Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

Not Applicable

Terminated

• Conditions: Cardiac Arrhythmia; Heart Failure; AV Block
• Interventions: Procedure: Ultrasound guided venous access

• Registration Number: NCT04867460
• Lead Sponsor: Region Skane

Brief Summary

The study will include patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured.

Detailed Description

Pacemaker- and defibrillator lead implants typically involve vascular access via the left cephalic, axillar or subclavian vein. Gaining access is usually straight forward for an experienced surgeon/implanter, but can be difficult in a minority of cases, or for implanters with less experience. Complications include arterial puncture, pneumothorax and local bleeding or hematoma. Traditionally cephalic vein cut-down is the first choice, but is only available in 70% of cases, and for more complex procedures involving three electrodes, an additional access is always required.

Ultrasound guidance is very common in other vascular access areas such as femoral artery, radial artery and internal jugular vein, but has not gained widespread acceptance in pacemaker procedures. High quality studies, demonstrating superiority or non-inferiority over other access methods are lacking.

The present study will include all comer patients scheduled for transvenous pacemaker- or implantable defibrillator surgery, where venous access is necessary for lead implantation. A 1:1 randomization will be performed to either standard access (at the discretion of the surgeon) or ultrasound-guided using a wireless vascular transducer (Siemens Freestyle). Implanters with various degrees of ultrasound experience and pacemaker surgery experience will participate in the study. All implanters will receive a 2-hour training lecture and additional hands-on training for the first 3 cases, by an ultrasound-experienced anaesthesiologist.

Access time and success rate will be recorded, and all acute complications will be recorded. Primary outcome is mean time to vascular access. In addition, success rate, complication rate and total procedure time will be measured. Outcome data will be analyzed for the entire cohort, but also stratified for implanter and excluding the first 10 cases for each implanter, to compensate for various experience and individual learning curve.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Status Verified: 2024-04
• Primary Completion: 2025-02-27
• Study Completion: 2025-02-27
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Planned pacemaker or implantable defibrillator surgery with at least one new transvenously placed lead.

Exclusion Criteria

• Difficult vascular access known before surgery, where special access technique is planned or required.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided venous access	Ultrasound guided venous access	Vascular access of the axillary vein will be performed using an ultrasound system (Siemens Acuson Freestyle) with a wireless vascular ultrasound probe (L8-3 or L13-5). One or more vascular punctures will be performed, as needed.

Primary Outcome Measures

Name	Time	Method
Mean time to complete venous access	Peroperatively	Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads)

Secondary Outcome Measures

Name	Time	Method
Mean time to first venous access	Peroperatively	Time from start of vascular access attempt to achieved access for the first introducer or lead
Successrate for full venous access	Peroperatively	Percentage of cases with achieved full venous access using the assigned technique, without having to change technique
Successrate for full venous access within 3 minutes	Peroperatively	Percentage of cases with achieved full venous access within 3 minutes, using the assigned technique, without having to change technique
Full venous access without any complication	Peroperatively within 24 hours	Percentage of full venous access without any complication (including arterial puncture, pneumothorax, hemothorax, local hematoma and other acute complications)

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Lund, Sweden