Comparison of Saphenous Vein Harvesting by Endoscopic Versus Open Conventional Methods

Clinical and Histological Evaluation of Saphenous Vein Harvesting by Endoscopic and Open Conventional Methods

The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Open vein harvest; Device: Endoscopic vein harvest

Detailed Description

BACKGROUND Ischemic heart disease is the leading cause of death globally that accounts for about 7.4 million mortalities worldwide annually as published by the World Health Organization. Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are the options for revascularization in patients suffering from coronary artery disease (CAD). The choice of the most appropriate modality is affected by the clinical presentation, comorbidities, anatomical complexity of the CAD, and baseline characteristics of the patient. Although advances in PCI with drug-eluting stents have provide good outcomes, CABG remains an important revascularization strategy in the treatment of CAD.

The initial experience of using saphenous vein as coronary bypass conduits was first published from the Cleveland clinic in 1967. Minimally invasive endoscopic vein harvest (EVH) was first reported in 1996 as an alternative to open vein harvest (OVH). An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision. Over the last decade, EVH has become the preferred technique for conduit harvest in many cardiothoracic centers owing to the overall reduction in complications compared with OVH and the obvious cosmetic advantage. However, concerns persist regarding the risk of microscopic damage incurred during EVH, and the consequences of this for long-term graft patency.

OBJECTIVES The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.

METHODS This is a prospective, single-center randomized controlled trial conducted in the department of cardiac surgery at the Sheba Medical Center. It will include a sample size of 50 patients (randomization ratio 1:1), who are planned to undergo an elective isolated CABG surgery, and a vein graft is necessary for the revascularization.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eilon Ram, M.D.; Phone Number: 972 3-5302710; Email: eilon.ram@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Eilon Ram, M.D.; Phone Number: 972 526669119; Email: eilonram@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients over the age of 18;
• Patients with ischemic heart disease who are planned to undergo CABG surgery;
• A vein graft in necessary for the revascularization;
• There is no indication for one specific method for vein harvesting;
• Informed consent obtained.

Exclusion Criteria:

• Patients who undergo a non-elective surgery
• Concomitant procedures during the CABG surgery;
• Any known infection in the past 6 months;
• Evidence of vein thrombosis in an ultrasound study prior to surgery;
• Morbid obesity patients;
• Patients with peripheral vascular disease;
• Patients who would gain from one technique more than the other by any reason (according to the surgeon or investigator opinion);
• Severe primary mitral and aortic valve stenosis or regurgitation;
• Patients who have undergone a previous cardiac surgery from any kind;
• Patients who underwent any surgery in the lower extremities in the past (i.e. orthopedic, vascular, etc.);
• Any serious disease likely to interfere with the conduct of the study;
• Participation in other clinical trial;
• Patients geographically not stable or unavailable for follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open vein harvest; For the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided.	Other: Open vein harvest; Open vein harvest
Experimental: Endoscopic vein harvest; We will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel.	Device: Endoscopic vein harvest; An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microscopic vein damage by histology examination	The amount of preserved endothelium and endothelial stretching seen in the histology examination in the two different vein harvesting strategies.	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehospitalization, myocardial infarction and all-cause mortality	Composite end point of rehospitalization, myocardial infarction and all-cause mortality up to 1-year.	12 months
New-York Heart Association (NYHA) functional class	New-York Heart Association (NYHA) functional class at 1-year	12 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Study Director: Leonid Sternik, M.D., Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Vein graft
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Sheba-19-6192-ER-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No