Abstract: Disclosed are methods and systems for preventing or treating cardiac dysfunction, particularly cardiac pacing dysfunction by genetic modification of the conduction system of the heart. In one embodiment, the invention provides a method of genetically modifying the cells by delivering to the cells one or more coding sequence in a genetic construct capable of modifying the expression of ion channels of the cells.

Abstract: Disclosed are methods and systems for preventing or treating cardiac dysfunction, particularly cardiac pacing dysfunction by genetic modification of the conduction system of the heart. In one embodiment, the invention provides a method of genetically modifying the cells by delivering to the cells one or more coding sequence in a genetic construct capable of modifying the expression of ion channels of the cells.

Abstract: A medical device identifies a hemodynamically unstable arrhythmia based upon optical hemodynamic sensor signals. The optical hemodynamic sensor includes a light source for transmitting light corresponding to first and second wavelengths through a blood perfused tissue of a patient and a light detector for generating optical signals corresponding to an intensity of the detected light at the first and second wavelengths. At a low motion period for the patient, optical signals are obtained from the optical hemodynamic sensor and are analyzed to determine a baseline motion level for the patient. Subsequent signals obtained from the optical hemodynamic sensor are compared to the baseline motion levels, with only those signals corresponding to periods where motion does not exceed the baseline level of motion being further analyzed to determine if they are consistent with a hemodynamically unstable arrhythmia.

Abstract: Disclosed are compositions, methods and systems for preventing or treating cardiac dysfunction, particularly cardiac pacing dysfunction by genetic modification of cells of targeted regions of the cardiac conduction system. In particular, a bio-pacemaker composition is delivered to cardiac cells to increase the intrinsic pacemaking rate of the cells, wherein the bio-pacemaker composition increases expression of a channel or subunit thereof that produces funny current and a T-type Ca2+ channel or subunit thereof, and expresses one or more molecules that suppresses the expression of the wild type potassium channel.

Abstract: SubQ ICDs are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion-defibrillation sense and stimulation electrodes for delivery of cardioversion-defibrillation shock and pacing therapies across the heart when necessary. Configurations include one hermetically sealed housing with 1 or, optionally, 2 subcutaneous sensing and cardioversion-defibrillation therapy delivery leads or alternatively, 2 hermetically sealed housings interconnected by a power/signal cable. The housings are generally dynamically configurable to adjust to varying rib structure and associated articulation of the thoracic cavity and muscles. Further the housings may optionally be flexibly adjusted for ease of implant and patient comfort.

Abstract: The invention is a method for identifying proteins associated with sudden cardiac death (SCD) and for assessing a patient's risk of SCD by determining the amount of one or more SCD-associated proteins in the patient. Typically, the patient submits a sample, such as a blood sample, which is tested for one or more SCD-associated proteins. Based upon the results of the tests, the patient's risk of SCD may be assessed.

Abstract: In general, the invention is directed to systems and techniques for assessing a risk of ventricular tachyarrhythmia in a patient by measuring one or more biochemical markers that reflect the health of a patient. Typically, the patient submits a sample, such as a blood sample, which is tested for one or more biomarkers. Based upon the results of the tests, the patient's risk of ventricular tachyarrhythmia may be assessed. When the patient is found to be at risk, the patient may receive an implantable medical device or drug therapy to address the risk.

Abstract: The invention is a method for identifying proteins associated with sudden cardiac death (SCD) and for assessing a patient's risk of SCD by determining the amount of one or more SCD-associated proteins in the patient. Typically, the patient submits a sample, such as a blood sample, which is tested for one or more SCD-associated proteins. Based upon the results of the tests, the patient's risk of SCD may be assessed.

Abstract: A cardiac pacemaker and method of its use. The pacemaker is provided with a pacing electrode array configured for location at a left anterior portion of a patient's thorax between the patients third and sixth ribs, outside the patient's thoracic cavity. The pacing electrode array includes multiple pacing electrodes and preferably includes one or more steering electrodes for configuring the electrical field produced by delivery of pacing pulses to avoid unwanted nerve and muscle stimulation while allowing cardiac stimulation. The electrode array may be located subcutaneously, submuscularly or on the patient's skin.

Abstract: Methods and process for detection of myocardial ischemia involve detection and analysis of changes in electrical conduction velocity within the heart to monitor changes in the condition of the cardiac muscle and indicate possible ischemia. Conduction velocity slows considerably when oxygen supply to the heart is reduced. Analysis of electrical conduction velocity can be used to verify the occurrence of myocardial ischemia in a more reliable manner. Changes in conduction velocity may be monitored based on conduction time between electrodes positioned in the left and right ventricles of the heart. The electrodes may be endocardial or epicardial electrodes. In general, the techniques may involve launching a stimulation waveform at one electrode and sensing a local cardiac depolarization at another electrode to assess conduction time.

Abstract: Implantable cardioverter-defibrillators (ICDs) are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion/defibrillation and pace/sense electrodes for delivery of cardioversion/defibrillation shock and pacing therapies across the heart when necessary. At least two hermetically sealed housings forming first and second hermetically sealed housings coupled together by a cable support first, second and, optionally, third cardioversion/defibrillation electrodes. The relatively bulky high voltage battery and high voltage capacitors, and circuitry powered by a low voltage power source for detecting a tachyarrhythmia, charging the high voltage capacitor, and discharging the high voltage capacitor to provide a cardioversion/defibrillation shock are distributed between the first and second hermetically sealed housings.

Abstract: An implantable medical device that includes a microprocessor that characterizes cardiac activity of a patient to enable the implantable medical device to deliver therapy in response to an identified arrhythmia event. A monitor/controller monitors the characterized cardiac activity and the delivered therapy, and controls activation of triggered overdrive pacing subsequent to the delivered therapy.

Abstract: Implantable cardioverter-defibrillators (ICDs) are disclosed that are entirely implantable subcutaneously with minimal surgical intrusion into the body of the patient and provide distributed cardioversion/defibrillation and pace/sense electrodes for delivery of cardioversion/defibrillation shock and pacing therapies across the heart when necessary. At least two hermetically sealed housings forming first and second hermetically sealed housings coupled together by a cable support first, second and, optionally, third cardioversion/defibrillation electrodes. The relatively bulky high voltage battery and high voltage capacitors, and circuitry powered by a low voltage power source for detecting a tachyarrhythmia, charging the high voltage capacitor, and discharging the high voltage capacitor to provide a cardioversion/defibrillation shock are distributed between the first and second hermetically sealed housings.

Abstract: An implantable medical device and associated method are provided for detecting non-sustained arrhythmias and determining a metric of non-sustained arrhythmias. The metric may be used for predicting the occurrence of a sustained arrhythmia or for automatically adjusting the parameters used for detecting a sustained arrhythmia.

Abstract: An implantable medical device and method are provided for assessing autonomic tone and risk factors associated with arrhythmias and, based on this assessment, an early recurrence of ventricular tachycardia or ventricular fibrillation is predicted. Specifically, changes in R—R interval, heart rate variability, patient activity, and myocardial ischemia are measured prior to and after a detected an arrhythmia episode. A recurrence score is calculated as a weighted sum of measured parameters and compared to a prediction criterion. The prediction criterion may be a preset threshold score or an individualized episode template based on previously calculated recurrence scores associated with recurring episodes. Stored parameters and episode-related data may be downloaded for offline analyses for optimizing prediction criteria and monitoring patient status.

Abstract: A system and method for treating an arrhythmia of the heart, involves delivery of anti-tachy pacing (ATP) pulses to the heart, possibly followed by the delivery of a high-voltage shock. ATP delivery is controlled such that the time delivery of any high-voltage shock is not affected by the prior delivery of the ATP pulses. System control may be accomplished using one or more programmable parameters, which may include a user-specified shock energy.

Abstract: The invention relates to devices that detect and/or treat tachyarrhythmias. The invention includes software systems that distinguish among various tachyarrhythmias in order to provide treatment for specific tachyarrhythmias. One aspect of the invention employs a methodology to provisionally detect ventricular tachycardia and/or fibrillation and thereafter apply a discrimination function to a series of measured intervals preceding the provisional detection. Discrimination is accomplished by sorting the intervals preceding provisional detection into bins corresponding to interval ranges and examining the relative distribution of the intervals within the bins.

Abstract: An implantable anti-tachyarrhythmia device which delivers anti-tachyarrhythmia therapies to a patient's heart in response to detection of tachyarrhythmias. The device defines first criteria indicating the presence of atrial tachycardia and second criteria indicating the presence of atrial fibrillation, and compares the time elapsed since the either the first or second criteria were initially met to a defined time duration. In response to the defined duration having passed and either of the first or second criteria being met, the device triggers delivery of an appropriate anti-tachyarrhythmia therapy. The timer is reset on detection of termination of atrial tachyarrhythmia, but not on failure of the first and second criteria to be met. The first and second criteria are defined such that they can not be concurrently met.

Abstract: Disclosed are compositions, methods and systems for preventing or treating cardiac dysfunction, particularly cardiac pacing dysfunction by genetic modification of cells of targeted regions of the cardiac conduction system. In particular, a bio-pacemaker composition is delivered to cardiac cells to increase the intrinsic pacemaking rate of the cells, wherein the bio-pacemaker composition increases expression of a channel or subunit thereof that produces funny current and a T-type Ca2+ channel or subunit thereof, and expresses one or more molecules that suppresses the expression of the wild type potassium channel.

Abstract: Disclosed are methods and systems for preventing or treating cardiac dysfunction, particularly cardiac pacing dysfunction by genetic modification of the conduction system of the heart. In one embodiment, the invention provides a method of genetically modifying the cells by delivering to the cells one or more coding sequence in a genetic construct capable of modifying the expression of ion channels of the cells.