So sánh hiệu quả và độ an toàn của các can thiệp đốt catheter trong điều trị rung nhĩ: phân tích mạng tổng hợp từ các thử nghiệm ngẫu nhiên có đối chứng

Springer Science and Business Media LLC - Tập 62 - Trang 199-211 - 2020
Xinbin Zhou1, Jin Dai1, Xiaoming Xu1, Miaojun Lian1, Yang Lou2, Zhengtian Lv2, Zhijun Wang1, Wei Mao1
1Department of Cardiology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
2The First College of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China

Tóm tắt

Đốt sóng cao tần (RF) từng điểm đã trở thành bước ngoặt trong việc cách ly tĩnh mạch phổi (PVI) đối với bệnh nhân bị rung nhĩ (AF); tuy nhiên, quy trình này vẫn còn phức tạp và tốn thời gian. Nhiều kỹ thuật đốt catheter (CA) mới đã được giới thiệu, nhưng liệu chúng có thực sự là những lựa chọn có giá trị hay không vẫn còn gây tranh cãi. Do đó, chúng tôi đã thực hiện một phân tích mạng tổng hợp để đánh giá toàn diện hiệu quả và độ an toàn của các can thiệp CA khác nhau. Chúng tôi đã tìm kiếm một cách có hệ thống trên nhiều cơ sở dữ liệu (Embase, PubMed, Thư viện Cochrane và ClinicalTrials.gov) từ khi thành lập đến tháng 3 năm 2020. Các kết quả chính được quan tâm là tự do khỏi loạn nhịp nhĩ (AT) và biến chứng liên quan đến thủ thuật; các kết quả thứ yếu bao gồm thời gian thủ thuật và thời gian chiếu xạ. Cuối cùng, 33 thử nghiệm ngẫu nhiên có đối chứng (RCTs) với tổng số 4801 bệnh nhân đã được đưa vào nghiên cứu. Không tìm thấy sự khác biệt đáng kể giữa các can thiệp khác nhau về các kết quả chính về hiệu quả hoặc độ an toàn. PVAC có khả năng có thời gian thực hiện ngắn nhất (Prbest = 61.5%) và nMARQ có thời gian chiếu xạ ngắn nhất (Prbest = 60.6%); so với đốt RF tưới thông thường (IRF), đốt cryoballoon (CBA) cho thấy hiệu quả lâm sàng và độ an toàn tương đương; CBA với bóng thứ hai (CB2) có thời gian thủ thuật ngắn hơn đáng kể so với IRF với công nghệ lực tiếp xúc (CF-IRF) (WMD = -20.75; p = 0.00). Chưa có đủ bằng chứng để khẳng định rằng một kỹ thuật CA thì ưu việt hơn so với các kỹ thuật khác. Tuy nhiên, PVAC có thể liên quan đến thời gian thực hiện ngắn hơn, và các catheter CB2 cũng dường như làm giảm thời gian thực hiện so với CF-IRF. Cần có các nghiên cứu quy mô lớn hơn để so sánh các kỹ thuật CA hiện có và cung cấp các khuyến nghị tối ưu mới nhất.

Từ khóa

#đốt sóng cao tần #rung nhĩ #can thiệp #phân tích mạng #hiệu quả #

Tài liệu tham khảo

Schnabel RB, Yin X, Gona P, Larson MG, Beiser AS, McManus DD, et al. 50 year trends in atrial fibrillation prevalence, incidence, risk factors, and mortality in the Framingham heart study: a cohort study. Lancet. 2015;386(9989):154–62. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016;18(11):1609–78. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, et al. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3(1):32–8. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (2019). Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Cochrane, 2019. Available from www.training.cochrane.org/handbook. You L, Yao L, Zhou B, Jin L, Yin H, Wu J, et al. Effects of different ablation strategies on long-term left atrial function in patients with paroxysmal atrial fibrillation: a single-blind randomized controlled trial. Sci Rep. 2019;9(1):7695. Giannopoulos G, Kossyvakis C, Vrachatis D, Aggeli C, Tsitsinakis G, Letsas K, et al. Effect of cryoballoon and radiofrequency ablation for pulmonary vein isolation on left atrial function in patients with nonvalvular paroxysmal atrial fibrillation: a prospective randomized study (Cryo-LAEF study). J Cardiovasc Electrophysiol. 2019;30(7):991–8. Bin Waleed K, Yin X, Yang X, Dai B, Liu Y, Wang Z, et al. Short and long-term changes in platelet and inflammatory biomarkers after cryoballoon and radiofrequency ablation. Int J Cardiol. 2019;285:128–32. Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L, et al. Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial. Circulation. 2019;140(22):1779–88. Watanabe R, Sairaku A, Yoshida Y, Nanasato M, Kamiya H, Suzuki H, et al. Head-to-head comparison of acute and chronic pulmonary vein stenosis for cryoballoon versus radiofrequency ablation. Pacing Clin Electrophysiol. 2018;41(4):376–82. Gunawardene MA, Hoffmann BA, Schaeffer B, Chung DU, Moser J, Akbulak RO, et al. Influence of energy source on early atrial fibrillation recurrences: a comparison of cryoballoon vs. radiofrequency current energy ablation with the endpoint of unexcitability in pulmonary vein isolation. Europace. 2018;20(1):43–9. Davtyan K, Shatakhtsyan V, Poghosyan H, Deev A, Tarasov A, Kharlap M, et al. Radiofrequency versus cryoballoon ablation of atrial fibrillation: an evaluation using ECG, Holter monitoring, and implantable loop recorders to monitor absolute and clinical effectiveness. Biomed Res Int. 2018;2018:3629384. Buist TJ, Adiyaman A, Smit JJJ, Ramdat Misier AR, Elvan A. Arrhythmia-free survival and pulmonary vein reconnection patterns after second-generation cryoballoon and contact-force radiofrequency pulmonary vein isolation. Clin Res Cardiol. 2018;107(6):498–506. 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):2235–45. Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hormann P, et al. Cryoballoon versus open irrigated radiofrequency ablation in patients with paroxysmal atrial fibrillation: the prospective, randomized, controlled. Noninferiority FreezeAF Study Circulation. 2015;132(14):1311–9. Hunter RJ, Baker V, Finlay MC, Duncan ER, Lovell MJ, Tayebjee MH, et al. Point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the Cryo versus RF trial). J Cardiovasc Electrophysiol. 2015;26(12):1307–14. Perez-Castellano N, Fernandez-Cavazos R, Moreno J, Canadas V, Conde A, Gonzalez-Ferrer JJ, et al. The COR trial: a randomized study with continuous rhythm monitoring to compare the efficacy of cryoenergy and radiofrequency for pulmonary vein isolation. Heart Rhythm. 2014;11(1):8–14. Pokushalov E, Romanov A, Artyomenko S, Baranova V, Losik D, Bairamova S, et al. Cryoballoon versus radiofrequency for pulmonary vein re-isolation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2013;24(3):274–9. Herrera Siklody C, Arentz T, Minners J, Jesel L, Stratz C, Valina CM, et al. Cellular damage, platelet activation, and inflammatory response after pulmonary vein isolation: a randomized study comparing radiofrequency ablation with cryoablation. Heart Rhythm. 2012;9(2):189–96. Tse HF, Kwong YL, Lau CP. Transvenous cryoablation reduces platelet activation during pulmonary vein ablation compared with radiofrequency energy in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2005;16(10):1064–70. Schirdewan A, Herm J, Roser M, Landmesser U, Endres M, Koch L, et al. Loop recorder detected high rate of atrial fibrillation recurrence after a single balloon- or basket-based ablation of paroxysmal atrial fibrillation: results of the MACPAF study. Front Cardiovasc Med. 2017;4:4. Koch L, Haeusler KG, Herm J, Safak E, Fischer R, Malzahn U, et al. Mesh ablator vs. cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation: results of the MACPAF study. Europace. 2012;14(10):1441–9. Malmborg H, Lonnerholm S, Blomstrom P, Blomstrom-Lundqvist C. Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study. Europace. 2013;15(11):1567–73. Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, et al. Incidence and clinical significance of cerebral embolism during atrial fibrillation ablation with duty-cycled phased-radiofrequency versus cooled-radiofrequency: a randomized controlled trial. JACC Clin Electrophysiol. 2019;5(3):318–26. Boersma LV, van der Voort P, Debruyne P, Dekker L, Simmers T, Rossenbacker T, et al. Multielectrode pulmonary vein isolation versus single tip wide area catheter ablation for paroxysmal atrial fibrillation: a multinational multicenter randomized clinical trial. Circ Arrhythm Electrophysiol. 2016;9(4):e003151. Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015;44(3):257–64. McCready J, Chow AW, Lowe MD, Segal OR, Ahsan S, de Bono J, et al. Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial. Europace. 2014;16(8):1145–53. Gal P, Aarntzen AE, Smit JJ, Adiyaman A, Misier AR, Delnoy PP, et al. Conventional radiofrequency catheter ablation compared to multi-electrode ablation for atrial fibrillation. Int J Cardiol. 2014;176(3):891–5. Bittner A, Monnig G, Zellerhoff S, Pott C, Kobe J, Dechering D, et al. Randomized study comparing duty-cycled bipolar and unipolar radiofrequency with point-by-point ablation in pulmonary vein isolation. Heart Rhythm. 2011;8(9):1383–90. Bulava A, Hanis J, Sitek D, Osmera O, Karpianus D, Snorek M, et al. Catheter ablation for paroxysmal atrial fibrillation: a randomized comparison between multielectrode catheter and point-by-point ablation. Pacing Clin Electrophysiol. 2010;33(9):1039–46. Kozluk E, Piatkowska A, Rodkiewicz D, Peller M, Kochanowski J, Opolski G. Direct results of a prospective randomized study comparing ablation with the nMARQ catheter and the PVAC catheter used with and without a 3D system (MAPER 3D study). Arch Med Sci. 2019;15(1):78–85. Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018;20(Fi_3):f384–f91. Grimaldi M, Swarup V, DeVille B, Sussman J, Jais P, Gaita F, et al. Importance of anticoagulation and postablation silent cerebral lesions: subanalyses of REVOLUTION and reMARQable studies. Pacing Clin Electrophysiol. 2017;40(12):1432–9. Ucer E, Janeczko Y, Seegers J, Fredersdorf S, Friemel S, Poschenrieder F, et al. A RAndomized trial to compare the acute reconnection after pulmonary vein ISolation with laser-BalloON versus radiofrequency ablation: RATISBONA trial. J Cardiovasc Electrophysiol. 2018;29(5):733–9. Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, et al. Laser balloon or wide-area circumferential irrigated radiofrequency ablation for persistent atrial fibrillation: a multicenter prospective randomized study. Circ Arrhythm Electrophysiol. 2017;10(12). Dukkipati SR, Cuoco F, Kutinsky I, Aryana A, Bahnson TD, Lakkireddy D, et al. Pulmonary vein isolation using the visually guided laser balloon: a prospective, multicenter, and randomized comparison to standard radiofrequency ablation. J Am Coll Cardiol. 2015;66(12):1350–60. Casella M, Dello Russo A, Russo E, Al-Mohani G, Santangeli P, Riva S, et al. Biomarkers of myocardial injury with different energy sources for atrial fibrillation catheter ablation. Cardiol J. 2014;21(5):516–23. Schmidt B, Gunawardene M, Krieg D, Bordignon S, Furnkranz A, Kulikoglu M, et al. A prospective randomized single-center study on the risk of asymptomatic cerebral lesions comparing irrigated radiofrequency current ablation with the cryoballoon and the laser balloon. J Cardiovasc Electrophysiol. 2013;24(8):869–74. Vogler J, Willems S, Sultan A, Schreiber D, Luker J, Servatius H, et al. Pulmonary vein isolation versus defragmentation: the CHASE-AF clinical trial. J Am Coll Cardiol. 2015;66(24):2743–52. Vurma M, Dang L, Brunner-La Rocca HP, Sutsch G, Attenhofer-Jost CH, Duru F, et al. Safety and efficacy of the nMARQ catheter for paroxysmal and persistent atrial fibrillation. Europace. 2016;18(8):1164–9. Mahida S, Hooks DA, Nentwich K, Ng GA, Grimaldi M, Shin DI, et al. nMARQ ablation for atrial fibrillation: results from a multicenter study. J Cardiovasc Electrophysiol. 2015;26(7):724–9. Laish-Farkash A, Suleiman M. Comparison of the efficacy of PVAC((R)) and nMARQ() for paroxysmal atrial fibrillation. J Atr Fibrillation. 2017;9(6):1550. Maagh P, van Bracht M, Butz T, Trappe HJ, Meissner A. Eighteen months follow-up of the clinical efficacy of the high density mesh ablator (HDMA) in patients with atrial fibrillation after pulmonary vein isolation. J Interv Card Electrophysiol. 2010;29(1):43–52. De Greef Y, Stroker E, Schwagten B, Kupics K, De Cocker J, Chierchia GB, et al. Complications of pulmonary vein isolation in atrial fibrillation: predictors and comparison between four different ablation techniques: results from the MIddelheim PVI-registry. Europace. 2018;20(8):1279–86. Arbelo E, Brugada J, Blomstrom-Lundqvist C, Laroche C, Kautzner J, Pokushalov E, et al. Contemporary management of patients undergoing atrial fibrillation ablation: in-hospital and 1-year follow-up findings from the ESC-EHRA atrial fibrillation ablation long-term registry. Eur Heart J. 2017;38(17):1303–16. Hoyt H, Bhonsale A, Chilukuri K, Alhumaid F, Needleman M, Edwards D, et al. Complications arising from catheter ablation of atrial fibrillation: temporal trends and predictors. Heart Rhythm. 2011;8(12):1869–74. Herrera Siklody C, Deneke T, Hocini M, Lehrmann H, Shin DI, Miyazaki S, et al. Incidence of asymptomatic intracranial embolic events after pulmonary vein isolation: comparison of different atrial fibrillation ablation technologies in a multicenter study. J Am Coll Cardiol. 2011;58(7):681–8. Gaita F, Leclercq JF, Schumacher B, Scaglione M, Toso E, Halimi F, et al. Incidence of silent cerebral thromboembolic lesions after atrial fibrillation ablation may change according to technology used: comparison of irrigated radiofrequency, multipolar nonirrigated catheter and cryoballoon. J Cardiovasc Electrophysiol. 2011;22(9):961–8. Leitz P, Guner F, Wasmer K, Foraita P, Pott C, Dechering DG, et al. Data on procedural handling and complications of pulmonary vein isolation using the pulmonary vein ablation catheter GOLD(R). Europace. 2016;18(5):696–701. Neumann T, Kuniss M, Conradi G, Janin S, Berkowitsch A, Wojcik M, et al. MEDAFI-trial (micro-embolization during ablation of atrial fibrillation): comparison of pulmonary vein isolation using cryoballoon technique vs. radiofrequency energy. Europace. 2011;13(1):37–44. Sauren LD, Vanb Y, Der L, Pison L, Lam M, van der Veen FH, et al. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009;20(10):1102–7. Deneke T, Schade A, Muller P, Schmitt R, Christopoulos G, Krug J, et al. Acute safety and efficacy of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation. J Cardiovasc Electrophysiol. 2014;25(4):339–45. Andrade JG, Dubuc M, Guerra PG, Macle L, Rivard L, Roy D, et al. Cryoballoon ablation for atrial fibrillation. Indian Pacing Electrophysiol J. 2012;12(2):39–53. Cheng X, Hu Q, Zhou C, Liu LQ, Chen T, Liu Z, et al. The long-term efficacy of cryoballoon vs irrigated radiofrequency ablation for the treatment of atrial fibrillation: a meta-analysis. Int J Cardiol. 2015;181:297–302. Straube F, Dorwarth U, Vogt J, Kuniss M, Heinz Kuck K, Tebbenjohanns J, et al. Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE cohort substudy. Europace. 2014;16(10):1434–42. Giovanni GD, Wauters K, Chierchia GB, Sieira J, Levinstein M, Conte G, et al. One-year follow-up after single procedure Cryoballoon ablation: a comparison between the first and second generation balloon. J Cardiovasc Electrophysiol. 2014;25(8):834–9. Casado-Arroyo R, Chierchia GB, Conte G, Levinstein M, Sieira J, Rodriguez-Manero M, et al. Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: a comparison between the first- and second-generation balloon. Heart Rhythm. 2013;10(9):1318–24. Patel N, Patel K, Shenoy A, Baker WL, Makaryus AN, El-Sherif N. Cryoballoon ablation for the treatment of atrial fibrillation: a meta-analysis. Curr Cardiol Rev. 2019;15(3):230–8. Buiatti A, von Olshausen G, Barthel P, Schneider S, Luik A, Kaess B, et al. Cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: an updated meta-analysis of randomized and observational studies. Europace. 2017;19(3):378–84. Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, et al. 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):225–31. Shao M, Shang L, Shi J, Zhao Y, Zhang W, Zhang L, et al. The safety and efficacy of second-generation cryoballoon ablation plus catheter ablation for persistent atrial fibrillation: a systematic review and meta-analysis. PLoS One. 2018;13(10):e0206362. 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):559–65. Knecht S, Kuhne M, Osswald S, Sticherling C. Quantitative assessment of a second-generation cryoballoon ablation catheter with new cooling technology-a perspective on potential implications on outcome. J Interv Card Electrophysiol. 2014;40(1):17–21.