Real-world safety of catheter ablation for atrial fibrillation with contact force or cryoballoon ablation

Andrea Natale, Sanghamitra Mohanty, Laura Goldstein, Tara Gomez, Tina D Hunter, Andrea Natale, Sanghamitra Mohanty, Laura Goldstein, Tara Gomez, Tina D Hunter

Abstract

Purpose: Real-world data can help medical administrators, physicians, and payers make evidence-based decisions regarding treatment choices. The objective of this study was to compare real-world safety outcomes with the latest catheter technologies used for the treatment of atrial fibrillation (AF).

Methods: The Vizient Health Systems database, a large US hospital database, was used to compare acute complications in AF ablation with the contact force sensing THERMOCOOL SMARTTOUCH® Catheter or the THERMOCOOL SMARTTOUCH® SF Catheter (ST) versus the second-generation Arctic Front Advance™ Cryoablation Catheter (CB2) between September 2015 and June 2017. The primary outcome was a composite safety endpoint of acute ablation-related complications defined via ICD-10 diagnosis and procedure codes, including tamponade and other pericardial events, respiratory complications, stroke, cerebral or pre-cerebral occlusion/stenosis without infarction, vascular access complications, hemorrhage, phrenic nerve injury, myocardial infarction, and pulmonary embolism.

Results: In total, 1473 ablations met all inclusion criteria (407 ST, 1066 CB2). Ablations for paroxysmal AF (PAF) had a lower complication rate than ablations for persistent AF (PsAF) (6.1% vs. 7.3%), as did ablations with ST compared with CB2 within each AF type (PAF 6.0% vs. 6.1%, PsAF 6.3% vs. 7.8%). Neither ablation catheter nor AF type was statistically significant after controlling for site volume, patient age, and comorbid conditions (ST vs. CB2: OR 0.86, p = 0.5544; PsAF vs. PAF: OR 1.08, p = 0.7376).

Conclusion: Acute ablation-related complication rates were low and were not significantly associated with catheter technology. Increased risk of complication was attributable to low-volume sites and baseline patient characteristics.

Keywords: Atrial fibrillation; Catheter ablation; Contact force; Cryoablation; Radiofrequency ablation; Safety.

Conflict of interest statement

A Natale is a paid consultant for Biosense Webster, Inc., Medtronic, Biotronik, St. Jude/Abbott, Boston Scientific, and Baylis. Neither honoraria nor payments were made for authorship. S Mohanty has no disclosures. L Goldstein and T Gomez are employees of Biosense Webster, Inc., a Johnson and Johnson company. TD Hunter is an employee of CTI Clinical Trial and Consulting Services, which is a consultant to Biosense Webster, Inc., the study sponsor.

Figures

Fig. 1
Fig. 1
Acute complications across high- and low-volume centers. A total of 5.8% of patients ablated at high-volume sites had an acute procedure-related complication versus 12.2% of patients ablated at low-volume sites (p = 0.0008). Complication rates did not vary significantly by catheter cohort within the high-volume sites (5.9% CB2 vs. 5.3% ST, p = 0.6904) or within the low-volume sites (13.4% CB2 vs. 10.1% ST, p = 0.5056)

References

    1. Khavjou O, Phelps D, Leib A & RTI International. Projections of cardiovascular disease prevalence and costs: 2015–2035. Technical report prepared for the American Heart Association; 2016. . Accessed Aug 2018.
    1. Nakamura K, Naito S, Sasaki T, Nakano M, Minami K, Nakatani Y, Ikeda K, Yamashita E, Kumagai K, Funabashi N, Oshima S. Randomized comparison of contact force-guided versus conventional circumferential pulmonary vein isolation of atrial fibrillation: prevalence, characteristics, and predictors of electrical reconnections and clinical outcomes. J Interv Card Electrophysiol. 2015;44(3):235–245. doi: 10.1007/s10840-015-0056-7.
    1. Kimura M, Sasaki S, Owada S, Horiuchi D, Sasaki K, Itoh T, Ishida Y, Kinjo T, Tomita H, Okumura K. Comparison of lesion formation between contact force-guided and non-guided circumferential pulmonary vein isolation: a prospective, randomized study. Heart Rhythm. 2014;11(6):984–991. doi: 10.1016/j.hrthm.2014.03.019.
    1. Pandya B, Sheikh A, Spagnola J, Bekheit S, Lafferty J, Kowalski M. Safety and efficacy of second-generation versus first-generation cryoballoons for treatment of atrial fibrillation: a meta-analysis of current evidence. J Interv Card Electrophysiol. 2016;45(1):49–56. doi: 10.1007/s10840-015-0075-4.
    1. Conti S, Moltrasio M, Fassini G, Tundo F, Riva S, Dello Russo A, et al. Comparison between first- and second-generation cryoballoon for paroxysmal atrial fibrillation ablation. Cardiol Res Pract. 2016;2016:5106127. doi: 10.1155/2016/5106127.
    1. Kardos A, Kis Z, Som Z, Nagy Z, Foldesi C. Two-year follow-up after contact force sensing radiofrequency catheter and second-generation cryoballoon ablation for paroxysmal atrial fibrillation: a comparative single Centre study. Biomed Res Int. 2016;2016:6495753. doi: 10.1155/2016/6495753.
    1. Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015;17(2):225–231. doi: 10.1093/europace/euu215.
    1. Matta M, Anselmino M, Ferraris F, Scaglione M, Gaita F. Cryoballoon vs. radiofrequency contact force ablation for paroxysmal atrial fibrillation: a propensity score analysis. J Cardiovasc Med (Hagerstown) 2018;19(4):141–147. doi: 10.2459/JCM.0000000000000633.
    1. Ciconte G, Baltogiannis G, de Asmundis C, Sieira J, Conte G, Di Giovanni G, et al. Circumferential pulmonary vein isolation as index procedure for persistent atrial fibrillation: a comparison between radiofrequency catheter ablation and second-generation cryoballoon ablation. Europace. 2015;17(4):559–565. doi: 10.1093/europace/euu350.
    1. Ciconte G, Velagic V, Mugnai G, Saitoh Y, Irfan G, Hunuk B, et al. Electrophysiological findings following pulmonary vein isolation using radiofrequency catheter guided by contact-force and second-generation cryoballoon: lessons from repeat ablation procedures. Europace. 2016;18(1):71–77. doi: 10.1093/europace/euv224.
    1. Deshmukh A, Patel NJ, Pant S, Shah N, Chothani A, Mehta K, Grover P, Singh V, Vallurupalli S, Savani GT, Badheka A, Tuliani T, Dabhadkar K, Dibu G, Reddy YM, Sewani A, Kowalski M, Mitrani R, Paydak H, Viles-Gonzalez JF. In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010: analysis of 93 801 procedures. Circulation. 2013;128(19):2104–2112. doi: 10.1161/CIRCULATIONAHA.113.003862.
    1. Hunter TD, Palli SR, Rizzo JA. Cost comparison of radiofrequency catheter ablation versus cryoablation for atrial fibrillation in hospitals using both technologies. J Med Econ. 2016;19(10):959–964. doi: 10.1080/13696998.2016.1187153.
    1. Andrade JG, Deyell MW, Badra M, Champagne J, Dubuc M, Leong-Sit P, Macle L, Novak P, Roux JF, Sapp J, Tang A, Verma A, Wells GA, Khairy P. Randomised clinical trial of cryoballoon versus irrigated radio frequency catheter ablation for atrial fibrillation-the effect of double short versus standard exposure cryoablation duration during pulmonary vein isolation (CIRCA-DOSE): methods and rationale. BMJ Open. 2017;7(10):e017970. doi: 10.1136/bmjopen-2017-017970.
    1. Andrade J, Champagne J, Dubuc M, Deyell M, Verma A, Macle L, et al. A randomized clinical trial of cryoballoon vs irrigated radiofrequency catheter ablation for atrial fibrillation: the CIRCA-DOSE study. Presented at The Annual Congress of the European Heart Rhythm Association; 2019. . Accessed Aug 2018.
    1. Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647–656. doi: 10.1016/j.jacc.2014.04.072.
    1. Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–2245. doi: 10.1056/NEJMoa1602014.
    1. Dulac A, Sarrazin J, Nault I, O’Hara G, Philippon F, Molin F, et al. Comparison of pulmonary vein isolation using cryoballoon artic front advance versus contact force-guided radiofrequency for paroxysmal atrial fibrillation. Can J Cardiol. 2014;30:S287–S288. doi: 10.1016/j.cjca.2014.07.512.13.
    1. Osorio J, Hunter TD, Bubien RS, Rajendra A, Arciniegas J, Morales G. Gains in paroxysmal atrial fibrillation ablation using a standardized workflow to optimize contact force technologies. J Atr Fibrillation. 2018;11(4):2097. doi: 10.4022/jafib.2097.
    1. Squara F, Zhao A, Marijon E, Latcu DG, Providencia R, Di Giovanni G, et al. Comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre European evaluation. Europace. 2015;17(5):718–724. doi: 10.1093/europace/euv060.
    1. Padala SK, Gunda S, Sharma PS, Kang L, Koneru JN, Ellenbogen KA. Risk model for predicting complications in patients undergoing atrial fibrillation ablation. Heart Rhythm. 2017;14(9):1336–1343. doi: 10.1016/j.hrthm.2017.04.042.
    1. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010;137(2):263–272. doi: 10.1378/chest.09-1584.
    1. Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile INR, elderly, drugs/alcohol concomitantly) score. J Am Coll Cardiol. 2011;57(2):173–180. doi: 10.1016/j.jacc.2010.09.024.
    1. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the euro heart survey. Chest. 2010;138(5):1093–1100. doi: 10.1378/chest.10-0134.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner