Abstract: A rate smoothing technique is applied by the pacing device to sensed and paced heart signals so as to prevent a sharp drop in heart rate, particularly for use within patients prone to vasovagal syncope. The rate smoothing technique is applied by the pacing device during the calculation of an escape interval employed by the device in determining whether to pace the heart. The rate smoothing technique has the effect of adjusting the escape interval to ensure the heart is paced for a period of time subsequent to a sharp drop in the natural heart rate of the patient permitting the heart rate to decrease gradually rather than suddenly. The rate smoothing technique however does not interfere with a sharp increase in heart rate as may be required during sudden physical exertion. System and method examples are described herein.

Abstract: A cardiac stimulation device and method deliver independent stimulation pulses to right and left cardiac chambers, based on the capture thresholds of each chamber, and confirm capture in each chamber. A threshold test is performed in one chamber while stimulating the opposite chamber at increased pulse energy and adjusted interchamber delay.

Abstract: A pacemaker or other implantable cardiac stimulation device is configured with both a rate hysteresis mode and a vasovagal syncope prevention mode. Within the rate hysteresis mode, the pacemaker detects when the intrinsic heart rate of the patient is below an escape rate, then paces the heart at a Base Rate until an intrinsic beat is detected. When programmed in the vasovagal syncope prevention mode, upon detecting the intrinsic rate falling below the Hysteresis Escape Rate, the pacemaker paces the heart at a Vasovagal Syncope Response Rate, which is considerably higher than the Base Rate. The pacemaker is preferably set to the syncope prevention mode for patients prone to recurrent vasovagal syncope. By pacing the heart at the higher Vasovagal Syncope Response Rate, the pacemaker thereby helps prevent a significant drop in blood pressure which might otherwise cause a loss of consciousness in the patient. System and method embodiments are described.

Abstract: An implantable cardiac stimulation device is described wherein a controller of the cardiac stimulation device controls selected functions of the device based on whether the patient is at rest and further based on whether the patient is prone to vagally-mediated arrhythmias. Functions of the device that may be controlled include, for example, a pacing base rate, an AV/PV delay, and a refractory period as well as overdrive pacing parameters and diagnostic data gathering parameters. In one example, if the patient is not prone to vagally-mediated arrhythmias, the base rate is lowered while the patient is at rest. Also, overdrive pacing parameters are set to be less aggressive. As such, the operation of the cardiac stimulation device is controlled to make it easier for the patient to rest while also reducing power consumption. However, if the patient is prone to vagally-mediated arrhythmias, the base rate is not lowered while the patient is at rest.

Abstract: An implantable cardiac stimulation device is described wherein a controller of the cardiac stimulation device controls selected functions of the device based on whether the patient is at rest and further based on whether the patient is prone to vagally-mediated arrhythmias. Functions of the device that may be controlled include, for example, a pacing base rate, an AV/PV delay, and a refractory period as well as overdrive pacing parameters and diagnostic data gathering parameters. In one example, if the patient is not prone to vagally-mediated arrhythmias, the base rate is lowered while the patient is at rest. Also, overdrive pacing parameters are set to be less aggressive. As such, the operation of the cardiac stimulation device is controlled to make it easier for the patient to rest while also reducing power consumption. However, if the patient is prone to vagally-mediated arrhythmias, the base rate is not lowered while the patient is at rest.

Abstract: An initial polarization measurement is made by applying two electrical calibration pulses to the heart separated by a first time period. The first pulse is sufficient to generate an evoked response. The second pulse is applied during a refractory period associated with the first pulse. A polarization measurement is made following the second pulse and compared against a predetermined threshold. If the polarization does not exceed the threshold, the evoked response is adjusted using the measured polarization and an automatic capture function of the pacing system is programmed using the adjusted evoked response. However, if the polarization exceeds the threshold, a second pair of pulses are applied to the heart separated by a second time period, different from the first time period.

Abstract: A method and apparatus for reducing the incidence of atrial arrhythmias by using an overdrive algorithm to determine the application of overdrive stimulation pulses to a patient's heart, e.g., in the atria. In a first aspect of the invention, the apparatus first determines an overdrive pacing rate and then applies pairs of temporally spaced (staggered) pacing pulses, i.e., primary and secondary pacing pulses, at the determined overdrive pacing rate. In a further aspect of the invention, the pairs of pacing pulses are applied at the overdrive pacing rate to multiple spatially spaced electrodes, i.e., electrodes distributed among multiple sites in a patient's heart, e.g., in the atria. In accordance with a first preferred embodiment, the electrodes may be distributed within a single atrium, e.g., the right atrium, of the patient's heart.

Abstract: Dynamic overdrive pacing adjustment techniques are described for use in implantable cardiac stimulation devices. In a first technique, an overdrive pacing unit of a microcontroller of the implantable device operates to optimize various control parameters that affect overdrive pacing so as to achieve a desired degree of overdrive pacing for the particular patient in which the stimulation device is implanted. Parameters to be optimized include the number of overdrive beats paced once overdrive pacing is trigged, the overdrive pacing response function, the recovery rate, and various base rates. The control parameters are adjusted in a hierarchical order of priority until the desired degree of overdrive pacing is achieved. Adjustment of the number of overdrive beats, the recovery rate, and various base rates is iteratively performed by using incremental numerical adjustments.

Abstract: Dynamic overdrive pacing adjustment techniques are described for use in implantable cardiac stimulation devices. In a first technique, an overdrive pacing unit of a microcontroller of the implantable device operates to optimize various control parameters that affect overdrive pacing so as to achieve a desired degree of overdrive pacing for the particular patient in which the stimulation device is implanted. Parameters to be optimized include the number of overdrive beats paced once overdrive pacing is trigged, the overdrive pacing response function, the recovery rate, and various base rates. The control parameters are adjusted in a hierarchical order of priority until the desired degree of overdrive pacing is achieved. Adjustment of the number of overdrive beats, the recovery rate, and various base rates is iteratively performed by using incremental numerical adjustments.

Abstract: An implantable cardiac stimulation device with automatic threshold testing capabilities. The device utilizes an algorithm for measuring a first and a second threshold settings. The first threshold setting is determined by decreasing the stimulation energy from an initially high, supra-threshold value until loss of capture is detected, and is set as the pulse energy at which capture is still detected. The second threshold setting is determined by increasing the stimulation energy from an initially low, sub-threshold value until capture is detected, and is set as the stimulation energy at which capture is regained. The algorithm further determines if the threshold test results are reliable by comparing the difference between the first and second threshold settings to an expected difference, known as the Wedensky Effect value. A deviation from the Wedensky Effect value which is known for a given patient, indicates a discrepancy in the threshold test result.

Abstract: An implantable cardiac stimulation device and associated method perform an automatic calibration procedure for evaluating whether automatic capture verification can be recommended. The calibration procedure calculates and displays a number of variables for use by a medical practitioner in programming automatic capture operating parameters. An average paced depolarization integral (PDI) is determined from the cardiac signals following delivery of multiple stimulation pulse below and above capture threshold such that both pure lead polarization signals and evoked response signals may be analyzed. From the paced depolarization integral data, a capture threshold, a stimulation response curve, a minimum evoked response, a maximum lead polarization, an evoked response sensitivity, an evoked response safety margin, and a polarization safety margin are determined. Based on these variables, the calibration procedure determines if automatic capture verification can be recommended.

Abstract: An implantable stimulation lead system comprises a lead including a lead body dimensioned for placement inside the coronary sinus region. The lead system further comprises a device dimensioned for insertion within a lumen in the lead, the device including a main body; a steering knob secured to a proximal extremity of the main body; and a flexible distal portion secured to a distal extremity of the main body. The main body has a length such that, with the main body of the device substantially completely advanced within the lead, the flexible distal portion of the device projects distally from the aperture in the distal tip of the lead body. The flexible distal portion of the device may comprise a proximal section and a distal section, the distal section being more flexible, and thus softer, than the proximal section.

Abstract: An implantable cardiac lead system suitable for placement in the coronary sinus region of the heart. The lead system comprises a lead having two or more non-helical bends in its distal portion. The two or more non-helical bends cooperate to prevent the lead from dislodgment or displacement inside the coronary sinus. The lead system may further comprise a stylet suitable for steering the lead into at least one of the coronary sinus vein, great cardiac vein, left marginal vein, left posterior ventricular vein, and small cardiac vein. The stylet is tapered in its distal portion to provide enhanced maneuverability and steerability inside the coronary sinus region. The lead system may also comprise an introducer which aids in introducing the lead into the heart.

Abstract: Techniques are described for overdrive pacing the heart using a pacemaker wherein the overdrive pacing rate only increases when at least two intrinsic beats are detected within a determined search period. In one specific technique, an increase in the pacing rate occurs only if two P-waves are detected within X cardiac cycles. In another specific technique, the overdrive pacing rate is increased only if at least two P-waves are detected within a block of N cardiac cycles. In both techniques, the overdrive pacing rate is decreased if no increase has occurred in the last Z cardiac cycles. By increasing the overdrive pacing rate only in response to detection of at least two P-waves within a determined number of cardiac cycles, an excessively high overdrive pacing rate is avoided. Other techniques are described for adaptively adjusting overdrive pacing parameters so as to achieve a determined target degree of pacing of, for example, 95% paced beats.

Abstract: The system and method discriminates P-waves or other electrical events originating in the atria from R-waves or other electrical events originating in the ventricles. In one example, far-field R-waves in the atria are distinguished from true P-waves using both a post-ventricular atrial blanking (PVAB) interval and a separate pre-ventricular blanking interval (pre-VAB) interval. Insofar as the pre-VAB interval is concerned, upon detection of a P-wave in the atria, the implantable medical device begins tracking a pre-VAB interval. If an R-wave is then detected in the ventricles during the pre-VAB interval, the P-wave is rejected as being a far-field R-wave. A PVAB interval may also be employed to filter out any P-waves detected in the atria immediately following detection of an R-wave in the ventricles. In another example, far-field R-waves are distinguished from true P-waves using template matching. P-waves detected in the atria are compared against a template representative of true P-waves.

Abstract: A system and corresponding method are provided to reliably detect capture during multi-chamber stimulation, and to further monitor the progression of congestive heart failure. The system provides a method by which intracardiac electrogram (IEGM) characteristics representing single-chamber capture and bi-ventricular capture are stored in memory and displayed. The annotation of the displayed waveforms is such that events associated with loss of capture, single-chamber capture, and bi-ventricular capture are clearly marked for ready interpretation by the physician. In a first situation, a stimulation pulse is followed by a time delay window and a subsequent depolarization complex that represents intrinsic responses of the chambers that have not been captured. In a second situation, a stimulation pulse is followed almost immediately by an evoked response that represents capture of one chamber, and a subsequent depolarization complex that represents an intrinsic response of one chamber that has not been captured.

Abstract: Techniques are described for pacing multiple sites in a patient's heart using overdrive pacing the heart using a pacemaker including techniques where the overdrive pacing rate only increases when at least two intrinsic beats are detected within a determined search period. In one specific technique, an increase in the pacing rate occurs only if two P-waves are detected within X cardiac cycles. In another specific technique, the overdrive pacing rate is increased only if at least two P-waves are detected within a block of N cardiac cycles. In both techniques, the overdrive pacing rate is decreased if no increase has occurred in the last Z cardiac cycles. By increasing the overdrive pacing rate only in response to detection of at least two P-waves within a determined number of cardiac cycles, an excessively high overdrive pacing rate is avoided.

Abstract: A single chronic implantable cardiac lead for use in the coronary sinus region of the heart provides both atrial and ventricular pacing and defibrillation therapy. The lead includes an elongated lead body having a distal end and a proximal end, a first electrode assembly including a ventricular pacing electrode and a ventricular defibrillation at the distal end, a second electrode assembly proximal to the first electrode assembly including at least one atrial pacing electrode and an atrial defibrillation electrode, and a further defibrillation electrode proximal to the second electrode assembly. The electrode assemblies and further defibrillation electrode are spaced apart so that when the lead is implanted within the coronary sinus region of the heart with the first electrode assembly adjacent the left ventricle, the second electrode assembly is adjacent the left atrium and the further defibrillation electrode is within the right atrium and/or the superior vena cava.

Abstract: An implantable stimulation device delivers a stimulation pulse in the ventricular chamber of a patient's heart and automatically adjusts a post-ventricular atrial blanking period. The stimulation device generates a ventricular stimulation pulse to trigger an evoked response, in order to produce a ventricular far-field signal that follows a successfully captured ventricular stimulation pulse. The stimulation device further includes an atrial sense circuit that senses the ventricular far-field signal, and a control system that adaptively segments the post-ventricular atrial blanking period in a post-ventricular atrial blanking period (PVAB) which is fixed in duration, and a variable far-field interval (FFI) window.

Abstract: An implantable cardiac stimulation device which determines stimulation based upon the patient's body position and activity level while eliminating special implantation or calibration procedures. To eliminate such special implantation and calibration procedures, the stimulation device correlates the patient's body position using a multi-axis DC accelerometer or other sensor during times of high activity and determines a patient's standing position value. During other times, the stimulation device compares the signals from the accelerometer to the standing position value to determine the patient's current body position. Based upon the current body position and the activity level, the stimulation device determines the necessary stimulation to deliver to the patient.