Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy

The VALID-CRT risk score

Maurizio Gasparini, Catherine Klersy, Cristophe Leclercq, Maurizio Lunati, Maurizio Landolina, Angelo Auricchio, Massimo Santini, Giuseppe Boriani, Alessandro Proclemer, Francisco Leyva-Leon

Research output: Contribution to journalArticle

Abstract

Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 ± 6.85%; NYHA class III-IV 77.5%; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.

Original languageEnglish
Pages (from-to)717-724
Number of pages8
JournalEuropean Journal of Heart Failure
Volume17
Issue number7
DOIs
Publication statusPublished - 1 Jul 2015

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Cardiac Resynchronization Therapy
Mortality
Survival
Stroke Volume
Cardiac Resynchronization Therapy Devices
Atrial Fibrillation
Coronary Disease

Keywords

  • Cardiac resynchronization therapy
  • Heart failure
  • Prognostic index
  • Risk-stratification

Cite this

Gasparini, Maurizio ; Klersy, Catherine ; Leclercq, Cristophe ; Lunati, Maurizio ; Landolina, Maurizio ; Auricchio, Angelo ; Santini, Massimo ; Boriani, Giuseppe ; Proclemer, Alessandro ; Leyva-Leon, Francisco. / Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy : The VALID-CRT risk score. In: European Journal of Heart Failure. 2015 ; Vol. 17, No. 7. pp. 717-724.
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title = "Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy: The VALID-CRT risk score",
abstract = "Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79{\%} male; LVEF 25.9 ± 6.85{\%}; NYHA class III-IV 77.5{\%}; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70{\%}) and validation (30{\%}) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1{\%} to 28.2{\%} at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3{\%}, 18.6{\%}, 27.6{\%}, 36.1{\%}, and 58.8{\%}, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.",
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author = "Maurizio Gasparini and Catherine Klersy and Cristophe Leclercq and Maurizio Lunati and Maurizio Landolina and Angelo Auricchio and Massimo Santini and Giuseppe Boriani and Alessandro Proclemer and Francisco Leyva-Leon",
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Gasparini, M, Klersy, C, Leclercq, C, Lunati, M, Landolina, M, Auricchio, A, Santini, M, Boriani, G, Proclemer, A & Leyva-Leon, F 2015, 'Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy: The VALID-CRT risk score', European Journal of Heart Failure, vol. 17, no. 7, pp. 717-724. https://doi.org/10.1002/ejhf.269

Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy : The VALID-CRT risk score. / Gasparini, Maurizio; Klersy, Catherine; Leclercq, Cristophe; Lunati, Maurizio; Landolina, Maurizio; Auricchio, Angelo; Santini, Massimo; Boriani, Giuseppe; Proclemer, Alessandro; Leyva-Leon, Francisco.

In: European Journal of Heart Failure, Vol. 17, No. 7, 01.07.2015, p. 717-724.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Validation of a simple risk stratification tool for patients implanted with Cardiac Resynchronization Therapy

T2 - The VALID-CRT risk score

AU - Gasparini, Maurizio

AU - Klersy, Catherine

AU - Leclercq, Cristophe

AU - Lunati, Maurizio

AU - Landolina, Maurizio

AU - Auricchio, Angelo

AU - Santini, Massimo

AU - Boriani, Giuseppe

AU - Proclemer, Alessandro

AU - Leyva-Leon, Francisco

PY - 2015/7/1

Y1 - 2015/7/1

N2 - Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 ± 6.85%; NYHA class III-IV 77.5%; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.

AB - Aims Mortality after cardiac resynchronization therapy (CRT) is difficult to predict. We sought to design and validate a simple prognostic score for patients implanted with CRT, based on readily available clinical variables, including age, gender, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, presence/absence of atrial fibrillation, presence/absence of atrioventricular junction ablation, coronary heart disease, diabetes, and implantation of a CRT device with defibrillation. Methods For predictive modelling, 5153 consecutive patients enrolled in 72 European centres (79% male; LVEF 25.9 ± 6.85%; NYHA class III-IV 77.5%; QRS 158.4 ± 32.3 ms) were randomly split into derivation (70%) and validation (30%) samples. The primary endpoint was total mortality and the secondary endpoint was cardiovascular mortality. The final predictive model fit was assessed by plotting observed vs. predicted survival. Results In the entire cohort, 1004 deaths occurred over a follow-up of 14 409 person years. Total mortality ranged from 3.1% to 28.2% at 2 years in the first and fifth quintile of the risk score, respectively. At 5 years, total mortality was 10.3%, 18.6%, 27.6%, 36.1%, and 58.8%, from the first to the fifth quintile. Compared with the lowest quintile (Q), total mortality was significantly higher in the other four quintiles [Q2 hazard ratio (HR) = 1.71; Q3 HR = 2.20; Q4 HR = 4.03; Q5 HR = 8.03; all P < 0.001). The final model, which was based on the entire cohort using the above variables, showed a good discrimination (Harrell's c = 0.70) and high explained variation (0.26). The mean predicted survival fitted well with the observed survival for up to 6 years of follow-up. Conclusions The VALID-CRT risk score, which is based on routine, readily available clinical variables, reliably predicted the long-term total and cardiovascular mortality in patients undergoing CRT. While this score cannot be used to predict the benefit of CRT, it may be useful for predicting survival after CRT. This may have useful implications for follow-up.

KW - Cardiac resynchronization therapy

KW - Heart failure

KW - Prognostic index

KW - Risk-stratification

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