دورية أكاديمية
Mechanical dyssynchrony as a selection criterion for cardiac resynchronization therapy: Design of the AMEND-CRT trial.
| العنوان: | Mechanical dyssynchrony as a selection criterion for cardiac resynchronization therapy: Design of the AMEND-CRT trial. |
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| المؤلفون: | Puvrez A; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium., Duchenne J; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium., Donal E; LTSI, Inserm 1099, LTSI, University of Rennes, Rennes, France.; Department of Cardiology, CHU Rennes, Rennes, France., Gorcsan J 3rd; Heart and Vascular Institute, Penn State University College of Medicine, Hershey, Pennsylvania, USA., Patel HC; Department of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.; Central Clinical School, Monash University, Melbourne, Victoria, Australia.; Baker Heart and Diabetes Institute, Melbourne, Australia., Marwick TH; Baker Heart and Diabetes Institute, Melbourne, Australia., Smiseth OA; Institute for Surgical Research, Oslo University Hospital and University of Oslo, Oslo, Norway., Søgaard P; Department of Cardiology, Aalborg University Hospital and University of Aalborg, Aalborg, Denmark.; Department of Cardiology, Rigshospitalet, Copenhagen, Denmark., Stankovic I; Faculty of Medicine, University of Belgrade, Belgrade, Serbia.; Department of Cardiology, Clinical Hospital Centre Zemun, Belgrade, Serbia., Diogo PG; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium., Vörös G; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium., Voigt JU; Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium.; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. |
| المصدر: | ESC heart failure [ESC Heart Fail] 2024 Jul 10. Date of Electronic Publication: 2024 Jul 10. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: John Wiley & Sons Ltd on behalf of the European Society of Cardiology Country of Publication: England NLM ID: 101669191 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2055-5822 (Electronic) Linking ISSN: 20555822 NLM ISO Abbreviation: ESC Heart Fail Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Oxford] : John Wiley & Sons Ltd on behalf of the European Society of Cardiology, [2014]- |
| مستخلص: | Aims: One third of patients do not improve after cardiac resynchronization therapy (CRT). Septal flash (SF) and apical rocking (ApRock) are deformation patterns observed on echocardiography in most patients eligible for CRT. These markers of mechanical dyssynchrony have been associated to improved outcome after CRT in observational studies and may be useful to better select patients. The aim of this trial is to investigate whether the current guideline criteria for selecting patients for CRT should be modified and include SF and ApRock to improve therapy success rate, reduce excessive costs and prevent exposure to device-related complications in patients who would not benefit from CRT. Methods: The AMEND-CRT trial is a multicentre, randomized, parallel-group, double-blind, sham-controlled trial with a non-inferiority design. The trial will include 578 patients scheduled for CRT according to the 2021 ESC guidelines who satisfy all inclusion criteria. The randomization is performed 1:1 to an active control arm ('guideline arm') or an experimental arm ('echo arm'). All participants receive a device, but in the echo arm, CRT is activated only when SF or ApRock or both are present. The outcome of both arms will be compared after 1 year. The primary outcome measures are the average change in left ventricular end-systolic volume and patient outcome assessed using a modified Packer Clinical Composite Score. Conclusions: The findings of this trial will redefine the role of echocardiography in CRT and potentially determine which patients with heart failure and a prolonged QRS duration should receive CRT, especially in patients who currently have a class IIa or class IIb recommendation. (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.) |
| References: | Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, et al. 2021 ESC guidelines on cardiac pacing and cardiac resynchronization therapy developed by the task force on cardiac pacing and cardiac resynchronization therapy of the European Society of Cardiology (ESC) with the special contribution of the European Heart Rhythm Association (EHRA). Eur Heart J 2021;42:3427‐3520. doi:10.1093/EURHEARTJ/EHAB364. Daubert C, Behar N, Martins RP, Mabo P, Leclercq C. Avoiding non‐responders to cardiac resynchronization therapy: a practical guide. Eur Heart J 2017;38:1463‐1472. doi:10.1093/eurheartj/ehw270. Aalen JM, Donal E, Larsen CK, Duchenne J, Lederlin M, Cvijic M, et al. Imaging predictors of response to cardiac resynchronization therapy: left ventricular work asymmetry by echocardiography and septal viability by cardiac magnetic resonance. Eur Heart J 2020;41:3813‐3823. doi:10.1093/eurheartj/ehaa603. Hadwiger M, Frielitz FS, Eisemann N, et al. Cardiac resynchronisation therapy in patients with moderate to severe heart failure in Germany: a cost–utility analysis of the additional defibrillator. Appl Health Econ Health Policy 2021;19:57‐68. doi:10.1007/S40258‐020‐00571‐Y/FIGURES/3. Yao G, Freemantle N, Calvert MJ, Bryan S, Daubert JC, Cleland JGF. The long‐term cost‐effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter‐defibrillator. Eur Heart J 2007;28:42‐51. doi:10.1093/EURHEARTJ/EHL382. Goldenberg I, Kutyifa V, Klein HU, et al. Survival with cardiac‐resynchronization therapy in mild heart failure. New Engl J Med 2014;370:1694‐1701. doi:10.1056/NEJMoa1401426. Stankovic I, Stefanovic M, Prinz C, Ciarka A, Daraban AM, Kotrc M, et al. The association of mechanical dyssynchrony and resynchronization therapy with survival in heart failure with a wide QRS complex: a two‐world study. Int J Cardiovasc Imag 2020;36:1507‐1514. doi:10.1007/s10554‐020‐01865‐x. Mullens W, Auricchio A, Martens P, Witte K, Cowie MR, Delgado V, et al. Optimized implementation of cardiac resynchronization therapy: a call for action for referral and optimization of care. Eur J Heart Fail 2020;22:2349‐2369. doi:10.1002/EJHF.2046. Beela AS, Ünlü S, Duchenne J, Ciarka A, Daraban AM, Kotrc M, et al. Assessment of mechanical dyssynchrony can improve the prognostic value of guideline‐based patient selection for cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging 2019;20:66‐74. doi:10.1093/ehjci/jey029. Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, et al. Results of the predictors of response to CRT (prospect) trial. Circulation 2008;117:2608‐2616. doi:10.1161/CIRCULATIONAHA.107.743120. Beshai JF, Grimm RA, Nagueh SF, Baker JH 2nd, Beau SL, Greenberg SM, et al. Cardiac‐resynchronization therapy in heart failure with narrow QRS complexes. New Engl J Med 2007;357:2461‐2471. doi:10.1056/NEJMoa0706695. Ruschitzka F, Abraham WT, Singh JP, Bax JJ, Borer JS, Brugada J, et al. Cardiac‐resynchronization therapy in heart failure with a narrow QRS complex. New Engl J Med. 2013;369:1395‐1405. doi:10.1056/NEJMoa1306687. McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2021;42:3599‐3726. doi:10.1093/EURHEARTJ/EHAB368. Puvrez A, Mirea O, Marchetta S, et al. Beyond the PROSPECT‐trial: markers of mechanical dyssynchrony to improve patient selection for cardiac resynchronization therapy. [Manuscript submitted for publication]. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata‐driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377‐381. doi:10.1016/J.JBI.2008.08.010. Popescu BA, Andrade MJ, Badano LP, et al. European Association of Echocardiography recommendations for training, competence, and quality improvement in echocardiography. Eur J Echocardiogr 2009;10:893‐905. doi:10.1093/EJECHOCARD/JEP151. Vijayaraman P, Sharma PS, Cano Ó, Ponnusamy SS, Herweg B, Zanon F, et al. Comparison of left bundle branch area pacing and biventricular pacing in candidates for resynchronization therapy. J Am Coll Cardiol 2023;82:228‐241. doi:10.1016/J.JACC.2023.05.006. Kularatna S, Byrnes J, Chan YK, Carrington MJ, Stewart S, Scuffham PA. Comparison of contemporaneous responses for EQ‐5D‐3L and Minnesota Living with Heart Failure; a case for disease specific multiattribute utility instrument in cardiovascular conditions. Int J Cardiol 2017;227:172‐176. doi:10.1016/J.IJCARD.2016.11.030. Solomon SD, Foster E, Bourgoun M, Shah A, Viloria E, Brown MW, et al. Effect of cardiac resynchronization therapy on reverse remodeling and relation to outcome: multicenter automatic defibrillator implantation trial: cardiac resynchronization therapy. Circulation 2010;122:985‐992. doi:10.1161/CIRCULATIONAHA.110.955039. Linde C, Abraham WT, Gold MR, St. John Sutton M, Ghio S, Daubert C. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol 2008;52:1834‐1843. doi:10.1016/j.jacc.2008.08.027. Curtis AB, Worley SJ, Chung ES, Li P, Christman SA, Sutton SJ, et al. Improvement in clinical outcomes with biventricular versus right ventricular pacing: the BLOCK HF study. J Am Coll Cardiol 2016;67:2148‐2157. doi:10.1016/J.JACC.2016.02.051. Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, et al. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol 2012;23:1317‐1325. doi:10.1111/J.1540‐8167.2012.02402.X. Friedman DJ, Al‐Khatib SM, Dalgaard F, Fudim M, Abraham WT, Cleland JGF, et al. Cardiac resynchronization therapy improves outcomes in patients with intraventricular conduction delay but not right bundle branch block: a patient‐level meta‐analysis of randomized controlled trials. Circulation Published online January 26 2023;147:812‐823. doi:10.1161/CIRCULATIONAHA.122.062124. Derval N, Duchateau J, Mahida S, Eschalier R, Sacher F, Lumens J, et al. Distinctive left ventricular activations associated with ECG pattern in heart failure patients. Circ Arrhythm Electrophysiol 2017;10: doi:10.1161/CIRCEP.117.005073. Maffessanti F, Jadczyk T, Wilczek J, Conte G, Caputo ML, Gołba KS, et al. Electromechanical factors associated with favourable outcome in cardiac resynchronization therapy. Europace 2023;25:546‐553. doi:10.1093/EUROPACE/EUAC157. Fantoni C, Kawabata M, Massaro R, Regoli F, Raffa S, Arora V, et al. Right and left ventricular activation sequence in patients with heart failure and right bundle branch block: a detailed analysis using three‐dimensional non‐fluoroscopic electroanatomic mapping system. J Cardiovasc Electrophysiol 2005;16:112‐119. doi:10.1046/j.1540‐8167.2005.40777.x. Auricchio A, Fantoni C, Regoli F, et al. Characterization of left ventricular activation in patients with heart failure and left bundle‐branch block. Circulation 2004;109:1133‐1139. doi:10.1161/01.CIR.0000118502.91105.F6. Ploux S, Lumens J, Whinnett Z, et al. Noninvasive electrocardiographic mapping to improve patient selection for cardiac resynchronization therapy: beyond QRS duration and left bundle branch block morphology. J Am Coll Cardiol 2013;61:2435‐2443. doi:10.1016/J.JACC.2013.01.093. Van Deursen CJM, Vernooy K, Dudink E, Bergfeldt L, Crijns HJ, Prinzen FW, et al. Vectorcardiographic QRS area as a novel predictor of response to cardiac resynchronization therapy. J Electrocardiol 2015;48:45‐52. doi:10.1016/J.JELECTROCARD.2014.10.003. Duckett SG, Camara O, Ginks MR, Bostock J, Chinchapatnam P, Sermesant M, et al. Relationship between endocardial activation sequences defined by high‐density mapping to early septal contraction (septal flash) in patients with left bundle branch block undergoing cardiac resynchronization therapy. Europace 2012;14:99‐106. doi:10.1093/europace/eur235. Ghani A, Delnoy PPHM, Ottervanger JP, Ramdat Misier AR, Smit JJ, Adiyaman A, et al. Association of apical rocking with long‐term major adverse cardiac events in patients undergoing cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging 2016;17:146‐153. doi:10.1093/EHJCI/JEV236. Maass AH, Vernooy K, Wijers SC, van't Sant J, Cramer MJ, Meine M, et al. Refining success of cardiac resynchronization therapy using a simple score predicting the amount of reverse ventricular remodelling: results from the markers and response to CRT (MARC) study. Europace 2018;20:e1‐e10. doi:10.1093/europace/euw445. Stankovic I, Prinz C, Ciarka A, Daraban AM, Kotrc M, Aarones M, et al. Relationship of visually assessed apical rocking and septal flash to response and long‐term survival following cardiac resynchronization therapy (PREDICT‐CRT). Eur Heart J Cardiovasc Imaging 2016;17:262‐269. doi:10.1093/ehjci/jev288. Szulik M, Tillekaerts M, Vangeel V, Ganame J, Willems R, Lenarczyk R, et al. Assessment of apical rocking: a new, integrative approach for selection of candidates for cardiac resynchronization therapy. Eur J Echocardiogr 2010;11:863‐869. doi:10.1093/ejechocard/jeq081. Stankovic I, Prinz C, Ciarka A, Daraban AM, Mo Y, Aarones M, et al. Long‐term outcome after CRT in the presence of mechanical dyssynchrony seen with chronic RV pacing or intrinsic LBBB. JACC Cardiovasc Imaging 2017;10:1091‐1099. doi:10.1016/j.jcmg.2016.08.015. Merkely B, Hatala R, Wranicz JK, Duray G, Földesi C, Som Z, et al. Upgrade of right ventricular pacing to cardiac resynchronisation therapy in heart failure: a randomised trial. Eur Heart J Published online August 26 2023;44:4259‐4269. doi:10.1093/EURHEARTJ/EHAD591. |
| معلومات مُعتمدة: | T002919N Research Foundation - Flanders (FWO), Belgium; MRF2006393 Medical Research Future Fund (MRFF) International Clinical Trial Collaborations Program-20.1, Australia |
| فهرسة مساهمة: | Keywords: Apical rocking; Cardiac resynchronization therapy; Echocardiography; Guidelines; Methods; Septal flash |
| تواريخ الأحداث: | Date Created: 20240710 Latest Revision: 20240710 |
| رمز التحديث: | 20240710 |
| DOI: | 10.1002/ehf2.14932 |
| PMID: | 38984947 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2055-5822 |
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| DOI: | 10.1002/ehf2.14932 |