systematic review and meta analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery

posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm.. [21,22] posterior to the phrenic nerve, extending from left inferior pulmonary vein toward

Mirosław Gozdek, MD, Wojciech Pawliszak, MD, Wojciech Hagner, MD, PhD, Paweł

Zalewski, PhD, Janusz Kowalewski, MD, PhD, Domenico Paparella, MD, PhD,

Thierry Carrel, MD, PhD, Lech Anisimowicz, MD, PhD, Mariusz Kowalewski, MD

Received Date: 6 September 2016

Revised Date: 7 November 2016

Accepted Date: 19 November 2016

Please cite this article as: Gozdek M, Pawliszak W, Hagner W, Zalewski P, Kowalewski J, Paparella

D, Carrel T, Anisimowicz L, Kowalewski M, Systematic Review and Meta-analysis of Randomized Controlled Trials Assessing Safety and Efficacy of Posterior Pericardial Drainage in Patients

Undergoing Heart Surgery, The Journal of Thoracic and Cardiovascular Surgery (2017), doi: 10.1016/

j.jtcvs.2016.11.057.

This is a PDF file of an unedited manuscript that has been accepted for publication As a service to our customers we are providing this early version of the manuscript The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

et al [20] CABG

Posterior pericardiotomy 50 61±9 nd 66±17 35±2 20 20 2.7±0.6

Bakhshandeh AR

et al [21,22]

CABG Valve replacement

Cakalagaoglu C et

al [24]

CABG Valve replacement

Posterior pericardiotomy 50 63±8 80 92±22 55±19 68 28 2.8±0.9

Ekim H et al [25] CABG

Posterior pericardiotomy 50 59±9 66 89±21 63±19 52 20 2.8±0.4

Erdil N et al [26]

Valve replacement Ascending aorta surgery

Posterior pericardiotomy 50 41±14 46 114±51 86±40

Fawzy H et al

Posterior pericardiotomy 100 54±9 64 89±29 55±21 56 48 2.7±0.6

Haddadzadeh M

et al [29] OPCAB

Posterior pericardiotomy 105 61±10 69 NA NA 55 41 2.1±0.7

Kaya M et al [30] CABG

Posterior pericardiotomy 30 60±10 77 80±26 43±16 50 53 3.37±1.19 Additional chest

Kaya M et al [31] CABG

Posterior pericardiotomy +additional chest tube

Kaya M et al [32] CABG

Posterior pericardiotomy +additional chest tube

Posterior pericardiotomy 228 54±16 60 110±46 67±29 41 43 NR

CABG, Coronary artery bypass grafting; CPB, cardiopulmonary bypass; X-clamp, aortic cross clamp; HT, hypertension; DM, diabetes mellitus; OPCAB, off-pump coronary artery bypass; NR, not reported; NA, not applicable

sFigure 1 Publication bias analysis (funnel plots) sFigure 2 Meta-analysis of total chest drainage volume sFigure 3 Meta-analysis of pleural effusion with or without intervention sFigure 4 Meta-analysis of pulmonary complications

sFigure 5 Meta-analysis of reoperation for bleeding sFigure 6 Meta-analysis of acute kidney injury sFigure 7 Meta-analysis of length of ICU and hospital stay sFigure 8 Sensitivity analysis of primary endpoint accounting for ‘0 events’

sFigure 9 Sensitivity analysis of primary endpoint stratified by operative technique sFigure 10 Primary endpoint influence analysis

Structured summary 2 Provide a structured summary including, as applicable: background; objectives; data sources; study eligibility criteria, participants, and

interventions; study appraisal and synthesis methods; results; limitations; conclusions and implications of key findings; systematic review registration number

3

INTRODUCTION

Objectives 4 Provide an explicit statement of questions being addressed with reference to participants, interventions, comparisons, outcomes, and study

design (PICOS)

5,6

METHODS

Protocol and registration 5 Indicate if a review protocol exists, if and where it can be accessed (e.g., Web address), and, if available, provide registration information

including registration number

NA

Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow - up) and report characteristics (e.g., years considered, language, publication

status) used as criteria for eligibility, giving rationale

6-7

Information sources 7 Describe all information sources (e.g., databases with dates of coverage, contact with study authors to identify additional studies) in the

search and date last searched

Data collection process 10 Describe method of data extraction from reports (e.g., piloted forms, independently, in duplicate) and any processes for obtaining and

confirming data from investigators

estimates and confidence intervals, ideally with a forest plot

11-13, fig.2-5

Synthesis of results 21 Present results of each meta-analysis done, including confidence intervals and measures of consistency 11-13, fig.2-5 Risk of bias across studies 22 Present results of any assessment of risk of bias across studies (see Item 15) appendix Additional analysis 23 Give results of additional analyses, if done (e.g., sensitivity or subgroup analyses, meta-regression [see Item 16]) 13, appendix

DISCUSSION

Summary of evidence 24 Summarize the main findings including the strength of evidence for each main outcome; consider their relevance to key groups (e.g.,

healthcare providers, users, and policy makers)

Funding 27 Describe sources of funding for the systematic review and other support (e.g., supply of data); role of funders for the systematic review 17

From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009) Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement PLoS Med 6(7): e1000097

doi:10.1371/journal.pmed1000097

For more information, visit: www.prisma - statement.org

Supplementary Table 2 Medline search strategy

10 pericardial drainage AND randomized 57

11 posterior pericardium drainage 34

12 posterior pericardium drainage AND randomized 2

13 posterior pericardial chest tube 10

14 posterior pericardial chest tube AND randomized 1

15 additional chest tube 480

16 additional chest tube AND randomized 57

Supplementary Table 3 Exclusion criteria and IRB approval

NR Asimakopoulos G

Bakhshandeh AR

Bolourian AA et

al [23]

Severe LV dysfunction with LVEF <25%, history of AF, concomitant valvular

Cakalagaoglu C et

al [24]

Re-do cases, left-sided pleural adhesions, arrhythmias, in particular AF, documented depression and anxiety, hyperthyroidism, LV aneurysm, renal failure (plasma creatinine >2.0 mg/dL), use of β-blocker, and inability to provide informed consent because of a neurologic or psychiatric illness

YES

Ekim H et al [25]

Hyperthyroidism, COPD, renal dysfunction, LV aneurysm, severe LV dysfunction, history of AF, previous CABG, concomitant valvular disease, dense adhesion of the lung, β-blocker therapy

YES

Farsak B et al

[11]

Hyperthyroidism, COPD, renal dysfunction, LV aneurysm, valvular heart

Fawzy H et al

[28]

Previous AF or anti-arrhythmic drugs therapy, severe LV dysfunction (LVEF

≤30%), COPD, renal impairment, hyperthyroidism, redo and emergency

CABG, combined cardiac procedures

YES Haddadzadeh M et

al [29]

Cardiac arrhythmia, pericardial effusion, electrolyte or hemodynamic

Kaya M et al [30]

Renal failure, hyperthyroidism, emergency coronary artery surgery, history of cardiac operations associated with valvular heart disease, LVEF < 35%, and preoperative AF or other rhythm disorders, no consent

YES

Kaya M et al [31]

P2Y12 inhibitor therapy, valve regurgitation, kidney failure, hyper- and or hypothyroidism, emergency or re-do cases, preoperative rhythm disorders, patients with pacemakers and OPCAB

YES

Kaygin MA et al

[33]

Renal failure, ventricular arrhythmias; LV aneurysm, COPD, severe LV dysfunction, hyperthyroidism, valvular heart disease, bleeding disorders, patients with rhythm problems and valvular pathologies on OAC; more than two chest tubes, and those who required concomitant surgery

Hyperthyroidism, COPD, renal dysfunction, LV aneurysm, severe LV

Sadeghpour A et

LV, left ventricular; MR, mitral regurgitation; COPD, chronic obstructive pulmonary disease; AF, atrial fibrillation; LVEF, left ventricle ejection fraction; CAD, coronary artery disease; CABG, coronary artery bypass grafting; OPCAB, off-pump coronary artery bypass graft; OAC, oral anticoagulation; NR, not reported

Pericardial effusion criteria Early effusion Late

effusion Postoperative atrial fibrillation

Arbatli H et al

[19] Not defined; NS

minimal 0-50ml, mild 50-100ml, moderate 100-500ml, severe > 500ml

Not defined Not defined AF sustained <15 min Asimakopoulos G

>30 days after surgery

≥15 days

after surgery

AF or atrial flutter >20 min

Ekim H et al [25]

Not defined; hemodynamic data and/or the echocardiographic findings

Maximum diastolic separation between pericardium and epicardium measured at the level of the tip of the mitral valve leaflet Any effusion >1 cm was considered significant

Not defined Not defined AF or atrial flutter >20 min Erdil N et al [26]

Hemodynamic data and/or the echocardiographic findings

Maximum diastolic separation between pericardium and epicardium measured at the level of the tip of the mitral valve leaflet Any effusion >1 cm was considered significant

<24 hours

5-7 days after surgery

NR Eryilmaz S et al

[27] Not defined; NS Effusion ≥10 mm were considered significant

first postoperative week

after the first week NR Farsak B et al

[11]

Not defined; NS

Maximum diastolic separation between pericardium and epicardium measured at the level of the tip of the mitral valve leaflet Any effusion >1 cm was considered significant

<30 days after surgery

≥30 days

after surgery

NR

Echo free space in diastole, small

≥30 days

after surgery

AF or atrial flutter >5 min

>20mm and compression of the heart

Not defined Not defined

Presence of irregular ventricular rate and absence of consistent P-waves before each QRS complex; persistence not specified Kaya M et al [32]

>20mm and compression of the heart

Not defined Not defined

Absence of consistent P waves before each QRS complex and an irregular ventricular rate; persistence not specified

Kaygin MA et al

[33] Not defined; NS

Any effusion between the epicardial and pericardial surfaces >1 cm in echocardiogram image was considered as significant

before discharge

1 month after discharge

Not defined; persistence not specified

<30 days after surgery

≥30 days

after surgery

AF or atrial flutter >30 min

Sadeghpour A et

al [36] Not defined; NS Not defined; NS

<3 days after surgery

>3 days after surgery

Not defined

Zhao J et al [37] Not defined; NS

<10 mm, localized in posterior pericardial cavity, small

10–20 mm, involving anterior wall of right ventricle, moderate

>20 mm, circumferential effusion, large

Not defined, NS effusion measured at 10 postoperative day

Not defined; persistence not specified

AF, atrial fibrillation; NS, not specified; NR, not reported

[19] mediastinum Lower part of the pericardium left open posterior to the phrenic nerve, extending from left

inferior pulmonary vein to the diaphragm

Bakhshandeh AR

et al [21,22]

posterior to the phrenic nerve, extending from left inferior pulmonary vein toward the inferior vena cava and diaphragm

Bolourian AA et

al [23]

nerve, 4 to 6 cm long, extending from left inferior pulmonary vein to the diaphragm

Cakalagaoglu C et

al [24]

Two drains in study and control group in CABG cases: one in the left pleural cavity and the other in the anterior mediastinum Two drains in study and control group in valve cases: anterior mediastinum (or three when left pleural cavity was opened)

Pericardium left open anteriorly

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Ekim H et al [25] Two drains in both groups One in the left pleural cavity and the other in the anterior

mediastinum

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Erdil N et al [26] Two drains in study group: one in the left pleural cavity and the other in the anterior

mediastinum One drain in the control group positioned in the anterior mediastinum

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Eryilmaz S et al

[27]

Two drains in study group: one in the anterior mediastinum and the other (thin closed-suction drain system) behind the heart One drain in control group: anterior mediastinum + another drain in both group when left or right pleura was opened

Kaya M et al [30] Two or three drains in study group One in the left pleural cavity and the other in the

anterior mediastinum Third drain in 33 patients positioned behind the heart Two drains in control group: One in the left pleural cavity and the other in the anterior mediastinum Pericardium left open (2 cm)

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm The left pleural cavity was opened

Kaya M et al [31] Three drains in study group One in the left pleural cavity, one in the anterior

mediastinum and the other in the pericardial sac along the right atrium Pericardium was closed Two drains in control group Left pleural cavity and anterior mediastinum Pericardium left open (2 cm)

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Kaya M et al [32] Three drains in study group One in the left pleural cavity, one in the anterior

mediastinum and the other in the pericardial sac along the right atrium Proximal anastomoses of the bypass grafts and nearly half of the anterior surface of the heart were covered by pericardium Two drains in control group: left pleural cavity and anterior mediastinum

A longitudinal, 4 cm long, incision parallel and posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Sadeghpour A et

al [36]

posterior to the phrenic nerve, extending from left inferior pulmonary vein to the diaphragm

Zhao J et al [37]

Two or three drains in study group One in the left or both pleural cavities, one in the anterior mediastinum Two drains in control group: one in the pericardial sac along the right atrium and the other in the anterior mediastinum

Inverse T, 2,5 cm long in both dimensions (left, right or bilateral window) incision, parallel and posterior to the phrenic nerve, extending from inferior pulmonary vein to the diaphragm CABG, coronary artery bypass grafting; NR, not reported; NA, not applicable.

1 Bakhshandeh AR et al

Bolourian AA et al [23]

1 Cakalagaoglu C et al [24]

2 Ekim H et al [25]

2 Erdil N et al [26]

2 Eryilmaz S et al [27]

2 Farsak B et al [11]

3 Fawzy H et al [28]

3 Haddadzadeh M et al [29]

2 Kaya M et al [30]

4 Kaya M et al [31]

5 Kaya M et al [32]

3 Kaygin MA et al [33]

3 Kongmalai P et al [34]

1 Kuralay E et al [35]