Abstract: A SubQ ICD that is entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and associated with subcutaneous leads provides distributed cardioversion-defibrillation sense and stimulation electrodes for delivery of cardioversion-defibrillation shock and pacing therapies across the heart when necessary. A level crossing detection system and process is implemented to detect noise, sinus rhythm and ventricular fibrillation in subcutaneous or body surface signals to deliver therapies as needed.

Abstract: A method and device for detecting arrhythmias in a patient that includes electrodes positioned subcutaneously within the patient, a microprocessor, coupled to the electrodes, determining one of a sequence of the sensing of cardiac signals by the electrodes and a duration between the sensing of cardiac signals by the electrodes, and control circuitry delivering a therapy in response to one of the determined sequence and the determined duration.

Abstract: A system and method are provided for assessing T-wave alternans (TWA) using cardiac EGM signals received from implanted electrodes. A T-wave signal parameter is measured from signals received by an automatic gain control sense amplifier. A TWA measurement is computed from a beat-by-beat comparison of T-wave parameter measurements or using frequency spectrum techniques. The TWA measurement magnitude and measurement conditions are used in detecting a clinically important TWA. TWA assessment further includes discriminating concordant and discordant TWA in a multi-vector TWA assessment, and determining the association of a TWA measurement with QRS alternans, mechanical alternans, and other physiological events. A prediction of a pathological cardiac event is made in response to a TWA assessment. A response to a cardiac event prediction is provided.

Abstract: A system and method are provided for assessing T-wave alternans (TWA) using cardiac EGM signals received from implanted electrodes. A T-wave signal parameter is measured from signals received by an automatic gain control sense amplifier. A TWA measurement is computed from a beat-by-beat comparison of T-wave parameter measurements or using frequency spectrum techniques. The TWA measurement magnitude and measurement conditions are used in detecting a clinically important TWA. TWA assessment further includes discriminating concordant and discordant TWA in a multi-vector TWA assessment, and determining the association of a TWA measurement with QRS alternans, mechanical alternans, and other physiological events. A prediction of a pathological cardiac event is made in response to a TWA assessment. A response to a cardiac event prediction is provided.

Abstract: A method and device for generating a template that includes determining whether there are consecutive events of a plurality of sensed events having first characteristics, and if a predetermined number of events of the plurality of sensed events subsequent to the consecutive events are identified as first selected events having second characteristics, the template is then generated from the first selected events.

Abstract: A method and device for generating a template that includes identifying events of a plurality of sensed events having predetermined characteristics as first selected events and generating the template from the first selected events. Events of the plurality of events having the predetermined characteristics are identified as second selected events, and a determination is made as to whether the template is valid in response to the second selected events. The template is updated from the second selected events in response to the template not being valid.

Abstract: An implantable medical device and associated method for automatically generating morphology templates during fast cardiac rhythms, confirming a provisional template as a confirmed template, and using the confirmed template to classify subsequent detected arrhythmias. A provisional SVT template may be created during a fast ventricular rate and activated as a confirmed SVT template upon verification that the fast rate was due to an SVT. The confirmed SVT template may be used to discriminate SVT from VT/VF.

Abstract: An extra-systolic stimulation (ESS) therapy addresses cardiac dysfunction including heart failure. ESS therapy employs atrial and/or ventricular extra-systoles via pacing-level stimulation to a heart. These extra-systoles must be timed correctly to achieve beneficial effects on myocardial mechanics (efficacy) while maintaining an extremely low level of risk of arrhythmia induction and excellent ICD-like arrhythmia sensing and detection (security). The present invention relates to therapy delivery guidance and options for improved ESS therapy delivery. These methods may be employed individually or in combinations in an external or implantable ESS therapy delivery device.

Abstract: The present invention relates to the secure delivery of an extra-systolic stimulation (ESS) therapy to treat cardiac dysfunction that employs atrial and/or ventricular extra-systoles via pacing-like stimulation of the heart. These extra-systoles must be timed correctly to achieve beneficial effects on myocardial mechanics (benefit) while maintaining an extremely low level of risk of arrhythmia induction and excellent ICD-like arrhythmia sensing and detection (security). Further experience with ESS has led to improved implementation methods that depend on better blanking, ESS stimulation timing (of an “extra-systolic interval” or ESI), and ESS therapy delivery options and guidance. These methods may be employed individually or in combinations in an external or implantable ESS therapy delivery device.