(Circulation. 1997;96:4057-4064.)
© 1997 American Heart Association, Inc.
Articles |
From the Cardiovascular Division, Department of Internal Medicine, University of Virginia Health Sciences Center, Charlottesville, and EP Technologies (D.P.), Sunnyvale, Calif.
| Abstract |
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Methods and Results A finite element model was used to predict the heating properties of new long electrode geometries. Sixteen dogs with atrial fibrillation underwent left and right atrial ablation using catheters with multiple 12.5-mm coil electrodes. Electrodes with a single thermistor were compared with electrodes with dual thermocouples placed at opposite ends and on opposing sides of the electrode. Power, temperature, and impedance were recorded for all lesions, and coagulum adhesion and magnitude were noted in a subset of lesions. Finite element analysis shows uneven heating, with the main heating concentrated at the electrode edges and a propensity toward temperatures >100°C with single-thermistor feedback control. Ablations with dual thermocouple electrodes achieved higher measured temperatures at lower power levels than those that used single-thermistor electrodes. Impedance rises and coagulum adherence occurred less frequently with dual thermocouple electrodes than with single, centered thermistor electrodes (176 of 395 versus 9 of 425 lesions; P<.0001; 46 of 98 versus 7 of 150 lesions; P<.0001, respectively).
Conclusions Maximum heating from radiofrequency energy occurs at the electrode edges, particularly with long electrodes. The safety of temperature-feedback atrial ablation with these electrodes is significantly improved by monitoring temperatures at the edges.
Key Words: ablation catheter atrial fibrillation finite element
| Introduction |
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The distribution of electric potential from a radiating source is governed by the Laplace equation. This equation explains observations of an "edge effect" in electrodes and antennae; that is, that there is a higher current and power density at areas of high geometric gradients such as the edges of electrodes (see "Appendix"). Because heating increases with power density during radiofrequency ablation, peak temperatures should also occur at the electrode edge at the junction between the electrode and insulator. Thus, it was hypothesized that positioning multiple temperature sensors at the edges of the electrode would be preferable to a single, centrally located sensor and should reduce the likelihood of overheating with associated impedance rise and thrombus formation. The purpose of this investigation was to compare the characteristics of temperature-controlled ablations performed with a single temperature sensor with those performed with sensors located at the electrode edges by use of a computer model and in vivo experimentation.
| Methods |
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Finite Element Model of a Coil Electrode
Finite element analysis is a numerical method for
solving differential equations under circumstances that restrict
empirical solutions, such as complex geometries or varying initial and
boundary conditions. A complex geometry is subdivided into finite
elements with a number of nodal solution sites. Numerical solutions to
the differential equations are calculated at the nodes systematically,
starting at the known boundaries and initial conditions. The nodal
values are then interpolated over each element via
element-interpolation functions. The finite element
technique19 and its validation20 21 22 have been
described previously. In this experiment, the Laplace equation and the
bioheat transfer function are solved at the nodes to determine the
electric field and then the temperatures that result from the
radiofrequency energy delivery. A three-dimensional finite element
model of the 7F, 12.5-mm coil electrode was used for this model. The
coil was modeled as stainless steel and the catheter body as an
insulator. The insulated layer of UV adhesive at the ends of the
electrodes was modeled as an area of very low electrical and thermal
conductivities. The model simulated an electrode lying on a 4-cm-thick
slice of cardiac tissue. The region modeling the blood extended 4 cm
above the tissue, and the blood-electrode-tissue region was 4 cm long.
It was assumed that there were negligible effects of both
radiofrequency energyderived heating and negligible electric field
strength at a great distance from the electrode (the external boundary
of the model), so conditions were defined as 37°C for the bioheat
transfer equation and 0 V for the Laplace equation on the model
boundary. The initial node temperatures were set at 37°C, assuming
temperature equilibrium within the model. Two models of radiofrequency
energy delivery were investigated emphasizing the steady-state
temperature distributions. The first model represented an
electrode with a centered temperature sensor for temperature feedback,
so energy was applied until the center of the electrode reached 70°C.
The second model represented electrodes with edge
temperature sensors, so edge conditions were set to 70°C. An
electrode-tissue contact surface of 40% of the electrode surface area
was assumed, and a flow velocity of blood causing convective cooling of
18 cm/s was selected.23 24 The overall finite element
model was formed of 9029 nodes and used 9056 hexahedral elements in a
nonuniform mesh. Regions of interest, such as boundaries between
different materials or material edges, were accorded a high
concentration of smaller-sized elements for increased regional model
resolution.
Animal Model
All experimental protocols observed the position of the American
Heart Association on research animal use and were accepted by an
Internal Animal Research Review Committee. Sixteen dogs with atrial
fibrillation were anesthetized with 0.5% to 1.0% halothane,
60% nitrous oxide, and 25 to 100 µg per hour intravenous
fentanyl. All dogs received 1 mg of intravenous atropine
during induction of anesthesia. The right femoral artery
and vein were exposed and cannulated via surgical cutdown. We performed
transseptal catheterization using a modified
Brockenbrough needle and Mullins sheath to provide access to the left
atrium. Arterial pressure and a six-lead ECG were
continuously monitored and periodically recorded on a
physiological recorder during the ablation
procedure.
Catheters and Ablation System
The ablation of atrial fibrillation was accomplished with the
use of steerable 8F ablation catheters (EP Technologies) composed of a
series of two to six of the previously described coil electrodes spaced
2 mm apart along the distal, deflectable portion of the catheter
(Fig 2
). Radiofrequency energy was
delivered to appropriate electrodes from an experimental high-power
generator (maximum output, 150 W root mean square; EP Technologies).
Power was controlled by a feedback control algorithm in the generator
that adjusted power to maintain a preset target temperature. For
multiple temperature sensors, a temperature-monitoring unit compared
the input temperatures and controlled the generator power with the
highest monitored temperature. The generator allowed the on-line
recording of voltage, current, impedance, and temperature. It
was also programmed to terminate radiofrequency energy delivery if the
impedance became >300
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Experimental Protocol
Ablation lesions were created in both left and right atria.
During lesion creation, power delivery was automatically controlled to
maintain a target temperature of 70°C for 60 seconds. The lesions
were created with sequential unipolar radiofrequency energy delivery to
selected electrodes that appeared to be in good contact with the atrial
wall in right anterior oblique and left anterior oblique fluoroscopic
views. An electrode was judged to be in good contact if the electrode
was moving in concert with the atrial wall. The impedance, voltage,
current, and electrode-tissue interface temperature were recorded
continuously on a personal computer during each delivery and stored in
a file for processing after the experiment. After a set of lesions was
created, the catheter was removed from the heart and examined for the
presence of adherent thrombus. Preliminary studies showed that clots on
the coil electrodes tend to propagate from the edges toward the center,
so the amount of electrode thrombus was assessed by measuring the
distance along the electrode that the thrombus progressed. The
instances of electrode thrombus adherence were assessed
semiquantitatively as follows: 0, clean electrode; 1, trace fibrin
only; 2, <1 mm of coagulum; 3, >1 mm of coagulum and
<2 mm of coagulum; and 4, >2 mm of coagulum. After the
completion of energy delivery, the dogs were euthanatized and the
hearts removed. The endocardial surface of each atria was inspected
grossly for charring, pitting, perforation, and the apparent continuity
of the lesions. The lesions were then bisected and stained with
nitro-blue tetrazolium, which demarcates viable from nonviable tissue.
The surface continuity was checked throughout the
myocardium, and the transmural portion of each lesion was
recorded and tabulated as a percentage of the gross endocardial
surface length. Any areas of lesion dropout were noted
qualitatively.
Data Analysis and Statistics
The impedance, temperature, and power characteristics were
analyzed off-line after the experiment. An increase in
impedance >20
above that observed at the initiation of
radiofrequency energy delivery was defined as a significant impedance
rise. Automatic power shutdowns when impedance exceeded 300
were
recorded. The observations of coagulum adherent to the electrode
were tabulated after the experiment and compared with impedance-rise
observations. Observations in which more than a single radiofrequency
delivery was made between catheter inspections were censored from this
analysis.
Raw data were stored in a computerized database. Normally distributed continuous data are presented as mean±SD. Comparisons between grouped data were made by use of the Student's t test. The comparison of alterations in event frequency was judged with Fisher's exact test. Statistical significance was determined as values of P<.05.
| Results |
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) to raise the temperature at
the center temperature sensor to 71°C. The maximum tissue temperature
was 161°C
0.5 mm directly below the edge of the electrode,
and the temperature at the edge of the electrode was 136°C. A finite
element technique cannot model the impedance rise subsequent to the
boiling and charring that occurs at the electrode-tissue interface at
temperatures >100°C, which restricts energy transfer and limits the
effective lesion dimensions. The analysis of radiofrequency
energy delivery to an electrode with a temperature sensor on the edge
for temperature feedback power control (Fig 4
) to raise the edge temperature sensor to 75°C.
The temperature at the center of the catheter was 56°C, and the
maximum tissue temperature was 97.7°C
0.5 mm directly below
the electrode edge. The 50°C isotherm predicts a lesion depth of
6.5 mm and a length of 20.5 mm.
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In Vivo Testing
Radiofrequency energy was delivered in a unipolar fashion to
single coil electrodes 833 times in 16 dogs. The single centered
thermistor electrode catheters were used in 8 dogs for a total of 395
energy deliveries. Ablation catheters with thermocouples on opposite
sides of the electrodes were used in 8 dogs for a total of 438 energy
deliveries. The mean measured electrode-tissue interface temperatures
were significantly higher and delivered powers associated with these
ablations were significantly lower with dual thermocouple electrodes
than with the single thermistor electrodes (Table 1
).
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The lesions were examined pathologically. There was no evidence of pitting or perforation by either electrode catheter, although there was one "pop" lesion associated with each electrode type. The lesions from the single-thermistor electrodes were continuous in 44 (69%) of 64 lesion lines versus 29 (53%) of 55 lines of lesion created with catheters with dual thermocouple electrodes (P=NS). Char was adhered to 36 (56%) of the single-thermistor electrode lesions and 20 (35%) of the dual thermocouple electrode lesions. Most of the char was found at the edges of the lesions. With single-thermistor electrodes, 93.9% of the epicardial length of each lesion was found to be transmural with nitro-blue tetrazolium staining, compared with 96.1% of the dual thermocouple controlled electrodes (P=NS). The transmural dropout regularly occurred in the center of the dual thermocouple electrode lesions and in the intercoil spaces of the single-thermistor electrode lesions.
Impedance Rise and Coagulum Adherence
Ablation performed with single centered thermistor electrodes
showed an impedance rise >20
above baseline measurements during
176 (45%) of the 395 radiofrequency deliveries versus 9 (3.6%) of 247
radiofrequency deliveries with dual-edge thermocouples
(P<.0001). Only 44 (27%) of those cases had an impedance
rise that exceeded the 300
automatic generator cutoff. Temperatures
of 100°C are associated with a rise in impedance, but high
temperatures (>90°C) were only observed in 13 (7%) of 176 impedance
rises with single-thermistor electrodes and 2 (22%) of 9 impedance
rises using dual thermocouple electrodes (P=NS). Sudden (>7
/s) impedance rises followed by a rapid return to baseline impedance
were observed in 46 (24%) of the 185 cases of impedance rise and were
associated with temperatures of 82.2±5.1°C and powers of 45.7±25.3
W. During the energy deliveries in which this type of impedance rise
occurred, the phenomenon of rapid rise and return to baseline could
oscillate throughout the energy delivery (Fig 5
) or rise and fall only a single time.
Slow impedance rises in which peak values did not exceed the 300-
power cutoff were seen in 95 (49%) of 185 cases of impedance rise and
were associated with lower temperatures of 67.9±6.4°C
(P<.0001) and higher powers of 77.8±31.3 W
(P<.0001; Fig 5
). These phenomena usually presented
as a gradual and consistent rise in impedance from baseline to
end impedance (between 40 and 150
above baseline).
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Coagulum Adherence to the Electrode
The catheters were removed and inspected for coagulum adherence
after a single radiofrequency energy delivery in 98 cases with
single-thermistor and 157 cases with dual thermocouple electrode
ablation. The coagulum found on the single-thermistor electrodes rated
2.3±1.5 versus that on the dual thermistor electrodes, which rated
0.6±0.9 (P<.001). A breakdown of the biophysical data
comparing those energy deliveries resulting in coagulum formation and
those without coagulum formation is shown in Table 2
. There were 10 impedance rises (5%)
out of 196 energy deliveries that did not result in coagulum adhesion
versus 31 (52%) of 59 with adherent coagulum (P<.0001).
Coagulum adherent to the electrode due to rapid impedance rises
amounted to 2.1±0.06 versus that due to a slow impedance rise, which
was 2.9±0.06 (P<.03).
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| Discussion |
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Previous Studies
It has been shown in vivo and in vitro that there is a strong
association between temperatures of 100°C and a sudden rise in
impedance.9 It is believed that when temperatures of
100°C are reached at an electrode-tissue interface, boiling occurs
and tissue contiguous to the electrode denatures and forms an
insulating layer that resists the flow of current. The resultant
loosely adherent thrombus is subsequently at risk for embolization. To
control the thrombus, radiofrequency ablation system designs are
incorporating integrated temperature feedback power control.
Closed-loop control has been added in some clinical
tools13 15 and is expected to be of primary importance in
most systems. The inclusion of closed-loop temperature control makes
the location of temperature sensors very important. Blouin et
al25 showed that the accuracy of temperature monitoring
could be improved by electrically insulating the sensor from the
electrode and placing it in contact with the tissue in the center of
the area to be heated. A single centered-tip temperature sensor was
considered adequate for standard 8F 4-mm electrodes.10
Tip-sensor temperature-monitored 8F electrodes of 8 mm and 12
mm lengths produced larger lesions than a standard 4-mm tip, but the
12-mm lesions were smaller than the 8-mm lesions, indicating an
overestimation of the tissue temperature by the tip temperature sensor
or partial electrode contact.26 The 12-mm-tip lesions were
also associated with char, indicating impedance rises11
and temperatures of 100°C at points on the electrode distal of the
tip.
The coil electrode was chosen to increase catheter flexibility and diminish the partial electrode contact without loss of the electrical and thermal properties studied in solid-ring electrodes. To this end, these electrodes were designed using finite element analysis such that the electric field formed during the delivery of radiofrequency energy would be similar to that of a long-ring electrode. Despite the improved flexibility, the irregular pattern of heating in this experiment indicated poor power control with a single centered temperature sensor. Subsequently, the temperature sensors were placed to improve the safety and control of atrial ablation. Other alterations in the coils have been considered, such as doubling the winding pitch (increasing the interwinding space) at the edges of the electrodes to decrease local current density and temperatures. However, preliminary finite element models of these coil electrodes demonstrated no change in the resultant current density and only a minimal reduction in edge temperature.27 Analysis also concluded that the pitch would have to be increased tenfold for a decrease to be observed, which would drastically reduce the electrode surface area available for the creation of lesions and decrease the solid-ringlike properties of the coils. It is also believed that a further reduction in the incidence of impedance rises, the amount of coagulum, and the efficacy of the lesions can be realized if electrode-tissue contact is optimized.
Monitoring the edges of the electrodes resulted in a dramatic decrease in the coagulum adherent to the electrode and the char on the lesions. However, there was a trend toward a reduction in lesion continuity. The advantage of greater control of power output is that it may allow a safe increase in target temperature from 70°C, as in the present study, to 80°C, which may improve the lesion continuity. As efforts to increase lesion size and length with new electrode geometries continue for the ablation of arrhythmias such as atrial fibrillation and atrial flutter, the risks of coagulum formation and embolism may increase if temperature monitoring is not designed around geometric concerns such as the edge effect.
Limitations
There were a limited number of temperature sensors on each
electrode of the catheters used in this protocol. Even with the
dual-edge thermocouple design, it is likely that only one temperature
sensor in each electrode was in contact during each ablation, because
the temperature sensors are on opposite sides of the electrodes. If the
electrode-tissue contact on one electrode edge has poor contact, then
the peak surface temperature may still be underestimated. In fact, when
coil electrode catheters were positioned under fluoroscopic guidance in
good contact and then judged with intravascular ultrasound, it was
concluded that those electrodes judged in good contact fluoroscopically
were not necessarily in contact along the entire length of the
electrode.28 Even with tissue contact ensured along the
entire length of the electrode, it is possible that the peak
temperature may occur at a position different from that of the
temperature sensor. This is an inherent limitation in the design of
multiple electrode catheters in which there is a trade-off between the
efficacy of temperature monitoring and the ability to fit multiple
wires and steering mechanisms inside a transvenous catheter. To counter
the possibility of unmonitored hot spots, the temperature selected for
temperature-controlled power regulation is usually limited to 70°C to
80°C. Because a number of ablation sites and catheter positions were
overlapping, it was not possible to correlate a specific radiofrequency
energy delivery to a specific pathological lesion. Therefore, only
summary pathological data were reported.
Conclusions
Using finite element analysis and in vivo testing in a
canine model, we determined that there is a significant disparity
between peak temperatures achieved at the electrode edges versus their
midpoint. The consequences of the edge effect may be excessive heating
and coagulum formation during temperature-feedback power-controlled
radiofrequency energy delivery if the temperature sensor is not
optimally placed. With long coil electrodes, use of dual-edge
temperature sensors results in comparable lesion efficacy but a much
lower risk of overheating and coagulum or char formation. To optimize
the safety profile of new electrode geometries, temperatures should be
monitored at all electrode edges or transition points to prevent excess
power delivery.
| Footnotes |
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| Appendix 1 |
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![]() | (1) |
T/
t) to the heat conduction caused by a temperature gradient
(
T is a derivative of temperature over three-dimensional space)
and added heat from a source, Qp (in the
present study, radiofrequency energy), and the loss to convection,
Qh. In Equation 1
is the density,
c is the specific heat, and
is the thermal conductivity
of tissue. During radiofrequency ablation, the heat loss due to
convection, Qh, is proportional to the
difference between tissue temperature and the temperature of the blood.
However, the energy derived from resistive radiofrequency energy
delivery, Qp, is dependent on geometric factors
and is the product of the current density, J, and the electric
field, E:
![]() | (2) |
:
![]() | (3) |
![]() | (4) |
![]() | (5) |
term simply represents the derivative of its
associated variable in three-dimensional space, so this equation
expands to
![]() | (6) |
Received May 20, 1997; revision received August 25, 1997; accepted August 27, 1997.
| References |
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