Residents' Learning Curve of Intraoperative Transit-time Flowmetry and High-frequency Ultrasound in CABG (LEARNERS)

NCT06589323 | Completed

• 1 other identifier: 6735
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Transit-time flowmetry (TTFM) allows grafts quality assessment during coronary artery bypass surgery by measuring the flow volume through them. Recently the intraoperative epicardial high-frequency ultrasound (HFUS) was introduced, with the possibility of capturing bidimensional images of the anastomoses. When combined, these two techniques provide high diagnostic yield reaching a positive predictive value of 100 percent. Despite current guidelines recommend the employment of TTFM and HFUS, they remain largely underused probably because of limited information and the lack of standardization. Furthermore, surgeons must overcome a learning curve to handle both techniques properly, but few data are available according the current literature. The main purpose of this study is to evaluate the complexity of HFUS and TTFM learning curve. This is a prospective, observational, monocentric cohort study. Adult patients undergoing coronary artery bypass surgery will be enrolled.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of anastomoses needed to reach a ratio (total score/n. of anastomoses) >= 11

  Number of anastomoses needed to reach a ratio between total score and the number of studied anastomoses of 11 or more

  This evaluation will require from 1 to 3 months.

Secondary Outcomes (2)

• Number of anastomoses needed to reach a ratio (HFUS score/n. of anastomoses) = 4

  This evaluation will require from 1 to 3 months.

• Number of anastomoses needed to reach a ratio (TTFM score/n. of anastomoses) >=7

  This evaluation will require from 1 to 3 months.

Study Arms (1)

Group 1

adult patients undergoing coronary artery bypass surgery

Procedure: Coronary artery bypass graft

Interventions

Coronary artery bypass graft PROCEDURE

All patients included will undergo coronary artery bypass graft surgery. During surgery, every graft will be evaluated through transit time flowmetry (TTFM) and intraoperative ultrasound control (HFUS).

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with coronary artery disease and an indication for surgical revascularization (coronary artery bypass grafting) who meet the above-described inclusion and exclusion criteria will be enrolled by signing the informed consent the day before surgery.

You may qualify if:

• Age \>= 18 years old;
• Written informed consent;
• Indication to CABG surgery (both "on-pump" and "off-pump");
• Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI).

You may not qualify if:

• Age \>= 18 years old;
• Written informed consent;
• Indication to CABG surgery (both "on-pump" and "off-pump");
• Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Roma, RM, 00168, Italy

Location

Related Publications (16)

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 RESULT

• Kieser TM, Rose S, Kowalewski R, Belenkie I. Transit-time flow predicts outcomes in coronary artery bypass graft patients: a series of 1000 consecutive arterial grafts. Eur J Cardiothorac Surg. 2010 Aug;38(2):155-62. doi: 10.1016/j.ejcts.2010.01.026. Epub 2010 Feb 21.

  PMID: 20176493 RESULT

• Kieser TM, Taggart DP. The use of intraoperative graft assessment in guiding graft revision. Ann Cardiothorac Surg. 2018 Sep;7(5):652-662. doi: 10.21037/acs.2018.07.06.

  PMID: 30505750 RESULT

• Amin S, Pinho-Gomes AC, Taggart DP. Relationship of Intraoperative Transit Time Flowmetry Findings to Angiographic Graft Patency at Follow-Up. Ann Thorac Surg. 2016 May;101(5):1996-2006. doi: 10.1016/j.athoracsur.2015.10.101. Epub 2016 Feb 12.

  PMID: 26876343 RESULT

• Di Giammarco G, Pano M, Cirmeni S, Pelini P, Vitolla G, Di Mauro M. Predictive value of intraoperative transit-time flow measurement for short-term graft patency in coronary surgery. J Thorac Cardiovasc Surg. 2006 Sep;132(3):468-74. doi: 10.1016/j.jtcvs.2006.02.014.

  PMID: 16935097 RESULT

• Xenogiannis I, Zenati M, Bhatt DL, Rao SV, Rodes-Cabau J, Goldman S, Shunk KA, Mavromatis K, Banerjee S, Alaswad K, Nikolakopoulos I, Vemmou E, Karacsonyi J, Alexopoulos D, Burke MN, Bapat VN, Brilakis ES. Saphenous Vein Graft Failure: From Pathophysiology to Prevention and Treatment Strategies. Circulation. 2021 Aug 31;144(9):728-745. doi: 10.1161/CIRCULATIONAHA.120.052163. Epub 2021 Aug 30.

  PMID: 34460327 RESULT

• Di Giammarco G, Canosa C, Foschi M, Rabozzi R, Marinelli D, Masuyama S, Ibrahim BM, Ranalletta RA, Penco M, Di Mauro M. Intraoperative graft verification in coronary surgery: increased diagnostic accuracy adding high-resolution epicardial ultrasonography to transit-time flow measurement. Eur J Cardiothorac Surg. 2014 Mar;45(3):e41-5. doi: 10.1093/ejcts/ezt580. Epub 2013 Dec 12.

  PMID: 24335472 RESULT

• Gaudino M, Sandner S, Di Giammarco G, Di Franco A, Arai H, Asai T, Bakaeen F, Doenst T, Fremes SE, Glineur D, Kieser TM, Lawton JS, Lorusso R, Patel N, Puskas JD, Tatoulis J, Taggart DP, Vallely M, Ruel M. The Use of Intraoperative Transit Time Flow Measurement for Coronary Artery Bypass Surgery: Systematic Review of the Evidence and Expert Opinion Statements. Circulation. 2021 Oct 5;144(14):1160-1171. doi: 10.1161/CIRCULATIONAHA.121.054311. Epub 2021 Oct 4.

  PMID: 34606302 RESULT

• Kieser TM. Graft quality verification in coronary artery bypass graft surgery: how, when and why? Curr Opin Cardiol. 2017 Nov;32(6):722-736. doi: 10.1097/HCO.0000000000000452.

  PMID: 28806185 RESULT

• Andreasen JJ, Nohr D, Jorgensen AS, Haahr PE. Peroperative epicardial ultrasonography of distal coronary artery bypass graft anastomoses using a stabilizing device. A feasibility study. J Cardiothorac Surg. 2020 Jan 8;15(1):3. doi: 10.1186/s13019-020-1057-x.

  PMID: 31915030 RESULT

• Andreasen JJ, Nohr D, Jorgensen AS. A case report on epicardial ultrasonography of coronary anastomoses using a stabilizing device without the use of ultrasound gel. J Cardiothorac Surg. 2019 Mar 13;14(1):59. doi: 10.1186/s13019-019-0882-2.

  PMID: 30866994 RESULT

• Wolf RK, Falk V. Intraoperative assessment of coronary artery bypass grafts. J Thorac Cardiovasc Surg. 2003 Sep;126(3):634-7. doi: 10.1016/s0022-5223(03)00747-5. No abstract available.

  PMID: 14502132 RESULT

• Budde RP, Meijer R, Dessing TC, Borst C, Grundeman PF. Detection of construction errors in ex vivo coronary artery anastomoses by 13-MHz epicardial ultrasonography. J Thorac Cardiovasc Surg. 2005 May;129(5):1078-83. doi: 10.1016/j.jtcvs.2004.09.002.

  PMID: 15867783 RESULT

• Jorgensen AS, Schmidt SE, Staalsen NH, Ostergaard LR. An Improved Algorithm for Coronary Bypass Anastomosis Segmentation in Epicardial Ultrasound Sequences. Ultrasound Med Biol. 2016 Dec;42(12):3010-3021. doi: 10.1016/j.ultrasmedbio.2016.07.014. Epub 2016 Sep 2.

  PMID: 27592558 RESULT

• Taggart DP, Thuijs DJFM, Di Giammarco G, Puskas JD, Wendt D, Trachiotis GD, Kieser TM, Kappetein AP, Head SJ. Intraoperative transit-time flow measurement and high-frequency ultrasound assessment in coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2020 Apr;159(4):1283-1292.e2. doi: 10.1016/j.jtcvs.2019.05.087. Epub 2019 Aug 22.

  PMID: 31685277 RESULT

• Cammertoni F, Di Giammarco G, Testa N, Pavone N, Marcolini A, D'Avino S, Bruno P, Grandinetti M, Bianchini F, Trapani AE, Massetti M. Learning Curve of Cardiac Surgery Residents in Transit-Time Flow Measurement and High-Resolution Epicardial Ultrasonography During Coronary Surgery. J Clin Med. 2026 Jan 13;15(2):620. doi: 10.3390/jcm15020620.

  PMID: 41598558 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Federico Cammertoni, Dr.

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 2, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)