Arm Restriction Strategies After Cardiac Device Surgery

(LENIENT Trial)

Overseen By Mehrdad Golian

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Standalone CIED generator replacement

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if altering arm movement restrictions after receiving a cardiac implant can enhance recovery and reduce complications. It compares strict restrictions, such as no lifting or moving the arm for several weeks, to more lenient ones, with only a few limits for a short time. The trial targets individuals who recently received a new cardiac device. Participants contribute to identifying which approach leads to a better recovery experience. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these arm restriction strategies?

Research has shown that moving soon after receiving a heart device is usually safe and doesn't increase complications. This trial compares two different sets of guidelines for arm movement after surgery.

The lenient arm restriction allows more freedom. Patients can move their arm freely after a short period, with no limits on reaching overhead or lifting weights, except for activities like shoveling or playing sports for a few days.

The strict arm restriction is more cautious. Patients should avoid lifting their arm above their head and lifting heavy objects for eight weeks. They should also refrain from sports or activities like swimming or golf during this time.

Both sets of guidelines are considered safe and align with common practices in Canada. No evidence suggests that either set causes harm. Therefore, participants in either group are expected to tolerate the guidelines well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing lenient and strict arm restrictions after cardiac device surgery because it may offer insights into patient recovery and quality of life. Currently, strict movement limitations are standard to prevent complications, but they can be cumbersome and affect daily activities. The lenient approach, which allows more freedom in arm movement sooner, could potentially lead to a quicker return to normal activities without increasing risks. This trial aims to determine if easing restrictions can maintain safety while improving comfort and convenience for patients.

What evidence suggests that this trial's arm restriction strategies could be effective for improving patient experience and reducing complications after cardiac device surgery?

This trial will compare two post-operative arm restriction strategies after cardiac device surgery. Research has shown that allowing more arm movement might improve recovery without increasing complications. Participants in the lenient arm restriction group will follow relaxed guidelines, which studies suggest are as safe as stricter rules, with no difference in complication rates. This approach can enhance daily life by permitting more normal activities. In contrast, the strict arm restriction group will adhere to traditional rules designed to prevent issues like surgical wound reopening. However, strong evidence does not support that strict rules are more effective at preventing these issues than relaxed ones. Overall, the trial aims to determine if relaxed rules offer a good balance between safety and comfort for patients. ^{2 3 6 7 8}

Who Is on the Research Team?

David Birnie

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for patients who have just had surgery to receive a Cardiac Implantable Electronic Device (CIED) and are facing postoperative recovery. It's open to those getting at least one new endovascular lead but not for patients only having their CIED generator replaced.

Inclusion Criteria

I am having surgery to implant a new device in my blood vessels.

Exclusion Criteria

Standalone CIED generator replacement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lenient or strict arm restriction instructions post CIED surgery

8 weeks

Regular follow-up visits as per standard of care

Crossover

Arm restriction instructions are changed every 7 months as per the crossover design

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of primary and secondary outcomes

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lenient Arm Restriction
• Strict Arm Restriction

Trial Overview The study compares two types of arm movement restrictions after CIED surgery: 'lenient' allows more freedom, while 'strict' limits arm use significantly. The goal is to see which leads to better patient experiences and fewer complications.

How Is the Trial Designed?

Group I: Strict Arm Active Control 1 Intervention

The strict arm group will be given the following restrictions. These restrictions are the current institutional protocol at the study site and falls within common practice pattern across Canada: 1. No arm or shoulder movement x 24 hours 2. No movement of affected arm overhead x 8 weeks 3. No lifting anything heavier than 5 lbs (2.5kg) and avoid any kind of sports or other vigorous activities including golf, tennis, swimming or sweeping x 8 weeks 4. Avoid any kind of shovelling x 8 weeks

Group II: Lenient Arm Active Control 1 Intervention

The lenient arm restriction group will be given the following restrictions. The justification for the selected lenient restriction is based on the current recommendations at a Canadian center as identified by the national survey: 1. No shoveling 7 days, 2. No golfing/swimming/tennis 14 days 3. No other restrictions (overhead activity and weight lifting no limitation)

Lenient Arm Restriction is already approved in Canada for the following indications:

Approved in Canada as Lenient Arm Restriction for:

• Post-operative care for patients receiving Cardiac Implantable Electronic Devices (CIEDs)

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Published Research Related to This Trial

Radial artery access (RA) for percutaneous coronary interventions (PCIs) in patients with acute coronary syndrome (ACS) significantly reduces major bleeding complications, access-related complications, mortality, and major adverse cardiac events compared to femoral artery access (FA), based on a meta-analysis of 15 randomized controlled trials and 17 cohort studies involving 44,854 patients.

The findings suggest that RA is a safer and more effective approach for managing ACS during PCI, highlighting the need for increased adoption of this technique in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-Analysis of Major Cardiovascular Outcomes for Radial Versus Femoral Access in Patients With Acute Coronary Syndrome. Ruiz-Rodriguez, E., Asfour, A., Lolay, G., et al.[2018]

In a study of 154 limbs, vascular closure devices (VCDs) were found to be as safe and effective as manual compression (MC) for achieving hemostasis after brachial artery access, with no significant differences in thrombotic or hemorrhagic complications between the two methods.

The study identified factors influencing thrombosis risk, including female sex and larger sheath sizes, but overall, VCDs demonstrated equivalent outcomes to MC in preventing major adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of vascular closure devices after transbrachial artery access. Mirza, AK., Steerman, SN., Ahanchi, SS., et al.[2022]

Patients who received adequate counseling on postoperative activity limitations were less likely to want to reschedule their surgery or adjust personal plans, indicating that clear communication can enhance patient satisfaction and planning.

Younger patients and those undergoing surgery on the lower extremities tended to limit their activities for longer periods, suggesting that tailored counseling may be necessary to address different patient needs and expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity Limitation Counseling in Dermatologic Surgery: A Survey and Retrospective Chart Review. Zamil, DH., Kamepalli, S., Alkul, S., et al.[2023]

A survey of 293 pediatric surgeons revealed significant variability in postoperative activity restrictions for children under 12 years old after common surgeries, with some surgeons recommending no restrictions at all, despite the potential risks of complications.

There is a lack of evidence supporting the necessity of these activity restrictions, which may negatively impact a child's psychosocial well-being and quality of life, highlighting the need for further research on their actual benefits and effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current practice patterns for postoperative activity restrictions in children. Baumann, LM., Williams, K., Ghomrawi, H., et al.[2019]

In a pilot study involving 5 patients with incomplete palmar arches, intermittent radial artery compression for 15 days led to increased collateral circulation in the nondominant hand, suggesting a potential method to improve blood flow for coronary artery bypass grafting.

While the modified Allen's test showed statistically significant improvements in blood flow, Doppler sonography results did not reach statistical significance, indicating that further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial artery compression in incomplete palmar arch for radial artery harvesting. Mohite, PN., Thingnam, SK., Saxena, AK.[2016]

In a study of 1891 STEMI patients undergoing routine PCI after fibrinolysis, those who had trans-radial access were generally younger and healthier compared to those with trans-femoral access.

At 30 days post-procedure, trans-radial PCI showed similar risks for major bleeding, mortality, and re-infarction compared to trans-femoral PCI, indicating that radial access is a safe alternative for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial versus femoral access for percutaneous coronary intervention in ST-elevation myocardial infarction patients treated with fibrinolysis: Results from the randomized routine early invasive clinical trials. Graham, JJ., Yan, AT., Tan, MK., et al.[2020]

Implementing a standard protocol for pre- and postoperative care, including aggressive pharmacologic therapy and patient education, can facilitate early release from the hospital after cardiac surgery.

Retrospective studies indicate that fast-tracked care does not significantly increase mortality or morbidity compared to conventional care, and patients report high satisfaction levels with their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early release following cardiac surgery. Keon, WJ., Sherrard, H.[2019]

In a study of 66 patients undergoing distal revascularization and interval ligation (DRIL) for hand ischemia, using an ipsilateral arm vein as a conduit resulted in significantly fewer wound complications compared to using the great saphenous vein (GSV) (11% vs 46%).

Both conduits provided similar rates of symptom resolution and access patency after 12 and 24 months, suggesting that the arm vein is a suitable and potentially safer alternative to the GSV for DRIL procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distal revascularization and interval ligation for dialysis access-related ischemia is best performed using arm vein conduit. Weaver, ML., Holscher, CM., Graham, A., et al.[2021]

The study measured sternal skin strain during various shoulder movements and found that most activities, including lifting weights and shoulder flexion, resulted in minimal strain, suggesting that current sternal precautions may be overly restrictive for patients recovering from cardiac surgery.

The findings indicate that allowing more shoulder movement and upper extremity activities could be beneficial for recovery, as the data do not support the need for strict restrictions post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noncontact Measurement of the Deformation of Sternal Skin During Shoulder Movements and Upper Extremity Activities Restricted by Sternal Precautions. Ge, W., Hians, B., Sfara, A.[2019]

A study involving 200 cardiac surgery patients showed that those following the 'Keep Your Move in the Tube' movement protocol had a significantly better ability to return to functional activities compared to those adhering to standard sternal precautions, especially in the early weeks post-surgery.

By 12 weeks post-operation, the differences in functional recovery between the two groups were minimized, suggesting that while the new protocol may enhance early recovery, both methods ultimately lead to similar outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In the tube" following sternotomy: A quasi-experimental study. Park, L., Coltman, C., Agren, H., et al.[2021]

Citations

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A Randomized Trial of Lenient Versus Strict Arm Instruction ... A single center nonblinded randomized prospective study designed to evaluate lenient compared to restrictive post-CIED care instructions.

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A Randomized Trial of Lenient Versus Strict Arm Instruction ... A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666084924003292

Rapid Return to Play After Extravascular Implantable ... Despite decades of use, there is a lack of consensus and evidence for exercise restriction following cardiac implantable electronic device ...

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A Randomized Trial of Lenient Versus Strict Arm Instruction ... The purpose and objectives of this study is to investigate whether reducing the existing restrictions on patients post CIED will result in an improved ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870323000236

A Randomized Trial of Lenient Versus Strict Arm Instruction ... This will be the first fully powered randomized study to assess restrictive compared to lenient postoperative arm mobilization instruction.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04858698

Reduction Or Elimination Of Radiation During Implantation ... In this study, the investigators aim to utilize ultrasound and echocardiography to gain vascular access and to direct the pacing lead into the right ventricle ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660658/

What is Known About Early Mobilisation After Cardiac ... Early mobilisation after a CIED procedure appears to be safe and not associated with other complications.