Is QRS width predictive of the clinical and echocardiographic response to chronic CRT in mildly symptomatic HF patients?
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1 Is QRS width predictive of the clinical and echocardiographic response to chronic CRT in mildly symptomatic HF patients? Data from REVERSE C Thébault 1, M Gold 2, C Linde 3, WT Abraham 4, C Leclercq 1, G Kervio 1, JC Daubert 1 1 University Hospital of Rennes, Department of Cardiology, France 2 Medical University of South Carolina, Charleston, USA 3 Karolinska University Hospital, Department of Cardiology, Stockholm, Sweden 4 Davis Heart and Lung Research Institute, Columbus, USA ESC Stockholm 2010
2 Introduction Cardiac resynchronisation therapy (CRT) : guidelines-established therapy in moderate to severe heart failure (HF) patients with depressed left ventricular (LV) systolic function and evidence of ventricular dyssynchrony To date, QRS duration (QRSd) is the only recommended dyssynchrony marker to select patients for CRT : QRS 120ms 30% of HF patients have a QRS 120ms (1) Prolonged QRS associated with: Depressed LV systolic function (2) Increased all cause mortality rate (3) QRS progression associated with: Worsening NYHA functional class (4) Earlier mortality if QRS increases >5ms/year (5) 1.Iuliano et al. AHJ 2002;143: Baldasseroni et al. AHJ 2002;143: Shenkman et al. Chest 2002;122; Xiao et al. IJC 1996;53: Kalra et al. IJC 2002;86:225-31
3 Controversial issues 1. Is QRSd at baseline predictive of the response to CRT? Yes in observational studies (1,2) No clear evidence in RCT s in class III-IV patients (3,4,5) 2. Is «acute» (immediately after CRT implant) QRS change predictive of the response to CRT? 3. Is «chronic» (during follow-up) QRS change predicitve of the response to CRT? QRSd (ms) inclusion criteria MUSTIC MIRACLE COMPANION CARE HF >150 >130 >120 >120 QRS <150ms 0% 12% 33% Rando 1:2:2 11% Mean QRSd (ms) 174 ± ± ± ± 28 (3) 1.Alonso et al. AJC 1999;84: Gervais et al. EJHF 2009;11: Penicka et al. Circ 2004;109: Abraham et al. NEJM 2002;24: Bristow et al. NEJM 2004,350: Randomized Controlled Trials in NYHA III-IV patients: wide mean QRSd small interindividual differences low proportion of patients with QRS<150ms
4 Controversial issues 1. Is QRSd at baseline predictive of the response to CRT? Positive correlation 2. Is «acute» post-implant QRS change predictive of the response to CRT? Yes (1,2) No (3) 3. Is «chronic» (during follow-up) QRS change predicitve of the response to CRT? Lack of significant evidence «Immediately after implantation of the pacemaker, there was a trend towards a larger reduction in QRS duration in the responders, although not significant (p=0.07)» (1) (3) 1.Kronberg et al. Europace 2010;12: Alonso et al. AJC 1999;84: Molhoek et al. Pacing Clin Electrophysiol 2004;27:308-13
5 Controversial issues 1. Is QRSd at baseline predictive of the response to CRT? Positive correlation 2. Is «acute» (immediately after CRT implant) QRS change predictive of the response to CRT? (1) 3. Is «chronic» post-implant QRS change predictive of the response to CRT? Lack of significant evidence Yes (1) No (2) 1.Lecoq et al. EHJ 2005;26: Reuter et al. AJC 2002;89: (2)
6 Study objectives Accuracy and reproducibility of QRSd measurement on surface ECG Predictive value on the clinical and echo response to CRT of: Baseline QRSd Acute change after CRT: discharge (D) - baseline (B) Chronic change after CRT: 12-months (12m) - baseline (B)
7 REVERSE study REVERSE study (1) : 610 patients, NYHA II or I-stage C (previously symptomatic), LV ejection fraction (LVEF) 40%, QRS 120ms, on optimal medical therapy Randomization 2:1 to CRT ON or CRT OFF after CRT device implantation in all subjects Primary endpoint: clinical composite response (CCS) at 1 year (2) Clinical responder: «improved» or «unchanged» Clinical Composite Response: death Pre-specified secondary endpoint: hospitalisation LV endsystolic for HF volume index change (LVESVi) at 1 year cross over or permanently discontinued double-blind treatment because of worsening HF NYHA class change Echocardiographic (echo) responder = LVESVi decrease 15% and/or LVEF increase 10% patient global assessment at 1 year 1.Linde et al. JACC 2008;52: Packer et al. JCardFail 2001;7:176-82
8 REVERSE study REVERSE study (1) : 610 patients, NYHA II or I-stage C (previously symptomatic), LV ejection fraction (LVEF) 40%, QRS 120ms, on optimal medical therapy Randomization 2:1 to CRT ON or CRT OFF after CRT device implantation in all subjects Primary endpoint: clinical composite response (CCS) at 1 year (2) Clinical responder: «improved» or «unchanged» Pre-specified secondary endpoint: LV endsystolic volume index change (LVESVi) at 1 year Echocardiographic (echo) responder = LVESVi decrease 15% and/or LVEF increase 10% 1.Linde et al. JACC 2008;52: Packer et al. JCardFail 2001;7:176-82
9 Methods: ECG analysis Among the REVERSE study population, 511 patients (83,8% of the total population) with complete data set and good quality ECG recordings Core center analysis of baseline (B), discharge (D) and 12-months (12m) ECG s by experienced operator unaware of patient s randomisation order and outcome Analysis on a tracer table, mean QRSd calculated from 9 cardiac cycles in leads II, V1 and V6 (maximum of 3 cycles in each lead) REVERSE baseline: Mean QRSd: 151,7 ± 22,6 ms % QRSd <150ms: 44,2%
10 ECG analysis: reproducibility Reproducibility of the measure 50 random ECG with intrinsic and paced QRS, at two paper speeds (25 and 50mm/s) Analysed twice by the same operator (intra-observer), and compared with a second analysis by an other operator (inter-observer) Intrinsic conduction/paced QRS ECG paper speed Coefficient of variation (%) Non-paced QRS BiV paced p-value 25mm/s 50mm/s p-value Intra-observer variability 1,6 % 6,4 % <0,01 1,4 % 6,7 % <0,001 Inter-observer variability 1,4 % 2,6 % NS 1,6 % 1,9 % NS
11 QRSd at baseline and clinical / echo response to CRT Clinical response Echocardiographic response Responder Non responder p-value Responder Non responder p-value QRSd at baseline (ms) 153,2 ± 21,7 141,2 ± 23,3 <0, ,7 ±20,3 143,7 ±22,4 <0,0001
12 Baseline QRSd and clinical / echo response to CRT QRSd at baseline (ms) Total number of patients Improved/ Unchanged CRT ON group Worsened < (78,9%) 29 (21,1%) (91,7%) 12 (8,3%) > (93,5%) 2 (6,5%) p-value for Cochran-Mantel-Heanszel test = 0,002 QRSd at baseline (ms) Total number of patients Echo responder Echo non responder Echo responder = LVESVi decrease 15% and/or LVEF increase 10% at 12months < (35,0%) 78 (65,0%) (68,3%) 40 (31,7%) > (69,0%) 9 (31,0%) p-value for Cochran-Mantel-Heanszel test < 0,0001
13 Acute QRS change after CRT implantation and clinical / echo response to CRT Acute QRS change: QRSd Discharge (D) - Baseline (B) Clinical response Echocardiographic response Responder Non responder p-value Responder Non responder p-value Acute QRS change D-B -7,7 ±26,1-2,3 ± 24,6 0,21-13,0 ±24-0,8 ± 26,3 0,0001
14 Acute QRS change after CRT implantation and death or HF hospitalization Acute QRS change: QRSd Discharge (D) - Baseline (B) p = 0,028 - Bigger acute QRS change is associated with decrease in HF hospit (p=0,02) and death + HF hospit (p=0,028) - 3 equal-sized groups for death / HF hospit incidence of acute QRS change: High: decrease 21,8-63,2 ms Mid: decrease 21,5 - increase 0,3 ms Low: increase 0,3-65,8 ms
15 Chronic QRS change during CRT and clinical /echo response to CRT Chronic QRS change: QRSd 12-months (12m) - Baseline (B) Clinical response Echocardiographic response Responder Non Responder p-value Responder Non responder p-value QRS change (ms) 12m - B -4,5 ±26,2 5,3 ± 27,9 0,025-10,7 ± 25,8 5,8 ± 25,9 <0,0001
16 Conclusion Acceptable reproducibility of QRS width measurement using a tracer table REVERSE (like MADIT-CRT) shows that QRSd at baseline is predictive of the clinical and echo response to CRT in mildly symptomatic HF patients Acute and chronic QRS narrowing after CRT are associated with greater likelihood to respond
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18 Controversial issues QRS width measurement on surface ECG Where and how to measure QRSd: still not internationally standardized (1) Methodology in multicenter studies : variable or not reported (2) Low accuracy of manual (visual or ECG-ruler) vs automatic methods (3) Accuracy may be improved using caliper or digitized ECGs (4) Even computerized methods show differences (5) Intra- and inter-observer reproducibility? 1.Kligfield et al. JACC 2007;49: Hamlin et al. JPharmToxMethods 2004;50: Kashani et al. JACC 2005;46: Badilini et al. JElectroCard 2006;39:S Tomlinson et al. Europace 2009;11:638-42
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