Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
US Guided Axillary venous access
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
    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.
Active Comparator
Conventional technique
Physician/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation.
  • Procedure: Conventional technique
    Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Kartik Munshi, MPH
kmunshi@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Kartik Munshi, MPH
913- 945- 6445
kmunshi@kumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.