Skeletonised Versus Pedicled Internal Thoracic Artery

Heart Diseases Clinical Trial

— TST  

Official title:

Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05562908
• Other study ID #: OP_764
• Secondary ID: S-20180083
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

1. That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).

2. Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)

• On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)

• Patients aged >18

• Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Exclusion Criteria:

• CABG combined with other heart surgery, except from LAAX

• Previous heart surgery

• LVEF < 40% (there is a known higher risk of postoperative complications with low LVEF)

• Known cancers (there is a known higher risk of postoperative complication)

• Thoracic radiation therapy (there is a known higher risk of postoperative complication)

• Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)

• Patients not able to understand written consent

• Urgent and emergent surgery (there is a known higher risk of postoperative complication)

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Procedure:
• Pedicled
Surgical procedure: A prior marking was made on both sides of the LIMA and its veins with bi-polar technique. Hereafter the LIMA and its veins were dissected free with scissor and forceps. Clips were added to all side branches. When the full length of LIMA was obtained, the LIMA and its veins were divided distally by adding clips on the peripheral part of the vessels and proximately dividing by scissor. A vessel-clamp was placed distally and the pedicled LIMA placed in the jugular cavity with a cloth containing papaverine.
• Surgical skeletonised
Surgical procedure: The fascia of the LIMA was opened with a scissor. Hereafter the LIMA was dissected free with scissor and forceps, clips on all LIMA side-branches and divided by scissor. When the full length of LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.
• Thunderbeat skeletonised
Surgical procedure: With Thunderbeat the fascia of LIMA was opened. The LIMA was dissected free with Thunderbeat including all side-branches. When the full length of the LIMA was obtained, the LIMA was divided distally by adding clips on the peripheral part of the vessel and proximately dividing by scissor. A vessel-clamp was placed distally, and the skeletonised LIMA placed in the jugular cavity with a cloth containing papaverine.

Locations

Country	Name	City	State
Denmark	Department of Cardio, Vascular and Thoracic Surgery	Odense	Region Of Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
Lars Peter Riber	GCP-unit at Odense University Hospital, Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

References & Publications (18)

Ben-Yehuda O, Chen S, Redfors B, McAndrew T, Crowley A, Kosmidou I, Kandzari DE, Puskas JD, Morice MC, Taggart DP, Leon MB, Lembo NJ, Brown WM, Simonton CA, Dressler O, Kappetein AP, Sabik JF, Serruys PW, Stone GW. Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial. Eur Heart J. 2019 Jun 21;40(24):1930-1941. doi: 10.1093/eurheartj/ehz113. — View Citation

Boczor S, Daubmann A, Eisele M, Blozik E, Scherer M. Quality of life assessment in patients with heart failure: validity of the German version of the generic EQ-5D-5L™. BMC Public Health. 2019 Nov 6;19(1):1464. doi: 10.1186/s12889-019-7623-2. — View Citation

Cheng K, Rehman SM, Taggart DP. A Review of Differing Techniques of Mammary Artery Harvesting on Sternal Perfusion: Time for a Randomized Study? Ann Thorac Surg. 2015 Nov;100(5):1942-53. doi: 10.1016/j.athoracsur.2015.06.087. Epub 2015 Sep 26. Review. — View Citation

Gahl B, Göber V, Odutayo A, Tevaearai Stahel HT, da Costa BR, Jakob SM, Fiedler GM, Chan O, Carrel TP, Jüni P. Prognostic Value of Early Postoperative Troponin T in Patients Undergoing Coronary Artery Bypass Grafting. J Am Heart Assoc. 2018 Feb 27;7(5). pii: e007743. doi: 10.1161/JAHA.117.007743. — View Citation

Harskamp RE, Lopes RD, Baisden CE, de Winter RJ, Alexander JH. Saphenous vein graft failure after coronary artery bypass surgery: pathophysiology, management, and future directions. Ann Surg. 2013 May;257(5):824-33. doi: 10.1097/SLA.0b013e318288c38d. Review. — View Citation

Kamiya H, Akhyari P, Martens A, Karck M, Haverich A, Lichtenberg A. Sternal microcirculation after skeletonized versus pedicled harvesting of the internal thoracic artery: a randomized study. J Thorac Cardiovasc Surg. 2008 Jan;135(1):32-7. doi: 10.1016/j.jtcvs.2007.09.004. — View Citation

Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum in: JAMA Cardiol. 2021 Aug 18;:null. — View Citation

Lee SW, Jo JY, Kim WJ, Choi DK, Choi IC. Patient and haemodynamic factors affecting intraoperative graft flow during coronary artery bypass grafting: an observational pilot study. Sci Rep. 2020 Jul 31;10(1):12968. doi: 10.1038/s41598-020-69924-w. — View Citation

Liberman M, Khereba M, Goudie E, Kazakov J, Thiffault V, Lafontaine E, Ferraro P. Pilot study of pulmonary arterial branch sealing using energy devices in an ex vivo model. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3219-23. doi: 10.1016/j.jtcvs.2014.05.089. Epub 2014 Jul 19. — View Citation

Loop FD, Lytle BW, Cosgrove DM, Stewart RW, Goormastic M, Williams GW, Golding LA, Gill CC, Taylor PC, Sheldon WC, et al. Influence of the internal-mammary-artery graft on 10-year survival and other cardiac events. N Engl J Med. 1986 Jan 2;314(1):1-6. — View Citation

Mannacio V, Di Tommaso L, De Amicis V, Stassano P, Vosa C. Randomized flow capacity comparison of skeletonized and pedicled left internal mammary artery. Ann Thorac Surg. 2011 Jan;91(1):24-30. doi: 10.1016/j.athoracsur.2010.06.131. — View Citation

Markman PL, Rowland MA, Leong JY, Van Der Merwe J, Storey E, Marasco S, Negri J, Bailey M, Rosenfeldt FL. Skeletonized internal thoracic artery harvesting reduces chest wall dysesthesia after coronary bypass surgery. J Thorac Cardiovasc Surg. 2010 Mar;139(3):674-9. doi: 10.1016/j.jtcvs.2009.03.066. Epub 2009 Sep 22. — View Citation

Mazur P, Litwinowicz R, Tchantchaleishvili V, Natorska J, Zabczyk M, Bochenek M, Przybylski R, Iwaniec T, K?dziora A, Filip G, Kapelak B. Left Internal Mammary Artery Skeletonization Reduces Bleeding-A Randomized Controlled Trial. Ann Thorac Surg. 2021 Sep;112(3):794-801. doi: 10.1016/j.athoracsur.2020.10.024. Epub 2020 Nov 7. — View Citation

Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43. — View Citation

Raja SG, Dreyfus GD. Internal thoracic artery: to skeletonize or not to skeletonize? Ann Thorac Surg. 2005 May;79(5):1805-11. Review. — View Citation

Sá MP, Cavalcanti PE, Santos HJ, Soares AF, Miranda RG, Araújo ML, Lima RC. Flow capacity of skeletonized versus pedicled internal thoracic artery in coronary artery bypass graft surgery: systematic review, meta-analysis and meta-regression. Eur J Cardiothorac Surg. 2015 Jul;48(1):25-31. doi: 10.1093/ejcts/ezu344. Epub 2014 Sep 15. Review. — View Citation

Takami Y, Ina H. Effects of skeletonization on intraoperative flow and anastomosis diameter of internal thoracic arteries in coronary artery bypass grafting. Ann Thorac Surg. 2002 May;73(5):1441-5. — View Citation

Thuijs DJFM, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Holmes DR Jr, Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Jüni P, Head SJ; SYNTAX Extended Survival Investigators. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet. 2019 Oct 12;394(10206):1325-1334. doi: 10.1016/S0140-6736(19)31997-X. Epub 2019 Sep 2. Erratum in: Lancet. 2020 Mar 14;395(10227):870. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in flow in LIMA and pulssatility index between the three groups.	mL/ min With transit time flowmetry (Sono TT flowlab), the graft flow and peripheral index (PI) are measured after weaning off the extracorporeal circulation with a systolic pressure aimed at 100 mmHg. The measurements are done with probe size 3 or 4.	Perioperative - After weaning off the extracorporeal circulation just before closing the thorax
Secondary	Postoperative bleeding	Unit: mL	Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
Secondary	Re-operation due to bleeding	Number of patients in each group	Up to 48 hours calculated from the end of primaery surgery
Secondary	Re-operation due to ischemia	Number of patients in each group	Up to 48 hours calculated from the end of primaery surgery
Secondary	Pleurocentesis	Number of patients in each group	Up to 10 days calculated from the end of primaery surgery
Secondary	Myocardial injury - creatine kinase-MB (CK-MB)	Unit: (µg/L)	Routine bloodsample measured four hours after aortic cross clamp removal.
Secondary	Myocardial injury - cardiac troponin (cTn)	Unit: (ng/L)	Routine bloodsample measured four hours after aortic cross clamp removal.
Secondary	Differences in pre and post operative regional oxygen saturation on the thorax.	Unit: oxygen saturation (rSO2)	Measured 7 days prior to surgery and again 3 days after surgery
Secondary	Length of stay on ICU	Unit: Days	Day of surgery to the day of discharge from ICU. Up to 52 weeks
Secondary	Length of stay in hospital	Unit: Days	Day of surgery to the day of discharge from hospital. Up to 52 weeks
Secondary	EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups	Developed by the EURO-QoF group in 1990 to describe five dimensions of quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems and a visual analogue scale recording the patient's self-rated health.	Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
Secondary	Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.	All questions are closed questions and qualitative variables (yes/no)	180 ± 7 days calculated from the date of surgery.
Secondary	Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early	Number of deaths in each group	Early (=30 days)
Secondary	Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate	Number of deaths in each group	Intermediate (=180 days)
Secondary	Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long	Number of deaths in each group	Long (=2 years)
Secondary	Rate of mortality due to cardiac event - Early	Number of deaths in each group	Early (=30 days)
Secondary	Rate of mortality due to cardiac event - Intermediate	Number of deaths in each group	Intermediate (=180 days)
Secondary	Rate of mortality due to cardiac event - Iong	Number of deaths in each group	Long (=2 years)
Secondary	Rate of all-cause mortality - Early	Number of deaths in each group	Early (=30 days)
Secondary	Rate of all-cause mortality - Intermediate	Number of deaths in each group	Intermediate (=180 days)
Secondary	Rate of all-cause mortality - long	Number of deaths in each group	Long (= 2 years)

External Links

•   EuroQol questionnairy 2021 22th march 2021