Israeli cardiac surgeons have introduced an innovative technology designed to improve the safety of coronary artery bypass grafting and reduce the risk of serious neurological complications.
Rambam Health Care Campus in Haifa became the first medical center in the world to perform a series of coronary bypass procedures using VIOLA™, a device developed by the Israeli medical technology company Vascular Graft Solutions.
The system allows surgeons to connect a bypass graft to the aorta without applying a conventional external clamp. This may reduce mechanical pressure on calcified sections of the vessel and lower the risk of material breaking away and entering the bloodstream.
Rambam reported that its cardiac surgery team had successfully completed a series of procedures using the new technology. The device has received FDA and CE regulatory clearance, according to the official report from Rambam Health Care Campus.
Why Is the Aorta Clamped During Bypass Surgery?
Coronary artery bypass grafting, commonly known as CABG or bypass surgery, is performed when the coronary arteries supplying blood to the heart become significantly narrowed or blocked.
During surgery, the cardiac surgeon creates an alternative route for blood to flow around the blocked artery. A healthy blood vessel taken from another part of the patient’s body is connected to the coronary circulation.
One end of the graft may need to be attached to the aorta—the body’s largest artery. In conventional surgery, the surgeon temporarily clamps part of the aorta to create a stable, relatively blood-free area for attaching the graft.
Although this is a standard surgical technique, external clamping may create additional risk in patients whose aortic walls contain extensive atherosclerotic plaques or calcium deposits.
Why Can Aortic Calcification Increase the Risk of Stroke?
Atherosclerosis and calcification can make the wall of the aorta less flexible and more vulnerable to mechanical manipulation.
When a surgical clamp presses against a heavily calcified area, small fragments of calcium or atherosclerotic material may potentially break away. If this material travels through the bloodstream to the brain, it may block a cerebral blood vessel and cause a stroke.
According to Professor Gil Bolotin, Director of the Department of Cardiac Surgery at Rambam’s Eyal Ofer Heart Hospital, conventional mechanical clamping can represent a vulnerable stage of bypass surgery in patients with a severely calcified aorta.
Rambam reports that stroke occurs in approximately 2% of patients undergoing bypass surgery. The individual risk depends on multiple factors, including age, previous stroke, vascular disease, calcification of the aorta and the patient’s general medical condition.
Reducing manipulation of the aorta has therefore been an important objective in cardiac surgery.
How Does the VIOLA Device Work?
VIOLA uses an internal approach instead of compressing the aorta from the outside.
The surgeon inserts the device through a small opening in the aortic wall. Once inside the vessel, VIOLA expands to create a protected and controlled area where the bypass graft can be attached.
At the same time, blood continues to flow through the aorta.
The potential advantages of this approach include:
- avoiding external compression of the aortic wall;
- maintaining blood flow through the aorta;
- reducing manipulation of calcified areas;
- limiting the risk of plaque or calcium fragmentation;
- creating a controlled area for graft attachment;
- potentially reducing the formation of emboli associated with aortic clamping.
The device occupies a limited amount of space inside the vessel and is designed to provide surgeons with access to the operative area without completely obstructing circulation.
Who May Benefit from This Technology?
The technology may be particularly relevant for patients who require coronary bypass surgery and have:
- significant atherosclerosis of the aorta;
- extensive aortic calcification;
- a “porcelain aorta,” in which the vessel wall is heavily calcified;
- an elevated risk of embolic complications;
- a previous stroke or transient ischemic attack;
- widespread peripheral vascular disease;
- other risk factors for neurological complications.
However, the presence of a new technology does not mean that it is suitable or necessary for every patient undergoing bypass surgery.
The decision depends on the anatomy of the coronary arteries and aorta, the number and position of required bypass grafts, the patient’s overall condition and the cardiac surgeon’s assessment.
Preoperative imaging, including CT angiography in selected cases, may help surgeons evaluate the condition of the aorta and plan the safest operative approach.
Does VIOLA Eliminate the Risk of Stroke?
No surgical device can completely eliminate the risk of stroke or other complications associated with open-heart surgery.
Stroke following cardiac surgery may result from several different mechanisms, including embolism, changes in blood pressure, cardiac arrhythmias and pre-existing cerebrovascular disease.
VIOLA is designed to reduce one particular source of risk: mechanical compression and manipulation of a calcified aorta during graft attachment.
Rambam describes the technology as an important advance with the potential to reduce neurological complications. However, the expected benefit for an individual patient must be evaluated by an experienced cardiac surgeon.
Patients should also understand that the availability and appropriateness of the device may vary between medical centers and individual surgical cases.
Israel’s Experience in Advanced Cardiac Surgery
Israel is internationally recognized for its achievements in cardiology, cardiac surgery and medical technology.
Leading Israeli heart centers combine the experience of multidisciplinary medical teams with advanced diagnostic imaging, catheter-based procedures, minimally invasive surgery and innovative operative technologies.
Modern treatment options available in Israel may include:
- coronary angiography and cardiac CT;
- percutaneous coronary intervention and stent placement;
- conventional coronary artery bypass surgery;
- off-pump coronary bypass surgery in selected patients;
- minimally invasive cardiac surgery;
- surgical and transcatheter valve procedures;
- complex aortic surgery;
- treatment of cardiac arrhythmias;
- mechanical circulatory support;
- cardiac rehabilitation.
The most appropriate treatment depends on the patient’s diagnosis, coronary anatomy, heart function, associated diseases and individual surgical risk.
Heart Surgery with Leading Israeli Specialists
A recommendation for coronary bypass surgery is a major medical decision. In complex cases, a second opinion from an experienced cardiologist or cardiac surgeon may help clarify:
- whether surgery is required;
- whether stenting may be an appropriate alternative;
- which type of bypass procedure is most suitable;
- how many grafts may be needed;
- whether the aorta is significantly calcified;
- whether a minimally invasive or off-pump approach is possible;
- which technologies may help reduce operative risk;
- what recovery and rehabilitation may involve.
Through Sapir Medical Clinic, international patients can access consultations and treatment by leading Israeli cardiologists and cardiac surgeons at major medical centers in Israel.
Depending on the patient’s condition, Sapir Medical Clinic can assist in organizing:
- consultation with a leading Israeli cardiologist;
- consultation with an experienced Israeli cardiac surgeon;
- a second medical opinion regarding bypass surgery or stenting;
- review of coronary angiography, cardiac CT and echocardiography;
- assessment of operative and neurological risks;
- development of an individualized diagnostic and treatment program;
- evaluation of advanced surgical technologies;
- coronary artery bypass grafting in Israel;
- minimally invasive cardiac procedures when medically appropriate;
- postoperative follow-up and cardiac rehabilitation;
- remote consultation before travelling to Israel.
A multidisciplinary team may include an interventional cardiologist, cardiac surgeon, cardiac imaging specialist, anesthesiologist and other physicians. This collaborative approach helps determine whether medication, stenting, bypass surgery or another treatment strategy offers the best balance of potential benefits and risks.
Sapir Medical Clinic coordinates the entire medical process—from reviewing records and selecting the appropriate specialist to arranging diagnostics, hospitalization, surgery and follow-up care in Israel.
For a preliminary case assessment, patients may submit:
- medical reports and hospital discharge summaries;
- coronary angiography images and reports;
- cardiac CT or CT angiography results;
- echocardiography findings;
- electrocardiogram and Holter monitoring results;
- recent blood-test results;
- a list of current medications;
- information about previous cardiac procedures;
- details of stroke, vascular disease or other chronic conditions.
Contact Sapir Medical Clinic
If you require a consultation with a leading Israeli cardiologist or cardiac surgeon, a second medical opinion or advanced heart treatment in Israel, contact Sapir Medical Clinic:
Important: This article is intended for informational purposes only and does not replace consultation, diagnosis or treatment by a qualified physician. VIOLA is designed to reduce risks associated with external aortic clamping, but it cannot eliminate every possible complication of cardiac surgery. The choice of surgical technique and device must be made individually by the treating cardiac surgeon.