Healthcare Industry News: Proximal Seal System
News Release - November 20, 2013
MAQUET Cardiovascular Announces Study Results Demonstrating HEARTSTRING(R) Device Associated with Significant Reduction in Coronary Artery Bypass Stroke RiskData were presented Saturday November 2, 2013 at the 60th Annual Meeting of the Southern Thoracic Surgical Association
SAN JOSE, Calif.--(Healthcare Sales & Marketing Network)--MAQUET Cardiovascular today announced results from a study demonstrating that risk of perioperative strokes may be minimized during coronary artery bypass graft (CABG) surgery by utilizing a completely “clampless” technique consisting of off-pump coronary artery bypass (OPCAB) in combination with the HEARTSTRING® Proximal Seal System.
The 1380-person study evaluated the incidence of post-operative stroke in people undergoing CABG while utilizing the unique HEARTSTRING® device to maintain hemostasis during the attachment of grafts to the aorta (proximal anastomosis). Prior to surgery, all patients underwent ultrasound evaluation of the aorta to determine the extent of aortic atherosclerosis. Increased aortic atherosclerosis is a powerful predictor of perioperative neurologic complications. In addition, other patient characteristics were used to calculate the expected risk of stroke for all patients using the Society of Thoracic Surgeons CABG Risk Model for Permanent Stroke. Across all aortic disease levels, the HEARTSTRING® device was associated with a 45% reduction in stroke risk compared with what would have been expected given patient risk factors. These data were presented Saturday, November 2, 2013 at the 60th Annual Meeting of the Southern Thoracic Surgical Association in Scottsdale, AZ.
Lead author on the study, Vinod Thourani, MD, Associate Professor of Cardiothoracic Surgery, Emory University stated, “Surgeons constantly strive to prevent stroke during CABG surgery, and these data provide additional evidence to support the use of an off-pump technique and HEARTSTRING® when performing this life saving procedure.” OPCAB expert John Puskas, MD, Associate Chief of Cardiothoracic Surgery at Emory University expanded, “Accumulating evidence points to the importance of eliminating the partial clamp in maximizing the potential benefits of off-pump surgery, particularly reduced stroke. The findings from our institution clearly demonstrate the advantage of the HEARTSTRING® device in further improving off-pump patient outcomes."
The objective of the study was to examine the incidence of post-operative stroke in CABG utilizing the HEARTSTRING® device in varying diseased aortas. These data were derived from a retrospective analysis of patients who underwent CABG with one or more proximal anastomoses constructed using the HEARTSTRING® technology at Emory University Hospital in Atlanta from April 2003 to December 2012. Patients had varying degrees of aortic atherosclerosis, ranging from mild (Grade 1) to very severe (Grade 5). Of the patients evaluated in the study, 92.5% underwent off-pump revascularization.
While benefit of the device was most pronounced in patients with more severe aortic disease, significant reduction in stroke risk was seen in patients with minimal or no evidence of aortic atherosclerosis. Of particular note, no strokes were observed in a group of 59 patients with the most severe aortic disease (Grade 5). This group of patients is typically at extremely high risk of perioperative neurologic events.
“Aortic clamping may cause atheroembolism from the ascending aorta. Stroke is a devastating complication of CABG for patients and their families and can lead to significant, unexpected costs for hospitals,” said Peter Hinchliffe, President of MAQUET Cardiac Systems. “We are proud to offer surgeons products like HEARTSTRING® and other tools for beating heart and on pump cardiac surgery that have the potential to reduce the risk of stroke significantly, enabling patients to recover and leave the hospital quickly, and most importantly, return to their normal lives as soon as possible."
OPCAB has been associated with many benefits to patients, especially those at higher risk for complications. However, increasing evidence suggests that clamping and other types of mechanical manipulation of the ascending aorta during proximal anastomosis can reduce the potential benefits of OPCAB. During CABG, aortic manipulation causes atherosclerotic plaque to break loose and be transported as emboli to the brain via the bloodstream. These emboli are a recognized cause of neurologic injury and cognitive dysfunction. Although cannulation and cross clamping of the aorta are avoided during an OPCAB procedure, a separate clamp may be used to isolate a portion of the aorta from blood flow to allow the surgeon to attach the bypass graft. The HEARTSTRING® device eliminates the need for that additional clamp by providing a seal that prevents blood from entering the surgical field during construction of the proximal graft to the aorta.
OPCAB or "beating-heart" surgery is a form of CABG surgery performed without relying on cardiopulmonary bypass (CPB), or a heart-lung machine. During on-pump CABG surgery the heart is stopped and a heart-lung machine takes over the work of the heart and lungs to oxygenate the body. During OPCAB, the heart is still beating while the graft attachments are made to bypass a blockage. A specialized stabilizing device is used to keep the portion of the heart undergoing the bypass still while the surgeon sews the graft.
MAQUET, a trusted partner for hospitals and physicians for over 175 years, is the global leader in providing medical systems that meet the needs of the most medically challenging patients, while exceeding the expectations of the hospital teams that care for them. MAQUET designs, develops and distributes innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital including the operating room (OR), hybrid OR/cath lab and intensive care unit (ICU) as well as intra and inter hospital patient transport.
Headquartered in Rastatt, Germany, MAQUET is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. MAQUET generated about 1.5 billion Euros in 2012, representing more than half of the Getinge Group’s annual revenue of 2.7 billion Euros. MAQUET has 6,500 employees in 45 international sales and service organizations, as well as a network of more than 300 sales partners. For more information please visit www.maquet.com.
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Source: MAQUET Cardiovascular
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