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PSST 10819_11/2008 Arrhythmia in Practice Today Content provided by Boston Scientific September 2008 Lessons in Lesions

PSST 10819_11/2008 Arrhythmia in Practice Today ™ Content provided by Boston Scientific September 2008 Lessons in Lesions

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Lessons in LesionsPSST 10819_11/2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20081ObjectivesControlable/un-controlableHow does cooling impact lesion size and safety?How does power affect lesions size and safety?How does catheter tip size affect lesion formation?Relation between catheter tip temperature and tissue temperatureChar and thrombus formationAffects of contact on lesion formationWhat does this 1st bullet mean? It seems incompletePSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Discovery of Cardiac AblationLesion Science 3Severe complications related to DC ablation led to the search for an alternative energy sourceFirst accidental ablation with DC (direct current) energy197919811985TODAYFirst radiofrequency (RF) ablation in humansFirst DC ablation in a humanPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20083It probably wont surprise you that the first cardiac lesion was created accidentally. In 1979 a patient was undergoing defibrillation. One defibrillator electrode came in electrical contact with a catheter electrode that was positioned at the bundle of His. The result was complete AV block

In 1981 Dr. Mel Scheinman (UCSF) performed the first DC ablation in humanspatient with severe chronic rheumatoid arthritis, sever chronic obstructive lung disease and recurrent episodes of afib, often accompanied by pulmonary edemarefractory to all available drugs (including amiodarone)poor surgical candidate; would not likely survive the postoperative periodprocedure was successfulalthough AV conduction ultimately resumed, the heart rate was easily controlled with low dose verapamillived until 1986 when he died of congestive heart failure

Though effective, the severe complications related to DC ablation (such as cardiac tamponade, hypotension following shock delivery, and induction of ventricular arrhythmias) lead to search for alternative energy source.

Radiofrequency (RF) energyImproved energy form for ablationLocalized thermal effect on the tissueNo muscle stimulation

Lesion Science 4Alternating electrical current (AC) at a frequency of 500kHz similar to commercial electricity @ 50 Hz

PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20084DorraGoals of Cardiac AblationSelective neutralization of tissue within the heart that causes or helps to sustain an arrhythmia

Apply sufficient energy to cause thermal injury and turn electrically active cardiac tissue into electrically inactive scar tissue (lesion)Tissue temperature of >50C is required for lesion formation

Understanding lesion science helps the clinician to deliver optimal therapy and may ultimately improve patient outcomes

Lesion Science 5123These 2 seem to say the same thingPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20085DorraThe GOAL of cardiac ablation is the selective neutralization of tissue within the heart that causes or helps to sustain an arrhythmia

This is accomplished by applying sufficient energy to cause thermal injury and turn electrically active cardiac tissue into electrically inactive scar tissueSpecifically, tissue temperatures above 50oC are required to produce irreversible necrosis, making the tissue unable to support conduction

The study of the biophysics of energy delivery and subsequent mechanisms of tissue injury is called lesion science

Understanding lesion science allows the clinician to deliver optimal therapy and may ultimately improve patient outcomes

Success FactorsLesion Science 6PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20086Many factors contribute to a successful ablation procedure. Some factors are more easily controlled than others.

First and foremost, you have to know where to create the lesion. An accurate diagnosis requires a thorough understanding of the physiology and anatomy of the arrhythmia.

Next, you have to navigate the ablation catheter into position, be able to keep it in position and deliver RF energy as appropriate for the anatomy. It helps to have a clear EP or anatomical endpoint to know when you have created an effective lesion.

Above all, be aware of variations in the anatomy and avoid complications such as collateral damage, perforation and thromboembolism

Resistive Heating: the light bulb analogyLight BulbRF Ablation

Lesion Science 7PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20087A good example of resistive heating is a light bulb. The lower resistance power lines leading to and from the light bulb filament are not heated. The filament offers significant resistance to the electrical current that passes through it. The resistance causes the filament to heat up and glow, providing light.

Similarly, heat is generated as electrical current passes through the highly resistive cardiac tissue. Application of sufficient energy causes irreversible thermal injury to the tissue, forming electrically inactive scar tissue (or, a lesion).

The RF energy delivery circuitClosed loop electrical circuitcatheterheart tissuedispersiveelectrode

generatorLesion Science 8PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20088RF energy is a high frequency form of AC current. Like any household electrical circuit, the RF delivery circuit must be a closed loop.Energy is delivered by an RF generator into a catheter. Current flows through catheter tip electrode, into and through the body tissues. It is collected by the dispersive electrode (or electrodes) on the body surface. Sometimes you will hear a dispersive electrode called a return patch or ground pad. The dispersive electrode is connected to the generator, completing the circuit and closing the loop.

Resistive heatingRF current is delivered via the catheter tip INTO the tissue Because tissue has a very high resistance, the passage of current generates heat in the tissueHaines, DE et. al. : Pacing Clinical Electrophysiol 1989 12:962-976Haines D. The Biophysics of Radiofrequency Catheter Ablation in the Heart. PACE Vol 16, Part II, March 1993; 586-591RF ablation is NOT burning with a hot tip!Blood

TissueLesion Science 9PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 20089Note: Catheters are NOT a branding irons! The catheter tip gets hot ONLY because of its close proximity to the heated tissue.

Lesions are formed when heat is generated within the cardiac tissue. Lets look at how it works.The catheter material has very LOW electrical resistance (meaning that the current flows easily through it)Body tissue has very HIGH electrical resistanceAs RF current passes from the LOW resistance catheter material through the HIGH resistance tissue (in this case, the myocardium), heat is generatedThe process of generating heat by passing an electric current through a resistive material is called resistive heating

Conductive HeatingHaines, DE et. al. : Pacing Clinical Electrophysiol 1989 12:962-976Haines D. The Biophysics of Radiofrequency Catheter Ablation in the Heart. PACE Vol 16, Part II, March 1993; 586-591Strickberger SA, Hummel J, Gallagher M, et al. Effect of accessory pathway location on the efficiency of heating during RF catheter ablation. AM Heart J 129:54-58. 1995.Blood

TissueHeat conducted fromwarm electrode into cooler bloodHeat conducted fromwarm tissue into cooler bloodHeat conducted fromresistively heated tissue into catheter tip Catheter tip heats upLesion Science 10Heat conducted from resistively heated tissue into surrounding tissue, expanding lesionPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200810It is important to note that only a narrow rim of tissue (2-3mm) in close contact with the catheter electrode is heated directly through resistive heating. The majority of a lesions volume is formed by thermal conduction, not resistive heating. Lets see why.

There are 2 major factors which occur at the tip electrode/tissue interface that have an important influence on the size of the lesion and the power/time it takes to create it. They are: thermal conduction, and convective cooling.

The second law of thermodynamics states, in part, that the transfer of heat is normally from a high temperature object to a lower temperature object. Applying this theory to ablation, when heat is generated at the surface of the tissue, it will spontaneously conduct to the deeper, cooler layers of tissue. Hence the term thermal conduction.

A commonplace example of thermal conduction is the handle of a pot on the stove. The handle is cool when you first place the pot on the stove. Once heat is applied to the pot and the contents begin to warm, heat is gradually conducted to the pot handle.

In the case of RF delivery and subsequent lesion formation,Note that only a narrow rim of tissue (2-3mm) in close contact with the catheter electrode is heated directly through resistive heating.All heating of deeper tissue layers occurs passively through thermal conduction from the tissue that has been heated via resistive heating.Most of a lesions volume is formed by thermal conduction.Thermal conduction is also responsible for heating the electrode tip and surrounding blood pool.

Blood

TissueHeat conducted fromwarm catheter tip into cooler bloodHeat conducted fromwarm tissue into cooler bloodHeat conducted fromresistively heated tissue into catheter tip Heat conducted from resistively heated tissue into surrounding tissue, expanding lesionCatheter tip heats up

Convective CoolingHaines, DE et. al. : Pacing Clinical Electrophysiol 1989 12:962-976Haines D. The Biophysics of Radiofrequency Catheter Ablation in the Heart. PACE Vol 16, Part II, March 1993; 586-591Strickberger SA, Hummel J, Gallagher M, et al. Effect of accessory pathway location on the efficiency of heating during RF catheter ablation. AM Heart J 129:54-58. 1995.Convective Cooling via (37C) Blood Flow Lesion Science 11PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200811The major factor opposing thermal conduction into deeper tissue layers is convective cooling. Convection is defined as the process by which heat removed from a medium by rapidly and actively mixing it.

In the case of RF ablation, convective cooling removes heat from the tip/tissue interface as the intracavity blood flows around the interface. If the blood is moving rapidly over the tissue surface, a large amount of the heat produced at the ablation site may be dissipated into the blood.

Convective cooling influences lesion creation. Generally, a higher the rate of blood flow increases the cooling effect, which is why higher RF power levels are required to produce lesions in regions of high local blood flow (such as the ablation of the slow pathways in AVNRT, right-sided accessory pathways, and especially anteroseptal pathways). Conversely, lower RF power levels may be appropriate for ablation sites shield from high blood flow (such as locations under the valves, behind the leaflets or at the apex).

In fact, the efficiency of energy coupling to tissue can be as low as 10% depending on electrode size, catheter stability, and catheter position relative to blood flow.

Power vs Temperature ControlPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Tip Tissue TemperaturesPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Tip SizePSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Cooled AblationPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Flow RatesPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Electrode to Tissue ContactPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Lesion ScienceMultiple Factors Influence Lesion Size & Quality:

RF Power Delivered to the Targeted TissueDurationBlood Flow Over the Tip/Tissue InterfaceElectrode Geometry*Electrode Tip/Tissue Contact*Type of TissueTip Orientation to the Tissue

* Effected by Catheter EngineeringPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 2008Lesion Science

It will be important to remind physicians that there are multiple factors that impact the size and quality of RF lesions - Catheter tip geometry, the amount of power delivered into the targeted tissue, ablation duration, etc.

While contact is obviously an important factor, it is not the only factor. Educating your physicians about lesion science and the factors that influence the size and quality of the lesion is an important strategy. Doing so will help build a strong foundation for BSCs Intellatip MiFi launch(es) in 2013.

18Lesion Growth with TimeLesion Size (mm)Time (sec)Steady State = MAXIMUM Lesion Size heat generated within lesion = heat transferred away from lesion

Haines D. Biophysics of Radiofrequency Lesion Formation. Catheter Ablation of Cardiac Arrhythmias (2006)~1/2 max lesion size created in the first 5-10 seconds of energy deliveryLesion Science 19PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200819We know that lesions do not form instantaneously they form over time based on the RF energy delivered and rate of thermal conduction.This graph illustrates lesion growth as a function of time. It is called a monoexponential relationshipNotice that half a lesions maximum size is created in the first 5-10 seconds of energy delivery. This is because tissue close to the surface heats up very quickly (direct, resistive heating)As time progresses, more thermal energy is transferred to deeper tissue layers (thermal conduction).

The Concept of Steady StateIf RF delivery is held at a consistent level and uninterrupted, the entire electrode-tissue system will eventually reach a steady state, meaning that the amount of energy entering the tissue at the thermal source equals the amount of energy being dissipated at the tissue margins beyond the lesion border. This is an important concept because it means that the lesion has reached its maximum size for that particular level of power delivery.If RF delivery is interrupted before a steady state is achieved, thermal conduction will cause the tissue temperature to continue to rise in deeper tissue for a short period of time. This effect is called thermal latency and has important clinical implications, depending on the location of the lesion (proximity to the esophagus).Temperature pattern within a lesionLesion Science 20

Conductive HeatingConvective CoolingPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200820This clip shows how thermal conduction causes heat to be transferred from the surface, deeper into the tissue.

Because of convective cooling on the surface, you can see that the highest temperature within a lesion is just below the surface.

You can also how the thermal energy emanates from the source and spreads in a radial fashion. Notice how the heating dissipates at a certain point within the tissue. Benchtop studies1 have shown that there is a fairly predictable decrease in the tissue temperature as the distance from the source increases.

This is why you dont see a lesion form from the point of contact with the myocardium to the return patch on the patients back!

***************************************1Haines DE, Watson DD: Tissue heating during RF catheter ablation: A thermodynamic model and observations in isolated perfused and superfused canine right ventricular free wall. Pacing Clin Electrophysiol 1989; 12:962-976

Consequences of overheating Heat is conducted to the catheter tip and deeper tissueCatheter tip heats up; Surrounding blood is heated and coagulatesCoagulum forms and adheres to the catheter tipFlow of current from the catheter tip to tissue is impededSystem impedance rapidly increasesPower delivery is terminatedResistive heat is generated in the tissue as current flows through itRF power is deliveredBlood becomes denaturedLesion Science 21PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200821Theoretically, in an ideal model with no convective cooling and stable tip/tissue contact, it seems that delivery of a very high level of energy should yield a very deep lesion. So what limits the amount of power delivered into the tissue?

There is a biologic phenomena at work called coagulum formation.Blood boils at 100C, denaturing the protein structures in the blood and causing coagulum to formCoagulum quickly accumulates on the tip electrode and may form charThis impedes the flow of electrical current and causes a sharp rise in system impedance.The rise in system impedance limits or the power delivered into the tissue and consequently, lesion formation

In addition to causing an impedance rise, coagulum formation increases the risk of char embolism and subsequent stroke. Excessive heating at the tip/tissue interface should be avoided.

Consequences of overheating Heat is conducted to the catheter tip and deeper tissueExcess power delivery causes tissue overheating Power delivery is not terminated automatically and must be terminated manuallyResistive heat is generated in the tissue as current flows through itRF power is deliveredVaporization of fluid causes steam pops and risk of ruptureLesion Science 22Add a video of steam popPSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200822Theoretically, in an ideal model with no convective cooling and stable tip/tissue contact, it seems that delivery of a very high level of energy should yield a very deep lesion. So what limits the amount of power delivered into the tissue?

There is a biologic phenomena at work called coagulum formation.Blood boils at 100C, denaturing the protein structures in the blood and causing coagulum to formCoagulum quickly accumulates on the tip electrode and may form charThis impedes the flow of electrical current and causes a sharp rise in system impedance.The rise in system impedance limits or the power delivered into the tissue and consequently, lesion formation

In addition to causing an impedance rise, coagulum formation increases the risk of char embolism and subsequent stroke. Excessive heating at the tip/tissue interface should be avoided.

Impedance rise associated with high temp015304560Time (sec)405060708090100Temperature ( C)100150200250300Impedance (ohms)Tip temperatureImpedanceHaines D: Biophysics of Ablation: Application to Technology. J Cardiovasc Electrophysiol 2004; 15:S2-S11Lesion Science 23PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200823This phenomena was demonstrated in a experiment using a canine model. Haines and Verow1 obtained in vitro and in vivo data on the relationship between the tip electrode temperature and the resultant effect on impedance. This and other data have consistently shown an sudden impedance rise at the peak temperature of 100C

*******************************1Haines DE, Watson DD: Tissue heating during RF catheter ablation: A thermodynamic model and observations in isolated perfused and superfused canine right ventricular free wall. Pacing Clin Electrophysiol 1989; 12:962-976Consequence of excessive intramural heatingNormal Lesion

Thiagalingam A, DAvila A, McPherson C, Malchano Z, Ruskin J, Reddy V. Impedance and Temperature Monitoring Improve the Safety of Closed-Loop Irrigated-Tip RF Ablation. J Card Electrophysiol 18:3:318-325, 2007.Lesion with Steam PopLesion Science 24PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200824The second consequence of excessive heating is a phenomena known as steam pops or pop lesions. Excessive heating may cause vaporization of water content to occur intramurally, causing a gas bubble to develop within the tissue under the electrode. Continued application of RF will cause the bubble to expand and its pressure to increase, which may lead to eruption of the gas bubble through the weakest path. When the gas is suddenly vented to the endocardial or epicardial surface (or both) it causes an audible pop and may potentially cause perforation and tamponade.

*************************1Nakagawa H, Yamanashi WS, Pitha JV, et al.: Comparison of in vivo tissue temperature profile and lesion geometry for RF ablation with a saline-irrigated electrode versus temperature control in a canine thigh muscle preparation. Circulation 91:2264-2273, 1995.Key points of lesion scienceRadiofrequency (RF) energy causes thermal lesion formation through resistive heating of myocardial tissue.Catheters are NOT a branding irons! The catheter tip gets hot ONLY because of its close proximity to the heated tissue. Heat is transferred to deeper layers of tissue (and the tip electrode and surrounding blood pool) via thermal conductionTissue temperatures of >50C or higher are required for lesion formation

Lesion Science 25PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200825Key points of lesion scienceBlood flow cools the electrode tip and tip/tissue interface through convective cooling the major factor opposing thermal conduction/lesion formationThe hottest spot in a lesion is below the tissue surfaceExcessive heating (>100C) at the tip/tissue interface causes coagulum formation, resulting in a system impedance rise, limiting RF deliveryBuildup of intramural gases, due to excessive heating, accompanied by continued RF delivery may cause a steam pop

Lesion Science 26PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200826ConclusionRF energy is the primary technology used in cardiac ablationhigh success rateslow complication rateseasy to use

Monitoring of tip electrode temperature may help prevent coagulum formation and steam pops

Ultimately, lesion size is directly proportional to tissue heatingLesion Science 27PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200827ConclusionBut, many factors influence tissue heatingRF power level and duration of deliveryblood flow over the electrode-tissue interfacecatheter tip geometrycatheter tip/tissue contact

Understanding lesion science allows delivery of optimal therapy and may ultimately improve patient outcomes

Lesion Science 28PSST 10819_11/2008Content provided by Boston Scientific September 2008Arrhythmia in Practice TodayContent provided by Boston Scientific September 200828