Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry

Study Overview
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Brief Summary
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Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.

Detailed Description
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Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation. In this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy. Aims of this registry: Evaluation of Incidence of lead induced tricuspid regurgitation Mortality and morbidity of lead induced tricuspid regurgitation Identification of risk factors for lead induced tricuspid regurgitation Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation

Official Title
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Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry

Conditions
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Tricuspid Valve Insufficiency, Pacemaker Complication, Echocardiography, Transesophageal

Intervention / Treatment
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* Procedure: Transesophageal guidance of lead implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines Exclusion Criteria: pre-existing RV lead pre-existing TR >2

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lead implantation with transesophageal echocardiography<br>All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance | Procedure: Transesophageal guidance of lead implantation<br>* In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions<br>|
| Lead implantation without transesophageal echocardiography (retrospective)<br>All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4) | Lead induced tricuspid regurgitation measured by transthoracic echocardiography | 2 - 7 days post-implant (at hospital discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-are product | Dose-are product applied during lead implantation | Intraprocedural | 
| Lead revisions | Incidence of acute lead revisions within 30 days | 30 days | 
| Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4) | Lead induced tricuspid regurgitation measured by transthoracic echocardiography | 3 months | 
| Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4) | Lead induced tricuspid regurgitation measured by transthoracic echocardiography | 12 months |