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Ultrathin bronchoscopy plus radial EBUS unreliable at making diagnoses
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
[email protected]
On Twitter @mitchelzoler
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
Although bronchoscopic tools are safe and accurate to evaluate both central and peripheral lung lesions, the diagnostic yield of the different available techniques is variable. In this study, a diagnostic yield of only 49% was achieved when ultrathin bronchoscopy with radial EBUS was performed for diagnosis of solid nodules. This yield is not much better than that obtained from conventional bronchoscopy with fluoroscopic guidance and much lower than the diagnostic yield from transthoracic needle biopsy. While there is no doubt that the advances in minimally invasive technologies for diagnosing lung nodules and diagnosing and staging lung cancer have revolutionized clinical practice, pulmonologists and thoracic surgeons need to recognize not only the utility but also the limitations of the available diagnostic procedures (as well as the cost). These technologies are complimentary and multidisciplinary discussions should facilitate selection of the best procedure for each individual case.
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
[email protected]
On Twitter @mitchelzoler
TORONTO – Ultrathin bronchoscopy plus radial endobronchial ultrasound is not a great method for determining whether a suspicious lesion is cancerous or benign, suggests new research.
In this study of patients with CT-detected solid lung lesions, the researchers were able to make a diagnosis for only 49% of those whose nodules were evaluated using ultrathin bronchoscopy plus radial endobronchial ultrasound (EBUS).
“When you do CT-guided biopsies of lung lesions, the [diagnostic] yield is about 94%. So do the math” by comparing it to the roughly 50% yield from ultrathin bronchoscopy plus radial EBUS to decide whether the latter procedure is worth doing, she noted.
The study Dr. Tanner and her associates designed compared the diagnostic yield of ultrathin bronchoscopy plus radial EBUS with standard bronchoscopy and fluoroscopy in patients with CT-detected solid lung lesions 1.5-5.0 cm in size. It ran at five U.S. centers and randomized 221 patients: 85 evaluable patients were tested using the standard methods, and 112 evaluable patients were tested using ultrathin bronchoscopy plus radial EBUS. Patients averaged 65-68 years of age and were divided evenly between women and men. Their lesions averaged slightly more than 3 cm. The ultrathin device had a 4 mm wide diameter and had a 2 mm working channel.
The diagnostic yield was 38% among patients who underwent standard bronchoscopy and fluoroscopy, and 49% among those biopsied using ultrathin bronchoscopy and radial EBUS, Dr. Tanner reported. The between-group difference in yield fell short of being statistically significant.
Forty-six of the 53 patients who were not diagnosable using standard bronchoscopy and fluoroscopy crossed over to the investigational method, which produced a diagnosis for an additional seven patients (15% of the biopsied crossover patients).
The results showed that standard bronchoscopy plus fluoroscopy is “very poor” for distinguishing cancerous and benign pulmonary lesions, Dr. Tanner concluded. The yield from ultrathin bronchoscopy plus radial EBUS in her study was similar to the diagnostic yields reported in prior studies of guided bronchoscopy, even when also using radial EBUS, she added.
Given the limitations of ultrathin bronchoscopy plus radial EBUS, Dr. Tanner suggested that the best scenario for using this diagnostic method would be in patients who need a linear EBUS procedure for mediastinal lymph node staging. Such staging often requires a biopsy of the primary tumor to make a cancer diagnosis, and in such cases, “while you’re in the neighborhood, you could do bronchoscopy with an ultrathin scope,” she suggested.
The potential also exists to augment the diagnostic yield of ultrathin bronchoscopy by applying a navigational software platform and needle biopsy, two methods not included in the study, Dr. Tanner noted. “More studies should be done using this combination,” she said.
The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
[email protected]
On Twitter @mitchelzoler
AT CHEST 2017
Key clinical point:
Major finding: The diagnostic yield using ultrathin bronchoscopy with radial EBUS was 49%, while standard bronchoscopy had a 38% yield.
Data source: Multicenter, randomized study with 221 total patients and 197 evaluable patients.
Disclosures: The study was funded by Olympus. Dr. Tanner has been a consultant to and has received research funding from Olympus. She has also been a consultant to Cook Medical, Integrated Diagnostics, Oncocyte, Veracyte, and Veran Medical Technologies, and she has also received research funding from Cook, Integrated Diagnostics, Oncocyte, Oncimmune, and Veracyte.
Treat Hypertension Even Earlier, Guidelines Say
High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.
The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.
The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.
High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.
The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.
The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.
High blood pressure should be treated at 130/80 mm Hg, rather than 140/90, according to findings from a landmark study that support a key change in the 2017 Hypertension Clinical Practice Guidelines.
The American Heart Association and American College of Cardiology announced the update along with the new guidelines, the first comprehensive high blood pressure guidelines in more than a decade.
The changes were informed by results from the NIH-funded Systolic Blood Pressure Intervention Trial (SPRINT), which was designed to determine the best way to treat high blood pressure in adults aged ≥ 50 years who are at high risk for heart disease. The study included > 9,300 participants and remains the largest of its kind to date to examine the effects on cardiovascular and kidney disease of maintaining systolic blood pressure at a lower than previously recommended level.
System helps predict RFS, OS in BCP-ALL
Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.
The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.
The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.
On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).
Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.
The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.
Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.
“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”
“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”
The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”
And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.
The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.
The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.
Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.
“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.” 
Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.
The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.
The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.
On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).
Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.
The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.
Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.
“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”
“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”
The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”
And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.
The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.
The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.
Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.
“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.”
Researchers say they have developed a more accurate risk scoring system for children with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who are typically thought to have standard- or medium-risk disease.
The scoring system includes 3 factors associated with higher-risk BCP-ALL—the presence of high-risk ALL gene microdeletions, having minimal residual disease (MRD) greater than 5 x 10-5 at day 33, and being high-risk according to National Cancer Institute (NCI) classification.
The researchers found that children with 2 or more of these characteristics were most likely to relapse or die within 7 years of treatment initiation.
On the other hand, children without any of the 3 characteristics had high rates of relapse-free survival (RFS) and overall survival (OS).
Rosemary Sutton, PhD, of Children’s Cancer Institute in Sydney, New South Wales, Australia, and her colleagues devised this risk scoring system and described it in the British Journal of Haematology.
The researchers created their system with the help of data from 475 patients (ages 1 to 18) who had BCP-ALL and were considered non-high-risk. The patients were enrolled on the ANZCHOG ALL8 trial.
Dr Sutton and her colleagues noted that children with standard- or medium-risk BCP-ALL typically receive less intensive treatment than children with high-risk BCP-ALL. However, some of the standard- and medium-risk patients do relapse.
“For the standard- to medium-risk group, we needed more information to get a better handle on the biology of the child’s cancer to better determine their risk,” Dr Sutton said. “So we supplemented MRD results with 2 other pieces of patient information—the presence or absence of specific gene microdeletions and a score called the NCI risk, based on age and white blood cell count.”
“We tested for microdeletions in 9 genes involved in leukemia and found that 2 of the genes—IKZF1 and P2RY8-CRLF2—were important predictors of relapse.”
The researchers combined patients with IKZF1 intragenic deletions, P2RY8-CRLF2 gene fusion, or both into a “high-risk deletion group.”
And the team based the scoring system on 3 factors—the high-risk deletion group, MRD >5 x 10-5 at day 33, and high risk according to NCI risk classification. Patients received 1 point for each of these factors.
The RFS rate was 93% for patients with a score of 0, 78% for those with a score of 1, and 49% for patients with a score of 2 or 3. The OS rate was 99%, 91%, and 71%, respectively.
The researchers said their scoring system provided greater discrimination than MRD-based risk stratification into a standard-risk group—which had an RFS of 89% and an OS of 96%—and a medium-risk group—which had an RFS of 79% and an OS of 91%.
Study author Toby Trahair, MBBS, PhD, of Sydney Children’s Hospital in Randwick, New South Wales, said this scoring system could make a big difference to the success of BCP-ALL treatment.
“We are always trying to improve how we diagnose and treat children with this most common childhood cancer,” Dr Trahair said. “This risk score will mean doctors can fine tune a child’s risk category and so fine tune their treatment. It will mean more kids can conquer this horrible disease, which, only 50 years ago, had survival rates of close to 0.”
FDA approves use of heparin products
The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.
This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.
These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.
Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.
This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.
The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).
Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.
“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.
“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”
The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.
This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.
These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.
Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.
This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.
The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).
Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.
“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.
“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”
The US Food and Drug Administration (FDA) has approved use of Mylan NV’s heparin products.
This includes Heparin Sodium Injection at 1000 USP/mL, 5000 USP/mL, 10,000 USP/mL, and 20,000 USP/mL, all of which are packaged in multi-dose vials.
These products should be available in the coming weeks, according to Rajiv Malik, the president of Mylan.
Mylan’s heparin products are approved for the same uses as other heparin products approved in the US.
This includes as prophylaxis and treatment for venous thrombosis and its extension, pulmonary embolism, and peripheral arterial embolism.
The heparin products can also be used to treat atrial fibrillation with embolization, prevent clotting in arterial and cardiac surgery, and diagnose/treat acute and chronic consumptive coagulopathies (disseminated intravascular coagulation).
Low-dose heparin can be used to prevent post-operative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.
Heparin can also be used as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures, as well as in blood samples for laboratory purposes.
“We are very proud of today’s FDA approval of Heparin Sodium Injection, as this approval adds yet another highly complex and difficult-to-manufacture product to our portfolio,” Malik said.
“We expect to make our heparin products available to US hospitals in the coming weeks, further supporting our institutional customers in meeting the needs of their patients who depend on high-quality anticoagulants.”
Cell-free DNA kit receives CE-IVD mark
Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.
The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.
The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.
The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.
Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.
The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.
Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.
Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.
The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.
The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.
The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.
Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.
The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.
Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.
Vela Diagnostics’ Sentosa® SX Cell-free DNA (cfDNA) Kit has received the CE-IVD mark, which means this kit is approved for in vitro diagnostics use in the European Union.
The Sentosa® SX cfDNA Kit is intended to extract free-circulating DNA from human plasma.
The kit was developed for use in next-generation sequencing and real-time polymerase chain reaction workflows.
The kit is designed to run on the Sentosa® SX101 instrument and works with whole blood samples collected in Cell-free DNA BCT from Streck, K2, or K3 EDTA tubes.
Automated sample extraction with the Sentosa® SX cfDNA Kit takes approximately 3.5 hours. It requires 20 minutes of operator hands-on time and 4 mL of plasma from the clinical sample.
The Sentosa® SX cfDNA Kit is able to recover low-frequency DNA variants in blood, according to Vela Diagnostics.
Results from a pilot study testing the kit were presented in a poster at the AMP 2016 Annual Meeting.
Continuous bedside monitoring improved safety of intracranial stereotactic EEG
WASHINGTON – After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.
“After initiating a full-time, bedside sitter, none of the major events we saw in the presitter period, which included unrecognized tonic-clonic seizures or patient removal of electrodes, was observed,” reported Brad Kamitaki, MD, who is completing an epilepsy fellowship at Columbia University, New York.
Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.
In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.
There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.
In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.
The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.
Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”
A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.
“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.
“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.
Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
WASHINGTON – After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.
“After initiating a full-time, bedside sitter, none of the major events we saw in the presitter period, which included unrecognized tonic-clonic seizures or patient removal of electrodes, was observed,” reported Brad Kamitaki, MD, who is completing an epilepsy fellowship at Columbia University, New York.
Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.
In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.
There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.
In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.
The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.
Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”
A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.
“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.
“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.
Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
WASHINGTON – After a life-threatening event prompted a trial of continuous monitoring of patients during intracranial stereotactic electroencephalogram (EEG), the rate of adverse events and missed seizures went to zero, according to a single-center analysis presented at the annual meeting of the American Epilepsy Society.
“After initiating a full-time, bedside sitter, none of the major events we saw in the presitter period, which included unrecognized tonic-clonic seizures or patient removal of electrodes, was observed,” reported Brad Kamitaki, MD, who is completing an epilepsy fellowship at Columbia University, New York.
Continuous observation of patients undergoing intracranial EEG has been described as mandatory in guidelines from the National Association of Epilepsy Centers (Epilepsia. 2010 Nov;51[11]:2322-33), but the type of monitoring, such as bedside sitter versus closed circuit video, has not been specified, according to Dr. Kamitaki. Although continuous bedside monitoring might offer the best opportunity to capture seizures and reduce the risk of adverse events, there are few comparative data.
In this study, the rate of adverse events was evaluated after a full-time, bedside sitter was initiated and compared with the rate observed prior to this step. There were 13 adult patients each in the presitter and sitter groups. All patients were admitted to an epilepsy unit for intracranial stereotactic EEG evaluation. Video monitoring by nursing staff was in place in the presitter period and continued to be active during the sitter periods.
There were 63 seizures captured in the presitter group and 53 in the sitter group. Of these, 21 were unrecognized in the presitter group versus 8 in the sitter group (P = .03). While most of the missed seizures were focal unaware in both groups (19 and 8, respectively), two focal-to-bilateral tonic-clonic seizures were missed in the presitter group versus zero in the sitter group.
In addition, there were two seizure-related adverse events in the presitter group versus none in the sitter group. Both of the adverse events, occurring in separate patients, were inappropriate electrode removals attributed to peri-ictal confusion during a focal unaware seizure. One required surgical reimplantation.
The greater mean time to nursing response after EEG onset of a seizure in the presitter group, compared with that of the sitter group, fell just short of statistical significance (77.1 vs. 56.7 seconds; P = .06), but the mean response time after clinical onset was significantly shorter in the sitter group (58.8 vs. 37.7 seconds; P = .02), according to Dr. Kamitaki.
Overall, the study “supports the likelihood that continuous bedside monitoring reduces the risk of adverse events,” Dr. Kamitaki said. “We did not look at what this costs, but concern about cost at our center was the reason that this program was not continued.”
A nursing assistant trained to recognize seizure activity performed the continuous bedside monitoring. The sitter remained beside the patient’s bed over a 24-hour period, leaving only if patient visitors obviated the need for a sitter. The monitoring was typically maintained over several days.
“Not all patients liked having a bedside sitter there at all times,” conceded Dr. Kamitaki, who acknowledged that other, less labor-intensive strategies might provide similar protection against adverse events. For example, a dedicated observer of multiple patients through video monitoring also might be effective, although formal studies are needed to evaluate how this compares with the current system of video monitors in a nursing station that do not have a dedicated observer.
“These data associate continuous bedside monitoring with fewer unrecognized seizures, quicker nursing response, and a reduced risk of seizure-related adverse events, but each center needs to decide whether it is practical,” Dr. Kamitaki said.
Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
AT AES 2017
Key clinical point: compared with closed circuit video monitoring.
Major finding: The missed seizures and unintentional electrode removals that occurred without continuous bedside monitoring did not occur in the course of monitoring.
Data source: Retrospective study of 26 patients.
Disclosures: Dr. Kamitaki reported having no potential conflicts of interest related to this topic.
Baylor sees first U.S. birth from uterine transplant recipient
A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.
“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.
With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”
“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”
In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.
However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.
The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.
Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.
The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.
To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.
Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*
Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.
Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.
Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.
All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.
It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”
Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”
Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.
[email protected]
On Twitter @karioakes
A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.
“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.
With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”
“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”
In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.
However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.
The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.
Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.
The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.
To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.
Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*
Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.
Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.
Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.
All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.
It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”
Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”
Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.
[email protected]
On Twitter @karioakes
A woman with a transplanted uterus gave birth to a live baby boy in Dallas, the first birth from a transplanted uterus in the United States. It is also the first birth resulting from uterine transplantation to be performed outside of Sweden, where a total of eight births have occurred.
“This really confirms that this is doable, that it can be replicated,” said Giuliano Testa, MD, chief of abdominal transplantation at Baylor University Medical Center, Dallas, during a press conference to discuss the birth.
With time, Dr. Testa said in an interview, he foresees uterine transplantation becoming a realistic alternative for some women. “It’s a great solution for the woman who really wants to carry her own pregnancy.”
“This is the best of academic medicine,” Dr. Testa said of the international collaboration and transparency among investigators working in the nascent field. “The communication is constant; we learn from each other ... I am very excited about what will come in the future.”
In order to protect the privacy of the patient and her family, physicians did not disclose the patient’s name, location, or the exact date of the birth. The patient also did not wish to share the infant’s gestational age at birth or birth weight, or whether the uterus had been removed after the birth. Transplanted uteri are meant to be removed after one or two pregnancies, so the recipient doesn’t have to be on lifelong immunosuppression once the desired pregnancies have been achieved.
However, during the press conference, the surgical team shared that the mother is home and doing well, and the infant is on room air and feeding well. A video of the birth shown at the press conference showed a vernix-covered baby who began crying vigorously even before his feet were delivered during the cesarean delivery.
The transplantation, pregnancy via in vitro fertilization, and subsequent birth were accomplished as part of a 10-patient clinical trial of uterine transplantation at Baylor University Medical Center. Women aged 20-35 years with absolute uterine factor infertility, such as those with congenitally absent uteri, were eligible to participate. Donors must have had one full-term delivery and may be aged 30-65 years; menopause does not render a uterus incapable of carrying a pregnancy. Donors are able to retain their ovaries.
Another study participant at Baylor is late into her pregnancy as well, Dr. Testa said.
The extensive screening process for uterus donation ensures that the team is using “a good organ from a good donor,” said Liza Johannesson, MD, PhD. In an interview, she said that the harvest is now about a 4-5 hour open procedure that takes the uterus, the cervix, and the very superior portion of the vagina, as well as the uterine arteries and veins out to the internal iliac bilaterally. The utero-ovarian veins also are harvested.
To date, the six women who have been donors in the Baylor program have not had serious complications and have returned to their previous level of function, said Dr. Johannesson, who came to Baylor from Sahlgrenska University Hospital’s successful uterine transplantation team in Gothenburg, Sweden.
Internationally, investigators have been working to reduce morbidity for women who donate their uterus. Since the vascular tree of the uterus must also be dissected and preserved during the organ harvesting procedure, operative time is longer than for a simple hysterectomy, and there’s increased risk of urinary dysfunction because of the extensive dissection, Antonio R. Gargiulo, MD, said in an interview.*
Dr. Gargiulo, medical director of the center for robotic surgery at Brigham and Women’s Hospital, Boston, said that the first few uterine harvest procedures took much longer, up to 10 hours. But, he said, the vascular harvest “is well within the capability of the best gynecologic oncology surgeons,” and newer techniques may further reduce the donor morbidity.
Using the utero-ovarian vein as the primary outflow tract is “a promising modification of this operation” that may be the “technical key to making this procedure the least morbid possible,” said Dr. Gargiulo, a reproductive endocrinologist who is involved with the development of a uterine transplantation program at the Brigham and Women’s Hospital.
Dr. Johannesson said that the Baylor team currently dissects the entire uterine vascular tree and reanastomoses what vessels they can. She pointed out that even with the best imaging techniques, it can be difficult to ascertain the best vessels until the surgery’s actually being performed.
All of the surgeons interviewed emphasized that each procedure represents an opportunity for growth in a young field with a steep learning curve. They expect ongoing technical advances, including the use of robotic surgery, to reduce operative time and lessen morbidity.
It’s worth pressing on in this field for the sake of the patients, said Dr. Testa, speaking for his transplant team. “We are all humbled by the depth of the desire of a woman to carry her own pregnancy.”
Dr. Johannesson said that she hopes that today when gynecologists talk to teenage patients who have absolute uterine infertility, they will be offering a message of hope. “When they meet young women, they should tell them that they shouldn’t stop hoping,” she said. “There is hope that they will be able to carry their own pregnancy.”
Dr. Gargiulo has been a paid consultant for Kawasaki Robotics and OmniGuide. Dr. Testa and Dr. Johannesson reported that they had no relevant conflicts of interest.
*Correction, 12/12/17: The reason for the increased risk of urinary dysfunction was misstated.
[email protected]
On Twitter @karioakes
Fecal microbiota transplants by oral capsule noninferior to colonoscopy
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
The AGA Center for Gut Microbiome Research and Education serves as a virtual “home” for AGA activities related to the gut microbiome, including the AGA FMT National Registry, which will assess short- and long-term patient outcomes associated with FMT. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-gut-microbiome-research-education.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Clostridium difficile infection costs the U.S. health care system an estimated $1.5 billion each year, with 450,000 cases reported annually, 20% of which involve a recurrence of the infection. Fecal microbiota transplantation is increasingly being used as a treatment, but more widespread adoption is limited partly by the logistical difficulties of delivery.
This study offers encouraging data on delivery of fecal microbiota transplants via capsule, which may reduce barriers to adoption of this treatment; however, there are still some questions to be answered about the treatment’s efficacy, such as the timing of delivery and the relative importance of stool components.
There are also other approaches that should be considered in future research on C. difficile infection, including the use of vancomycin tapers with and without “chasers” of fidaxomicin/rifaximin, the use of defined microbial communities, and the use of sterile, fecal-derived products, which may even supplant standard fecal microbial transplants in the future.
Krishna Rao, MD, Vincent B. Young, MD, PhD, and Preeti N. Malani, MD, are with the division of infectious diseases in the department of internal medicine at the University of Michigan, Ann Arbor. These comments are taken from an accompanying editorial (JAMA. 2017 Nov 28;381:1979-80. doi: 10.1001/jama.2017.17969). Dr. Young reported consulting fees from Vedanta, Merck, and Finch Therapeutics and grants from MedImmune. No other disclosures were reported.
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
The AGA Center for Gut Microbiome Research and Education serves as a virtual “home” for AGA activities related to the gut microbiome, including the AGA FMT National Registry, which will assess short- and long-term patient outcomes associated with FMT. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-gut-microbiome-research-education.
Fecal microbiota transplantation (FMT) using oral capsules as the delivery method has been shown to be noninferior to delivery using colonoscopy for the treatment of Clostridium difficile infection, but with a significantly lower price tag.
In an unblended noninferiority trial, published in the Nov. 28 issue of JAMA, 116 adults with at least three documented episodes of C. difficile infection were randomized to either 360 mL of fecal slurry delivered to the cecum via colonoscopy or to 40 capsules of processed fecal microbiota swallowed under direct observation.
Dina Kao, MD, of the department of medicine at the University of Alberta, Edmonton, and coauthors commented that the response rate with the capsules was higher than that seen in other studies of fecal microbiota capsules, which they suggested may partly be due to the larger amount of donor stool used in the study: 80-100 g, compared with 17 g and 25 g used in other studies.
“The higher efficacy observed in this study suggests a dose-dependent response to FMT, and a benefit of bowel lavage prior to FMT, because residual vancomycin was detected up to 8 days despite its discontinuation,” they wrote.
Both treatment modalities achieved similar quality of life improvements. Both groups reported major improvements in domains including physical and emotional health, physical and social functioning, and general health, with no significant differences between the two arms of the study.
The cost per treatment in the colonoscopy group was $874 per patient, compared with $308 per patient in the capsule group.
“Although colonoscopy delivery is more invasive, resource intensive, costly, and inconvenient for patients, it has the advantage of identifying alternative diagnoses,” the authors wrote. “Conversely, when FMT is given by oral capsules, it can be administered in an office setting, which could substantially reduce cost and wait time.”
Both groups also showed significantly improved gut microbiota diversity, which approached that of the donor just 1 week after administration of the treatment.
While 30% of patients characterized FMTs as “unpleasant, gross, or disgusting,” 79% of participants said the unpleasantness was the same or less than anticipated, and 97% said they would undergo the same treatment by the same delivery method again if needed.
However, significantly more patients in the capsule group described their experience as “not at all unpleasant,” compared with the colonoscopy group (66% vs. 44%; 95% CI, 3%-40%; P = .01).
There were no colonic perforations seen in the colonoscopy group, and no infectious complications relating to the treatment in either group. One patient in each group died of underlying cardiopulmonary illness that was unrelated to the treatment, and the rate of minor adverse events was 5.4% in the capsule group and 12.5% in the colonoscopy group.
The authors acknowledged that the lack of a placebo group in the study meant they were not able to measure the size of the effect of fecal microbiota transplantation by either route. One earlier trial had also shown a placebo response rate of 45%.
The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
The AGA Center for Gut Microbiome Research and Education serves as a virtual “home” for AGA activities related to the gut microbiome, including the AGA FMT National Registry, which will assess short- and long-term patient outcomes associated with FMT. Learn more at http://www.gastro.org/about/initiatives/aga-center-for-gut-microbiome-research-education.
FROM JAMA
Key clinical point: Delivering fecal microbiota transplants using oral capsules is noninferior to delivery via colonoscopy in the treatment of Clostridium difficile infection.
Major finding: The rates of resolution of recurrent C. difficile infection with fecal microbiota transplants are similar for delivery via oral capsule or via colonoscopy.
Data source: A randomized, unblended noninferiority trial in 116 adults with recurrent C. difficile infection.
Disclosures: The study was funded by Alberta Health Services and the University of Alberta Hospital Foundation. Four authors declared grants and other funding from the study funder and the pharmaceutical industry.
FDA approves first trastuzumab biosimilar
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health-care professionals and patients about biosimilars. Visit www.gastro.org/biosimilars to learn more.
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health-care professionals and patients about biosimilars. Visit www.gastro.org/biosimilars to learn more.
The Food and Drug Administration has approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with HER2+ breast or metastatic gastric or gastroesophageal junction adenocarcinoma.
This is the first biosimilar approved in the United States for the treatment of breast cancer or gastric cancer and the second biosimilar approved for the treatment of cancer, the FDA said in a statement.
The approval of trastuzumab-dkst is based on structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data.
Common expected side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Common expected side effects for the treatment of HER2+ metastatic gastric cancer include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.
The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity.
The FDA’s Oncologic Drugs Advisory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon.
To prepare for the entry of biosimilars to the market, AGA is taking the lead in educating health-care professionals and patients about biosimilars. Visit www.gastro.org/biosimilars to learn more.
Hippocampal features may predispose children with febrile status epilepticus to poorer memory
WASHINGTON – Children with febrile status epilepticus (FSE) may be at risk for memory impairment when abnormal hippocampal development or acute injury is also present, according to research presented at the annual meeting of the American Epilepsy Society.
This analysis of patients enrolled in the FEBSTAT study presents some of the first prospective data available regarding significant risk factors for cognitive dysfunction in children with FSE.
“Overall, children with FSE have generally intact memory function and generally intact IQ,” said Erica Weiss, PhD, a neurology instructor at the Albert Einstein College of Medicine, New York. “However, children with acute T2 [hyperintensities on MRI] and kids who have hippocampal malrotation [HIMAL] tend to have weaker memory scores.”
The investigators conducted a prospective study of 113 children with FSE using data gathered from five medical centers across the United States between June 2003 and March 2010.
Children included in the study were followed with serial MRIs and electroencephalograms for more than 5 years after their having FSE; during this time, their verbal, visual, and screening memory abilities were tested using the Wide Range Assessment of Memory and Learning, Second Edition, (WRAML2) test.
Patients had an average age of 15.5 months at time of FSE. Of the children in the study, 46% were female, and 46% were non-white.
Overall, mean scores at baseline on the WRAML2 were significantly lower for children with acute hippocampal injury shown on T2 hyperintensities or HIMAL than they were for children with a normal MRI scan. On individual memory functions of the WRAML2, mean scores at baseline for children with acute T2 hyperintensities were lower than they were for those with a normal MRI on the verbal index (79 vs. 102.3), visual index (81 vs. 93.7), and screening memory index (76 vs. 97.7). Children with HIMAL at baseline also had lower scores on those indexes (94.9 for verbal memory, 82.5 for visual memory, and 97 for screening memory) than did children with a normal MRI.
The differences were statistically significant for lower verbal memory and screening memory scores in patients with acute T2 hyperintensities and for lower visual memory scores in patients with HIMAL. The differences trended toward statistical significance for lower visual memory scores in children with acute T2 hyperintensities and for lower verbal memory scores in children with focal FSE seizures.
The researchers found no significant differences in memory task performances when stratifying for age at time of FSE, duration of FSE, or patients’ sex, according to Dr. Weiss.
With this initial connection uncovered, Dr. Weiss and her colleagues are looking to dive deeper into different aspects of hippocampal properties and FSE.
“We’re looking into the relationship between hippocampus size and memory performances, as well as continue to track these studies,” Dr. Weiss said in an interview. “Another factor to consider when you talk about memory is attention, and we have looked into it a bit, but we need more information.”
This study was funded by a grant from the National Institute of Neurological Disorders and Stroke. The presenters reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – Children with febrile status epilepticus (FSE) may be at risk for memory impairment when abnormal hippocampal development or acute injury is also present, according to research presented at the annual meeting of the American Epilepsy Society.
This analysis of patients enrolled in the FEBSTAT study presents some of the first prospective data available regarding significant risk factors for cognitive dysfunction in children with FSE.
“Overall, children with FSE have generally intact memory function and generally intact IQ,” said Erica Weiss, PhD, a neurology instructor at the Albert Einstein College of Medicine, New York. “However, children with acute T2 [hyperintensities on MRI] and kids who have hippocampal malrotation [HIMAL] tend to have weaker memory scores.”
The investigators conducted a prospective study of 113 children with FSE using data gathered from five medical centers across the United States between June 2003 and March 2010.
Children included in the study were followed with serial MRIs and electroencephalograms for more than 5 years after their having FSE; during this time, their verbal, visual, and screening memory abilities were tested using the Wide Range Assessment of Memory and Learning, Second Edition, (WRAML2) test.
Patients had an average age of 15.5 months at time of FSE. Of the children in the study, 46% were female, and 46% were non-white.
Overall, mean scores at baseline on the WRAML2 were significantly lower for children with acute hippocampal injury shown on T2 hyperintensities or HIMAL than they were for children with a normal MRI scan. On individual memory functions of the WRAML2, mean scores at baseline for children with acute T2 hyperintensities were lower than they were for those with a normal MRI on the verbal index (79 vs. 102.3), visual index (81 vs. 93.7), and screening memory index (76 vs. 97.7). Children with HIMAL at baseline also had lower scores on those indexes (94.9 for verbal memory, 82.5 for visual memory, and 97 for screening memory) than did children with a normal MRI.
The differences were statistically significant for lower verbal memory and screening memory scores in patients with acute T2 hyperintensities and for lower visual memory scores in patients with HIMAL. The differences trended toward statistical significance for lower visual memory scores in children with acute T2 hyperintensities and for lower verbal memory scores in children with focal FSE seizures.
The researchers found no significant differences in memory task performances when stratifying for age at time of FSE, duration of FSE, or patients’ sex, according to Dr. Weiss.
With this initial connection uncovered, Dr. Weiss and her colleagues are looking to dive deeper into different aspects of hippocampal properties and FSE.
“We’re looking into the relationship between hippocampus size and memory performances, as well as continue to track these studies,” Dr. Weiss said in an interview. “Another factor to consider when you talk about memory is attention, and we have looked into it a bit, but we need more information.”
This study was funded by a grant from the National Institute of Neurological Disorders and Stroke. The presenters reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
WASHINGTON – Children with febrile status epilepticus (FSE) may be at risk for memory impairment when abnormal hippocampal development or acute injury is also present, according to research presented at the annual meeting of the American Epilepsy Society.
This analysis of patients enrolled in the FEBSTAT study presents some of the first prospective data available regarding significant risk factors for cognitive dysfunction in children with FSE.
“Overall, children with FSE have generally intact memory function and generally intact IQ,” said Erica Weiss, PhD, a neurology instructor at the Albert Einstein College of Medicine, New York. “However, children with acute T2 [hyperintensities on MRI] and kids who have hippocampal malrotation [HIMAL] tend to have weaker memory scores.”
The investigators conducted a prospective study of 113 children with FSE using data gathered from five medical centers across the United States between June 2003 and March 2010.
Children included in the study were followed with serial MRIs and electroencephalograms for more than 5 years after their having FSE; during this time, their verbal, visual, and screening memory abilities were tested using the Wide Range Assessment of Memory and Learning, Second Edition, (WRAML2) test.
Patients had an average age of 15.5 months at time of FSE. Of the children in the study, 46% were female, and 46% were non-white.
Overall, mean scores at baseline on the WRAML2 were significantly lower for children with acute hippocampal injury shown on T2 hyperintensities or HIMAL than they were for children with a normal MRI scan. On individual memory functions of the WRAML2, mean scores at baseline for children with acute T2 hyperintensities were lower than they were for those with a normal MRI on the verbal index (79 vs. 102.3), visual index (81 vs. 93.7), and screening memory index (76 vs. 97.7). Children with HIMAL at baseline also had lower scores on those indexes (94.9 for verbal memory, 82.5 for visual memory, and 97 for screening memory) than did children with a normal MRI.
The differences were statistically significant for lower verbal memory and screening memory scores in patients with acute T2 hyperintensities and for lower visual memory scores in patients with HIMAL. The differences trended toward statistical significance for lower visual memory scores in children with acute T2 hyperintensities and for lower verbal memory scores in children with focal FSE seizures.
The researchers found no significant differences in memory task performances when stratifying for age at time of FSE, duration of FSE, or patients’ sex, according to Dr. Weiss.
With this initial connection uncovered, Dr. Weiss and her colleagues are looking to dive deeper into different aspects of hippocampal properties and FSE.
“We’re looking into the relationship between hippocampus size and memory performances, as well as continue to track these studies,” Dr. Weiss said in an interview. “Another factor to consider when you talk about memory is attention, and we have looked into it a bit, but we need more information.”
This study was funded by a grant from the National Institute of Neurological Disorders and Stroke. The presenters reported no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
AT AES 2017
Key clinical point:
Major finding: On individual memory functions of the Wide Range Assessment of Memory and Learning, Second Edition, test, mean scores at baseline for children with acute T2 hyperintensities or hippocampal malrotation were lower than they were for those with a normal MRI on the verbal index (79 and 94.9, respectively, vs. 102.3), the visual index (81 and 82.5 vs. 93.7), and the screening memory (76 and 97 vs. 97.7) index.
Data source: Prospective study of 113 children, the data for which was gathered from five medical centers across the United States between 2003 and 2010.
Disclosures: The study was funded by a grant from the National Institute of Neurological Disorders and Stroke. The presenters reported no relevant financial disclosures.