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

NCT04382430 | Completed

• 1 other identifier: STUDY00145717
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Complications; Cardiac Device Implant; Venous Access

Keywords

US Guided Venous access

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

US Guided Axillary venous access

EXPERIMENTAL

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

Conventional technique

ACTIVE COMPARATOR

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

Procedure: Conventional technique

Interventions

Ultrasound guided venous access 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.

US Guided Axillary venous access

Conventional technique PROCEDURE

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

Conventional technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written Informed Consent Form.
• ≥18 years of age up to 90 years old.
• Eligible and referred for cardiac device implantation.
• BMI \< 35.

You may not qualify if:

• Unable to sign consent.
• Patient eligible for cardiac device upgrades/ extractions, subcutaneous implantable cardioverter defibrillators (SICD) \& leadless devices.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (8)

• 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.

  PMID: 9382004 BACKGROUND

• 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.

  PMID: 24583974 BACKGROUND

• 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.

  PMID: 28064251 BACKGROUND

• 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.

  PMID: 26880272 BACKGROUND

• 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.

  PMID: 16923001 BACKGROUND

• 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.

  PMID: 23131025 BACKGROUND

• 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.

  PMID: 28752227 BACKGROUND

• 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.

  PMID: 29335840 BACKGROUND

Study Officials

• Seth Sheldon, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Medicine - Cardiology, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 11, 2020
• Study Start: May 28, 2020
• Primary Completion: June 6, 2021
• Study Completion: June 6, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)