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Magnetic vascular coupling for distal anastomosis in coronary artery bypass grafting: a multicenter trial.

AbstractOBJECTIVE:
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.
AuthorsUwe Klima, Volkmar Falk, Michael Maringka, Steffen Bargenda, Steven Badack, Anton Moritz, Friedrich Mohr, Axel Haverich, Gerhard Wimmer-Greinecker
JournalThe Journal of thoracic and cardiovascular surgery (J Thorac Cardiovasc Surg) Vol. 126 Issue 5 Pg. 1568-74 (Nov 2003) ISSN: 0022-5223 [Print] United States
PMID14666034 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Anastomosis, Surgical (instrumentation)
  • Coronary Angiography
  • Coronary Artery Bypass (instrumentation, methods)
  • Coronary Disease (diagnosis, surgery)
  • Equipment Design
  • Equipment Safety
  • Female
  • Graft Rejection
  • Graft Survival
  • Humans
  • Magnetics
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures (instrumentation)
  • Postoperative Complications (prevention & control)
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Vascular Patency

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