A randomised comparison of Cartomerge vs. NavX fusion in the catheter ablation of atrial fibrillation: the CAVERN Trial

Malcolm C Finlay, Ross J Hunter, Victoria Baker, Laura Richmond, Farai Goromonzi, Glyn Thomas, Kim Rajappan, Edward Duncan, Muzahir Tayebjee, Mehul Dhinoja, Simon Sporton, Mark J Earley, Richard J Schilling, Malcolm C Finlay, Ross J Hunter, Victoria Baker, Laura Richmond, Farai Goromonzi, Glyn Thomas, Kim Rajappan, Edward Duncan, Muzahir Tayebjee, Mehul Dhinoja, Simon Sporton, Mark J Earley, Richard J Schilling

Abstract

Purpose: Integration of a 3D reconstruction of the left atrium into cardiac mapping systems can aid catheter ablation of atrial fibrillation (AF). The two most widely used systems are NavX Fusion and Cartomerge. We aimed to compare the clinical efficacy of these systems in a randomised trial.

Methods: Patients undergoing their first ablation were randomised to mapping using either NavX fusion or CartoMerge. Pulmonary vein isolation by wide area circumferential ablation was performed for paroxysmal AF with additional linear and fractionated potential ablation for persistent AF. Seven-day Holter monitoring was used for confirmation of sinus rhythm maintenance at 6 months.

Results: Ninety-seven patients were randomised and underwent a procedure. There was no difference in the primary endpoint of freedom from arrhythmia at 6 months (51% in the Cartomerge group vs. 48% in the NavX Fusion group, p = 0.76). 3D image registration was faster with Cartomerge (24 vs. 33 min, p = 0.0001), used less fluoroscopic screening (11 vs. 15 min, p = 0.039) with a lower fluoroscopic dose (840 vs. 1,415 mGyCm(2), p = 0.043). There was a strong trend to lower ablation times in the Cartomerge group, overall RF time (3,292 s vs. 4,041, p = 0.07). Distance from 3D lesion to 3D image shell was smaller in the Cartomerge group (2.7 ± 1.9 vs. 3.3 ± 3.7 mm, p < 0.001).

Conclusions: Cartomerge appears to be faster and uses less fluoroscopy to achieve registration than NavX Fusion, but overall procedural times and clinical outcomes are similar.

Trial registration: ClinicalTrials.gov NCT01432743.

Figures

Fig. 1
Fig. 1
Clinical outcomes—Kaplain–Meier diagram of survival free from documented episodes of AF
Fig. 2
Fig. 2
Key procedural time points, shown as cumulatives (rather than true order in which ablations progressed). This illustrates the contributions of each procedural stage to the overall time taken. Inset numerals show times for each stage as mean ± SD. Time from start of case to registration was significantly shorter with Cartomerge, but this did not translate into overall reduced case time. pAF paroxysmal atrial fibrillation, persAF persistent atrial fibrillation, DTSP double transseptal puncture, RPV right pulmonary vein, LPV left pulmonary vein

References

    1. Cappato R, Calkins H, Chen S, Davies W, Iesaka Y, Kalman J, et al. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. 2005;111(9):1100–1105. doi: 10.1161/01.CIR.0000157153.30978.67.
    1. Cappato R, Calkins H, Chen S, Davies W, Iesaka Y, Kalman J, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. Arrhythmia and Electrophysiology. 2010;3(1):32–38. doi: 10.1161/CIRCEP.109.859116.
    1. Powell B, Packer D. Does image integration improve atrial fibrillation ablation outcomes, or are other aspects of the ablation the key to success? Europace. 2009;11(8):973–974. doi: 10.1093/europace/eup192.
    1. Kistler P, Rajappan K, Harris S, Earley M, Richmond L, Sporton S, et al. The impact of image integration on catheter ablation of atrial fibrillation using electroanatomic mapping: a prospective randomized study. European Heart Journal. 2008;29(24):3029–3036. doi: 10.1093/eurheartj/ehn453.
    1. Della Bella P, Fassini G, Cireddu M, Riva S, Carbucicchio C, Giraldi F, et al. Image integration-guided catheter ablation of atrial fibrillation: a prospective randomized study. Journal of Cardiovascular Electrophysiology. 2009;20(3):258–265. doi: 10.1111/j.1540-8167.2008.01311.x.
    1. Bertaglia E, Bella P, Tondo C, Proclemer A, Bottoni N, De Ponti R, et al. Image integration increases efficacy of paroxysmal atrial fibrillation catheter ablation: results from the CartoMerge Italian Registry. Europace. 2009;11(8):1004–1010. doi: 10.1093/europace/eup152.
    1. Bertaglia E, Brandolino G, Zoppo F, Zerbo F, Pascotto P. Integration of three-dimensional left atrial magnetic resonance images into a real-time electroanatomic mapping system: validation of a registration method. Pacing and Clinical Electrophysiology. 2008;31(3):273–282. doi: 10.1111/j.1540-8159.2008.00986.x.
    1. Earley M, Showkathali R, Alzetani M, Kistler P, Gupta D, Abrams D, et al. Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. European Heart Journal. 2006;27(10):1223–1229. doi: 10.1093/eurheartj/ehi834.
    1. Tops L, Bax J, Zeppenfeld K, Jongbloed M, Lamb H, van der Wall E, et al. Fusion of multislice computed tomography imaging with three-dimensional electroanatomic mapping to guide radiofrequency catheter ablation procedures. Heart Rhythm. 2005;2(10):1076–1081. doi: 10.1016/j.hrthm.2005.07.019.
    1. Richmond L, Rajappan K, Voth E, Rangavajhala V, Earley M, Thomas G, et al. Validation of computed tomography image integration into the EnSite NavX mapping system to perform catheter ablation of atrial fibrillation. Journal of Cardiovascular Electrophysiology. 2008;19(8):821–827. doi: 10.1111/j.1540-8167.2008.01127.x.
    1. Brooks A, Wilson L, Kuklik P, Stiles M, John B, Shashidhar, et al. Image integration using NavX Fusion: initial experience and validation. Heart Rhythm. 2008;5(4):526–535. doi: 10.1016/j.hrthm.2008.01.008.
    1. Dong J, Dalal D, Scherr D, Cheema A, Nazarian S, Bilchick K, et al. Impact of heart rhythm status on registration accuracy of the left atrium for catheter ablation of atrial fibrillation. Journal of Cardiovascular Electrophysiology. 2007;18(12):1269–1276. doi: 10.1111/j.1540-8167.2007.00956.x.
    1. Moher DSK, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357(9263):1191–1194. doi: 10.1016/S0140-6736(00)04337-3.
    1. Dong J, Calkins H, Solomon S, Lai S, Dalal D, Lardo A, et al. Integrated electroanatomic mapping with three-dimensional computed tomographic images for real-time guided ablations. Circulation. 2006;113(2):186–194. doi: 10.1161/CIRCULATIONAHA.105.565200.
    1. Hunter R, Ginks M, Ang R, Diab I, Goromonzi F, Page S, et al. Impact of variant pulmonary vein anatomy and image integration on long-term outcome after catheter ablation for atrial fibrillation. Europace. 2010;12(12):1691–1697. doi: 10.1093/europace/euq322.
    1. Khaykin Y, Oosthuizen R, Zarnett L, Wulffhart Z, Whaley B, Hill C, et al. CARTO-guided vs. NavX-guided pulmonary vein antrum isolation and pulmonary vein antrum isolation performed without 3-D mapping: effect of the 3-D mapping system on procedure duration and fluoroscopy time. Journal of Interventional Cardiac Electrophysiology. 2011;30(3):233–240. doi: 10.1007/s10840-010-9538-9.

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