Surgery News - March 2008 - (Page 10) 10 THORACIC SURGERY NEWS • M A R C H 2 0 0 8 Volume Cutoff for Heart Transplant Centers Questioned BY DAMIAN MCNAMARA Else vier Global Medical Ne ws F O R T L A U D E R D A L E , F L A . — The Centers for Medicare and Medicaid Services stipulates that orthotopic heart transplantation centers perform a minimum of 10 cases annually to qualify for funding. However, this cutoff is arbitrary and does not accurately reflect an optimal difference in outcomes, according to a study presented at the annual meeting of the Society of Thoracic Surgeons. Dr. Eric Weiss and his associates at Johns Hopkins University, Baltimore, reviewed the records of 14,401 adults who underwent a first heart transplantation from 1996 to 2006 at one of 143 licensed centers in the United States. They found that institutions where surgeons performed 14 or more transplantations per year had statistically lower 30-day mortality rates, compared with outcomes at lower-volume centers. The implications of the study may be particularly important because CMS recently relaxed the standard from 12 cases to 10 cases per year. “I am sure this will be a controversial manuscript,” study discussant Dr. Nicholas Smedira said. He cautioned against judgment of heart transplantation centers based on volume alone. Although it is true that “volume is not everything,” Dr. Weiss replied, “for 30 years, substantial evidence has demonstrated the importance of volume— provider and institutional—for outcomes following surgery.” Dr. Weiss is a cardiac surgeon at Johns Hopkins. “How will you respond to a low-volume center with great results when they find out they are being closed down for not meeting the 10 or 14 case cutoff ?” asked Dr. Smedira, an ACS Fellow who is a cardiothoracic surgeon at the Cleveland Clinic. “A clear problem is that not all low-volume centers have poor outcomes,” Dr. Weiss replied. “If there is high mortality, there should be enforceable actions.” Processes of care that optimize care at successful transplantation centers should be shared with low-volume centers with poorer outcomes, he added. A total of 1,800 patients in the study died within a year of transplant, for an overall 12.5% 1-year mortality rate. Volume was a significant factor only with regard to 30-day mortality. For example, mortality steadily increased at institutions that performed fewer than 14 heart transplantations per year, and flattened for a majority of patients at centers with higher annual volumes. Patients had more than a twofold greater chance of dying 30 days post pro- ALTHOUGH IT IS TRUE THAT ‘VOLUME IS NOT EVERYTHING, FOR 30 YEARS, SUBSTANTIAL EVIDENCE HAS DEMONSTRATED THE IMPORTANCE OF VOLUME.’ cedure at a hospital that performed two or fewer heart transplants per year (odds ratio, 2.15), according to a multivariate analysis. The risk was attenuated somewhat at institutions that performed 10 procedures or fewer per year (OR, 1.8). In contrast, the risk was much lower at centers that averaged more than 40 cases per year (OR, 0.5). Mean annual case volume ranged from 1 to 99. About 12 institutions performed more than 20 cases annually. In addition, fewer than 10 hospitals provided more than 30 procedures, and fewer than 5 hospitals performed more than 40 transplantations. All study data came from the UNOS (United Network for Organ Sharing) registry. There were some limitations to the study, Dr. Smedira said. “Patient risk factors directly affect complication rates. It appears from data that the patients at the lower volume centers were at lower risk; for example, they were younger. Other factors, such as underlying congenital heart disease, were not examined,” he noted. Ideally, the study should include hospital factors, such as staffing of residents and nurses, Dr. Smedira said. Increased staffing can improve the response to complications, he said. “The bar for patient safety, quality of care, and survival needs to be set pretty high,” said Dr. John Conte, a study investigator and director of heart and lung transplantation at the Johns Hopkins Hospital, in a news release. “Our results clearly demonstrate that current standards have been arbitrarily set too low.” ■ http://www.hitachimed.com http://www.hitachimed.com
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