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The purpose of the registry is to collect information regarding the number and type of coronary artery bypass (CAB) surgical procedure changes that are made based on intraoperative guidance information using transit time flow measurements (TTFM) and ultrasound image capabilities provided with the Medistim device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medistim device | Device | This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in planned surgical procedure | Identify how often epiaortic scanning With the Medistim Device, leads to a change in the planned surgical procedure and to identify the reason and the procedure change | Day 1 (During Surgery) |
| Procedure adaptions | Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function | Day 1 (During surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Record number of revisions | Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision | Day 1 (During surgery) |
| Record number of events |
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Inclusion Criteria:
Exclusion Criteria:
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Subject has been scheduled for coronary bypass surgery
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| Name | Affiliation | Role |
|---|---|---|
| Anne Waaler, MSc Pharm | Medistim ASA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center | Washington DC | Maryland | 20422 | United States | ||
| Mount Sinai Beth Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34243799 | Derived | Leviner DB, von Mucke Similon M, Rosati CM, Amabile A, Thuijs DJFM, Giammarco GD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ, Taggart DP, Puskas JD. Transit time flow measurement of coronary bypass grafts before and after protamine administration. J Cardiothorac Surg. 2021 Jul 9;16(1):195. doi: 10.1186/s13019-021-01575-y. | |
| 34166508 |
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Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge
| Day 1-14 (During hospitalization) |
| Incidence rate | To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry | 2 years (Throughout the study) |
| New York |
| New York |
| 10003 |
| United States |
| University of Calgary | Calgary | Alberta | AB T2N 1N4 | Canada |
| University of Duisburg-Essen, Dept. of Cardiothoracic Surgery | Essen | 45122 | Germany |
| Clinica Cardiochirurgica | Chieti | 66100 | Italy |
| Erasmus University Medical Center | Rotterdam | 3015 GD | Netherlands |
| University of Oxford | Oxford | OX3 9DU | United Kingdom |
| Rosenfeld ES, Trachiotis GD, Napolitano MA, Sparks AD, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative transit-time flow measurement and high-frequency ultrasound in coronary artery bypass grafting: impact in off versus on-pump, arterial versus venous grafting and cardiac territory grafted. Eur J Cardiothorac Surg. 2021 Dec 27;61(1):204-213. doi: 10.1093/ejcts/ezab239. |
| 33675642 | Derived | Rosenfeld ES, Trachiotis GD, Sparks AD, Napolitano MA, Lee KB, Wendt D, Kieser TM, Puskas JD, DiGiammarco G, Taggart DP. Intraoperative surgical strategy changes in patients with chronic and end-stage renal disease undergoing coronary artery bypass grafting. Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1210-1217. doi: 10.1093/ejcts/ezab104. |