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A systematic review of intravenous gamma globulin for therapy of acute myocarditis.

Robinson JL, Hartling L, Crumley E, Vandermeer B, Klassen TP - BMC Cardiovasc Disord (2005)

Bottom Line: The objective of this study was to systematically review the literature evaluating this practice.Ten case reports and two case series (total n = 21) described improvement in cardiac function after administration of IVGG; two case reports showed no benefit of IVGG.One case of hemolytic anemia was attributed to IVGG.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Pediatrics, Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada. jr3@ualberta.ca

ABSTRACT

Background: Intravenous gamma globulin (IVGG) is commonly used in the management of acute myocarditis. The objective of this study was to systematically review the literature evaluating this practice.

Methods: We conducted a comprehensive search (electronic databases, trials registries, conference proceedings, reference lists, contact with authors) to identify studies evaluating the use of IVGG in adults and children with a clinical or histologically proven diagnosis of myocarditis of possible viral etiology and symptoms of less than six months duration. Two reviewers independently screened the searches, applied inclusion criteria, and graded the evidence.

Results: Results were described qualitatively; data were not pooled because only one randomized controlled trial (RCT) with 62 patients was identified. The RCT showed no benefit with respect to cardiac function, functional outcome, or event-free survival. A small, uncontrolled trial (n = 10) showed significant improvement in LVEF from a mean of 24% to 41% 12 months after IVGG in nine survivors. A retrospective cohort study of pediatric patients showed improvement in cardiac function and a trend towards improved survival in patients receiving IVGG (n = 21) versus historic controls (n = 25). Ten case reports and two case series (total n = 21) described improvement in cardiac function after administration of IVGG; two case reports showed no benefit of IVGG. One case of hemolytic anemia was attributed to IVGG.

Conclusion: There is insufficient data from methodologically strong studies to recommend routine use of IVGG for acute myocarditis. Future randomized studies that take into account the etiology of acute myocarditis will be required to determine the efficacy of IVGG.

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Flow diagram of studies considered for inclusion in the review
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Figure 1: Flow diagram of studies considered for inclusion in the review

Mentions: Figure 1 presents a flow diagram of studies considered for inclusion in the review. Only one RCT evaluating IVGG for acute myocarditis has been reported to date [16]. The trial was of moderate methodological quality according to the Jadad scale (3 out of maximum 5 points, where 5 indicates highest quality); allocation concealment was unclear. The study enrolled 62 adults (mean age 43.0 +/- 12.3 years; 37 men), of which only ten had cellular inflammation on endomyocardial biopsy (four fulfilled the Dallas criteria for acute myocarditis, and three for borderline myocarditis). The authors reported that the given sample size would provide 80% power to detect a difference between groups of ≥ 8% in ejection fraction (EF) change scores. Patients were randomized to receive either 2 g/kg IVGG or an equivalent volume of 0.1% albumin in a blinded fashion. The incidence of death or requirement for cardiac transplant or placement of a left ventricular assist device was low in both groups. Event-free survival was not significantly different but favored the control group (OR 0.52, 95% CI 0.12, 2.30). Follow-up at 6 and 12 months showed no significant difference in improvement in left ventricular ejection fraction for cases and controls (mean difference 0.00, 95% CI -0.07, 0.07 at six months; 0.01, 95% CI -0.06, 0.08 at 12 months). Functional capacity as assessed by peak oxygen consumption was not significantly different in the two groups at 12 months (mean difference -0.80, 95% CI -4.57, 2.97). Infusion-related side effects occurred significantly more often in the treated group (RD 0.33, 95% CI 0.17, 0.50; number needed to harm = 3, 95% CI 2, 6), but all appeared to be mild.


A systematic review of intravenous gamma globulin for therapy of acute myocarditis.

Robinson JL, Hartling L, Crumley E, Vandermeer B, Klassen TP - BMC Cardiovasc Disord (2005)

Flow diagram of studies considered for inclusion in the review
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1173096&req=5

Figure 1: Flow diagram of studies considered for inclusion in the review
Mentions: Figure 1 presents a flow diagram of studies considered for inclusion in the review. Only one RCT evaluating IVGG for acute myocarditis has been reported to date [16]. The trial was of moderate methodological quality according to the Jadad scale (3 out of maximum 5 points, where 5 indicates highest quality); allocation concealment was unclear. The study enrolled 62 adults (mean age 43.0 +/- 12.3 years; 37 men), of which only ten had cellular inflammation on endomyocardial biopsy (four fulfilled the Dallas criteria for acute myocarditis, and three for borderline myocarditis). The authors reported that the given sample size would provide 80% power to detect a difference between groups of ≥ 8% in ejection fraction (EF) change scores. Patients were randomized to receive either 2 g/kg IVGG or an equivalent volume of 0.1% albumin in a blinded fashion. The incidence of death or requirement for cardiac transplant or placement of a left ventricular assist device was low in both groups. Event-free survival was not significantly different but favored the control group (OR 0.52, 95% CI 0.12, 2.30). Follow-up at 6 and 12 months showed no significant difference in improvement in left ventricular ejection fraction for cases and controls (mean difference 0.00, 95% CI -0.07, 0.07 at six months; 0.01, 95% CI -0.06, 0.08 at 12 months). Functional capacity as assessed by peak oxygen consumption was not significantly different in the two groups at 12 months (mean difference -0.80, 95% CI -4.57, 2.97). Infusion-related side effects occurred significantly more often in the treated group (RD 0.33, 95% CI 0.17, 0.50; number needed to harm = 3, 95% CI 2, 6), but all appeared to be mild.

Bottom Line: The objective of this study was to systematically review the literature evaluating this practice.Ten case reports and two case series (total n = 21) described improvement in cardiac function after administration of IVGG; two case reports showed no benefit of IVGG.One case of hemolytic anemia was attributed to IVGG.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Pediatrics, Stollery Children's Hospital and University of Alberta, Edmonton, Alberta, Canada. jr3@ualberta.ca

ABSTRACT

Background: Intravenous gamma globulin (IVGG) is commonly used in the management of acute myocarditis. The objective of this study was to systematically review the literature evaluating this practice.

Methods: We conducted a comprehensive search (electronic databases, trials registries, conference proceedings, reference lists, contact with authors) to identify studies evaluating the use of IVGG in adults and children with a clinical or histologically proven diagnosis of myocarditis of possible viral etiology and symptoms of less than six months duration. Two reviewers independently screened the searches, applied inclusion criteria, and graded the evidence.

Results: Results were described qualitatively; data were not pooled because only one randomized controlled trial (RCT) with 62 patients was identified. The RCT showed no benefit with respect to cardiac function, functional outcome, or event-free survival. A small, uncontrolled trial (n = 10) showed significant improvement in LVEF from a mean of 24% to 41% 12 months after IVGG in nine survivors. A retrospective cohort study of pediatric patients showed improvement in cardiac function and a trend towards improved survival in patients receiving IVGG (n = 21) versus historic controls (n = 25). Ten case reports and two case series (total n = 21) described improvement in cardiac function after administration of IVGG; two case reports showed no benefit of IVGG. One case of hemolytic anemia was attributed to IVGG.

Conclusion: There is insufficient data from methodologically strong studies to recommend routine use of IVGG for acute myocarditis. Future randomized studies that take into account the etiology of acute myocarditis will be required to determine the efficacy of IVGG.

Show MeSH
Related in: MedlinePlus