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Leadless pacemakers (LP) are associated with a lower risk of revision compared with transvenous pacemakers. However, LPs implantation is associated with a 0.6% risk of complication at the femoral vein puncture site (e.g. arteriovenous fistula, haemorrhage, pseudoaneurysm, etc.). As a consequence, the need for prolonged in-hospital monitoring after LP implantation though the right femoral (RF)vein is a barrier to same-day discharge. Recently, right internal jugular (RIJ) vein access has emerged an alternative to right RF vein access for LP implantation (with a regulatory approval for MEDTRONIC Micra LP).
The aims of this registry are the following :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leadless pacemaker implantation through right internal jugular vein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leadless pacemaker implantation through right internal jugular vein | Device | Leadless pacemaker implantation through right internal jugular vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of effective of jugular access | Feasibility of jugular access for leadless pacemaker implantation, defined as the percentage of patients with a successful leadless pacemaker implantation through the jugular vein. | [0 - 1 Month] |
| Rate of effective same-day discharge | Feasibility of same-day discharge after implantation of a leadless pacemaker through the jugular vein, defined as a successful same-day discharge with no readmission during the first postoperative month. | [0 - 1 Month] |
| Incidence of major cardiovascular event | Incidence of major complications related to the implantation of a leadless through the jugular vein:
| [0 - 12 Month] |
| Measure | Description | Time Frame |
|---|---|---|
| Description of procedural characteristics | Procedural characteristics of leadless pacemaker implantation through the jugular vein (duration, position, number of attempts, ...). | During implantation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients with a guideline-based pacemaker indication and eligible to leadless pacemaker implantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers University Hospital | Angers | France | ||||
| Caen University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38426911 | Result | El-Chami MF, Garweg C, Clementy N, Al-Samadi F, Iacopino S, Martinez-Sande JL, Roberts PR, Tondo C, Johansen JB, Vinolas-Prat X, Cha YM, Grubman E, Bordachar P, Stromberg K, Fagan DH, Piccini JP. Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. 2024 Apr 7;45(14):1241-1251. doi: 10.1093/eurheartj/ehae101. | |
| 30653690 |
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| Caen |
| France |
| Grenoble University Hospital | Grenoble | France |
| Lille University Hospital | Lille | France |
| Lyon University Hospital | Lyon | France |
| Metz-Thionville Regional Hospital | Metz | France |
| Le Millénaire Private Hospital | Montpellier | France |
| Les Franciscaines Private Hospital | Nîmes | France |
| Rennes University Hospital | Rennes | France |
| La Réunion University Hospital | Saint Pierre de La Réunion | France |
| Strasbourg University Hospital | Strasbourg | France |
| Toulouse University Hospital | Toulouse | France |
| Tours University Hospital | Tours | France |
| Saleem-Talib S, van Driel VJ, Chaldoupi SM, Nikolic T, van Wessel H, Borleffs CJW, Ramanna H. Leadless pacing: Going for the jugular. Pacing Clin Electrophysiol. 2019 Apr;42(4):395-399. doi: 10.1111/pace.13607. Epub 2019 Feb 25. |
| 36031774 | Result | Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12. |