The present disclosure relates generally to a system and method for repositioning an ablation catheter to points on the cardiac tissue where contact with the catheter was lost, in order to continue line or ring ablations in the treatment of tachycardia.
Tachycardia can be caused by abnormal conduction of the electric pulse, where the pulse doesn't follow its physiological pathway but creates feedback loops, e.g. from one of the ventricles back to the atrium (reentry tachycardia) or by non-physiologic circular conduction pathways in one of the ventricles e.g. around scar tissue or in one of the atria, resulting in a high heart rate. A ring or line ablation is required to block reentry tachycardia or abnormal conduction pathways, and there must be no gaps in the ablation path.
Electrophyisologic (EP) diagnosis and treatment of cardiac arrhythmia receives more and more clinical attention. Tachycardia (irregular increases of the pulse rate with irregular heart beat configuration) requires treatment because it has been identified as a major source for small blood coagulations that induce a high risk of stroke or cardiac infarction. Sources of tachycardia can be either ectotopic (local diseased heart tissue that creates false impulses) or due to reentry conduction where the electric pulse does not follow its physiologic pathways but creates parasitic feedback loops that result in a pathologically high heart rate.
Cardiac mapping is used to locate aberrant electrical pathways and currents within the heart, as well as to diagnose mechanical and other aspects of cardiac activity. Various methods and devices have been described for mapping the heart. Radiofrequency (RF) ablation is used to treat cardiac arrhythmia by ablating and killing cardiac tissue in order to create non-conducting lesions that disrupt the abnormal electrical pathway causing the arrhythmia. In RF ablation, heat is induced at the tip of an ablation catheter to create lesions in the myocardium. Such ablated scar tissue can no longer create or transport electric impulses. Local ablation destroys irregular local sources, whereas a ring or line ablation is required to block reentry tachycardia.
Line and ring ablations are extremely time-intense, lasting hours because any gap in the disabled tissue can cause a continued reentry tachycardia. It is desired that the intervention allow for a fast revisit of candidate positions where the ablation catheter was not in sufficient contact with the heart tissue when ablation was intended by the interventionalist.
The present disclosure provides a method for ablating tissue in a heart (24) of a subject (25) during an ablation procedure. The method includes: contacting an ablation catheter tip (48) to tissue of the heart (24) at a plurality of sites designated for ablation; sensing at each respective site a feedback signal from the ablation catheter indicative of success of the intended local ablation; storing any available data defining a current position of the ablation catheter tip (48) relative to the heart (24) at a moment of sensing the feedback signal indicative of a failed intended ablation for later re-visit; displaying a map (60) of a region of interest of the heart (24); and designating, on the map display (60), indications of the sites corresponding to when the required electrical current is above the threshold current value indicative of a gap in an ablation line or ring.
The present disclosure also provides an apparatus for ablating tissue in a heart (24) of a subject (25) during an ablation procedure. The apparatus includes: an ablation catheter tip (48) contacting tissue of the heart (24) at a plurality of sites designated for ablation; a sensor means for sensing at each respective site electrical current required to maintain the tip (48) at a target temperature; a storage means for storing any available data defining a current position of the ablation catheter tip (48) relative to the heart (24) at a moment of sensing the required electrical current above a threshold current value for later re-visit; and a display means (60) for displaying a map of a region of interest of the heart (24), wherein indications of the sites corresponding to when the required electrical current is above the threshold current value indicative of a gap in an ablation line or ring are designated on the display means.
The present disclosure also provides a computer software product (100) for ablating tissue in a heart (24) of a subject (25) during an ablation procedure. The product includes a computer-readable medium, in which program instructions are stored, which instructions, when read by a computer, cause the computer (50) to: sense electrical current required to maintain an ablation catheter tip (48) at a target temperature at a plurality of sites designated for ablation during an ablation procedure; store any available data defining a current position of the ablation catheter tip (48) relative to the heart (24) at a moment of sensing the required electrical current above a threshold current value for later re-visit; display a map (60) of a region of interest of the heart (24); and designate, on the map display (60), indications of the sites corresponding to when the required electrical current is above the threshold current value indicative of a gap in an ablation line or ring.
Additional features, functions and advantages associated with the disclosed system and method will be apparent from the detailed description which follows, particularly when reviewed in conjunction with the figures appended hereto.
To assist those of ordinary skill in the art in making and using the disclosed system and method, reference is made to the appended figures, wherein:
As set forth herein, the present disclosure advantageously facilitates detection of the loss of contact between the catheter tip and heart tissue using an automated navigation support to revisit those parts of the ablation line or ring where gaps are possible. The present disclosure may be advantageously employed in cardio applications including automated acquisition and storage of position information at the moment where ablation contact to the heart tissue is lost serving to massively reduce the amount of time that is spent in trial and error corrections of incomplete ring and line ablations to treat reentry tachycardia.
Reference is again made to
Junction box 32 preferably routes (a) conducting wires and temperature sensor signals from catheter 30 to ablation power generator 38, (b) location sensor information from sensor 40 of catheter 30 to location system control unit 36, and (c) the diagnostic electrode signals generated by tip electrode 48 to ECG monitor 34. Alternatively or additionally, junction box 32 routes one or more of these signals directly to computer 50. ECG monitor 34 is preferably also coupled to receive signals from one or more body surface electrodes, so as to provide an ECG synchronization signal to computer 50.
The imaging system 39 is further operably connected to computer 50 for control and receipt of images from the imaging system 39. In an exemplary embodiment, imaging system is a fluoroscopy x-ray system. However, other imaging modalities are contemplated including, but not limited to, MRI, echocardiography, CT, or any other modality suitable to provide an instantaneous image that captures the current position of the catheter together with heart tissue.
A location system 11 preferably comprises a set of external radiators 28, position sensor 40 of catheter 30 and any additional position sensors, and location system control unit 36. External radiators 28 are preferably adapted to be located at respective positions external to subject 25 and to generate fields, such as electromagnetic fields, towards position sensor 40, which is adapted to detect the fields and facilitate a calculation of its position coordinates by location system control unit 36 responsive to the fields. Alternatively, position sensor 40 generates fields, which are detected by external radiators 28. For some applications, a reference position sensor, typically either on an externally-applied reference patch attached to the exterior of the body of the subject, or on an internally-placed catheter, is maintained in a generally fixed position relative to heart 24. By comparing the position of catheter 30 to that of the reference catheter, the coordinates of catheter 30 are accurately determined relative to the heart, irrespective of motion of the subject. In an exemplary embodiment, ECG 34 and an additional respiration sensor are used to provide heartbeat and respiration motion compensation discussed further below.
Location system control unit 36 receives signals from position sensor 40 (or from external radiators 28 when position sensor 40 generates the energy fields), calculates the location of sensor 40 and catheter 30, and transmits to computer 50 the location information and energy dose information (received from ablation power generator 38, as described below) which relates to the location information. The location system control unit preferably generates and transmits location information essentially continuously.
Ablation power generator 38 preferably generates power used by tip electrode 48 to perform ablation. Preferably, the ablation power generator generates RF power for performing RF ablation. Alternatively or additionally, the ablation power generator induces ablation by means of other ablation techniques, such as laser ablation or ultrasound ablation, for example. Preferably, suitable feedback techniques are applied to facilitate identifying less than suitable ablated regions on the cardiac map, as discussed more fully below.
Ablation power generator 38 measures the current needed to maintain the tip at a constant temperature of between about 50° C. to about 65° C. The ablation power generator 38 transmits electrical current information related to the current needed to maintain a constant tip temperature and preferably over a serial communications line, to computer 50. The technical means of transportation over a “serial communications line” are not relevant. What is important is that the signal feed is synchronous and real-time capable such that ECG(t), depth of respiration(t), ablation feedback(t) and position(t) are all available close to the time (t) when they have been acquired, which is mentioned later as “essentially continuously”. The ablation power generator preferably measures and transmits the electrical current needed to sustain the tip at a constant temperature essentially continuously.
Alternatively, a cardiac map generated during a previous cardiac procedure is used. In an exemplary embodiment, a cardiac map adapted to the patient heart's anatomy is acquired from another source, such as an imaging modality (e.g., fluoroscopy, MRI, echocardiography, CT, single-photon computed tomography (SPECT), or positron emission tomography (PET)), and the location of the catheter is visualized on this map for at least sites of ablation that are not successful because of lack of contact between the tip and tissue of the heart. In this case, computer 50 marks the intended ablation lesion locations on this map as gaps in a line or ring ablation. Alternatively, for some applications, a cardiac map adapted to the anatomy of the patient's heart is not acquired, in which case only a map indicative of a proximate location of where the catheter ablation tip was located is acquired when lack of contact between the tip and tissue is detected.
In exemplary embodiments, the data includes current localizer information and x-ray images (
Two modes of operation are supported using data defining a current position of the catheter tip corresponding with a moment that lost contact between the cardiac tissue and tip is detected. The modes of operation relate to the point in time when the interventionalist makes use of this information, either as soon as the gap candidate has been identified or the ablation is continued as normal and the interventionalist navigates back if and only if the ablation was not successful. By use of mask overlays, i.e. a mixing of live images and images acquired when contact was lost, the current position of the catheter and the position where contact was lost can be presented such that a revisit of the lost position is guided by an image or by localizer geometry and, therefore, easily achievable. In a second mode, a list of candidate positions can be displayed when a fmished line or ring ablation has not been successful, which is easily detectable on the ECG 34 as soon as the ablation is considered finished. In this manner, corrections need only be applied to these candidate positions and it is not necessary to retrace the complete ablation procedure.
One proposed embodiment of the invention consists of a software module that is integrated into an EP workstation or console 20 depicted generally at 100 within computer 50. Such an EP workstation is the central control and display unit of an EP procedure and combines the EP-specific ECG signals, x-ray and localizer information. The software module 100 receives data corresponding to the sensed electrical current that is required to heat the ablation catheter tip to the target temperature. When the electrical current rises above a threshold, lost contact between the tip and heart tissue is detected. The software module 100 then instructs computer 50 to automatically store any and all available data that defines the current catheter position together with available information on the patient's status, namely the current cardiac phase determined from ECG and the depth of respiration intake determined from an external sensor or the optionally acquired image.
For example, when localizers are used, then the available data defining current position of the catheter tip includes storing localizer geometry. For ablations under x-ray surveillance, a current fluoroscopy image is stored (
This information indicative of position of the catheter tip when contact is lost with the heart tissue can be used either in an immediate mode in a revisit mode discussed above. To start the ablation immediately after the contact was lost as close as possible to the previous position, a respiration and heart motion compensated mask overlay of the automatically stored image or the position of the localizers and their distance to the target position are displayed to the interventionalist 22 on monitor 52 such that the user 22 can easily reposition the catheter to continue with the interrupted ablation.
The revisit mode is used when the EP ablation procedure is finished, but the reentry tachycardia is not blocked. It will be recognized that immediate treatment results are obtained once the ablation is complete using ECG 34. Then, the interventionalist 22 is provided with a list of candidate positions where insufficient contact between the catheter and heart tissue was present during ablation and can successively use the navigation support provided in the immediate mode via monitor 52, as described above, for these candidate positions until success of the intervention is obtained.
The offer of advanced dedicated EP lab equipment incorporating the software module 100 as described above offers the assignee of the current application a tremendous opportunity in this growing market. The automated acquisition and storage of position information at the moment when ablation contact to the heart tissue is lost serves as a unique selling proposition for such an EP lab. One advantage includes the massive reduction in the amount of time that is spent in trial and error corrections of incomplete ring and line ablations to treat reentry tachycardia.
All dedicated EP labs may incorporate the EP workstation according to the exemplary embodiments described herein, e.g. a target hardware that controls and combines the various hardware (e.g., x-ray imager, EP ECG acquisition, ablation catheter control, and localizer system). The invention is easily included in a software package for such a workstation.
In sum, the disclosed, apparatus, method, computer software product provide significant benefits to users of EP workstations, particularly physicians desiring a reduction in the amount of time to complete line and ring ablations to treat reentry tachycardia. The handling of possible gaps in an incomplete line or ring ablation includes automated creation and display of an image of the current catheter tip position or the storage of the current position image for later re-visit, which is necessary if the treatment goal is not reached at the end of the ablation path. Further, the immediate or later re-visit of a gap candidate in the path is simplified when heartbeat and/or respiration motion compensation is provided using an ECG and information on depth of respiration. In this manner, the revisit can be image-guided using interventional imaging devices or based on localizer information. In contrast to the current use of the localizer information in daily clinical routine and the above described exemplary embodiments, it is proposed to use the localizer information for targeted navigation support. For example, the indication of current position information is replaced with information indicative of where the catheter should be disposed. For example, the localizer information would give the distance and direction to gap candidates from the current position of the tip, rather than information pertaining to only the current position of the ablation tip, and in so doing, applying heartbeat and respiraton motion compensation. For this, the comparison between the position of the gap candidate and the current position of the catheter is corrected for heart and respiration motion using the synchronously acquired ECG and depth of respiration together with information how the catheter moves locally due to heart beat and respiration. The latter information can be extracted by observing the position of the catheter tip over a heart cycle and an independent observation of the motion of the heart in the rib cage due to respiration.
Advantageously, embodiments of the present disclosure enable a user of the apparatus, method and computer software product to visually determine, in real-time during a procedure, which areas of the surface of the cardiac chamber have not been ablated and which require application or re-application of the ablating electrode. As a result, a more complete non-conducting lesion is typically formed, without unnecessary ablation of excess cardiac tissue and in less time than before possible.
Although the method, apparatus and software product of the present disclosure have been described with reference to exemplary embodiments thereof, the present disclosure is not limited to such exemplary embodiments. Rather, the method, apparatus and software product disclosed herein are susceptible to a variety of modifications, enhancements and/or variations, without departing from the spirit or scope hereof. Accordingly, the present disclosure embodies and encompasses such modifications, enhancements and/or variations within the scope of the claims appended hereto.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/IB2006/052756 | 8/9/2006 | WO | 00 | 2/21/2008 |
Number | Date | Country | |
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60711320 | Aug 2005 | US |