Original research
A Delphi-Based Consensus Statement on the Management of Anticoagulated Patients With Botulinum Toxin for Limb Spasticity

Presented as a poster to the American College of Rehabilitation Medicine Annual Conference, October 23-28, 2017, Atlanta, GA.
https://doi.org/10.1016/j.apmr.2018.04.023Get rights and content

Abstract

Objective

To create a consensus statement on the considerations for treatment of anticoagulated patients with botulinum toxin A (BoNTA) intramuscular injections for limb spasticity.

Design

We used the Delphi method.

Setting

A multiquestion electronic survey.

Participants

Canadian physicians (N=39) who use BoNTA injections for spasticity management in their practice.

Interventions

After the survey was sent, there were e-mail discussions to facilitate an understanding of the issues underlying the responses. Consensus for each question was reached when agreement level was ≥75%.

Main Outcome Measures

Not applicable.

Results

When injecting BoNTA in anticoagulated patients: (1) BoNTA injections should not be withheld regardless of muscles injected; (2) a 25G or smaller size needle should be used when injecting into the deep leg compartment muscles; (3) international normalized ratio (INR) level should be ≤3.5 when injecting the deep leg compartment muscles; (4) if there are clinical concerns such as history of a fluctuating INR, recent bleeding, excessive or new bruising, then an INR value on the day of injection with point-of-care testing or within the preceding 2-3 days should be taken into consideration when injecting deep compartment muscles; (5) the concern regarding bleeding when using direct oral anticoagulants (DOACs) should be the same as with warfarin (when INR is in the therapeutic range); (6) the dose and scheduling of DOACs should not be altered for the purpose of minimizing the risk of bleeding prior to BoNTA injections.

Conclusions

These consensus statements provide a framework for physicians to consider when injecting BoNTA for spasticity in anticoagulated patients. These consensus statements are not strict guidelines or decision-making steps, but rather an effort to generate common understanding in the absence of evidence in the literature.

Section snippets

Methods

A total of 39 physicians from across Canada were invited to participate in this Delphi-based consensus survey (supplemental data, available online only at http://www.archives-pmr.org/). In addition, we invited a physician with expertise in thromboembolism (I.B.). A summary of the literature was compiled and sent via e-mail to all participants. Subsequently, survey questions were sent to all participants using Google Forms. Survey questions focused on the following domains: (1) physician

Participants

Specialty: Physical medicine and rehabilitation (n=34); neurologists (n=5). Representation was from across Canada: British Columbia (4), Alberta (3), Saskatchewan (1), Manitoba (1), Ontario (19), Quebec (7), New Brunswick (2), and Nova Scotia (2). The average number of years of practice with spasticity management with BoNTA was 13±5 years. The average number of patients injected with BoNTA for spasticity per month in the participants’ individual practice was 36±26 patients. Approximately 5±3

Discussion

Focal limb spasticity in anticoagulated patients can be treated with chemodenervation with BoNTA. There is variability in physician practice in treating patients who are receiving anticoagulants,9, 10, 11 even though the reported risk of serious bleeding complications is low.12, 15 In this Delphi study, we present the consensus opinion of Canadian physicians regarding the approach to chemodenervation with BoNTA in anticoagulated patients with spasticity.

Conclusions

In this Delphi study, we explored the issue of chemodenervation with BoNTA in patients with spasticity who are receiving anticoagulants. This study provides a framework for decision making in the following 3 areas: procedural aspects, approach to patients on warfarin or on DOACs. These consensus statements are not strict guidelines or decision-making steps, but rather an effort to generate common understanding in the absence of evidence in the literature.

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    Disclosures: Chris Boulias, Farooq Ismail, Chetan P Phadke, Robert Chen, Muriel Haziza, Kathryn Wilkins, Thomas Miller, Mark Mason, Lalith Satkunam, Christine Short, Genevieve Sirois, Theodore Wein, and Pierre Naud received funding (research grants, speaker fees, or honoraria) from Allergan; Chetan P Phadke, Farooq Ismail, Chris Boulias, Robert Chen, Muriel Haziza, Mark Mason, Lalith Satkunam, Christine Short, and Genevieve Sirois from Merz; Colleen O’Connell, Mark Mason, Lalith Satkunam, Genevieve Sirois, Theodore Wein, and Pierre Naud from Ipsen; and Isabelle Bureau from Leo Pharma, Pfizer Canada, and Sanofi. The other authors have nothing to disclose.

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    © 2018 by the American Congress of Rehabilitation Medicine