US 20070049915 A1
Embodiments of the invention comprise methods and devices that allow quantification of blood convective cooling at the cardiac RF catheter ablation site and allow for prediction of lesion size and/or computation of RF energy parameters and characteristics.
1. A method for determining ablation lesion size comprising:
a. Applying a pulse of RF energy to a treatment site positioned catheter;
b. Taking a temperature measurement of the catheter over time;
c. Generating a parameter representing convective cooling for the treatment site;
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12. A device for performing cardiac ablation comprising:
a. A catheter for receiving and emitting RF energy wherein the catheter comprises a tip;
b. A means for generating and transmitting to the catheter RF energy;
c. A temperature measuring device contiguous with the catheter tip;
d. A controller wherein said controller is coupled to the RF energy generating and transmitting means and controls the RF energy transmitted to the catheter;
e. A processing unit comprising a means for receiving and processing the temperature measurement signals from the temperature measuring device, and computing a convection cooling parameter.
13. The device of
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18. A computer readable medium having stored therein a computer program that when executed causes a computer to perform the steps comprised of:
a. Receiving temperature measurements from a temperature measuring device located contiguous to a cardiac ablation catheter;
b. Receiving control information from a controller wherein the controller controls the characteristics of RF energy applied to the cardiac ablation catheter;
c. Generating a convective cooling parameter from data comprising the temperature measurements and the control information.
19. The medium of
20. The medium of
The application claims the benefit of Provisional Patent Application entitled “Quantification of Local Convectional Cooling During Cardiac Radiofrequency Catheter Ablation”, by Haemmerich and Saul, Ser. No. 60/711,742 filed on Aug. 26, 2005, and hereby incorporated by reference as if rewritten in full.
Radiofrequency (RF) ablation is a medical procedure which can be used to treat some types of rapid heart beating including conditions such as supraventricular tachyarrhythmias. Ablation can be used to treat a wide variety of tachycardias, which can involve heart tissues in the upper chambers (atria), also called supraventricular, or the lower chambers (ventricles), called ventricular tachycardias (SVT or VT). In some cases, a small number of cells (a “focus”) start firing rapidly and ablation can eliminate the focus. In other types of tachycardia, an electrical circuit exists within which the electrical signal travels more or less in a circle (“reentry”). Many cases of SVT and VT are due to reentry. A special type of SVT, called atrial fibrillation, is characterized by extremely fast impulses in the atrium (up to 600/min), for which ablation can be used either to decrease the number of impulses getting to the ventricles or in some cases to locate and ablate the area(s) from which the fibrillation starts. (Circulation. 2002;106:e203.)
An example of an ablation procedure is as follows: A physician guides a catheter with an electrode at its tip to the area of heart muscle where there's an accessory (extra) pathway. The catheter is guided with real-time, moving X-rays (fluoroscopy) displayed on a video screen. The procedure helps the doctor place the catheter at the exact site inside the heart where cells give off the electrical signals that stimulate the abnormal heart rhythm. Then a mild, radiofrequency energy (similar to microwave heat) is transmitted to the pathway. This destroys carefully selected heart muscle cells in a very small area (about ⅕ of an inch). That stops the area from conducting the extra impulses that caused the rapid heartbeats.
Radiofrequency current can be alternating current that is delivered at cycle lengths of 300 to 750 kHz when used for catheter ablation. It causes resistive heating of the tissue in contact with the electrode. Because the degree of tissue heating is inversely proportional to the radius to the fourth power, the lesions created by radiofrequency energy are small. Typical ablation catheters, which are 2.2 mm in diameter (7 French) and have a distal electrode 4 mm long, create lesions approximately 5 to 6 mm in diameter and 2 to 3 mm deep. Larger lesions are possible with larger electrodes or saline-irrigated ablation catheters. Although electrical injury may be a contributing factor, the primary mechanism of tissue destruction by radiofrequency current is thermal injury. Irreversible tissue destruction can require a tissue temperature of approximately 50° C. In most ablation procedures, the power output of the radiofrequency generator is adjusted manually or automatically to achieve a temperature of 60 to 75° C. at the electrode-tissue interface. If the temperature at the electrode-tissue interface reaches about 100° C., coagulated plasma and desiccated tissue may form on the electrode, preventing effective delivery of the current, predisposing the patient to thromboembolic complications, and necessitating the removal of the catheter so that the coagulated material can be wiped off the electrode. The acute lesion created by radiofrequency can consist of a central zone of coagulation necrosis surrounded by a zone of hemorrhage and inflammation. Chronic lesions are often characterized by coagulation necrosis and have a discrete border. Changes that occur in the border zone can explain why arrhythmias may recur several days to several weeks after apparently successful ablation. The arrhythmia may recur if the target tissue is in the zone bordering a lesion instead of in the central area of necrosis and if the inflammation resolves without residual necrosis. Conversely, the site of origin of an arrhythmia that has not been successfully ablated may later become permanently nonfunctional if it is within the border zone of a lesion and if microvascular injury and inflammation within this zone result in progressive necrosis. (New England J of Medicine, Volume 340:534-544, Feb. 18, 1999).
Embodiments of the invention comprise methods for computing convection cooling parameters associated with the site for the application of RF ablation. Additional embodiments of the invention comprise devices for the control of cardiac RF ablation. Further embodiments of the invention comprise computer readable medium capable of execution in a computer or other processing unit whereby an ablation lesion size is predicted based upon the input of certain parameters or measurements. Parameters can be such things as temperature measured at the electrode tip of a catheter while the catheter is energized with RF energy. Other parameters can be temperature measured at the electrode tip of a catheter for a fixed time period after the application of RF energy to the catheter. Parameters can also be those known to one of ordinary skill in the art that characterize the RF energy applied to the tip, including frequency, pulse shape, pulse duration, magnitude, and temperature of the tip.
Table 1. Temperature, Power, Impedance, and lesion dimensions at different flow rates.
Table 2. Absolute (mm) and relative error (%) of lesion width and depth predicted by parameters dTmax, and slope using linear regression equations.
Table 3. t-test: comparison of lesion dimensions at different flow rates.
Cardiac radiofrequency (RF) catheter ablation has become the treatment of choice for a wide array of both supraventricular and ventricular arrhythmia. The dimensions of the lesion created during RF ablation depend on several factors such as catheter geometry, catheter-endocardial contact, and blood flow. Several studies examined the dependence of lesion size on blood flow [1-4]. Convective cooling by the blood carries away heat from the catheter tip and endocardium, enabling deposition of more RF energy deeper into the tissue. When RF power is not limited, higher blood flow can result in wider and deeper RF lesions. These results have been shown in ex vivo experiments [1, 3] and computer models [4, 5]. Similarly, in vivo experiments in a porcine animal model have shown that ablation site within the heart affects lesion size. Mukherjee, et al., classified different ablation sites in the endocardium according to flow conditions (low/medium/high), and found significant differences in lesion size depending on ablation site .
Embodiments of the invention present two methods to quantify convective cooling at the ablation site before cardiac RF catheter ablation is performed. These methods can be used to directly predict lesion size at the ablation site. Quantitative data on convective cooling can also be used as input parameters for computer models [4-7] in order to more-accurately estimate lesion size and include this information in treatment planning.
While RF energy is applied, heat is transferred to and from the tissue, simultaneously, by several different mechanisms (see
The equations describing this heat transfer process in the tissue are:
From equations 1 and 2 we notice that the only absolute temperature present is Tblood (blood temperature, which is equal to initial tissue temperature). If we measure parameters relative to Tblood, we can avoid introducing errors as a result of variations in Tblood (e.g. different body temperatures in different patients).
The following two parameters were measured following a brief RF pulse (see
The catheter can have a thermocouple, thermistor, or other temperature measuring means adjacent to or near the electrode tip of the catheter. The temperature measuring means can be located within the catheter including within the tip. The temperature measuring means are generally known to one of ordinary skill in the art.
RF energy for the catheter is generated using means known to one of ordinary skill in the art. Control of that RF energy can be done using means known to one of ordinary skill in the art. Control of the RF energy can comprise a digital control signal that is used to control an RF energy generator or transmitter. That control signal can also be used as an input into a processing unit that performs some of the methods of embodiments of the invention. Thus RF energy parameters such as pulse shape, pulse duration, pulse magnitude, and the like can be provided to the processing unit for inclusion in the convection cooling parameter generation and/or lesion size estimation. Further embodiments of the invention can include generation of a lesion size estimate based upon information inputted into a processing unit wherein the information comprises such things as the RF energy control parameters and the temperature measurements described herein.
Embodiments of the invention can include a processing unit wherein the processing unit is a personal computer such as a Windows based, or Linux based, PC generally known to one of ordinary skill in the art. The processing unit can also comprise a CPU, microcontroller, BASICstamp or similar device or apparatus for the performance of executable instructions that carry out the methodology of embodiments of the invention described herein. Storage media, communication media, and other input and output devices generally known to one of ordinary skill in the art can be used in embodiments of the invention. Processing means can be included within the devices and apparatus currently known in the art for performing cardiac catheter ablation but which do not incorporate embodiments of the invention described herein.
Lesion sizes obtained during cardiac radiofrequency (RF) catheter ablation are dependent on convective cooling mediated by blood flow in the heart. For temperature controlled catheters, larger lesions can be obtained at locations with high blood flow. We performed ex vivo ablation experiments in porcine cardiac tissue in a saline bath with flow of varying flow rates (0, 1, 2, 3 L/min) directed over the ablation site. We investigated whether catheter tip temperature change following a brief low-power RF pulse can be used to predict lesion dimensions. Before the ablation procedure, we applied a pulse of constant power (15 W) for five seconds, and a pulse of varying time length and constant power (30 W) until electrode temperature reached 43° C. We determined maximum tip temperature change (dTmax) and the slope of tip temperature decay at 5° C. above initial temperature (slope). We correlated these two parameters with flow rate and lesion dimensions. Lesion dimensions varied significantly with flow rate. Without flow (0 L/min), lesion depth, width and volume were 4.5±0.5 mm, 6.8±1.1 mm, and 120.7±50.7 mm3, respectively. At maximum flow (3 L/min), lesion depth, width and volume were 7.6±0.9 mm, 11.3±1.2 mm and 548.9±157.0 mm3, respectively. dTmax showed strong negative correlation with lesion width (r2=0.68), depth (r2=0.57), and volume (r2=0.56); slope also correlated negatively and strongly with lesion width (r2=0.62), depth (r2=0.52), and volume (r2=0.5 1). Both parameters can be used to predict lesion dimensions depending on local blood flow at the treatment site.
We used freshly-excised porcine heart obtained from a local butcher. Upon excision, the hearts were infused with chilled physiological saline (0.9% NaCl) for transport. The porcine hearts were dissected to create square pieces of myocardium (˜20×20 mm, ˜15 mm thick). This tissue sample was then placed in a gel block made of Agar-Water (5 mass% Agar) (see
We immersed the gel block with tissue in 0.3% saline having same thermophysical properties as blood (0.67 S/m) at 37° C. and 500 kHz  (see
We measured maximum flow velocity at different flow rates by injecting a droplet of dye at the inlet of the rigid tube and recording the wavefront at the phantom surface with a digital camera at 30 frames/s. Maximum flow velocity was found to be 15.5 cm/s at 3 L/min flow rate. This velocity is comparable to blood flow velocities inside the beating heart as measured by an ultrasound Doppler transducer . The catheter was placed centered on the tissue sample, perpendicular to the endocardial surface. To control pressure between catheter and tissue, a 10 gram piece of Copper was attached to the neck of the catheter. Power was supplied to the RF ablation catheter by a commercial cardiac ablation generator (Boston Scientific, EPT-1000XP). The electrode of the catheter (Blazer II XP) was 10 mm long and 8 FR (2.7 mm) in diameter. As grounding pad we used a piece of aluminum foil (15×10 cm) placed in the saline bath, more than 20 cm distant from the ablation electrode.
Test Pulses to Quantify Cooling
Before commencing ablation, two RF test pulses were delivered to measure the two parameters shown in
one pulse of constant power (15 W), for 5 s
one pulse of constant power (30 W), until tip temperature reached 43°°C.
We waited 1 min in-between test pulses to allow tip temperature to return to baseline. Ablation parameters (T, P, Z) were recorded for 30 s from start of the test pulse. After application of the test pulse to the ablation catheter, RF power was diverted to electrodes placed in a beaker filled with saline; this was necessary since the RF generator doesn't report catheter tip temperature after RF power is shut down. We wrote software in Visual Basic 6.0 (Microsoft, Redmond, Wash.) to automate control of the switch for the two test pulses. The test pulses never resulted in tissue damage as confirmed in preliminary experiments.
From the temperature time-course of the first test pulse (15 W, 5 s) we measured the maximum change in tip temperature (dTmax) from the initial temperature. From the temperature time-course of the second test pulse (30W until T=43° C.) we determined the slope of temperature decay at 5° C. over initial temperature (slope).
Since slope measurements are very sensitive to noise, we then used following method to determine slope:
Customized software written in Matlab 6.5 (Mathworks, Natick, Mass.) was used to automate the slope measurements.
After application of the test pulses, we performed temperature-controlled ablation for 60 sec. at a target temperature of 65° C. After the ablation was complete, the tissue sample was removed and cut through the center of the lesion perpendicular to the endocardial surface. Pictures of each lesion were taken with a digital camera (Canon PowerShot A510), and downloaded to a computer. We approximated the lesion boundary by an ellipsoid with image processing software (Paint Shop Pro 5.0). We then used the software ImageJ (available from N1H) to determine lesion dimensions (measurements A, B, C, D, see
We found that lesion dimensions changed significantly with flow rate (
For the parameter of depth, all comparisons of flow rates showed a significant difference between depth except between flow rates 2 and 3 L/min (see Table 3). For the parameter of width, all comparisons showed a significant difference except between flow rates 1 and 2 L/min. Finally, the parameter of volume showed a significant difference for all comparisons.
Table 1 displays the electrode temperature, power, impedance, and lesion dimensions for each flow rate.
Most clinical RF ablation systems for catheter treatment of cardiac arrhythmias employ temperature control. Typically, a sensor located in the electrode tip measures temperature and applied power is controlled to keep tip temperature constant (usually between 60 and 70° C.). A number of studies employing computer models, ex vivo experiments, and in vivo animal models, have demonstrated the dependence of RF lesion dimension generated on local convective cooling [1-5]. Embodiments of this invention comprise a quantitative and practical system to assess local convective cooling in vivo, and predict lesion size during clinical cases.
Local convective cooling can have a dramatic and significant effect on RF lesion size during temperature controlled ablation in the absence of power limitations. In our results, the greater the convective cooling was, the larger the lesion (see Table 1,
Both parameters (dTmax, slope) exhibited linear relationships with both lesion width and depth (see
Certain embodiments of the invention correlated the measured parameters directly with lesion dimensions. Other embodiments of the invention can first use the parameters to estimate convective cooling, and then use this estimate together with other a-priori information from computer models to calculate lesion dimensions [4, 5]. A recently published article presents treatment planning software for cardiac RF catheter ablation which estimates lesion size depending on factors such as blood flow, ablation time, and target temperature . However, estimates of convective cooling had to be used in these models since no patient specific data were available. Ablation site, heart rate, stroke volume and other factors all affect convective cooling within the heart. Embodiments of this invention provide a patient and site-specific estimate of convective cooling, allowing the use of a computer model to provide more accurate estimates of lesion dimensions (
Actual conditions in the heart denote pulsatile flow. Pulsatile flow can make measurement of the parameters (dTmax, slope) more difficult, and can in some instances require more elaborate signal processing than used here. Also, insertion angle and depth vary in clinical practice, and can have a significant impact on both lesion sizes. Therefore, an estimate for catheter insertion depth or tissue contact can be incorporated into embodiments of the invention. Previous studies have proposed several methods to estimate catheter-tissue contact [12-14]. A parameter describing tissue contact can also be included in embodiments of the invention as an additional input parameter in computer models to estimate lesion dimensions with procedure-specific data on both flow conditions and tissue contact.
While various embodiments of the invention have been described, it may be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention. For instance, application of embodiments of the invention can be made to cryo ablation by either heating or cooling the catheter briefly and measuring thermal dynamics. All such modifications are intended to be included within the scope of this disclosure and the present invention and protected by the following claims.