Bypass surgery done on a beating heart is just as effective as the conventional operation performed with a heart-lung machine, and less expensive, according to a study reported last month. Results of the SMART (Surgical Management of Arterial Revascularization) trial, published in the April 21 issue of the Journal of the American Medical Association (JAMA), provide compelling evidence of the benefits of performing coronary artery bypass graft (CABG) surgery while the patient's heart continues to beat.
While the results were positive, longer-term data likely will be required by cardiovascular surgeons, who perform the majority of CABG procedures. This largely conservative group may require five to 10 years of positive data showing that these off-pump grafts are as durable as their on-pump counterparts before they begin large scale adoption of a technique that is known to be more technically demanding.
The prospective, randomized, blinded study of 197 patients who were treated by cardiac surgeon John Puskas, MD, of Emory Crawford Long Hospital (Atlanta, Georgia) revealed that grafts performed during beating-heart procedures are as effective as conventional CABG surgery in restoring blood flow to the heart muscle and maintaining complete revascularization over time. Moreover, the number of grafts performed per patient during beating-heart procedures was virtually identical to the number performed in the conventional CABG operation, demonstrating that completeness of revascularization was similar between groups.
In his beating-heart procedures, Puskas, a pioneer of the off-pump technique, used the two most recent generations of Medtronic's (Minneapolis, Minnesota) Octopus Tissue Stabilizer, which holds the beating heart's surface tissue nearly stationary as the bypass graft is sutured in place. The Octopus device was the original suction-based stabilizer, and Medtronic has used feedback from its customers to develop seven generations of the device. The Octopus has been used in more than 345,000 procedures worldwide, the company said. Guidant (Indianapolis, Indiana), St. Jude Medical (St. Paul, Minnesota) and Johnson & Johnson (New Brunswick, New Jersey) also are working on products in the off-pump field.
Puskas said that publication of these results has given additional visibility and credibility to his findings that beating-heart patients do just as well and in fact recover sooner with shorter ICU and hospital stays than those put on heart-lung machines for bypass. "This is important information for physicians, who until now haven't had good prospective data comparing revascularization and other efficacy measures," he said. "I expect these results will be replicated as more surgeons adopt and become comfortable with the off-pump procedure."
Puskas pointed out that since he began doing the off-pump procedure in the late 1990s, the technology used for the surgery has improved vastly, and he predicts a significant increase in the use of the beating-heart CABG in the near future with the addition of more positive data. "In 1997, less than 3% of all coronary bypasses were done off-pump. Last year, it was about 22%," he said, adding that in five years the rate of adoption could rise to around 50% nationwide.
All of Puskas' patients who qualified for CABG surgery between March 2000 and August 2001 were considered eligible for and invited to participate in the study. All were treated by Puskas, assuring consistency of technique, and all were followed by the same patient management team. Neither the patients nor their families, cardiologists and post-operative caregivers and evaluators knew which surgical procedure had been used for a full year following treatment. Of 197 patients, 98 underwent off-pump surgery and 99 underwent the standard bypass. Four in each group died within a year of the operation.
The first patients in the SMART trial will reach the five-year data plateau in 2005, and Puskas said he hopes to report on that all-important data after all the patients reach that benchmark in two to three years. The SMART trial was supported by Medtronic and Emory Crawford Long Hospital's Carlyle Fraser Heart Center Foundation. While Puskas noted that 95% of the CABG procedures he does now are off-pump, he said that the traditional procedure still has a place in the surgeon's arsenal, noting that the heart-lung machine is still preferred for people with irregular heart rhythm or blood pressure, or those suffering a cardiac crisis, such as a heart attack at the time of surgery.
Feigal leaves post as CDRH director
David Feigal Jr., MD, last month resigned as director of the FDA's Center for Devices and Radiological Health (CDRH), a post he had held since 1999. After initially indicating he would be seeking an academic position in Arizona, where his wife was taking a new job, NDA Partners (Falls Church, Virginia), a product development consultancy firm, said early this month that Feigal would join the company to develop and lead its medical devices and biologics practice.
Feigal, who departed from the agency at month's end, had been with the FDA since 1992, initially with the Center for Drug Evaluation and Research, where he later headed the Antiviral Drug Division. He also served as acting director of the Anti-Infective Drug Division and director of the office of Drug Evaluation IV. In 1997 he was named medical deputy director of the Center for Biologics Evaluation and Research, where he focused on blood and tissue regulation, including blood and tissue devices regulated by the center.
He succeeded Bruce Burlington, MD, as director of CDRH in 1999 after Burlington resigned in January of that year to become head of regulatory affairs for Wyeth-Ayerst. "[Feigal] served as an articulate spokesman for the center," said Elizabeth Jacobson, executive vice president of technology & regulatory affairs for the Advanced Medical Technology Association (AdvaMed; Washington). "He was very open to discussing issues and concerns, and we need somebody like that. This is a very broad and vibrant industry and our regulatory structure must be equally brilliant." Jacobson said Feigal helped to open the center up to new ways of approaching the many challenges faced by the medical device industry.
"Responding to industry calls, he set up a program to bring in experts," she said. "The device world is so big and so varied that it is hard to have experts in all fields on staff." Feigal's approach brought in specialists from different areas of the medical device field to weigh in on important topics. "In addition," Jacobson said, "he was really on board during the MDUFMA [Medical Device User Fee and Modernization Act of 2002] negotiations, and he played a big role in making sure it was implemented."
Mark Leahy, executive director of the Medical Device Manufacturers Association (MDMA; also Washington) said communication was never a problem with Feigal. "Any time we needed to, we could always call David," Leahy told Cardiovascular Device Update. "His willingness to maintain an open dialogue with the device community was one of his greatest achievements."
Chris Chavez, president, and chief executive officer of Advanced Neuromodulation Systems (Dallas, Texas) and chairman of the board of directors of MDMA, said, "I was very impressed with Dr. Feigal. He has really represented the best in what government officials should be all about. He is an organization builder, and he made a wonderful contribution in positioning the department for the future by bringing in new talent." Feigal "opened the lines of communication, which is very important," Chavez said, echoing Leahy's comments. "He is intelligent and very responsive. We may not always have seen eye to eye, but the exchange of information and ideas was essential."
Daniel Schulz, MD, director of the CDRH's office of device evaluation, will serve as acting director. "I think Dan Schulz will do a great job for however long he serves," Leahy said. "He understands the indus- try and knows the device community."