MicroTEE guided lead extraction.
Completed
- Conditions
- defibrillator or pacemaker lead removalcomparing two types of oesophgeal heart echo's10007521
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
- subjects who require extraction of (one or more) pace/sense or shock leads.
- age > 18 years
Exclusion Criteria
- incapacitated adults
- contraindication for TEE: dysphagia, odynophagia, mediastinal radiation, recent upper gastrointestinal surgery, recent esophagitis, thoracic aortic aneurysm and esophageal pathology (stricture, tumour, diverticulum, varices).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Covering of the lead by the shadow of the TEE probe on fluoroscopic X-ray (in<br /><br>AP view). Score: no covering, slight covering (no pullback needed), significant<br /><br>covering (probe pull back necessary).<br /><br>- Image quality assessment of intraoperative microTEE, sufficient for detection<br /><br>of complications such as pericardial effusion, tamponade, myocardial<br /><br>perforation and vascular laceration (score: good or bad. If bad: switch probe<br /><br>if microTEE was used).<br /><br>- Time delay to first pull back (in min, from first attempt to pull the lead<br /><br>after insertion of a normal stilet).<br /><br>- The number of TEE probe pull backs and reinsertions.<br /><br>- Quantification of image quality of 3D MicroTEE reconstructions, compared to<br /><br>3D TTE and conventional 3D TEE images. (Image quality score of the 3D MicroTEE<br /><br>reconstructions compared to 3D TTE/conventional 3D TEE : better, similar,<br /><br>worse) </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Location of assumed lead adhesions in preoperative 3D TTE/TEE (subclavian<br /><br>vein, innominate vein, superior caval vein, atrial or ventricular wall,<br /><br>tricuspid valve).<br /><br>- Severity of pre- and post-procedural TR (score: 0: no TR, 1: mild TR, 2:<br /><br>moderate TR, 3: moderate to severe, 4: severe) and calculation of increase in<br /><br>severity of TR.<br /><br>- Correlation between the surface of the tricuspid valve tissue present on the<br /><br>lead after extraction and (1) pre- and periprocedural TEE assumed lead<br /><br>adhesions, (2) attempts made to adapt the extraction technique, and (3) the<br /><br>increase in the severity of the TR.</p><br>