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Leadless pacemakers (LP) are safe and effective alternatives to transvenous pacemakers in select patients. Advances in battery and electronics technology allow for the entire pacemaker system to be implanted into the right ventricle, bypassing many of the weaknesses of transvenous pacemakers. Traditionally leadless pacemakers have been implanted in the right ventricular (RV) septum to prevent cardiac perforation, and much emphasis is placed during implantation to ensure a septal implant. However, in Asians with smaller heart sizes, septal implantation may be unfeasible. Cases of RV free wall implant have been achieved without any complications. This study aims to examine patients previously implanted with LP and determine their final attachment location. If a substantial portion of complication-free patients had RV free wall implants, then it can be argued the additional effort to ensure a septal implant is unnecessary. Additionally, intraoperative data, such as the intracardiac electrogram, may contain parameters correlated with implant position. This study also aims to study this correlation to guide future implant procedures.
This is a prospective-retrospective cohort study. Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. The attachment of the leadless pacemaker to the RV will be adjudicated from the CT. The patients' pre-operative laboratory tests, baseline demographics, medical history, LP electrical data and pre- and post-operative medication regiment will be collected retrospectively from their medical records in the Hospital Authority's Clinical Management System (CMS) and Clinical Data Analysis and Reporting System (CDARS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT | Other | All patients will have a non-contrast, ECG-gated CT heart to adjudicate implant position of leadless pacemaker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leadless pacemaker | Device | Patients who will implant leadless pacemakers or already implanted leadless pacemakers since 1 Jan 2015 will be recruited. After the implantation, patients will be invited back for a noncontrast, ECG-gated CT heart. It will be timed at the end diastole and a 3D reconstruction will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Location of leadless pacemaker implantation | Determine the exact location of leadless pacemaker implantation | From date of enrollment to date of CT or echocardiogram, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Implant location prediction with electrical parameters | Correlate leadless pacemaker electrical parameters (including electrogram characteristics, pacing threshold and sensing) to leadless pacemaker implant position (septal, apex or free wall). | From date of enrollment to date of CT or echocardiogram, up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsz Kin Mark Tam | Contact | 852 35051750 | marktam@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
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