# Patent

## Title
Method and apparatus for reducing early recurrence of atrial fibrillation with defibrillation shock therapy

## Abstract

An apparatus and method for delivering electrical shock therapy in order to treat atrial tachyarrhythmias such as fibrillation in which atrial defibrillation pulses are delivered within a maximum pre-shock R—R synchronization interval. The method has been found to reduce the incidence of early recurrence of atrial fibrillation (ERAF).

## Background
FIELD OF THE INVENTION
This invention pertains to methods for treating atrial tachyarrhythmias. In particular, the invention relates to an apparatus and method for delivering shock therapy to terminate atrial fibrillation.
BACKGROUND
Tachyarrhythmias are abnormal heart rhythms characterized by a rapid heart rate, typically expressed in units of beats per minute (bpm). They can occur in either chamber of the heart (i.e., ventricles or atria) or both. Examples of tachyarrhythmias include sinus tachycardia, ventricular tachycardia, ventricular fibrillation (VF), atrial tachycardia, and atrial fibrillation (AF). Tachycardia is characterized by a rapid rate, either due to an ectopic excitatory focus or abnormal excitation by normal pacemaker tissue. Fibrillation occurs when the chamber depolarizes in a chaotic fashion with abnormal depolarization waveforms as reflected by an EKG.
An electrical shock applied to a heart chamber (i.e., defibrillation or cardioversion) can be used to terminate most tachyarrhythmias by depolarizing excitable myocardium, which thereby prolongs refractoriness, interrupts reentrant circuits, and discharges excitatory foci. Implantable cardioverter/defibrillators (ICDs) provide this kind of therapy by delivering a shock pulse to the heart when fibrillation is detected by the device. An ICD is a computerized device containing a pulse generator that is usually implanted into the chest or abdominal wall. Electrodes connected by leads to the ICD are placed on the heart, or passed transvenously into the heart, to sense cardiac activity and to conduct the shock pulses from the pulse generator. ICDs can be designed to treat either atrial or ventricular tachyarrhythmias, or both, and also incorporate cardiac pacing functionality.
The most dangerous tachyarrythmias are ventricular tachycardia and ventricular fibrillation, and ICDs have most commonly been applied in the treatment of those conditions. ICDs are also capable, however, of detecting atrial fibrillation and delivering a shock pulse to the atria in order to terminate the arrhythmia. Although not immediately life-threatening, it is important to treat atrial fibrillation for several reasons. First, atrial fibrillation is associated with a loss of atrio-ventricular synchrony which can be hemodynamically compromising and cause such symptoms as dyspnea, fatigue, vertigo, and angina. Atrial fibrillation can also predispose to strokes resulting from emboli forming in the left atrium. Although drug therapy and/or in-hospital cardioversion are acceptable treatment modalities for atrial fibrillation, ICDs configured to treat AF offer a number of advantages to certain patients, including convenience and greater efficacy.
An ICD terminates atrial fibrillation by delivering a shock pulse to electrodes disposed in or near the atria. The resulting depolarization also spreads to the ventricles, however, and there is a risk that such an atrial shock pulse can actually induce ventricular fibrillation, a condition much worse than atrial fibrillation. This risk can be reduced by delaying the delivery of an atrial shock pulse until the intrinsic ventricular rhythm is below a specified maximum rate and then delivering the shock synchronously with a sensed ventricular depolarization.
Another problem associated with defibrillation shock therapy is early recurrence of atrial fibrillation or ERAF. ERAF is defined as the recurrence of atrial fibrillation within a few minutes after successful cardioversion with atrial shock therapy. Certain patients are more prone than others to experience ERAF, and these patients may experience difficulty with repeated atrial defibrillation therapy. Reducing the incidence of ERAF would improve the efficacy of atrial defibrillation and expand the population of patients for whom an ICD is an acceptable therapy option. It is this problem with which the present invention is primarily concerned.
SUMMARY OF THE INVENTION
The present invention is a method and apparatus for delivering atrial defibrillation therapy in which an atrial shock pulse is delivered within a specified maximum time interval after a preceding sensed ventricular depolarization or ventricular pace (R wave). In one embodiment, an R—R interval, defined as the time elapsed between a previous R wave and a present R wave, is measured after each sensed R wave. The atrial defibrillation shock pulse is then delivered synchronously with an R wave that occurs within a specified time window with respect to the previous R wave as defined by specified minimum and maximum R—R interval values. In another embodiment, an atrial shock pulse is delivered at a specified time after the previous R wave unless inhibited by an intrinsic ventricular depolarization occurring before the specified time. The atrial defibrillation shock can also be delivered in synchrony with a ventricular pace delivered at a specified time after the previous R wave unless inhibited by an R wave occurring before that time.
In one embodiment, an R—R interval, defined as the time elapsed between a previous R wave and a present R wave, is measured after each sensed R wave. The atrial defibrillation shock pulse is then delivered synchronously with an R wave that occurs within a specified time window with respect to the previous R wave as defined by specified minimum and maximum R—R interval values. In another embodiment, an atrial shock pulse delivered at a specified time after the previous R wave unless inhibited by an intrinsic ventricular depolarization occurring before the specified time. The atrial defibrillation shock can also be delivered in synchrony with a ventricular pace delivered at a specified time after the previous R wave unless inhibited by an R wave occurring before that time.



BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A and 1B are timing diagrams illustrating embodiments of the invention.
FIG. 2 is a system diagram of an implantable defibrillator.



DETAILED DESCRIPTION OF THE INVENTION
The present invention is a method and apparatus for delivering atrial defibrillation shock therapy. As used herein, atrial defibrillation shock therapy should be taken to mean shock therapy for treating any atrial tachyarrhythmia, such as atrial flutter, as well as atrial fibrillation.
In order to avoid the possible induction of ventricular fibrillation, atrial defibrillation shocks are usually delivered synchronously with a sensed R wave and after a minimum pre-shock R—R interval. (The R—R interval is the time between the immediately preceding R wave and the presently sensed R wave, and an R wave may be regarded as either a spontaneously occurring depolarization or a ventricular pace.) This is done because the ventricle is especially vulnerable to induction of fibrillation by a depolarizing shock delivered at a time too near the end of the preceding ventricular contraction (i.e., close to the T wave on an EKG). Delivering the shock synchronously with a sensed R wave thus moves the shock away from the vulnerable period, but at a very rapid ventricular rhythm, the ventricular beats may be so close together that even synchronously delivered shocks may induce ventricular fibrillation. To prevent this, shocking can be delayed until the ventricular rhythm is slow enough to safely deliver the defibrillation pulse as determined by measuring the R—R interval. That is, a minimum limit value for the R—R interval is specified, and shocking is inhibited if the sensed R wave occurs after a shorter interval. Recent clinical data has shown, however, that the incidence of early recurrence of atrial fibrillation (ERAF) after atrial defibrillation is positively correlated with the length of the pre-shock R—R interval.
In accordance with the present invention, atrial defibrillation shocks are delivered within a specified maximum time interval after a preceding sensed ventricular depolarization or ventricular pace (R wave). In one embodiment, the atrial defibrillation shock is delivered in synchrony with a sensed R wave. An R—R interval, defined as the time elapsed between a previous R wave and a present R wave, is measured after each sensed R wave. In contradistinction to previous methods, however, a shockable R—R interval is specified with both minimum and maximum limit values. The atrial defibrillation shock pulse is thus delivered synchronously with an R wave that occurs within a time window with respect to the previous R wave as defined by specified minimum and maximum R—R interval values. FIG. 1A is a diagram showing a sequence of intrinsic ventricular depolarizations IVD occurring during an episode of atrial defibrillation. After the depolarization labeled IVD1, a time window TW as defined by a minimum R—R interval MIN and a maximum R—R interval MAX is shown. This time window is considered a shockable R—R interval, and exemplary minimum and maximum limit values are 500 and 800 milliseconds, respectively. Thus, an atrial defibrillation shock ADF can be delivered in synchrony with an R wave IVD2 occurring within the shockable interval and with a reduced risk of causing either ventricular fibrillation or ERAF.
In another embodiment, an atrial shock pulse is delivered at a specified time after the previous R wave unless inhibited by an intrinsic ventricular depolarization occurring before the specified time. FIG. 1B shows another exemplary sequence of intrinsic ventricular depolarizations IVD occurring during an episode of atrial defibrillation. After the depolarization labeled IVD1, a specified time T1 is defined in which an atrial defibrillation shock ADF is to be delivered. The time T1 would preferably fall somewhere within the shockable R—R interval as defined above even though the atrial shock is not delivered in synchrony with an R wave. Delivering the atrial shock pulse at the time T1 thus reduces the risk of ERAF as in the first embodiment. Induction of ventricular fibrillation is prevented by both specifying the time T1 to be above a minimum value considered safe to shock and inhibiting the atrial shock if an intrinsic R wave occurs prior to the time T1. The atrial defibrillation shock can also be delivered in synchrony with a ventricular pace delivered at the specified time T1 after the previous R wave unless inhibited by an R wave occurring before that time.
FIG. 2 is a system diagram of a microprocessor-based implantable cardioverter/defibrillator device for treating atrial tachyarrthmias that also incorporates a pacemaker functionality. In this embodiment, a microprocessor and associated circuitry make up the controller of the device, enabling it to output pacing or shock pulses in response to sensed events and lapsed time intervals. The microprocessor 10 communicates with a memory 12 via a bidirectional data bus. The memory 12 typically comprises a ROM or RAM for program storage and a RAM for data storage. The ICD has atrial sensing and pacing channels comprising electrode 34, lead 33, sensing amplifier 31, pulse generator 32, and an atrial channel interface 30 which communicates bidirectionally with a port of microprocessor 10. The ventricular sensing and pacing channels similarly comprise electrode 24, lead 23, sensing amplifier 21, pulse generator 22, and a ventricular channel interface 20. For each channel, the same lead and electrode are used for both sensing and pacing. The sensing channels are used to control pacing and for measuring heart rate in order to detect tachyarrythmias such as fibrillation. The ICD detects an atrial tachyarrhythmia, for example, by measuring the atrial rate as well as possibly performing other processing on data received from the atrial sensing channel. A shock pulse generator 50 is interfaced to the microprocessor for delivering shock pulses to the atrium via a pair of terminals 51a and 51b that are connected by defibrillation leads to shock electrodes placed in proximity to regions of the heart. The defibrillation leads have along their length electrically conductive coils that act as electrodes for defibrillation stimuli. A similar shock pulse generator 60 and shock electrodes 61a and 61b are provided to deliver ventricular fibrillation therapy in the event of an induced ventricular fibrillation from atrial shock pulses.
The device depicted in FIG. 2 can be configured to deliver atrial defibrillation therapy in accordance with the invention as described above by appropriate programming of the microprocessor. Thus, once an episode of atrial fibrillation is detected with the atrial sensing channel, the device prepares to deliver an atrial defibrillation shock. As described above, the ventricular rhythm can monitored by measuring the R—R interval associated with each sensed R wave. If a sensed R wave occurs at an R—R interval longer than a specified minimum limit value and shorter than a specified maximum limit value, the interval is considered shockable so that the sensed R wave is safe to shock on. An atrial defibrillation shock can then delivered immediately so as to be practically synchronous with the sensed R wave. Alternatively, the atrial shock pulse can be delivered at a specified time after the preceding sensed R wave, either synchronously with a ventricular pace or not, unless inhibited by a sensed intrinsic R wave occurring prior to the time specified for delivering the atrial shock.
In another embodiment of the invention, an atrial defibrillation shock pulse is preceded by ventricular pacing in order to decrease the intrinsic ventricular rhythm to a rate at which the atrial defibrillation shock pulse can be more safely delivered. After atrial fibrillation is detected, a sequence of one or more ventricular pacing pulses is delivered at a rate intended to be above the intrinsic ventricular rate. After the last pacing pulse in the sequence is delivered, a compensatory pause is produced before the next intrinsic ventricular beat. The atrial defibrillation shock pulse can then be delivered synchronously with that beat if the sensed R wave occurs within the shockable R—R interval as defined by specified minimum and maximum limit value. In the embodiment where the atrial defibrillation pulse is to be delivered at a specified time after the preceding R wave, either with or without an accompanying ventricular pace, the compensatory pause also delays the next R wave so that inhibition of the atrial shock is less likely to occur.
Although the invention has been described in conjunction with the foregoing specific embodiment, many alternatives, variations, and modifications will be apparent to those of ordinary skill in the art. Such alternatives, variations, and modifications are intended to fall within the scope of the following appended claims.

## Claims

1. A method for delivering atrial defibrillation therapy, comprising:
detecting an episode of atrial fibrillation; 
sensing ventricular depolarizations (R waves); 
delivering a first ventricular pacing pulse after a sensed R wave; and 
delivering an atrial defibrillation shock without an accompanying second ventricular pacing pulse at a specified time after the first ventricular pacing pulse but inhibiting the atrial defibrillation shock if a second R wave subsequent to the first ventricular pacing pulse occurs before the specified time.

2. The method of claim 1 wherein the specified time for delivering the atrial defibrillation shock is less than 800 milliseconds.

3. The method of claim 1 wherein the specified time for delivering the atrial defibrillation shock is greater than 500 milliseconds and less than 800 milliseconds.

4. The method of claim 1 wherein the first ventricular pacing pulse is preceded by one or more additional ventricular pacing pulses delivered after the sensed R wave at a rate greater than the measured intrinsic rate.

5. The method of claim 1 wherein the specified time for delivering the atrial defibrillation shock is less than 800 milliseconds.

6. The method of claim 5 wherein the specified time for delivering the atrial defibrillation shock is greater than 500 milliseconds and less than 800 milliseconds.

7. The method of claim 1 wherein the first ventricular pacing pulse is delivered after the sensed R wave at a rate above an intrinsic ventricular rate.

8. An apparatus for delivering atrial defibrillation therapy to an atrium, comprising:
sensing channels for sensing atrial and ventricular depolarizations (R waves); 
a ventricular pacing channel for delivering ventricular pacing pulses; 
an atrial defibrillation pulse generator and electrodes disposed in proximity to the atrium; and 
a controller for detecting atrial fibrillation and for controlling delivery of atrial defibrillation shocks and ventricular pacing pulses, wherein, upon detection of atrial fibrillation, the controller is configured to: 
deliver a first ventricular pacing pulse after a sensed R wave; and 
deliver an atrial defibrillation shock without an accompanying second ventricular pacing pulse at a specified time after the first ventricular pacing pulse but inhibit the atrial defibrillation shock if an R wave subsequent to the first ventricular pacing pulse occurs before the specified time.

9. The apparatus of claim 8 wherein the specified time for delivering the atrial defibrillation shock is less than 800 milliseconds.

10. The apparatus of claim 8 wherein the specified time for delivering the atrial defibrillation shock is greater than 500 milliseconds and less than 800 milliseconds.

11. The apparatus of claim 8 wherein the controller is configured to deliver the first ventricular pacing pulse preceded by one or more additional ventricular pacing pulses delivered after the sensed R wave at a rate greater than the measured intrinsic rate.

12. The apparatus of claim 8 wherein the first ventricular pacing pulse is delivered after the sensed R wave at a rate above an intrinsic ventricular rate.