Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

Overview

The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. A prospective randomized trial.

Full Title of Study: “Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

Detailed Description

The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. Patients undergoing aortic and / or valvular surgery will be randomized in two groups. In group A, mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. In group B, mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. In both groups, conventional chest tubes will be removed on the first postoperative day, while patients in the group A will have prolonged drainage using the Blake drain until output is less than 50 ml over 24 hour. Patients will be followed during their postoperative course for occurrence of significant pericardial effusion as detected on routine echocardiogram and late cardiac tamponade requiring reintervention.

Interventions

  • Device: Blake Drains (Blake drain, Ethicon USA)
    • 19F Blake drain located in the posterior pericardial cavity
  • Device: Standard mediastinal drainage
    • Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum

Arms, Groups and Cohorts

  • Experimental: 1
    • mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity.
  • Active Comparator: 2
    • mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.

Clinical Trial Outcome Measures

Primary Measures

  • Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention.
    • Time Frame: Day 5 – post surgery

Secondary Measures

  • Total volume of mediastinal drainage. Pain intensity on postoperative days 1 to 5. Incidence of postoperative atrial fibrillation Drain-associated infection or any other drain-associated adverse event.
    • Time Frame: Days 1 or till discharge – post surgery

Participating in This Clinical Trial

Inclusion Criteria

  • Patients aged between 18 and 90 years old, undergoing either surgery of the ascending and/or transverse aorta, or surgery of the mitral and/or aortic valves – Availability for follow-up at the Montreal Heart Institute Exclusion criteria Exclusion Criteria:

  • Emergency surgery – Unavailability for follow-up at the Montreal Heart Institute

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Montreal Heart Institute
  • Collaborator
    • Johnson & Johnson
  • Provider of Information About this Clinical Study
    • Philippe Demers M.D., M.Sc., FRCSC, Montreal Heart Institute – Cardiac surgeon
  • Overall Official(s)
    • Phillippe Demers, MD, Principal Investigator, Montreal Heart Institute

References

Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049.

Agati S, Mignosa C, Gitto P, Trimarchi ES, Ciccarello G, Salvo D, Trimarchi G. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1306-9. doi: 10.1016/j.jtcvs.2006.02.013.

Ege T, Tatli E, Canbaz S, Cikirikcioglu M, Sunar H, Ozalp B, Duran E. The importance of intrapericardial drain selection in cardiac surgery. Chest. 2004 Nov;126(5):1559-62. doi: 10.1378/chest.126.5.1559.

Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg. 2000 Sep;70(3):1109-10. doi: 10.1016/s0003-4975(00)01800-2.

Kuvin JT, Harati NA, Pandian NG, Bojar RM, Khabbaz KR. Postoperative cardiac tamponade in the modern surgical era. Ann Thorac Surg. 2002 Oct;74(4):1148-53. doi: 10.1016/s0003-4975(02)03837-7.

Shah A, van den Brink A, de Mol B. Raised international normalized ratio: an early warning for a late cardiac tamponade? Ann Thorac Surg. 2006 Sep;82(3):1090-1. doi: 10.1016/j.athoracsur.2006.01.035.

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