Trial DesignsA Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT)
Section snippets
Background
Advances in cardiac implantable electronic devices (CIED) and widening clinical indications have led to a steady rise in CIED use.1 Indeed, an estimated 1.4 million devices are implanted every year worldwide.2 Currently, varying postoperative restrictions are given to patients; however, there is no universally accepted protocol or advice on restrictions for patients post-CIED surgery.1,3,4 The advice on postoperative arm movement can range from wearing a sling to immobilize the operative arm
Establishing clinical equipoise
In preparation for this trial, we conducted a national survey of restriction recommendations post-CIED implantation. The survey included 11 questions (see Appendix A) and was distributed among the Canadian Heart Rhythm Society Device Committee members. We collected 34 responses from 18 centers located in 7 provinces. Of the respondents, 80% were CIED implanting physicians and 20% were nurses specialized in device management. We used the survey results to understand the practice pattern
Discussion
Complications associated with CIED placement can be devastating and costly. Current postoperative measures for reducing risk are not based on evidence and are directed by institutional or individual physician preference (see Table I for summary of range of current Canadian practices).
The major driver of postoperative arm restriction is to reduce lead dislodgement. But despite small case report series describing lead displacement with arm movement, data suggests displacement is more related to
Conclusion
This will be the first fully powered randomized study to assess restrictive compared to lenient postoperative arm mobilization instruction. There is a clear evidence gap and a lack of standardized instructions. LENIENT study has the potential to provide guidance and standardization on postoperative arm instructions. Also, if lenient postoperative instructions are proven to be noninferior to strict care, this may reduce unnecessary mobility restrictions and improve the patient experience.
Funding
Funding for the project provided by Ottawa Heart Institute Research Corporation (UOH-21- 011)
Disclosures
None reported.
Acknowledgement
The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.
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