Clinical Study Demonstrates Decreased Risk of Neurological Complications for Patients Undergoing Beating Heart Surgery.

Business Editors and Health/Medical Writers

INDIANAPOLIS, Ind. & CUPERTINO, Calif.--(BW HealthWire)--March 20, 2001

Data from a recent clinical study(1) show that among patients experiencing neurological complications after coronary artery bypass surgery, those who undergo traditional stopped heart coronary artery bypass grafting surgery (CABG) are at a greater risk for overall post-operative neurological complications than those who undergo coronary artery bypass grafting without cardiopulmonary bypass (Off-Pump CABG, or "beating heart") procedures. Research was presented today in a poster by Paul J. Corso, M.D. of the Washington Hospital Center, Washington D.C, at the 50th Scientific Sessions of the American College of Cardiology in Orlando, Florida.

Researchers compared the occurrence of early and delayed neurological complications after On-Pump (3980 patients) and "beating heart" procedures (1563 patients) between January 1998 and July 2000. The two groups were similar with respect to baseline characteristics and risk stratification, and the Northern New England cardiovascular disease study group estimated risk of cerebrovascular accident was 1.9% for both groups.

Key results of the study include:

-- The overall (early and delayed) rate of neurological complications was 4.9%
(194 patients) for the on-pump group vs. 2.7% (42 patients) for the beating
heart group

-- The rate of stroke for the two groups also favored the beating heart group
(2.3% vs. 1.3%, respectively)

"Research published recently in the New England Journal of Medicine shows that patients treated with traditional stopped heart bypass surgery who experience neurological complications may show a long-lasting loss of brain power," said Paul J. Corso, M.D., Director, Section of Cardiac Surgery, Washington Hospital Center, who served as principal investigator for this study. "As a result, data from the Washington Hospital Center study are encouraging for physicians treating patients who require coronary artery bypass surgery, since beating heart bypass procedures are associated with a lower rate of neurological complications."

A study by Duke University researchers published in the February 8 edition of The New England Journal of Medicine(2) showed that in 261 patients who underwent traditional on-pump CABG procedures, using a heart-lung machine, more than 40 percent experienced neurocognitive decline five years following their procedures.

Less Invasive Coronary Artery Bypass Procedures Offer Patient

Benefits

Nearly 350,000 heart bypass procedures are performed in the United States each year, approximately 20 percent of which are beating heart procedures. Beating heart bypass procedures have been shown to provide several benefits to patients. When compared to procedures that require the heart to be stopped, beating heart bypass procedures have been shown to reduce transfusion rates by 48 percent,(3) to reduce post-operative cognitive dysfunction by 36 percent at 5 days and 90 percent at 3 months,(4) to reduce the postoperative length of hospital stay from 5.5 to 3.3 days,(3) and to decrease hospital costs by 24 percent.(3)

In January 2001, Guidant introduced its latest-generation off-pump system, called the AXIUS(TM) Off-Pump System. It is designed for use in beating heart bypass procedures, allowing surgeons to bypass clogged arteries without stopping the patient's heart and re-directing blood flow through a heart-lung machine. This system includes Guidant's unique AXIUS XPOSE(TM) device, which was developed to provide surgeons with access to all locations on the heart. This device was designed to help make the beating heart bypass procedure applicable to a broader number of patients and making the procedure easier to perform for the physician.

This system, when coupled with Guidant's VasoView(R) Endoscopic Vessel Harvesting System, offers a comprehensive suite of products that enable physicians to conduct the less-invasive OPCRES (Off-Pump Coronary Revascularization with Endoscopic Saphenous vein harvesting) procedure - combining beating heart bypass surgery with endoscopic vessel harvesting.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information on Guidant's products and services, visit the company's web site at www.guidant.com.

NOTES:

(1) Corso PJ; Peel GK, Stamou SC; Hill PC; Bafi AS; Dullum MCK;
Pfister AJ; Boyce SW; Garcia JM. Beating Heart Versus Conventional
Coronary Artery Bypass: Early Versus Late Postoperative Neurological
Complications.

(2) Newman, MF et al.; Longitudinal Assessment of Neurocognitive
Function After Coronary Artery Bypass Surgery. New England Journal of
Medicine, February 8, 2001, 344 (6): 395-402

(3) Puskas JD; Wright CE, Ronson RS; Brown WM; Gott JP; Guyton RA.
Clinical Outcomes and Angiographic Patency in 125 Consecutive Off-Pump
Coronary Bypass Patients. Heart Surgery Forum 1999; 2(3): 216-221

(4) Murkin JM; Boyd WD; Ganapathy S; Adams SJ; Peterson RC; Beating
heart surgery: why expect less central nervous system morbidity?
Annals of Thoracic Surgery, 1999 Oct, 68(4): 1498-501