Microemboli, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
Conditions
Brief summary
This is an observational cohort study addressing the incidence of cerebral microemboli and alterations of cerebral hemodynamic physiology of the Relay®Branch thoracic stent-graft system.
Detailed description
This study is a prospective multi-center observational study. Eligible patients will be enrolled in RelayBranch (NCT03214601). Participating centers must have capabilities of performing intra-operative TCD monitoring and post-operative TCD monitoring. If sites have performed TCD microembolic monitoring during previous RelayBranch procedures, we will also incorporate these data in our analysis. The primary objective is to assess the number and timing of cerebral microemboli during Relay®Branch thoracic stent-graft deployment, to identify the highest risk portions of the procedure. Secondary objectives include: correlate procedural microembolic burden with neuroimaging and clinical outcome; quantify post-operative microemboli, correlating with neuroimaging and clinical outcome; and quantify the changes in cerebral blood flow and cerebral autoregulation that happens during critical procedural epochs, correlating with neuroimaging and clinical outcome.
Interventions
Transcranial Doppler (TCD) is a non-invasive ultrasound-based technique that facilitates insonation of the cerebral arteries. TCD probe design enables continuous monitoring of cerebral blood flow velocity (CBFv). TCD has a variety of clinical applications, including intraoperative monitoring for detection of microemboli. The TCD probe can be comfortably secured to the patient's head by a headframe in order to maintain continuous vessel insonation. Microembolic signals (MES) can be reliably detected based on standard criteria: 1. Brief in duration (\<300msec) 2. High intensity (amplitude \>3 dB above background) 3. Unidirectional 4. Audible chirp or snap Further, CBFv monitoring during may inform flow perturbations that occur during cardiac or vascular manipulations.
Sponsors
University of Pennsylvania
Bolton Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrollment in NCT03214601 based on presence of a thoracic aortic aneurysm, penetrating atherosclerotic ulcer, or chronic type B dissection that would require coverage of the brachiocephalic trunk and/or left carotid if a non-branching endograft were implanted Advanced heart failure with plan to treat with LVAD * At least 18 years of age * Patients enrolled prospectively must sign the informed consent form * If patients underwent TCD monitoring during a previous RelayBranch procedure as part of routine clinical care, we will also incorporate their data in our analysis
Exclusion criteria
* Skull defect or skull surgery that will preclude monitoring * Known lack of TCD temporal acoustic window (if had TCD in past) * Expected surgical position will preclude access to the patient's head for monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of intra-operative cerebral microemboli | during RelayBranch procedure | TCD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative microemboli (seen on post-op day 1 study) | post-op day 1 | TCD |
| Change in CBFv | intra-op and post-op day 1 | TCD |
| Change in cerebral autoregulation | intra-op and post-op day 1 | TCD |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven R Messe, MD
University of Pennsylvania
Outcome results
None listed