Implantable cardiac defibrillators for people with non‐ischaemic cardiomyopathy

Mohamad El Moheb<sup>a</sup>; Johny Nicolas<sup>a</sup>; Assem M Khamis; Ghida Iskandarani; Elie A Akl; Marwan Refaat

doi:10.1002/14651858.CD012738.pub2

Cochrane Database of Systematic Reviews

Desfibriladores cardíacos implantables para los pacientes con miocardiopatía no isquémica

Información

DOI:

https://doi.org/10.1002/14651858.CD012738.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

08 diciembre 2018see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Corazón

Copyright:

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

Altmetric:

Citado por:

Citado 0 veces por enlace Crossref Cited-by

Contraer

Autores

Mohamad El Moheb^a

Faculty of Medicine, American University of Beirut Medical Center, Beirut, Lebanon

Co‐first author
Johny Nicolas^a

Faculty of Medicine, American University of Beirut Medical Center, Beirut, Lebanon

Co‐first author
Assem M Khamis

Clinical Research Institute, American University of Beirut Medical Center, Beirut, Lebanon
Ghida Iskandarani

Faculty of Medicine, American University of Beirut Medical Center, Beirut, Lebanon
Elie A Akl

Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon
Marwan Refaat

Correspondencia a: Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon

[email protected]

Contributions of authors

Mohamad El Moheb conceived the review.

Johny Nicolas conceived the review.

Assem Khamis helped with data analysis.

Ghida Iskandarani helped draft the protocol.

Elie A Akl helped draft and revise the review.

Marwan Refaat helped draft the review and revised the review.

Sources of support

Internal sources

No sources of support supplied

External sources

Northwestern University Feinberg School of Medicine and the Northwestern University Clinical and Translational Science (NUCATS) Institute (UL1TR000150), USA.

The Cochrane Heart Group US Satellite is supported by intramural support from the Northwestern University Feinberg School of Medicine and the NUCATS Institute (UL1TR000150).
National Institute for Health Research (NIHR), UK.

This project was supported by the NIHR, via Cochrane Infrastructure funding to the Cochrane Heart Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, the NIHR, the National Health Service (NHS), or the Department of Health.

Declarations of interest

Mohamad El Moheb has no conflict of interest to declare.

Johny Nicolas has no conflict of interest to declare.

Assem Khamis has no conflict of interest to declare.

Ghida Iskandarani has no conflict of interest to declare.

Elie A Akl has no conflict of interest to declare.

Marwan Refaat has no conflict of interest to declare.

Acknowledgements

We thank Cochrane Heart for providing a template protocol.

We thank Nicole Martin and other staff in Cochrane Heart for their assistance with the review.

We thank Cochrane Information Specialist Charlene Bridges and Cochrane Information Specialist Support for running the initial search for us.

We thank Ms Aida Farha (Librarian at the Saab Medical Library at the American University of Beirut) who helped us review the literature.

We thank Ms Lara Kahale and Ms Amena El Harakeh for revising our review.

Version history

Published

Title

Stage

Authors

Version

2018 Dec 08

Implantable cardiac defibrillators for people with non‐ischaemic cardiomyopathy

Review

Mohamad El Moheb, Johny Nicolas, Assem M Khamis, Ghida Iskandarani, Elie A Akl, Marwan Refaat

https://doi.org/10.1002/14651858.CD012738.pub2

2017 Jul 28

Implantable cardiac defibrillators for patients with non‐ischaemic cardiomyopathy

Protocol

Mohamad El Moheb, Johny Nicolas, Ghida Iskandarani, Elie A Akl, Marwan Refaat

https://doi.org/10.1002/14651858.CD012738

Differences between protocol and review

There were several differences between how we conducted the review and how we planned to do so in the protocol (El Moheb 2017).

We initially planned to analyse dichotomous data as risk ratio only. However, since more studies reported hazard ratio than risk ratio, and since hazard ratio accounts for time and censorship, we decided to perform an analysis for hazard ratio as well.

In addition to the databases listed in the protocol (i.e. CENTRAL, MEDLINE, Embase, Web of Science), we searched the grey literature using the European Association for Grey Literature Exploitation (EAGLE) and National Technical Information Serve (NTIS) databases.

In the protocol, we planned to study the cost of ICD treatment compared to optimal medical therapy as a secondary outcome. We revised the Methods section and decided that it would be more valuable to report data on the cost‐effectiveness of ICDs.

In the protocol, we planned to include in our analysis only data from participants with non‐ischaemic cardiomyopathy. We found little data for the effect of ICD on adverse events and quality of life in participants with non‐ischaemic cardiomyopathy. A number of trials that included participants with ischaemic cardiomyopathy and those with non‐ischaemic cardiomyopathy reported adverse events and quality of life for the total population (i.e. participants with ischaemic cardiomyopathy and those with non‐ischaemic cardiomyopathy), but not for non‐ischaemic participants only. Hence, we pooled data from trials with mixed participants when the percentage of participants with ischaemic cardiomyopathy was less than 25%.

We performed a post hoc meta‐regression based on the number of participants included per hospital per year to explore sources of heterogeneity.

We made several modifications with respect to the subgroup analyses. First, we only performed a subgroup analysis for all‐cause mortality and adverse events, as the necessary data were lacking for the other outcomes. Moreover, we defined the following subgroups for analysis in our protocol: follow‐up duration of studies (< 24 months versus 24 to 36 months versus > 36 months), diabetes (yes versus no), mean estimated glomerular filtration rate (< 60 mL/min/1.73 m² versus ≥ 60 mL/min/1.73 m²), and pre‐existing pacemaker (yes versus no). Since no study had a follow‐up time of less than 24 months, we have redefined the subgroup in the review as follows: follow‐up duration of studies < 36 months versus ≥ 36 months. We did not conduct an analysis on the last three subgroups since it would be unlikely for the differences, if detected, to be real rather than due to residual confounding.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 4

Inclusion rate meta‐regression.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.1

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 1 All‐cause mortality (HR) ‐ main analysis.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.2

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 2 All‐cause mortality (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.3

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 3 All‐cause mortality (HR) ‐ 'Risk of bias' sensitivity analysis.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.4

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 4 All‐cause mortality (HR) ‐ amiodarone sensitivity analysis.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.5

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 5 All‐cause mortality (HR) ‐ subgroup analysis (age).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.6

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 6 All‐cause mortality (HR) ‐ subgroup analysis (gender).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.7

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 7 All‐cause mortality (HR) ‐ subgroup analysis (CRT).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.8

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 8 All‐cause mortality (HR) ‐ subgroup analysis (NYHA).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.9

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 9 All‐cause mortality (HR) ‐ subgroup analysis (heart failure duration).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.10

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 10 All‐cause mortality (HR) ‐ subgroup analysis (LVEF).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.11

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 11 All‐cause mortality (HR) ‐ subgroup analysis (year of publication).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.12

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 12 All‐cause mortality (HR) ‐ subgroup analysis (mean follow‐up time).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.13

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 13 Cardiovascular mortality (HR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.14

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 14 Cardiovascular mortality (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.15

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 15 Sudden cardiac death (HR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.16

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 16 Sudden cardiac death (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.17

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 17 Adverse events ‐ device infection (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.18

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 18 Adverse events ‐ pneumothorax (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.19

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 19 Adverse events ‐ serious device infection (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.20

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 20 Adverse events ‐ bleeding requiring intervention (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.21

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 21 Device infection subgroup analysis (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.22

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 22 Serious device infection subgroup analysis (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.23

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 23 Non‐cardiovascular mortality (HR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.24

Comparison 1 ICD plus optimal medical therapy compared to optimal medical therapy alone, Outcome 24 Non‐cardiovascular mortality (RR).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Summary of findings for the main comparison. ICD plus optimal medical therapy compared to optimal medical therapy alone for people with non‐ischaemic cardiomyopathy

ICD plus optimal medical therapy compared to optimal medical therapy alone for people with non‐ischaemic cardiomyopathy Population: people with non‐ischaemic cardiomyopathy Setting: USA, Israel, New Zealand, Canada, Germany, and Denmark Intervention: implantable cardioverter‐defibrillator in addition to optimal medical therapy Comparator: optimal medical therapy alone
Outcomes length of follow‐up (range)	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**
				Risk with optimal medical therapy alone	Risk difference with ICD plus optimal medical therapy
All‐cause mortality (HR) ‐ main analysis^a 16.5 to 67.6 months	3128 (6 RCTs)	⊕⊕⊕⊕ HIGH ¹	HR 0.78 (0.66 to 0.92)	Study population
				216 per 1000	43 fewer per 1000 (68 fewer to 15 fewer)
Cardiovascular mortality (RR)^b 22.8 to 67.6 months	1781 (4 RCTs)	⊕⊕⊕⊝ MODERATE ²	RR 0.75 (0.46 to 1.21)	Study population
				142 per 1000	35 fewer per 1000 (77 fewer to 30 more)
Sudden cardiac death (HR)^a 24 to 67.6 months	1677 (3 RCTs)	⊕⊕⊕⊕ HIGH	HR 0.45 (0.29 to 0.70)	Study population
				74 per 1000	40 fewer per 1000 (52 fewer to 22 fewer)
Adverse events 67.7 months	1116 (1 RCT)	⊕⊕⊕⊝ MODERATE ³	‐	The adverse events reported were: device infection, serious device infection, bleeding requiring intervention, and pneumothorax. An analysis of 1116 participants showed that ICD when added to optimal medical therapy probably increases the risk of device infection and pneumothorax (RR 1.36, 95% CI 0.77 to 2.40 and RR 1.85, 95% CI 0.69 to 4.96, respectively). Implantable cardioverter‐defibrillator probably slightly increases the risk for serious device infection (RR 1.16, 95% CI 0.56 to 2.42) and may increase the risk for bleeding requiring intervention (RR 3.02, 95% CI 0.12 to 74.01).
Noncardiovascular mortality (RR)^b 22.8 to 67.6 months	1781 (4 RCTs)	⊕⊕⊕⊝ MODERATE ²	RR 1.17 (0.81 to 1.68)	Study population
				57 per 1000	10 more per 1000 (11 fewer to 39 more)
Health‐related quality of life 24 to 29 months	561 (2 RCTs)	⊕⊕⊕⊝ MODERATE ^{4, 5}	‐	The health‐related quality of life of 561 participants extracted from 2 studies was evaluated using 4 different scales. None of the studies showed a statistically significant difference in score between the ICD and the control group.
First ICD‐related hospitalisation ‐ not reported	‐	‐	‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HR: hazard ratio; ICD: implantable cardioverter‐defibrillator; RCT: randomised controlled trial; RR: risk ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aBoth HR and RR were calculated. However, we reported HR since it is more informative for this outcome, pooling more participants than RR. ^bBoth HR and RR were calculated. However, we reported RR since it is more informative for this outcome, pooling more participants than HR. ¹One of six studies appears to be at high risk of bias (COMPANION). However, the weight of this study in the meta‐analysis was only 5.3%. We conducted a sensitivity analysis excluding this study, and the results did not change significantly. ²We downgraded the certainty of evidence by one level to moderate due to imprecision. The confidence interval of the absolute effect includes values suggesting clinically significant benefit and values suggesting no effect. ³We downgraded the certainty of evidence by one level to moderate due to imprecision. The confidence interval of effect estimate has a very wide range and includes values suggesting clinically significant benefit and values suggesting no effect. ⁴Clinical (population, intervention and control) and methodological (study design and quality) heterogeneity across the two studies was low. ⁵We downgraded the certainty of evidence by one level to moderate due to serious risk of bias. Lack of blinding could affect a subjective outcome.

Summary of findings for the main comparison. ICD plus optimal medical therapy compared to optimal medical therapy alone for people with non‐ischaemic cardiomyopathy

Ir a la tabla de la revisión

Table 1. Health‐related quality of life

Study	Questionnaire		Total number of participants	Measure	Baseline score	Score/change at 3 months	Score/change at 6 months	Score/change at 12 months	Score/change at 30 months	Notes
AMIOVIRT	Quality of Well‐Being Schedule		103	Baseline vs 1 year (mean ± SD)	Amiodarone: 70 ± 17 ICD: 67 ± 15	N/A	N/A	Amiodarone: 70 ± 22 ICD: 74 ± 19	N/A	Scores were not significantly different at 1 year between ICD and amiodarone groups (P > 0.05).
	State‐Trait Anxiety Inventory				Amiodarone: 79 ± 21 ICD: 75 ± 25			Amiodarone: 67 ± 20 ICD: 61 ± 17
DEFINITE	MLHFQ	Physical	458	Change in quality of life (mean ± SD per month)	Placebo: 20 ± 12 ICD: 20 ± 12	Placebo: ‐0.7 ± 0.1/month ICD: ‐0.8 ± 0.1/month	N/A	Placebo: 0.7 ± 0.3/year ICD: 0.6 ± 0.2/year		No significant difference in long‐term MLHFQ scores between ICD and control groups
		Emotional			Placebo: 10 ± 8 ICD: 11 ± 8	Placebo: ‐1.6 ± 0.2/month ICD: ‐1.5 ± 0.2/month		N/A
	SF‐12	Physical (PCS)			Placebo: 38 ± 10 ICD: 37 ± 11	Placebo: +1.0 ± 0.2/month ICD: +1.2 ± 0.2/month		Placebo: ‐0.4 ± 0.3/year ICD: ‐0.2 ± 0.2/year		No significant difference in long‐term PCS scores between ICD and placebo groups
		Mental (MCS)			Placebo: 47 ± 11 ICD: 45 ± 11	Placebo: 0.3 ± 0.2/month ICD: 1.0 ± 0.2/month		Placebo: ‐1.8 ± 0.3/year ICD: ‐0.7 ± 0.3/year P = 0.89		No significant difference in long‐term MCS scores between ICD and placebo groups (P = 0.89)
Abbreviations: ICD: implantable cardioverter‐defibrillator; MCS: mental component summary; MLHFQ: Minnesota Living With Heart Failure Questionnaire; N/A: not available; PCS: physical component symmary; SD: standard deviation; SF‐12: 12‐item Short Form Health Survey ¹95% confidence intervals for difference in mean values for continuous variables.

Table 1. Health‐related quality of life

Ir a la tabla de la revisión

Table 2. Values used for inclusion rate meta‐regression

Study	Start year	End year	Duration	Country	Number of participants	Number of centres	Number of patients included per hospital per year
AMIOVIRT	1996	2001	4 years 10 months	USA	103	10	2.13
CAT	1991	1997	5 years 9 months	Germany	104	15	1.21
COMPANION	2000	2002	3 years	USA	555	128	1.45
DANISH	2007	2016	8 years 7 months	Denmark	1116	5	26
DEFINITE	2002	2004	3 years	USA/Israel	458	48	3.18
SCD‐HeFT	1997	2001	3 years 10 months	Canada/New Zealand/USA	792	148	1.40

Table 2. Values used for inclusion rate meta‐regression

Ir a la tabla de la revisión

Table 3. Comparison of reviews

Our study

Outcomes

All‐cause mortality

Yes

0.78 (0.66, 0.92)

Yes

0.8 (0.67, 0.96)

Yes

0.88 (0.73, 1.07)

Yes

0.78 (0.66, 0.92)

Yes

0.75 (0.61, 0.93)

Yes

0.79 (0.64, 0.93)

Yes

0.76 (0.65, 0.91)

Yes

0.77 (0.64, 0.91)

Yes

0.81 (0.72, 0.91)

Yes

0.76 (0.64, 0.91)

Cardiovascular mortality

Yes

0.80 (0.47, 1.35)

No

Yes

0.66 (0.42, 1.03)

Yes

0.77 (0.60, 0.98)

No

Yes

0.80 (0.40, 1.59)

No

Sudden cardiac death

Yes

0.45 (0.29, 0.70)

Yes

0.51 (0.34, 0.76)

Yes

0.47 (0.30, 0.73)

Yes

0.45 (0.29, 0.70)

No

Yes

0.47 (0.30, 0.73)

No

Yes

0.44 (0.17, 1.12)

No

Non‐cardiovascular mortality

Yes

1.17 (0.81, 1.68)

No

Yes

1.08 (0.58, 2.02)

No

Adverse events

Yes

No

Cost‐effectiveness

Yes

No

Studies included

COMPANION

Yes

No

Yes

No

Yes

No

Yes

CAT

Yes

AMIOVIRT

Yes

No

Yes

DANISH

Yes

DEFINITE

Yes

SCD‐HeFT

Yes

No

Yes

Analysis performed (HR/RR/OR)

HR & HR

HR

RR

HR & RR

HR

RR

HR

OR

GRADE

Yes

No

Yes

No

Yes

No

Risk of bias

Yes

No

Yes

No

Yes

No

Yes

Subgroup analysis

Yes

No

Yes

No

Yes

No

HR: hazard ratio; OR: odds ratio; RR: risk ratio

Table 3. Comparison of reviews

Ir a la tabla de la revisión

Table 4. Comparison of reviews 2

Outcomes

All‐cause mortality

Yes

0.79 (0.66, 0.91)

Yes

0.84 (0.71, 0.99)

Yes

0.832 (0.712, 0.973)

Yes

0.76 (0.64, 0.90)

Yes

0.79 (0.68, 0.91)

Yes

0.78 (0.66, 0.92)

Yes

0.75 (0.64, 0.89)

Yes

0.77 (0.64, 0.93)

Yes

0.83 (0.71, 0.97)

Yes

0.76 (0.64, 0.91)

Yes

0.76 (0.63, 0.91)

Cardiovascular mortality

No

Yes

0.83 (0.62, 1.12)

No

Yes

0.75 (0.39, 1.44)

No

Sudden cardiac death

No

Yes

0.47 (0.30, 0.73)

No

Yes

0.46 (0.29, 0.71)

Yes

0.45 (0.28, 0.71)

Yes

0.43 (0.27, 0.69)

Yes

0.54 (0.21, 1.37)

Yes

0.40 (0.18, 0.90)

Yes

0.27 (0.15, 0.50)

Non‐cardiovascular mortality

No

Yes

1.18 (0.76, 1.83)

No

Adverse events

No

Cost‐effectiveness

No

Studies included

COMPANION

Yes

No

Yes

No

Yes

CAT

Yes

AMIOVIRT

Yes

No

Yes

DANISH

Yes

DEFINITE

Yes

SCD‐HeFT

Yes

Analysis performed (HR/RR/OR)

RR

HR

RR

HR

RR

OR

RR

GRADE

No

Yes

No

Risk of bias

No

Yes

No

Yes

No

Yes

No

Yes

No

Subgroup analysis

No

Yes

No

Yes

HR: hazard ratio; OR: odds ratio; RR: risk ratio

Table 4. Comparison of reviews 2

Ir a la tabla de la revisión

Comparison 1. ICD plus optimal medical therapy compared to optimal medical therapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All‐cause mortality (HR) ‐ main analysis Show forest plot	6	3128	Hazard Ratio (Random, 95% CI)	0.78 [0.66, 0.92]

2 All‐cause mortality (RR) Show forest plot	4	1781	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.72, 1.05]

3 All‐cause mortality (HR) ‐ 'Risk of bias' sensitivity analysis Show forest plot	5	2573	Hazard Ratio (Random, 95% CI)	0.79 [0.67, 0.95]

4 All‐cause mortality (HR) ‐ amiodarone sensitivity analysis Show forest plot	5	3025	Hazard Ratio (Random, 95% CI)	0.78 [0.65, 0.92]

5 All‐cause mortality (HR) ‐ subgroup analysis (age) Show forest plot	1	1116	Hazard Ratio (Random, 95% CI)	0.74 [0.40, 1.40]

5.1 Age ≥ 65	1	768	Hazard Ratio (Random, 95% CI)	0.98 [0.73, 1.31]
5.2 Age < 65	1	348	Hazard Ratio (Random, 95% CI)	0.51 [0.29, 0.91]
6 All‐cause mortality (HR) ‐ subgroup analysis (gender) Show forest plot	1	1116	Hazard Ratio (Random, 95% CI)	0.88 [0.68, 1.13]

6.1 Male	1	809	Hazard Ratio (Random, 95% CI)	0.85 [0.64, 1.12]
6.2 Female	1	307	Hazard Ratio (Random, 95% CI)	1.03 [0.57, 1.87]
7 All‐cause mortality (HR) ‐ subgroup analysis (CRT) Show forest plot	6	3128	Hazard Ratio (Random, 95% CI)	0.78 [0.65, 0.92]

7.1 CRT	2	1200	Hazard Ratio (Random, 95% CI)	0.79 [0.51, 1.23]
7.2 No CRT	5	1928	Hazard Ratio (Random, 95% CI)	0.76 [0.62, 0.93]
8 All‐cause mortality (HR) ‐ subgroup analysis (NYHA) Show forest plot	1	1116	Hazard Ratio (Random, 95% CI)	0.86 [0.67, 1.10]

8.1 NYHA I‐II	1	597	Hazard Ratio (Random, 95% CI)	0.92 [0.63, 1.35]
8.2 NYHA III‐IV	1	519	Hazard Ratio (Random, 95% CI)	0.81 [0.58, 1.13]
9 All‐cause mortality (HR) ‐ subgroup analysis (heart failure duration) Show forest plot	1	1115	Hazard Ratio (Random, 95% CI)	0.83 [0.65, 1.06]

9.1 Heart failure duration < 18 months	1	531	Hazard Ratio (Random, 95% CI)	0.88 [0.54, 1.43]
9.2 Heart failure duration ≥ 18 months	1	584	Hazard Ratio (Random, 95% CI)	0.81 [0.61, 1.08]
10 All‐cause mortality (HR) ‐ subgroup analysis (LVEF) Show forest plot	1	1116	Hazard Ratio (Random, 95% CI)	0.83 [0.65, 1.07]

10.1 LVEF < 25%	1	506	Hazard Ratio (Random, 95% CI)	0.87 [0.62, 1.22]
10.2 LVEF ≥ 25%	1	610	Hazard Ratio (Random, 95% CI)	0.79 [0.55, 1.14]
11 All‐cause mortality (HR) ‐ subgroup analysis (year of publication) Show forest plot	6		Hazard Ratio (Random, 95% CI)	0.78 [0.66, 0.92]

11.1 Year of publication before 2003	2		Hazard Ratio (Random, 95% CI)	0.82 [0.45, 1.50]
11.2 Year of publication 2004 or after	4		Hazard Ratio (Random, 95% CI)	0.77 [0.65, 0.93]
12 All‐cause mortality (HR) ‐ subgroup analysis (mean follow‐up time) Show forest plot	6		Hazard Ratio (Random, 95% CI)	0.78 [0.66, 0.92]

12.1 Mean follow‐up time < 36 months	2		Hazard Ratio (Random, 95% CI)	0.68 [0.44, 1.06]
12.2 Mean follow‐up time ≥ 36 months	4		Hazard Ratio (Random, 95% CI)	0.80 [0.66, 0.96]
13 Cardiovascular mortality (HR) Show forest plot	2	1219	Hazard Ratio (Random, 95% CI)	0.78 [0.58, 1.05]

14 Cardiovascular mortality (RR) Show forest plot	4	1781	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.46, 1.21]

15 Sudden cardiac death (HR) Show forest plot	3	1677	Hazard Ratio (Random, 95% CI)	0.45 [0.29, 0.70]

16 Sudden cardiac death (RR) Show forest plot	3	1677	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.30, 0.73]

17 Adverse events ‐ device infection (RR) Show forest plot	1	1116	Risk Ratio (M‐H, Random, 95% CI)	1.36 [0.77, 2.40]

18 Adverse events ‐ pneumothorax (RR) Show forest plot	1	1116	Risk Ratio (M‐H, Random, 95% CI)	1.85 [0.69, 4.96]

19 Adverse events ‐ serious device infection (RR) Show forest plot	1	1116	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.56, 2.42]

20 Adverse events ‐ bleeding requiring intervention (RR) Show forest plot	1	1116	Risk Ratio (M‐H, Random, 95% CI)	3.02 [0.12, 74.01]

21 Device infection subgroup analysis (RR) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

21.1 CRT	1	645	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.43, 1.63]
21.2 No CRT	1	471	Risk Ratio (M‐H, Random, 95% CI)	6.08 [1.38, 26.86]
22 Serious device infection subgroup analysis (RR) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

22.1 CRT	1	645	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.34, 1.95]
22.2 No CRT	1	471	Risk Ratio (M‐H, Random, 95% CI)	3.04 [0.62, 14.90]
23 Non‐cardiovascular mortality (HR) Show forest plot	2	1219	Hazard Ratio (Random, 95% CI)	1.11 [0.72, 1.71]

24 Non‐cardiovascular mortality (RR) Show forest plot	4	1781	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.81, 1.68]

Comparison 1. ICD plus optimal medical therapy compared to optimal medical therapy alone

Ir a la tabla de la revisión

The Cochrane Library

Scolaris Language Selector Scolaris Language Selector

Idioma de la Revisión Cochrane

Idioma de la web

Scolaris Content Language Banner Portlet Scolaris Content Language Banner Portlet

Scolaris Content Display Scolaris Content Display

Desfibriladores cardíacos implantables para los pacientes con miocardiopatía no isquémica

Información

Cifras del artículo

Altmetric:

Citado por:

Autores

Contributions of authors

Sources of support

Internal sources

External sources

Declarations of interest

Acknowledgements

Version history

Differences between protocol and review

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

PICO

PICO

Population

Intervention

Comparison

Outcome

Scolaris Language Selector Scolaris Language Selector

Scolaris Content Display Scolaris Content Display

Instituciones a las que se accedió previamente

Scolaris Content Display Scolaris Content Display

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso

	Idioma de la Revisión Cochrane Escoja su idioma de preferencia para las revisiones Cochrane y otros contenidos. Las secciones sin una traducción aparecerán en inglés.

	Idioma de la web Escoja su idioma de preferencia para la web de la Biblioteca Cochrane.

Idioma de la Revisión Cochrane

Idioma de la web

Información

Cifras del artículo

Altmetric:

Citado por:

Autores

Contributions of authors

Sources of support

Internal sources

External sources

Declarations of interest

Acknowledgements

Version history

Differences between protocol and review

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

PICO

PICO

Population

Intervention

Comparison

Outcome

Copiar o descargar referencia

Idioma de la Revisión Cochrane

Idioma de la web

Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso