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1.
Pediatr Cardiol ; 39(8): 1535-1539, 2018 Dec.
Article in English | MEDLINE | ID: mdl-29948034

ABSTRACT

Post-pericardiotomy syndrome (PPS) is an inflammatory process involving the pleura, pericardium, or both and occurs after cardiothoracic surgery. Surgical atrial septal defect (ASD) closure is associated with higher incidence of PPS post-operatively as compared to other operations. Reported incidence of PPS varies from 1 to 40%. NSAIDs are often used to treat PPS and in our center, some practitioners have prescribed ibuprofen prophylactically. This study sought to investigate the impact of prophylactic treatment with ibuprofen on the development and severity of PPS following surgical ASD closure, with particular attention to secundum-type ASDs. We retrospectively reviewed clinical and operative data of all surgical ASD repairs in our center from 1/2007 to 7/2017. ASDs were grouped by subtype. PPS was considered positive if the primary cardiologist diagnosed and documented clinical signs of PPS on post-operative outpatient follow-up. Records were reviewed to confirm documented diagnosis of PPS. A total of 245 cases were reviewed with 207 having sufficient data. Median age was 2 years (range 4 months-27 years), female 57%. Overall incidence of PPS was 10%. There was no difference in incidence of PPS in those prescribed ibuprofen as compared to those who were not. This was true for both the entire cohort and the subgroup analysis (P = 1.0). Four patients overall required pericardiocentesis, none of whom received prophylactic ibuprofen. Prophylactic ibuprofen prescription following surgical ASD repair did not reduce the rate of PPS in our cohort.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Cardiac Surgical Procedures/adverse effects , Heart Septal Defects, Atrial/surgery , Ibuprofen/administration & dosage , Postpericardiotomy Syndrome/prevention & control , Adolescent , Adult , Aged , Female , Humans , Incidence , Infant , Male , Postpericardiotomy Syndrome/epidemiology , Retrospective Studies
2.
Expert Rev Cardiovasc Ther ; 16(6): 405-412, 2018 Jun.
Article in English | MEDLINE | ID: mdl-29745734

ABSTRACT

INTRODUCTION: Post-pericardiotomy syndrome is a well-recognized inflammatory phenomenon that commonly occurs in patients following cardiac surgery. Due to the increased morbidity and resource utilization associated with this condition, research has recently focused on ways of preventing its prevention this condition; primarily using colchicine, NSAIDs and corticosteroids. Areas covered: This systematic review summarizes the three clinical studies that have used corticosteroids for PPS primary prevention in the perioperative period. Due to the heterogeneity amongst these three studies in terms of population (both pediatric and adult patients), surgical procedure, administration regimen and results (only 1/3 studies reporting a positive effect), the effectiveness of corticosteroids remains unproven. Expert commentary: Corticosteroids have shown to be useful in the treatment of PPS but have thus far have shown mixed results as a primary prevention method. Research on patients taking corticosteroids pre-operatively have shown a significant reduction in the risk of developing PPS. Further research is required to determine if corticosteroids are helpful in preventing PPS in patient undergoing cardiac surgery, before any recommendations regarding their use in cardiovascular surgery can be made.


Subject(s)
Adrenal Cortex Hormones/administration & dosage , Pericardiectomy/methods , Postpericardiotomy Syndrome/prevention & control , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cardiac Surgical Procedures/methods , Colchicine/administration & dosage , Humans , Primary Prevention
3.
Eur Rev Med Pharmacol Sci ; 20(3): 514-9, 2016.
Article in English | MEDLINE | ID: mdl-26914128

ABSTRACT

OBJECTIVE: Postpericardiotomy syndrome (PPS) occurs in 10-40% of patients after cardiac operations. Pericardial effusions and tamponade occurring > 7 days after surgery are usually related to PPS and remain an important cause of cardiac surgery-related morbidity and mortality; therefore, preventing PPS is important. Colchicine affords safe and efficacious protection against PPS and related complications. However, the roles of corticosteroids and nonsteroidal anti-inflammatory drugs in PPS prevention remains unclear. This study aimed to determine whether the intraoperative use of single-dose methylprednisolone can effectively prevent PPS. PATIENTS AND METHODS: This retrospective study included 100 patients undergoing elective coronary artery bypass grafting (CABG) who received a single intraoperative dose of 1 mg/kg methylprednisolone. A further 100 patients undergoing CABG, who were not given methylprednisolone, comprised the control group. The presence and severity of pericardial effusion was determined by echocardiography, with chest X-ray used to assess pleural effusion. RESULTS: PPS occurrence and pericardial effusion occurrence were significantly lower in patients who received methylprednisolone (p = 0.02 and p = 0.007 respectively). Although the differences were not statistically significant, pericardial and pleural effusions were more severe in the control group than in the methylprednisolone group. Logistic regression analysis demonstrated that methylprednisolone administration was independently associated with prevention of PPS (OR 0.8, 95% CI 0.25-0.91, p <  0.026). CONCLUSIONS: Intraoperative, single-dose methylprednisolone may confer protection against PPS in patients undergoing CABG.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , Cardiac Surgical Procedures/adverse effects , Intraoperative Care/methods , Methylprednisolone/administration & dosage , Postpericardiotomy Syndrome/diagnosis , Postpericardiotomy Syndrome/prevention & control , Aged , Coronary Artery Bypass/adverse effects , Echocardiography/methods , Female , Humans , Male , Middle Aged , Postpericardiotomy Syndrome/etiology , Retrospective Studies
4.
Vasc Health Risk Manag ; 11: 373-8, 2015.
Article in English | MEDLINE | ID: mdl-26170687

ABSTRACT

OBJECTIVE: Postpericardiotomy syndrome (PPS), which is thought to be related to autoimmune phenomena, represents a common postoperative complication in cardiac surgery. Late pericardial effusions after cardiac surgery are usually related to PPS and can progress to cardiac tamponade. Preventive measures can reduce postoperative morbidity and mortality related to PPS. In a previous study, diclofenac was suggested to ameliorate autoimmune diseases. The aim of this study was to determine whether postoperative use of diclofenac is effective in preventing early PPS after cardiac surgery. METHODS: A total of 100 patients who were administered oral diclofenac for postoperative analgesia after cardiac surgery and until hospital discharge were included in this retrospective study. As well, 100 patients undergoing cardiac surgery who were not administered nonsteroidal anti-inflammatory drugs were included as the control group. The existence and severity of pericardial effusion were determined by echocardiography. The existence and severity of pleural effusion were determined by chest X-ray. RESULTS: PPS incidence was significantly lower in patients who received diclofenac (20% vs. 43%) (P<0.001). Patients given diclofenac had a significantly lower incidence of pericardial effusion (15% vs. 30%) (P=0.01). Although not statistically significant, pericardial and pleural effusion was more severe in the control group than in the diclofenac group. The mean duration of diclofenac treatment was 5.11±0.47 days in patients with PPS and 5.27±0.61 days in patients who did not have PPS (P=0.07). Logistic regression analysis demonstrated that diclofenac administration (odds ratio [OR] 0.34, 95% confidence interval [CI] 0.18-0.65, P=0.001) was independently associated with PPS occurrence. CONCLUSION: Postoperative administration of diclofenac may have a protective role against the development of PPS after cardiac surgery.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Diclofenac/administration & dosage , Postpericardiotomy Syndrome/epidemiology , Postpericardiotomy Syndrome/prevention & control , Adult , Aged , Case-Control Studies , Echocardiography , Female , Humans , Logistic Models , Male , Middle Aged , Postpericardiotomy Syndrome/complications , Postpericardiotomy Syndrome/drug therapy , Thoracic Surgical Procedures/adverse effects , Turkey/epidemiology
5.
Eur Heart J Cardiovasc Pharmacother ; 1(2): 117-25, 2015 Apr.
Article in English | MEDLINE | ID: mdl-27533981

ABSTRACT

The aim of this study is to assess the safety and efficacy of colchicine in prevention of recurrence, symptom reduction, and complications in patients with pericarditis. Pericarditis is an important cause of chest pain leading to frequent emergency room visits and reduced quality of life. Pericarditis has traditionally been treated symptomatically with anti-inflammatory drugs, but growing evidence suggests the use of colchicine for both first episode and recurrent pericarditis in the prevention of recurrences and reducing symptoms. PubMed, EMBASE, and the Cochrane Central register of controlled trials (CENTRAL) databases were searched and the studies were selected using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. All randomized clinical trials with head-to-head comparison between colchicine and standard of care were included. A total of five studies were included in the primary analysis of pericarditis and three in the analysis for prevention of post-pericardiotomy syndrome (PPS). Colchicine reduced the incidence rate of recurrent pericarditis in patients with both the first episode and recurrent pericarditis, compared with placebo [16.7 vs. 36.8%; risk ratio (RR) 0.46; 95% confidence interval (CI) 0.36-0.58; P < 0.00001; I(2) = 0%], with a significant increase in adverse effects (12.5 vs. 8.5%, RR 1.45; 95% CI 1.09-1.95; P = 0.01; I(2) = 0%) and drug withdrawal rate (10.8 vs. 8.5%; RR 1.44; 95% CI 1.01-2.05; P = 0.04; I(2) = 14%). In addition, colchicine decreased symptom duration in patients with recurrent pericarditis (63.1 vs. 78.6%; RR 0.58; 95% CI 0.39-0.87; P = 0.02; I(2) = 65%), but had no significant effect on symptom duration in patients with an initial episode of pericarditis (RR 0.91; 95% CI 0.65-1.28; P = 0.57; I(2) = 0%). Colchicine was superior to placebo in the prevention of PPS at 1 year (13.2 vs. 25.8%, RR 0.56, 95% CI 0.42-0.76; P < 0.01). In this quantitative analysis of randomized clinical data, colchicine demonstrated superior clinical efficacy compared with standard therapy for the prevention of recurrent pericarditis and PPS at the cost of a small increase in the incidence rate of side effects.


Subject(s)
Colchicine/administration & dosage , Pericardiectomy , Pericarditis/prevention & control , Postpericardiotomy Syndrome/prevention & control , Randomized Controlled Trials as Topic , Secondary Prevention/methods , Anti-Inflammatory Agents , Humans , Recurrence , Treatment Outcome , Tubulin Modulators/administration & dosage
7.
JAMA ; 312(10): 1016-23, 2014 Sep 10.
Article in English | MEDLINE | ID: mdl-25172965

ABSTRACT

IMPORTANCE: Postpericardiotomy syndrome, postoperative atrial fibrillation (AF), and postoperative effusions may be responsible for increased morbidity and health care costs after cardiac surgery. Postoperative use of colchicine prevented these complications in a single trial. OBJECTIVE: To determine the efficacy and safety of perioperative use of oral colchicine in reducing postpericardiotomy syndrome, postoperative AF, and postoperative pericardial or pleural effusions. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, double-blind, placebo-controlled, randomized clinical trial among 360 consecutive candidates for cardiac surgery enrolled in 11 Italian centers between March 2012 and March 2014. At enrollment, mean age of the trial participants was 67.5 years (SD, 10.6 years), 69% were men, and 36% had planned valvular surgery. Main exclusion criteria were absence of sinus rhythm at enrollment, cardiac transplantation, and contraindications to colchicine. INTERVENTIONS: Patients were randomized to receive placebo (n=180) or colchicine (0.5 mg twice daily in patients ≥70 kg or 0.5 mg once daily in patients <70 kg; n=180) starting between 48 and 72 hours before surgery and continued for 1 month after surgery. MAIN OUTCOMES AND MEASURES: Occurrence of postpericardiotomy syndrome within 3 months; main secondary study end points were postoperative AF and pericardial or pleural effusion. RESULTS: The primary end point of postpericardiotomy syndrome occurred in 35 patients (19.4%) assigned to colchicine and in 53 (29.4%) assigned to placebo (absolute difference, 10.0%; 95% CI, 1.1%-18.7%; number needed to treat = 10). There were no significant differences between the colchicine and placebo groups for the secondary end points of postoperative AF (colchicine, 61 patients [33.9%]; placebo, 75 patients [41.7%]; absolute difference, 7.8%; 95% CI, -2.2% to 17.6%) or postoperative pericardial/pleural effusion (colchicine, 103 patients [57.2%]; placebo, 106 patients [58.9%]; absolute difference, 1.7%; 95% CI, -8.5% to 11.7%), although there was a reduction in postoperative AF in the prespecified on-treatment analysis (placebo, 61/148 patients [41.2%]; colchicine, 38/141 patients [27.0%]; absolute difference, 14.2%; 95% CI, 3.3%-24.7%). Adverse events occurred in 21 patients (11.7%) in the placebo group vs 36 (20.0%) in the colchicine group (absolute difference, 8.3%; 95% CI; 0.76%-15.9%; number needed to harm = 12), but discontinuation rates were similar. No serious adverse events were observed. CONCLUSIONS AND RELEVANCE: Among patients undergoing cardiac surgery, perioperative use of colchicine compared with placebo reduced the incidence of postpericardiotomy syndrome but not of postoperative AF or postoperative pericardial/pleural effusion. The increased risk of gastrointestinal adverse effects reduced the potential benefits of colchicine in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01552187.


Subject(s)
Atrial Fibrillation/prevention & control , Cardiac Surgical Procedures , Colchicine/therapeutic use , Postoperative Complications/prevention & control , Postpericardiotomy Syndrome/prevention & control , Tubulin Modulators/therapeutic use , Aged , Colchicine/adverse effects , Double-Blind Method , Female , Gastrointestinal Diseases/chemically induced , Humans , Male , Middle Aged , Pericardial Effusion/prevention & control , Perioperative Care , Pleural Effusion/prevention & control , Tubulin Modulators/adverse effects
8.
Am Heart J ; 168(1): 126-31.e1, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24952869

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Dexamethasone/administration & dosage , Postpericardiotomy Syndrome/prevention & control , Aged , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Glucocorticoids/administration & dosage , Humans , Incidence , Intraoperative Period , Male , Middle Aged , Netherlands/epidemiology , Postpericardiotomy Syndrome/epidemiology , Prognosis , Retrospective Studies , Survival Rate/trends
9.
G Ital Cardiol (Rome) ; 13(10): 665-72, 2012 Oct.
Article in Italian | MEDLINE | ID: mdl-23022970

ABSTRACT

Colchicine has been recently demonstrated to be efficacious and safe for the prevention of several postoperative complications including the postpericardiotomy syndrome (PPS), postoperative pericardial and pleural effusions, and postoperative atrial fibrillation according to the results of the COPPS trial. The aim of the present paper is to critically review the premise, results and implications of this trial for current clinical practice and future research. The COPPS study is a multicenter, double-blind, randomized trial. On the third postoperative day, 360 patients (mean age 65.7 ± 12.3 years, 66% males) were randomized to receive placebo or colchicine (1.0 mg twice daily for the first day followed by 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). Colchicine significantly reduced the incidence of the PPS at 12 months [relative risk reduction (RRR) 58%; number needed to treat (NNT) 8], postoperative pericardial (RRR 43.9%; NNT 10) and pleural effusions (RRR 52.3%; NNT 8) as well as the incidence of postoperative atrial fibrillation (RRR, 45%; NNT 11) with similar side effects in the study groups. Colchicine is a promising drug for the prevention of several postoperative complications (PPS, postoperative effusions and postoperative atrial fibrillation) based on its anti-inflammatory effects and good tolerability at the study doses. Although further studies are needed before routine recommendation of the drug will be possible for patients undergoing cardiac surgery, colchicine seems to have the potentiality of becoming a new therapeutic standard in the perioperative period.


Subject(s)
Atrial Fibrillation/prevention & control , Cardiac Surgical Procedures/adverse effects , Colchicine/therapeutic use , Pericardial Effusion/prevention & control , Pleural Effusion/prevention & control , Postpericardiotomy Syndrome/prevention & control , Humans , Multicenter Studies as Topic , Postoperative Complications/prevention & control , Randomized Controlled Trials as Topic
11.
Curr Opin Pulm Med ; 18(4): 366-74, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22487945

ABSTRACT

PURPOSE OF REVIEW: The postpericardiotomy syndrome (PPS) is a relatively common complication following cardiac surgery, whose epidemiology is not well known because there are no standardized definitions. The aim of the present study is to review more recent updates on the diagnosis, therapy, prognosis, and especially prevention of the PPS. RECENT FINDINGS: Recent studies suggest that it is time to develop standardized criteria for the diagnosis of the PPS to allow early recognition and treatment. Limited knowledge is still available on the pathogenesis of the syndrome, but it is now clear that the presumptive immune-mediated origin is not able to explain all cases. Treatment is largely empirical and based on antiinflammatory drugs either nonsteroidal or corticosteroids with the possible adjunct of colchicine, that has been demonstrated as a promising well tolerated and efficacious means to prevent several postoperative complications, including the PPS, pericardial and pleural effusions, and atrial fibrillation. SUMMARY: Contemporary series of the PPS are scarce. About 20% of patients are affected by the syndrome after cardiac surgery with a significant increase in hospital stay, readmissions, and management costs. The overall short-term and middle-term prognosis is relatively good but constriction may develop in a long-term follow-up in a minority of patients. Therapeutic and preventive strategies, especially based on the use of colchicine, are worthy of further investigations to develop a more evidence-based approach to treatment and prevention.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Atrial Fibrillation/etiology , Cardiac Surgical Procedures , Colchicine/therapeutic use , Postpericardiotomy Syndrome/diagnosis , Adult , Atrial Fibrillation/prevention & control , Colchicine/adverse effects , Humans , Postpericardiotomy Syndrome/drug therapy , Postpericardiotomy Syndrome/prevention & control , Prognosis , Risk Factors , Treatment Outcome
12.
Int J Cardiol ; 159(1): 1-4, 2012 Aug 09.
Article in English | MEDLINE | ID: mdl-22360943

ABSTRACT

The post-pericardiotomy syndrome (PPS) is not uncommon following cardiac surgery and may be a cause of severe complications (cardiac tamponade, large pleural effusion), hospital stay prolongation, and readmissions. The estimated incidence of the syndrome has a relatively wide range affecting from 10 to 40% of patients, depending on the adopted diagnostic criteria, institution, and type of cardiac surgery. On this basis, there is a need for standardized criteria for epidemiological and clinical purposes. These criteria should be adopted in future clinical trials and studies on the PPS as well. Such criteria should include both clinical and instrumental findings considering the spectrum of pleuropericardial involvement of the syndrome. In any case, pharmacologic preventive strategies are worthy of further investigation. At present, data from 2 RCTs enrolling a total of 471 patients, have shown that colchicine was associated with a reduced risk of PPS (OR=0.38 95% CI 0.22 to 0.65). Available evidence suggests that colchicine 0.5-1.0mg/day is effective for reducing recurrences of pericarditis and at the same doses is efficacious to prevent the PPS.


Subject(s)
Pericardiectomy/adverse effects , Postpericardiotomy Syndrome/diagnosis , Postpericardiotomy Syndrome/prevention & control , Humans , Postpericardiotomy Syndrome/etiology , Randomized Controlled Trials as Topic/methods
13.
Am J Cardiol ; 108(8): 1183-7, 2011 Oct 15.
Article in English | MEDLINE | ID: mdl-21798503

ABSTRACT

Contemporary series of postpericardiotomy syndrome (PPS) are lacking. The aim of this study was to evaluate the incidence, time course, features at presentation, risk factors, and prognosis of PPS. The study population consisted of 360 consecutive candidates to cardiac surgery enrolled in a prospective cohort study. PPS was diagnosed in 54 patients (15.0%; mean age 66 ± 12 years, 48.1% women): 79.6% in the first month, 13.0% in the second month, and 7.4% in the third month. Specific symptoms, signs, or features were pleuritic chest pain (55.6%), fever (53.7%), elevated markers of inflammation (74.1%), pericardial effusion (88.9%), and pleural effusion (92.6%). Cardiac tamponade was rare at presentation (1.9%). Female gender (hazard ratio 2.32, 95% confidence interval 1.22 to 4.39, p = 0.010), and pleura incision (hazard ratio 4.31, 95% confidence interval 2.22 to 8.33, p <0.001) were identified as risk factors in multivariate analysis. Patients with PPS had longer cardiac surgery stays (11.5 ± 4.6 vs 9.9 ± 4.7 days, p = 0.021) and rehabilitation stays (16.4 ± 6.7 vs 12.4 ± 6.2 days, p <0.001) and more readmissions (13.0% vs 0%, p <0.001). Adverse events after a mean follow-up period of 19.8 months were recurrences (3.7%), cardiac tamponade (<2%), but no cases of constriction. In conclusion, despite advances in cardiac surgery techniques, PPS is a common postoperative complication, generally occurring in the first 3 months after surgery. Severe complications are rare, but the syndrome is responsible for hospital stay prolongation and readmissions. Female gender and pleura incision are risk factors for PPS.


Subject(s)
Colchicine/therapeutic use , Postpericardiotomy Syndrome/epidemiology , Aged , Echocardiography , Female , Follow-Up Studies , Humans , Incidence , Israel/epidemiology , Length of Stay/trends , Magnetic Resonance Imaging, Cine , Male , Middle Aged , Postpericardiotomy Syndrome/diagnosis , Postpericardiotomy Syndrome/prevention & control , Prognosis , Prospective Studies , Recurrence , Risk Factors , Survival Rate/trends , Tomography, X-Ray Computed
14.
Am J Cardiol ; 108(4): 575-9, 2011 Aug 15.
Article in English | MEDLINE | ID: mdl-21624554

ABSTRACT

The natural history of postpericardiotomy syndrome (PPS), a relatively common complication of cardiac surgery, varies from mild self-limited episodes to cases with protracted courses, recurrences, and readmissions. Preventive strategies may be valuable to decrease morbidity and management costs. We thus aimed to conduct a comprehensive systematic review on available data for pharmacologic primary prevention of PPS. Controlled clinical studies were searched in several databases and were included provided they focused on pharmacologic primary prevention of PPS. Random-effect odds ratios (ORs) were computed for occurrence of PPS. From the initial sample of 343 citations, 4 controlled clinical trials for primary prevention of PPS were finally included (894 patients); 3 studies were double-blind randomized controlled trials (RCTs). Treatment comparisons were colchicine versus placebo (2 RCTs enrolling 471 patients), methylprednisolone versus placebo (1 RCT on 246 pediatric patients), and aspirin versus historical controls (1 nonrandomized study on 177 pediatric patients). Meta-analytic pooling showed that colchicine was associated with decreased risk of PPS (OR 0.38, 0.22 to 0.65). Data on methylprednisolone (OR 1.13, 0.57 to 2.25) or aspirin (OR 1.00, 0.16 to 6.11) were negative but inconclusive because these were based on 1 study and/or a nonrandomized design. In conclusion, clinical evidence for primary prevention of PPS is still limited to few studies of variable quality. Nevertheless, available data suggest a beneficial profile for colchicine and open a new therapeutic strategy for prevention of PPS.


Subject(s)
Meta-Analysis as Topic , Postpericardiotomy Syndrome/prevention & control , Primary Prevention , Randomized Controlled Trials as Topic , Humans , Risk Factors
15.
Ann Pharmacother ; 45(6): 803-6, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21652788

ABSTRACT

OBJECTIVE: To review literature regarding the safety and efficacy of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS). DATA SOURCES: Searches of MEDLINE (1966-April 2011) and Cochrane Database (1993-April 2011) were conducted. Key search terms included postpericardiotomy syndrome, postcardiac injury syndrome, and colchicine. Limits were set for articles written in English with human subjects. Additional data were identified through bibliographic reviews. STUDY SELECTION AND DATA EXTRACTION: All English-language articles identified from the data sources were evaluated. All primary data were eligible for inclusion if they evaluated the safety and/or efficacy of colchicine for the primary prevention of PPS. Two prospective trials were identified and included for review. DATA SYNTHESIS: PPS occurs in 10-40% of patients who undergo cardiac surgery and is associated with significant morbidity. Effective medications used for the treatment of PPS include nonsteroidal antiinflammatory drugs or corticosteroids. Unfortunately, effective drug therapy for the primary prevention of PPS does not exist. Colchicine, an antiinflammatory agent with possible immunopathic antifibroblast properties, has shown benefit in the treatment and secondary prevention of pericarditis; thus, its use for primary prevention of PPS has been investigated. Limited data evaluating colchicine for the primary prevention of PPS have been published. However, results of the largest, well-designed trial showed positive efficacy outcomes for colchicine reducing the incidence of PPS with minimal adverse effects. CONCLUSIONS: At this time, there are not sufficient data to recommend colchicine as routine therapy for the primary prevention of PPS in patients undergoing cardiac surgery. Large clinical trials need to be conducted.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Colchicine/therapeutic use , Postpericardiotomy Syndrome/prevention & control , Anti-Inflammatory Agents/adverse effects , Cardiac Surgical Procedures/adverse effects , Colchicine/adverse effects , Humans , Postpericardiotomy Syndrome/etiology , Primary Prevention/methods , Treatment Outcome
16.
Eur Heart J ; 31(22): 2749-54, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20805112

ABSTRACT

AIMS: No drug has been proven efficacious to prevent the post-pericardiotomy syndrome (PPS), but colchicine seems safe and effective for the treatment and prevention of pericarditis. The aim of the COlchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS) trial is to test the efficacy and safety of colchicine for the primary prevention of the PPS. METHODS AND RESULTS: The COPPS study is a multicentre, double-blind, randomized trial. On the third post-operative day, 360 patients (mean age 65.7 ± 12.3 years, 66% males), 180 in each treatment arm, were randomized to receive placebo or colchicine (1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients <70 kg or intolerant to the highest dose). The primary efficacy endpoint was the incidence of PPS at 12 months. Secondary endpoint was the combined rate of disease-related hospitalization, cardiac tamponade, constrictive pericarditis, and relapses. Baseline characteristics were well balanced between the study groups. Colchicine significantly reduced the incidence of the PPS at 12 months compared with placebo (respectively, 8.9 vs. 21.1%; P = 0.002; number needed to treat = 8). Colchicine also reduced the secondary endpoint (respectively, 0.6 vs. 5.0%; P = 0.024). The rate of side effects (mainly related to gastrointestinal intolerance) was similar in the colchicine and placebo groups (respectively, 8.9 vs. 5.0%; P = 0.212). CONCLUSION: Colchicine is safe and efficacious in the prevention of the PPS and its related complications and may halve the risk of developing the syndrome following cardiac surgery. ClinicalTrials.gov number, NCT00128427.


Subject(s)
Colchicine/therapeutic use , Postpericardiotomy Syndrome/prevention & control , Tubulin Modulators/therapeutic use , Aged , Cardiac Tamponade/etiology , Double-Blind Method , Female , Hospitalization/statistics & numerical data , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Pericarditis/etiology , Recurrence , Treatment Outcome
17.
Ann Pharmacother ; 43(12): 2075-81, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19903861

ABSTRACT

OBJECTIVE: To review the efficacy and safety of colchicine as primary and secondary prophylaxis for pericarditis. DATA SOURCES: We searched MEDLINE, EMBASE, PubMed, BIOSIS Previews, International Pharmaceutical Abstracts, Web of Science, and CENTRAL for controlled studies from database inception date to July 2009. Search terms included colchicine, pericarditis, and postpericardiotomy syndrome (PPS). STUDY SELECTION AND DATA EXTRACTION: Prospective, randomized, controlled trials investigating the use of colchicine in preventing pericarditis were included. Data extracted included design, inclusion criteria, demographics, interventions, background therapy, and pericarditis-related clinical outcomes. DATA SYNTHESIS: Data were synthesized qualitatively, given variable study designs. Three trials were identified. A single trial examining primary prevention evaluated the use of colchicine versus placebo for preventing PPS in patients undergoing cardiopulmonary bypass grafting. No significant reduction in PPS was found. Two studies examined secondary prevention of pericarditis, comparing colchicine plus aspirin versus aspirin alone. One study examined using these comparators to treat a first episode of pericarditis. After 3 months, there was a significant reduction in recurrent pericarditis with colchicine plus aspirin (11.7% vs 33%; p = 0.009). Another study examined this same regimen in recurrent pericarditis, finding a significant reduction in recurrence after 6 months (21% vs 45%; p = 0.02). CONCLUSIONS: Despite limitations in study designs, current evidence suggests a role for colchicine in the secondary prophylaxis for recurrent pericarditis. The evidence for use of colchicine as primary prophylaxis in PPS is indeterminate; therefore, colchicine cannot be recommended routinely. While colchicine should be recommended for the prevention of recurrent pericarditis, questions regarding the optimal regimen and long-term safety profile need to be further elucidated.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Colchicine/therapeutic use , Pericarditis/prevention & control , Anti-Inflammatory Agents/adverse effects , Anti-Inflammatory Agents/pharmacology , Cardiopulmonary Bypass/adverse effects , Colchicine/adverse effects , Colchicine/pharmacology , Humans , Postpericardiotomy Syndrome/prevention & control , Primary Prevention/methods , Randomized Controlled Trials as Topic , Secondary Prevention/methods
18.
Klin Med (Mosk) ; 87(7): 29-32, 2009.
Article in Russian | MEDLINE | ID: mdl-19705788

ABSTRACT

This study was designed to identify major risk factors of PCTS and elucidate the possibility of early laboratory diagnosis of this syndrome for the choice of optimal therapeutic strategy. Retrospective analysis covered medical records of 500 patients who had experienced open heart surgery. Prospective studies included 60 patients of whom 50 had clinical manifestations of PCTS. Risk of its development depended on the severity of the underlying disease and increased after mechanical revascularization of myocardium. Urgency surgical intervention and greater extent of coronary shunting increased the probability of PCTS. Results of the measurement of serum procalcitonin by a highly sensitive method and of relative content of different protein fractions in serum and pleural/pericardial fluid suggest high informative value of these methods as diagnostic tools for PCTS. Preventive treatment with non-steriodal anti-inflammatory agents decreased the incidence of PCTS by 53%.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Postpericardiotomy Syndrome/diagnosis , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Biomarkers/analysis , Blood Proteins/analysis , Calcitonin/blood , Calcitonin Gene-Related Peptide , Early Diagnosis , Female , Humans , Male , Middle Aged , Pericardial Effusion/diagnosis , Pleural Effusion/diagnosis , Postpericardiotomy Syndrome/etiology , Postpericardiotomy Syndrome/prevention & control , Prospective Studies , Protein Precursors/blood , Retrospective Studies , Risk Factors
19.
Pediatr Cardiol ; 30(8): 1061-7, 2009 Nov.
Article in English | MEDLINE | ID: mdl-19636482

ABSTRACT

Postpericardiotomy syndrome (PPS), a potential complication of open heart surgery, has a variable clinical course and severity. This study evaluated the effectiveness of acetylsalicylic acid (ASA) prophylaxis in preventing PPS after surgical closure of atrial septal defects (ASDs) in pediatric patients. A retrospective review was performed for 177 patients who underwent uncomplicated ASD closure from 1986 to 2006. The study group received prophylactic ASA 20 to 50 mg/kg/day for 1 to 6 weeks after surgery, whereas the control group did not. The primary outcome was a diagnosis of PPS based on the presence of two or more of the following symptoms or signs occurring at least 72 h postoperatively: fever (temperature >38 degrees C), pericardial or pleural rub, and worsening or recurring anterior pleuritic chest pain. Consequently, PPS developed in 5 (2.8%) of the 177 children: 2.8% (3/106) in the control group and 2.8% (2/71) in the study group (p = 1.00). The secondary outcomes were frequency of other postoperative complications. Postoperative pericardial effusions experienced by 26.7% of the patients were identified more frequently in the treatment group (p < 0.001). Postoperative prophylaxis ASA at a dose of 20 to 50 mg/kg/day for 1 to 6 weeks after surgical closure of ASD does not decrease the incidence of PPS in pediatric patients.


Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Heart Septal Defects, Atrial/surgery , Postoperative Care , Postpericardiotomy Syndrome/prevention & control , Adolescent , Case-Control Studies , Child , Child, Preschool , Female , Humans , Incidence , Infant , Infant, Newborn , Male , Pericardiectomy/adverse effects , Postpericardiotomy Syndrome/drug therapy , Postpericardiotomy Syndrome/etiology , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
20.
Klin Med (Mosk) ; 86(10): 67-71, 2008.
Article in Russian | MEDLINE | ID: mdl-19069464

ABSTRACT

Postcardiotomy syndrome (PCTS) is an idiopathic inflammatory disease affecting pericardium and pleura; it complicates the postoperative period in cardiosurgery. High efficiency of corticosteroid therapy suggests autoimmune nature of PCTS. As a rule, this condition develops within two weeks after surgery although cases of its delayed onset (after 1 year) were reported too. PCTS may proceed both as an acute disease and as a mild disorder characterized by general inflammation and obscure serositis making difficult its diagnosis. The existence of such "restricted" forms of PCTS is not universally recognized, however glucoocticoids are widely prescribed to patients with this condition.


Subject(s)
Cardiac Surgical Procedures/adverse effects , Drainage/methods , Heart Diseases/surgery , Pericardium/surgery , Pleural Effusion/prevention & control , Postpericardiotomy Syndrome/prevention & control , Pulmonary Atelectasis/prevention & control , Aged , Aged, 80 and over , Cardiac Tamponade/prevention & control , Cardiopulmonary Bypass , Extracorporeal Circulation , Female , Humans , Male , Pericardial Effusion/prevention & control , Postpericardiotomy Syndrome/etiology
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