Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation

Study Overview
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Brief Summary
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The purpose of this study is to determine the learning curve associated with Ultrasound (US) guided axillary vein access for cardiac device implantation based on length of procedure among operators of various levels of experience and to assess the 30-day complication rate for patients undergoing US guided device placement versus traditional implant methods.

Detailed Description
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Ultrasound (US) guided axillary vein access for device implantation is an uncommon approach to gain venous access for cardiac device implantation - an extremely common procedure. However, there has been a growing trend of utilizing this approach to obtain venous access for device implantation among operators. Axillary vein access was described back as far as 1997, when it was utilized for contrast guided venipuncture to access the axillary vein for device implantation. Literature has suggested that an axillary venous approach, with either a superficial landmark or radiographic contrast, has better long-term efficacy and lower lead complications than a conventional subclavian approach for patients that had permanent pacemaker implantation. There are a variety of ways to access the axillary vein including contrast venography to help localization, blind puncture (utilizing fluoroscopy to identify anatomical landmarks), and US. More recently, operators have begun to utilize US guidance for axillary vein access. Esmaiel has described that US guidance for axillary vein access could potentially improve the success rate of venous access and limit complications. Others, albeit few, have reported US guided access for cardiac device implantation has the ability to reduce complications, is faster to complete, and easier to learn. According to the Agency for Healthcare Research and Quality in the United States, US guided central venous catheter placement is one of the 11 patient safety practices that have the strongest evidence supporting its use in improving patient outcomes. Evidence supports US guidance being standard of care in central venous catheter placement and using US for axillary access as helpful in cardiac device implantation, but providers still utilize predominantly alternative approaches to obtain venous access via the subclavian vein, cephalic cutdown, extrathoracic axillary using fluoroscopy and thoracic axillary using fluoroscopy. Currently, there is limited data describing outcomes, the efficiency of US guided axillary access for cardiac device implantation, and the learning curve associated with this technique. Data suggests that utilizing the US approach can improve outcomes, be more efficient, and be easier to learn. Investigators recently reported a high success (95%) and low complication rate with US guided axillary access in 187 patients. Despite this limited data, operators still largely use alternative approaches for venous access. In part, this may be due to the learning curve associated with US axillary venous access. While there is data demonstrating the utility of US guided axillary access, there is little evidence showing the learning curve for operators associated with this technique. The aim of this project is to assess the learning curve of this technique among operators of various levels of experience.

Official Title
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Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation

Conditions
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Ultrasound Therapy; Complications, Cardiac Device Implant, Venous Access

Intervention / Treatment
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* Procedure: Ultrasound guided venous access
* Procedure: Conventional technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign written Informed Consent Form. ≥18 years of age up to 90 years old. Eligible and referred for cardiac device implantation. BMI < 35. Exclusion Criteria: Unable to sign consent. Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) & leadless devices.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Study Group for this study will include 1 US experienced Electrophysiology (EP) attending, 4 US inexperienced EP attendings, and 1 US inexperienced EP fellow performing US cardiac device implantation (CDI). Each provider will perform 5 conventional CDI, 2 assisted US CDI to learn the procedure (except for experienced US attending), and 10 solo US CDI for a total of 17 procedures per provider (15 for experienced US attending). 100 patients will be needed for this study. This study will take approximately 16 weeks to complete.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US Guided Axillary venous access<br>Physician/ provider will perform 2 unassisted & 10 solo Ultrasound (US) guided venous access and pocket creation cardiac device implant. First 2 device implant will be done to educate physicians about ultrasound guided venous access. Subsequent subject will be randomized to 2:1 in ultrasound vs. conventional technique. | Procedure: Ultrasound guided venous access<br>* Each physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant.<br>|
| Active Comparator: Conventional technique<br>Physician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation. | Procedure: Conventional technique<br>* Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous access time between US guided and conventional technique | Assess changes in venous access and pocket creation time with progressive experience with US guided axillary venous access (learning curve). | During procedure | 
| Time spent for pocket creation between US guided venous access technique and conventional technique. | Compare the pocket creation time with US guided axillary venous access versus conventional techniques. | During procedure | 
| Time spent to obtain venous access & pocket creation between experienced and inexperienced physicians. | Compare venous access and pocket creation time amongst experienced and inexperienced physicians. | During procedure | 
| To assess 30 day post procedure complications | Assess 30-day complications between techniques. | 30 Day post procedure | 
| Assess acute procedural success between two techniques. | Compare overall procedural success whether device was successfully placed or not post procedure between US guided axillary venous access & conventional technique. Success as Assigned- whether implant technique assigned was successful or whether had to switch to an alternative technique. | During procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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US Guided Venous access