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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Bridge or continue Coumadin for device surgery: a randomized controlled trial rationale and design
David Birnie1, Jeffrey S Healey, Andrew Krahn
1University of Ottawa Heart Institute, Ottawa, Canada. dbirnie@ottawaheart.ca
Insights
Managing anticoagulation for cardiac device surgery is challenging. Continuing oral anticoagulation, instead of bridging, may reduce hematoma risk without increasing thromboembolic events.
Area of Science:
- Cardiology
- Electrophysiology
- Anticoagulation Management
Background:
- Patients needing cardiac device surgery often take oral anticoagulation.
- Periprocedural anticoagulation management poses a dilemma, especially for high thromboembolic risk patients.
- Bridging anticoagulation increases hematoma risk, thromboembolic events, and costs.
Purpose of the Study:
- To evaluate the safety and efficacy of continuing oral anticoagulation versus bridging during cardiac device surgery.
- To determine the optimal anticoagulation strategy for patients undergoing cardiac device implantation.
Main Methods:
- Prospective, single-blind, randomized controlled trial.
- Conventional arm: bridging anticoagulation.
- Experimental arm: continued oral anticoagulation.
- Primary outcome: clinically significant hematoma.
Main Results:
- Observational data suggest reduced hematoma rates with continued oral anticoagulation.
- Randomized trial data are needed to confirm safety and efficacy.
- The study addresses a clinical question relevant to approximately 70,000 North American patients annually.
Conclusions:
- A randomized trial is designed to compare bridging versus continued oral anticoagulation for cardiac device surgery.
- The study aims to provide evidence-based guidance for managing anticoagulation in this patient population.
Purpose Of Review:
Many patients requiring cardiac arrhythmia device surgery are on chronic oral anticoagulation therapy. The periprocedural management of their anticoagulation presents a dilemma to physicians, particularly in the subset of patients with moderate-to-high risk of arterial thromboembolic events. Physicians have responded by treating patients with bridging anticoagulation while oral anticoagulation is temporarily discontinued. However, there are a number of downsides to bridging anticoagulation around device surgery; there is a substantial risk of significant device pocket hematoma with important clinical sequelae; bridging anticoagulation may lead to more arterial thromboembolic events and bridging anticoagulation is expensive.
Recent Findings:
In response to these issues, a number of centers have explored the option of performing device surgery without cessation of oral anticoagulation. The observational data suggest a greatly reduced hematoma rate with this strategy. Despite these encouraging results, most physicians are reluctant to move to operating on continued Coumadin in the absence of confirmatory data from a randomized trial.
Summary:
We have designed a prospective, single-blind, randomized, controlled trial to address this clinical question. In the conventional arm, patients will be bridged. In the experimental arm, patients will continue on oral anticoagulation and the primary outcome is clinically significant hematoma. Our study has clinical relevance to at least 70 000 patients per year in North America.
