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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead implantation with transesophageal echocardiography | All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance |
| |
| Lead implantation without transesophageal echocardiography (retrospective) | All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transesophageal guidance of lead implantation | Procedure | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Braun, PD Dr. med. | LMU Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum | Munich | Bavaria | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34887055 | Derived | Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available. |
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|
| 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 |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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