Ultrasound Axillary Vein Access: Evaluation of Learning Curve for an Alternative Approach to Cardiac Device Implantation
Condition: Ultrasound Therapy; Complications; Cardiac Device Implant; Venous Access
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Ultrasound guided venous access; Conventional technique
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Supportive Care
Keywords: US Guided Venous access