• Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for prevention of thromboembolism after cavopulmonary anastomosis (bidirectional Glenn and Fontan operations). Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2006 May. 14 p. [34 references]

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for prevention of thromboembolism after cavopulmonary anastomosis (bidirectional Glenn and Fontan operations). Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2001 May 29. 10 p.

Once the guideline has been in place for four years, the development team reconvenes to explore the continued validity of the guideline. This phase can be initiated at any point that evidence indicates a critical change is needed.

Each recommendation is followed by evidence grades identifying the type of supporting evidence. Definitions of the evidence grades are presented at the end of the "Major Recommendations" field.

Assessment

1. Preoperative history and physical exam
   • Patient or family history of coagulopathy, salicylate allergy, or viral exposures
   • Physical findings suggestive of coagulopathy (e.g., petechiae, purpura)

2. Laboratory assessment
   • Preoperative complete blood count (CBC) with platelets
   • Coagulation studies if history or physical suggests abnormalities and prior to initiation of warfarin

     Note: Available evidence does not support routine screening for coagulopathies.

Treatment Recommendations

1. It is recommended that patients begin antithrombotic aspirin therapy upon resuming oral intake following the bidirectional Glenn or Fontan operation. (Jacobs et al., 2002 [C/D]; Barker et al., 2005 [D]); Local Expert Consensus (E))

   Note: Both aspirin and warfarin reduce the risk of thromboembolism. Although the choice of pharmacologic regimen remains controversial, the risk of hemorrhagic complications in children, compounded by the difficulties of monitoring and maintaining appropriate anticoagulation on warfarin, favors the use of aspirin for antithrombotic therapy (Barker et al., 2005 [D]). The two appear equivalent in the prevention of myocardial infarction and stroke in the setting of atherosclerosis (Anand & Yusuf, 1999 [M]); however, in pediatric and adult populations, the risk of hemorrhagic complications is higher with warfarin therapy (Anand & Yusuf, 1999 [M]; Hart et al., 1999 [M]; Rao et al., 1989 [D]; Bradley et al., 1985 [D])

2. It is recommended that warfarin therapy be considered in patients at higher risk due to the following factors:
   • Previous thromboembolic complications (Kaulitz et al., 2005 [D])
   • Poor ventricular function (Kaulitz et al., 2005 [D]; Al-Khadra et al., 1998 [D])
   • Extracardiac Fontan connections (Shirai et al., 1998[D]; Petrossian et al., 1999 [E]; Laschinger et al., 1996 [E])
   • Pulmonary stump (Oski et al., 1996) [D])
   • Atrial tachyarrhythmias (Cheung et al., 2005; Kaulitz et al., 2005 [D])

   Note: Children with Fontan operations require a lower warfarin dosage than children receiving warfarin after other types of congenital heart surgery for a similar degree of anticoagulation (Streif et al.,1999 [C]). The recommended starting dose is 0.1 mg/kg to maintain a target international normalized ratio (INR) range of 2.0 to 3.0.

3. It is recommended that alternative antithrombotic therapy be considered during periods when aspirin therapy is temporarily contraindicated (reference See note).

   Note: Examples of aspirin contraindications may include exposure to influenza or varicella, receipt of varicella vaccine (American Academy of Pediatrics, 2003 [O]), and elective surgical or dental procedures associated with bleeding. Risks of discontinuation of aspirin versus the risk of Reye's syndrome or bleeding associated with dental or surgical procedures must be considered by the clinician and family on an individual basis.

Definitions:

Evidence Based Grading Scale

M: Meta-analysis or systematic review
A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
S: Review article
O: Other evidence
E: Expert opinion or consensus
F: Basic laboratory research
L: Legal requirement
Q: Decision analysis
X: No evidence

None provided

The type of evidence is identified and classified for each recommendation (see "Major Recommendations") using the following scheme:

Evidence Based Grading Scale:

M: Meta-analysis or systematic review
A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
S: Review article
O: Other evidence
E: Expert opinion or consensus
F: Basic laboratory research
L: Legal requirement
Q: Decision analysis
X: No evidence

• Cincinnati Children's Hospital Medical Center. Evidence-based care guideline for prevention of thromboembolism after cavopulmonary anastomosis (bidirectional Glenn and Fontan operations). Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2006 May. 14 p. [34 references]

Not applicable: The guideline was not adapted from another source.

2001 May 29 (revised 2006 May)

Cincinnati Children's Hospital Medical Center - Hospital/Medical Center

Cincinnati Children's Hospital Medical Center

Cardiac Guideline Development Team 2006

Cincinnati Children's Hospital Medical Center Physicians: Peter Manning , MD, Cardiac Surgery; Catherine Dent, MD, Cardiac Intensive Care; William Border, MD, Cardiology; James Spaeth, MD, Anesthesia; Michael Alice Moga, MD, Cardiology/Fellow

Patient Services: Karen Uzark, PhD, CPNP, Cardiology; Susan Ryckman, MS, CPNP, Cardiac Services; Betsy Adler, MS, PNP, Cardiac Surgery; Christa Barlow, CNP, Cardiac Surgery; Karen Jones, MS, PNP, Cardiac Surgery; Melissa Magness, RN, Cardiac ICU; Tammy Lingsch, RN, A6 Central; Cynthia Wedekind, Pharm D, Clinical Pharmacy; Martha Willis, CNP, Cardiac Surgery; Jenni Raake, RRT, Respiratory Care

Division of Health Policy & Clinical Effectiveness Support: Eloise Clark, MPH; Danette Stanko, MA, MPH, Epidemiologist; Kate Rich, Lead Decision Support Analyst; Carol Frese, RN, Medical Reviewer; Eduardo Mendez, RN, MPH, Dir. Evidence-Based Care

This guideline was developed without external funding.

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for prevention of thromboembolism after cavopulmonary anastomosis (bidirectional Glenn and Fontan operations). Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2001 May 29. 10 p.

Once the guideline has been in place for four years, the development team reconvenes to explore the continued validity of the guideline. This phase can be initiated at any point that evidence indicates a critical change is needed.

None available

This NGC summary was completed by ECRI on March 11, 2004. The information was verified by the guideline developer on December 19, 2006. This summary was updated by ECRI on March 6, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin sodium). This summary was updated by ECRI Institute on September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin).