DOI: 10.1161/CIRCEP.113.001094 Relationship between Catheter Contact Force and Radiofrequency Lesion Size and Incidence of Steam Pop in the Beating Canine Heart: Electrode Amplitude, Impedance and Electrode Temperature are Poor Predictors of Electrode-Tissue Contact Force and Lesion Size Running title: Ikeda et al.; Contact Force vs. RF Lesion Size Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Atsushi Ikeda, MD, PhD1; Hiroshi Nakagawa, MD, PhD1; Hendrik dri rikk La Lamb Lambert, mber mb ert, er t P t, PhD hD2; shar S Sharma, harm ha rmaa M rm MD, D M MPH1; Dipen C. Shah, MD3; Edouard Fonck, PhD2; Aude Yulzari, MS2; Tushar JJan Ja n V. Pit Pitha, tha ha,, MD M MD,, Ph PhD hD4; Ralph Ralp Ra lphh Lazzara, lp Lazz La zzar zz a a,, M MD D1; Warren W rren Wa rrren nM M.. Ja JJackman, ck kma man, n, M MD D1 Heart Rhythm h hm hythm m IInstitute, nsti ns titu ti tu utee, 4De Department epa part r me rt ment n ooff Pa Pathology, ath holog oggy, V Veterans e er et e an ns Ad Admi Administration mini mi n st ni s ra rati tion ti on Medical Med edic iccall Ce Center, e University of Ok Okla Oklahoma l ho h maa H Health ealt lhS Sciences cie i nces C Center, ente t r, O Oklahoma klah kl homa Ci City City, ty, OK; ty O ; 2En OK Endosense E d sense SA do SA;; 3Ho Hospital o Cantonal Cant Ca n on nt o al al de de Geneve, Gene Ge neevee, Geneva, Gene Ge neva ne v , Sw va Swit Switzerland itze itze z rllan nd 1 Correspondence: Hiroshi Nakagawa, MD, PhD Heart Rhythm Institute University of Oklahoma Health Sciences Center 1200 Everett Drive (TUH-6E-103) Oklahoma City, OK 73104 Tel: 405-271-9696 Fax: 405-271-7455 E-mail: [email protected] Journal Subject Codes: [22] Ablation/ICD/surgery, [5] Arrhythmias, clinical electrophysiology, drugs 1 DOI: 10.1161/CIRCEP.113.001094 Abstract: Background - Electrode-tissue CF is believed to be a major factor in RF lesion size. The purpose of this study was to determine, in the beating canine heart, the relationship between contact force (CF) and radiofrequency (RF) lesion size and the accuracy of predicting CF and lesion size by measuring electrogram amplitude, impedance and electrode temperature. Methods and Results - Eight dogs were studied closed chest. Using a 7F catheter with a 3.5mm irrigated electrode and CF sensor (TactiCath, ENDOSENSE SA), RF applications were delivered to 3 separate sites in the right ventricle (RV, 30W, 60 sec, 17 ml/min irrigation) and 3 sites in the left ventricle (LV, 40W, 60 sec, 30 ml/min irrigation) at either: 1) low CF (median 8g); ( g); 2)) Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 moderate CF (median 21g); and 3) high CF (median 60g). Dogs were sa sacrificed sacr crif cr ific if iced ic ed aand nd llesion esio esio ionn size was measured. At constant RF and time, lesion size increased significantly with ntly w ithh in it iincreasing crea cr easi ea sing si n ccontact ng force (p<0.01). incidence increased 01) 1). Th 1) Thee in nci c de dence of a steam pop increas ased as ed with both increasing i crea in easing CF and higher ppower. ea Peak electrode temperature correlated with lesion The rodee tempera ro atu turre co corr rrel rr elat el ated at ed ppoorly oorl ryw ith les esionn ssize. ize zee. T he ddecrease he e reas ec a e in as i iimpedance m ed mp dan nce during the RF application lesions in lication li ica cati tion correlated ti corrre r latted w well ell w with i h le it lesion esiionn si size ize fo for or les lesions sionss iin n tthe he LV, V, but u lesss w ut well elll forr le les es the RV. There wass a ppoor relationship CF and amplitude h wa here w oor re rela lationsh la shhip p between nC F an nd the am ampl p itud udde of the hee bipolar bip ip pol o ar or unipolar unipp ventricular electrog electrogram, current, gram, m, uunipolar niipo p la l r iinjury nju jury y current t, andd im iimpedance. p dance. pe Conclusions strikingly with increasing ns - RF lesion leesiion size lesi siz i e and an nd the t e incidence th iinncide ciide d nc ncee off ssteam tteeam ppop opp increase inc ncre reas asee st triki riiki king ngly l w ly ithh in it incr increa crea ea CF. Electrogram parameters and initial impedance are poor predictors of CF for RF ablation. Key words: catheter ablation, radiofrequency, ventricular arrhythmia, atrial fibrillation, conatct force 2 DOI: 10.1161/CIRCEP.113.001094 Introduction Several experimental studies have shown that electrode-tissue contact force (CF) is a major determinant of lesion size during radiofrequency (RF) ablation.1-7 Until recently, contact force (CF) could not be measured directly by ablation catheters. As a result, surrogate measures of CF have been proposed, including electrogram amplitude, pre-ablation impedance and changes during ablation in electrode temperature and impedance.1,3,4 The accuracy of these surrogate measures has not been extensively validated. Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Recently, two designs of ablation catheters have been developed ed to measure rea real-time al-ti tim m catheter-tissue CF during catheter mapping and RF ablation. One type of catheter cath ca thet th etter uuses ses three se thrree th re optical fibers CF deformable e to ers to measure meas me a uree C as F as the microdeformation microdeformatiion o of a deform mablee bbody ody in the catheter tip -12 2 (TactiCath,, ENDOSENSE SA). EN NDOSENS SE SA A). 88-12 Thee other othe her catheter catthetter inc incorporates ncor orpo or poraatees a sm small mall spri spring ingg cconnecting onnecctii the elect c ro ct rode d to th de the cath theter th h sshaft ha an ha haft nd us uses a magn gnettic tra ans n miitt tter and nd location locati tion sensors ti senss to ablation tipp electrode catheter and magnetic transmitter measure CF F as th the he mi microdeflection icrod oddeffle l ctio i n off the spr spring p ingg (THERMOCOOL (T THE HERM RMOC RM OCOO OC OO OL SMARTTOUCH, SMAR SM ARTT AR TT TOU O CH CH, Biosense B osee Bi 13,14 ,14 14 88-14 Webster, Inc). nc)) 13 IInn bbench ch h ttesting, testing ti bboth oth th systems s st stems t have hhaa e a CF resol resolution oll ttion io off less l than th 1gram 1gram. 1 Although clinical practice is suggesting that increasing CF improves RF lesion formation,11,12 there are no studies correlating RF lesion size to CF in the beating heart. The purpose of this study was to determine, in the canine beating heart: 1) the relationship between CF and RF lesion size, as well as the incidence of steam pop; and 2) the accuracy of predicting CF and RF lesion size by the surrogate measures of CF, i.e., intracardiac electrogram amplitude and downstroke slope, pre-ablation impedance, and the change in electrode temperature and impedance during RF delivery. 3 DOI: 10.1161/CIRCEP.113.001094 Methods Contact Force Sensing Ablation Catheter The 7 F quadripolar ablation catheter with a CF sensor (TactiCath, ENDOSENSE SA, Geneva, Switzerland) has a 3.5 mm tip electrode with 6 small irrigation holes (0.4 mm diameter) around the circumference, located 1.2 mm from the tip for saline irrigation during RF delivery (Fig 1). The ablation electrode contains a thermocouple to measure the electrode temperature. The CF sensor consists of a deformable body (elastic polymer) and 3 optical fibers (0.125 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 mm diameter, Fig 1) attached circumferentially around the deformablee body. bodyy. Force on the the 88,9,11,12 9 11,1 9, 11 12 11 deformable body changes the reflected wavelength of light in the 3 optical ticall fibers. fib iber ers. s 8, By By g the he rreflected efle ef leect cted e w avelength, the system is ab ble to calculat a e th at he amplitude and displ l the monitoring wavelength, able calculate the display vector of the he C he CF F at 100 ms in intervals. nteerval alss. al Experimental n lM ntal Model od odel d The experimental m mental l pprotocol rotoco co ol was approved ap ppr p oved d bby y th the he Un U University iversity ty off Ok O Oklahoma laaho h ma m C Committee ommitt tteee on on thee Use and Care off Animals A Animals. niimall E Eight ight ht mongrel ell dogs do weighing eighing eiighi hin 31 to t 39 kg kg were ere anestheti anesthetized theti ti ed d with iith th sod sodium odd pentobarbital (30 mg/kg) and ventilated mechanically with room air. The right carotid artery was cannulated for monitoring arterial pressure. A 7 F, 20-electrode catheter was inserted into the right jugular vein and advanced into the coronary sinus under fluoroscopic guidance. A 10 F ultrasound catheter (AcuNav, Acuson) was inserted into the left femoral vein and advanced into the right atrium to be used for intracardiac echocardiography (ICE). Heparin (5,000 IU) was administered intravenously, with additional doses, as necessary to maintain the ACT >250 seconds. Transeptal puncture was performed under ICE and fluoroscopic guidance. The CF ablation catheter was inserted into the left atrium through the transeptal sheath. The CF catheter was initially positioned centrally within the left atrium, without endocardial contact (confirmed by ICE), to calibrate the 4 DOI: 10.1161/CIRCEP.113.001094 CF sensor to 0 g (baseline non-contact value). The CF ablation catheter was advanced into the left ventricle (LV) for ablation. After LV ablation was complete, the transeptal sheath was withdrawn into the right atrium and the CF ablation catheter was positioned into the right ventricle (RV). Ablation was then performed in the RV as described below. Ablation Protocol RF applications were performed at 3 separate sites in the LV (septum, lateral free-wall and apical region) and 3 separate sites in the RV (basal free-wall, medial wall of the outflow tract and apical Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 region). These 6 locations were sufficiently far apart to accurately identify ntifyy during g lesion n assessment. The 3 RF applications in the LV and the 3 RF applications in the were delivered at h RV w he eree de er deli livv li 3 different leve levels moderate vels ve l ooff CF ls C (one (oone each, randomized): 1) low low o CF (range 22-10 -100 gg,, median 8 g); 2) mo o CF (range 220-30 high CF (range median Fig CF 0-30 g, mediann 21 g); aand nd 33)) hi igh C F (ran ange 550-100 0--1000 gg,, med ediaan 60 gg,, Fi F g 2). C F was stabilized and seconds before onset the a averaged av vera erraged d over th the h 5 se eco conds be befo fore tthe for h ons he set of of th he RF application. appliica cati tion. Data ti D ta ffor Da or RF applications during ns were not included incl in cludded cl d if if the th he catheter cath hetter pposition ositiion and/or and/ d//or movement movvemen nt had h d changed ha ch hange geed du ged durin ablation or if the the C CF F measured meas red ed d immediately immediatel i edi diattell postt ablation abl blati ti had had d changed ha ed d (>5-10 ((>5 >5 110 0 g). g)) In In order rdd to selectively examine the effect of CF on lesion size, RF applications were delivered at constant RF power and application time. In the LV, RF applications were delivered at 40 Watts for 60 sec, using a saline irrigation flow rate of 30 ml/min. RF applications in the RV were delivered at 30 Watts for 60 sec, using an irrigation flow rate of 17 ml/min. In the event of a steam pop (abrupt small increase of impedance, audible or not, confirmed by histology with small cavitation or crater formation) or impedance rise (>10 Ohms), the RF application was continued for the full 60 sec in order to allow the comparison of lesion size. Lidocaine (100mg) was administered intravenously just prior to ablation to prevent RF-induced ventricular fibrillation. Additional doses of lidocaine were administered as needed. 5 DOI: 10.1161/CIRCEP.113.001094 A custom RF generator (Radionics, model RFG-3DJ) was used to allow the recording of power, impedance and electrode temperature at 20 ms intervals. Intracardiac electrograms (bipolar and unipolar signals), CF, RF power, impedance, and electrode temperature were monitored continuously and recorded (LabSystem Duo, CR Bard, Inc). The dogs were sacrificed 30 minutes after the final RF application. The hearts were excised and stained with triphenyl terazolium chloride, which stains intracellular dehydrogenase a deep red color, distinguishing viable (red) and necrotic (pale) tissue. The hearts were fixed in 10% Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 formalin and sectioned to measure RF lesion size (maximum depth, maximum at aximum diameter, diameterr, ddepth e the maximum diameter and surface diameter). Measurement m nt of men o Electrogram Ele l ct c ro ogram Parameters Bipolar electrograms recorded between the ectrrograms were ec re reco corded ed d bet twe w en en th he tip eelectrode lect ctro ct rooddee and nd 2ndd eelectrode lecctrrodee and and filt filtered terred d at Uniipo pola laa electrograms lar electtrog ograms were werre recorded we reco ord rded ed d bbetween etween t en tthe h ttip he ip electrode e ecttrode an el andd a ne ed dle l ski ki 30-500 Hz.. Unipolar needle skin electrode, filtered f d at 11-500 -500 -5 00 H Hz. z. T The he ffollowing olllowiingg el electrogram lectroggram measur measurements rem e en nts were obtained obt btai aine n d at each ne ablation site ttee prior rii to t the th onsett off the the R RF F application: pli licati tion 1) bipolar bipoll ventricular entric triic llar potential ott tiall amplitude amplit litt li (peak to peak); 2) bipolar ventricular potential mean negative dV/dt (amplitude / duration, downstroke slope); 3) unipolar ventricular potential amplitude (peak to peak); 4) unipolar ventricular potential mean negative dV/dt (amplitude / duration, downstroke slope); and 5) unipolar injury current amplitude (Fig 2). Statistical Analysis Statistical analyses were performed using SAS software (version 9.2). The relationships between average CF, peak electrode temperature and decrease in impedance (the impedance at the onset of RF application minus the minimum impedance during the RF application) versus lesion depth and lesion diameter were assessed by a mixed effects model using Proc Genmod, providing beta 6 DOI: 10.1161/CIRCEP.113.001094 coefficients for x variables and their corresponding 95% confidence intervals (CIs). Chi square test and Fisher’s exact test was used to test the overall association between CF category and the incidence of steam pop and impedance rise. The relationships between average CF, electrogram amplitude, mean negative dV/dt (downstroke slope), injury current amplitude, impedance at the onset of RF application and impedance decrease were assessed by a mixed effects model using Proc Genmod. The relationship between the degree of impedance decrease and the occurrence of steam pop was assessed by Mann-Whitney U test. A probability value of <0.05 was considered to Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 be statistically significant. Results Relationship Contact Force Lesion Size Steam Pop hip between Co hi C nttac actt Fo Forc r e an and d Le Lesi s on S ize aand nd In IIncidence cciide d ncee off S teeam mP op p A total of 48 4 lesions leesi sion onss were on were r created cre reat ated at ed in ed n tthe hee 8 ddogs: ogss: 244 lesions og lesio ions n in ns in the th he RV (30 (30 Watts, Wat a ts ts,, 60 6 seconds) seccon onds ds) at low ds CF (n=8), mod moderate Watts, m derrat atee CF (n=8) (n= n=8) 8 aand 8) nd hi high g CF (n=8); gh (n= n=8) 8 ; an 8) aand d 24 llesions e io es i nss in i the the LV (40 (400 W a ts at ts,, 600 seconds) se at low CF (n (n=8). measurements in ((n=8), =8 8), mod moderate odder e atte CF ((n=8) n 8) n= 8 aand ndd hi high gh CF ((n gh n=8 8)).. Lesion Leesi L sion o mea easu sureemeents ntts were we e not ot uutilized tl ti the 4 transmural lesions observed in the RV (1 at moderate CF and 3 at high CF), since these values would be artificially low. Lesion size was independent of the 3 locations in the RV and the 3 locations in the LV. At constant RF power and application time, lesion depth and diameter increased significantly with increasing contact force (Figs 3 and 4). Lesions at lower power (30 Watts) and moderate CF were significantly deeper (6.7 ± 0.8mm vs. 5.9 ± 1.2 mm) and wider (9.6 ± 1.1 mm vs. 8.0 ± 1.9 mm) than lesions at higher power (40 Watts) at low CF (Fig 3C). Lesions at lower power (30 Watts) and high CF were similar in depth and diameter to lesions at higher power (40 Watts) at moderate CF (Fig 3C). Lesion depth and diameter correlated well with average CF for both RV and LV. (Fig 4). Peak electrode temperature during the RF application correlated poorly with 7 DOI: 10.1161/CIRCEP.113.001094 lesion depth and diameter (Fig 5). The decrease in impedance during the RF application relatively correlated well with lesion depth and diameter for lesions in the LV: 95% CI = (0.13, 0.28) and 95% CI = (0.20, 0.33), respectively, and in the RV: 95% CI = (0.03, 0.14) and 95% CI = (0.06, 0.19), respectively, Figs 6A and 6B. The incidence of a steam pop increased significantly with increasing CF at 40 Watts (p=0.03) and with higher power (40 Watts vs. 30 Watts, p=0.02, Fig 7). At 30 Watts in the RV, a steam pop occurred during 0/8 RF applications at low CF, 1/8 RF applications at moderate CF and Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 1/8 RF applications at high CF. At 40 Watts in the LV, a steam pop occurred during RF g 0/8 /8 R applications at low CF, 4/8 RF applications at moderate CF and 5/8 RF applications high F appl pllicattio plic i ns aatt hi hig gh CF. gh $QLPSHGDQFHULVH2KPVLQFUHDVH occurred LPS PSHG PS HGDQ HG DQQFH F ULVVH 2KPVLQFUHDVH from m the thhe minimum m value vallue u during RF) occurre e only in 3/8 RF applications CF Watts). at ap ppllications at hhigh hiigh hC F and an hi hhigh gh ppower ow werr (40 40 W Watts atts at ts)). An ts n impedance imppeda danc nce rise s did se id not noot occur oc lower CF or Watts. o at 330 0W atts. Relationship Parameters Contact Force Lesion h p between hip bettween Surrogate Surroga g te P arameters t and dC onta t ctt F orrce and nd dL esio i n Size S ze Si The peak-to-peak amplitude downstroke o peak ak k amplit plit lit de d and d ddo o nstroke stt ke slope lo off the th bi bipolar la and d unipolar nipolar ipoll ventricular entric triic llar potentials correlated poorly with CF (Fig 8A-8D). The amplitude of unipolar injury current correlated better with CF, but still had a wide overlap in values (Fig 8E). The ratio of injury current/unipolar ventricular potential amplitude correlated less well with CF than injury current amplitude, Y=0.34 + 0.01*X, 95% CI = (0.002, 0.02), p=0.022 and Y=4.19 + 0.14*X, 95% CI = (0.06, 0.22), p=0.006, respectively. Impedance at the onset of RF application (initial impedance) also correlated very poorly with CF (Fig 8F). The degree of decrease in impedance during the RF application correlated only slightly better with CF (Fig 8G). At higher RF power (40 Watts), the occurrence of a steam pop correlated with the degree of impedance decrease (Fig 8H), but there was no significant relationship between the time of steam pop and the degree of impedance 8 DOI: 10.1161/CIRCEP.113.001094 decrease (Fig 8I). Discussion To our knowledge, this is a first study to examine the relationship between RF lesion size and CF in the beating heart. We found a very wide range of lesion size (depth and diameter) for RF applications with varying CF, but same power and application time. Under these conditions (constant RF power and time), lesion size correlated well with CF (Figs 3 and 4). Increasing from low CF to high CF increased lesion depth by 70% at 30 Watts and by 90% at 40 Watts ((Fig g 3C). Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Lesions produced at 30 Watts and moderate CF were larger than lesions produced Watts and ns pro roodu duce cedd at 440 ce 0 Wa low CF, and moderate CF nd lesi lesions sion si onss at 300 Wa on W Watts tts and high CF were si similar imi m lar to lesions aatt 40 Watts and moder (Fig 3). These indicate comparable increasing esee data indi ica catte th tthat at iincreasing ncre nc r assin re ng CF F is i com mpara r bl ra blee to in ncrrea eassingg RF RF power. poower. r r. By measuring CF prior RF meaasu suri riing C F pr prio i r to the io hee oonset nsset ooff an nR F application, appl ap p ic icat atio at io on, an an appropriate ap ppr prop o ri op riat atee RF at R power pow wer an aand n time can be selected achieve (lesion depth) minimize steam Low ectedd to t ach chie ch ieve ie vee eefficacy ffic ff icac ic acyy (l ac lesio es on de es dept ptth) h aand nd m i im in imiz izee the iz the ri risk skk of of st stea eam ea m po pop. p Lo p. L w CF may be compensated mpensated mpe penssat ated ed d bby y dde delivering eli l ve veri ringg hig higher igher he RF power. he pow ower e . Th Thee in inci incidence ciide d ncce off ssteam team te a ppop op may ay bbee decreased while maintaining similar RF lesion size by using lower RF power and maintaining good CF. Peak electrode temperature during RF applications was not predictive of lesion depth or diameter (Fig 5). The decrease in impedance during the RF application (initial impedance minus minimum impedance) correlated relatively well with lesion size (especially in the LV at 40 Watts, Fig 6). The degree of impedance decrease correlated with the occurrence of a steam pop at higher RF power (40 Watts), but did not correlate with the time of occurrence of the steam pop (Figs 8H and 8I). One limitation of the impedance decrease is that this measure is not available before the onset of the RF application. This study also demonstrates that the surrogate parameters of CF have limited or no value. 9 DOI: 10.1161/CIRCEP.113.001094 Electrogram amplitude (unipolar and bipolar) and downstroke slope correlated very poorly with CF. Even the amplitude of the injury current is a weak predictor of CF, although the presence of an injury current indicates some contact. Impedance is also not predictive of the magnitude of CF. These findings indicate the surrogate measures are very poor predictors of CF and confirm the importance of directly measuring CF. Study Limitation A principal limitation of the study was that all RF applications were delivered for a relatively long Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 interval (60 sec). The impact of CF on lesion size may be even greaterr during g shorter RF application times. The role of CF may also be greater or lesser at higher her orr lower l we lo werr RF power pow owee than the 30 Watts Watts Further t and tts andd 440 0 Wa W ttts used in this study. Furthe her studies are re he rrequired quuir i ed to compare the importancee off CF to diff different application fer erentt RF RF power powerr and nd app plicaati tion ttime. im mee.. Clinical Implications m ica mpli atio tiions Incorporating real-time measurement RF ablation catheter o poratiing real orp all-ti tiime CF measureme ntt in an iirrigated rrig igatted ig dR F ab blaattiion cathe h te t r sh sshould ouldd help optimize the maximize hhee selection ell ti off RF power po er and nd d application li ti ttime im tto o ma iimi mii e RF lesion l io fformation o ati tio aand reduce the risk of steam pop in clinical application. Funding Sources: This study was supported in part by a grant from Endosense SA. Conflict of Interest Disclosures: H Nakagawa, DC Shah and WM Jackman are consultants for Endosense SA. H Lambert, E Fonck and A Yulzari are employees of Endosense SA. The other authors report no conflicts. References: 1. Avitall B, Mughal K, Hare J, Helms R, Krum D. The effects of electrode-tissue contact on radiofrequency lesion generation. PACE. 1997;20:2899-2910. 2. Haines DE. Determinants of lesion size during radiofrequency catheter ablation: the role of 10 DOI: 10.1161/CIRCEP.113.001094 electrode-tissue contact force and duration of energy delivery. J Cardiovasc Electrophysiol. 1991;2:509-515. 3. Strickberger SA, Vorperian VR, Man KC, Williamson BD, Kalbfleisch SJ, Hasse C, Morady F, Langberg JJ.. Relation between impedance and endocardial contact during radiofrequency catheter ablation. Am Heart J. 1994;128:226-229. 4. Zheng X, Walcott GP, Hall JA, Rollins DL, Smith WM, Kay GN, Ideker RE. Electrode impedance: an indicator of electrode-tissue contact and lesion dimensions during linear ablation. J Interv Card Electrophysiol. 2000;4:645-654. 5. Eick OJ, Wittkampf FH, Bronneberg T, Schumacher B. The LEFTR-Principle: a novel method to assess electrode-tissue contact in radiofrequency ablation. J Cardiovasc Electrophysiol. 1998;9:1180-1185. Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 6. Wittkampf FHM, Nakagawa H. RF catheter ablation: lessons and lesions. PACE. esi sion ons. on s. PA PACE CE.. CE 2006;29:1285-1297. 7. Biase LD, Arruda M, D, Natale Nat a al a e A, A Barrerr Barrerr C, Tan C, Elayi CS, Ching Ching CK, Wang Wangg P, P, Al-Ahmad A, Arru Burkhard JD Schweikert JD, D, Wisnoskey Wisnosk skey sk ey BJ, BJ,, Chowdhury Choowdhu wddhu hury ry y P, P, Marco Marc Ma r o S, Armaganijan Arm rm rmag mag agan nij ijan a L, an L, Litwak Litw wak K, K, Schweike Sc Schw chw hwei eike RA, Cummings JE. JE. Relationship Relationsship between betwee be een contact ee co ontac actt forces, foorcces,, lesion lesiionn characteristics, charaacterissticss, “popping,” “pop op pping ng, ng,” ,” and and char formation: Experience with robotic system. Cardiovasc Electrophysiol. Exp xperiencce w itth rob obotic icc nnavigation avig ig igat g tio on sy system em. J C arrddiova va asc E lect ctro ct rophys ro y io ys ol. 2009;20:436-440. 3 4440. 36-44 8. Yokoyama H,, Sh Shah DC, Lambert H,, L Leo G,, A Aeby N,, IIkeda A,, Pi Pitha Sharma T, ma K, K, Nakagawa Nakaga gaw wa H ah hD C, L ambe b rt H eo G eb by N keeda d A Pith ha JV JV, Sha Lazzara R, Jackman WM. Novel sensor radiofrequency nW M. N M. o ell contact ov con o ta tact ct force for o ce c se sens nssor inco iincorporated in nco corp rpor rp orat or a ed at d iin n iirrigated r ig rr igat atted ra radi d ofrequenn ablation catheter size pop. Circ Electrophysiol. ath ttheter hette predicts dictt llesion esii si i e andd incidence incid ide off steam te pop Ci Arrhythm A h thh El t h 2008;1:354-362. 9. Shah DC, Lambert H, Nakagawa H, Langenkamp A, Aeby N, Leo G. Area under the real-time contact force curve (force-time integral) predicts radiofrequency lesion size in an in vitro contractile model. J Cardiovasc Electrophysiol. 2010;21:1038-1043. 10. Thiagalingam A, d’Avila A, Foley L, Guerrero JL, Lambert H, Leo G, Ruskin JN, Reddy VY. Importance of catheter contact force during irrigated radiofrequency ablation: evaluation in a porcine ex vivo model using a force-sensing catheter. J Cardiovasc Electrophysiol. 2010;21:806-811. 11. Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012;9:18-23. 12. Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaia P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012;9:1789-1795. 11 DOI: 10.1161/CIRCEP.113.001094 13. Perna P, Heist EK, Danik SB, Barrett CD, Ruskin JN, Mansour M. Assessment of catheter tip contact force resulting in cardiac perforation in swine atria using force sensing technology. Circ Arrhythmia Electrophysiol. 2011;4:218-224. 14. Martinek M, Lemes C, Sigmund E, Derndorfer M, Aichinger J, Winter S, Nesser HJ, Pürerfellner H. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. PACE. 2012;35:1312-1318. Figure Legends: Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Figure 1: Schematic representation of the distal end of the 7F contact forcee (CF) sensing (CF) se sens nsin ns ingg ablation in ab catheter. Th The sensor three optical fibers circumferentially Fiber T he CF sens sor iincludes nncclude lu ude dess th hreee op opti tica ti c l fi fibe b rss attached attac acche ache hedd circ ci irc rcum umfe um ferenttia fe iall llyy with ll wit ithh Fi ibe b r Bragg Gratings (FBG) body. the deformable FBG) to a de FB ddeformable foorm mab ble bod ody. od y CF y. C oon n th he de efo form mable body bod oddy changes ch hange g s thee FBG ge F G refractive FB reefrracc index pattern change in rn wh which hicch ch chan changes ange an g s th ge thee re refl reflected flec fl ecte ec t d wa wave wavelength vele ve lenggth ooff li ligh light ghtt in tthe gh he 3 ooptical ptic pt iccal ffibers. ical iber ib ers. er s. Th Thee cha reflected wavelength w h is is pproportional ropo ro port po rtio rt iona io ona nall to CF CF (magnitude (mag (m agni ag nitu ni tude tu de and andd angle), ang ngle le)), measured le meas me asur as u ed aatt iintervals ur nter nt e vals of 1100ms. Figure 2: Examples of measurements of electrogram parameters on a bipolar ventricular potential (top) and unipolar ventricular potential (bottom). Electrogram amplitude was measured from peak-to-peak. The mean negative dV/dt was measured as the amplitude of the downstroke divided by its duration. The amplitude of injury current was measured on the unfiltered unipolar electrogram from the baseline to the peak of ST elevation. Figure 3: Radiofrequency (RF) ablation lesion size as function of low CF, moderate CF and high CF. A. Examples of RF lesions (30 Watts, 60 sec) in the right ventricle (RV). Increasing from low to high CF, increased the lesion depth from 4.8 mm to 8.7 mm and increased lesion diameter 12 DOI: 10.1161/CIRCEP.113.001094 from 5.9 mm to 9.4 mm. B. Examples of RF lesions (40 Watts, 60 sec) in the left ventricle (LV). Increasing from low to high CF, doubled the lesion depth from 5.0 mm to 10.5 mm and almost tripled lesion diameter from 5.7 mm to 15.0 mm. The crater in the high CF lesion resulted from a steam pop. C. Lesion measurements (mean ± SD) at low, moderate and high CF for the RV (top) and LV (bottom). Measurements include maximum depth, maximum diameter, depth at maximum diameter and surface lesion diameter. Increasing from low to high CF, increased lesion depth in the RV from 5.0 ± 0.7 mm to 8.5 ± 1.3 mm and increased lesion depth in the LV from 5.9 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 ± 1.2 mm to 11.2 ± 0.9 mm. Lesion measurements were not utilized inn the 4 transmural lesions transmuraal le les observed in the RV (1 at moderate CF and 3 at high CF) Figure 4: R Relationship lesion size. Graphs lesion depth function of elationship between betweeen CF CF and d RF F lesio io on si ize. A. A G Gr rap phs off le esion on dep pth h as as a fu fun nc CF in the RV (right panel), highly B. R (left (le left ft panel) ft panell) and d LV LV (ri igh ghtt pane neel) l), showing shhowiing a hi high ghlly ssignificant gh igniifiicant ig ntt rrelationship. elatio el i nshi hip. B hi Graphs of lesion diameter diamete teer as a ffunction unctio i n off C CF F iinn the h R RV V (left (llefft pa ppanel) neel) l and ndd LV LV (r ((right ight ig ht ppanel), anel an e ), ) aalso showing a si relationship. interval. significant i if ifiic t relationship lati ti shi hip CI CI:confidence nfid fid iinter ntt all Figure 5: Non-significant relationship between peak electrode temperature during the RF application and RF lesion depth (A) and diameter (B). Figure 6: Relationship between the decrease in impedance during the RF application and RF lesion depth (A) and diameter (B). Figure 7: Incidence of steam pop for RF applications at low, moderate and high CF in the RV (30 Watts for 60 sec, left panel) and LV (40 Watts for 60 sec, right panel). 13 DOI: 10.1161/CIRCEP.113.001094 Figure 8: Weak relationships between surrogate parameters and CF. Graphs of bipolar electrogram amplitude vs. CF (A), mean negative dV/dt of the bipolar electrogram vs. CF (B), unipolar electrogram amplitude vs. CF (C), mean negative dV/dt of the unipolar electrogram vs. CF (D), amplitude of the unipolar injury current vs. CF (E), initial impedance (impedance at the onset RF application) vs. CF (F) and impedance decrease vs. CF (G). The deference of the degree of impedance decease between RF applications with and without steam pop (H), and the Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 relationship between the degree of impedance decrease and the time off occurrence of th the he ssteam t pop (I). 14 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Relationship between Catheter Contact Force and Radiofrequency Lesion Size and Incidence of Steam Pop in the Beating Canine Heart: Electrode Amplitude, Impedance and Electrode Temperature are Poor Predictors of Electrode-Tissue Contact Force and Lesion Size Atsushi Ikeda, Hiroshi Nakagawa, Hendrik Lambert, Dipen C. Shah, Edouard Fonck, Aude Yulzari, Tushar Sharma, Jan V. Pitha, Ralph Lazzara and Warren M. Jackman Downloaded from http://circep.ahajournals.org/ by guest on June 15, 2017 Circ Arrhythm Electrophysiol. published online November 7, 2014; Circulation: Arrhythmia and Electrophysiology is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2014 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-3149. Online ISSN: 1941-3084 The online version of this article, along with updated information and services, is located on the World Wide Web at: http://circep.ahajournals.org/content/early/2014/11/07/CIRCEP.113.001094 Permissions: Requests for permissions to reproduce figures, tables, or portions of articles originally published in Circulation: Arrhythmia and Electrophysiology can be obtained via RightsLink, a service of the Copyright Clearance Center, not the Editorial Office. 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