Mitchel L. Zoler, PhD

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm² reduction in maximal bone marrow lesion (BML) area beyond the placebo-treated patients, which was a cut in BML area of about 37%, compared with the starting BML area, Dr. Graeme Jones said at the annual European Congress of Rheumatology. Dr. Jones visualizes BMLs using MRI knee scans.

"This is the first intervention shown to work on BMLs" in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

"This is exciting for treating existing OA. It is one of the first positive structure modification trials," commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

"Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain," Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. "If you reduce BMLs, it should produce good outcomes in patients," he said.

"The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years," Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

"I use it off label. Patients need to know it’s off label, and they [therefore] must be willing to pay for it, but I use it. It’s been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it’s been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year," Dr. Jones said.

He recommended an infusion of 5 mg of zoledronic acid for patients who are at least 50 years old with knee OA that fulfills the American College of Rheumatology clinical criteria, and knee BMLs that are visible on an MRI scan of the affected knee. In his experience, 88% of these knee OA patients have BMLs. Dr. Jones noted that he does not use a maximal BML area threshold for initiating treatment, although in his study the average maximal BML area was about 465 mm². About one-third of people aged 50 years or older with no clinical evidence of OA also have BMLs, he noted.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug’s beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction. He has not yet given any OA patients a third dose of the drug.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens. The zoledronic acid infusion was well tolerated: Although infusion reactions were reported in 90% of the patients who received the drug and in 43% of the placebo patients, serious adverse effects occurred in only 19% of the patients who received zoledronic acid and in 4% of the placebo patients.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

The study was funded by Novartis, which markets zoledronic acid (Reclast). Dr. Jones and Dr. Conaghan said that they had no disclosures.

*Correction, 6/6/2011: An earlier version of this story incorrectly stated that Dr. Jones had no disclosures. Dr. Jones has received speaker fees, travel sponsorship, and research support from Novartis and from several other drug companies.

 

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA – U.S. cardiac surgeons increasingly performed coronary artery bypass surgery on more complex patients during 2000-2009, yet significant drops in the rates of perioperative deaths and strokes were seen during those years, according to a review of more than 1.4 million procedures.

"The major implication of this study is that we are operating on a more complex cohort of patients, and we’re doing a better job, with less death and stroke than [was the case] not too long ago. This has implications for how we stratify patients for revascularization therapy," said Dr. Andrew W. ElBardissi at the annual meeting of the American Association for Thoracic Surgery.

"A lot of the patterns that we are seeing reflect the results from some of the more rigorous prospective studies that have dictated practice. We have seen improvements in process and surgical decision making, including more optimal medical management when patients go to surgery – not just in the operating room, but throughout the perioperative period (preop, op, and the ICU). Not only have outcomes improved, but we seem to be operating on the correct cohort of patients," said Dr. ElBardissi, a cardiac surgeon at Brigham and Women’s Hospital in Boston.

"These outcomes appear to reflect improvements in perioperative surgical care as they continue to be significant after adjustment for patient risk," he added.

Dr. T. Bruce Ferguson Jr. concurred with Dr. ElBardissi’s assessment. "This study clearly documented continued improvement in CABG [coronary artery bypass grafting], particularly in the CABG-PCI [percutaneous coronary intervention] era of the last decade. These are clearly more technically difficult operations, with increased rates of prior PCI, left main disease, and distal anastomoses," said Dr. Ferguson, professor of surgery and chairman of cardiovascular sciences at East Carolina University in Greenville, N.C.

Dr. ElBardissi’s analysis used data that were collected on more than 1.4 million patients who underwent first-time, isolated CABG surgery at a hospital participating in the Society of Thoracic Surgeons’ adult cardiac surgery database. The data he presented compared 136,513 patients who underwent CABG in 2000 vs. 160,905 patients who had this surgery in 2009.

Major shifts during those years included a statistically significant drop in the prevalence of recent smoking (from 60% in 2000 to 30% in 2009), but significant increases in the prevalence of patients with hypercholesterolemia (84% in 2009 vs. 60% in 2000), hypertension (85% vs. 71%), and chronic obstructive pulmonary disease (23% vs. 16%). The percentage of patients who were previously treated by PCI also jumped to 26% in 2009, compared with 19% in 2000.

Significant rises in the rate of preoperative treatment with cardioprotective drugs were also seen, notably in the use of aspirin, beta-blockers, ACE inhibitors, and statins. Beta-blocker use jumped from 61% of patients in 2000 to 81% in 2009.

The prevalence of left main coronary artery stenosis rose from 23% of patients in 2000 to 32% in 2009.

The statistics also documented meaningful changes in how CABG occurred. Use of an internal mammary artery graft rose from 84% of cases in 2000 to 95% in 2009, and off-pump surgery increased from 14% of cases to 21%.

Elective procedures dropped from 58% in 2000 to 41% in 2009. The largest subgroup of patients shifted to urgent cases, which rose from 38% of patients in 2000 to 54% in 2009.

Mortality during 30-day follow-up fell significantly, from 2.4% in 2000 to 1.9% in 2009 – a 24% relative rate reduction after adjustment for differences in patient risk. Among elective and urgent cases, 30-day mortality fell from 2.1% in 2000 to 1.6% in 2009.

The rate of 30-day stoke in all patients dropped from 1.6% in 2000 to 1.2% in 2009, a statistically significant decline. The risk-adjusted analysis showed this as a 26% relative fall in stroke rates. In elective and urgent cases, the rate declined from 1.6% to 1.1%.

The 30-day outcome results also showed significant declines in deep sternal wound rates (from 0.55% in 2000 to 0.37% in 2009), and in the need for reoperations because of bleeding (2.5% vs. 2.2%). The statistics showed no significant changes in the rates of postoperative renal failure or new-onset atrial fibrillation.

Dr. ElBardissi and Dr. Ferguson said they had no disclosures.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

PHILADELPHIA (EGMN) – Morbidly obese patients with a body mass index of 40 mg/m² or greater respond to kidney transplants as well as do ideal-weight patients, based on a review of 120,000 U.S. kidney transplant patients who received their organs during 1996-2009.

"The survival benefit of a kidney transplant is no different for morbidly obese and for ... ideal-weight patients," Dr. Roberto Kalil said at the American Transplant Congress, which was sponsored by the American Society of Transplant Surgeons. In both BMI categories, kidney transplants led to an average 45% reduction in the subsequent mortality risk, said Dr. Kalil, a nephrologist and kidney transplant physician at the University of Iowa in Iowa City.

"BMI is not a critical issue," agreed Dr. Lawrence G. Hunsicker, a professor of medicine at Iowa and a coauthor of the study. "You still need to evaluate each morbidly obese patient as a candidate for surgery and as a candidate for kidney transplant, as you would any patient. But should surgeons use BMI as a criterion for surgery? Probably not," Dr. Hunsicker said in an interview.

"BMI is a very imperfect parameter" for judging a patient’s suitability for transplant, added Dr. Kalil.

Despite this finding, many surgeons and transplant programs deny kidney transplants to morbidly obese patients, and many programs have a BMI ceiling for allowing transplants.

"Most centers do not accept patients for kidney transplant with a BMI of 35" or higher, noted Dr. Ignatius Y.S. Tang, a nephrologist and transplant physician at the University of Illinois in Chicago. Even the University of Iowa, where until recently Dr. Hunsicker served as medical director of organ transplantation, has a policy of not placing kidney transplants in patients with a BMI of 40 or higher. "I don’t think that’s right," Dr. Hunsicker said. Transplant centers apply BMI cutoffs individually, and the United Network for Organ Sharing (UNOS) has no blanket U.S. policy, he noted.

The findings reported by Dr. Kalil used data on 237,537 U.S. patients aged 18 years or older who were listed for a first kidney transplant with UNOS during 1996-2009. The group included 8,382 patients with a BMI of 40 or greater (4%). Among these morbidly obese patients, 2,581 actually received a transplant, which accounted for 2% of the more than 120,000 total U.S. patients who received a kidney transplant during the 14-year period examined.

In an analysis that controlled for age, sex, race and ethnicity, diabetes, blood type, listing priority, and type of health insurance, a kidney transplant improved the survival rate among morbidly obese patients by 48%, compared with the survival of morbidly obese patients who did not receive a transplant – similar to the 45% improvement seen in ideal-weight patients, and similar to the survival benefit seen in every other BMI subgroup. Dr. Kalil reported.

The finding carries one important caveat: The analysis could assess the outcomes of only the morbidly obese patients whose physicians decided to add them to the UNOS kidney waiting list. So the findings may represent exceptional, low-risk morbidly obese patients. "I think that’s unlikely, because generally the decision to list these patients or not depends on a center’s policy," said Dr. Hunsicker. "I think some centers listed these patients and others did not. I think the selection was by centers, not by patients," he said.

Additional, BMI-based analyses of the UNOS data showed that the listed morbidly obese patients had a statistically significant (26%) reduced chance of receiving a kidney transplant, compared with ideal-weight patients. Listed patients with a BMI of 40 or greater formed the only BMI subgroup with a significantly different transplantation rate.

The analysis also showed that patients who started with a BMI of 40 or more at the time they first appeared on the UNOS kidney transplant list lost an average index value of 4.7 in the period before they actually received a transplant. However, the change in BMI prior to transplantation had no relationship to the graft survival following transplantation, Dr. Kalil said. Waiting for patients to lose weight before proceeding with a transplant "was not associated with decreased mortality, and it wasted time," Dr. Hunsicker said. The better approach is to proceed with the transplant as soon as possible, he said.

Dr. Kalil, Dr. Hunsicker, and Dr. Tang all said that they had no disclosures.

Major Finding: A 5-mg infusion of zoledronic acid given to 31 patients with knee OA and associated bone marrow lesions reduced pain by 15 points more on a visual analog scale than did placebo, and reduced maximal bone marrow lesion area by 170 mm

Data Source: A single-center, randomized study with 31 patients who received a zoledronic acid infusion and 28 patients who received a placebo infusion.

Disclosures: The study was funded by Novartis, which markets zoledronic acid. Dr. Jones said that he has received speaker fees, travel sponsorship, and research support from Novartis and several other drug companies. Dr. Conaghan said that they had no disclosures.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm

“This is the first intervention shown to work on BMLs” in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

“This is exciting for treating existing OA. It is one of the first positive structure modification trials,” commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

“Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain,” Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. “If you reduce BMLs, it should produce good outcomes in patients,” he said.

“The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years,” Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

“I use it off label. Patients need to know it's off label, and they [therefore] must be willing to pay for it, but I use it. It's been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it's been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year,” Dr. Jones said.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug's beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget's disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

MRI knee scans from two patients taken before (left) and 6 months after treatment with zoledronic acid show shrinkage of bone marrow lesions.

Source Courtesy Dr. Graeme Jones

Major Finding: A 5-mg infusion of zoledronic acid given to 31 patients with knee OA and associated bone marrow lesions reduced pain by 15 points more on a visual analog scale than did placebo, and reduced maximal bone marrow lesion area by 170 mm

Data Source: A single-center, randomized study with 31 patients who received a zoledronic acid infusion and 28 patients who received a placebo infusion.

Disclosures: The study was funded by Novartis, which markets zoledronic acid. Dr. Jones said that he has received speaker fees, travel sponsorship, and research support from Novartis and several other drug companies. Dr. Conaghan said that they had no disclosures.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm

“This is the first intervention shown to work on BMLs” in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

“This is exciting for treating existing OA. It is one of the first positive structure modification trials,” commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

“Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain,” Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. “If you reduce BMLs, it should produce good outcomes in patients,” he said.

“The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years,” Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

“I use it off label. Patients need to know it's off label, and they [therefore] must be willing to pay for it, but I use it. It's been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it's been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year,” Dr. Jones said.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug's beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget's disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

MRI knee scans from two patients taken before (left) and 6 months after treatment with zoledronic acid show shrinkage of bone marrow lesions.

Source Courtesy Dr. Graeme Jones

Major Finding: A 5-mg infusion of zoledronic acid given to 31 patients with knee OA and associated bone marrow lesions reduced pain by 15 points more on a visual analog scale than did placebo, and reduced maximal bone marrow lesion area by 170 mm

Data Source: A single-center, randomized study with 31 patients who received a zoledronic acid infusion and 28 patients who received a placebo infusion.

Disclosures: The study was funded by Novartis, which markets zoledronic acid. Dr. Jones said that he has received speaker fees, travel sponsorship, and research support from Novartis and several other drug companies. Dr. Conaghan said that they had no disclosures.

LONDON – A single 5-mg infusion of zoledronic acid, a bisphosphonate, in patients with knee osteoarthritis led to significant pain reduction and shrinkage of bone marrow lesions in a randomized, placebo-controlled study with 59 patients.

The zoledronic acid treatment led to an average 15-point drop in pain (on a visual analog scale of 0-100) beyond what occurred in the placebo group, and the active treatment was also linked with an average 170-mm

“This is the first intervention shown to work on BMLs” in patients with osteoarthritis (OA), said Dr. Jones, professor of rheumatology and epidemiology and head of the musculoskeletal unit at the Menzies Research Institute Tasmania, Hobart, Australia.

“This is exciting for treating existing OA. It is one of the first positive structure modification trials,” commented Dr. Philip Conaghan, professor and chairman of musculoskeletal medicine at the University of Leeds (England).

“Results from several studies have linked BMLs with pain and cartilage damage in OA patients. The larger the BML, the faster the cartilage loss and the worse the pain,” Dr. Jones said in an interview. Based on studies his group has done, about 20% of BMLs that are associated with knee OA spontaneously enlarge over the course of 3 years, another 20% shrink in size, and about 60% remain the same, he said. Their earlier research findings also showed that BMLs are independently linked with fast progression of OA and the need for knee replacement. “If you reduce BMLs, it should produce good outcomes in patients,” he said.

“The next step is to show that treatment with zoledronic acid not only reduces BML size but also slows cartilage loss. Sixty patients followed for 12 months were not enough to assess cartilage. We will need about 400 patients followed for 2 years,” Dr. Jones added.

Despite not yet having information on cartilage effects, he said that his results so far have convinced him that treatment with zoledronic acid is reasonable for patients with painful knee OA and BMLs.

“I use it off label. Patients need to know it's off label, and they [therefore] must be willing to pay for it, but I use it. It's been shown to work, and nothing else works. Zoledronic acid [Reclast] is available, we know about its safety, and it's been used for a long time to treat osteoporosis and cancers. If you have OA patients with BMLs, this is something to actively consider for them. Patients with OA have very limited treatment options. This can make a large difference in their pain, and it has long-lasting benefit so it can be given once a year,” Dr. Jones said.

The benefits of zoledronic acid that were seen in his study might be a class effect that may be replicated by treatment with another bisphosphonate, but zoledronic acid is more potent than oral bisphosphonates and hence the drug's beneficial effect on pain and BML shrinkage may exceed the effect that other bisphosphonates might have, he said.

The pain benefit appeared to start wearing off about a year after the zoledronic acid injection. Dr. Jones said that he has a small number of patients whom he has infused a second time, which produced a second round of pain reduction.

The 59 patients who were enrolled in the study had an average age of about 60 years, with an average knee pain score of about 52 on the visual analog scale; all patients had BMLs as seen on MRI scans of their affected knees. In all, 31 patients received a 5-mg infusion of zoledronic acid and 28 patients received a placebo infusion. All patients also continued their conventional pain medication regimens.

The Food and Drug Administration has approved zoledronic acid under a number of brand names to prevent or treat osteoporosis in postmenopausal women or patients who are at risk for osteoporosis because they are taking or have taken corticosteroid therapy; to manage Paget's disease; and to prevent chemotherapy-induced bone fractures or fractures in patients with multiple myeloma or cancer that has metastasized to the bones from other locations.

MRI knee scans from two patients taken before (left) and 6 months after treatment with zoledronic acid show shrinkage of bone marrow lesions.

Source Courtesy Dr. Graeme Jones

Major Finding: Maternal colonization with Staphylococcus aureus had no significant impact on the rate of S. aureus colonization in neonates.

Data Source: Review of 2,789 infants born to 2,702 women in New York during 2009.

Disclosures: Dr. Top and Dr. Saiman said they had no relevant financial disclosures.

PHILADELPHIA – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said. “Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections,” said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

“People have been saying that maybe we should culture pregnant women” to determine whether they have anovaginal S. aureus colonization, “but it's a huge expense, and you'd have to really convince yourself that it matters,” said Dr. Lisa Saiman, a professor of clinical pediatrics at the university and a collaborator on the study. “S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don't want people to worry about what's normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora” she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35–37 weeks' gestation. Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization. Dr. Top's analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days.

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold. In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Women who had a caesarean delivery were significantly more likely to become infected than women with a vaginal delivery.

The low 1% transmission rate from colonized mothers to their children precludes the need to screen pregnant women.

Source DR. TOP

Major Finding: Maternal colonization with Staphylococcus aureus had no significant impact on the rate of S. aureus colonization in neonates.

Data Source: Review of 2,789 infants born to 2,702 women in New York during 2009.

Disclosures: Dr. Top and Dr. Saiman said they had no relevant financial disclosures.

PHILADELPHIA – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said. “Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections,” said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

“People have been saying that maybe we should culture pregnant women” to determine whether they have anovaginal S. aureus colonization, “but it's a huge expense, and you'd have to really convince yourself that it matters,” said Dr. Lisa Saiman, a professor of clinical pediatrics at the university and a collaborator on the study. “S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don't want people to worry about what's normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora” she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35–37 weeks' gestation. Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization. Dr. Top's analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days.

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold. In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Women who had a caesarean delivery were significantly more likely to become infected than women with a vaginal delivery.

The low 1% transmission rate from colonized mothers to their children precludes the need to screen pregnant women.

Source DR. TOP

Major Finding: Maternal colonization with Staphylococcus aureus had no significant impact on the rate of S. aureus colonization in neonates.

Data Source: Review of 2,789 infants born to 2,702 women in New York during 2009.

Disclosures: Dr. Top and Dr. Saiman said they had no relevant financial disclosures.

PHILADELPHIA – Neonates do not face an increased risk of colonization or infection by Staphylococcus aureus when they are born to mothers who have anovaginal colonization with this pathogen, based on a review of more than 2,700 deliveries.

The low 1% rate of transmission of S. aureus from colonized mothers to their children precludes the need to routinely screen pregnant women for anovaginal S. aureus colonization, Dr. Karina A. Top said. “Maternal anovaginal S. aureus colonization may be a risk factor for maternal infections, but it does not appear to be associated with neonatal infections,” said Dr. Top, a pediatric infectious disease physician at Columbia University and New York-Presbyterian Hospital in New York.

“People have been saying that maybe we should culture pregnant women” to determine whether they have anovaginal S. aureus colonization, “but it's a huge expense, and you'd have to really convince yourself that it matters,” said Dr. Lisa Saiman, a professor of clinical pediatrics at the university and a collaborator on the study. “S. aureus is normal flora. If there is a skin break it can lead to infection, but usually not. You don't want people to worry about what's normal. The message [from these results] is that there is no role for routine screening of pregnant women and neonates, because these are normal flora” she said in an interview.

This is the first study to systematically look at mother-to-neonate transmission of S. aureus, she added.

The current analysis is based on a prior study by Dr. Top of 2,921 pregnant woman in New York during 2009 that found colonization with methicillin-sensitive S. aureus (MSSA) in 345 women (12%) and colonization with methicillin-resistant S. aureus (MRSA) in 18 women (0.6%). Dr. Top and her associates collected specimens from these women at 35–37 weeks' gestation. Subsequently, 2,702 of these women delivered an infant, resulting in 2,789 live births.

Collection and analysis of specimens from the infants during their first 3 months of life revealed 10 cases of definite S. aureus infection in the neonates, 8 cases of probable infection, and 7 cases of S. aureus colonization. Dr. Top's analysis showed a 1.1% rate of neonatal infection or colonization in babies born to colonized mothers, and a 0.9% rate in those born to uncolonized mothers, a difference that was not significant. The median age for the first positive S. aureus culture in these infants occurred at 27 days.

Delivery mode, cesarean or vaginal, had no significant impact on S. aureus transmission to the infants, but three other variables did significantly link with an increased rate of positive cultures: preterm birth (less than 37 weeks), multiple gestations, and admission to the neonatal ICU. Each of these three factors increased the rate of S. aureus colonization by 6- to 17-fold. In contrast, maternal colonization had a statistically significant impact on the rate of maternal infection with S. aureus following delivery. Colonized women had a 2.1% rate of postpartum infection, more than threefold higher than the rate in uncolonized women. Women who had a caesarean delivery were significantly more likely to become infected than women with a vaginal delivery.

The low 1% transmission rate from colonized mothers to their children precludes the need to screen pregnant women.

Source DR. TOP

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

Major Finding: Treatment with several different dosages of fulranumab led to statistically significant improvements in a number of efficacy measures and was well tolerated. The primary efficacy end point of change in average pain intensity at 12 weeks from the start of treatment showed significant drops compared with the placebo group for the three largest dosages of fulranumab tested.

Data Source: Phase II randomized, placebo-controlled trial that assessed the efficacy and safety of five dosages of fulranumab after 12 weeks of treatment in patients with moderate to severely painful osteoarthritis of the hip or knee.

Disclosures: Dr. Thipphawong and several of his associates are employees of Johnson & Johnson, the company developing fulranumab.

LONDON – An investigational nerve growth factor inhibitor, fulranumab, showed promising efficacy and safety as a pain reliever for patients with hip or knee osteoarthritis in 12-week results from a phase II study of 466 patients.

Further study of fulranumab in osteoarthritis had been on hold. The Food and Drug Administration issued a moratorium last December that halted clinical testing of fulranumab and most other investigational agents in the anti–nerve growth factor class, following reports that some of these drugs appeared to trigger episodes of rapid progression of hip or knee osteoarthritis that led to joint replacement and possible osteonecrosis. The FDA lifted that moratorium on research with fulranumab in cancer pain this month. The moratorium on research involving OA pain remains in place, according to investigators.

Whether or not osteoarthritis progressed rapidly in any patient treated with fulranumab remains unknown. “Cases of joint replacement reported during the entire trial are under investigation, and will be reported in a future publication,” Dr. John Thipphawong said.

The safety data Dr. Thipphawong presented for 12 weeks of treatment showed a well-tolerated profile compared with placebo. Specifically, serious adverse events occurred in 1% of patients treated with fulranumab, compared with 2% of those on placebo. Adverse events led to discontinuation of the assigned drug in 2% of fulranumab recipients and 1% of those on placebo. Adverse events that occurred more often in fulranumab-treated patients were paresthesia, with a 6%–10% rate in the higher fulranumab dosage subgroups, compared with a 3% rate for patients on placebo, and a hypoesthesia rate of 5%–6% in the higher dosage fulranumab subgroups, compared with a 1% rate with placebo. The fulranumab-treated patients also had no significant changes in laboratory values, ECG, or vital signs at 12 weeks after treatment began.

The study enrolled patients with documented hip or knee osteoarthritis who met the diagnostic criteria of the American College of Rheumatology and showed radiographic evidence of the disease, with a Kellgren-Lawrence grade of 2 or greater. All patients also reported moderate to severe pain, with a pain score of at least 5 on a 0–10 numerical rating scale despite treatment with an opioid, a nonsteroidal anti-inflammatory drug, or both.

The study randomized patients to receive fulranumab or placebo once every 4 or 8 weeks as a subcutaneous injection in addition to standard pain medications. The protocol tested five different fulranumab dosages: 1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks, or 10 mg every 8 weeks. Fulranumab is a fully human, recombinant monoclonal antibody that neutralizes the biological actions of human nerve growth factor. About 78 patients entered each of the five active-treatment arms as well as a placebo arm. The study's primary efficacy end point was the change in average pain score from baseline to the end of week 12 of the study.

The patients' average age was 61 years, 58% were women, and two-thirds were white. Their average body mass index was 32 kg/m

At 12 weeks after the start of treatment, average pain reduction with fulranumab significantly surpassed the placebo group in the 3–mg every 4 weeks, 6–mg every 8 weeks, and 10–mg every 8 weeks subgroups. In these three groups, pain scores fell by an average of 3.05, 2.64, and 2.65 points, respectively, compared with an average drop of 1.91 points in the placebo group, reported Dr. Thipphawong, who is senior director of clinical development, Johnson & Johnson Pharmaceutical Research & Development.

The study also included several secondary efficacy measures. The three highest-dosage subgroups, as well as the 3–mg every 8 weeks subgroup, showed statistically significant declines compared with placebo after 12 weeks in the average levels of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscales for pain and global function. For the WOMAC subscales of physical function and stiffness, all five fulranumab dosage subgroups showed significant reductions compared with placebo.

On the Brief Pain Inventory-Short Form, patients in the 3–mg every 4 weeks and 10–mg every 8 weeks subgroups had significant average reductions compared with the placebo group for the subscales of pain intensity and pain interference with activities The three highest-dosage subgroups also produced average drops in patient global assessment of disease status that were statistically significant compared with the placebo group's average.

In a separate poster at the meeting, Dr. Thipphawong and his associates also reported that several of the fulranumab subgroups showed statistically significant average improvements compared with placebo in several subscale measures on the Short Form-36, specifically bodily pain, vitality, and physical component. The four highest-dosage subgroups also had significant average improvements in pain interference with sleep compared with placebo, and all five fulranumab dosage subgroups had significant average improvements in sleep adequacy compared with the placebo group.

Major Finding: A significant correlation was found between 24-hour ambulatory systolic hypertension, brain damage, and functional and cognitive impairment in elderly people. Each 1–mm Hg rise in systolic pressure over a 2-year period linked with an average 0.04% increased brain volume of white matter hyperintensity.

Data Source: Two-year follow-up study of 72 people aged 75-89 years (average age, 82 at baseline) who were normotensive or mildly hypertensive at entry.

Disclosures: Dr. White said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the meeting.

“These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people,” said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. “If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don't think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important” determinant of declines in cognition and mobility and in an MRI measure of brain damage, “and blood pressure is something where we can intervene,” he said.

“Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don't think about the chronic burden on the brain,” said Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer's disease probably had poorly controlled hypertension over their lifetime.”

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. “The people only averaged 144 mm Hg. That's not so bad, but they had progression,” Dr. White said.

Blood pressure was the most important determinant of declines in cognition and mobility.

Source DR. WHITE

Major Finding: A significant correlation was found between 24-hour ambulatory systolic hypertension, brain damage, and functional and cognitive impairment in elderly people. Each 1–mm Hg rise in systolic pressure over a 2-year period linked with an average 0.04% increased brain volume of white matter hyperintensity.

Data Source: Two-year follow-up study of 72 people aged 75-89 years (average age, 82 at baseline) who were normotensive or mildly hypertensive at entry.

Disclosures: Dr. White said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the meeting.

“These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people,” said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. “If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don't think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important” determinant of declines in cognition and mobility and in an MRI measure of brain damage, “and blood pressure is something where we can intervene,” he said.

“Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don't think about the chronic burden on the brain,” said Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer's disease probably had poorly controlled hypertension over their lifetime.”

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. “The people only averaged 144 mm Hg. That's not so bad, but they had progression,” Dr. White said.

Blood pressure was the most important determinant of declines in cognition and mobility.

Source DR. WHITE

Major Finding: A significant correlation was found between 24-hour ambulatory systolic hypertension, brain damage, and functional and cognitive impairment in elderly people. Each 1–mm Hg rise in systolic pressure over a 2-year period linked with an average 0.04% increased brain volume of white matter hyperintensity.

Data Source: Two-year follow-up study of 72 people aged 75-89 years (average age, 82 at baseline) who were normotensive or mildly hypertensive at entry.

Disclosures: Dr. White said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the meeting.

“These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people,” said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. “If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don't think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important” determinant of declines in cognition and mobility and in an MRI measure of brain damage, “and blood pressure is something where we can intervene,” he said.

“Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don't think about the chronic burden on the brain,” said Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. “Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer's disease probably had poorly controlled hypertension over their lifetime.”

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. “The people only averaged 144 mm Hg. That's not so bad, but they had progression,” Dr. White said.

Blood pressure was the most important determinant of declines in cognition and mobility.

Source DR. WHITE

NEW ORLEANS – Hypertensive patients with persistent left ventricular hypertrophy despite normalized BP faced a substantially higher risk for death and cardiovascular events, compared with patients without hypertrophy on antihypertensive treatment, according to a study involving 463 patients.

“These results suggest that persistence of left ventricular hypertrophy [LVH] in a subset of patients with lower achieved blood pressure during treatment may in part explain the lack of benefit seen in hypertensive patients, despite treatment to lower systolic blood pressure,” Dr. Peter M. Okin said at the meeting.

Based on these results, it may be necessary to track end-organ damage in addition to BP to fully assess response to treatment in hypertensive patients, said Dr. Okin, professor of medicine at Cornell University in New York.

The analysis Dr. Okin reported came from a subset of participants in the LIFE (Losartan Intervention for End Point Reduction in Hypertension) study, which enrolled 9,193 patients aged 55-80 years with a BP of 160/95 mm Hg to 200/115 mm Hg. The study randomized patients to two different antihypertensive treatment arms, one based primarily on losartan and the control based primarily on atenolol, with a target BP of 140/90 mm Hg or less (Lancet 2002;359:995-1003).

The subgroup used for the new analysis included the 463 patients in the study who achieved a systolic BP of 130 mm Hg or less. During an average follow-up of more than 4 years, the combined rate of cardiovascular death, MI, or stroke was 15%.

The researchers used data from the 12-lead ECG recordings of these patients, as analyzed to calculate left ventricular size. They considered any patient with a Cornell product greater than 2440 mm × msec to have residual LVH. This identified 211 patients (46%) with persistent hypertrophy despite their low achieved systolic BP, and 252 patients without LVH.

Patients with persistent LVH were significantly older (66 years) than were those without LVH (64 years), and were significantly more likely to be women (53%) compared with the 40% rate of women in the group without LVH.

During the average 4.4 years of follow-up, patients with residual hypertrophy had significantly higher rates of MI, strokes, cardiovascular death, and all-cause mortality, as well as a significantly higher rate of the combined end point of MI, stroke, or cardiovascular death, compared with the patients without hypertrophy. (See box.)

Dr. Okin said that he receives a financial benefit from GE Medical Systems. The LIFE trial was sponsored by Merck, which markets losartan (Cozaar).

Source Elsevier Global Medical News

Persistence of LVH in certain patients with lower achieved BP may explain the lack of benefit of treatment.

Source DR. OKIN

NEW ORLEANS – Hypertensive patients with persistent left ventricular hypertrophy despite normalized BP faced a substantially higher risk for death and cardiovascular events, compared with patients without hypertrophy on antihypertensive treatment, according to a study involving 463 patients.

“These results suggest that persistence of left ventricular hypertrophy [LVH] in a subset of patients with lower achieved blood pressure during treatment may in part explain the lack of benefit seen in hypertensive patients, despite treatment to lower systolic blood pressure,” Dr. Peter M. Okin said at the meeting.

Based on these results, it may be necessary to track end-organ damage in addition to BP to fully assess response to treatment in hypertensive patients, said Dr. Okin, professor of medicine at Cornell University in New York.

The analysis Dr. Okin reported came from a subset of participants in the LIFE (Losartan Intervention for End Point Reduction in Hypertension) study, which enrolled 9,193 patients aged 55-80 years with a BP of 160/95 mm Hg to 200/115 mm Hg. The study randomized patients to two different antihypertensive treatment arms, one based primarily on losartan and the control based primarily on atenolol, with a target BP of 140/90 mm Hg or less (Lancet 2002;359:995-1003).

The subgroup used for the new analysis included the 463 patients in the study who achieved a systolic BP of 130 mm Hg or less. During an average follow-up of more than 4 years, the combined rate of cardiovascular death, MI, or stroke was 15%.

The researchers used data from the 12-lead ECG recordings of these patients, as analyzed to calculate left ventricular size. They considered any patient with a Cornell product greater than 2440 mm × msec to have residual LVH. This identified 211 patients (46%) with persistent hypertrophy despite their low achieved systolic BP, and 252 patients without LVH.

Patients with persistent LVH were significantly older (66 years) than were those without LVH (64 years), and were significantly more likely to be women (53%) compared with the 40% rate of women in the group without LVH.

During the average 4.4 years of follow-up, patients with residual hypertrophy had significantly higher rates of MI, strokes, cardiovascular death, and all-cause mortality, as well as a significantly higher rate of the combined end point of MI, stroke, or cardiovascular death, compared with the patients without hypertrophy. (See box.)

Dr. Okin said that he receives a financial benefit from GE Medical Systems. The LIFE trial was sponsored by Merck, which markets losartan (Cozaar).

Source Elsevier Global Medical News

Persistence of LVH in certain patients with lower achieved BP may explain the lack of benefit of treatment.

Source DR. OKIN

NEW ORLEANS – Hypertensive patients with persistent left ventricular hypertrophy despite normalized BP faced a substantially higher risk for death and cardiovascular events, compared with patients without hypertrophy on antihypertensive treatment, according to a study involving 463 patients.

“These results suggest that persistence of left ventricular hypertrophy [LVH] in a subset of patients with lower achieved blood pressure during treatment may in part explain the lack of benefit seen in hypertensive patients, despite treatment to lower systolic blood pressure,” Dr. Peter M. Okin said at the meeting.

Based on these results, it may be necessary to track end-organ damage in addition to BP to fully assess response to treatment in hypertensive patients, said Dr. Okin, professor of medicine at Cornell University in New York.

The analysis Dr. Okin reported came from a subset of participants in the LIFE (Losartan Intervention for End Point Reduction in Hypertension) study, which enrolled 9,193 patients aged 55-80 years with a BP of 160/95 mm Hg to 200/115 mm Hg. The study randomized patients to two different antihypertensive treatment arms, one based primarily on losartan and the control based primarily on atenolol, with a target BP of 140/90 mm Hg or less (Lancet 2002;359:995-1003).

The subgroup used for the new analysis included the 463 patients in the study who achieved a systolic BP of 130 mm Hg or less. During an average follow-up of more than 4 years, the combined rate of cardiovascular death, MI, or stroke was 15%.

The researchers used data from the 12-lead ECG recordings of these patients, as analyzed to calculate left ventricular size. They considered any patient with a Cornell product greater than 2440 mm × msec to have residual LVH. This identified 211 patients (46%) with persistent hypertrophy despite their low achieved systolic BP, and 252 patients without LVH.

Patients with persistent LVH were significantly older (66 years) than were those without LVH (64 years), and were significantly more likely to be women (53%) compared with the 40% rate of women in the group without LVH.

During the average 4.4 years of follow-up, patients with residual hypertrophy had significantly higher rates of MI, strokes, cardiovascular death, and all-cause mortality, as well as a significantly higher rate of the combined end point of MI, stroke, or cardiovascular death, compared with the patients without hypertrophy. (See box.)

Dr. Okin said that he receives a financial benefit from GE Medical Systems. The LIFE trial was sponsored by Merck, which markets losartan (Cozaar).

Source Elsevier Global Medical News

Persistence of LVH in certain patients with lower achieved BP may explain the lack of benefit of treatment.

Source DR. OKIN