Hyperbaric oxygen therapy for acute coronary syndrome

Michael H Bennett; Jan P Lehm; Nigel Jepson

doi:10.1002/14651858.CD004818.pub4

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Figure 1

Study flow diagram

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Figure 2

Forest plot of comparison: 1 Death, outcome: 1.1 Death at any time.

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Analysis 1.1

Comparison 1: Death, Outcome 1: Death at any time

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Analysis 1.2

Comparison 1: Death, Outcome 2: Death ‐ best case scenario

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Analysis 1.3

Comparison 1: Death, Outcome 3: Death ‐ worst case scenario

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Analysis 2.1

Comparison 2: Major Adverse Cardiac Events, Outcome 1: Major Adverse Cardiac Events

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Analysis 2.2

Comparison 2: Major Adverse Cardiac Events, Outcome 2: MACE ‐ Best case scenario

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Analysis 2.3

Comparison 2: Major Adverse Cardiac Events, Outcome 3: MACE ‐ worst case scenario

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Analysis 2.4

Comparison 2: Major Adverse Cardiac Events, Outcome 4: Recurrent acute myocardial infarction (AMI)

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Analysis 2.5

Comparison 2: Major Adverse Cardiac Events, Outcome 5: Recurrent AMI ‐ best case scenario

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Analysis 2.6

Comparison 2: Major Adverse Cardiac Events, Outcome 6: Recurrent AMI ‐ Worst case scenario

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Analysis 3.1

Comparison 3: Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole), Outcome 1: Overall (CHB, VF and asystole combined)

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Analysis 3.2

Comparison 3: Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole), Outcome 2: Significant dysrrythmias (complete heart block, ventricular fibrillation or asystole)

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Analysis 3.3

Comparison 3: Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole), Outcome 3: Overall best case

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Analysis 3.4

Comparison 3: Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole), Outcome 4: Overall worst case

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Analysis 4.1

Comparison 4: Time to pain relief, Outcome 1: Time to relief of pain

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Analysis 5.1

Comparison 5: Magnitude of cardiac enzyme changes, Outcome 1: 12 hour Plasma Creatine Phosphokinase

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Analysis 5.2

Comparison 5: Magnitude of cardiac enzyme changes, Outcome 2: 24 hour Plasma Creatine Phosphate

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Analysis 5.3

Comparison 5: Magnitude of cardiac enzyme changes, Outcome 3: Maximum Plasma Creatine Phosphate

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Analysis 6.1

Comparison 6: Improvement in left ventricular function, Outcome 1: Improved contraction in at least one segment (post‐HBOT echo)

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Analysis 6.2

Comparison 6: Improvement in left ventricular function, Outcome 2: Left Ventricular Ejection Fraction‐ % (final estimate)

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Analysis 7.1

Comparison 7: Length of Stay, Outcome 1: Overall length of stay (days)

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Analysis 8.1

Comparison 8: Adverse events of therapy, Outcome 1: Total adverse events

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Summary of findings 1. hyperbaric oxygen therapy for acute coronary syndrome

Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)
hyperbaric oxygen therapy for acute coronary syndrome
Patient or population: patients with acute coronary syndrome Settings: Acute care hospital Intervention: hyperbaric oxygen therapy
	Assumed risk	Corresponding risk
	Control	hyperbaric oxygen therapy
Death at any time	Study population		RR 0.58 (0.36 to 0.92)	614 (5 studies)	⊕⊕⊝⊝ low^1,2
	116 per 1000	67 per 1000 (42 to 107)
	Medium risk population
	102 per 1000	59 per 1000 (37 to 94)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Critical outcome ² Small sample with low numbers of events

Summary of findings 1. hyperbaric oxygen therapy for acute coronary syndrome

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Summary of findings 2. hyperbaric oxygen therapy for acute coronary syndrome

Outcomes	*Illustrative comparative risks (95% CI)**		No of Participants (studies)	Quality of the evidence (GRADE)
hyperbaric oxygen therapy for acute coronary syndrome
Patient or population: patients with acute coronary syndrome Settings: acute care hospital Intervention: hyperbaric oxygen therapy
	Assumed risk	Corresponding risk
	Control	hyperbaric oxygen therapy
12 hour Plasma Creatine Phosphokinase		The mean 12 hour Plasma Creatine Phosphokinase in the intervention groups was 138 lower (843.83 lower to 567.83 higher)	84 (1 study)	⊕⊕⊕⊝ moderate¹
24 hour Plasma Creatine Phosphate		The mean 24 hour Plasma Creatine Phosphate in the intervention groups was 65 lower (530.96 lower to 400.96 higher)	72 (1 study)	⊕⊕⊕⊝ moderate¹
Maximum Plasma Creatine Phosphate		The mean Maximum Plasma Creatine Phosphate in the intervention groups was 493.16 lower (838.74 to 147.58 lower)	184 (2 studies)	⊕⊕⊕⊕ high
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Single trial only

Summary of findings 2. hyperbaric oxygen therapy for acute coronary syndrome

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Comparison 1. Death

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Death at any time Show forest plot	5	614	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.36, 0.92]

1.1.1 Subjects presenting in cardiogenic shock	1	12	Risk Ratio (M‐H, Fixed, 95% CI)	0.61 [0.32, 1.18]
1.1.2 Subjects presenting without cardiogenic shock	5	602	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.33, 0.98]
1.2 Death ‐ best case scenario Show forest plot	5	617	Risk Ratio (M‐H, Fixed, 95% CI)	0.37 [0.23, 0.58]

1.3 Death ‐ worst case scenario Show forest plot	5	617	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.91, 1.96]

Comparison 1. Death

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Comparison 2. Major Adverse Cardiac Events

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Major Adverse Cardiac Events Show forest plot	1	61	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.02, 0.85]

2.2 MACE ‐ Best case scenario Show forest plot	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 0.61]

2.3 MACE ‐ worst case scenario Show forest plot	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.23, 1.40]

2.4 Recurrent acute myocardial infarction (AMI) Show forest plot	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.08, 0.95]

2.5 Recurrent AMI ‐ best case scenario Show forest plot	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.05, 0.55]

2.6 Recurrent AMI ‐ Worst case scenario Show forest plot	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.42, 2.02]

Comparison 2. Major Adverse Cardiac Events

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Comparison 3. Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Overall (CHB, VF and asystole combined) Show forest plot	1	208	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.39, 0.89]

3.2 Significant dysrrythmias (complete heart block, ventricular fibrillation or asystole) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.2.1 Complete heart block	1	208	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.12, 0.84]
3.2.2 Ventricular fibrillation	1	208	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.36, 1.71]
3.2.3 Asystole	1	208	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.34, 1.56]
3.3 Overall best case Show forest plot	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.51 [0.34, 0.77]

3.4 Overall worst case Show forest plot	1	221	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.50, 1.06]

Comparison 3. Significant dysrhythmias (complete heart block, ventricular fibrillation, asystole)

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Comparison 4. Time to pain relief

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Time to relief of pain Show forest plot	1	81	Mean Difference (IV, Fixed, 95% CI)	‐353.00 [‐487.55, ‐218.45]

Comparison 4. Time to pain relief

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Comparison 5. Magnitude of cardiac enzyme changes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 12 hour Plasma Creatine Phosphokinase Show forest plot	1	84	Mean Difference (IV, Fixed, 95% CI)	‐138.00 [‐843.83, 567.83]

5.2 24 hour Plasma Creatine Phosphate Show forest plot	1	72	Mean Difference (IV, Fixed, 95% CI)	‐65.00 [‐530.96, 400.96]

5.3 Maximum Plasma Creatine Phosphate Show forest plot	2	184	Mean Difference (IV, Fixed, 95% CI)	‐493.16 [‐838.74, ‐147.58]

Comparison 5. Magnitude of cardiac enzyme changes

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Comparison 6. Improvement in left ventricular function

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
6.1 Improved contraction in at least one segment (post‐HBOT echo) Show forest plot	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	0.09 [0.01, 1.40]

6.2 Left Ventricular Ejection Fraction‐ % (final estimate) Show forest plot	2	190	Mean Difference (IV, Random, 95% CI)	5.47 [2.19, 8.75]

Comparison 6. Improvement in left ventricular function

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Comparison 7. Length of Stay

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
7.1 Overall length of stay (days) Show forest plot	1	64	Mean Difference (IV, Fixed, 95% CI)	‐1.80 [‐3.70, 0.10]

Comparison 7. Length of Stay

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Comparison 8. Adverse events of therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
8.1 Total adverse events Show forest plot	3		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1.1 Tympanic membrane rupture	2	269	Risk Ratio (M‐H, Fixed, 95% CI)	4.56 [0.19, 107.54]
8.1.2 Acute neurological oxygen toxicity	2	274	Risk Ratio (M‐H, Fixed, 95% CI)	Not estimable
8.1.3 Claustrophobia	1	208	Risk Ratio (M‐H, Fixed, 95% CI)	31.60 [1.92, 521.22]

Comparison 8. Adverse events of therapy

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