Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F19%3A73599440" target="_blank" >RIV/61989592:15110/19:73599440 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.sciencedirect.com/science/article/pii/S0140673619319968" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0140673619319968</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/S0140-6736(19)31996-8" target="_blank" >10.1016/S0140-6736(19)31996-8</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

Popis výsledku v původním jazyce

Background A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. Methods We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (&lt;= 35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. Findings Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2.7 years [IQR 2.0-3.3] in the ICD group and 1.2 years [0.8-2.7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0.57 [95% CI 0.41-0.79]; p=0.0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0.0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7.5 deg or higher (n=199; adjusted HR 0.25 [95% CI 0.13-0.47] for the ICD group vs the control group; p&lt;0.0001) than in those with periodic repolarisation dynamics less than 7.5 deg (n=1166; adjusted HR 0.69 [95% CI 0.47-1.00]; p=0.0492; P-interaction=0.0056). The number needed to treat was 18.3 (95% CI 10.6-4895.3) in patients with periodic repolarisation dynamics less than 7.5 deg and 3.1 (2.6-4.8) in those with periodic repolarisation dynamics of 7.5 deg or higher. Interpretation Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Název v anglickém jazyce

Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator: a prospective, controlled, multicentre cohort study

Popis výsledku anglicky

Background A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. Methods We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (&lt;= 35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. Findings Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2.7 years [IQR 2.0-3.3] in the ICD group and 1.2 years [0.8-2.7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0.57 [95% CI 0.41-0.79]; p=0.0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0.0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7.5 deg or higher (n=199; adjusted HR 0.25 [95% CI 0.13-0.47] for the ICD group vs the control group; p&lt;0.0001) than in those with periodic repolarisation dynamics less than 7.5 deg (n=1166; adjusted HR 0.69 [95% CI 0.47-1.00]; p=0.0492; P-interaction=0.0056). The number needed to treat was 18.3 (95% CI 10.6-4895.3) in patients with periodic repolarisation dynamics less than 7.5 deg and 3.1 (2.6-4.8) in those with periodic repolarisation dynamics of 7.5 deg or higher. Interpretation Periodic repolarisation dynamics predict mortality reductions associated with prophylactic implantation of ICDs in contemporarily treated patients with ischaemic or non-ischaemic cardiomyopathy. Periodic repolarisation dynamics could help to guide treatment decisions about prophylactic ICD implantation. Copyright (C) 2019 Elsevier Ltd. All rights reserved.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2019

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

LANCET

ISSN

0140-6736

e-ISSN

—

Svazek periodika

394

Číslo periodika v rámci svazku

10206

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

1344-1351

Kód UT WoS článku

000489613700029

EID výsledku v databázi Scopus

2-s2.0-85072928936