to predict and select the most appropriate pacing algorithm or mode to achieve the desired treatment outcome. To ensure the model remains accurate and effective, it can be periodically updated or modified based on new data collected during patient monitoring and treatment. This update process may involve retraining the model with the latest data to refine its predictions and improve its performance. The system can be configured to initiate these updates automatically or manually at regular intervals or in response to specific events such as changes in patient condition or the introduction of new treatment protocols. By continuously incorporating new data, the machine learning model can adapt to the evolving needs of each patient, thereby enhancing the personalization and effectiveness of pacing therapy over time.

[0092] All aspects described in this disclosure (including references incorporated herein by reference, appended claims, abstract, and drawings) may be combined in any order, in part or in whole, or in any combination or modification, unless such aspects are incompatible or inconsistent. Furthermore, unless expressly stated otherwise or inconsistent with the teachings herein, each aspect may be replaced by an alternative feature for the same, equivalent, or similar purpose. Therefore, unless expressly stated otherwise, each aspect disclosed herein may be merely an example of an equivalent or similar feature. The invention is intended to be defined by the appended claims and their legal equivalents.

[0093] The embodiments disclosed herein include:

[0094] Example 1. A method for operating a walking pacemaker, the method comprising: receiving a patient's physiological condition index; selecting a pacing algorithm from a first pacing algorithm or a second pacing algorithm based on the physiological condition index, wherein the first pacing algorithm provides first pacing parameters based on the patient's physiological condition index, and the second pacing algorithm provides second pacing parameters independently of the physiological condition index; and operating the walking pacemaker based on the first pacing parameters or the second pacing parameters.

[0095] Example 2. The method as described in Example 1, wherein the patient's physiological condition indicators are based on measured electrocardiogram (ECG) data.

[0096] Example 3. The method as described in Example 1, wherein these second pacing parameters include a decreasing pacing pulse rate (PPR) over time.

[0097] Example 4. The method as described in Example 1, wherein the second pacing parameters decrease the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm further includes measuring heart rate (HR) over time.

[0098] Example 5. The method as described in Example 1, wherein the second pacing algorithm includes decreasing the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm further includes measuring the heart rate (HR) over time, and further includes increasing the PPR when the HR reaches a threshold indicating pacing dependence.

[0099] Example 6. The method as described in Example 4, wherein the second pacing algorithm includes decreasing the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm further includes measuring the heart rate (HR) over time, and further includes decreasing the PPR when the HR reaches a threshold indicating pacing independence.

[0100] Example 7. The method of Example 1, further comprising: performing a periodic capture test to determine whether one or more pacing signals effectively pace the patient's heart, wherein the periodic capture test comprises: pacing the heart at an increasing rate for a predetermined number of beats; skipping a pacing signal; and determining that the one or more pacing signals effectively pace the patient's heart by detecting an intrinsic heartbeat after skipping the one pacing signal.

[0101] Example 8. The method of Example 1 further includes: comparing the number of pacing suppressions per unit time with a predetermined threshold; and adjusting one or more pacing parameters based on the result of comparing the number of pacing suppressions per unit time with the predetermined threshold to determine a measure of pacing dependence.

[0102] Example 9. The method as described in Example 1, wherein the walking pacemaker includes a communication circuit for transmitting data to and receiving commands from a remote site.

[0103] Example 10. The method as described in Example 1, wherein the patient's physiological condition indicator is received from a medical lead located in the patient's vein.

[0104] Example 11. A device for cardiac pacing, the device comprising: an implantable medical device; a medical lead configured to be inserted into a patient's vein; a processor; and a memory storing instructions that, when executed by the processor, cause the device to: select a pacing algorithm from a first pacing algorithm configured to provide intermittent pacing support and a second pacing algorithm configured to provide continuous pacing support; execute the selected pacing algorithm to deliver pacing therapy to the patient via the medical lead; perform a periodic capture check to determine whether the pacing signal effectively paces the patient's heart; and determine a measure of pacing dependence by comparing pacing suppression per unit time with a threshold.

[0105] Example 12. The device as described in Example 11, wherein the implantable medical device includes an electrocardiogram (ECG) sensor, and wherein the instructions cause the device to select the pacing algorithm based on ECG data measured by the ECG sensor.

[0106] Example 13. The device as described in Example 11, wherein the second pacing algorithm is configured to decrease the pacing pulse rate (PPR) over time.

[0107] Example 14. The device as described in Example 11, wherein the second pacing algorithm is configured to decrease the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm is further configured to measure heart rate (HR) over time and adjust the PPR based on the measured HR.

[0108] Example 15. The device as described in Example 11, wherein the periodic capture check includes: pacing the heart at an increased rate for a predetermined number of beats; skipping a pacing signal; and determining that one or more pacing signals effectively pace the patient's heart by detecting an intrinsic heartbeat after skipping the pacing signal.

[0109] Example 16. The device as described in Example 11 further includes: a retainer, wherein the retainer includes a rear surface shaped to conform to the skin surface of the patient's adjacent insertion site.

[0110] Example 17. The device as described in Example 11, wherein the implantable medical device includes an audible tone generator configured to alert the patient to a predetermined condition.

[0111] Example 18. A device for cardiac pacing, the device comprising: a processor; and a memory storing instructions that, when executed by the processor, cause the device to perform operations including: receiving a pacing method used during cardiac surgery, the pacing method used during cardiac surgery being based on an input signal indicative of a preoperative electrocardiogram (ECG) assessment of the patient and a determination of a preoperative risk level for the patient derived from the preoperative ECG assessment; receiving a postoperative pacing method based on an input signal indicative of a postoperative ECG assessment of the patient and a determination of a postoperative risk level for the patient derived from the postoperative ECG assessment, wherein the postoperative pacing method is selected from a first algorithm configured to provide intermittent pacing support, a second algorithm configured to provide continuous pacing support, and no pacing support; and updating one or more pacing parameters based on the received pacing method and the received postoperative pacing method.

[0112] Example 19. The device as described in Example 18, wherein the instructions further cause the device to perform operations including adjusting one or more pacing parameters in real time based on continuous monitoring of one or more biological parameters of the patient.

[0113] Example 20. The device as described in Example 18, wherein the instructions further enable the device to periodically update the postoperative pacing method based on new ECG data collected during follow-up evaluation.

Claims

1. A method for operating a walking pacemaker, the method comprising: Receive patient physiological status indicators; A pacing algorithm is selected from a first pacing algorithm or a second pacing algorithm based on the physiological condition index, wherein the first pacing algorithm provides first pacing parameters based on the patient's physiological condition index, and the second pacing algorithm provides second pacing parameters independently of the physiological condition index; as well as The walking pacemaker is operated based on these first pacing parameters or these second pacing parameters.

2. The method as described in claim 1, wherein, Patient physiological indicators are based on measured electrocardiogram (ECG) data.

3. The method as described in claim 1, wherein, These second pacing parameters include decreasing the pacing pulse rate (PPR) over time.

4. The method of claim 1, wherein, These second pacing parameters decrease the pacing pulse rate (PPR) over time, and the second pacing algorithm further includes measuring heart rate (HR) over time.

5. The method of claim 1, wherein, The second pacing algorithm includes decreasing the pacing pulse rate (PPR) over time, and further includes measuring the heart rate (HR) over time, and further includes increasing the PPR when the HR reaches a threshold indicating pacing dependence.

6. The method of claim 4, wherein, The second pacing algorithm includes decreasing the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm further includes measuring the heart rate (HR) over time, and further includes decreasing the PPR when the HR reaches a threshold indicating pacing independence.

7. The method of claim 1, further comprising: Performing a periodic capture test to determine whether one or more pacing signals are effectively pacing the patient's heart, wherein the periodic capture test includes: The heart is paced at an increased rate for a predetermined number of beats. Skip a pacing signal; and The effectiveness of one or more pacing signals in pacing the patient's heart is determined by detecting the intrinsic heartbeat after the pacing signal has been skipped.

8. The method of claim 1, further comprising: The number of pacing suppressions per unit time is compared with a predetermined threshold; as well as One or more pacing parameters are adjusted based on the result of comparing the number of pacing suppressions per unit time with the predetermined threshold to determine a measure of pacing dependence.

9. The method of claim 1, wherein, The walking pacemaker includes a communication circuit for transmitting data to and receiving commands from a remote site.

10. The method of claim 1, wherein, The patient's physiological indicators were received from a medical lead positioned in the patient's vein.

11. A device for cardiac pacing, the device comprising: Implantable medical devices; A medical lead, configured to be inserted into a patient's vein; processor; as well as The memory stores instructions that, when executed by the processor, cause the device to: Choose a pacing algorithm from a first pacing algorithm configured to provide intermittent pacing support and a second pacing algorithm configured to provide continuous pacing support; The selected pacing algorithm is executed to deliver pacing therapy to the patient via the medical lead; Perform periodic capture tests to determine whether the pacing signal is effectively pacing the patient's heart; as well as The measure of pacing dependence is determined by comparing pacing suppression per unit time with a threshold.

12. The device as claimed in claim 11, wherein, The implantable medical device includes an electrocardiogram (ECG) sensor, and wherein the instructions enable the device to select the pacing algorithm based on ECG data measured by the ECG sensor.

13. The device as claimed in claim 11, wherein, The second pacing algorithm is configured to decrease the pacing pulse rate (PPR) over time.

14. The device as claimed in claim 11, wherein, The second pacing algorithm is configured to decrease the pacing pulse rate (PPR) over time, and wherein the second pacing algorithm is further configured to measure the heart rate (HR) over time and adjust the PPR based on the measured HR.

15. The device as claimed in claim 11, wherein, This periodic capture check includes: The heart is paced at an increased rate for a predetermined number of beats. Skip a pacing signal; and One or more pacing signals are used to determine if the patient's heart is effectively paced by detecting the intrinsic heartbeat after the pacing signal has been skipped.

16. The apparatus of claim 11, further comprising: A retainer, wherein the retainer includes a rear surface shaped to conform to the skin surface of the patient's adjacent insertion site.

17. The device as claimed in claim 11, wherein, The implantable medical device includes an audible tone generator configured to alert the patient to a predetermined condition.

18. A device for cardiac pacing, the device comprising: processor; as well as The memory stores instructions that, when executed by the processor, cause the device to perform operations including the following: Receive the pacing method used during cardiac surgery, which is based on the input signal indicating the patient's preoperative electrocardiogram (ECG) assessment and the determination of the patient's preoperative risk level derived from the preoperative ECG assessment; The method receives a postoperative pacing method based on an input signal indicative of a postoperative ECG assessment of the patient and a determination of the patient's postoperative risk level derived from the postoperative ECG assessment, wherein the postoperative pacing method is selected from a first algorithm configured to provide intermittent pacing support, a second algorithm configured to provide continuous pacing support, and no pacing support. as well as One or more pacing parameters are updated based on the received pacing method and the received postoperative pacing method.

19. The device as claimed in claim 18, wherein, These instructions further enable the device to perform operations including adjusting one or more pacing parameters in real time based on continuous monitoring of one or more biological parameters of the patient.

20. The device as claimed in claim 18, wherein, These instructions further enable the device to periodically update the postoperative pacing method based on new ECG data collected during follow-up assessments.

Images