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

NCT ID: NCT04382430

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-28
• Study Completion Date: 2021-06-06

Brief 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.

Conditions

Ultrasound Therapy; Complications; Cardiac Device Implant; Venous Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound guided venous access

Intervention Type: PROCEDURE

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/ provider will perform 5 cardiac device implant using conventional technique for venous access and pocket creation.

Group Type: ACTIVE_COMPARATOR

Conventional technique

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Conventional technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seth Sheldon

Clinical Assistant Professor of Medicine - Cardiology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Sheldon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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. doi: 10.1016/s0002-9149(97)00542-0.

Reference Type: BACKGROUND

PMID: 9382004 (View on PubMed)

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. doi: 10.1253/circj.cj-13-0884. Epub 2014 Mar 3.

Reference Type: BACKGROUND

PMID: 24583974 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28064251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26880272 (View on PubMed)

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. doi: 10.1111/j.1540-8159.2006.00451.x.

Reference Type: BACKGROUND

PMID: 16923001 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23131025 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28752227 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29335840 (View on PubMed)

Other Identifiers

STUDY00145717

Identifier Type: -

Identifier Source: org_study_id