Ultrasound-guided Venous Access for Pacemaker and Defibrillator Implants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound-guided Venous Access, Using a Wireless Probe, for Pacemaker and Defibrillator Implants - a Randomized Study

Conditions
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Cardiac Arrhythmia, Heart Failure, AV Block

Intervention / Treatment
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* Procedure: Ultrasound guided venous access


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided venous access<br>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. | Procedure: Ultrasound guided venous access<br>* Access of the axillary vein using ultrasound guidance.<br>|
| No Intervention: Standard of care<br>Vascular access of the axillary or subclavian vein will be performed using anatomical landmarks, fluoroscopy and/or injection of X-ray contrast in the antecubital vein, at the choice of the implanter. One or more vascular punctures will be performed, as needed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to complete venous access | Time from start of vascular access attempt to achieved access for the required number access points (ie number of leads) | Peroperatively | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker, Implantable defibrillator, Venous access, Ultrasound