Electrical Reconnection Following PVI is Contingent on Contact Force during Initial Treatment Results From the EFFICAS I Study
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1 Electrical Reconnection Following PVI is Contingent on Contact Force during Initial Treatment Results From the EFFICAS I Study Running title: Neuzil et al.; EFFICAS I contact force predicts gaps in PVI Petr Neuzil, MD, PhD 1 ; Vivek Y. Reddy, MD 2 ; Josef Kautzner, MD, PhD 3 ; Jan Petru, MD 1 ; Downloaded from by guest on June 15, 2018 Dan Wichterle, MD, PhD 3 ; Dipen Shah, MD 4 ; Hendrik Lambert, PhD 5 ; Aude Yulzari, MSc 5 ; Erik Wissner, MD 6 ; Karl-Heinz Kuck, MD, PhD, FHRS 6 1 Dept of Cardiology, Na Homolce Hospital, Prague, Czech Republic; 2 Cardiac Arrhythmia rhyt Service, Mount Sinai School of Medicine, e, New York, NY; 3 Dept of Cardiology, og Institute t for Clinical & Experimental Medicine ine (IKEM), Prague, Czech Republic; 4 Hopital Universitaire Geneve, Geneve, Switzerland; 5 Endosense nse SA, Geneva, Switzerland; 6 Abt Kardiologie, Asklepios Klinik ik St. Georg, Hamburg, Germany Corresponding author: Petr Neuzil, MD, PhD Department of Cardiology Na Homolce Hospital Roentgenova Prague 5 Czech Republic Tel: +420 (25) Fax: +420 (25) Petr.Neuzil@homolka.cz Journal Subject Code: [22] Ablation /ICD /surgery 1
2 Abstract: Background - Pulmonary vein (PV) isolation is the most prevalent approach for catheter ablation of paroxysmal atrial fibrillation (PAF). Long-term success of the procedure is diminished by arrhythmia recurrences occurring predominantly due to reconnections in previously isolated PVs. The aim of the EFFICAS I multicenter study was to demonstrate the correlation between contact force (CF) parameters during initial procedure and the incidence of isolation gaps ( gap ) at 3 month follow-up (FU). Method and Results - A radiofrequency ablation catheter with integrated contact force sensor (TactiCath, Endosense, Geneva, Switzerland) was used to perform PV isolation in 46 patients with PAF. During the ablation procedure, the operator was blinded to CF information. on. At FU, an interventional diagnostic procedure was performed to assess gap location as correlated rela to index procedure ablation parameters. At FU, 65% (26/40) of patients showed one or more gaps. Ablations with Minimum Force-Time integral (FTI) < 400 g.s showed increased ed likelihood ihoo for reconnection (p<0.001).. Reconnection ctio n correlated strongly with Minimum CF (p<0.0001) and Minimum FTI (p=0.0007) 00 07) at the site of gap. Gap occurrence showed a strong trend with lower average CF and average FTI. CF and FTI are generally ly higher h on the right side, although the left anterior segment presents a unique ue challenge to achieve stable l position io with good CF. Conclusions - Minimum CF and Minimum FTI values are strong predictors of gap formation. Optimal contact force parameter recommendations are a target CF of 20 g and a minimum FTI of 400 g.s for each new lesion. Key words: catheter ablation, atrial fibrillation, contact force, gaps 2
3 Introduction Despite significant improvements in catheter ablation strategies to treat atrial fibrillation in recent years, refractory recurrence of arrhythmia remains a continuing concern. Recurrence rates of AF after a radiofrequency (RF) ablation are still relatively high (from 20% to 55%) 1-5. For patients treated with circumferential isolation of the pulmonary veins, it is well understood that failure to create durable lesions may result in gaps in the isolation line allowing PV potentials to reconnect with the left atrium. The specific relationship between gap formation and subsequent recurrence of clinical arrhythmia is less clear 6, although the likelihood of recurrence increases in the presence of gaps. Isolation gaps in the ipsilateral line may result either from areas omitted from initial treatment, or from lesions that are not sufficiently transmural ral to prevent conduction. c n. Modern visualization techniques including 3D imagery, intra-cardiac echo and fluoroscopy have been employed to ensure that t the catheter tip is well positioned i to create contiguous ous lesions, s thus minimizing the risk of untreated ted areas. New technologies using real-time monitoring in of tip-totissue contact force are also useful to confirm that appropriate pressure is applied by the ablating electrode to effectively facilitate RF energy transfer and the ensuing thermal injury. Contact force (CF) has been identified as a potential determinant of lesion quality during RF ablation Prior studies have characterized the optimal CF parameters needed to achieve transmurality while other trials have shown a clear correlation with long-term freedom from recurrence 12. To date, no clinical study has prospectively examined the recurrent conductivity of specific lesion sites as a function of initial treatment parameters. An irrigated RF ablation catheter able to measure real time contact force between the catheter tip and the beating heart wall (TactiCath, Endosense, Geneva, Switzerland) was used 3
4 during the Toccata clinical trial, to show that the number of ablations made with low CF was a predictor of clinical outcome at 12 months. These low CF applications may be related to incomplete, impermanent or superficial lesions resulting in isolation gaps. The left atrial substrate is not uniform with differences in wall thickness, positional stability and access contributing to lesion effectiveness. This variation may result in more or shorter ablations in specific segments, particularly when catheter position is difficult to maintain. The CF parameter may be a useful tool to describe these challenges relative to the anatomy. The EFFICAS I study was undertaken to investigate the exact relationship between en CF parameters measured during ablation and the incidence of isolation gaps in the PV line measured invasively during a 3-month follow-up electrophysiologic ologic study. It was hypothesized that lesions produced with inadequate CF would result in a measurable increase in the rate of reconnection t thus giving g rise to more arrhythmia recurrence. ce In addition, ion, a comparison of CF parameters during lesion delivery across segments ents might expose risks of reconnection ctio n as a function of anatomy. Finally, it was expected ed that t a detailed examination atio of CF parameters used in an actual clinical setting would yield information regarding minimal CF criterion for success. Methods Study protocol EFFICAS I was a multicenter study conducted at 3 European centers. The protocol was approved by the institutional review board (Ethics Committee) at each center and consisted of two procedures: an index ablation procedure for PVI at which the operator was blinded to CF data and a follow-up procedure at 3 months to invasively assess isolation gap occurrence in the PVI lines. The study endpoint was to correlate the occurrence of either an isolation gap ( gap ) or successful isolation at 3 months with the CF parameters applied at each location on the PVI line 4
5 during initial ablation. Study participation ended with a follow-up exam at 3 months, an interval traditionally construed to coincide with the end of blanking. An isolation gap was defined by the detection of a PV potential using a circular mapping catheter and pacing, if needed, to conclusively differentiate these potentials from far-field signals. Complications related to the procedures were recorded to comply with local regulatory requirements for safety and vigilance. Patient population Forty-six consecutive patients with predominantly paroxysmal AF following lowing ACC/AHA/ESC A/E guidelines 4 who signed informed consent prior to the procedure were enrolled. le Patient characteristics tics are given in Table 1 and cardiovascular r history are available aila on the online supplement for the enrolled led patient population and for the subgroup of 40 patients t who participated in the 3-month follow-up procedure. e. Patient t characteristics ti cs are similar in both the enrolled population and subgroup. Contact-Force Sensing Catheter t and Display The TactiCath catheter with CF capabilities was used for index procedures in the study. It includes a deflectable 3.5 mm electrode, 6 hole irrigation (between cc/min) and was used with an approved pump and RF generator. This technology uses the diffraction of light to gauge real-time tip deflection with a sensitivity of 1 gram of force in any direction. Three individual sensors (Fiber Bragg Grating type) aligned circumferentially around the tip electrode allow for the calculation of CF as a vector, thus providing information on the total force (vector sum) as well as the direction (orientation) of applied force. CF data is sampled every 100 ms and is simultaneously recorded in a digital log file for later retrieval and analysis. Sensor operation is unaffected by ablation energy. A comprehensive 5
6 real-time display of CF in numerical and graphical formats is normally available to the user. In this study, the operator was blinded to the screen with CF information to prevent bias and adaptation. In effect, the operator manipulated the catheter as he would any similar device without the benefit of CF information. To characterize the effect of CF applied over time, the system automatically detects the beginning and end of RF current delivery and calculates the Force-Time Integral (FTI) defined as the total CF integrated over the time of RF delivery 11. Index ablation procedure PVI was achieved with a wide antrum ablation line around the PVs guided by a 3D mapping pin system (EnSite, SJM, St Paul, MN, USA). The specifics of line creation was left to the operators standard practice, as were settings for RF power and choice of long or steerable sheath. The site of RF application was recorded relative to 8 predefined efined circumferential cumf positions around each ipsilateral pair of PVs 14 : numbered 1-8 around the left PV (LPV) and 9-16 around the right PV (RPV) (Figure 1a). The 8 positions were later consolidated into 4 larger segments to facilitate comparison with 3-month data, to maintain an acceptable level of localization accuracy and to provide a more anatomical representation (Figure 1b). Specifically, multiple anterior positions were grouped together and referred to as the anterior segment for LPV and RPV, as were posterior positions. The following parameters were recorded for each ablation: position, segment, RF power, CF, FTI, duration of ablation and sheath type. The PVI was achieved with either point (focal) or dragging lesions depending on each operator s technique. Each lesion was limited to a maximum of 60 seconds in a single position to allow for clear identification of the energy delivered to each of the positions. 6
7 At the end of LPV and RPV isolation, a circumferential diagnostic catheter was used to confirm PVI by entrance block. For the sake of consistency, the waiting period and attempts to provoke dormant conduction were minimized. Follow-up procedure at 3 months The invasive follow-up procedure was performed following similar preparatory steps as during the index procedure 15. A diagnostic catheter was used to evaluate the status of isolation or reconnection per vein. In order to define successful treatment of a patient, all 8 segments needed to be gap-free. Gap sites were determined for each segment and vein. The location of each gap was defined as site of PV potential on the diagnostic catheter, and in the case of retreatment, eatmen confirmed by a change in PV activation. Correlation of CF parameters to outcome Results related to the index procedure re are presented ed for the 8 positions io around each pair of PVs. Results related to the follow-up procedure are presented for the 4 segments. e Ablation parameters, CF and FTI from all index procedure re ablations were correlated to the isolation status s of each segment at follow-up (gap or successful isolation). CF parameters and incidence of gaps were tabulated for each segment. Aggregate isolation success across all patients was used to deduce criterion for optimal CF parameters. Statistical Analysis CF, FTI, number of ablations and power are reported as median and mean ± standard deviation. Mann-Whitney's non parametric test was performed. The results reached a level of significance when p < To compare success ratios, odds ratios and Fisher s test were calculated to account for size effects between ablation parameters and the outcome. All statistical calculations were done using Excel 2007 or Prism 5 (2008). 7
8 Results Index ablation procedure Ten operators treated 46 patients at index procedure at 3 sites. All 92 pairs of PVs (100%) were successfully isolated. Reflecting the variety of approaches used, delivered RF power ranged from Watts, total number of ablations was from and total RF time ranged from seconds per patient. CF and FTI distribution for all ablations at index procedure (n=3152) are displayed in Figure 2a and 2b. Mean CF was 19.4 ± 16.2 g and median 14.9 g. The average FTI per ablation was 730 ± 773 g.s and median FTI was 479 g.s. A deflectable sheath was used for 22 patients (Agilis, SJM, St Paul, MN, USA) and a non-deflectable e sheath (SL1, SJM, St Paul, MN, USA) for 26 patients. The CF was similar in both groups (medians of 14.9 g versus 14.9 g, p=0.82), with average CF of 19.5 ± 16.8 g versus 19.3 ± 15.8 g. The average waiting period after PV isolation to assess acute reconnection was 2 ± 2 minutes. CF was generally higher h at all positions in the RPV than in the LPV (Figure 2c) with the exception of the posterior superior position. Lowest CFs were observed in the LPV, from 15.2 ± 14.4 g at the anterior superior (ridge) and down to 10.7 ± 8.8 g in the anterior inferior. The anterior inferior in the RPV was remarkable for having the highest average CF of all positions at 29.5 ± 21.8 g. FTI values were also generally higher on the right side with clearly lower FTIs in the left anterior positions (Figure 2d). The power on the posterior wall was significantly lower than in other locations (average 24.1 ± 4.8 W versus 26.8 ± 6.3 W, median 25.0 W versus 25.0 W p<0.0001). Follow-up procedure Six patients withdrew from the study leaving 40 who underwent the 3-month follow-up 8
9 procedure (87%). Of these, 26 patients (65%) had one or more gaps. Six of the patients had gaps only in the LPV and 7 patients had gaps only in the RPV. Thirteen patients had gaps in both LPV and RPV. Specifically, of 80 ipsilateral PV pairs, 39 (49%) were reconnected at 3 months. Of the 318 segments originally treated, there were 52 segments with gaps (16%) whereas isolation was confirmed in 266 segments (84%). The power for gap and no gap segments was not different (26.1 vs 25.0 W, p= 0.26). Twenty patients with follow-up procedures (50%) were treated with a deflectable sheath. Sheath type had no impact on gap ratio at 3 months. Gaps occurred in all 4 segments around each pair of veins. A majority of gaps appeared pea on the physically ly larger posterior and anterior segments, especially the right posterior (12 gaps, 23%) and left anterior (13 gaps, 25%). Discriminative CF parameters rs For the 40 patients who completed follow-up, table 2 summarizes the ablation atio parameters for the segments that remained ed isolated at 3 months compared to those that t had gaps. Average AerageCF and FTI were higher in segments without gaps but not strongly significant. There was significant differences in the number of ablations in segments without and with gaps. The greatest significance was noted when comparing Minimum CF in segments with no gap versus gap (8.1 g versus 3.6 g, p < ) (Figure 3a) and Minimum FTI (232 g.s versus 118 g.s, p=0.0007) (Figure 3b). In terms of success ratio, segments with a Minimum FTI > 400 g.s had a 95% chance of remaining isolated, compared to those with a Minimum FTI < 400 g.s that had a 79% chance of remaining isolated (p < 0.001) (Figure 4a). The likelihood of successful treatment for the full patient results from the aggregate isolation rates of each segment. For successful treatment of a patient, all 8 segments need to be 9
10 gap-free. If the number of segments with Minimum FTI < 400 g.s in the same patient increases, then the probability of successful treatment of the patient (extrapolated from isolation of all PVI rates) results from the multiplication of probabilities for each segment and decreases rapidly. If all 8 segments had a Minimum FTI < 400 g.s, the likelihood of successful treatment of the patient would drop to around 15%. Serious Adverse Events There were no serious adverse events within 30 days after index procedure. One patient (2.5%) developed a pericardial effusion after the follow-up procedure with Thermocool Celsius catheter (Biosense Webster, Diamond Bar, CA, USA). Discussion Acute isolation of PVs in AF patients is usually ly achievable e (100% in this study), but t recurrence r rr resulting from PV reconnection ecti is common. mon. 4,5 Most clinicians ic ia ns would agree that freedom from early recurrence rence is a good od measure of treatment tm en t success. This study did not measure long-term clinical recurrence, yet it is likely that the number of veins that remain isolated at the end of a 3- month blanking period is a predictor of long-term success. The opportunity to assess PV reconnection normally occurs only at the time of retreatment thus giving an incomplete picture of the actual reconnections that occur in the full patient population after PVI. In this study, the 3-month follow-up study revealed that as many as 65% of patients had PV reconnections. The invasive diagnostic technique used in this protocol definitively identified the location of gaps as compared with other clinical measures, therefore gaps were found more frequently than usually reported clinical recurrence rates 4,5. Contact Force Parameters In the TOCCATA study, an average CF > 20 g was associated with higher long-term treatment 10
11 success although this was obtained by only half of operators 12. In EFFICAS I, the average CF for all index procedures was nearly 20g, perhaps suggesting a high level of experience at participating sites despite being blinded to CF. Also in TOCCATA, ablations with CF < 10 g were associated with unstable catheter contact and reduced patient outcome at 12 months. Similarly, EFFICAS I showed a tendency for better isolation results at segments with higher average CF and FTI. However, the strongest indicators for isolation versus gap occurrence at 3 months are Minimum CF and Minimum FTI per segment. In segments with a Minimum FTI below 400 g.s, the probability for isolation reaches only 79%, but increases to 95% when the Minimum FTI is greater than 400 g.s. One may observe e that ablations atio in any given segment are only as effective as the worst ablation ation performed in that segment, quantified i by the Minimum FTI. Consecutive segments with low Minimum imum FTI may considerably decrease the likelihood for successful outcome (Figure 4). There may be several reasons why the worst ablation, defined d as ablation atio with minimum i FTI at a given site, is a strong predictor for electrical l reconnection of a PV. One is that t the tissue surface is altered because of initial RF current, making subsequent ablations more difficult to penetrate deep in the tissue 16. A more plausible explanation is that creation of a non-transmural lesion results in edema. It has been reported that heart wall thickness can double after 1 minute of ablation due to tissue edema formation 16. Hence, a non-transmural first lesion may increase wall thickness, reducing the effect of tissue heating and making it difficult to achieve full transmurality with subsequent ablations. Therefore, the goal of any RF ablation should be to achieve transmurality with the first attempt. Another important lesson from the study is that the average number of ablations per segment is inversely correlated to isolation. This suggests that successful and transmural first 11
12 lesions don t require subsequent corrections, but once a bad ablation is made (FTI < 400 g.s), it becomes very difficult to correct for it afterwards and the risk of gap increases. This might further support the idea of edema formation as a complication for subsequent ablations at the same site. Anatomical Variation Gaps were found in all segments but as expected, they were most prevalent in the ridge between the LPV and the appendage and in the RPV posterior and superior segments. The relatively low FTI value on all left anterior positions indicates that operators had difficulty ficulty sustaining both CF and duration. The difficulty associated with catheter stability at this segment is well understood and may be responsible for the increased number of ablations (14.9 ± 6.6) compared to other segments 17. Given these limitations, tions, it is advisable that t the operator or evaluates ates the quality and stability of the catheter contact before each application plicatioi of RF energy. A practical al observation among a variety of operators confirms that t starting t an ablation atio before ensuring catheter t stability is commonplace, resulting in high numbers of short and abrupt ablations. This is consistent with the EFFICAS I data, showing a high rate of low FTI (FTI < 400 g.s in over 40% of lesions, Figure 2b) many of which arose in the left anterior segment. To ensure transmurality, each ablation should be delivered with adequate CF and FTI levels. A persistently successful PVI is critically dependent upon the weakest ablation of each segment. The probability of successful treatment for each patient is the product of all probabilities for each segment and becomes very low in case of multiple bad ablations. In summary, EFFICAS I has shown that ablations performed with low Minimum CF and Minimum FTI predict delayed gap formation and that segments with gaps received more 12
13 ablations then those with no gap. Based on these findings, and combined with the TOCCATA study results, we make the current recommendations: 1) position the catheter carefully prior to ablation, preferably with a CF of 20 g but not less than 10 g; 2) ensure positional stability by monitoring CF before applying RF; 3) sustain RF delivery until a minimum FTI of 400 g.s is achieved before moving the catheter to a new location. These findings will be tested prospectively in a subsequent study. The EFFICAS II trial will unblind operators to CF at the initial procedure in an otherwise identical protocol. Study Limitations 1. Treatment methodology specified by the protocol (fixed 60s duration per ablation, pointby-point or limiting dragging allowed) describes s one of several eral ablation strategies in current ren clinical practice. 2. The goal of the study had an electrophysiology lo endpoint at 3 months. Translation into clinical results on longer term recurrence may be inferred. Conclusion Invasive electrophysiologic assessment of conduction gaps at PVI ablation sites at 3 month follow-up has shown that the Minimum CF and Minimum FTI values obtained at the index procedure ablations correlate strongly with subsequent gap formation. The 3-month ablation outcome at any segment is only as effective as the Minimum FTI of any ablation delivered in that segment, particularly when the ablation is less than 400 g.s. CF stability is required prior to ablation to minimize the risk of unstable contact and ineffective lesions, particularly in the left anterior segment. In order to achieve durable successful PVI, a target CF of 20 g is recommended, with an absolute minimum CF of 10 g and an absolute Minimum FTI of 400 g.s per individual ablation lesion. 13
14 Acknowledgments: Data was analyzed by Olivier Fremont from the engineering department of the Ecole Polytechnique Fédérale, Lausanne (EPFL), Switzerland. Funding Sources: This study was supported by a research grant from Endosense SA. Conflict of Interest Disclosures: Authors hereafter mentioned are consultant for following companies: Kautzner for Medtronic, Biosense Webster, Boston Scientific, Medtronic, Hansen Medical, Siemens and St Jude Medical; Kuck for Stereotaxis and Biotronik; Neuzil for Ev3, Endosense and CryoCath Technologies; Reddy for Ev3, Voyage Medical and is also advisor for CardioFocus and Endosense. Kuck and Shah are advisors and stakeholders of Endosense. Wissner received speaker honoraria from Biosense Webster, Biotronik, CardioFocus and Medtronic. Lambert and Yulzari are Endosense employees. References: 1. Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy dy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators, Comparison on of Antiarrhythmic rhythmic Drug Therapy and Radiofrequency ency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation: illati A Randomized Controlled Trial, JAMA ;303: Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven en K, Köktürk B, Konstantinidou nidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter er ablation a in paroxysmal atrial al fibrillation: ion: lessons sons from a 5-year follow-up. low Circulation. ion. 2010;122: : Hussein AA, Saliba WI, Martin DO, Bhargava M, Sherman M, Magnelli-Reyes C, Chamsi- Pasha M, John S, Williams-Adrews M, Baranowski B, Dresing T, Callahan T, Kanj M, Tchou P, Lindsay BD, Natale A, Wazni O. Natural history and long term outcomes of ablated atrial fibrillation. Circ Arrhythm Electrophysiol. 2011;4: Natale A, Raviele A, Arentz T, Calkins H, Chen SA, Haïssaguerre M, Hindricks G, Ho Y, Kuck KH, Marchlinski F, Napolitano C, Packer D, Pappone C, Prystowsky EN, Schilling R, Shah D, Themistoclakis S, Verma A. Venice Chart International Consensus Document on Atrial Fibrillation Ablation, J Cardiovasc Electrophysiol, 2007;18: Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2012;14:
15 6. Pratola C, Baldo E, Notarstefano P, Toselli T, Ferrari R.Radiofrequency ablation of atrial fibrillation: is the persistence of all intraprocedural targets necessary for long-term maintenance of sinus rhythm? Circulation. 2008;117: Yokoyama K, Nakagawa H, Shah DC, Lambert H, Leo G, Aeby N, Ikeda A, Pitha JV, Sharma T, Lazzara R, Jackman WM.Novel contact force sensor incorporated in irrigated radiofrequency ablation catheter predicts lesion size and incidence of steam pop and thrombus. Circ Arrhythmia Electrophysiol. 2008;1: Santangeli P, Di Biase L, Burkhardt DJ, Horton R, Sanchez J, Bai R, Pump A, Perez M, Wang PJ, Natale A, Al-Ahmad A. Catheter ablation of atrial fibrillation: state-of-the-art techniques and future perspectives. J Cardiovasc Med (Hagerstown). 2012;13: 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: Okumura ura Y, Johnson SB, Bunch TJ, Henz BD, O'Brien CJ, Packer DL. A systematical analysis of in vivo contact forces on virtual catheter er tip/tissue issu sue surface contact during cardiac a mapping and intervention.j Cardiovasc Electrophysiol. 2008;19: ;19: Shah DC, Lambert H, Nakagawa H, Langenkamp A, Aeby N, Leo G. Area under the realtime contact ct force curve (force-time integral) predicts radiofrequency requ ency lesion size in an in vitro contractile model.j J Cardiovasc Electrophysiol. l. 2010;21: ;21 21: Reddy VY, Shah h D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaïs P, Hindricks i 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: Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jaïs P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012;9: Wang XH, Shi HF, Sun YM, Gu JN, Zhou L, Liu X. Circumferential pulmonary vein isolation: the role of key target sites. Europace. 2008;10: Ahmed H, Neuzil P, Skoda J, D'Avila A, Donaldson DM, Laragy MC, Reddy VY. The permanency of pulmonary vein isolation using a balloon cryoablation catheter. J Cardiovasc Electrophysiolo. 2010;21: Ren J-F, Callans DJ, Schwartzman D, Michele JJ, Marchlinski FE. Changes in local wall thickness correlate with pathologic lesion size following radiofrequency catheter ablation: an intracardiac echocardiographic inmaging study, Echocardiography. 2001;18:
16 17. Kistler PM, Ho SY, Rajappan K, Morper M, Harris S, Abrams D, Sporton SC, Schilling RJ. Electrophysiologic and anatomic characterization of sites resistant to electrical isolation during circumferential pulmonary vein ablation for atrial fibrillation: a prospective study. J Cardiovasc Electrophysiol. 2007;18: Table 1. Patient characteristics for the forty-six patients that were enrolled. 46 patients index Range / Percentage 40 patients follow-up Range / Percentage Age (yo) 60 +/ / Gender (males) % % Paroxysmal al Atrial Fibrillation Persistent Atrial Fibrillation out-of-protocol tocol % % 1 2.2% 2% 1 2.5% Table 2. Ablation parameters for the segments that remained isolated at 3 months compared to those that had gaps for the 40 patients that completed follow-up. Parameter CF (g) Medians for Isolated Segments 19.5 Medians for Gap Segments p value 15.5 p = FTI (g.s) p = Total number of ablations 6 9 p < Minimum CF (g) p < Minimum FTI (g.s) p = N=2519 ablations (40 patients who completed follow-up) 16
17 Figure Legends: Figure 1. Data collection around Pulmonary Veins. A: Data collection around 8 numbered positions: 1, 9: superior; 2, 16: anterior-superior; 3, 15: anterior-middle; 4, 14: anterior-inferior; 5, 13: inferior; 6, 12: posterior-inferior; 7, 11: posterior-middle; 8, 10: posterior-superior. B: Positions 2,3,4 and 14,15,16 were grouped into respectively into left and right anterior segments and positions 6,7,8 and 10,11,12 were grouped into respectively left and right posterior segments. Figure 2. Distributions of force parameters at index procedure. Forty-six patients received ed 3152 ablations. A: Histogram of Contact t Forces. B: Histogram of Force-Time-Integral. -Inte C: Distribution of average age Contact Forces per position. ion. D: Distribution of average Force-Timee Integrals per position. on. Figure 3. Force Parameters discriminators for segments with isolation versus gaps. A: Minimum Contact Force per segment is shown for successful ablations (left) and for gaps (right) in box plot graph with 5%-95% limits. B: The Minimum FTI per segments is shown for successful ablations (left) and for gaps (right). Statistically significant difference between each group s median is observed and specified above graphs. Figure 4. Minimum Force-Time Integral success ratio. In 40 patients, 318 segments were ablated. Success or isolation ratio is shown in black per segments ablated with Minimum FTI < or > 400 g.s respectively. Level of statistical difference and odds ratio are displayed above graph. Number of segments is indicated for each group below the graph. 17
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27 Electrical Reconnection Following PVI is Contingent on Contact Force during Initial Treatment - Results From the EFFICAS I Study Petr Neuzil, Vivek Y. Reddy, Josef Kautzner, Jan Petru, Dan Wichterle, Dipen Shah, Hendrik Lambert, Aude Yulzari, Erik Wissner and Karl-Heinz Kuck Circ Arrhythm Electrophysiol. published online March 20, 2013; Circulation: Arrhythmia and Electrophysiology is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX Copyright 2013 American Heart Association, Inc. All rights reserved. Print ISSN: Online ISSN: The online version of this article, along with updated information and services, is located on the World Wide Web at: Data Supplement (unedited) at: 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. Once the online version of the published article for which permission is being requested is located, click Request Permissions in the middle column of the Web page under Services. Further information about this process is available in the Permissions and Rights Question and Answerdocument. Reprints: Information about reprints can be found online at: Subscriptions: Information about subscribing to Circulation: Arrhythmia and Electrophysiology is online at:
28 SUPPLEMENTAL MATERIAL
29 Table: Cardiovascular History 46 patients Percentage / 40 patients Percentage / index Range follow-up Range Previous AAD * % % No other disease % % Other cardiac disease % % Hypertension % % Diabetes 4 8.7% 3 7.5% Transient ischemic attack 3 6.5% 3 7.5% Valvular regurgitation 3 6.5% 3 7.5% Obesity 3 6.5% 3 7.5% NYHA Classification n/a NYHA 4 8.7% 3 7.5% NYHA Class I or II % % Left Atrium diameter (mm) 42+/ / * Anti-arrhythmic drug New-York Heart Association
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