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Published on: November 24, 2014
Magnetic vascular coupling for distal anastomosis in coronary artery bypass grafting: a multicenter trial
Uwe Klima1, Volkmar Falk, Michael Maringka
1Division of Thoracic and Cardiovascular Surgery, Medical School, Hannover, Germany. klima@thg-mh.hannover.de
Insights
A novel Magnetic Vascular Positioner System for coronary artery bypass grafts demonstrated safe and effective use with high patency rates comparable to traditional hand-sewn methods. This technology shows promise for facilitating minimally invasive and beating heart procedures.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- Hand-sewn anastomosis is the gold standard for coronary artery bypass grafts (CABG).
- Less invasive CABG approaches (e.g., totally endoscopic, beating heart) present challenges for traditional hand-sewn anastomoses.
- Exploration of alternative distal anastomotic techniques is crucial for advancing minimally invasive cardiac surgery.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel distal anastomotic device, the Magnetic Vascular Positioner System.
- To assess the predischarge angiographic findings and 30-day clinical outcomes of patients undergoing CABG with this new technology.
- To compare the performance of the Magnetic Vascular Positioner System to conventional hand-sewn anastomoses.
Main Methods:
- A multicenter trial involving 32 patients requiring multivessel CABG.
- One anastomosis per patient was created using the Magnetic Vascular Positioner System.
- The remaining anastomoses were performed using the conventional hand-sewn technique; predischarge angiograms assessed graft patency.
Main Results:
- The Magnetic Vascular Positioner System was successfully applied in 78% of intended cases (32/41).
- No device-related major adverse events were reported; overall patency was 93.5% for the device vs. 91.7% for hand-sewn grafts (not significant).
- Median anastomotic time for the device was 137 seconds; complications included small target arteries and non-hemostatic anastomoses requiring conversion to hand-sewn.
Conclusions:
- Magnetic vascular coupling is a safe and effective technique for coronary surgery.
- The Magnetic Vascular Positioner System achieves acceptable early patency rates.
- This novel technique holds potential for facilitating beating heart and minimally invasive coronary artery bypass grafting.
Objective:
The hand-sewn anastomosis is the "gold standard" for performing coronary artery bypass grafts. However, performing a hand-sewn anastomosis is more demanding and time-consuming when used in less invasive approaches such as small access, totally endoscopic or beating heart surgery. In conjunction with attempts to reduce the surgical trauma of coronary artery bypass grafts by using these less invasive approaches, alternative methods for constructing distal anastomoses should be explored. These data report on predischarge angiographic findings and 30-day clinical follow up of patients who have received a new distal anastomotic device.
Methods:
In a multicenter trial, 32 patients (mean age: 65 +/- 9 years; 85% men) requiring multivessel coronary artery bypass surgery had 1 of the anastomoses performed using a novel anastomotic technology. The Magnetic Vascular Positioner System was used in 1 of the bypass grafts and the other bypasses were completed by conventional hand-sewn technique. The Magnetic Vascular Positioner System consists of 4 magnetic, gold-plated implants and 2 delivery devices that facilitate the creation of a functional end-to-side anastomosis. A predischarge angiogram was performed to evaluate graft patency.
Results:
There were no device-related major adverse events. The application of the Magnetic Vascular Positioner device was successful in 32 of 41 cases (78%). Nine patients were intended for treatment but did not receive the Magnetic Vascular Positioner System. In 5 of the cases the coronary artery was too small; 1 case had a posterior wall plaque in the target artery; and 3 patients had a nonhemostatic anastomosis after coupling of the port and were subsequently converted to hand-sewn anastomoses. The median total Magnetic Vascular Positioner anastomotic time was 137 seconds with a range from 65 to 370 seconds. Overall patency rate of the Magnetic Vascular Positioner anastomosis was 93.5% versus 91.7% (P = not significant) in hand-sewn grafts. One patient (3.1%) died due to low cardiac output but had patent grafts at autopsy. One myocardial infarction (3.1%) occurred the day after a percutaneous transluminal coronary angioplasty of a hand-sewn graft. One prolonged mechanical ventilation (3.1%) was required because of pneumonia and adult respiratory distress syndrome.
Conclusions:
Magnetic vascular coupling in coronary surgery is safe and effective and has acceptable early patency rates. This new technique may facilitate beating heart and minimally invasive coronary artery bypass grafts.
