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

Ultrasound Therapy; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382430
• Other study ID #: STUDY00145717
• Status: Completed
• Phase: N/A
• Start date: May 28, 2020
• Est. completion date: June 6, 2021

Study information

• Verified date: September 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 6, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Device Implant
• Ultrasound Therapy; Complications
• Venous Access

Intervention

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.
• Conventional technique
Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23. — View Citation

Jones DG, Stiles MK, Stewart JT, Armstrong GP. Ultrasound-guided venous access for permanent pacemaker leads. Pacing Clin Electrophysiol. 2006 Aug;29(8):852-7. — View Citation

Kim KH, Park KM, Nam GB, Kim DK, Oh M, Choi H, Hong TJ, Park BM, Seo GW, Song PS, Kim DK, Seol SH, Kim DI, Kim YH, Choi KJ. Comparison of the axillary venous approach and subclavian venous approach for efficacy of permanent pacemaker implantation. 8-Year follow-up results. Circ J. 2014;78(4):865-71. Epub 2014 Mar 3. — View Citation

Liccardo M, Nocerino P, Gaia S, Ciardiello C. Efficacy of ultrasound-guided axillary/subclavian venous approaches for pacemaker and defibrillator lead implantation: a randomized study. J Interv Card Electrophysiol. 2018 Mar;51(2):153-160. doi: 10.1007/s10840-018-0313-7. Epub 2018 Jan 15. — View Citation

Lin J, Adsit G, Barnett A, Tattersall M, Field ME, Wright J. Feasibility of ultrasound-guided vascular access during cardiac implantable device placement. J Interv Card Electrophysiol. 2017 Oct;50(1):105-109. doi: 10.1007/s10840-017-0273-3. Epub 2017 Jul 27. — View Citation

Ramza BM, Rosenthal L, Hui R, Nsah E, Savader S, Lawrence JH, Tomaselli G, Berger R, Brinker J, Calkins H. Safety and effectiveness of placement of pacemaker and defibrillator leads in the axillary vein guided by contrast venography. Am J Cardiol. 1997 Oct 1;80(7):892-6. — View Citation

Seto AH, Jolly A, Salcedo J. Ultrasound-guided venous access for pacemakers and defibrillators. J Cardiovasc Electrophysiol. 2013 Mar;24(3):370-4. doi: 10.1111/jce.12005. Epub 2012 Nov 6. Review. — View Citation

Squara F, Tomi J, Scarlatti D, Theodore G, Moceri P, Ferrari E. Self-taught axillary vein access without venography for pacemaker implantation: prospective randomized comparison with the cephalic vein access. Europace. 2017 Dec 1;19(12):2001-2006. doi: 10.1093/europace/euw363. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	To assess 30 day post procedure complications	Assess 30-day complications between techniques.	30 Day post procedure
Primary	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