Registry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery

Conditions

Coronary Artery Bypass

Brief summary

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.

Leviner DB, von Mücke Similon M, Rosati CM, Amabile A, Thuijs DJFM, Giammarco GD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ, Taggart DP, Puskas JD.

2021-07-095 citations

10.1186/s13019-021-01575-y

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

Ethan S. Rosenfeld, Gregory D. Trachiotis, Michael A. Napolitano, Andrew Sparks, Daniel Wendt et al. (9 authors)

European Journal of Cardio-Thoracic Surgery2021-05-067 citations

10.1093/ejcts/ezab239

Intraoperative surgical strategy changes in patients with chronic and end-stage renal disease undergoing coronary artery bypass grafting

Ethan S. Rosenfeld, Gregory D. Trachiotis, Andrew Sparks, Michael A. Napolitano, Kyongjune B. Lee et al. (10 authors)

European Journal of Cardio-Thoracic Surgery2021-02-115 citations

10.1093/ejcts/ezab104

Interventions

DEVICEMedistim device

This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

No

Inclusion criteria

* Subject has been scheduled for coronary bypass surgery * Subject understands the nature of the procedure and has signed the subject informed consent prior to the procedure * Subject has been diagnosed with 2-3 vessel disease

Exclusion criteria

* Subject is scheduled for other surgical procedures during the bypass surgery (valve replacement/repair, carotid endarterectomy, etc.) * Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with surgery or follow-up testing * Subject is undergoing an emergency cardiac bypass surgery * Subject has history or presence of muscle disease (i.e. myopathy, myalgia, myasthenia, rhabdomyolysis) with or without concomitant CK-elevation \> 5 ULN that cannot be ascribed to any other medical condition (e.g. myocardial infarction) * Subject has any condition that the investigator believes should exclude him/her from this registry

Design outcomes

Primary

Measure	Time frame	Description
Change in planned surgical procedure	Day 1 (During Surgery)	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
Procedure adaptions	Day 1 (During surgery)	Identify the procedure adaptions made by a surgeon when TTFM and/or Medistim ultrasound imaging identify suboptimal graft function

Secondary

Measure	Time frame	Description
Record number of revisions	Day 1 (During surgery)	Record how many Cardiac bypass patients experience intraoperative graft revision, the type of revision, and the key identifier motivating the revision
Record number of events	Day 1-14 (During hospitalization)	Record post-surgical major adverse cardiac and cerebral events (MACCE) of all bypass procedure patients entered into the registry and occuring prior to discharge
Incidence rate	2 years (Throughout the study)	To determine the incidence rate of Serious Adverse Events (SAE) and/or Unanticipated Adverse Events (UAE) throughout the registry

Countries

Canada, Germany, Italy, Netherlands, United Kingdom, United States

Outcome results

None listed