The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery.
Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices.
Instructions within both arms of this study are considered within reasonable practice in Canada.
All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions.
All patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24/7 on call nursing program.
all patients undergoing device surgery which includes implantation of at least one new endovascular lead
Standalone CIED generator replacement
Subcutaneous implantable cardioverter defibrillators
Leadless endocardial pacemakers
Temporary permanent pacemakers
Crossover
Lenient Arm Restriction
BehavioralThe study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Strict Arm Restriction
BehavioralThe study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation
Definitions of each component of primary outcome: 1. Lead dislodgement; dislodgment requiring surgical repair and dislodgement not occurring in the immediate post-op period (i.e., before the randomized intervention begins). Immediate post-op period is defined as from pocket closure to dislodgement suspected on first post- operative CXR (which is done 2-4hrs post-op). 2. Frozen shoulder in this study is defined as: Nursing or physician note mention of chronologically related (to index surgery) patient complaint of new or markedly worsened shoulder pain and/or restricted and stiffness of active and passive range of motion. 3. Upper arm venous thrombosis. 4. Clinically significant hematoma is defined as done in BRUISE CONTROL 2 trial: a hematoma that required re-operation and/or resulted in prolongation of hospitalization and/or required interruption of oral anticoagulation.
Rate of hematoma
1\. Rate of hematoma (# of clinically significant hematoma / total number of procedures performed for each arm)
Rate of lead dislodgement
2\. Rate of lead dislodgement (# of lead dislodgements / total number of new leads placed in each arm) separate by type of lead (RA vs. RV vs. LV)
Rate of frozen shoulder
3\. Rate of frozen shoulder (# of frozen shoulders / total number of procedures performed for each arm)
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