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FDA aims to boost safety of platelets for transfusion
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.
The Food and Drug Administration is asking for comments on its
The draft document, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through Feb. 4, 2019.
It is the first update to the policy document since 2016.
In the draft guidance, the FDA recommended three strategies for platelets stored for 5 days from collection. For apheresis platelets and prestorage pools, the FDA suggested an initial primary culture followed by a secondary culture on day 3 or day 4 or an initial primary culture followed by secondary testing with a rapid test. The third strategy – for apheresis platelets – is pathogen reduction alone.
The FDA also outlined three strategies for testing platelets stored for 7 days, all of which apply to apheresis platelets. The methods include an initial primary culture followed by a secondary culture no earlier than day 4, using a device labeled as a safety measure; an initial primary culture followed by a secondary rapid test, labeled as a safety measure; or large volume delayed sampling.
The supply of blood and blood components in the United States is among the safest in the world, FDA Commissioner Scott Gottlieb, MD, said in a statement. The FDA’s continuously updated protocols are intended to keep it that way.
“Blood and blood components are some of the most critical medical products American patients depend upon,” Dr. Gottlieb wrote. “But there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
Since the 2016 guidance document was issued, new strategies for bacterial detection have become available that could potentially reduce the risk of contamination of platelets and permit extension of platelet dating up to 7 days, including bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen reduction technology.
The recommendations in the draft guidance incorporate ideas put forth during a July 2018 meeting of the agency’s Blood Products Advisory Committee. Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved. Their comments have been incorporated into the new draft guidance document.
In late November 2018, the FDA held a public workshop to encourage a scientific discussion on a range of pathogen reduction topics, including the development of novel technologies. “The ideal pathogen reduction technology would: be relatively inexpensive, be simple to implement on whole blood, allow treated blood to subsequently be separated into components or alternatively could be performed on apheresis products, inactivate a broad range of pathogens, and would have no adverse effect on product safety or product yield,” the FDA noted in a statement.
Moderate approach best for NET liver mets
BOSTON – Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City. 
“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.
There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.
It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.
The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.
CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.
Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.
Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.
He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.
BOSTON – Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City.
“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.
There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.
It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.
The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.
CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.
Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.
Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.
He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.
BOSTON – Even partial reduction of liver metastases from malignant small bowel neuroendocrine tumors will help symptoms and improve survival, according to James Howe, MD, director of surgical oncology and endocrine surgery at the University of Iowa, Iowa City.
“Hepatic cytoreduction is not just to cut down on hormone production” to relieve carcinoid syndrome symptoms, but also “there seems to be a survival benefit,” he said at the annual clinical congress of the American College of Surgeons.
There was a time when it was thought that at least 90% of liver metastases needed to be removed for patients benefit, but it’s become clear that even clearing 70% will help.
It’s important, however, to use parenchymal sparing techniques such as wedge excision, enucleation, and ablation. “We don’t do a lot of right and left hepatectomies anymore,” because patients often live a long time with the disease, many past 10 years, so the goal is management without undo side effects from aggressive treatment. “The key thing with all patients is to avoid morbidity. These patients are going to live a long time if you do not do very much,” Dr. Howe said.
The general surgical approach is to remove the primary neuroendocrine tumor (NET) plus regional lymph nodes; debulk peritoneal disease; cytoreduce liver metastases, and remove the gallbladder, because many patients go on to somatostatin analogs; in 2 years or so, they’ll develop gallstones.
CT is overall the most useful imaging tool for workup. The terminal ileum is the most common location of small bowel NETs, but often “the primary will not be seen,” so “the main thing I look for is mesenteric lymphadenopathy. Liver metastases are even more suspicious.” PET imaging with gallium-labeled somatostatin analogues is also “very good for determining if a lesion is indeed a NET and to determine sites of distant metastases,” Dr. Howe said.
Suspicious findings are followed by surgical exploration, which he usually does by midline incision, the size of which depends on if hepatic cytoreduction is planned. “It’s critically important to palpate the entire small bowel, or you are going to miss lesions. You can feel them quite easily even if they are just 1 or 2 mm,” he said.
Laparoscopy is an option for quicker recovery and other benefits, but the downside is “you are going to miss multifocal disease if you are using metal graspers to feel the small bowel,” and challenging node resection is impossible. One compromise is to do a small incision of a few inches; “you can actually palpate the small bowel through a small incision, and resect a section of bowel through it,” he said.
He saves systemic therapy for patients who progress despite surgery and somatostatin analogues. Everolimus is an option, but the most promising option is lutetium Lu 177 dotatate (Lutathera), approved by the Food and Drug Administration in early 2018 for pancreatic and gastrointestinal NETs.
EXPERT ANALYSIS FROM THE ACS CLINICAL CONGRESS
Beware “The Great Mimicker” that can lurk in the vulva
LAS VEGAS – Officially a type of precancerous lesion is known as vulvar intraepithelial neoplasia (VIN); unofficially, an obstetrician-gynecologist calls it something else: “The Great Mimicker.” That’s because symptoms of VIN can fool physicians into thinking they’re seeing other vulvar conditions. The good news: A biopsy can offer crucial insight and should be performed on any dysplastic or unusual lesion on the vulva.
Amanda Nickles Fader, MD, of Johns Hopkins Hospital in Baltimore, offered this advice and other tips about this type of precancerous vulvar lesion in a presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.
According to Dr. Nickles Fader, vulvar cancer accounts for 5% of all gynecologic malignancies, and it appears most in women aged 65-75 years. However, about 15% of all vulvar cancers appear in women under the age of 40 years. “We’re seeing a greater number of premenopausal women with this condition, probably due to HPV [human papillomavirus],” she said, adding that HPV vaccines are crucial to prevention.
The VIN form of precancerous lesion is most common in premenopausal women (75%) and – like vulvar cancer – is linked to HPV infection, HIV infection, cigarette smoking, and weakened or suppressed immune systems, Dr. Nickles Faber said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
VIN presents with symptoms such as pruritus, altered vulvar appearance at the site of the lesion, palpable abnormality, and perineal pain or burning. About 40% of cases do not show symptoms and are diagnosed by gynecologists at annual visits.
It’s important to biopsy these lesions, she said, because they can mimic other conditions such as vulvar cancer, condyloma acuminatum (genital warts), lichen sclerosus, lichen planus, and condyloma latum (a lesion linked to syphilis).
“Biopsy, biopsy, biopsy,” she urged.
In fact, one form of VIN – differentiated VIN – is associated with dermatologic conditions such as lichen sclerosus, and treatment of these conditions can prevent development of this VIN type.
As for treatment, Dr. Nickles Faber said surgery is the mainstay. About 90% of the time, wide local excision is the “go-to” approach, although the skinning vulvectomy procedure may be appropriate in lesions that are more extensive or multifocal and confluent. “It’s a lot more disfiguring.”
Laser ablation is a “very reasonable” option when cancer has been eliminated as a possibility, she said. It may be appropriate in multifocal or extensive lesions and can have important cosmetic advantages when excision would be inappropriate.
Off-label use of imiquimod 5%, a topical immune response modifier, can be appropriate in multifocal high-grade VINs, but it’s crucial to exclude invasive squamous cell carcinoma. As she noted, imiquimod is Food and Drug Administration–approved for anogenital warts but not for VIN. Beware of toxicity over the long term.
Dr. Nickles Fader reported no relevant financial disclosures.
LAS VEGAS – Officially a type of precancerous lesion is known as vulvar intraepithelial neoplasia (VIN); unofficially, an obstetrician-gynecologist calls it something else: “The Great Mimicker.” That’s because symptoms of VIN can fool physicians into thinking they’re seeing other vulvar conditions. The good news: A biopsy can offer crucial insight and should be performed on any dysplastic or unusual lesion on the vulva.
Amanda Nickles Fader, MD, of Johns Hopkins Hospital in Baltimore, offered this advice and other tips about this type of precancerous vulvar lesion in a presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.
According to Dr. Nickles Fader, vulvar cancer accounts for 5% of all gynecologic malignancies, and it appears most in women aged 65-75 years. However, about 15% of all vulvar cancers appear in women under the age of 40 years. “We’re seeing a greater number of premenopausal women with this condition, probably due to HPV [human papillomavirus],” she said, adding that HPV vaccines are crucial to prevention.
The VIN form of precancerous lesion is most common in premenopausal women (75%) and – like vulvar cancer – is linked to HPV infection, HIV infection, cigarette smoking, and weakened or suppressed immune systems, Dr. Nickles Faber said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
VIN presents with symptoms such as pruritus, altered vulvar appearance at the site of the lesion, palpable abnormality, and perineal pain or burning. About 40% of cases do not show symptoms and are diagnosed by gynecologists at annual visits.
It’s important to biopsy these lesions, she said, because they can mimic other conditions such as vulvar cancer, condyloma acuminatum (genital warts), lichen sclerosus, lichen planus, and condyloma latum (a lesion linked to syphilis).
“Biopsy, biopsy, biopsy,” she urged.
In fact, one form of VIN – differentiated VIN – is associated with dermatologic conditions such as lichen sclerosus, and treatment of these conditions can prevent development of this VIN type.
As for treatment, Dr. Nickles Faber said surgery is the mainstay. About 90% of the time, wide local excision is the “go-to” approach, although the skinning vulvectomy procedure may be appropriate in lesions that are more extensive or multifocal and confluent. “It’s a lot more disfiguring.”
Laser ablation is a “very reasonable” option when cancer has been eliminated as a possibility, she said. It may be appropriate in multifocal or extensive lesions and can have important cosmetic advantages when excision would be inappropriate.
Off-label use of imiquimod 5%, a topical immune response modifier, can be appropriate in multifocal high-grade VINs, but it’s crucial to exclude invasive squamous cell carcinoma. As she noted, imiquimod is Food and Drug Administration–approved for anogenital warts but not for VIN. Beware of toxicity over the long term.
Dr. Nickles Fader reported no relevant financial disclosures.
LAS VEGAS – Officially a type of precancerous lesion is known as vulvar intraepithelial neoplasia (VIN); unofficially, an obstetrician-gynecologist calls it something else: “The Great Mimicker.” That’s because symptoms of VIN can fool physicians into thinking they’re seeing other vulvar conditions. The good news: A biopsy can offer crucial insight and should be performed on any dysplastic or unusual lesion on the vulva.
Amanda Nickles Fader, MD, of Johns Hopkins Hospital in Baltimore, offered this advice and other tips about this type of precancerous vulvar lesion in a presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium.
According to Dr. Nickles Fader, vulvar cancer accounts for 5% of all gynecologic malignancies, and it appears most in women aged 65-75 years. However, about 15% of all vulvar cancers appear in women under the age of 40 years. “We’re seeing a greater number of premenopausal women with this condition, probably due to HPV [human papillomavirus],” she said, adding that HPV vaccines are crucial to prevention.
The VIN form of precancerous lesion is most common in premenopausal women (75%) and – like vulvar cancer – is linked to HPV infection, HIV infection, cigarette smoking, and weakened or suppressed immune systems, Dr. Nickles Faber said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.
VIN presents with symptoms such as pruritus, altered vulvar appearance at the site of the lesion, palpable abnormality, and perineal pain or burning. About 40% of cases do not show symptoms and are diagnosed by gynecologists at annual visits.
It’s important to biopsy these lesions, she said, because they can mimic other conditions such as vulvar cancer, condyloma acuminatum (genital warts), lichen sclerosus, lichen planus, and condyloma latum (a lesion linked to syphilis).
“Biopsy, biopsy, biopsy,” she urged.
In fact, one form of VIN – differentiated VIN – is associated with dermatologic conditions such as lichen sclerosus, and treatment of these conditions can prevent development of this VIN type.
As for treatment, Dr. Nickles Faber said surgery is the mainstay. About 90% of the time, wide local excision is the “go-to” approach, although the skinning vulvectomy procedure may be appropriate in lesions that are more extensive or multifocal and confluent. “It’s a lot more disfiguring.”
Laser ablation is a “very reasonable” option when cancer has been eliminated as a possibility, she said. It may be appropriate in multifocal or extensive lesions and can have important cosmetic advantages when excision would be inappropriate.
Off-label use of imiquimod 5%, a topical immune response modifier, can be appropriate in multifocal high-grade VINs, but it’s crucial to exclude invasive squamous cell carcinoma. As she noted, imiquimod is Food and Drug Administration–approved for anogenital warts but not for VIN. Beware of toxicity over the long term.
Dr. Nickles Fader reported no relevant financial disclosures.
EXPERT ANALYSIS FROM PAGS
Can robotics reduce hepatic surgery conversions?
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
The conversion rate from minimally invasive to open surgery for liver resection has been known to be high, but researchers from the University of Illinois, Chicago, have reported that conversion rates are considerably lower in robot-assisted liver resections, which may ultimately improve survival and complication rates.
Their study, published in the International Journal of Medical Robotics and Computer Assisted Surgery, found that the overall conversion rate of robot-assisted to open surgery for liver resection was 4.4%, considerably lower than that for the pure laparoscopic approach. “The robotic assist could potentially help in decreasing the conversion rate,” said Federico Gheza, MD, and his coauthors. They claimed that this is the first paper to focus on reasons for conversion from robot-assisted liver resection to open surgery.
The study findings are based on a systematic review of 29 series of 1,091 patients who had robot-assisted liver resection, including Dr. Gheza’s and his coauthors’ own series of 139 patients who had the operation from 2007 to 2017. The series were published from 2009 to 2017.
Dr. Gheza’s and his coauthors’ series had a conversion rate of 7.9%. When their results were included with those of the previously published studies, the conversion rate was 4.8%.
Dr. Gheza and his coauthors noted that the conversion rate for minimally invasive hepatic operations is one of the highest among all types of laparoscopic operations, with rates reported as high as 23% in published series (Ann Surg. 2016;263:761-77). “More importantly, preliminary database analysis and large series review suggested an association between conversion and higher morbidity and mortality,” the study noted.
The purpose of the systematic review was to better understand reasons for conversion from robotic to open in liver resections, Dr. Gheza and his coauthors said. They noted a study of 2,861 laparoscopic resections reported that more than one-third of patients were converted for bleeding, and almost one-fifth (18.9%) for peritoneal adhesions (Ann Surg. 2017;268:1051-7). “In the whole literature on hepatic robotic surgery, no conversion due to adhesion was reported,” Dr. Gheza and his coauthors said.
A subanalysis of nine series that included both robotic (360 patients) and laparoscopic (462 patients) surgeries found conversion rates of 2.5% vs. 8%, respectively (P less than .01).
Dr. Gheza and his coauthors called for a prospective trial to further define the impact of robotic surgery on conversions, but the clinical implications of conversions to open surgery in minimally invasive hepatic surgery remain unclear.
Dr. Gheza disclosed relationships with Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
SOURCE: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018; doi:10.1002/rcs.1976.
FROM THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY
Key clinical point: Robotic liver resection has the potential to lower conversion rates.
Major finding: The conversion rate in robot-assisted liver resection was 4.8%.
Study details: Systematic review of 29 series of 1,091 robot-assisted liver resections published from 2009 to 2017, including the authors’ own cohort of 139 consecutive patients from May 2007 to September 2017.
Disclosures: Dr. Gheza disclosed being a consultant for Medtronic. Coauthor P. C. Giulianotti, MD, reported financial relationships with Intuitive, Covidien/Medtronic and Ethicon/Johnson & Johnson. The other coauthors had no relationships to disclose.
Source: Gheza F et al. Intl J Med Robotics Comp Assisted Surg. 2018. doi: 10.1002/rcs.1976.
Clinical trial: The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma trial is an interventional study recruiting patients with human papillomavirus (HPV)–positive oropharyngeal cancer.
Patients who are recruited will undergo robotic surgery after being screened for poor prognosis. Patients with good prognosis will be followed without receiving postoperative radiation. Those in this group who experience a recurrence will receive either more surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognosis will receive reduced-dose radiotherapy or chemoradiotherapy based on pathology.
Few trials have examined deescalation using surgery alone in intermediate- and early-stage HPV-positive cancer, the investigators noted, adding that they expect more than half of participants will undergo curative treatment with surgery alone and that withholding radiation in these patients will not noticeably affect their long-term survival.
Patients are eligible for the study if they have early- or intermediate-stage, resectable, HPV-positive oropharyngeal cancer. Patients must be at aged at least 18 years; cannot be pregnant; cannot have active alcohol addiction or tobacco usage; must have adequate bone marrow, hepatic, and renal functions; have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; have a limiting serious illness; and have had previous surgery, radiation therapy, or chemotherapy for squamous cell carcinoma other than biopsy or tonsillectomy.
The primary outcome measures of the study are disease-free survival and local regional control after 3 and 5 years. Secondary outcome measures include overall survival, toxicity rates, quality of life outcomes after 3 and 5 years, and local regional control after 5 years.
Recruitment for the study ends in March 2019. About 200 people are expected to be included in the final analysis.
Find more information on the study page at Clinicaltrials.gov.
QOL is poorer for young women after mastectomy than BCS
SAN ANTONIO – , according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.
Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.
“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”
Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.
“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
Moving away from mastectomy
“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.
“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”
The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
Study details
The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)
Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).
Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).
Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).
The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.
Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.
“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”
Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.
SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,
SAN ANTONIO – , according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.
Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.
“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”
Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.
“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
Moving away from mastectomy
“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.
“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”
The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
Study details
The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)
Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).
Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).
Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).
The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.
Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.
“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”
Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.
SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,
SAN ANTONIO – , according to investigators for a multicenter cross-sectional cohort study reported at the San Antonio Breast Cancer Symposium.
Women aged 40 or younger make up about 7% of all newly diagnosed cases of breast cancer in the United States, according to lead author, Laura S. Dominici, MD, of Dana-Farber/Brigham and Women’s Cancer Center and Harvard Medical School, Boston.
“Despite the fact that there is equivalent local-regional control with breast conservation and mastectomy, the rates of mastectomy and particularly bilateral mastectomy are increasing in young women, with a 10-fold increase seen from 1998 to 2011,” she noted in a press conference. “Young women are at particular risk for poorer psychosocial outcomes following a breast cancer diagnosis and in survivorship. However, little is known about the impact of surgery, particularly in the era of increasing bilateral mastectomy, on the quality of life of young survivors.”
Nearly three-fourths of the 560 young breast cancer survivors studied had undergone mastectomy, usually with some kind of reconstruction. Roughly 6 years later, compared with peers who had undergone breast-conserving surgery, women who had undergone unilateral or bilateral mastectomy had significantly poorer adjusted BREAST-Q scores for satisfaction with the appearance and feel of their breasts (beta, –8.7 and –9.3 points) and psychosocial well-being (–8.3 and –10.5 points). The latter also had poorer adjusted scores for sexual well-being (–8.1 points). Physical well-being, which captures aspects such as pain and range of motion, did not differ significantly by type of surgery.
“Local therapy decisions are associated with a persistent impact on quality of life in young breast cancer survivors,” Dr. Dominici concluded. “Knowledge of the potential long-term impact of surgery and quality of life is of critical importance for counseling young women about surgical decisions.”
Moving away from mastectomy
“The data are, to me anyway, more disconcerting when you consider the high mastectomy rate in this country relative to Europe, and this urge to have bilateral mastectomies, which, pardon the expression, is ridiculous in some cases because it doesn’t improve your outcome. And yet, it does have deleterious effects that last for years psychologically,” commented SABCS codirector and press conference moderator C. Kent Osborne, MD, who is director of the Dan L. Duncan Cancer Center at Baylor College of Medicine, Houston. “What can we do about that?” he asked.
“It’s a really challenging problem,” Dr. Dominici replied. “Part of what we are missing in the conversation that we have with our patients is this kind of information. We can certainly tell patients that the outcomes are equivalent, but if they don’t know that the long-term [quality of life] impact is potentially worse, then that may not affect their decision. The more prospective data that we generate to help us figure out which patients are going to have better or worse outcomes with these different types of surgery, the better we will be able to counsel patients with things that will be meaningful to them in the long run.”
The study was not designed to tease out the specific role of anxiety about a recurrence or a new breast cancer, which is a major driver of the decision to have mastectomy and also needs to be addressed during counseling, Dr. Dominici and Dr. Osborne agreed. “I think I spend more time talking patients out of bilateral mastectomy or mastectomy at all than anything,” he commented.
Study details
The women studied were participants in the prospective Young Women’s Breast Cancer Study (YWS) and had a mean age of 37 years at diagnosis. Most (86%) had stage 0-2 breast cancer. (Those with metastatic disease at diagnosis or a recurrence during follow-up were excluded.)
Overall, 52% of the women underwent bilateral mastectomy, 20% underwent unilateral mastectomy, and 28% underwent breast-conserving surgery, Dr. Dominici reported. Within the mastectomy group, most underwent implant-based reconstruction (69%) or flap reconstruction (12%), while some opted for no reconstruction (11%).
Multivariate analyses showed that, in addition to mastectomy, other significant predictors of poorer breast satisfaction were receipt of radiation therapy (beta, –7.5 points) and having a financially uncomfortable status as compared with a comfortable one (–5.4 points).
Additional significant predictors of poorer psychosocial well-being were receiving radiation (beta, –6.0 points), being financially uncomfortable (–7 points), and being overweight or obese (–4.2 points), and additional significant predictors of poorer sexual well-being were being financially uncomfortable (–6.8 points), being overweight or obese (–5.3 points), and having lymphedema a year after diagnosis (–3.8 points).
The only significant predictors of poorer physical health were financially uncomfortable status (beta, –4.8 points) and lymphedema (–6.4 points), whereas longer time since surgery (more than 5 years) predicted better physical health (+6.0 points), according to Dr. Dominici.
Age, race, marital status, work status, education level, disease stage, chemotherapy, and endocrine therapy did not significantly predict any of the outcomes studied.
“This was a one-time survey of women who were enrolled in an observational cohort study, and we know that preoperative quality of life likely drives surgical choices,” she commented, addressing the study’s limitations. “Our findings may have limited generalizability to a more diverse population in that the majority of our participants were white and of high socioeconomic status.”
Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.
SOURCE: Dominici LS et al. SABCS 2018, Abstract GS6-06,
REPORTING FROM SABCS 2018
Key clinical point: More extensive breast surgery has a long-term negative impact on QOL for young breast cancer survivors.
Major finding: Compared with peers who underwent breast-conserving surgery, young women who underwent unilateral or bilateral mastectomy had significantly poorer adjusted scores for breast satisfaction (beta, –8.7 and –9.3 points) and psychosocial well-being (beta, –8.3 and –10.5 points).
Study details: A multicenter cross-sectional cohort study of 560 women with a mean age of 37 years at breast cancer diagnosis who completed the BREAST-Q questionnaire a median of 5.8 years later.
Disclosures: Dr. Dominici disclosed that she had no conflicts of interest. The study was funded by the Agency for Healthcare Research and Quality, Susan G. Komen, the Breast Cancer Research Foundation, and The Pink Agenda.
Source: Dominici LS et al. SABCS 2018, Abstract GS6-06.
Expert panel publishes consensus on robotic TME
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
in an effort to establish uniform training and education and improve outcomes for the robotic operations.
“The aim of this consensus study was to establish a detailed description of technical steps for robotic anterior resection and TME of the rectum as recommended by a representative group of established European expert surgeons,” wrote Danilo Miskovic, PhD, FRCS, of St. Mark’s Hospital in London, and his coauthors. The study, published in Colorectal Disease, provides a baseline for technical standards and structured training in robotic rectal surgery.
The consensus authors acted at the behest of the European Academy for Robotic Colorectal Surgery (EARCS), a nonprofit organization that provides training for robotic colorectal surgery. They cited evidence suggesting that the robotic approach to TME confers significant benefits in selected patients, compared with laparoscopic surgery (Dis Colon Rectum. 2014;57:570-7), but that the ROLARR trial found no benefit with robotic surgery (Int J Colorectal Dis. 2012;27:233-41).
“Notwithstanding the absence of evidence, robotic surgery continues to increase in popularity in many countries,” Dr. Miskovic and his coauthors wrote.
The consensus statement covers recommendations for the da Vinci Si and Xi robotic platforms in the following areas.
- Surgical setup, including patient positioning and port placement and docking.
- Colonic mobilization, including vascular pedicle dissection and splenic flexure mobilization.
- Pelvic dissection, including establishing operative planes and specimen extraction.
Dr. Miskovic and his coauthors arrived at the consensus statement by asking 24 EARCS faculty members to complete a 72-item questionnaire. The initial responses yielded an 87% agreement among the responses, but after suggested modifications, the average level of agreement for all items was 97%.
One of the limitations of the study that the investigators acknowledged is that it covers only two da Vinci robotic platforms; the recommendations may not apply to new robotic systems. Secondly, a selected group of experts provided input. “There may be other experienced surgeons who might disagree with some aspects of our recommendations,” the authors wrote. “This document should therefore be seen as a foundation for debate and modification in light of future technical developments.”
Future research should evaluate how training of technical standards within a group like EARCS impacts clinical outcomes, Dr. Miskovic and his coauthors noted.
The investigators had no financial relationships to report. Participating surgeons are members of the EARCS faculty and/or its scientific committee
SOURCE: Miskovic D et al. Colorectal Dis. 2018 Nov 29. doi: 10.1111/codi.14502.
FROM COLORECTAL DISEASE
Recommended reading: Board picks the ‘best of 2018’
Recommended Reading lists have been over the years among the most popular features in this publication. It is therefore fitting that for this last issue of ACS Surgery News, we have once again imposed upon our Editorial Advisory Board to come up with their choice of the most important studies published in 2018. They were asked to choose a few studies that they consider most significant in their subspecialties and to explain why these studies should matter to all surgeons.
Some editorial advisers for some publications fill honorary positions with no real responsibility or work involved. Not so for the Editorial Advisory Board of ACS Surgery News. Each member provided a steady stream of commentaries, recommendations, and advice. The publication and the managing editor would have been lost without their kind and willing assistance. In their busy professional lives, they somehow found the time to contribute their expertise to assist their colleagues and their profession. We all owe them a debt of gratitude for their many years of service.
We hope our readers will find the list and the comments of interest.
Otolaryngology
St. Laurent J et al. HPV vaccination and the effects on rates of HPV-related cancers. Curr Probl Cancer 2018; https://doi.org/10.1016/j.currproblcancer.2018.06.004
As a head and neck surgeon over the past 30+ years, I have seen the dramaticrise of one form of HPV-related cancer in the United States, namely, HPV-associated oropharyngeal cancer. This is a true epidemic. It is also a cancer that may well be preventable through vaccination. We have slowly made progress over the past 4 decades in reducing the number of tobacco- and alcohol-related cancers. Here is another cancer that truly falls within the category of a public health problem for which public health solution of vaccination is clearly the most rational approach. Everyone should be aware of these virally induced cancers and what can be done to prevent them. This article presents the “state of the art” knowledge about these cancers and what we can hopefully accomplish through worldwide public health initiatives.
Mark C. Weissler, MD, FACS
Palliative Care
Kopecky KE et al. Third-year medical students’ reactions to surgical patients in pain: Doubt, distress, and depersonalization. J Pain and Symptom Manage. 2018;56(5):719-26.
This insightful study done by surgeons, two of them possessing palliative care and bioethics expertise, is a qualitative analysis of the content of 341 essays written by third-year medical students who described their experiences with surgical patients in pain. Students found it difficult to reconcile patient suffering with the therapeutic objective of treatment. As a result they learned constrained empathy and preference for technical solutions and because they feared an empathic response to pain might compromise the fortitude and efficiency required to be a doctor they pursued strategies to distance themselves from these feelings. The authors note, “Although doctors frequently interact with patients who have serious emotional and physical pain, few have received formal instruction on how to attend to these needs or developed a personal approach to cope with the tragedy of patient illness. Instead, the physician’s response to patients in pain is learned passively and perpetuated through generations. Students now seek to suppress empathy to get the job done. These observations have important implications for physicians, patients, and educators.” For me the study is like a parachute flare illuminating the landscape of early surgical educational experience during which the seeds for future problems such as lost patient trust and burnout are sown. It offers the hope that structured introspective activities may mitigate this.
Su A et al. Beyond pain: Nurses’ assessment of patient suffering, dignity, and dying in the intensive care unit. J Pain Symptom Manage. 2018;55:1591-98.
After reading this sobering study, my reaction was, “If the gold rusts what will happen to the iron?” In this study using chart abstraction, nurses caring for 200 patients in a tertiary care cardiac ICU and a surgical ICU were interviewed about their assessment and perception of the physical and psychosocial dimensions of ICU patients’ experiences in their final week of life. The authors note that nursing symptom assessments have been previously shown to be highly reliable and end-of-life comfort and dignity have been shown to be compatible with ICU level of care. Despite this and the availability of extensive interdisciplinary support from palliative care teams, chaplains, and social workers, dying ICU patients are perceived by nurses to experience extreme indignities and suffer beyond physical pain. The study found that attention to symptoms such as dyspnea and edema might improve the quality of death in the ICU. It is small wonder that moral fatigue and burnout have become prevalent themes of ICU caring.
Balboni T et al. The spiritual event of serious illness. J Pain Symptom Manage. 2018;56(5):816-22.
An ashen-faced dear friend gently reminded me as he was hemorrhaging from an advanced gastric cancer, “Geoff, lets make this a spiritual event, not a medical one.” This paper conjured up this memory with the thoughtful, in-depth account and analysis of patients’ experiences and attitudes that shaped the authors concept of illness as a spiritual event. The idea of spirituality as a basic component of consciousness, especially as it relates to suffering, has been present from the very beginning of modern palliative care and can be traced back to the concept of “total pain” introduced by Dame Cicely Saunders in 1963. The capacity to reframe biophysical calamity as spiritual opportunity is the signature of the most skilled and adroit supportive care we can offer our patients and their families.
Geoffrey P. Dunn, MD, FACS
Colorectal Surgery
Cercek A et al. Adoption of total neoadjuvant therapy for locally advanced rectal cancer. JAMA Oncol. 2018;4(6):e180071. doi:10.1001/jamaoncol.2018.0071.
This moderate sized retrospective study demonstrates a single-institution’s experience with total neoadjuvant therapy (TNT) with chemoradiation and chemotherapy as opposed to traditional chemoradiation, surgery, and chemotherapy in patients with locally advanced rectal cancer. They demonstrate equivalent or potentially better outcomes including better complete response rate – 36% versus 21% and rates of chemotherapy completion. While further studies are needed to understand long term outcomes, this study support the use of TNT for locally advanced rectal cancer as now supported by the National Comprehensive Cancer Network guidelines.
Brouquet A et al. Anti-TNF therapy is associated with an increased risk of postoperative morbidity after surgery for ileocolonic Crohn disease: Results of a prospective nationwide cohort. Ann Surg. 2018 Feb;267(2):221-228. doi: 10.1097/SLA.0000000000002017.
This large prospective study of almost 600 consecutive Crohn’s disease patients with surgery at 19 French specialty centers demonstrates that anti-TNF therapy less than 3 months prior to ileocolic surgery to be an independent risk factor of the overall postoperative morbidity, preoperative hemoglobin less than10 g/dL, operative time more than180 min, and recurrent Crohn’s disease, as well as a higher risk of overall and intra-abdominal septic postoperative morbidities.
Howard R et al. Taking control of your surgery: Impact of a prehabilitation program on major abdominal surgery. J Am Coll Surg. 2018 Oct 22; https://doi.org/10.1016/j.jamcollsurg.2018.09.018
Results from the Michigan Surgical and Health Optimization Program (MSHOP) are reported in colectomy patients. This prehabilitation program engages patients in four activities before surgery: physical activity, pulmonary rehabilitation, nutritional optimization, and stress reduction. MSHOP patients were matched to emergency and elective, non-MSHOP patients. Overall, 70% of MSHOP patients complied with the program. MSHOP patients were more likely to have improved blood pressure and heart rate intraoperatively, reduction in Clavien-Dindo class 3-4 complications in the MSHOP group (30%), compared with the nonprehabilitation (38%) and emergency (48%) groups (P = .05), as well as average savings of $21,946 per patient.
Genevieve Melton-Meaux, MD, PhD, FACS
Bariatric Surgery
Kalff MC et al. Diagnostic value of computed tomography for detecting anastomotic or staple line leakage after bariatric surgery. Surg Obes Relat Dis. 2018;14(9):1310-16
The most dreaded complication in the current era of metabolic and bariatric surgery, from a technical point of view, remains an anastomotic or staple-line leak. The authors present their findings corresponding to a multivariable regression analysis of a retrospective review of all CT abdomen and pelvis scans conducted from November 2007 to August 2016 at their large teaching hospital and Bariatric Center of Excellence. A CT is especially useful at ruling out low-suspicion cases of leaks, when the surgeon is trying to decide if a diagnostic laparoscopy is indicated, with a sensitivity of 90%-100%, and a negative predictive value of 97%-100%. A negative CT scan is highly accurate for ruling out a leak, especially in those patients without co-existing tachycardia and tachypnea. With caution based on clinical expertise, it may serve to prevent unnecessary diagnostic laparoscopy when appropriately indicated.
Alizadeh RF et al. Risk factors for gastrointestinal leak after bariatric surgery: MBSAQIP analysis. J Am Coll Surg. 2018;227(1):135-141.
The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) 2015 database of accredited centers was the object of study. Multivariate logistic regression analysis was used to examine risk factors for GI leaks that are not typically included in similar studies. Of particular interest is finding that Roux-en-Y gastric bypass comes with a higher risk for leak, compared with a sleeve gastrectomy, but with an overall leak rate for both of 0.7% based on current results. In addition, the study found that use of an intraoperative provocative leak test and placement of a surgical drain are associated with a higher leak rate. The same is not true of a postoperative swallow contrast study, which has no effect on the incidence of leaks.
Altieri MS et al. Evaluation of VTE prophylaxis and the impact of alternate regimens on post-operative bleeding and thrombotic complications following bariatric procedures. Surg Endosc. 2018;32(12):4805-4812.
The field of venous thromboembolism prevention after bariatric surgery remains a challenging one due to the lack of consensus among surgeons. This study analyzes the Cerner Health Facts database from 2003 to 2013, particularly with ICD-9 codes, for patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy. While the authors confirm the statement that there is a lack of consistency and, therefore, there is ample variability among bariatric centers and surgeons, the use of postoperative VTE chemoprophylaxis leads to a lower incidence of VTE events, and less frequent bleeding episodes, compared with pre-operative chemoprophylaxis. Finally, mixed therapy using heparin and enoxaparin led to more bleeding complications and blood transfusion requirements.
Rodolfo J. Oviedo, MD, FACS, FASMBS
Cardiothoracic Surgery
Stone GW et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018 Sep 23; doi:10.1056/NEJMoa1806640.
This study, known as the COAPT trial, assessed the value of adding transcatheter mitral valve repair to best medical therapy for the treatment of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure. Not only was transcatheter mitral valve repair exceedingly safe (more than 96% freedom from device-related complications at 12 months), patients were hospitalized less for heart failure management and had lower all-cause mortality compared with best medical therapy alone. The results of the COAPT trial are an important step forward for transcatheter therapies, which are rapidly becoming an integral part of the treatment algorithms for structural heart disease.
Gaudino M et al. Radial-artery or saphenous-vein grafts in coronary-artery bypass surgery. N Engl J Med. 2018;378(22):2069-77.
This analysis of randomized trials comparing radial artery to saphenous vein grafts for coronary artery bypass surgery is quite possibly a practice-changing publication. Routine use of the left internal thoracic (mammary) artery is commonplace among cardiac surgeons; however, the debate over conduit choice for additional bypass grafts is a “tale as old as time.” This study, part of the RADIAL project, combined patient-level data from six trials in order to achieve adequate power to identify differences in clinical outcomes. The use of radial artery grafts as opposed to saphenous vein grafts was associated with less adverse cardiac events, a lower incidence of repeat revascularization, and a higher patency rate at 5 years. Although there was no difference in all-cause mortality, the results of this study support the use of radial artery grafts when additional conduits are needed in coronary artery bypass surgery.
Irving L. Kron, MD, FACS, and Eric J. Charles, MD, PhD
Vascular Surgery
Anand SS. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: An international, randomised, double-blind, placebo-controlled trial. Lancet 2018;391(10117):219-29.
This landmark study was terminated early due to a significant difference in outcomes. Prior to this point, aspirin and statins have been the mainstay of decreasing long-term adverse outcomes for patients with vascular disease. The COMPASS study has found a decrease in combined cardiovascular adverse events when rivaroxaban 2.5 mg was combined with low-dose aspirin in patients with stable PAD or CAD over aspirin alone. This is the first major change supporting use of additional medications for PAD in over 2 decades, when statins were found to impact outcomes. The differences were not impacted by gender, age, or race. Patients with end-tage renal disease were excluded, so it is unclear whether it would be beneficial in this population. The higher rate of bleeding, 3.1% vs 1.9%, was primarily GI, so caution should be used if patients are felt to be at increased risk of bleeding.
These findings suggest the need for a major change in the guidelines and management for the majority of our patients with PAD. Certainly we should look to add this data point to the Vascular Quality Initiative to gather further data and confirm the findings in real world use. It is unclear whether this benefit will be unique to rivaroxaban, or whether other Direct Xa inhibitors will have similar effects. I will certainly be adding ribaroxaban to patients at low risk for bleeding based on this data. Further, rivaroxaban alone did not reduce major cardiovascular adverse events, but did reduce major adverse limb events.
Gohel MS et al. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med. 2018;378:2105-14.
This multicenter study in the UK looked at over 450 patients with venous ulceration. Deep-venous reflux was also present in one-third of patients in each group. The median time to ulcer healing was decreased significantly from 82 days to 56 days. This study demonstrates the importance of early intervention for superficial reflux to enhance ulcer healing and decrease risk of recurrence. This study found that early endovenous ablation resulted in faster healing of venous ulcers, and more ulcer-free time than delayed intervention in patients treated with maximal medical therapy, including appropriate compression therapy. Previously, ablation was typically planned after ulcers healed to decrease risk of recurrence. Based on these findings, ablation should be offered to patients with nonhealing venous ulcers early in the course of therapy, in addition to standard wound care.
Linda Harris, MD, FACS
Surgical Education
Ellison EC. Ten-year reassessment of the shortage of general surgeons: Increases in graduation numbers of general surgery residents are insufficient to meet the future demand for general surgeons. Surgery. 2018 Oct;164(4):726-32.
Ellison EC et al. The impact of the aging population and incidence of cancer on future projections of general surgery workforce needs. Surgery. 2018 Mar;163(3):553-59.
In 2008, Ellison et al. projected that a deficit in the general surgery workforce would grow to 19% by 2050. The group recently re-examined this projection by reviewing Census Bureau data, the available pool of surgeons with both allopathic and osteopathic degrees and factored in the losses of new surgeons who subspecialize and older surgeons who retire every year. Their conclusion states that, without increasing future general surgeons training numbers, the projected future general surgery workforce shortage will continue to grow.
A second paper by the same group reviewed population and age-adjusted incidence of cancer to estimate the number of general surgeons needed for initial surgical treatment of the patient with cancer in the year 2035 compared with 2010. The total number of new patients with cancers treated by general surgeons is projected to increase 56% in that time span. This would require an increase of over 9,000 general surgeons over that based on current training numbers. Together, the papers predict that there will be an ever-increasing demand for general surgeons in the near future and that general surgeons, currently caring for over 50% of cancer patients in the US, will play an even more important role in surgical cancer treatment.
Michael D. Sarap, MD, FACS
General Surgery
Takada T. Tokyo Guidelines 2018 (TG18). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):1-2.
This is the updated set of guidelines, awaited since 2013, regarding treatment of acute cholecystitis and cholangitis, with updated management strategies from an international panel of experts. The most significant change, and considered overdue by some surgeons, is the modification of the management algorithm to propose that some patients with Grade III acute cholecystitis (severe cholecystitis with evidence of organ dysfunction) may be treated with immediate laparoscopic cholecystectomy, rather than percutaneous cholecystostomy, “when performed at advanced centers with specialized surgeons experienced in this procedure.” As cholecystectomy is the most common general surgery procedure in the United States, most community surgeons have expertise. Whether there is truly need of a specialized gallbladder surgeon at an advanced center to safely complete a laparoscopic cholecystectomy can still be debated. But the change in recommendation from the experts is welcome.
Acuna SA. Operative strategies for perforated diverticulitis: A systematic review and meta-analysis. Dis Colon Rectum. 2018 Dec; 61(12):1442-53.
This analysis of the literature considers the three predominant operations for Hinchey III and Hinchey IV perforated diverticulitis: Hartmann procedure, resection and primary anastomosis, and laparoscopic lavage. The importance of this review is that it considers the initial operation and the downstream procedures when determining overall morbidity and mortality. Laparoscopic lavage did not fare well in this review of randomized controlled trials, resulting in higher morbidity than resection in Hinchey III patients. Interestingly, none of the individual studies analyzed had shown a statistical difference, but in the meta-analysis, the number of patients was sufficient to show statistical significance. The other important conclusion was that primary resection with anastomosis (possibly with diverting ileostomy) was superior to Hartmann procedure, when the likelihood of stoma reversal and the morbidity of the second operation was taken into account.
Mark Savarise, MD, FACS
Foregut
Alicuben ET. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018; 22(8):1442-47.
Although magnetic sphincter augmentation of the lower esophageal sphincter initially appeared to provide excellent reflux control with essentially no risk of erosion, there have now been multiple reports throughout the world of device erosion over time. Fortunately, most erosions occurred with the smallest available device which is no longer on the market and the erosions currently being treated are usually done so with endoscopic/laparoscopic removal without the need for major esophageal resection.
Xiong YQ. Comparison of narrow-band imaging and confocal laser endomicroscopy for the detection of neoplasia in Barrett’s esophagus: A meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Feb;42(1):31-9.
The days of endoscopic screening and surveillance of patients at risk for the development of Barrett’s esophagus via four-quadrant biopsy every couple of centimeters are numbered. The use of confocal laser microscopy to provide accurate real-time visual data regarding the areas of interest in the esophagus is showing promise and gaining traction compared to standard biopsy techniques and narrow-band imaging.
Borbély Y. Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy. Surg Obes Relat Dis. 2018 May;14(5):611-5.
The development of GERD following sleeve gastrectomy is a real problem in a substantial minority of patients due to structural compromise of the lower esophageal sphincter during the procedure. Conversion to gastric bypass as a way to alleviate acid regurgitation has been the mainstay of treatment; however, many patients selected sleeve gastrectomy specifically because they did not want to undergo gastric bypass. For those patients a sleeve preserving procedure such as magnetic sphincter augmentation (currently in clinical trial), Hill procedure, or remnant gastric fundoplication are potential options. Electrical stimulation of the lower esophageal sphincter is revealing itself to be another exciting option (currently in clinical trial) which can be used in patients with as few as 30% peristaltic swallows thus expanding the treatment options for these deserving patients.
Kevin M. Reavis, MD, FACS
Trauma/Critical Care
Teixeira PGR et al. Civilian prehospital tourniquet use is associated with improved survival in patients with peripheral vascular injury . J Am Coll Surg. 2018;226(5):769-76.
The use of tourniquets for hemorrhage control in trauma patients has been widely condemned in the past because of concerns regarding complications and potential limb loss. However, evidence from liberal tourniquet use in combat situations documenting survival benefits has continued to accumulate. Prompt hemorrhage control in trauma patients, including the use of tourniquets where applicable, has been validated by recent combat zone studies but improved survival hasn’t yet been shown in the civilian setting. In this multicenter, retrospective study of 1,026 patients with peripheral vascular injuries, only a relatively small number (17.6%) had pre-hospital tourniquets applied, yet multivariable analysis showed a significant survival benefit (odds ratio, 5.86). Importantly, no difference was seen in delayed amputation rates, of approximately 1% in both groups. This study helps to emphasize the importance of the Stop the Bleed (STB) campaign which includes education on the effective and safe use of tourniquets for prehospital hemorrhage. The STB program offers surgeons the opportunity to educate members of their own communities in effective bystander first aid.
Pileggi C et al. Ventilator bundle and its effects on mortality among ICU patients: A meta-analysis. Crit Care Med. 2018;46(7):1167-74.
Critically ill patients requiring mechanical ventilation are at risk for a number of complications, including ventilator-associated pneumonia (VAP) (now a subset of ventilator-associated events (VAE) which prolong ventilator and ICU time and contribute to further complication. Ventilator “bundles,” incorporating simple measures such as elevation of the head of the bed; daily “sedation holidays”; and evaluation of readiness for extubation, peptic ulcer, and DVT prophylaxis have been widely used in ICUs for nearly 20 years. Effective implementation has also emphasized multidisciplinary teamwork. Reductions in ventilator-associated pneumonia (VAP) incidence have been widely demonstrated but mortality benefits have been inconsistent. In this meta-analysis of 13 studies, 6 in Europe, 6 in the US and 1 in Brazil, an overall reduction in mortality (odds ratio, 0.9) was demonstrated. The effect was even larger when limited to studies with patients with VAP (OR, 0.71). This study both validates the effectiveness of relatively simple and inexpensive measures and emphasizes the benefits of a team approach to the care of ICU patients.
Krista L. Kaups, MD, FACS
Recommended Reading lists have been over the years among the most popular features in this publication. It is therefore fitting that for this last issue of ACS Surgery News, we have once again imposed upon our Editorial Advisory Board to come up with their choice of the most important studies published in 2018. They were asked to choose a few studies that they consider most significant in their subspecialties and to explain why these studies should matter to all surgeons.
Some editorial advisers for some publications fill honorary positions with no real responsibility or work involved. Not so for the Editorial Advisory Board of ACS Surgery News. Each member provided a steady stream of commentaries, recommendations, and advice. The publication and the managing editor would have been lost without their kind and willing assistance. In their busy professional lives, they somehow found the time to contribute their expertise to assist their colleagues and their profession. We all owe them a debt of gratitude for their many years of service.
We hope our readers will find the list and the comments of interest.
Otolaryngology
St. Laurent J et al. HPV vaccination and the effects on rates of HPV-related cancers. Curr Probl Cancer 2018; https://doi.org/10.1016/j.currproblcancer.2018.06.004
As a head and neck surgeon over the past 30+ years, I have seen the dramaticrise of one form of HPV-related cancer in the United States, namely, HPV-associated oropharyngeal cancer. This is a true epidemic. It is also a cancer that may well be preventable through vaccination. We have slowly made progress over the past 4 decades in reducing the number of tobacco- and alcohol-related cancers. Here is another cancer that truly falls within the category of a public health problem for which public health solution of vaccination is clearly the most rational approach. Everyone should be aware of these virally induced cancers and what can be done to prevent them. This article presents the “state of the art” knowledge about these cancers and what we can hopefully accomplish through worldwide public health initiatives.
Mark C. Weissler, MD, FACS
Palliative Care
Kopecky KE et al. Third-year medical students’ reactions to surgical patients in pain: Doubt, distress, and depersonalization. J Pain and Symptom Manage. 2018;56(5):719-26.
This insightful study done by surgeons, two of them possessing palliative care and bioethics expertise, is a qualitative analysis of the content of 341 essays written by third-year medical students who described their experiences with surgical patients in pain. Students found it difficult to reconcile patient suffering with the therapeutic objective of treatment. As a result they learned constrained empathy and preference for technical solutions and because they feared an empathic response to pain might compromise the fortitude and efficiency required to be a doctor they pursued strategies to distance themselves from these feelings. The authors note, “Although doctors frequently interact with patients who have serious emotional and physical pain, few have received formal instruction on how to attend to these needs or developed a personal approach to cope with the tragedy of patient illness. Instead, the physician’s response to patients in pain is learned passively and perpetuated through generations. Students now seek to suppress empathy to get the job done. These observations have important implications for physicians, patients, and educators.” For me the study is like a parachute flare illuminating the landscape of early surgical educational experience during which the seeds for future problems such as lost patient trust and burnout are sown. It offers the hope that structured introspective activities may mitigate this.
Su A et al. Beyond pain: Nurses’ assessment of patient suffering, dignity, and dying in the intensive care unit. J Pain Symptom Manage. 2018;55:1591-98.
After reading this sobering study, my reaction was, “If the gold rusts what will happen to the iron?” In this study using chart abstraction, nurses caring for 200 patients in a tertiary care cardiac ICU and a surgical ICU were interviewed about their assessment and perception of the physical and psychosocial dimensions of ICU patients’ experiences in their final week of life. The authors note that nursing symptom assessments have been previously shown to be highly reliable and end-of-life comfort and dignity have been shown to be compatible with ICU level of care. Despite this and the availability of extensive interdisciplinary support from palliative care teams, chaplains, and social workers, dying ICU patients are perceived by nurses to experience extreme indignities and suffer beyond physical pain. The study found that attention to symptoms such as dyspnea and edema might improve the quality of death in the ICU. It is small wonder that moral fatigue and burnout have become prevalent themes of ICU caring.
Balboni T et al. The spiritual event of serious illness. J Pain Symptom Manage. 2018;56(5):816-22.
An ashen-faced dear friend gently reminded me as he was hemorrhaging from an advanced gastric cancer, “Geoff, lets make this a spiritual event, not a medical one.” This paper conjured up this memory with the thoughtful, in-depth account and analysis of patients’ experiences and attitudes that shaped the authors concept of illness as a spiritual event. The idea of spirituality as a basic component of consciousness, especially as it relates to suffering, has been present from the very beginning of modern palliative care and can be traced back to the concept of “total pain” introduced by Dame Cicely Saunders in 1963. The capacity to reframe biophysical calamity as spiritual opportunity is the signature of the most skilled and adroit supportive care we can offer our patients and their families.
Geoffrey P. Dunn, MD, FACS
Colorectal Surgery
Cercek A et al. Adoption of total neoadjuvant therapy for locally advanced rectal cancer. JAMA Oncol. 2018;4(6):e180071. doi:10.1001/jamaoncol.2018.0071.
This moderate sized retrospective study demonstrates a single-institution’s experience with total neoadjuvant therapy (TNT) with chemoradiation and chemotherapy as opposed to traditional chemoradiation, surgery, and chemotherapy in patients with locally advanced rectal cancer. They demonstrate equivalent or potentially better outcomes including better complete response rate – 36% versus 21% and rates of chemotherapy completion. While further studies are needed to understand long term outcomes, this study support the use of TNT for locally advanced rectal cancer as now supported by the National Comprehensive Cancer Network guidelines.
Brouquet A et al. Anti-TNF therapy is associated with an increased risk of postoperative morbidity after surgery for ileocolonic Crohn disease: Results of a prospective nationwide cohort. Ann Surg. 2018 Feb;267(2):221-228. doi: 10.1097/SLA.0000000000002017.
This large prospective study of almost 600 consecutive Crohn’s disease patients with surgery at 19 French specialty centers demonstrates that anti-TNF therapy less than 3 months prior to ileocolic surgery to be an independent risk factor of the overall postoperative morbidity, preoperative hemoglobin less than10 g/dL, operative time more than180 min, and recurrent Crohn’s disease, as well as a higher risk of overall and intra-abdominal septic postoperative morbidities.
Howard R et al. Taking control of your surgery: Impact of a prehabilitation program on major abdominal surgery. J Am Coll Surg. 2018 Oct 22; https://doi.org/10.1016/j.jamcollsurg.2018.09.018
Results from the Michigan Surgical and Health Optimization Program (MSHOP) are reported in colectomy patients. This prehabilitation program engages patients in four activities before surgery: physical activity, pulmonary rehabilitation, nutritional optimization, and stress reduction. MSHOP patients were matched to emergency and elective, non-MSHOP patients. Overall, 70% of MSHOP patients complied with the program. MSHOP patients were more likely to have improved blood pressure and heart rate intraoperatively, reduction in Clavien-Dindo class 3-4 complications in the MSHOP group (30%), compared with the nonprehabilitation (38%) and emergency (48%) groups (P = .05), as well as average savings of $21,946 per patient.
Genevieve Melton-Meaux, MD, PhD, FACS
Bariatric Surgery
Kalff MC et al. Diagnostic value of computed tomography for detecting anastomotic or staple line leakage after bariatric surgery. Surg Obes Relat Dis. 2018;14(9):1310-16
The most dreaded complication in the current era of metabolic and bariatric surgery, from a technical point of view, remains an anastomotic or staple-line leak. The authors present their findings corresponding to a multivariable regression analysis of a retrospective review of all CT abdomen and pelvis scans conducted from November 2007 to August 2016 at their large teaching hospital and Bariatric Center of Excellence. A CT is especially useful at ruling out low-suspicion cases of leaks, when the surgeon is trying to decide if a diagnostic laparoscopy is indicated, with a sensitivity of 90%-100%, and a negative predictive value of 97%-100%. A negative CT scan is highly accurate for ruling out a leak, especially in those patients without co-existing tachycardia and tachypnea. With caution based on clinical expertise, it may serve to prevent unnecessary diagnostic laparoscopy when appropriately indicated.
Alizadeh RF et al. Risk factors for gastrointestinal leak after bariatric surgery: MBSAQIP analysis. J Am Coll Surg. 2018;227(1):135-141.
The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) 2015 database of accredited centers was the object of study. Multivariate logistic regression analysis was used to examine risk factors for GI leaks that are not typically included in similar studies. Of particular interest is finding that Roux-en-Y gastric bypass comes with a higher risk for leak, compared with a sleeve gastrectomy, but with an overall leak rate for both of 0.7% based on current results. In addition, the study found that use of an intraoperative provocative leak test and placement of a surgical drain are associated with a higher leak rate. The same is not true of a postoperative swallow contrast study, which has no effect on the incidence of leaks.
Altieri MS et al. Evaluation of VTE prophylaxis and the impact of alternate regimens on post-operative bleeding and thrombotic complications following bariatric procedures. Surg Endosc. 2018;32(12):4805-4812.
The field of venous thromboembolism prevention after bariatric surgery remains a challenging one due to the lack of consensus among surgeons. This study analyzes the Cerner Health Facts database from 2003 to 2013, particularly with ICD-9 codes, for patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy. While the authors confirm the statement that there is a lack of consistency and, therefore, there is ample variability among bariatric centers and surgeons, the use of postoperative VTE chemoprophylaxis leads to a lower incidence of VTE events, and less frequent bleeding episodes, compared with pre-operative chemoprophylaxis. Finally, mixed therapy using heparin and enoxaparin led to more bleeding complications and blood transfusion requirements.
Rodolfo J. Oviedo, MD, FACS, FASMBS
Cardiothoracic Surgery
Stone GW et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018 Sep 23; doi:10.1056/NEJMoa1806640.
This study, known as the COAPT trial, assessed the value of adding transcatheter mitral valve repair to best medical therapy for the treatment of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure. Not only was transcatheter mitral valve repair exceedingly safe (more than 96% freedom from device-related complications at 12 months), patients were hospitalized less for heart failure management and had lower all-cause mortality compared with best medical therapy alone. The results of the COAPT trial are an important step forward for transcatheter therapies, which are rapidly becoming an integral part of the treatment algorithms for structural heart disease.
Gaudino M et al. Radial-artery or saphenous-vein grafts in coronary-artery bypass surgery. N Engl J Med. 2018;378(22):2069-77.
This analysis of randomized trials comparing radial artery to saphenous vein grafts for coronary artery bypass surgery is quite possibly a practice-changing publication. Routine use of the left internal thoracic (mammary) artery is commonplace among cardiac surgeons; however, the debate over conduit choice for additional bypass grafts is a “tale as old as time.” This study, part of the RADIAL project, combined patient-level data from six trials in order to achieve adequate power to identify differences in clinical outcomes. The use of radial artery grafts as opposed to saphenous vein grafts was associated with less adverse cardiac events, a lower incidence of repeat revascularization, and a higher patency rate at 5 years. Although there was no difference in all-cause mortality, the results of this study support the use of radial artery grafts when additional conduits are needed in coronary artery bypass surgery.
Irving L. Kron, MD, FACS, and Eric J. Charles, MD, PhD
Vascular Surgery
Anand SS. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: An international, randomised, double-blind, placebo-controlled trial. Lancet 2018;391(10117):219-29.
This landmark study was terminated early due to a significant difference in outcomes. Prior to this point, aspirin and statins have been the mainstay of decreasing long-term adverse outcomes for patients with vascular disease. The COMPASS study has found a decrease in combined cardiovascular adverse events when rivaroxaban 2.5 mg was combined with low-dose aspirin in patients with stable PAD or CAD over aspirin alone. This is the first major change supporting use of additional medications for PAD in over 2 decades, when statins were found to impact outcomes. The differences were not impacted by gender, age, or race. Patients with end-tage renal disease were excluded, so it is unclear whether it would be beneficial in this population. The higher rate of bleeding, 3.1% vs 1.9%, was primarily GI, so caution should be used if patients are felt to be at increased risk of bleeding.
These findings suggest the need for a major change in the guidelines and management for the majority of our patients with PAD. Certainly we should look to add this data point to the Vascular Quality Initiative to gather further data and confirm the findings in real world use. It is unclear whether this benefit will be unique to rivaroxaban, or whether other Direct Xa inhibitors will have similar effects. I will certainly be adding ribaroxaban to patients at low risk for bleeding based on this data. Further, rivaroxaban alone did not reduce major cardiovascular adverse events, but did reduce major adverse limb events.
Gohel MS et al. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med. 2018;378:2105-14.
This multicenter study in the UK looked at over 450 patients with venous ulceration. Deep-venous reflux was also present in one-third of patients in each group. The median time to ulcer healing was decreased significantly from 82 days to 56 days. This study demonstrates the importance of early intervention for superficial reflux to enhance ulcer healing and decrease risk of recurrence. This study found that early endovenous ablation resulted in faster healing of venous ulcers, and more ulcer-free time than delayed intervention in patients treated with maximal medical therapy, including appropriate compression therapy. Previously, ablation was typically planned after ulcers healed to decrease risk of recurrence. Based on these findings, ablation should be offered to patients with nonhealing venous ulcers early in the course of therapy, in addition to standard wound care.
Linda Harris, MD, FACS
Surgical Education
Ellison EC. Ten-year reassessment of the shortage of general surgeons: Increases in graduation numbers of general surgery residents are insufficient to meet the future demand for general surgeons. Surgery. 2018 Oct;164(4):726-32.
Ellison EC et al. The impact of the aging population and incidence of cancer on future projections of general surgery workforce needs. Surgery. 2018 Mar;163(3):553-59.
In 2008, Ellison et al. projected that a deficit in the general surgery workforce would grow to 19% by 2050. The group recently re-examined this projection by reviewing Census Bureau data, the available pool of surgeons with both allopathic and osteopathic degrees and factored in the losses of new surgeons who subspecialize and older surgeons who retire every year. Their conclusion states that, without increasing future general surgeons training numbers, the projected future general surgery workforce shortage will continue to grow.
A second paper by the same group reviewed population and age-adjusted incidence of cancer to estimate the number of general surgeons needed for initial surgical treatment of the patient with cancer in the year 2035 compared with 2010. The total number of new patients with cancers treated by general surgeons is projected to increase 56% in that time span. This would require an increase of over 9,000 general surgeons over that based on current training numbers. Together, the papers predict that there will be an ever-increasing demand for general surgeons in the near future and that general surgeons, currently caring for over 50% of cancer patients in the US, will play an even more important role in surgical cancer treatment.
Michael D. Sarap, MD, FACS
General Surgery
Takada T. Tokyo Guidelines 2018 (TG18). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):1-2.
This is the updated set of guidelines, awaited since 2013, regarding treatment of acute cholecystitis and cholangitis, with updated management strategies from an international panel of experts. The most significant change, and considered overdue by some surgeons, is the modification of the management algorithm to propose that some patients with Grade III acute cholecystitis (severe cholecystitis with evidence of organ dysfunction) may be treated with immediate laparoscopic cholecystectomy, rather than percutaneous cholecystostomy, “when performed at advanced centers with specialized surgeons experienced in this procedure.” As cholecystectomy is the most common general surgery procedure in the United States, most community surgeons have expertise. Whether there is truly need of a specialized gallbladder surgeon at an advanced center to safely complete a laparoscopic cholecystectomy can still be debated. But the change in recommendation from the experts is welcome.
Acuna SA. Operative strategies for perforated diverticulitis: A systematic review and meta-analysis. Dis Colon Rectum. 2018 Dec; 61(12):1442-53.
This analysis of the literature considers the three predominant operations for Hinchey III and Hinchey IV perforated diverticulitis: Hartmann procedure, resection and primary anastomosis, and laparoscopic lavage. The importance of this review is that it considers the initial operation and the downstream procedures when determining overall morbidity and mortality. Laparoscopic lavage did not fare well in this review of randomized controlled trials, resulting in higher morbidity than resection in Hinchey III patients. Interestingly, none of the individual studies analyzed had shown a statistical difference, but in the meta-analysis, the number of patients was sufficient to show statistical significance. The other important conclusion was that primary resection with anastomosis (possibly with diverting ileostomy) was superior to Hartmann procedure, when the likelihood of stoma reversal and the morbidity of the second operation was taken into account.
Mark Savarise, MD, FACS
Foregut
Alicuben ET. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018; 22(8):1442-47.
Although magnetic sphincter augmentation of the lower esophageal sphincter initially appeared to provide excellent reflux control with essentially no risk of erosion, there have now been multiple reports throughout the world of device erosion over time. Fortunately, most erosions occurred with the smallest available device which is no longer on the market and the erosions currently being treated are usually done so with endoscopic/laparoscopic removal without the need for major esophageal resection.
Xiong YQ. Comparison of narrow-band imaging and confocal laser endomicroscopy for the detection of neoplasia in Barrett’s esophagus: A meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Feb;42(1):31-9.
The days of endoscopic screening and surveillance of patients at risk for the development of Barrett’s esophagus via four-quadrant biopsy every couple of centimeters are numbered. The use of confocal laser microscopy to provide accurate real-time visual data regarding the areas of interest in the esophagus is showing promise and gaining traction compared to standard biopsy techniques and narrow-band imaging.
Borbély Y. Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy. Surg Obes Relat Dis. 2018 May;14(5):611-5.
The development of GERD following sleeve gastrectomy is a real problem in a substantial minority of patients due to structural compromise of the lower esophageal sphincter during the procedure. Conversion to gastric bypass as a way to alleviate acid regurgitation has been the mainstay of treatment; however, many patients selected sleeve gastrectomy specifically because they did not want to undergo gastric bypass. For those patients a sleeve preserving procedure such as magnetic sphincter augmentation (currently in clinical trial), Hill procedure, or remnant gastric fundoplication are potential options. Electrical stimulation of the lower esophageal sphincter is revealing itself to be another exciting option (currently in clinical trial) which can be used in patients with as few as 30% peristaltic swallows thus expanding the treatment options for these deserving patients.
Kevin M. Reavis, MD, FACS
Trauma/Critical Care
Teixeira PGR et al. Civilian prehospital tourniquet use is associated with improved survival in patients with peripheral vascular injury . J Am Coll Surg. 2018;226(5):769-76.
The use of tourniquets for hemorrhage control in trauma patients has been widely condemned in the past because of concerns regarding complications and potential limb loss. However, evidence from liberal tourniquet use in combat situations documenting survival benefits has continued to accumulate. Prompt hemorrhage control in trauma patients, including the use of tourniquets where applicable, has been validated by recent combat zone studies but improved survival hasn’t yet been shown in the civilian setting. In this multicenter, retrospective study of 1,026 patients with peripheral vascular injuries, only a relatively small number (17.6%) had pre-hospital tourniquets applied, yet multivariable analysis showed a significant survival benefit (odds ratio, 5.86). Importantly, no difference was seen in delayed amputation rates, of approximately 1% in both groups. This study helps to emphasize the importance of the Stop the Bleed (STB) campaign which includes education on the effective and safe use of tourniquets for prehospital hemorrhage. The STB program offers surgeons the opportunity to educate members of their own communities in effective bystander first aid.
Pileggi C et al. Ventilator bundle and its effects on mortality among ICU patients: A meta-analysis. Crit Care Med. 2018;46(7):1167-74.
Critically ill patients requiring mechanical ventilation are at risk for a number of complications, including ventilator-associated pneumonia (VAP) (now a subset of ventilator-associated events (VAE) which prolong ventilator and ICU time and contribute to further complication. Ventilator “bundles,” incorporating simple measures such as elevation of the head of the bed; daily “sedation holidays”; and evaluation of readiness for extubation, peptic ulcer, and DVT prophylaxis have been widely used in ICUs for nearly 20 years. Effective implementation has also emphasized multidisciplinary teamwork. Reductions in ventilator-associated pneumonia (VAP) incidence have been widely demonstrated but mortality benefits have been inconsistent. In this meta-analysis of 13 studies, 6 in Europe, 6 in the US and 1 in Brazil, an overall reduction in mortality (odds ratio, 0.9) was demonstrated. The effect was even larger when limited to studies with patients with VAP (OR, 0.71). This study both validates the effectiveness of relatively simple and inexpensive measures and emphasizes the benefits of a team approach to the care of ICU patients.
Krista L. Kaups, MD, FACS
Recommended Reading lists have been over the years among the most popular features in this publication. It is therefore fitting that for this last issue of ACS Surgery News, we have once again imposed upon our Editorial Advisory Board to come up with their choice of the most important studies published in 2018. They were asked to choose a few studies that they consider most significant in their subspecialties and to explain why these studies should matter to all surgeons.
Some editorial advisers for some publications fill honorary positions with no real responsibility or work involved. Not so for the Editorial Advisory Board of ACS Surgery News. Each member provided a steady stream of commentaries, recommendations, and advice. The publication and the managing editor would have been lost without their kind and willing assistance. In their busy professional lives, they somehow found the time to contribute their expertise to assist their colleagues and their profession. We all owe them a debt of gratitude for their many years of service.
We hope our readers will find the list and the comments of interest.
Otolaryngology
St. Laurent J et al. HPV vaccination and the effects on rates of HPV-related cancers. Curr Probl Cancer 2018; https://doi.org/10.1016/j.currproblcancer.2018.06.004
As a head and neck surgeon over the past 30+ years, I have seen the dramaticrise of one form of HPV-related cancer in the United States, namely, HPV-associated oropharyngeal cancer. This is a true epidemic. It is also a cancer that may well be preventable through vaccination. We have slowly made progress over the past 4 decades in reducing the number of tobacco- and alcohol-related cancers. Here is another cancer that truly falls within the category of a public health problem for which public health solution of vaccination is clearly the most rational approach. Everyone should be aware of these virally induced cancers and what can be done to prevent them. This article presents the “state of the art” knowledge about these cancers and what we can hopefully accomplish through worldwide public health initiatives.
Mark C. Weissler, MD, FACS
Palliative Care
Kopecky KE et al. Third-year medical students’ reactions to surgical patients in pain: Doubt, distress, and depersonalization. J Pain and Symptom Manage. 2018;56(5):719-26.
This insightful study done by surgeons, two of them possessing palliative care and bioethics expertise, is a qualitative analysis of the content of 341 essays written by third-year medical students who described their experiences with surgical patients in pain. Students found it difficult to reconcile patient suffering with the therapeutic objective of treatment. As a result they learned constrained empathy and preference for technical solutions and because they feared an empathic response to pain might compromise the fortitude and efficiency required to be a doctor they pursued strategies to distance themselves from these feelings. The authors note, “Although doctors frequently interact with patients who have serious emotional and physical pain, few have received formal instruction on how to attend to these needs or developed a personal approach to cope with the tragedy of patient illness. Instead, the physician’s response to patients in pain is learned passively and perpetuated through generations. Students now seek to suppress empathy to get the job done. These observations have important implications for physicians, patients, and educators.” For me the study is like a parachute flare illuminating the landscape of early surgical educational experience during which the seeds for future problems such as lost patient trust and burnout are sown. It offers the hope that structured introspective activities may mitigate this.
Su A et al. Beyond pain: Nurses’ assessment of patient suffering, dignity, and dying in the intensive care unit. J Pain Symptom Manage. 2018;55:1591-98.
After reading this sobering study, my reaction was, “If the gold rusts what will happen to the iron?” In this study using chart abstraction, nurses caring for 200 patients in a tertiary care cardiac ICU and a surgical ICU were interviewed about their assessment and perception of the physical and psychosocial dimensions of ICU patients’ experiences in their final week of life. The authors note that nursing symptom assessments have been previously shown to be highly reliable and end-of-life comfort and dignity have been shown to be compatible with ICU level of care. Despite this and the availability of extensive interdisciplinary support from palliative care teams, chaplains, and social workers, dying ICU patients are perceived by nurses to experience extreme indignities and suffer beyond physical pain. The study found that attention to symptoms such as dyspnea and edema might improve the quality of death in the ICU. It is small wonder that moral fatigue and burnout have become prevalent themes of ICU caring.
Balboni T et al. The spiritual event of serious illness. J Pain Symptom Manage. 2018;56(5):816-22.
An ashen-faced dear friend gently reminded me as he was hemorrhaging from an advanced gastric cancer, “Geoff, lets make this a spiritual event, not a medical one.” This paper conjured up this memory with the thoughtful, in-depth account and analysis of patients’ experiences and attitudes that shaped the authors concept of illness as a spiritual event. The idea of spirituality as a basic component of consciousness, especially as it relates to suffering, has been present from the very beginning of modern palliative care and can be traced back to the concept of “total pain” introduced by Dame Cicely Saunders in 1963. The capacity to reframe biophysical calamity as spiritual opportunity is the signature of the most skilled and adroit supportive care we can offer our patients and their families.
Geoffrey P. Dunn, MD, FACS
Colorectal Surgery
Cercek A et al. Adoption of total neoadjuvant therapy for locally advanced rectal cancer. JAMA Oncol. 2018;4(6):e180071. doi:10.1001/jamaoncol.2018.0071.
This moderate sized retrospective study demonstrates a single-institution’s experience with total neoadjuvant therapy (TNT) with chemoradiation and chemotherapy as opposed to traditional chemoradiation, surgery, and chemotherapy in patients with locally advanced rectal cancer. They demonstrate equivalent or potentially better outcomes including better complete response rate – 36% versus 21% and rates of chemotherapy completion. While further studies are needed to understand long term outcomes, this study support the use of TNT for locally advanced rectal cancer as now supported by the National Comprehensive Cancer Network guidelines.
Brouquet A et al. Anti-TNF therapy is associated with an increased risk of postoperative morbidity after surgery for ileocolonic Crohn disease: Results of a prospective nationwide cohort. Ann Surg. 2018 Feb;267(2):221-228. doi: 10.1097/SLA.0000000000002017.
This large prospective study of almost 600 consecutive Crohn’s disease patients with surgery at 19 French specialty centers demonstrates that anti-TNF therapy less than 3 months prior to ileocolic surgery to be an independent risk factor of the overall postoperative morbidity, preoperative hemoglobin less than10 g/dL, operative time more than180 min, and recurrent Crohn’s disease, as well as a higher risk of overall and intra-abdominal septic postoperative morbidities.
Howard R et al. Taking control of your surgery: Impact of a prehabilitation program on major abdominal surgery. J Am Coll Surg. 2018 Oct 22; https://doi.org/10.1016/j.jamcollsurg.2018.09.018
Results from the Michigan Surgical and Health Optimization Program (MSHOP) are reported in colectomy patients. This prehabilitation program engages patients in four activities before surgery: physical activity, pulmonary rehabilitation, nutritional optimization, and stress reduction. MSHOP patients were matched to emergency and elective, non-MSHOP patients. Overall, 70% of MSHOP patients complied with the program. MSHOP patients were more likely to have improved blood pressure and heart rate intraoperatively, reduction in Clavien-Dindo class 3-4 complications in the MSHOP group (30%), compared with the nonprehabilitation (38%) and emergency (48%) groups (P = .05), as well as average savings of $21,946 per patient.
Genevieve Melton-Meaux, MD, PhD, FACS
Bariatric Surgery
Kalff MC et al. Diagnostic value of computed tomography for detecting anastomotic or staple line leakage after bariatric surgery. Surg Obes Relat Dis. 2018;14(9):1310-16
The most dreaded complication in the current era of metabolic and bariatric surgery, from a technical point of view, remains an anastomotic or staple-line leak. The authors present their findings corresponding to a multivariable regression analysis of a retrospective review of all CT abdomen and pelvis scans conducted from November 2007 to August 2016 at their large teaching hospital and Bariatric Center of Excellence. A CT is especially useful at ruling out low-suspicion cases of leaks, when the surgeon is trying to decide if a diagnostic laparoscopy is indicated, with a sensitivity of 90%-100%, and a negative predictive value of 97%-100%. A negative CT scan is highly accurate for ruling out a leak, especially in those patients without co-existing tachycardia and tachypnea. With caution based on clinical expertise, it may serve to prevent unnecessary diagnostic laparoscopy when appropriately indicated.
Alizadeh RF et al. Risk factors for gastrointestinal leak after bariatric surgery: MBSAQIP analysis. J Am Coll Surg. 2018;227(1):135-141.
The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) 2015 database of accredited centers was the object of study. Multivariate logistic regression analysis was used to examine risk factors for GI leaks that are not typically included in similar studies. Of particular interest is finding that Roux-en-Y gastric bypass comes with a higher risk for leak, compared with a sleeve gastrectomy, but with an overall leak rate for both of 0.7% based on current results. In addition, the study found that use of an intraoperative provocative leak test and placement of a surgical drain are associated with a higher leak rate. The same is not true of a postoperative swallow contrast study, which has no effect on the incidence of leaks.
Altieri MS et al. Evaluation of VTE prophylaxis and the impact of alternate regimens on post-operative bleeding and thrombotic complications following bariatric procedures. Surg Endosc. 2018;32(12):4805-4812.
The field of venous thromboembolism prevention after bariatric surgery remains a challenging one due to the lack of consensus among surgeons. This study analyzes the Cerner Health Facts database from 2003 to 2013, particularly with ICD-9 codes, for patients undergoing Roux-en-Y gastric bypass and sleeve gastrectomy. While the authors confirm the statement that there is a lack of consistency and, therefore, there is ample variability among bariatric centers and surgeons, the use of postoperative VTE chemoprophylaxis leads to a lower incidence of VTE events, and less frequent bleeding episodes, compared with pre-operative chemoprophylaxis. Finally, mixed therapy using heparin and enoxaparin led to more bleeding complications and blood transfusion requirements.
Rodolfo J. Oviedo, MD, FACS, FASMBS
Cardiothoracic Surgery
Stone GW et al. Transcatheter mitral-valve repair in patients with heart failure. N Engl J Med. 2018 Sep 23; doi:10.1056/NEJMoa1806640.
This study, known as the COAPT trial, assessed the value of adding transcatheter mitral valve repair to best medical therapy for the treatment of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure. Not only was transcatheter mitral valve repair exceedingly safe (more than 96% freedom from device-related complications at 12 months), patients were hospitalized less for heart failure management and had lower all-cause mortality compared with best medical therapy alone. The results of the COAPT trial are an important step forward for transcatheter therapies, which are rapidly becoming an integral part of the treatment algorithms for structural heart disease.
Gaudino M et al. Radial-artery or saphenous-vein grafts in coronary-artery bypass surgery. N Engl J Med. 2018;378(22):2069-77.
This analysis of randomized trials comparing radial artery to saphenous vein grafts for coronary artery bypass surgery is quite possibly a practice-changing publication. Routine use of the left internal thoracic (mammary) artery is commonplace among cardiac surgeons; however, the debate over conduit choice for additional bypass grafts is a “tale as old as time.” This study, part of the RADIAL project, combined patient-level data from six trials in order to achieve adequate power to identify differences in clinical outcomes. The use of radial artery grafts as opposed to saphenous vein grafts was associated with less adverse cardiac events, a lower incidence of repeat revascularization, and a higher patency rate at 5 years. Although there was no difference in all-cause mortality, the results of this study support the use of radial artery grafts when additional conduits are needed in coronary artery bypass surgery.
Irving L. Kron, MD, FACS, and Eric J. Charles, MD, PhD
Vascular Surgery
Anand SS. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: An international, randomised, double-blind, placebo-controlled trial. Lancet 2018;391(10117):219-29.
This landmark study was terminated early due to a significant difference in outcomes. Prior to this point, aspirin and statins have been the mainstay of decreasing long-term adverse outcomes for patients with vascular disease. The COMPASS study has found a decrease in combined cardiovascular adverse events when rivaroxaban 2.5 mg was combined with low-dose aspirin in patients with stable PAD or CAD over aspirin alone. This is the first major change supporting use of additional medications for PAD in over 2 decades, when statins were found to impact outcomes. The differences were not impacted by gender, age, or race. Patients with end-tage renal disease were excluded, so it is unclear whether it would be beneficial in this population. The higher rate of bleeding, 3.1% vs 1.9%, was primarily GI, so caution should be used if patients are felt to be at increased risk of bleeding.
These findings suggest the need for a major change in the guidelines and management for the majority of our patients with PAD. Certainly we should look to add this data point to the Vascular Quality Initiative to gather further data and confirm the findings in real world use. It is unclear whether this benefit will be unique to rivaroxaban, or whether other Direct Xa inhibitors will have similar effects. I will certainly be adding ribaroxaban to patients at low risk for bleeding based on this data. Further, rivaroxaban alone did not reduce major cardiovascular adverse events, but did reduce major adverse limb events.
Gohel MS et al. A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med. 2018;378:2105-14.
This multicenter study in the UK looked at over 450 patients with venous ulceration. Deep-venous reflux was also present in one-third of patients in each group. The median time to ulcer healing was decreased significantly from 82 days to 56 days. This study demonstrates the importance of early intervention for superficial reflux to enhance ulcer healing and decrease risk of recurrence. This study found that early endovenous ablation resulted in faster healing of venous ulcers, and more ulcer-free time than delayed intervention in patients treated with maximal medical therapy, including appropriate compression therapy. Previously, ablation was typically planned after ulcers healed to decrease risk of recurrence. Based on these findings, ablation should be offered to patients with nonhealing venous ulcers early in the course of therapy, in addition to standard wound care.
Linda Harris, MD, FACS
Surgical Education
Ellison EC. Ten-year reassessment of the shortage of general surgeons: Increases in graduation numbers of general surgery residents are insufficient to meet the future demand for general surgeons. Surgery. 2018 Oct;164(4):726-32.
Ellison EC et al. The impact of the aging population and incidence of cancer on future projections of general surgery workforce needs. Surgery. 2018 Mar;163(3):553-59.
In 2008, Ellison et al. projected that a deficit in the general surgery workforce would grow to 19% by 2050. The group recently re-examined this projection by reviewing Census Bureau data, the available pool of surgeons with both allopathic and osteopathic degrees and factored in the losses of new surgeons who subspecialize and older surgeons who retire every year. Their conclusion states that, without increasing future general surgeons training numbers, the projected future general surgery workforce shortage will continue to grow.
A second paper by the same group reviewed population and age-adjusted incidence of cancer to estimate the number of general surgeons needed for initial surgical treatment of the patient with cancer in the year 2035 compared with 2010. The total number of new patients with cancers treated by general surgeons is projected to increase 56% in that time span. This would require an increase of over 9,000 general surgeons over that based on current training numbers. Together, the papers predict that there will be an ever-increasing demand for general surgeons in the near future and that general surgeons, currently caring for over 50% of cancer patients in the US, will play an even more important role in surgical cancer treatment.
Michael D. Sarap, MD, FACS
General Surgery
Takada T. Tokyo Guidelines 2018 (TG18). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):1-2.
This is the updated set of guidelines, awaited since 2013, regarding treatment of acute cholecystitis and cholangitis, with updated management strategies from an international panel of experts. The most significant change, and considered overdue by some surgeons, is the modification of the management algorithm to propose that some patients with Grade III acute cholecystitis (severe cholecystitis with evidence of organ dysfunction) may be treated with immediate laparoscopic cholecystectomy, rather than percutaneous cholecystostomy, “when performed at advanced centers with specialized surgeons experienced in this procedure.” As cholecystectomy is the most common general surgery procedure in the United States, most community surgeons have expertise. Whether there is truly need of a specialized gallbladder surgeon at an advanced center to safely complete a laparoscopic cholecystectomy can still be debated. But the change in recommendation from the experts is welcome.
Acuna SA. Operative strategies for perforated diverticulitis: A systematic review and meta-analysis. Dis Colon Rectum. 2018 Dec; 61(12):1442-53.
This analysis of the literature considers the three predominant operations for Hinchey III and Hinchey IV perforated diverticulitis: Hartmann procedure, resection and primary anastomosis, and laparoscopic lavage. The importance of this review is that it considers the initial operation and the downstream procedures when determining overall morbidity and mortality. Laparoscopic lavage did not fare well in this review of randomized controlled trials, resulting in higher morbidity than resection in Hinchey III patients. Interestingly, none of the individual studies analyzed had shown a statistical difference, but in the meta-analysis, the number of patients was sufficient to show statistical significance. The other important conclusion was that primary resection with anastomosis (possibly with diverting ileostomy) was superior to Hartmann procedure, when the likelihood of stoma reversal and the morbidity of the second operation was taken into account.
Mark Savarise, MD, FACS
Foregut
Alicuben ET. Worldwide experience with erosion of the magnetic sphincter augmentation device. J Gastrointest Surg. 2018; 22(8):1442-47.
Although magnetic sphincter augmentation of the lower esophageal sphincter initially appeared to provide excellent reflux control with essentially no risk of erosion, there have now been multiple reports throughout the world of device erosion over time. Fortunately, most erosions occurred with the smallest available device which is no longer on the market and the erosions currently being treated are usually done so with endoscopic/laparoscopic removal without the need for major esophageal resection.
Xiong YQ. Comparison of narrow-band imaging and confocal laser endomicroscopy for the detection of neoplasia in Barrett’s esophagus: A meta-analysis. Clin Res Hepatol Gastroenterol. 2018 Feb;42(1):31-9.
The days of endoscopic screening and surveillance of patients at risk for the development of Barrett’s esophagus via four-quadrant biopsy every couple of centimeters are numbered. The use of confocal laser microscopy to provide accurate real-time visual data regarding the areas of interest in the esophagus is showing promise and gaining traction compared to standard biopsy techniques and narrow-band imaging.
Borbély Y. Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy. Surg Obes Relat Dis. 2018 May;14(5):611-5.
The development of GERD following sleeve gastrectomy is a real problem in a substantial minority of patients due to structural compromise of the lower esophageal sphincter during the procedure. Conversion to gastric bypass as a way to alleviate acid regurgitation has been the mainstay of treatment; however, many patients selected sleeve gastrectomy specifically because they did not want to undergo gastric bypass. For those patients a sleeve preserving procedure such as magnetic sphincter augmentation (currently in clinical trial), Hill procedure, or remnant gastric fundoplication are potential options. Electrical stimulation of the lower esophageal sphincter is revealing itself to be another exciting option (currently in clinical trial) which can be used in patients with as few as 30% peristaltic swallows thus expanding the treatment options for these deserving patients.
Kevin M. Reavis, MD, FACS
Trauma/Critical Care
Teixeira PGR et al. Civilian prehospital tourniquet use is associated with improved survival in patients with peripheral vascular injury . J Am Coll Surg. 2018;226(5):769-76.
The use of tourniquets for hemorrhage control in trauma patients has been widely condemned in the past because of concerns regarding complications and potential limb loss. However, evidence from liberal tourniquet use in combat situations documenting survival benefits has continued to accumulate. Prompt hemorrhage control in trauma patients, including the use of tourniquets where applicable, has been validated by recent combat zone studies but improved survival hasn’t yet been shown in the civilian setting. In this multicenter, retrospective study of 1,026 patients with peripheral vascular injuries, only a relatively small number (17.6%) had pre-hospital tourniquets applied, yet multivariable analysis showed a significant survival benefit (odds ratio, 5.86). Importantly, no difference was seen in delayed amputation rates, of approximately 1% in both groups. This study helps to emphasize the importance of the Stop the Bleed (STB) campaign which includes education on the effective and safe use of tourniquets for prehospital hemorrhage. The STB program offers surgeons the opportunity to educate members of their own communities in effective bystander first aid.
Pileggi C et al. Ventilator bundle and its effects on mortality among ICU patients: A meta-analysis. Crit Care Med. 2018;46(7):1167-74.
Critically ill patients requiring mechanical ventilation are at risk for a number of complications, including ventilator-associated pneumonia (VAP) (now a subset of ventilator-associated events (VAE) which prolong ventilator and ICU time and contribute to further complication. Ventilator “bundles,” incorporating simple measures such as elevation of the head of the bed; daily “sedation holidays”; and evaluation of readiness for extubation, peptic ulcer, and DVT prophylaxis have been widely used in ICUs for nearly 20 years. Effective implementation has also emphasized multidisciplinary teamwork. Reductions in ventilator-associated pneumonia (VAP) incidence have been widely demonstrated but mortality benefits have been inconsistent. In this meta-analysis of 13 studies, 6 in Europe, 6 in the US and 1 in Brazil, an overall reduction in mortality (odds ratio, 0.9) was demonstrated. The effect was even larger when limited to studies with patients with VAP (OR, 0.71). This study both validates the effectiveness of relatively simple and inexpensive measures and emphasizes the benefits of a team approach to the care of ICU patients.
Krista L. Kaups, MD, FACS
Clinical trial: Robotic or open radical cystectomy in treating patients with bladder cancer
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at Clinicaltrials.gov.
Texas judge strikes down ACA putting law in peril — again
The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.
Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.
“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”
The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”
The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.
“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”
It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.
It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.
The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.
In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.
The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.
The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.
President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”
But congressional leaders were quick to point out that the suit is far from over.
“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).
Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.
Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.
Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.
“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”
The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”
The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.
“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”
It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.
It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.
The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.
In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.
The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.
The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.
President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”
But congressional leaders were quick to point out that the suit is far from over.
“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).
Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.
Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
The future of the Affordable Care Act is threatened – again – this time by a ruling Friday from a federal district court judge in Texas.
Judge Reed C. O’Connor struck down the law, siding with a group of 18 Republican state attorneys general and two GOP governors who brought the case. Judge O’Connor said the tax bill passed by Congress in December 2017 effectively rendered the entire health law unconstitutional.
That tax measure eliminated the penalty for not having insurance. An earlier Supreme Court decision upheld the ACA based on the view that the penalty was a tax and thus the law was valid because it relied on appropriate power allowed Congress under the Constitution. Judge O’Connor’s decision said that without that penalty, the law no longer met that constitutional test.
“In some ways, the question before the court involves the intent of both the 2010 and 2017 Congresses,” Judge O’Connor wrote in his 55-page decision. “The former enacted the ACA. The latter sawed off the last leg it stood on.”
The decision came just hours before the end of open enrollment for ACA plans in most states that use the federal HealthCare.gov insurance exchange. It is not expected that the ruling will impact the coverage for those people – the final decision will likely not come until the case reaches the Supreme Court again.
Seema Verma, the administrator of the Centers for Medicare & Medicaid Services, which oversees those insurance exchanges, said in a tweet: “The recent federal court decision is still moving through the courts, and the exchanges are still open for business and we will continue with open enrollment. There is no impact to current coverage or coverage in a 2019 plan.”
The 16 Democratic state attorneys general who intervened in the case to defend the health law immediately vowed to appeal.
“The ACA has already survived more than 70 unsuccessful repeal attempts and withstood scrutiny in the Supreme Court,” said a statement from California Attorney General Xavier Becerra. “Today’s misguided ruling will not deter us: our coalition will continue to fight in court for the health and wellbeing of all Americans.”
It is all but certain the case will become the third time the Supreme Court decides a constitutional question related to the ACA. In addition to upholding the law in 2012, the court rejected another challenge to the law in 2015.
It is hard to overstate what would happen to the nation’s health care system if the decision is ultimately upheld. The Affordable Care Act touched almost every aspect of health care, from Medicare and Medicaid to generic biologic drugs, the Indian Health Service, and public health changes like calorie counts on menus.
The case, Texas v. United States, was filed in February. The plaintiffs argued that because the Supreme Court upheld the ACA in 2012 as a constitutional use of its taxing power, the elimination of the tax makes the rest of the law unconstitutional.
In June, the Justice Department announced it would not fully defend the law in court. While the Trump administration said it did not agree with the plaintiffs that the tax law meant the entire ACA was unconstitutional, it said that the provisions of the law guaranteeing that people with preexisting health conditions could purchase coverage at the same price as everyone else were so inextricably linked to the tax penalty that they should be struck.
The administration urged the court to declare those provisions invalid beginning Jan. 1, 2019. That is the day the tax penalty for not having insurance disappears.
The protections for people with preexisting conditions was one of the top health issues in the midterm elections in November. While the issue mostly played to the advantage of Democrats, one of the Republican plaintiffs, Missouri Attorney General Josh Hawley, defeated Democratic incumbent Sen. Claire McCaskill. Another plaintiff, West Virginia Attorney General Patrick Morrisey, lost to Democratic incumbent Sen. Joe Manchin.
President Donald Trump was quick to take a victory lap, and pressed Senate Majority Leader Mitch McConnell (R-Ky.) and presumed incoming House Speaker Nancy Pelosi (D-Calif.) to fix the problem. He tweeted Friday night that “As I predicted all along, Obamacare has been struck down as an UNCONSTITUTIONAL disaster! Now Congress must pass a STRONG law that provides GREAT healthcare and protects pre-existing conditions. Mitch and Nancy, get it done!”
But congressional leaders were quick to point out that the suit is far from over.
“The ruling seems to be based on faulty legal reasoning and hopefully it will be overturned,” said a statement from Senate Minority Leader Chuck Schumer (D-N.Y.).
Many legal experts agreed with that. “This is insanity in print, and it will not stand up on appeal,” tweeted University of Michigan Law School professor Nicholas Bagley, an expert in health law.
Even some conservatives were left scratching their heads. “Congress acted last year to repeal the mandate, but leave everything else in place and the courts should have deferred to that,” tweeted former congressional GOP aide Chris Jacobs.
Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.