Sharon Worcester

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

Blood transfusions in cardiac surgery patients often are performed inappropriately, and transfusion rates would improve if more restrictive strategies for performing them were employed, according to the results of two separate studies reported in the Oct. 13 issue of JAMA.

In one large observational study, investigators showed that, despite the availability of clinical practice guidelines for blood transfusion, rates of transfusion among cardiac surgery patients vary dramatically among hospitals in the United States. Transfusion rates in the multicenter study of 102,470 patients who underwent primary isolated coronary artery bypass graft surgery with cardiopulmonary bypass during 2008 varied from 8% to 93% for red blood cell transfusions, from 0% to 98% for fresh-frozen plasma, and from less than 1% to more than 90% for platelets at hospitals performing at least 100 eligible on-pump coronary artery bypass graft operations, Dr. Elliott Bennett-Guerrero of Duke University, Durham, N.C., and his colleagues found.

After adjusting for patient-level risk factors, some significant variation in transfusion rates was seen based on geography, hospital academic status, and hospital volume, but these factors accounted for only 11% of the variation and case mix accounted for about 20%. Furthermore, no significant association between hospital-specific transfusion rates and all-cause mortality was seen on either adjusted or unadjusted analysis (JAMA 2010;304:1568-75).

Given that cardiac surgery patients receive a large proportion of the 14 million units of red blood cell transfusions performed each year in the United States, and that such transfusions are costly and have been shown to increase the risk of adverse outcomes, the variability in transfusion rates should be seen as a potential quality improvement opportunity, the investigators said.

Studies have shown that the use of blood conservation programs can be effective for improving transfusion rates, and since this study demonstrated that the availability of practice guidelines does not appear to improve transfusion rates, such programs might be a more effective approach, Dr. Bennett-Guerrero and his associates noted.

Indeed, the findings from the second study – a randomized controlled noninferiority trial showing that a perioperative red blood cell (RBC) transfusion strategy restricting transfusions to patients with hematocrit values less than 24% resulted in 30-day mortality and severe morbidity rates that were similar to those with a more liberal strategy that allowed transfusions in patients with hematocrit values less than 30% – appear to support a more conservative approach. In this study, it was the receipt of any red blood cell transfusion, not the treatment strategy, that was associated with higher complication and mortality rates after surgery, Dr. Ludhmila A. Hajjar of the University of Sao Paulo (Brazil) and colleagues found (JAMA 2010;304:1559-67).

Although the Brazilian investigation, known as the TRACS (Transfusion Requirements After Cardiac Surgery) study, was designed to explore optimal transfusion practices rather than to evaluate a blood conservation strategy, the finding that RBC transfusion was independently associated with a 1.2-fold increased risk of death at 30 days for each unit transfused nonetheless “supports a restrictive therapy in cardiac surgery,” the investigators wrote.

They studied 502 consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at a university hospital in Brazil between February 2009 and February 2010. The restrictive and liberal transfusion strategies resulted in transfusion rates of 47% and 78%, respectively, yet the rate of the composite outcome of 30-day all-cause mortality and severe morbidity was similar, at 11% and 10%, respectively.

Severe morbidity included cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration during the patient’s hospital stay.

“As expected, the restrictive-strategy patients received fewer RBC units than the liberal-strategy patients and, consequently, had lower mean hemoglobin levels during the study [mean of 9.1 g/dL and 10.5 g/dL, respectively]. Interestingly, this did not result in a higher incidence of clinical complications,” the investigators wrote, adding that this was presumably because the restrictive strategy did not lead to reduced oxygen availability to the cells.

The finding that the number of transfused RBC units predicted 30-day mortality in a dose-dependent fashion not only supports a more restrictive strategy for transfusion in cardiac surgery, but also suggests that clinicians should administer only 1 unit at a time, as this may provide similar benefits with less risk, Dr. Hajjar and associates said.

Taken together, the findings suggest that there is a great need for improvement of transfusion rates and that a primary strategy in patients undergoing cardiac surgery should be to avoid giving red blood cell transfusion solely to correct low hemoglobin levels.

Dr. Bennett-Guerrero is principal investigator for a multicenter, National Institutes of Health–funded study assessing the impact of blood transfusion on peripheral and cerebral oxygenation and the microcirculation. He is also a named inventor on a patent application related to methods of washing red blood cells. His study was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute. Dr. Hajjar and coauthors had no disclosures to report.

ST. LOUIS — Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004;64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn't seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

▸ It is a totally vaginal, unified approach; all defects can be treated during one procedure.

▸ There is efficacy for both urethral hypermobility and ISD-related SUI.

▸ It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

▸ It is easy to learn and teach.

▸ There is low or no pain.

▸ There is rapid return to normal voiding postoperatively.

▸ There is no need for blindly placed trocars.

▸ Surgical time is less than 30 minutes.

▸ There is no need for mesh, so there are no mesh-related complications.

▸ There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.

ST. LOUIS — Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004;64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn't seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

▸ It is a totally vaginal, unified approach; all defects can be treated during one procedure.

▸ There is efficacy for both urethral hypermobility and ISD-related SUI.

▸ It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

▸ It is easy to learn and teach.

▸ There is low or no pain.

▸ There is rapid return to normal voiding postoperatively.

▸ There is no need for blindly placed trocars.

▸ Surgical time is less than 30 minutes.

▸ There is no need for mesh, so there are no mesh-related complications.

▸ There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.

ST. LOUIS — Treatment of urinary incontinence by means of a pubic bone stabilization sling – a suburethral sling that is anchored to the pubic bone using titanium screws – is highly effective and is not associated with an increased risk of osteomyelitis, according to findings from the largest prospective observational study to date.

Although concerns that the procedure could cause osseous complications have been circulating for years and have discouraged some surgeons from using the pubic bone stabilization sling, only 1 case occurred in the 2,331 patients in the study, for an incidence of 0.000043%, Dr. S. Robert Kovac reported at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Patients were treated for intrinsic sphincter dysfunction (ISD) and/or stress urinary incontinence (SUI), and were followed for a mean of 13 years, and up to 17 years at four different institutions, said Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the center for pelvic reconstructive surgery and urogynecology at Emory University, Atlanta. His associates are Dr. P.D. Dietz, Dr. M. Muniz, and Dr. S.H. Cruikshank.

Follow-up was done by exams, questionnaires, and telephone conversations.

The cure rate for those with ISD and/or SUI who had total dryness was 92%.

In a prospective study published in 2004, the incidence of osteomyelitis was 0.08% in 1,228 patients who underwent transvaginal bone anchor fixation in female pelvic reconstructive surgery, Dr. Kovac noted (Urology 2004;64:669-74).

By comparison, abdominal sacrocolpopexy is associated with an osteomyelitis incidence of 11%, according to reports in the literature, Dr. Kovac said.

“I think we got off on the wrong track,” he said of the unfounded fears regarding osteomyelitis in patients undergoing pubic bone stabilization (PBS) sling procedures.

Dr. Kovac, who developed the PBS sling procedure more than 20 years ago, said that more than 350,000 have been performed worldwide, and that in all that time he hasn't seen a single case of osteomyelitis or osteitis pubis in any of his patients who underwent the procedure.

Furthermore, the PBS sling has the lowest complication rate and the best long-term outcomes of the various suburethral slings currently used for urinary incontinence, he said.

Currently, the procedure is performed transvaginally by placing a suburethral sling of Biodesign Surgisis over the midurethra, and securing it with titanium bone screws to the posterior-inferior pubis to restore proper anatomy for continence.

In addition to the high cure rate and low complication rate, the approach has several other advantages, Dr. Kovac said, including the following:

▸ It is a totally vaginal, unified approach; all defects can be treated during one procedure.

▸ There is efficacy for both urethral hypermobility and ISD-related SUI.

▸ It functions as a retropubic procedure, a vaginal Marshall-Marchetti-Krantz (MMK) operation without the need for an abdominal incision.

▸ It is easy to learn and teach.

▸ There is low or no pain.

▸ There is rapid return to normal voiding postoperatively.

▸ There is no need for blindly placed trocars.

▸ Surgical time is less than 30 minutes.

▸ There is no need for mesh, so there are no mesh-related complications.

▸ There is no voiding dysfunction; it is truly tension free.

The procedure also has little reliance on cystoscopy, although Dr. Kovac said that he recommends cystoscoping all patients to avoid potential bladder-related hazards.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon-Endo Surgery Inc., but he sold his patent on the PBS sling to American Medical Systems and has no financial interest in the procedure.

ST. LOUIS — Vaginal cerclage, a novel surgical procedure for pelvic organ prolapse, is proving effective as a treatment option for severe and refractory prolapse in select patients.

Also known as introital cerclage, the procedure involves permanent suturing of the introitus, and is often performed in conjunction with vaginectomy. This obliterative approach is suitable only in those who are certain they no longer desire coital function, but on its own, vaginal cerclage also can serve as a bridge to nonobliterative repair, Dr. S. Robert Kovac and Dr. Carl W. Zimmerman said at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the Emory Center for Reconstructive Pelvic Surgery at Emory University, Atlanta, used a video demonstration to show the surgical technique in an 82-year-old woman who had undergone two prior procedures for the treatment of prolapse, including a total abdominal hysterectomy followed by transvaginal repair with graft augmentation.

She presented with recurrent prolapse and complaints of vaginal bulge and discomfort, difficulty with voiding, and recurrent urinary tract infections.

A decision was made to perform vaginectomy augmented by the placement of a simple introital cerclage.

Dr. Kovac adequately infiltrated the introitus with 0.5% Marcaine with epinephrine, then used nonabsorbable braided sterile polyester suture beginning at the 12 o'clock position. The suture was placed away from the mid-urethra and closer to the bladder neck to decrease the risk of de novo stress urinary incontinence.

Suture placement continued in a circumferential manner toward the 6 o'clock position in several steps, ending at the 7 o'clock position to minimize discomfort. The suture ends were cut and tied down to obliterate the vagina and reduce the prolapse, and the ends were buried under the skin to decrease discomfort.

The same approach was used in a 77-year-old patient who had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy, as well as multiple prior prolapse repairs, including transvaginal repair with graft augmentation, a pubic bone sling, and transvaginal enterocele repair with graft augmentation and repeat enterocele repair with colpocleisis.

The patient presented with vaginal bulge, pressure, discharge, defecation dysfunction, and abdominal pain; she was diagnosed with stage IV vaginal vault prolapse. As in the first patient, vaginectomy was performed and augmented by vaginal cerclage. The patient's vagina was obliterated, and her prolapse reduced with no change in urethral angle.

Both patients were doing well at 8 months' follow-up, Dr. Kovac said.

Dr. Kovac, who argued that vaginal cerclage is superior to the “very outdated” LeFort colpocleisis procedure that's used in patients with severe prolapse who still have their uterus, noted that the new technique also can be used as an intermediate procedure in certain patients awaiting nonobliterative prolapse repair.

For example, he described a patient with a significant prolapse who was unable to undergo surgery because of elevated creatinine. Vaginal cerclage allowed for temporary relief over the 8-9 days required for her creatinine levels to normalize.

“This approach provided improved comfort and quality of life, and reduced her hydronephrosis, which was causing the elevated creatinine, thus enabling her to undergo the full repair,” he said.

Similarly, Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University in Nashville, Tenn., described a patient who was preparing to undergo liver transplant and was found to have severe prolapse during a pelvic exam prior to surgery. Vaginal cerclage was used as a rescue procedure so that she could undergo the transplant surgery. The prolapse was reduced, the cerclage was placed, and the transplant was successful, he said.

Vaginal cerclage is a simple and “clever” procedure that can be accomplished in about 5 minutes, is reimbursed as a colpocleisis, and vastly improves patient comfort, Dr. Kovac said.

“It has great advantages, and we're doing it routinely today on select patients who come in with recurrent prolapse after multiple attempts at correctional surgery – with excellent results.”

The availability of such a technique is important because, typically, the repair used for a failed colpocleisis is a repeat colpocleisis.

Also, an increase in patients who seek treatment is anticipated, given that U.S. Census data indicate that the number of adults older than age 65 is expected to reach 90 million by 2050, and that 30%-50% of women experience prolapse in their lifetime, 11% undergo surgery for prolapse, and a third of prolapse and incontinence surgeries are for recurrent prolapse.

Improved techniques are needed, particularly in light of the high rate of repeat repairs, Dr. Kovac said.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon Endo-Surgery Inc. Dr. Zimmerman is a speaker/proctor for Cook Medical, proctor for Boston Scientific Corp. and Covidien, and receives Royalties from Lumitex Inc. and Marina Medical Instruments Inc.

ST. LOUIS — Vaginal cerclage, a novel surgical procedure for pelvic organ prolapse, is proving effective as a treatment option for severe and refractory prolapse in select patients.

Also known as introital cerclage, the procedure involves permanent suturing of the introitus, and is often performed in conjunction with vaginectomy. This obliterative approach is suitable only in those who are certain they no longer desire coital function, but on its own, vaginal cerclage also can serve as a bridge to nonobliterative repair, Dr. S. Robert Kovac and Dr. Carl W. Zimmerman said at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the Emory Center for Reconstructive Pelvic Surgery at Emory University, Atlanta, used a video demonstration to show the surgical technique in an 82-year-old woman who had undergone two prior procedures for the treatment of prolapse, including a total abdominal hysterectomy followed by transvaginal repair with graft augmentation.

She presented with recurrent prolapse and complaints of vaginal bulge and discomfort, difficulty with voiding, and recurrent urinary tract infections.

A decision was made to perform vaginectomy augmented by the placement of a simple introital cerclage.

Dr. Kovac adequately infiltrated the introitus with 0.5% Marcaine with epinephrine, then used nonabsorbable braided sterile polyester suture beginning at the 12 o'clock position. The suture was placed away from the mid-urethra and closer to the bladder neck to decrease the risk of de novo stress urinary incontinence.

Suture placement continued in a circumferential manner toward the 6 o'clock position in several steps, ending at the 7 o'clock position to minimize discomfort. The suture ends were cut and tied down to obliterate the vagina and reduce the prolapse, and the ends were buried under the skin to decrease discomfort.

The same approach was used in a 77-year-old patient who had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy, as well as multiple prior prolapse repairs, including transvaginal repair with graft augmentation, a pubic bone sling, and transvaginal enterocele repair with graft augmentation and repeat enterocele repair with colpocleisis.

The patient presented with vaginal bulge, pressure, discharge, defecation dysfunction, and abdominal pain; she was diagnosed with stage IV vaginal vault prolapse. As in the first patient, vaginectomy was performed and augmented by vaginal cerclage. The patient's vagina was obliterated, and her prolapse reduced with no change in urethral angle.

Both patients were doing well at 8 months' follow-up, Dr. Kovac said.

Dr. Kovac, who argued that vaginal cerclage is superior to the “very outdated” LeFort colpocleisis procedure that's used in patients with severe prolapse who still have their uterus, noted that the new technique also can be used as an intermediate procedure in certain patients awaiting nonobliterative prolapse repair.

For example, he described a patient with a significant prolapse who was unable to undergo surgery because of elevated creatinine. Vaginal cerclage allowed for temporary relief over the 8-9 days required for her creatinine levels to normalize.

“This approach provided improved comfort and quality of life, and reduced her hydronephrosis, which was causing the elevated creatinine, thus enabling her to undergo the full repair,” he said.

Similarly, Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University in Nashville, Tenn., described a patient who was preparing to undergo liver transplant and was found to have severe prolapse during a pelvic exam prior to surgery. Vaginal cerclage was used as a rescue procedure so that she could undergo the transplant surgery. The prolapse was reduced, the cerclage was placed, and the transplant was successful, he said.

Vaginal cerclage is a simple and “clever” procedure that can be accomplished in about 5 minutes, is reimbursed as a colpocleisis, and vastly improves patient comfort, Dr. Kovac said.

“It has great advantages, and we're doing it routinely today on select patients who come in with recurrent prolapse after multiple attempts at correctional surgery – with excellent results.”

The availability of such a technique is important because, typically, the repair used for a failed colpocleisis is a repeat colpocleisis.

Also, an increase in patients who seek treatment is anticipated, given that U.S. Census data indicate that the number of adults older than age 65 is expected to reach 90 million by 2050, and that 30%-50% of women experience prolapse in their lifetime, 11% undergo surgery for prolapse, and a third of prolapse and incontinence surgeries are for recurrent prolapse.

Improved techniques are needed, particularly in light of the high rate of repeat repairs, Dr. Kovac said.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon Endo-Surgery Inc. Dr. Zimmerman is a speaker/proctor for Cook Medical, proctor for Boston Scientific Corp. and Covidien, and receives Royalties from Lumitex Inc. and Marina Medical Instruments Inc.

ST. LOUIS — Vaginal cerclage, a novel surgical procedure for pelvic organ prolapse, is proving effective as a treatment option for severe and refractory prolapse in select patients.

Also known as introital cerclage, the procedure involves permanent suturing of the introitus, and is often performed in conjunction with vaginectomy. This obliterative approach is suitable only in those who are certain they no longer desire coital function, but on its own, vaginal cerclage also can serve as a bridge to nonobliterative repair, Dr. S. Robert Kovac and Dr. Carl W. Zimmerman said at the conference, which was sponsored by the Society of Pelvic Reconstructive Surgeons.

Dr. Kovac, the John D. Thompson Distinguished Professor of Gynecologic Surgery and director of the Emory Center for Reconstructive Pelvic Surgery at Emory University, Atlanta, used a video demonstration to show the surgical technique in an 82-year-old woman who had undergone two prior procedures for the treatment of prolapse, including a total abdominal hysterectomy followed by transvaginal repair with graft augmentation.

She presented with recurrent prolapse and complaints of vaginal bulge and discomfort, difficulty with voiding, and recurrent urinary tract infections.

A decision was made to perform vaginectomy augmented by the placement of a simple introital cerclage.

Dr. Kovac adequately infiltrated the introitus with 0.5% Marcaine with epinephrine, then used nonabsorbable braided sterile polyester suture beginning at the 12 o'clock position. The suture was placed away from the mid-urethra and closer to the bladder neck to decrease the risk of de novo stress urinary incontinence.

Suture placement continued in a circumferential manner toward the 6 o'clock position in several steps, ending at the 7 o'clock position to minimize discomfort. The suture ends were cut and tied down to obliterate the vagina and reduce the prolapse, and the ends were buried under the skin to decrease discomfort.

The same approach was used in a 77-year-old patient who had undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy, as well as multiple prior prolapse repairs, including transvaginal repair with graft augmentation, a pubic bone sling, and transvaginal enterocele repair with graft augmentation and repeat enterocele repair with colpocleisis.

The patient presented with vaginal bulge, pressure, discharge, defecation dysfunction, and abdominal pain; she was diagnosed with stage IV vaginal vault prolapse. As in the first patient, vaginectomy was performed and augmented by vaginal cerclage. The patient's vagina was obliterated, and her prolapse reduced with no change in urethral angle.

Both patients were doing well at 8 months' follow-up, Dr. Kovac said.

Dr. Kovac, who argued that vaginal cerclage is superior to the “very outdated” LeFort colpocleisis procedure that's used in patients with severe prolapse who still have their uterus, noted that the new technique also can be used as an intermediate procedure in certain patients awaiting nonobliterative prolapse repair.

For example, he described a patient with a significant prolapse who was unable to undergo surgery because of elevated creatinine. Vaginal cerclage allowed for temporary relief over the 8-9 days required for her creatinine levels to normalize.

“This approach provided improved comfort and quality of life, and reduced her hydronephrosis, which was causing the elevated creatinine, thus enabling her to undergo the full repair,” he said.

Similarly, Dr. Zimmerman, professor of obstetrics and gynecology at Vanderbilt University in Nashville, Tenn., described a patient who was preparing to undergo liver transplant and was found to have severe prolapse during a pelvic exam prior to surgery. Vaginal cerclage was used as a rescue procedure so that she could undergo the transplant surgery. The prolapse was reduced, the cerclage was placed, and the transplant was successful, he said.

Vaginal cerclage is a simple and “clever” procedure that can be accomplished in about 5 minutes, is reimbursed as a colpocleisis, and vastly improves patient comfort, Dr. Kovac said.

“It has great advantages, and we're doing it routinely today on select patients who come in with recurrent prolapse after multiple attempts at correctional surgery – with excellent results.”

The availability of such a technique is important because, typically, the repair used for a failed colpocleisis is a repeat colpocleisis.

Also, an increase in patients who seek treatment is anticipated, given that U.S. Census data indicate that the number of adults older than age 65 is expected to reach 90 million by 2050, and that 30%-50% of women experience prolapse in their lifetime, 11% undergo surgery for prolapse, and a third of prolapse and incontinence surgeries are for recurrent prolapse.

Improved techniques are needed, particularly in light of the high rate of repeat repairs, Dr. Kovac said.

Disclosures: Dr. Kovac disclosed that he is a consultant for Cook Medical Inc. and Ethicon Endo-Surgery Inc. Dr. Zimmerman is a speaker/proctor for Cook Medical, proctor for Boston Scientific Corp. and Covidien, and receives Royalties from Lumitex Inc. and Marina Medical Instruments Inc.

Major Finding: The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population. The estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population. The absolute incidence of varicella-related hospitalizations remains low, at about 3 cases per 10,000 person-years of exposure.

Data Source: A secondary analysis of data from two large databases.

Disclosures: Various authors on the study reported serving on the advisory board for and/or receiving lecture fees or honoraria from Wyeth, Abbott, Schering-Plough, Roche, and/or Bristol-Myers Squibb.

Rheumatic disease patients who are exposed to tumor necrosis factor antagonists have a 10-fold increased risk of hospitalization for varicella zoster virus infections, compared with the general population, according to a secondary analysis of two large databases.

Nonetheless, the absolute incidence of varicella-related hospitalizations remains low at about three cases per 10,000 person-years of exposure, and the risks of using vaccination for prevention likely outweigh the benefits, Dr. Ignacio Garcia-Doval of Complexo Hospitalario de Pontevedra (Spain) and colleagues reported.

The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population, and the estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population.

This finding is based on analysis of data from a national registry of rheumatic disease patients who were treated with TNF agents (BIOBADASER database) and from a database of all hospital admissions in public centers in Spain (Conjunto Minimo Basico de Datos al Alta Hospitalaria, or CMBD), which together represent more than 114 million patient-years.

The estimated age- and sex-standardized incidence rate per 100,000 person-years, and the estimated standardized incidence difference were 9 and 26, respectively, for shingles, and 19 and 33, respectively, for chickenpox, they said (Ann. Rheum. Dis. 2010;69:1751-5).

TNF antagonists are associated with an increased risk of tuberculosis in particular and of opportunistic infections in general. There is a biological basis for an increased risk of viral infections, the investigators said, noting that although some studies have shown an increased rate of viral infection in TNF antagonist–treated patients, the clinical relevance of the increase is uncertain. The current study does not allow differentiation of the causes for the increased risk, but it does show that the absolute rate is low.

The researchers said it is unlikely that the cohorts received systematic vaccination against varicella zoster virus because the general health mandate in Spain was given in 2005 and only for children aged 11-14 years. “Standard guidelines for chickenpox vaccination probably apply to the population included in our study,” they wrote.

However, shingles vaccine (an attenuated vaccine with a higher dose of antigen) could potentially lead to more side effects in an immunosuppressed population, they said.

For example, in a randomized trial of adults older than age 60 years, shingles vaccine was associated with 7 cases of severe adverse events and 14 cases of vaccine-related adverse events per 10,000 vaccinations, they noted.

“These vaccination-associated risks are similar in rate and severity to the risks of hospitalized infections in our study. Hence, shingles vaccination before starting a TNF antagonist may not be warranted at present,” they wrote.

The investigators concluded that although vaccination in healthy children is warranted, it is not warranted in adults with “immunosuppression secondary to the baseline inflammatory disease and its complications.”

View on The News

Vaccinate Prior to Anti-TNF Therapy

The rationale for zoster vaccination goes beyond the goal of simply preventing hospitalized herpes zoster. Vaccination in RA patients who are at least 60 years of age should be the standard of care before initiation of anti-TNF or other long-term immunosuppressive therapy.

Prospective data on the efficacy of herpes zoster vaccination, particularly in patients with RA, are lacking. But there is strong evidence for the protective effects of vaccination in adults aged 60 years and older.

Given that patients with rheumatoid arthritis are at increased risk for herpes zoster and that vaccination with live viruses is contraindicated while biological therapies are used, it would make sense to target this group for vaccination before anti-TNF therapy is initiated.

The purpose of vaccination is not only to lower the risk of rare, serious manifestations of herpes zoster, but also to lower the risk of uncomplicated herpes zoster, which causes considerable morbidity.

Future studies should look at the potential benefits of vaccinating those younger than age 60 and those receiving other types of immunosuppressive therapy.

DR. FURST

The opinions above are excerpted from an editorial accompanying the research report (Ann. Rheum. Dis. 2010;69:1735-7). KEVIN L. WINTHROP, M.D., is in the department of infectious diseases at the Oregon Health and Science University, Portland. DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Winthrop reported receiving funding from the Agency for Healthcare Research and Quality for work on the manuscript, and receiving a grant from UCB Pharmaceuticals, as well as consulting fees from Amgen, Wyeth, and Genentech. Dr. Furst reported receiving research support for studies of abatacept, adalimumab, certolizumab, etanercept, infliximab, rituximab, and tocilizumab, and consulting with Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and UCB.

Major Finding: The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population. The estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population. The absolute incidence of varicella-related hospitalizations remains low, at about 3 cases per 10,000 person-years of exposure.

Data Source: A secondary analysis of data from two large databases.

Disclosures: Various authors on the study reported serving on the advisory board for and/or receiving lecture fees or honoraria from Wyeth, Abbott, Schering-Plough, Roche, and/or Bristol-Myers Squibb.

Rheumatic disease patients who are exposed to tumor necrosis factor antagonists have a 10-fold increased risk of hospitalization for varicella zoster virus infections, compared with the general population, according to a secondary analysis of two large databases.

Nonetheless, the absolute incidence of varicella-related hospitalizations remains low at about three cases per 10,000 person-years of exposure, and the risks of using vaccination for prevention likely outweigh the benefits, Dr. Ignacio Garcia-Doval of Complexo Hospitalario de Pontevedra (Spain) and colleagues reported.

The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population, and the estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population.

This finding is based on analysis of data from a national registry of rheumatic disease patients who were treated with TNF agents (BIOBADASER database) and from a database of all hospital admissions in public centers in Spain (Conjunto Minimo Basico de Datos al Alta Hospitalaria, or CMBD), which together represent more than 114 million patient-years.

The estimated age- and sex-standardized incidence rate per 100,000 person-years, and the estimated standardized incidence difference were 9 and 26, respectively, for shingles, and 19 and 33, respectively, for chickenpox, they said (Ann. Rheum. Dis. 2010;69:1751-5).

TNF antagonists are associated with an increased risk of tuberculosis in particular and of opportunistic infections in general. There is a biological basis for an increased risk of viral infections, the investigators said, noting that although some studies have shown an increased rate of viral infection in TNF antagonist–treated patients, the clinical relevance of the increase is uncertain. The current study does not allow differentiation of the causes for the increased risk, but it does show that the absolute rate is low.

The researchers said it is unlikely that the cohorts received systematic vaccination against varicella zoster virus because the general health mandate in Spain was given in 2005 and only for children aged 11-14 years. “Standard guidelines for chickenpox vaccination probably apply to the population included in our study,” they wrote.

However, shingles vaccine (an attenuated vaccine with a higher dose of antigen) could potentially lead to more side effects in an immunosuppressed population, they said.

For example, in a randomized trial of adults older than age 60 years, shingles vaccine was associated with 7 cases of severe adverse events and 14 cases of vaccine-related adverse events per 10,000 vaccinations, they noted.

“These vaccination-associated risks are similar in rate and severity to the risks of hospitalized infections in our study. Hence, shingles vaccination before starting a TNF antagonist may not be warranted at present,” they wrote.

The investigators concluded that although vaccination in healthy children is warranted, it is not warranted in adults with “immunosuppression secondary to the baseline inflammatory disease and its complications.”

View on The News

Vaccinate Prior to Anti-TNF Therapy

The rationale for zoster vaccination goes beyond the goal of simply preventing hospitalized herpes zoster. Vaccination in RA patients who are at least 60 years of age should be the standard of care before initiation of anti-TNF or other long-term immunosuppressive therapy.

Prospective data on the efficacy of herpes zoster vaccination, particularly in patients with RA, are lacking. But there is strong evidence for the protective effects of vaccination in adults aged 60 years and older.

Given that patients with rheumatoid arthritis are at increased risk for herpes zoster and that vaccination with live viruses is contraindicated while biological therapies are used, it would make sense to target this group for vaccination before anti-TNF therapy is initiated.

The purpose of vaccination is not only to lower the risk of rare, serious manifestations of herpes zoster, but also to lower the risk of uncomplicated herpes zoster, which causes considerable morbidity.

Future studies should look at the potential benefits of vaccinating those younger than age 60 and those receiving other types of immunosuppressive therapy.

DR. FURST

The opinions above are excerpted from an editorial accompanying the research report (Ann. Rheum. Dis. 2010;69:1735-7). KEVIN L. WINTHROP, M.D., is in the department of infectious diseases at the Oregon Health and Science University, Portland. DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Winthrop reported receiving funding from the Agency for Healthcare Research and Quality for work on the manuscript, and receiving a grant from UCB Pharmaceuticals, as well as consulting fees from Amgen, Wyeth, and Genentech. Dr. Furst reported receiving research support for studies of abatacept, adalimumab, certolizumab, etanercept, infliximab, rituximab, and tocilizumab, and consulting with Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and UCB.

Major Finding: The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population. The estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population. The absolute incidence of varicella-related hospitalizations remains low, at about 3 cases per 10,000 person-years of exposure.

Data Source: A secondary analysis of data from two large databases.

Disclosures: Various authors on the study reported serving on the advisory board for and/or receiving lecture fees or honoraria from Wyeth, Abbott, Schering-Plough, Roche, and/or Bristol-Myers Squibb.

Rheumatic disease patients who are exposed to tumor necrosis factor antagonists have a 10-fold increased risk of hospitalization for varicella zoster virus infections, compared with the general population, according to a secondary analysis of two large databases.

Nonetheless, the absolute incidence of varicella-related hospitalizations remains low at about three cases per 10,000 person-years of exposure, and the risks of using vaccination for prevention likely outweigh the benefits, Dr. Ignacio Garcia-Doval of Complexo Hospitalario de Pontevedra (Spain) and colleagues reported.

The estimated incidence rate of hospitalization for shingles in the rheumatic population was 32 cases per 100,000 patient-years, compared with an expected rate of 3.4 in the general population, and the estimated incidence of hospitalization for chickenpox in the rheumatic patients was 26 per 100,000, compared with 1.9 in the general population.

This finding is based on analysis of data from a national registry of rheumatic disease patients who were treated with TNF agents (BIOBADASER database) and from a database of all hospital admissions in public centers in Spain (Conjunto Minimo Basico de Datos al Alta Hospitalaria, or CMBD), which together represent more than 114 million patient-years.

The estimated age- and sex-standardized incidence rate per 100,000 person-years, and the estimated standardized incidence difference were 9 and 26, respectively, for shingles, and 19 and 33, respectively, for chickenpox, they said (Ann. Rheum. Dis. 2010;69:1751-5).

TNF antagonists are associated with an increased risk of tuberculosis in particular and of opportunistic infections in general. There is a biological basis for an increased risk of viral infections, the investigators said, noting that although some studies have shown an increased rate of viral infection in TNF antagonist–treated patients, the clinical relevance of the increase is uncertain. The current study does not allow differentiation of the causes for the increased risk, but it does show that the absolute rate is low.

The researchers said it is unlikely that the cohorts received systematic vaccination against varicella zoster virus because the general health mandate in Spain was given in 2005 and only for children aged 11-14 years. “Standard guidelines for chickenpox vaccination probably apply to the population included in our study,” they wrote.

However, shingles vaccine (an attenuated vaccine with a higher dose of antigen) could potentially lead to more side effects in an immunosuppressed population, they said.

For example, in a randomized trial of adults older than age 60 years, shingles vaccine was associated with 7 cases of severe adverse events and 14 cases of vaccine-related adverse events per 10,000 vaccinations, they noted.

“These vaccination-associated risks are similar in rate and severity to the risks of hospitalized infections in our study. Hence, shingles vaccination before starting a TNF antagonist may not be warranted at present,” they wrote.

The investigators concluded that although vaccination in healthy children is warranted, it is not warranted in adults with “immunosuppression secondary to the baseline inflammatory disease and its complications.”

View on The News

Vaccinate Prior to Anti-TNF Therapy

The rationale for zoster vaccination goes beyond the goal of simply preventing hospitalized herpes zoster. Vaccination in RA patients who are at least 60 years of age should be the standard of care before initiation of anti-TNF or other long-term immunosuppressive therapy.

Prospective data on the efficacy of herpes zoster vaccination, particularly in patients with RA, are lacking. But there is strong evidence for the protective effects of vaccination in adults aged 60 years and older.

Given that patients with rheumatoid arthritis are at increased risk for herpes zoster and that vaccination with live viruses is contraindicated while biological therapies are used, it would make sense to target this group for vaccination before anti-TNF therapy is initiated.

The purpose of vaccination is not only to lower the risk of rare, serious manifestations of herpes zoster, but also to lower the risk of uncomplicated herpes zoster, which causes considerable morbidity.

Future studies should look at the potential benefits of vaccinating those younger than age 60 and those receiving other types of immunosuppressive therapy.

DR. FURST

The opinions above are excerpted from an editorial accompanying the research report (Ann. Rheum. Dis. 2010;69:1735-7). KEVIN L. WINTHROP, M.D., is in the department of infectious diseases at the Oregon Health and Science University, Portland. DANIEL E. FURST, M.D., is Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles. Dr. Winthrop reported receiving funding from the Agency for Healthcare Research and Quality for work on the manuscript, and receiving a grant from UCB Pharmaceuticals, as well as consulting fees from Amgen, Wyeth, and Genentech. Dr. Furst reported receiving research support for studies of abatacept, adalimumab, certolizumab, etanercept, infliximab, rituximab, and tocilizumab, and consulting with Abbott, Amgen, Bristol-Myers Squibb, Centocor, Genentech, and UCB.

Carotid stenting may be a safe alternative to endarterectomy in patients under age 70 years with symptomatic carotid stenosis, but stenting should be avoided in those aged 70 years or older, according to findings from a meta-analysis of data from three randomized controlled trials.

While current recommendations restrict the use of stenting to symptomatic patients with contraindications to endarterectomy, carotid stenosis at surgically inaccessible sites, recurrent stenosis after previous endarterectomy, and stenosis after irradiation, this meta-analysis suggests stenting is also a viable alternative in younger patients in whom surgery could otherwise be undertaken without increased risk, said Dr. Leo H. Bonati of University Hospital Basel, Switzerland, and the Institute of Neurology at University College, London, and his colleagues from the Carotid Stenting Trialists' Collaboration.

They advised, however, that some uncertainty remains about whether recurrent stenosis rates are high after stenting vs. endarterectomy and recommended an approach of offering stenting when “technically feasible as an alternative option to endarterectomy to patients younger than 65-70 years with symptomatic carotid stenosis, in centers in which acceptable periprocedural outcomes have been independently verified … as long as patient are made aware of a possible increase in the risk of restenosis.”

Among the 3,433 patients in the trials, the overall incidence of any stroke or death in the 120 days following randomization in the three trials was significantly greater in those who underwent carotid stenting vs. carotid endarterectomy (8.9% vs. 5.8%, respectively; risk ratio 1.53).

However, further analysis showed that age modified the treatment effect; no difference was seen in the estimated 120-day risk of stroke or death in those under age 70 years who underwent stenting vs. endarterectomy (5.8% and 5.7%, respectively; risk ratio 1.00), but the risk of stroke or death was doubled in those aged 70 years or older who had stenting vs. endarterectomy (12.0% vs. 5.9%; risk ratio 2.04).

Similarly, the relative risk estimates for stroke or death at 30 days after treatment were comparable in those under age 70 years who underwent stenting vs. endarterectomy (5.1% and 4.5%, respectively; risk ratio 1.11), but were more than double in those aged 70 years or older for stenting vs. endarterectomy (10.5% and 4.4%, respectively; risk ratio 2.41).

For their meta-analysis, which was funded by the Stroke Association, the researchers analyzed pooled data from the Endarterectomy vs. Angioplasty in Patients With Symptomatic Severe Carotid Stenosis trial (EVA-3S), the Stent-Protected Angioplasty vs. Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS).

These and other trials have suggested there is a higher periprocedural risk of stroke with stenting vs. endarterectomy, but none of the trials were sufficiently powered to show whether stenting might be a safe alternative in specific subgroups of patients, the investigators noted (Lancet 2010 [doi:10.1016/S0140-6736(10)61009-4

Disclosures: The authors stated that they have no conflicts of interest.

Vitals

Source Elsevier Global Medical News

Carotid stenting may be a safe alternative to endarterectomy in patients under age 70 years with symptomatic carotid stenosis, but stenting should be avoided in those aged 70 years or older, according to findings from a meta-analysis of data from three randomized controlled trials.

While current recommendations restrict the use of stenting to symptomatic patients with contraindications to endarterectomy, carotid stenosis at surgically inaccessible sites, recurrent stenosis after previous endarterectomy, and stenosis after irradiation, this meta-analysis suggests stenting is also a viable alternative in younger patients in whom surgery could otherwise be undertaken without increased risk, said Dr. Leo H. Bonati of University Hospital Basel, Switzerland, and the Institute of Neurology at University College, London, and his colleagues from the Carotid Stenting Trialists' Collaboration.

They advised, however, that some uncertainty remains about whether recurrent stenosis rates are high after stenting vs. endarterectomy and recommended an approach of offering stenting when “technically feasible as an alternative option to endarterectomy to patients younger than 65-70 years with symptomatic carotid stenosis, in centers in which acceptable periprocedural outcomes have been independently verified … as long as patient are made aware of a possible increase in the risk of restenosis.”

Among the 3,433 patients in the trials, the overall incidence of any stroke or death in the 120 days following randomization in the three trials was significantly greater in those who underwent carotid stenting vs. carotid endarterectomy (8.9% vs. 5.8%, respectively; risk ratio 1.53).

However, further analysis showed that age modified the treatment effect; no difference was seen in the estimated 120-day risk of stroke or death in those under age 70 years who underwent stenting vs. endarterectomy (5.8% and 5.7%, respectively; risk ratio 1.00), but the risk of stroke or death was doubled in those aged 70 years or older who had stenting vs. endarterectomy (12.0% vs. 5.9%; risk ratio 2.04).

Similarly, the relative risk estimates for stroke or death at 30 days after treatment were comparable in those under age 70 years who underwent stenting vs. endarterectomy (5.1% and 4.5%, respectively; risk ratio 1.11), but were more than double in those aged 70 years or older for stenting vs. endarterectomy (10.5% and 4.4%, respectively; risk ratio 2.41).

For their meta-analysis, which was funded by the Stroke Association, the researchers analyzed pooled data from the Endarterectomy vs. Angioplasty in Patients With Symptomatic Severe Carotid Stenosis trial (EVA-3S), the Stent-Protected Angioplasty vs. Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS).

These and other trials have suggested there is a higher periprocedural risk of stroke with stenting vs. endarterectomy, but none of the trials were sufficiently powered to show whether stenting might be a safe alternative in specific subgroups of patients, the investigators noted (Lancet 2010 [doi:10.1016/S0140-6736(10)61009-4

Disclosures: The authors stated that they have no conflicts of interest.

Vitals

Source Elsevier Global Medical News

Carotid stenting may be a safe alternative to endarterectomy in patients under age 70 years with symptomatic carotid stenosis, but stenting should be avoided in those aged 70 years or older, according to findings from a meta-analysis of data from three randomized controlled trials.

While current recommendations restrict the use of stenting to symptomatic patients with contraindications to endarterectomy, carotid stenosis at surgically inaccessible sites, recurrent stenosis after previous endarterectomy, and stenosis after irradiation, this meta-analysis suggests stenting is also a viable alternative in younger patients in whom surgery could otherwise be undertaken without increased risk, said Dr. Leo H. Bonati of University Hospital Basel, Switzerland, and the Institute of Neurology at University College, London, and his colleagues from the Carotid Stenting Trialists' Collaboration.

They advised, however, that some uncertainty remains about whether recurrent stenosis rates are high after stenting vs. endarterectomy and recommended an approach of offering stenting when “technically feasible as an alternative option to endarterectomy to patients younger than 65-70 years with symptomatic carotid stenosis, in centers in which acceptable periprocedural outcomes have been independently verified … as long as patient are made aware of a possible increase in the risk of restenosis.”

Among the 3,433 patients in the trials, the overall incidence of any stroke or death in the 120 days following randomization in the three trials was significantly greater in those who underwent carotid stenting vs. carotid endarterectomy (8.9% vs. 5.8%, respectively; risk ratio 1.53).

However, further analysis showed that age modified the treatment effect; no difference was seen in the estimated 120-day risk of stroke or death in those under age 70 years who underwent stenting vs. endarterectomy (5.8% and 5.7%, respectively; risk ratio 1.00), but the risk of stroke or death was doubled in those aged 70 years or older who had stenting vs. endarterectomy (12.0% vs. 5.9%; risk ratio 2.04).

Similarly, the relative risk estimates for stroke or death at 30 days after treatment were comparable in those under age 70 years who underwent stenting vs. endarterectomy (5.1% and 4.5%, respectively; risk ratio 1.11), but were more than double in those aged 70 years or older for stenting vs. endarterectomy (10.5% and 4.4%, respectively; risk ratio 2.41).

For their meta-analysis, which was funded by the Stroke Association, the researchers analyzed pooled data from the Endarterectomy vs. Angioplasty in Patients With Symptomatic Severe Carotid Stenosis trial (EVA-3S), the Stent-Protected Angioplasty vs. Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS).

These and other trials have suggested there is a higher periprocedural risk of stroke with stenting vs. endarterectomy, but none of the trials were sufficiently powered to show whether stenting might be a safe alternative in specific subgroups of patients, the investigators noted (Lancet 2010 [doi:10.1016/S0140-6736(10)61009-4

Disclosures: The authors stated that they have no conflicts of interest.

Vitals

Source Elsevier Global Medical News

Daily B vitamin supplementation is no more effective than is placebo for reducing the incidence of major vascular events in patients who have had a recent stroke or transient ischemic attack, according to findings from the Vitamins to Prevent Stroke (VITATOPS) trial.

Among 8,164 patients enrolled in the multicenter, parallel, double-blind trial, major vascular events (nonfatal stroke, nonfatal myocardial infarction, or death from any vascular cause) occurred in 15% of patients randomized to B vitamin supplementation and in 17% randomized to placebo after a median follow-up period of 3.4 years. This translated into a nonsignificant relative risk of 0.91, Dr. Graeme J. Hankey of Royal Perth (Australia) Hospital and his colleagues from the VITATOPS Trial Study Group reported.

When each type of vascular event was analyzed separately, B vitamin supplementation was not associated with a significant reduction in the relative risk for nonfatal or fatal stroke, nonfatal or fatal MI, or death from any cause. However, there was a slight, but statistically significant, reduction in the risk of death from vascular causes (relative risk, 0.86).

Dr. Hankey and his associates wrote that the findings suggest that B vitamins, while safe in poststroke and post-TIA patients, should not be recommended to prevent recurrent stroke (Lancet Neurology 2010 Aug. 4 [doi:10.1016/S1474-4422(10)70187-3

Study participants were enrolled between November 1998 and December 2008, within 7 months of experiencing stroke or TIA and were randomized to receive placebo or 2 mg of folic acid, 25 mg of vitamin B₆, and 0.5 mg of vitamin B₁₂ daily in addition to usual medical care.

No unexpected adverse events occurred during follow-up, and no significant differences were seen between the treatment and placebo groups in regard to common adverse events, the investigators noted.

Although prior cross-sectional and observational epidemiological studies have suggested that raised plasma concentrations of total homocysteine are associated with increased risk for major vascular events, and that B vitamin supplementation can lower total homocysteine – as it did in the current study – this did not translate to a reduced incidence of subsequent vascular events in the study, they said.

Fasting blood tests performed at the end of follow-up in 1,164 patients showed that the B vitamin group had 3.8 micromol/L lower homocysteine than the placebo group (10.5 vs. 14.3 micromol/L). An analysis of a subset of 925 patients with fasting blood levels of homocysteine available from baseline and follow-up indicated that each 1.0-micromol/L decrease in total homocysteine was associated with only a nonstatistically significant 2% reduction in risk of the primary outcome.

The study is limited by incomplete adherence to trial drugs and by incomplete follow-up, as well as by a relatively short duration of follow-up, which “might not have been long enough to adequately identify or exclude any long-term effects of B vitamins,” the investigators noted.

To control for random error, the researchers added their data to those from other randomized controlled trials of homocysteine-lowering therapy in patients with or without preexisting cardiovascular disease. This “updated meta-analysis” also showed that B vitamins are not significantly more effective than placebo for reducing the risk of the composite outcome of stroke, myocardial infarction, or vascular death (RR, 0.99).

Disclosures: The study was funded by the Australia National Health and Medical Research Council, the U.K. Medical Research Council, the Singapore Biomedical Research Council, the Singapore National Medical Research Council, the Australia National Heart Foundation, the Royal Perth Hospital Medical Research Foundation, and the Health Department of Western Australia. Dr. Hankey and some other authors of the study reported receiving payments and honoraria for various duties for companies that manufacture stroke therapies, including Johnson and Johnson, Sanofi-Aventis, Schering Plough, Boehringer Ingelheim, and Pfizer.

Daily B vitamin supplementation is no more effective than is placebo for reducing the incidence of major vascular events in patients who have had a recent stroke or transient ischemic attack, according to findings from the Vitamins to Prevent Stroke (VITATOPS) trial.

Among 8,164 patients enrolled in the multicenter, parallel, double-blind trial, major vascular events (nonfatal stroke, nonfatal myocardial infarction, or death from any vascular cause) occurred in 15% of patients randomized to B vitamin supplementation and in 17% randomized to placebo after a median follow-up period of 3.4 years. This translated into a nonsignificant relative risk of 0.91, Dr. Graeme J. Hankey of Royal Perth (Australia) Hospital and his colleagues from the VITATOPS Trial Study Group reported.

When each type of vascular event was analyzed separately, B vitamin supplementation was not associated with a significant reduction in the relative risk for nonfatal or fatal stroke, nonfatal or fatal MI, or death from any cause. However, there was a slight, but statistically significant, reduction in the risk of death from vascular causes (relative risk, 0.86).

Dr. Hankey and his associates wrote that the findings suggest that B vitamins, while safe in poststroke and post-TIA patients, should not be recommended to prevent recurrent stroke (Lancet Neurology 2010 Aug. 4 [doi:10.1016/S1474-4422(10)70187-3

Study participants were enrolled between November 1998 and December 2008, within 7 months of experiencing stroke or TIA and were randomized to receive placebo or 2 mg of folic acid, 25 mg of vitamin B₆, and 0.5 mg of vitamin B₁₂ daily in addition to usual medical care.

No unexpected adverse events occurred during follow-up, and no significant differences were seen between the treatment and placebo groups in regard to common adverse events, the investigators noted.

Although prior cross-sectional and observational epidemiological studies have suggested that raised plasma concentrations of total homocysteine are associated with increased risk for major vascular events, and that B vitamin supplementation can lower total homocysteine – as it did in the current study – this did not translate to a reduced incidence of subsequent vascular events in the study, they said.

Fasting blood tests performed at the end of follow-up in 1,164 patients showed that the B vitamin group had 3.8 micromol/L lower homocysteine than the placebo group (10.5 vs. 14.3 micromol/L). An analysis of a subset of 925 patients with fasting blood levels of homocysteine available from baseline and follow-up indicated that each 1.0-micromol/L decrease in total homocysteine was associated with only a nonstatistically significant 2% reduction in risk of the primary outcome.

The study is limited by incomplete adherence to trial drugs and by incomplete follow-up, as well as by a relatively short duration of follow-up, which “might not have been long enough to adequately identify or exclude any long-term effects of B vitamins,” the investigators noted.

To control for random error, the researchers added their data to those from other randomized controlled trials of homocysteine-lowering therapy in patients with or without preexisting cardiovascular disease. This “updated meta-analysis” also showed that B vitamins are not significantly more effective than placebo for reducing the risk of the composite outcome of stroke, myocardial infarction, or vascular death (RR, 0.99).

Disclosures: The study was funded by the Australia National Health and Medical Research Council, the U.K. Medical Research Council, the Singapore Biomedical Research Council, the Singapore National Medical Research Council, the Australia National Heart Foundation, the Royal Perth Hospital Medical Research Foundation, and the Health Department of Western Australia. Dr. Hankey and some other authors of the study reported receiving payments and honoraria for various duties for companies that manufacture stroke therapies, including Johnson and Johnson, Sanofi-Aventis, Schering Plough, Boehringer Ingelheim, and Pfizer.

Daily B vitamin supplementation is no more effective than is placebo for reducing the incidence of major vascular events in patients who have had a recent stroke or transient ischemic attack, according to findings from the Vitamins to Prevent Stroke (VITATOPS) trial.

Among 8,164 patients enrolled in the multicenter, parallel, double-blind trial, major vascular events (nonfatal stroke, nonfatal myocardial infarction, or death from any vascular cause) occurred in 15% of patients randomized to B vitamin supplementation and in 17% randomized to placebo after a median follow-up period of 3.4 years. This translated into a nonsignificant relative risk of 0.91, Dr. Graeme J. Hankey of Royal Perth (Australia) Hospital and his colleagues from the VITATOPS Trial Study Group reported.

When each type of vascular event was analyzed separately, B vitamin supplementation was not associated with a significant reduction in the relative risk for nonfatal or fatal stroke, nonfatal or fatal MI, or death from any cause. However, there was a slight, but statistically significant, reduction in the risk of death from vascular causes (relative risk, 0.86).

Dr. Hankey and his associates wrote that the findings suggest that B vitamins, while safe in poststroke and post-TIA patients, should not be recommended to prevent recurrent stroke (Lancet Neurology 2010 Aug. 4 [doi:10.1016/S1474-4422(10)70187-3

Study participants were enrolled between November 1998 and December 2008, within 7 months of experiencing stroke or TIA and were randomized to receive placebo or 2 mg of folic acid, 25 mg of vitamin B₆, and 0.5 mg of vitamin B₁₂ daily in addition to usual medical care.

No unexpected adverse events occurred during follow-up, and no significant differences were seen between the treatment and placebo groups in regard to common adverse events, the investigators noted.

Although prior cross-sectional and observational epidemiological studies have suggested that raised plasma concentrations of total homocysteine are associated with increased risk for major vascular events, and that B vitamin supplementation can lower total homocysteine – as it did in the current study – this did not translate to a reduced incidence of subsequent vascular events in the study, they said.

Fasting blood tests performed at the end of follow-up in 1,164 patients showed that the B vitamin group had 3.8 micromol/L lower homocysteine than the placebo group (10.5 vs. 14.3 micromol/L). An analysis of a subset of 925 patients with fasting blood levels of homocysteine available from baseline and follow-up indicated that each 1.0-micromol/L decrease in total homocysteine was associated with only a nonstatistically significant 2% reduction in risk of the primary outcome.

The study is limited by incomplete adherence to trial drugs and by incomplete follow-up, as well as by a relatively short duration of follow-up, which “might not have been long enough to adequately identify or exclude any long-term effects of B vitamins,” the investigators noted.

To control for random error, the researchers added their data to those from other randomized controlled trials of homocysteine-lowering therapy in patients with or without preexisting cardiovascular disease. This “updated meta-analysis” also showed that B vitamins are not significantly more effective than placebo for reducing the risk of the composite outcome of stroke, myocardial infarction, or vascular death (RR, 0.99).

Disclosures: The study was funded by the Australia National Health and Medical Research Council, the U.K. Medical Research Council, the Singapore Biomedical Research Council, the Singapore National Medical Research Council, the Australia National Heart Foundation, the Royal Perth Hospital Medical Research Foundation, and the Health Department of Western Australia. Dr. Hankey and some other authors of the study reported receiving payments and honoraria for various duties for companies that manufacture stroke therapies, including Johnson and Johnson, Sanofi-Aventis, Schering Plough, Boehringer Ingelheim, and Pfizer.

Attention-deficit/hyperactivity disorder is a neurodevelopmental disorder, rather than a purely social construct, according to British researchers who have found that a type of genetic variation associated with brain disorders such as schizophrenia and autism also occurs in excess in ADHD patients.

The findings provide the first direct evidence of a genetic basis for ADHD, Dr. Nigel Williams of Cardiff University, Wales, and his colleagues reported.

The investigators performed a genome-wide analysis of large, rare chromosomal deletions and duplications known as copy number variants (CNVs) in 366 children with ADHD and 1,047 controls. The genome-wide burden of CNVs was significantly greater in the ADHD patients, compared with that in the controls – rates of 0.156 and 0.075, respectively, they found (Lancet 2010 Sept. 30 [doi:10.1016/S0140–6736(10)61109-9]).

The CNVs identified in this study are similar to those found in patients with schizophrenia and autism, and are significantly enriched for loci that have previously been implicated in those disorders – with particular overlap at a region on chromosome 16 that spans a number of genes, including one that affects brain development.

Furthermore, although the rate of CNVs was significantly higher in children with ADHD with and without intellectual disability, compared with the general population, the rate was particularly high in those with intellectual disability, defined as those with an IQ of less than 70 (rates of 0.424 and 0.075, respectively).

The findings are noteworthy because despite evidence that ADHD might be a genetic condition – for example, it has an estimated heritability of 76% – there has been a great deal of debate over whether it is a result of bad parenting or other external factors, coauthor Dr. Anita Thapar said during a press conference.

"ADHD can be stigmatizing … and finding this direct genetic link to ADHD should help clear this misunderstanding and address this issue of stigma," said Dr. Thapar, professor of child and adolescent psychiatry at Cardiff University.

In addition to providing a window into the biology of the brain, the findings will also influence the way in which ADHD is classified and will improve communication between scientists and clinicians about “what we mean by ADHD,” she said. "This will be the start of a much more scientific venture because our findings are going to help us unravel the biologic basis of ADHD, and that's going to be really important in turn in the further future to help us develop new and much more effective treatments for affected individuals."

The subjects were recruited from community clinics and had met diagnostic criteria for ADHD or hyperkinetic disorder. They were aged 5–17 years (mean, 10.5 years), were of white U.K. origin, and had a mean IQ of 86. Controls were unrelated, ethnically matched children from the 1958 British Birth Cohort.

The finding that more than a third of ADHD children with intellectual disability carried a large, rare CNV – and the fact that none of these children had been assessed for this type of mutation by clinical services – suggest that routine referral to clinical geneticists and screening for such mutations could be helpful for children with ADHD who also have intellectual disability, they said.

Attention-deficit/hyperactivity disorder is a neurodevelopmental disorder, rather than a purely social construct, according to British researchers who have found that a type of genetic variation associated with brain disorders such as schizophrenia and autism also occurs in excess in ADHD patients.

The findings provide the first direct evidence of a genetic basis for ADHD, Dr. Nigel Williams of Cardiff University, Wales, and his colleagues reported.

The investigators performed a genome-wide analysis of large, rare chromosomal deletions and duplications known as copy number variants (CNVs) in 366 children with ADHD and 1,047 controls. The genome-wide burden of CNVs was significantly greater in the ADHD patients, compared with that in the controls – rates of 0.156 and 0.075, respectively, they found (Lancet 2010 Sept. 30 [doi:10.1016/S0140–6736(10)61109-9]).

The CNVs identified in this study are similar to those found in patients with schizophrenia and autism, and are significantly enriched for loci that have previously been implicated in those disorders – with particular overlap at a region on chromosome 16 that spans a number of genes, including one that affects brain development.

Furthermore, although the rate of CNVs was significantly higher in children with ADHD with and without intellectual disability, compared with the general population, the rate was particularly high in those with intellectual disability, defined as those with an IQ of less than 70 (rates of 0.424 and 0.075, respectively).

The findings are noteworthy because despite evidence that ADHD might be a genetic condition – for example, it has an estimated heritability of 76% – there has been a great deal of debate over whether it is a result of bad parenting or other external factors, coauthor Dr. Anita Thapar said during a press conference.

"ADHD can be stigmatizing … and finding this direct genetic link to ADHD should help clear this misunderstanding and address this issue of stigma," said Dr. Thapar, professor of child and adolescent psychiatry at Cardiff University.

In addition to providing a window into the biology of the brain, the findings will also influence the way in which ADHD is classified and will improve communication between scientists and clinicians about “what we mean by ADHD,” she said. "This will be the start of a much more scientific venture because our findings are going to help us unravel the biologic basis of ADHD, and that's going to be really important in turn in the further future to help us develop new and much more effective treatments for affected individuals."

The subjects were recruited from community clinics and had met diagnostic criteria for ADHD or hyperkinetic disorder. They were aged 5–17 years (mean, 10.5 years), were of white U.K. origin, and had a mean IQ of 86. Controls were unrelated, ethnically matched children from the 1958 British Birth Cohort.

The finding that more than a third of ADHD children with intellectual disability carried a large, rare CNV – and the fact that none of these children had been assessed for this type of mutation by clinical services – suggest that routine referral to clinical geneticists and screening for such mutations could be helpful for children with ADHD who also have intellectual disability, they said.

Attention-deficit/hyperactivity disorder is a neurodevelopmental disorder, rather than a purely social construct, according to British researchers who have found that a type of genetic variation associated with brain disorders such as schizophrenia and autism also occurs in excess in ADHD patients.

The findings provide the first direct evidence of a genetic basis for ADHD, Dr. Nigel Williams of Cardiff University, Wales, and his colleagues reported.

The investigators performed a genome-wide analysis of large, rare chromosomal deletions and duplications known as copy number variants (CNVs) in 366 children with ADHD and 1,047 controls. The genome-wide burden of CNVs was significantly greater in the ADHD patients, compared with that in the controls – rates of 0.156 and 0.075, respectively, they found (Lancet 2010 Sept. 30 [doi:10.1016/S0140–6736(10)61109-9]).

The CNVs identified in this study are similar to those found in patients with schizophrenia and autism, and are significantly enriched for loci that have previously been implicated in those disorders – with particular overlap at a region on chromosome 16 that spans a number of genes, including one that affects brain development.

Furthermore, although the rate of CNVs was significantly higher in children with ADHD with and without intellectual disability, compared with the general population, the rate was particularly high in those with intellectual disability, defined as those with an IQ of less than 70 (rates of 0.424 and 0.075, respectively).

The findings are noteworthy because despite evidence that ADHD might be a genetic condition – for example, it has an estimated heritability of 76% – there has been a great deal of debate over whether it is a result of bad parenting or other external factors, coauthor Dr. Anita Thapar said during a press conference.

"ADHD can be stigmatizing … and finding this direct genetic link to ADHD should help clear this misunderstanding and address this issue of stigma," said Dr. Thapar, professor of child and adolescent psychiatry at Cardiff University.

In addition to providing a window into the biology of the brain, the findings will also influence the way in which ADHD is classified and will improve communication between scientists and clinicians about “what we mean by ADHD,” she said. "This will be the start of a much more scientific venture because our findings are going to help us unravel the biologic basis of ADHD, and that's going to be really important in turn in the further future to help us develop new and much more effective treatments for affected individuals."

The subjects were recruited from community clinics and had met diagnostic criteria for ADHD or hyperkinetic disorder. They were aged 5–17 years (mean, 10.5 years), were of white U.K. origin, and had a mean IQ of 86. Controls were unrelated, ethnically matched children from the 1958 British Birth Cohort.

The finding that more than a third of ADHD children with intellectual disability carried a large, rare CNV – and the fact that none of these children had been assessed for this type of mutation by clinical services – suggest that routine referral to clinical geneticists and screening for such mutations could be helpful for children with ADHD who also have intellectual disability, they said.

ATLANTA — Reports of febrile seizures in young children in Australia and New Zealand following vaccination with a 2010–2011 seasonal trivalent influenza vaccine have the Centers for Disease Control and Prevention watching closely for signs of trouble in the United States.

The CDC will collaborate closely with international scientists, partners, and regulatory authorities, and will collaborate on animal pyrogenicity studies using the vaccine in question, Dr. Michael McNeil reported at the meeting.

Furthermore, existing vaccine safety data systems currently in place for the 2009 H1N1 monovalent vaccine – which is included in the 2010–2011 seasonal vaccine, will be used to monitor for seizures and febrile seizures following vaccination with the seasonal vaccine. These systems, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), are capable of detecting signals for seizure risk early in the course of the vaccination season, said Dr. McNeil of the CDC's immunization safety office.

The reports of seizures in Australia earlier this year led the chief medical officer there to suspend use of the 2010–2011 seasonal trivalent influenza vaccine for all children younger than 5 years. Prior to that suspension, the recommendation for all of Australia was that seasonal vaccination be administered to children with chronic medical conditions who were aged 6 months to 18 years. In Western Australia, vaccination was recommended for all children aged 6 months to 5 years.

The predominant vaccine used in Australia was trivalent Fluvax Junior, manufactured by the Australia-based biopharmaceutical company CSL Ltd., which dominates the market there; CSL vaccine accounted for nearly all trivalent seasonal vaccine distributed there by late April. A preliminary investigation revealed a signal suggesting an increase in febrile seizures, mostly among children younger than 5 years in the 24 hours following vaccination, with an estimate of up to 9 cases per 1,000 vaccinated, compared with an estimate of fewer than 1 case per 1,000 vaccinated with the 2009 H1N1 monovalent vaccine alone, Dr. McNeil reported.

To date, no biologic, clinical, or epidemiologic factors have been identified to explain the increase in febrile seizures following vaccination, and no abnormalities have been detected in the vaccine, he said.

Although New Zealand has suspended use of the CSL vaccine following the four reports of febrile seizures after vaccination with that product there, other countries in the Southern hemisphere that have childhood vaccination programs, including Argentina, Chile, and South Africa, have not reported febrile seizures, and the World Health Organization has received no reports of febrile seizures associated with other 2010–2011 seasonal influenza vaccines, including Vaxigrip (Sanofi-Aventis) and Influvac (Solvay Pharmaceticals Inc.).

Dr. McNeil noted that CSL vaccines have been used for those aged 18 years and older in the United States since 2007, and that a CSL vaccine was licensed for children aged 6 months and older in November 2009, although very few doses of that trivalent seasonal vaccine were distributed in the 2009–2010 influenza season.

VAERS data showed no cases of febrile seizures following administration of CSL's seasonal vaccine for children aged 6 months and older, and only four cases following administration of the CSL 2009 H1N1 monovalent vaccine, all of which occurred in adults. No signal was detected by VAERS or VSD for seizure following any 2009–2010 seasonal influenza vaccines or H1N1 vaccines, he said.

ATLANTA — Reports of febrile seizures in young children in Australia and New Zealand following vaccination with a 2010–2011 seasonal trivalent influenza vaccine have the Centers for Disease Control and Prevention watching closely for signs of trouble in the United States.

The CDC will collaborate closely with international scientists, partners, and regulatory authorities, and will collaborate on animal pyrogenicity studies using the vaccine in question, Dr. Michael McNeil reported at the meeting.

Furthermore, existing vaccine safety data systems currently in place for the 2009 H1N1 monovalent vaccine – which is included in the 2010–2011 seasonal vaccine, will be used to monitor for seizures and febrile seizures following vaccination with the seasonal vaccine. These systems, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), are capable of detecting signals for seizure risk early in the course of the vaccination season, said Dr. McNeil of the CDC's immunization safety office.

The reports of seizures in Australia earlier this year led the chief medical officer there to suspend use of the 2010–2011 seasonal trivalent influenza vaccine for all children younger than 5 years. Prior to that suspension, the recommendation for all of Australia was that seasonal vaccination be administered to children with chronic medical conditions who were aged 6 months to 18 years. In Western Australia, vaccination was recommended for all children aged 6 months to 5 years.

The predominant vaccine used in Australia was trivalent Fluvax Junior, manufactured by the Australia-based biopharmaceutical company CSL Ltd., which dominates the market there; CSL vaccine accounted for nearly all trivalent seasonal vaccine distributed there by late April. A preliminary investigation revealed a signal suggesting an increase in febrile seizures, mostly among children younger than 5 years in the 24 hours following vaccination, with an estimate of up to 9 cases per 1,000 vaccinated, compared with an estimate of fewer than 1 case per 1,000 vaccinated with the 2009 H1N1 monovalent vaccine alone, Dr. McNeil reported.

To date, no biologic, clinical, or epidemiologic factors have been identified to explain the increase in febrile seizures following vaccination, and no abnormalities have been detected in the vaccine, he said.

Although New Zealand has suspended use of the CSL vaccine following the four reports of febrile seizures after vaccination with that product there, other countries in the Southern hemisphere that have childhood vaccination programs, including Argentina, Chile, and South Africa, have not reported febrile seizures, and the World Health Organization has received no reports of febrile seizures associated with other 2010–2011 seasonal influenza vaccines, including Vaxigrip (Sanofi-Aventis) and Influvac (Solvay Pharmaceticals Inc.).

Dr. McNeil noted that CSL vaccines have been used for those aged 18 years and older in the United States since 2007, and that a CSL vaccine was licensed for children aged 6 months and older in November 2009, although very few doses of that trivalent seasonal vaccine were distributed in the 2009–2010 influenza season.

VAERS data showed no cases of febrile seizures following administration of CSL's seasonal vaccine for children aged 6 months and older, and only four cases following administration of the CSL 2009 H1N1 monovalent vaccine, all of which occurred in adults. No signal was detected by VAERS or VSD for seizure following any 2009–2010 seasonal influenza vaccines or H1N1 vaccines, he said.

ATLANTA — Reports of febrile seizures in young children in Australia and New Zealand following vaccination with a 2010–2011 seasonal trivalent influenza vaccine have the Centers for Disease Control and Prevention watching closely for signs of trouble in the United States.

The CDC will collaborate closely with international scientists, partners, and regulatory authorities, and will collaborate on animal pyrogenicity studies using the vaccine in question, Dr. Michael McNeil reported at the meeting.

Furthermore, existing vaccine safety data systems currently in place for the 2009 H1N1 monovalent vaccine – which is included in the 2010–2011 seasonal vaccine, will be used to monitor for seizures and febrile seizures following vaccination with the seasonal vaccine. These systems, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), are capable of detecting signals for seizure risk early in the course of the vaccination season, said Dr. McNeil of the CDC's immunization safety office.

The reports of seizures in Australia earlier this year led the chief medical officer there to suspend use of the 2010–2011 seasonal trivalent influenza vaccine for all children younger than 5 years. Prior to that suspension, the recommendation for all of Australia was that seasonal vaccination be administered to children with chronic medical conditions who were aged 6 months to 18 years. In Western Australia, vaccination was recommended for all children aged 6 months to 5 years.

The predominant vaccine used in Australia was trivalent Fluvax Junior, manufactured by the Australia-based biopharmaceutical company CSL Ltd., which dominates the market there; CSL vaccine accounted for nearly all trivalent seasonal vaccine distributed there by late April. A preliminary investigation revealed a signal suggesting an increase in febrile seizures, mostly among children younger than 5 years in the 24 hours following vaccination, with an estimate of up to 9 cases per 1,000 vaccinated, compared with an estimate of fewer than 1 case per 1,000 vaccinated with the 2009 H1N1 monovalent vaccine alone, Dr. McNeil reported.

To date, no biologic, clinical, or epidemiologic factors have been identified to explain the increase in febrile seizures following vaccination, and no abnormalities have been detected in the vaccine, he said.

Although New Zealand has suspended use of the CSL vaccine following the four reports of febrile seizures after vaccination with that product there, other countries in the Southern hemisphere that have childhood vaccination programs, including Argentina, Chile, and South Africa, have not reported febrile seizures, and the World Health Organization has received no reports of febrile seizures associated with other 2010–2011 seasonal influenza vaccines, including Vaxigrip (Sanofi-Aventis) and Influvac (Solvay Pharmaceticals Inc.).

Dr. McNeil noted that CSL vaccines have been used for those aged 18 years and older in the United States since 2007, and that a CSL vaccine was licensed for children aged 6 months and older in November 2009, although very few doses of that trivalent seasonal vaccine were distributed in the 2009–2010 influenza season.

VAERS data showed no cases of febrile seizures following administration of CSL's seasonal vaccine for children aged 6 months and older, and only four cases following administration of the CSL 2009 H1N1 monovalent vaccine, all of which occurred in adults. No signal was detected by VAERS or VSD for seizure following any 2009–2010 seasonal influenza vaccines or H1N1 vaccines, he said.

Major Finding: Factors found to be significantly associated with developing a first basal cell carcinoma lesion were age (ORs of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair). Factors found to be associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (HR 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level).

Data Source: A large, prospective, population-based cohort study.

Disclosures: The investigators reported no financial disclosures.

The risk profiles for individuals who develop single vs. multiple basal cell carcinoma lesions differ, according to data from the Rotterdam Study.

Of the 10,820 eligible members of the two cohorts used for the large, Dutch, population-based study, 361 (3%) were diagnosed with a single initial basal cell carcinoma (BCC) lesion, and 163 (1.5%) were diagnosed with subsequent BCC lesions during the study period.

After adjusting for numerous factors such as sex, age, smoking history, and educational level, factors found to be significantly associated with developing a first BCC lesion were age (odds ratios of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair), reported Dr. Ville Kiiski and colleagues at Erasmus Medical Center, Rotterdam, the Netherlands.

Factors associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (hazard ratio 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level), the investigators found (Arch. Dermatol. 2010;146:848–55).

This last finding “may be explained by the probability that people with higher levels of education (which correlates strongly with socioeconomic status) have different lifestyles,” such as more frequent exposure to ultraviolet rays for intermittent periods, they said. Also, people of higher socioeconomic status generally may be expected to live longer and, thus have more time to acquire lesions.

Patients were adults aged 55 years or older from the two Rotterdam Study cohorts, including one studied in 1990, and one studied in 1999. Participants were followed for a mean of 9.5 years.

The findings — particularly regarding increased risk among younger patients and red-heads — largely support those of previous studies, although in the current study men were not shown to be at significantly increased risk of developing a first lesion, which contrasts with findings from some prior studies, the investigators noted.

The differences in risk factor profiles for those who develop single vs. multiple BCC lesions, as seen in the current study, may suggest that phenotypic characteristics of patients are less important for determining risk once “cumulative environmental-genetic interaction has surpassed a certain threshold and resulted in a lesion,” Dr. Kiiski and colleagues wrote.

“The clinical relevance of this finding is that physicians' risk assessment efforts should differentiate between patients at risk for a first lesion and those who have a history of BCC,” they said, noting that those with the identified risk factors for multiple lesions may require a more stringent follow-up regimen.

That's not to say, however, that other BCC patients do not require follow-up. “In this sample of the general population, more than 30% of the patients with BCC developed subsequent skin cancer, emphasizing the need for annual follow-up for several years,” Dr. Kiiski and colleagues stressed.

Major Finding: Factors found to be significantly associated with developing a first basal cell carcinoma lesion were age (ORs of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair). Factors found to be associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (HR 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level).

Data Source: A large, prospective, population-based cohort study.

Disclosures: The investigators reported no financial disclosures.

The risk profiles for individuals who develop single vs. multiple basal cell carcinoma lesions differ, according to data from the Rotterdam Study.

Of the 10,820 eligible members of the two cohorts used for the large, Dutch, population-based study, 361 (3%) were diagnosed with a single initial basal cell carcinoma (BCC) lesion, and 163 (1.5%) were diagnosed with subsequent BCC lesions during the study period.

After adjusting for numerous factors such as sex, age, smoking history, and educational level, factors found to be significantly associated with developing a first BCC lesion were age (odds ratios of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair), reported Dr. Ville Kiiski and colleagues at Erasmus Medical Center, Rotterdam, the Netherlands.

Factors associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (hazard ratio 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level), the investigators found (Arch. Dermatol. 2010;146:848–55).

This last finding “may be explained by the probability that people with higher levels of education (which correlates strongly with socioeconomic status) have different lifestyles,” such as more frequent exposure to ultraviolet rays for intermittent periods, they said. Also, people of higher socioeconomic status generally may be expected to live longer and, thus have more time to acquire lesions.

Patients were adults aged 55 years or older from the two Rotterdam Study cohorts, including one studied in 1990, and one studied in 1999. Participants were followed for a mean of 9.5 years.

The findings — particularly regarding increased risk among younger patients and red-heads — largely support those of previous studies, although in the current study men were not shown to be at significantly increased risk of developing a first lesion, which contrasts with findings from some prior studies, the investigators noted.

The differences in risk factor profiles for those who develop single vs. multiple BCC lesions, as seen in the current study, may suggest that phenotypic characteristics of patients are less important for determining risk once “cumulative environmental-genetic interaction has surpassed a certain threshold and resulted in a lesion,” Dr. Kiiski and colleagues wrote.

“The clinical relevance of this finding is that physicians' risk assessment efforts should differentiate between patients at risk for a first lesion and those who have a history of BCC,” they said, noting that those with the identified risk factors for multiple lesions may require a more stringent follow-up regimen.

That's not to say, however, that other BCC patients do not require follow-up. “In this sample of the general population, more than 30% of the patients with BCC developed subsequent skin cancer, emphasizing the need for annual follow-up for several years,” Dr. Kiiski and colleagues stressed.

Major Finding: Factors found to be significantly associated with developing a first basal cell carcinoma lesion were age (ORs of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair). Factors found to be associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (HR 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level).

Data Source: A large, prospective, population-based cohort study.

Disclosures: The investigators reported no financial disclosures.

The risk profiles for individuals who develop single vs. multiple basal cell carcinoma lesions differ, according to data from the Rotterdam Study.

Of the 10,820 eligible members of the two cohorts used for the large, Dutch, population-based study, 361 (3%) were diagnosed with a single initial basal cell carcinoma (BCC) lesion, and 163 (1.5%) were diagnosed with subsequent BCC lesions during the study period.

After adjusting for numerous factors such as sex, age, smoking history, and educational level, factors found to be significantly associated with developing a first BCC lesion were age (odds ratios of 1.39 and 1.01 for those aged 65–74 years and for those aged 75 years and older, respectively, vs. those younger than age 65 years), and red hair color (OR of 1.98 for red vs. brown or black hair), reported Dr. Ville Kiiski and colleagues at Erasmus Medical Center, Rotterdam, the Netherlands.

Factors associated with a significantly increased risk of developing multiple lesions were lesion location on an upper extremity (hazard ratio 1.49), age younger than 65 years (HRs of 0.58 and 0.65 for those aged 75 years and older and for those aged 65 to 74 years, respectively, vs. those younger than age 65 years), hair color (HR of 1.43 for red vs. brown/black hair), and education level (HR of 1.42 for high vs. low education level), the investigators found (Arch. Dermatol. 2010;146:848–55).

This last finding “may be explained by the probability that people with higher levels of education (which correlates strongly with socioeconomic status) have different lifestyles,” such as more frequent exposure to ultraviolet rays for intermittent periods, they said. Also, people of higher socioeconomic status generally may be expected to live longer and, thus have more time to acquire lesions.

Patients were adults aged 55 years or older from the two Rotterdam Study cohorts, including one studied in 1990, and one studied in 1999. Participants were followed for a mean of 9.5 years.

The findings — particularly regarding increased risk among younger patients and red-heads — largely support those of previous studies, although in the current study men were not shown to be at significantly increased risk of developing a first lesion, which contrasts with findings from some prior studies, the investigators noted.

The differences in risk factor profiles for those who develop single vs. multiple BCC lesions, as seen in the current study, may suggest that phenotypic characteristics of patients are less important for determining risk once “cumulative environmental-genetic interaction has surpassed a certain threshold and resulted in a lesion,” Dr. Kiiski and colleagues wrote.

“The clinical relevance of this finding is that physicians' risk assessment efforts should differentiate between patients at risk for a first lesion and those who have a history of BCC,” they said, noting that those with the identified risk factors for multiple lesions may require a more stringent follow-up regimen.

That's not to say, however, that other BCC patients do not require follow-up. “In this sample of the general population, more than 30% of the patients with BCC developed subsequent skin cancer, emphasizing the need for annual follow-up for several years,” Dr. Kiiski and colleagues stressed.