MAQUET Cardiovascular Announces Long-Term Follow-Up Data from Landmark 'SMART' Study Reinforce Positive Results for Patients Undergoing Off-Pump Coronary Artery Bypass Surgery (OPCAB)

WAYNE, N.J., Jan. 25 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced today that long-term results from the landmark SMART (Surgical Management of Arterial Revascularization) study will be presented tomorrow to attendees of the Society of Thoracic Surgeons's 46th Annual Meeting by John Puskas, M.D., Chief of Cardiac Surgery, Emory Crawford Long Hospital, Associate Chief of Cardiothoracic Surgery, Emory University, and SMART Study lead investigator. The data provide confirmation of the efficacy of performing Coronary Artery Bypass Graft surgery (CABG) while the patient's heart continues to beat – a procedure known as Off-Pump Coronary Artery Bypass (OPCAB).

Initiated in March 2000, the SMART study was the first randomized U.S. trial to compare OPCAB with conventional on-pump CABG surgery (in which the patient's heart is stopped and a machine takes over the work of the heart and lungs).  Long-term follow-up data collected from SMART study patients confirm that outcomes are similar based on an analysis of early- and late-graft patency (freedom from blockage), incidence of recurrent heart attack, need for re-intervention, and long-term survival between the two procedures at a mean of nearly eight years after surgery.  These results will be presented on Tuesday, January 26, at 2:30 p.m. EST in Room Palm A/B at the Greater Fort Lauderdale/Broward County Convention Center in Florida.

"These long-term follow-up data provide additional evidence that the early benefits of OPCAB are not obtained at the expense of long-term survival or freedom from re-intervention," said Dr. Puskas.  "The SMART follow-up data add to the growing body of evidence supporting the long-term durability of OPCAB, including randomized studies performed in the U.K. and 10-year follow-up of CABG patients at our university."

Data confirming the durability of off-pump surgery complement conclusions from numerous previous studies showing that OPCAB offers significant post-operative patient benefits by reducing the risk of complications.  This is particularly true among high-risk patients, such as those with other medical conditions, including diabetes, a history of stroke, or poor physical health, or the elderly, obese and women, who typically do not fare as well under conventional cardiopulmonary bypass procedures. Taken together, there is mounting evidence to support the clinical benefits of OPCAB.

"Surgeon experience may explain differences between these findings and those of a recently published trial reporting poorer graft patency and increased mortality and cardiac events at one year," added Dr. Puskas. "Appropriate surgeon training and use of available off-pump technology are critical components of excellent outcomes."

SMART Study Follow-Up Design and Results

A total of 200 patients with multi-vessel coronary artery disease were randomized to off-pump (OPCAB) or on-pump coronary artery bypass grafting between March 2000 and August 2001. Of the 148 patients who survived, 87 were evaluated after a minimum of 6.8 years to assess graft patency (via computed tomographic angiography [CTA]) and myocardial ischemia (via positron emission tomography [PET] and 12-lead electrocardiogram [ECG]).

After a mean of 7.5 years of follow-up, 22 OPCAB patients and 27 on-pump patients had died from all causes. Graft patency was similar between groups prior to hospital discharge (99 percent OPCAB vs. 97.7 percent on-pump), at one year (93.6 percent OPCAB vs. 95.8 percent on-pump) and at late follow-up (76 percent OPCAB vs. 83.5 percent on-pump). No patient in either group has undergone repeat CABG.

Previous published results from the SMART study demonstrated that grafts performed during OPCAB are as effective as on-pump surgery in restoring blood flow to the heart muscle and maintaining complete revascularization over time.  The number of grafts performed per patient during OPCAB was virtually identical to the number performed in on-pump surgery, demonstrating that completeness of revascularization was similar between groups.  In addition, there were no significant differences between the groups in the incidence of death, heart attack, stroke, recurrent angina, hospital readmissions or percutaneous intervention 30 days and one year after surgery. Furthermore,

• Study participants who underwent OPCAB lost less blood during surgery, had less damage to their hearts during surgery and recovered more quickly than those who underwent on-pump surgery.
• Beating-heart patients in the study also were able to breathe on their own sooner after surgery, spent less time in intensive care and left the hospital one day sooner, on average, than conventional CABG patients.

"MAQUET Cardiovascular is highly committed to technologies that improve outcomes and make a difference in the lives of patients with cardiovascular disease," said Patrick Walsh, President of the Cardiac Surgery Business Unit of MAQUET Cardiovascular.  "As a primary sponsor of this long-term study follow-up, we are pleased to contribute to the growing body of evidence that advances understanding of how technology can support surgeons to better meet the needs of their patients."

The SMART Study was supported by Medtronic, Inc. and Emory Crawford Long Hospital's Carlyle Fraser Heart Center Foundation. The long-term SMART follow-up was supported by MAQUET Cardiovascular and Medtronic, Inc.

About MAQUET Cardiovascular

MAQUET Cardiovascular is a leader in providing innovative products for cardiac surgery, vascular intervention and cardiac support to hospitals and clinics and the cardiac surgeons, interventional cardiologists, perfusionists and other healthcare professionals who care for patients with cardiovascular disease. MAQUET Cardiovascular is focused on providing clinicians with future-oriented technology that fits into their daily practice and improves the therapeutic management of patients. MAQUET Cardiovascular continues to invest in the development of innovative technologies and solutions that advance clinical practice, improve patient outcomes and enhance quality of life.

MAQUET Cardiovascular was formed in 2003 when MAQUET, the world's leading medical technology company, combined its existing Cardiopulmonary business with Jostra's equipment and consumables for open heart surgery and Siemens Life Support Systems, which the publicly-listed Swedish GETINGE Group acquired in 2003. In 2008, MAQUET added the Cardiac Surgery and Vascular Interventions businesses acquired by GETINGE from Boston Scientific and Guidant. In 2009, it added the cardiac assist businesses that GETINGE acquired from Datascope. MAQUET Cardiovascular provides healthcare professionals with products in four business units: Cardiopulmonary (perfusion products), Cardiac Surgery (clampless beating heart and endoscopic vessel harvesting), Vascular Interventions (grafts for vascular surgery), and Cardiac Assist (intra-aortic balloon counterpulsation therapy).

About The MAQUET Group

The MAQUET Group is the global market leader for Medical Systems, focusing on the Operating Room (OR) and Intensive Care Unit (ICU). The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapy concepts within acute care hospitals. MAQUET provides innovative medical solutions from three Divisions:

• Cardiovascular -- with products for cardiac assist (intra-aortic balloon counterpulsation therapy), coronary artery bypass surgery, aneurysm and vascular repair and peripheral interventions
• Critical Care -- for intensive care ventilators and anesthesia machines
• Surgical Workplaces -- for OR tables, lights and ceiling service units, prefabricated OR and ICU suites as well as telemedicine for the OR integration.

MAQUET is a subsidiary of the publicly-listed Swedish GETINGE GROUP, a company with over $2.8 billion in revenues (2008 fiscal year) and 12,800 employees worldwide. In 2008 MAQUET itself generated pro-forma revenues (including the acquisition of Datascope Corp.) of over $1.4 billion. The company now has 5,000 employees in 35 international sales and service organizations, as well as a network of more than 200 sales representatives.

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SOURCE MAQUET Cardiovascular LLC