Medtronic Supports Physician Report on Safety and Effectiveness of ''Beating Heart'' Bypass Surgery; Review of Evidence Shows Off-Pump Surgery Equal to Conventional Approach for Most Patients; More Appropriate for At-Risk Patients.MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ), an innovator in the development of medical instrumentation for surgery on the beating heart, today hailed a first-of-its-kind consensus statement issued by the International Society of Minimally Invasive Cardiothoracic Surgery presenting evidence that off-pump coronary artery bypass Coronary artery bypass Surgical procedure to reroute blood around a blocked coronary artery. Mentioned in: Heart Failure coronary artery bypass, n (OPCAB OPCAB Off-pump coronary artery bypass Interventional cardiology A type of minimally invasive cardiac surgery in which cardiopulmonary bypass is eliminated and the heart continues to beat while the surgery is being performed as with MIDCAB, but in which a full ) surgery, or "beating heart" surgery, is as safe and effective as conventional coronary artery bypass graft coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) surgery in which the heart is stopped for repairs. And, the authors said, OPCAB may be better in some cases for patients that are poor candidates for traditional bypass surgery because of preexisting pre·ex·ist or pre-ex·ist v. pre·ex·ist·ed, pre·ex·ist·ing, pre·ex·ists v.tr. To exist before (something); precede: Dinosaurs preexisted humans. v.intr. medical conditions such as diabetes, renal problems, and patient history of stroke or heart attack. Conventional arrested-heart CABG surgeries utilize a complex perfusion circuit - usually called the "heart-lung machine" - to pump and oxygenate oxygenate /ox·y·gen·ate/ (-je-nat) to saturate with oxygen. ox·y·gen·ate or ox·y·gen·ize v. To treat, combine, or infuse with oxygen. the patients' blood while the heart is stopped during the procedure. In OPCAB procedures, surgeons can avoid the perfusion system by employing advanced medical instruments that allow them to suture a graft on an isolated area of a beating heart. The "Consensus Statement," authored by 12 of the world's leading cardiac surgeons and conducted according to American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. and American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. standards for the development of clinical practice guidelines clinical practice guidelines Clinical policies, practice guidelines, practice parameters, practice policies Medtalk Systematically developed statements to assist practitioner and Pt decisions about appropriate health care for specific clinical circumstances. See Psychology. , included conclusions based on a comprehensive analysis of existing worldwide published clinical evidence. The panel was chaired by Dr. John Puskas of Emory Crawford Long Hospital at Emory University, Atlanta. The review was supported by an unrestricted grant by Medtronic and other industry organizations. "This effort represents the first and most extensive review of all studies related to OPCAB," said Puskas. "It's clear that this growing body of medical evidence collected over the past decade suggests that off-pump procedures are safe, effective and easier on the patient than conventional CABG surgery." The authors acknowledge that a large prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial evaluating numerous endpoints will firmly answer outstanding questions regarding the relative merits of on- and off-pump surgical coronary revascularization, particularly in high-risk patients, but note that the rigorous meta-analysis of collected evidence allows several recommendations to be made. Findings published in the Society's official publication state that OPCAB: --should be considered a safe alternative to conventional bypass surgery with similar or reduced risk of mortality at 30 days with mixed-risk patients, --is recommended in certain patient populations to reduce post-surgical problems such as stroke, heart attack, atrial fibrillation and renal failure, which are less likely to occur when grafting is done as the heart continues to beat, --patients are less likely to experience neurocognitive dysfunction after 30 days (after a year, neurocognitive outcomes are about the same for each type of procedure), --is recommended to reduce the length of stay in intensive care unit and in the hospital, and --should be considered for use on high-risk patients. "Once again, there is a persuasive story to the benefits of beating heart surgery beating heart surgery Cardiology Any cardiovascular procedure, often performed endoscopically, in which the heart is not stopped. See CABG. ," said Dr. Oern Stuge, Medtronic senior vice president and president, Medtronic Cardiac Surgery. "We expect that more physicians will continue to embrace, and more patients will continue to request, this surgical approach." Approximately 350,000 U.S. patients undergo coronary artery grafting operations every year. Currently, approximately 25 percent of the general population and 30 percent of the Medicare cases are being performed off-pump. The Medtronic Octopus(R) System, a combination of devices including the eighth-generation Octopus tissue stabilizer and its partner, the Starfish(TM) or Urchin(TM) heart positioner have been used on more than 400,000 patients worldwide. The devices use innovative suction stabilization technology to hold, lift and rotate the beating heart to expose coronary arteries on any of its surfaces, and then hold the tissue almost stationary where the surgeon is working. About Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world. EDITOR NOTE: Physicians are available for interviews to discuss experience with beating-heart surgery in most major markets. Broadcast quality video and animation also is available. Contact Rich Fischer at 763-505-2975 to arrange interviews or request footage. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 29, 2005. Actual results may differ materially from anticipated results. |
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