Elsevier

American Heart Journal

Volume 259, May 2023, Pages 52-57
American Heart Journal

Trial Designs
A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT)

https://doi.org/10.1016/j.ahj.2023.01.016Get rights and content

Background

Arm restriction after cardiac implantable electronic device (CIED) placement is common practice despite minimal supporting evidence. Patients receive a range of restriction recommendations of variable durations with the goal of reducing complications such as wound dehiscence, infection, lead dislodgement, or hematoma formation. These movement limitations can lead to emotional stress and anxiety, complications such as frozen shoulder, and upper extremity venous thrombosis due to immobilization. There are no published clinical trials assessing the benefits and risks of arm restrictions post-CIED implant.

Objectives

The randomized trial of lenient vs strict arm and activity instruction post-CIED surgery (LENIENT trial; NCT04915261) is a single center nonblinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions. We hypothesize that there will be no significant difference in complications between the arms.

Methods/Design

All patients receiving a de novo CIED or those with upgrades and revisions requiring a new lead implant will be enrolled. Subjects are enrolled in a nonblinded randomized prospective trial with 6 randomly assigned 8-month periods, during which either a lenient or restrictive postoperative activity instructions will be given to all patients. Postoperative instructions are given at the time of discharge and further reinforced by recurrent interactive voice recognition (IVR) phone calls, text messages and emails. The requirement for individual consent has been waived. The primary end point is a composite of (1) lead dislodgement, (2) frozen shoulder, (3) upper extremity venous thrombosis, (4) clinically significant hematoma, and (5) infection occurring within 52 weeks of index surgery. The study is a noninferiority trial with a sample size of 1,250 per group.

Discussion

This is the first large randomized clinical trial designed to establish an evidence-based postoperative standard of care for patients undergoing CIED implantation. This will improve the quality of care provided to patients and help guide implanting physicians providing postoperative care instructions.

Trial registration

ClinicalTrials.gov NCT04915261

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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