Dexamethasone for the prevention of postpericardiotomy syndrome: A DExamethasone for Cardiac Surgery substudy

doi:10.1016/j.ahj.2014.03.017

American Heart Journal

Volume 168, Issue 1, July 2014, Pages 126-131.e1

https://doi.org/10.1016/j.ahj.2014.03.017 Get rights and content

Background

The postpericardiotomy syndrome (PPS) is a common complication following cardiac surgery. The pathophysiology remains unclear, although evidence exists that surgical trauma and the use of cardiopulmonary bypass provoke an immune response leading to PPS. We hypothesized that an intraoperative dose of dexamethasone decreases the risk of PPS, by reducing this inflammatory response.

Methods

We performed a subanalysis of the DECS study, which is a multicenter, double-blind, placebo-controlled, randomized trial of 4,494 patients undergoing cardiac surgery with use of cardiopulmonary bypass. The aim of the DECS study was to investigate whether a single intraoperative dose of 1 mg/kg dexamethasone reduced the incidence of a composite of death, myocardial infarction, stroke, renal failure, or respiratory failure, within 30 days of randomization. In this substudy, we retrospectively analyzed the occurrence of PPS in 822 patients who were included in the DECS trial and underwent valvular surgery. Postpericardiotomy syndrome was diagnosed if 2 of 5 listed symptoms were present: unexplained fever, pleuritic chest pain, pericardial or pleural rub, new or worsening pericardial or pleural effusion. All medical charts, x-rays, and echocardiograms were reviewed. Secondary end point was the occurrence of complicated PPS, defined as PPS with need for evacuation of pleural effusion, pericardiocentesis, and tamponade requiring intervention or hospital readmission for PPS. This is a blinded, single-center, post hoc analysis.

Results

Postpericardiotomy syndrome occurred in 119 patients (14.5%). The incidence of PPS after dexamethasone compared with placebo was 13.5% vs 15.5% (relative risk 0.88, 95% CI 0.63-1.22). For complicated PPS, the incidence was 3.8% versus 3.2% (relative risk 1.17, 95% CI 0.57-2.41, P = .66), respectively.

Conclusion

In patients undergoing valvular cardiac surgery, high-dose dexamethasone treatment had no protective effect on the occurrence of PPS or complicated PPS.

Section snippets

Study design and population

The DECS study was a multicenter, randomized, double-blind, placebo-controlled trial comparing a single intraoperative dose of 1 mg/kg dexamethasone with placebo in 4,494 patients undergoing cardiac surgery, between April 13, 2006, and November 23, 2011, in 8 centers in The Netherlands (trial registration: ClinicalTrials.gov, number NCT00293592). Inclusion criteria were age >18 years and elective or urgent cardiac surgery requiring CPB. Exclusion criteria were emergency and off-pump procedures.

Baseline characteristics

Of the 852 patients undergoing valvular surgery, 30 (3.5%) were excluded because of missing echocardiograms (n = 20) or missing clinical data (n = 10). The flowchart of patients in the present study is depicted in Figure. A total of 401 patients were randomized to receive placebo treatment, and 421 patients received dexamethasone. The baseline characteristics are listed in Table I. The study groups were similar with respect to all demographic, clinical, and surgical characteristics, except for

Discussion

The present study is the largest trial investigating the potential beneficial effect of corticosteroids on the incidence of PPS after cardiac surgery. We found no protective effect of a single high intraoperative dose of dexamethasone on the occurrence of PPS or complicated PPS in a cohort of adult patients undergoing valvular surgery.

The etiology of PPS is not exactly known, but multiple factors related to inflammation are involved. First, it has been hypothesized that surgical trauma may

Conclusion

Prophylactic dexamethasone treatment was not able to reduce the occurrence of PPS or complicated PPS. A useful preventive strategy for PPS as a common complication after cardiac surgery remains to be defined, as patients who develop PPS are at risk for complications.

Disclosures

Conflict of interests

All authors report no conflicts of interests.

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However, after multivariable analysis there was no significant association between chronic corticosteroid use and PPS anymore, questioning the potential efficacy of corticosteroid treatment for the prevention of PPS. Earlier trials investigating corticosteroid treatment for the prevention of PPS also do not show convincing evidence in favor of corticosteroids.6,18,19 In our study, treatment for pulmonary disease was defined as pulmonary disease requiring daily inhaled maintenance treatment with bronchodilators and/or corticosteroids.
The study aim was to investigate the long-term prognosis and risk factors of postpericardiotomy syndrome (PPS).
We performed a single-center cohort study in 822 patients undergoing nonemergent valve surgery. Risk factors of PPS were evaluated using multivariable logistic regression analysis. We also compared the incidence of reoperation for tamponade at 1 year between patients with and without PPS. Main secondary outcomes were hospital stay and mortality.
Of the 822 patients, 119 (14.5%) developed PPS. A higher body mass index (odds ratio (OR) per point increase, 0.94; 95% confidence interval (CI), 0.89-0.99) was associated with a lower risk of PPS, whereas preoperative treatment for pulmonary disease without corticosteroids (OR, 2.55; 95% CI, 1.25-5.20) was associated with a higher risk of PPS. The incidence of reoperation for tamponade at 1 year in PPS versus no PPS was 20.9% versus 2.5% (OR, 15.49; 95% CI, 7.14-33.58). One-year mortality in PPS versus no PPS was 4.2% versus 5.5% (OR, 0.68; 95% CI, 0.22-2.08). Median hospital stay was 13 days (interquartile range, 9-18 days) versus 11 days (interquartile range, 8-15 days) (P = .001), respectively.
Despite longer hospital stays and more short-term reoperations for tamponade, patients with PPS had an excellent 1-year prognosis.
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The incidence of postoperative cognitive dysfunction also was not a function of steroid exposure both at 1 month (RR 1.87; 95% CI 0.90-3.88; p = 0.09) and at 1 year (RR 1.98; 95% CI 0.61-6.40; p = 0.24) after surgery.110 In a similar fashion, further cohort analysis examined whether high-dose dexamethasone influenced the risks of redo thoracotomy and postpericardiotomy syndrome after cardiac surgery with CPB.111,112 Steroid exposure in this setting appeared to increase the risk of redo thoracotomy for bleeding (9.7% v 7.3%; RR 1.32; 95% CI 1.09-1.61; p = 0.005).111
Management of pericardial effusion: systematic review of literature
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Revisar sistemáticamente la efectividad del tratamiento no quirúrgico para el manejo del derrame pericárdico moderado o severo.
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Se identificaron un total de 2.998 referencias; posteriormente, se seleccionaron 138 artículos, de los cuales se evaluaron sus resúmenes. Se eligieron dos artículos para la lectura a texto completo, y se aplicaron a estos las guías Strobe, para estudios observacionales, y Consort, para ensayos clínicos aleatorizados. Se evidenció que la pericarditis recurrente ocurrió en 26 de los 120 pacientes en el grupo de colchicina y en 51 de 120 en el grupo placebo, RRR: 0, 49 (IC = 0, 24–0, 65; p = 0, 0009).
la colchicina asociada a antiinflamatorios no esteroides evidenció ser efectiva en la pericarditis aguda idiopática y asimismo en sus recurrencias. Sin embargo, aún es necesario consultar más ensayos clínicos con mayor tamaño de muestra para determinar con exactitud la efectividad del tratamiento.
To present a systematic review of the effectiveness of non-surgical treatment for the management of moderate or severe pericardial effusion.
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A total of 2,998 references where identified, from which 138 articles were later selected, and their Abstracts were evaluated. Two articles were chosen in order to read the full text, and the Strobe guidelines for observational studies and the Consort guidelines for randomised clinical trials were used. It was shown that recurrent pericarditis occurred in 26 of the 120 patients in the colchicine group, and in 51 of 120 in the placebo group, with a relative risk ratio (RRR): 0.49 (95% CI; 0.24– 0.65; P=.0009).
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: Funding: The DECS trial was supported by grants 80-82310-98-08607 from the Netherlands Organization for Health Research and Development (ZonMw) and 2007B125 from the Dutch Heart Foundation. No extramural funding was used to support this substudy.

^d: J.J.H. Bunge and D. van Osch contributed equally to this work.

^e: See online Appendix for complete listing of DECS Study Group.

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Clinical InvestigationSurgeryDexamethasone for the prevention of postpericardiotomy syndrome: A DExamethasone for Cardiac Surgery substudy

Background

Methods

Results

Conclusion

Section snippets

Study design and population

Baseline characteristics

Discussion

Conclusion

Disclosures

Chest

Am J Cardiol

Chest

J Pediatr

J Am Coll Cardiol

J Thorac Cardiovasc Surg

Am Heart J

Prophylactic corticosteroids for cardiopulmonary bypass in adults

Cochrane Database Syst Rev

Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial

JAMA

Postpericardiotomy syndrome: a proposal for diagnostic criteria

J Cardiovasc Med (Hagerstown)

Clinical Investigation
Surgery
Dexamethasone for the prevention of postpericardiotomy syndrome: A DExamethasone for Cardiac Surgery substudy